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The Safecare Urinary Tract Infection Test is for the qualitative detection of Leukocytes (LEU,white blood cells) and nitrite (NIT) in urine as an aid in the screening of a Urinary Tract infection (UTI). It is intended for over-the-counter home use.

Urinary Tract Infection Test is in vitro diagnostic test device for qualitative detection of leukocyte and nitrite in urine. The device is composed of two-color pads aligned on a strip. One pad is employed for testing leukocyte and the other for nitrite by visually reading the color change of the pad and comparing with the corresponding blocks on a color chart. The Safecare Urinary Tract Infection Test are for the qualitative detection of Leukocytes (white blood cells) and nitrite in urine as an aid in the screening of a Urinary Tract infection (UTI). It is intended for over-the-counter home use only.

This document, particularly the "510(k) Summary" section, details the performance characteristics of the Safecare Urinary Tract Infection Test. While it doesn't present a formal "acceptance criteria" table in the typical sense of a pre-defined set of numerical thresholds for device performance, the data provided in the "Lay user Study" serves as the proof that the device meets the necessary performance for its intended use, especially for over-the-counter home use, by demonstrating high agreement with a predicate device.

Here's a breakdown of the requested information based on the provided text:

Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the agreement rates deemed acceptable for an over-the-counter device intended for screening, where high agreement with a physician-used predicate device signifies adequate performance for lay users. The study aimed to demonstrate that lay users could achieve results comparable to healthcare professionals using a predicate device.

Note: For the Leukocytes, "Agreement (+/- Color Block)" was 100% for all grades, indicating excellent performance when allowing for slight variations in visual interpretation around the color block, which is common in visual assays.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 154 lay users with UTI symptoms.
• Data Provenance: The document does not explicitly state the country of origin for the lay user study data. It was conducted at "Three (3) sites." Given the applicant is Safecare Biotech (Hangzhou) Co., Ltd. in China, it is plausible the study was conducted in China, though this is not confirmed. The study was prospective, as it involved recruiting participants to test their own urine samples in real-time.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: The ground truth was established by "healthcare professionals" using the predicate device. The exact number of individual healthcare professionals is not specified, but it implies a standard clinical practice setting where trained personnel perform the testing.
• Qualifications of Experts: They are referred to as "healthcare professionals." Their specific qualifications (e.g., medical technologists, nurses, physicians) and years of experience are not detailed in this summary.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The ground truth was established by "healthcare professionals using the predicate device." It appears to be a direct comparison between the lay user's result on the Safecare device and the healthcare professional's result on the predicate device, implying the predicate device's result, as performed by a healthcare professional, was taken as the reference.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This document describes a diagnostic test strip for visual interpretation (Urinary Tract Infection Test). It does not involve AI assistance or a comparison of human reader performance with and without AI. It focuses on the ability of lay users to correctly interpret the visual results compared to healthcare professionals using a predicate device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not Applicable. This device is a visual test strip intended for human (lay user) interpretation. There is no automated algorithm or standalone performance without human input.

7. The Type of Ground Truth Used

The ground truth for the lay user study was established by comparison to a legally marketed predicate device (Healgen URS Test Strips, K231045) as interpreted by healthcare professionals. This serves as a clinical reference standard for diagnostic performance in the context of this 510(k) submission.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of a machine learning model, as this is a traditional in-vitro diagnostic test strip. However, if "training set" refers to the data used for internal development, optimization, or early analytical studies, the following information is provided:

• Precision and Reproducibility Study: "A total of forty-five (45) assays results on each of eight levels of control were obtained." This involved three (3) clinical sites, two (2) operators per site, three (3) replicate assays over five (5) days.
• Analytical Specificity Interference: "Potentially interfering substances were added to negative urine with different leukocyte and nitrite concentrations. These samples were tested with three lots of the Safecare Urinary Tract by three different operators (one operator per lot)."
• Assay Cut-off/Sensitivity Study: "Urine samples were spiked to known concentrations of each analyte. These samples were then diluted to the lowest positive concentrations...Each sample was tested in 30 replicates with three (3) different operators."

These analytical studies use controlled samples and protocols to define the device's inherent performance characteristics, prior to the lay user study which demonstrates real-world applicability.

9. How the Ground Truth for the Training Set Was Established

For the analytical studies (which might be considered analogous to a "training/development" phase for traditional IVDs):

• Precision and Reproducibility: Ground truth involved preparing "eight levels of control" which are presumably well-characterized, spiked samples with known concentrations.
• Analytical Specificity Interference: Ground truth involved "negative urine with different leukocyte and nitrite concentrations" and then spiking them with "potentially interfering substances" at known concentrations.
• Assay Cut-off/Sensitivity: Ground truth involved "Urine samples...spiked to known concentrations of each analyte." This means the true concentration of the analytes was known by design. Readings were taken by multiple operators and likely compared against these known concentrations to define the lower limits of detection and appropriate cut-offs.

In summary, the "ground truth" for the analytical and development phases was established through controlled laboratory experiments using precisely prepared and characterized samples with known analyte concentrations.

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SAFECARE Fentanyl Urine Test Cassette is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of fentanyl in human urine at the cutoff concentrations of 1 ng/mL. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. The test is intended for over-the-counter use and for in vitro diagnostic use only.

The SAFECARE Fentanyl Urine Tests are immunoassays intended for the qualitative detection of fentanyl in human urine. Each SAFECARE Fentanyl Urine Test device consists of a Test Cassette, a Dropper and a package insert. Each Test Cassette is sealed with sachets of desiccant in an aluminum pouch.

Here's a breakdown of the acceptance criteria and the study details for the SAFECARE Fentanyl Urine Test Cassette, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" percentages (e.g., "must achieve X% sensitivity"). Instead, it presents performance data that implies the device met sufficient standards for clearance. The "performance" column below summarizes the key findings.

• 39/40 (97.5%) agreement for Negative/Low Negative/Near Cutoff Negative.
• 38/40 (95%) agreement for Near Cutoff Positive/High Positive.
• Discordant (1 positive at 0.985 ng/mL LC/MS; 2 negative at 1.055 and 1.097 ng/mL LC/MS).
  Operator 2:
• 40/40 (100%) agreement for Negative/Low Negative/Near Cutoff Negative.
• 39/40 (97.5%) agreement for Near Cutoff Positive/High Positive.
• Discordant (2 positive at 0.954 and 0.993 ng/mL LC/MS; 1 negative at 1.055 ng/mL LC/MS).
  Operator 3:
• 40/40 (100%) agreement for Negative/Low Negative/Near Cutoff Negative.
• 39/40 (97.5%) agreement for Near Cutoff Positive/High Positive.
• Discordant (2 positive at 0.980 and 0.985 ng/mL LC/MS; 1 negative at 1.055 ng/mL LC/MS). |
  | Lay-User Study | High percentage of correct results by lay users when following instructions, particularly for concentrations clearly below or above the cutoff. User instructions should be easily understood. | Correct result percentages: 100% for -100%, -75%, -50% cutoff; 95% for -25% cutoff; 100% for +25%, +50%, +75% cutoff. All lay users indicated instructions were easily followed. Flesch-Kincaid score indicated reading grade level

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SAFECARE® Multi-Drug Urine Test Dip Card is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline d-Propoxyphene and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) in human urine at the cutoff concentrations of:

Configuration of SAFECARE® Multi-Drug Urine Test Dip Card can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

The tests are intended for over-the-counter use.

SAFECARE® Multi-Drug Urine Test Cup is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine. Oxazepam. Marijuana. Methamphetamine, Morphine. Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline d-Propoxyphene and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) in human urine at the cutoff concentrations of:

Configuration of SAFECARE® Multi-Drug Urine Test Cup can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

The tests are intended for over-the-counter use.

The SAFECARE® Dip Card Tests and SAFECARE® Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Secobarbital, Methadone, Methylenedioxymethamphetamine, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline, Propoxyphen and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (target analytes) in human urine. The products are single-use in vitro diagnostic devices, which come in the formats of Dip Cards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.

The provided document describes the performance characteristics and studies for the SAFECARE® Multi-Drug Urine Test Dip Card and SAFECARE® Multi-Drug Urine Test Cup. It does not describe an AI/ML device but rather an in-vitro diagnostic device (IVD) for drug screening. Therefore, several of the requested categories for AI/ML device evaluation are not applicable (e.g., number of experts, adjudication method, MRMC study, standalone performance, training set).

Here's the information extracted from the document, tailored to the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for qualitative drug tests are typically defined by precision around the cutoff concentration. The device is expected to consistently classify samples below the cutoff as negative and above the cutoff as positive. For samples near the cutoff, some variability in classification is expected.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Precision Study (Test Set):

  • For each drug (Amphetamine, Cocaine, Methamphetamine, Morphine), 9 concentrations were tested around the cutoff (-100%, -75%, -50%, -25%, Cut-off, +25%, +50%, +75%, +100%).
  • For each concentration, tests were performed two runs per day for 25 days, using 3 different lots of the device. This equates to 50 replicates per concentration per lot, totaling 450 tests per lot per drug.
  • Total replicates for 4 drugs (AMP, COC, MET, MOP): 9 concentrations x 50 replicates/concentration x 3 lots = 1350 tests per drug. (Some data for other drugs were referenced from prior 510(k)s: K182654, K181968, K153646, K201120).
  • Data Provenance: The document states "in-house" for comparison studies and "urine samples were prepared by spiking drug in negative samples" for precision studies. This suggests a controlled laboratory setting (likely prospective, artificial samples). The document does not specify the country of origin of the data.

• Method Comparison Study (Clinical/Test Set):

  • 80 "unaltered clinical samples" were used for each drug. These samples were split into categories: 10 negative, 10 low negative, 20 near cutoff negative, 20 near cutoff positive, 20 high positive for each drug.
  • Total samples per device type (Dip Card or Cup) for 4 drugs mentioned: 80 samples x 4 drugs = 320 samples per device type.
  • Data Provenance: "in-house" and "unaltered clinical samples," implying real-world samples but processed within the manufacturer's lab. The document does not specify the country of origin or whether these clinical samples were retrospective or prospectively collected for the study.

• Lay-User Study (Test Set):

  • 310 lay persons participated for each device format (Dip Card and Cup).
  • Urine samples were prepared at 7 concentrations: negative, +/-75%, +/-50%, +/-25% of the cutoff.
  • Total samples: For each drug, the number of samples varied across concentrations. For example, for AMP500, 20 samples at -100% cutoff, 20 at -75%, 170 at -50%, 20 at -25%, 20 at +25%, 40 at +50%, 20 at +75%. This totals 310 samples per drug per device format.
  • Data Provenance: "at three intended user sites." Samples were "prepared by spiking drugs into drug free-pooled urine specimens," making them artificial but intended to mimic a range of concentrations. This suggests a prospective study design, mimicking real-world use conditions but with controlled samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Precision Study: Ground truth was established by preparing urine samples with known drug concentrations confirmed by LC/MS. No human experts were involved in establishing ground truth, as it was an analytical study.
• Method Comparison Study: The ground truth for clinical samples was established by LC/MS results. No mention of human experts for ground truth.
• Lay-User Study: Ground truth was established by LC/MS results of the prepared spiked urine samples.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. This device is a qualitative diagnostic test read directly by users, not an AI/ML imaging device requiring expert adjudication. In the method comparison study, three laboratory assistants "ran" the samples, implying they performed the test, but the ground truth was LC/MS, not their consensus.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is not an AI/ML device, and no MRMC study comparing human readers with and without AI assistance was mentioned. The lay-user study evaluated the device's performance with lay users, not an "AI assistance" scenario.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. The device is a physical, lateral flow immunochromatographic assay. Its performance inherently involves a human interpreting the result line, even if it's a simple positive/negative visual interpretation. It is not an algorithm-only device. The precision and method comparison studies evaluate the device's analytical performance, which is its inherent "standalone" capability.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• LC/MS (Liquid Chromatography-Mass Spectrometry) was used as the ground truth method to confirm drug concentrations in both spiked samples (for precision and lay-user studies) and clinical samples (for method comparison studies). This is a highly accurate and quantitative analytical method.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a "training set" in the machine learning sense. The device is based on immunoassay principles.

9. How the ground truth for the training set was established

• Not applicable, as there is no training set for an AI/ML device.

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The hCG Urine Test Strip is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy.

The hCG Urine Test Cassette is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy.

The hCG Urine Test Midstream is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy.

The hCG Urine Test will be sold in three formats: cassette, test strip, and midstream. The test strip and midstream kits consist of one test device and a package insert. The cassette kit consists of one test device and a disposable plastic dropper, and a package insert. Each test device contains mouse monoclonal anti-βhCG antibody coated membrane and a pad containing mouse monoclonal anti-α-hCG antibody colloidal gold conjugate. The control antibodies are goat anti-rabbit IgG.

The provided document is an FDA 510(k) summary for a set of hCG Urine Test devices. This document focuses on demonstrating analytical performance and user comprehension/accuracy for an In-Vitro Diagnostic (IVD) device, specifically a pregnancy test, not an AI-powered medical device. Therefore, many of the requested criteria related to AI/MRMC studies, expert ground truth, and training sets are not applicable to this type of device and submission.

However, I can extract the relevant information regarding the acceptance criteria and study proving the device meets these for an IVD device.

Acceptance Criteria and Device Performance for hCG Urine Test Strip, Cassette, and Midstream

This submission primarily focuses on analytical performance characteristics and comparison studies to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Analytical Performance Studies (Precision, Specificity, Hook Effect, pH, Specific Gravity):
  • Sample Size: Varies by test. For precision, it's 3 lots x 3 runs/day x 10 days x 6 concentrations = 540 tests per format per operator x 3 operators (though total tests are reported per concentration per lot, e.g., 30 results). For other analytical tests, specific numbers are not always given but imply multiple runs with spiked samples.
  • Data Provenance: Fresh urine samples from normal, non-pregnant females, spiked with HCG or interfering substances. The origin of the samples (e.g., country) is not specified but the manufacturer is in Hangzhou, China. The studies are retrospective in the sense that they are laboratory-controlled experiments designed to test specific analytical characteristics.
• Comparison Studies (Professional Method):
  • Sample Size: 120 women's urine samples.
  • Data Provenance: Urine samples collected from women at a hospital laboratory. Origin not specified (likely China). Retrospective collection for testing by both devices.
• Comparison Studies (Lay User Method):
  • Sample Size: 360 women.
  • Data Provenance: Urine samples collected from women at a hospital laboratory. Origin not specified (likely China). Retrospective collection.
• OTC User Performance (Spiked Masked Samples):
  • Sample Size: 30 positive samples (31.25 mIU/mL hCG) and 30 negative samples (18.75 mIU/mL hCG) were tested by lay users for each of the four test methods (strip, cassette, midstream dip, midstream simulated). So, 60 samples per format/method, totaling 240 masked spiked samples.
  • Data Provenance: Spiked urine samples prepared in a laboratory setting. This is a prospective experimental design for evaluating lay user performance.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

• Analytical Studies: Ground truth for these studies (e.g., specific hCG concentrations, presence/absence of interfering substances) is established by the preparation of the samples themselves in a laboratory setting using traceable reference materials (e.g., WHO 5th IS for hCG). The "experts" here are essentially the laboratory personnel setting up and verifying these conditions. No specific number or qualifications are provided beyond general lab personnel.
• Professional Method Comparison: The "predicate device professional" interpretation serves as a comparator, implying professional users (e.g., lab technicians, medical staff) were involved in interpreting the predicate device results. The document does not specify the number of individuals or their specific qualifications.
• Lay User Method Comparison & OTC User Performance: The "professional interpretation of the hCG Test Strip/cassette/midstream" (Safecare device professional) appears to serve as the ground truth against which lay user interpretation/performance is compared. This implies that trained professionals used the new device to establish the correct result for each sample before the lay users interpreted their results. The number and qualifications of these "professionals" are not specified.

4. Adjudication Method for the Test Set

• For analytical studies, the "ground truth" is defined by the prepared samples (e.g., 25 mIU/mL hCG is positive, 0 mIU/mL is negative). No formal adjudication method is mentioned for reconciling conflicting results, as the expectation is 100% conformity based on the controlled sample preparation.
• For comparison studies (professional and lay user), the document states "the agreement of hCG Test Strip/cassette/midstream with the predicate device was 100%" or "the conformity between the user interpretation of the and the professional interpretation... is 100%." This implies that there were no discrepancies that required adjudication, or if there were, they are not reported. The "professional interpretation" acts as the reference standard.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC study was not done. This type of study is primarily relevant for AI-powered medical imaging devices where the AI assists human readers, and the goal is to show improved diagnostic performance with AI assistance. For a simple in-vitro diagnostic test like a pregnancy strip, this framework does not apply.
• The comparison studies involved both professional and lay users, but it was to compare the new device's performance against a predicate (professional) or a professional's interpretation of the new device (lay user), not to evaluate the effect of AI assistance on human readers.

6. Standalone (Algorithm-Only) Performance

• Yes, in the context of an IVD device, the "standalone" performance is assessed through the analytical performance studies. The device (the test kits) is the "algorithm," and its ability to correctly detect or not detect hCG at various concentrations (sensitivity, specificity, precision, hook effect, etc.) is its standalone performance demonstrated in the "Analytical performance" section. There is no separate digital algorithm being evaluated here.

7. Type of Ground Truth Used

• Analytical Studies: Lab-defined ground truth based on precisely prepared samples using traceable standards (e.g., WHO 5th IS for hCG) at specified concentrations. This is a form of spike-in ground truth.
• Professional Method Comparison: The results from the predicate device served as the comparator/reference.
• Lay User Method Comparison & OTC User Performance: The professional interpretation of the new device's results served as the ground truth.

8. Sample Size for the Training Set

• Not applicable. This document describes the validation of a manufactured in-vitro diagnostic test kit, not an AI/Machine Learning model that requires a training set. The device itself is a chemical-based test.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. (As above, no training set for an AI/ML model here).

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SAFECARE® Multi-Drug Urine Test Dip Card is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline d-Propoxyphene and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) in human urine at the cutoff concentrations listed. The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. The tests are intended for over-the-counter use.

SAFECARE® Multi-Drug Urine Test Cup is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline d-Propoxyphene and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) in human urine at the cutoff concentrations listed. The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. The tests are intended for over-the-counter use.

The SAFECARE® Dip Card Tests and SAFECARE® Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Secobarbital, Methadone, Methylenedioxymethamphetamine, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline, Propoxyphen and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (target analytes) in human urine. The products are single-use in vitro diagnostic devices, which come in the formats of Dip Cards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.

The provided text describes the performance characteristics of the SAFECARE® Multi-Drug Urine Test Dip Card and SAFECARE® Multi-Drug Urine Test Cup. The document details analytical performance (precision, linearity, stability, interference, specificity, effect of specific gravity and pH) and comparison studies (method comparison and lay-user study).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for each analytical performance characteristic are implicitly defined by the successful results reported in the study. The study aims to demonstrate that the device performs as expected according to its intended use and analytical specifications.

• Precision:

  • Acceptance Criteria for -100% to -25% Cut-off: All samples should test negative.
  • Acceptance Criteria for +25% to +100% Cut-off: All samples should test positive.
  • Acceptance Criteria for Cut-off (nominal concentration): Approximately 50% positive and 50% negative results (reflecting the nature of the cut-off).
  • Reported Device Performance (for 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine as an example):
    • Dip Card (Lot 1, 2, 3):
      • -100% Cut-off to -25% Cut-off: 50-/0+ (All negative)
      • +25% Cut-off to +100% Cut-off: 50+/0- (All positive)
      • Cut-off: 24-/26+, 25-/25+, 26-/24+ (Split between positive and negative, as expected)
    • Cup (Lot 1, 2, 3):
      • -100% Cut-off to -25% Cut-off: 50-/0+ (All negative)
      • +25% Cut-off to +100% Cut-off: 50+/0- (All positive)
      • Cut-off: 27-/23+, 24-/26+, 26-/24+ (Split between positive and negative, as expected)

• Interference:

  • Acceptance Criteria: No interference from common physiological or pathological substances at specified concentrations.
  • Reported Device Performance: No interference observed for a comprehensive list of compounds at 100ug/mL (except albumin at 100mg/dL and ethanol at 1% volume).

• Specificity (Cross-Reactivity):

  • Acceptance Criteria: Related compounds should either not cross-react or cross-react at concentrations significantly higher than the cut-off, as defined by medical relevance.
  • Reported Device Performance (for 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine as an example):
    • Methadone: Positive at 300000 ng/mL (0.1% cross-reactivity)
    • EMDP: Positive at 300000 ng/mL (0.1% cross-reactivity)
    • Doxylamine, Disopyramide, LAAM HCl, Alpha Methadol: Positive at >100,000 ng/mL (

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SAFECARE® THC Urine Strip Test is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 50 ng/mL.

The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

The test is intended for over-the-counter use.

SAFECARE® THC Urine Strip Test devices are immunochromatographic assays for the qualitative detection of 11-nor-A9-THC-9 COOH (target analyte) in human urine. The product is a single-use in vitro diagnostic device. It contains a Test Device and a package insert. Each test device is sealed with a desiccant in an aluminum pouch.

The provided document outlines the acceptance criteria and performance data for the SAFECARE® THC Urine Strip Test, which is a qualitative lateral flow immunoassay for detecting Marijuana in human urine.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for precision or accuracy using specific numerical thresholds (e.g., >95% agreement). Instead, it presents the results of various performance studies. The overall acceptance is inferred from the device being deemed "substantially equivalent" to a predicate device.

However, based on the performance characteristics, we can infer performance goals for accuracy at different concentrations relative to the cutoff.

2. Sample Size Used for the Test Set and Data Provenance

• Precision Study:
  • Sample Size: 9 different concentrations, with 50 tests performed for each concentration per lot (2 runs per day for 25 days). Since 3 lots were tested, this amounts to 9 concentrations * 50 tests/lot * 3 lots = 1350 tests in total for the precision study itself. The samples were prepared by spiking drug in "negative samples." The provenance is not explicitly stated but implies laboratory-prepared samples.
• Comparison Studies (Clinical Samples):
  • Sample Size: 80 unaltered clinical samples (40 negative and 40 positive).
  • Data Provenance: The document states "unaltered clinical samples." The country of origin for these clinical samples is not specified. It is a retrospective analysis as the samples were collected and then tested.
• Lay-User Study:
  • Sample Size: 140 lay persons tested individual samples. There were 7 concentration levels, with 20 samples per concentration. So, 7 concentrations * 20 samples/concentration = 140 samples in total.
  • Data Provenance: The samples were "spiked drug THC into drug free-pooled urine specimens." The country of origin is not specified. It is a prospective study in the sense that the lay users tested the devices with prepared samples, but the samples themselves were laboratory-prepared.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Precision Study: The ground truth was established by laboratory preparation of samples with known concentrations confirmed by LC/MS. No human experts are explicitly mentioned for ground truth.
• Comparison Studies (Clinical Samples): The ground truth was established by LC/MS results. "LC/MS is the preferred confirmatory method." The number of LC/MS operators or analysts is not specified, nor are their qualifications.
• Lay-User Study: The ground truth for the prepared urine samples was established by LC/MS. The number of LC/MS operators or analysts is not specified, nor are their qualifications.

4. Adjudication Method for the Test Set

• Precision Study: Not applicable, as results were quantitative (known concentrations) rather than subjective interpretations needing adjudication.
• Comparison Studies (Clinical Samples): The document mentions "three different laboratory assistants" performing the tests. Their results were compared to LC/MS. There is no explicit adjudication method stated for discrepancies between human readers or between human readers and LC/MS. The discordant results table simply lists them.
• Lay-User Study: Not explicitly stated. Each lay person provided their own result. Their individual results were then compared to the LC/MS confirmed concentration.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

• No, an MRMC comparative effectiveness study was not done.
• This device is a standalone diagnostic strip test intended for visual interpretation, not an AI-assisted diagnostic tool. Therefore, there is no AI component or human readers improving with/without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

• Yes, in essence, the "device performance" in all studies represents a standalone performance relative to the ground truth (LC/MS). The device itself (the strip test) produces a visual result. While a human reads the result, the performance studies assess the accuracy of the device's output (presence/absence of a line) against known concentrations.
• For the "Comparison Studies," the performance of the "Safecare THC Urine Strip Test" is measured for each viewer by comparing their reading of the device against LC/MS. This measures the combined device-human performance.
• For the "Lay-User Study," it also measures the combined device-lay user performance.

7. The Type of Ground Truth Used

• For all performance studies (Precision, Comparison, Lay-User), the ground truth was primarily established by LC/MS (Liquid Chromatography-Mass Spectrometry). This is a highly accurate and quantitative laboratory method.
• For the precision study, it specifies "THC drug concentration was confirmed by LC/MS."
• For the comparison studies, it states "The samples were blind labeled and compared to LC/MS results. LC/MS is the preferred confirmatory method."
• For the lay-user study, it states "The concentrations of the samples were confirmed by LC/MS."

8. The Sample Size for the Training Set

• Based on the provided document, this is a 510(k) submission for a diagnostic device. Such submissions typically focus on analytical and clinical performance validation rather than explicitly detailing a "training set" for an algorithm.
• There is no information provided regarding a "training set" as this is not an AI/machine learning device. The immunoassay device relies on chemical reactions, not on data training.

9. How the Ground Truth for the Training Set Was Established

• As there is no mention of a "training set" or an algorithm that requires training, this question is not applicable based on the provided document.

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SAFECARE® Multi-Drug Urine Test Dip Card is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamine, Phencyclidine, Methadone, Nortriotyline and d-Propoxyphene in human urine at the cutoff concentrations of:

Configuration of SAFECARE® Multi-Drug Urine Test Dip Card can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine. Oxazepam, Secobarbital. Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GCMS or LC/MS is the preferred confirmatory method.

The tests are intended for over-the-counter use.

SAFECARE® Multi-Drug Urine Test Cup is competitive binding, lateral flow immunichromatographic assays for qualitative and simultaneous detection of Amphetanine, Oxazepam, Methamphetamine, Morghine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamphetamine, Phencyclidine, Methadone, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of:

Configuration of SAFECARE® Multi-Drug Urine Test Cup contination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine. Oxazenam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GCMS or LC/MS is the preferred confirmatory method.

The tests are intended for over-the-counter use.

The SAFECARE Dip Card Tests and SAFECARE Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Secobarbital, Methadone, Methylenedioxymethamphetamine, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline and Propoxyphene (target analytes) in human urine. The products are single-use in vitro diagnostic devices, which come in the formats of Dip Cards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.

The document describes the performance characteristics and studies for the SAFECARE Multi-Drug Urine Test Dip Card and SAFECARE Multi-Drug Urine Test Cup.

Here's an analysis of the acceptance criteria and study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a separate section. However, the performance data presented implies a very high standard for accuracy, particularly around the established cutoff concentrations. The "precision" studies demonstrate the device's ability to consistently produce correct results for samples at varying concentrations relative to the cutoff. The "comparison studies" compare the device's qualitative results to a quantitative gold standard (LC/MS) to establish concordance. The "lay-user study" assesses the ability of untrained individuals to correctly use and interpret the device.

Based on the provided data, the implied acceptance criteria for qualitative immunoassay devices for drug testing would typically be:

• 100% agreement for samples significantly below the cutoff (Negative).
• 100% agreement for samples significantly above the cutoff (Positive).
• High percentage agreement for samples near the cutoff (typically >90%).

For the Precision Study (Analytical Performance - "Test Set" Data):

The table below summarizes the reported performance for Methylenedioxymethamphetamine (MDMA), Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline, and Propoxyphene (results from 3 lots, 50 tests per concentration per lot, per device type). The format is (Number of Negative Results)/(Number of Positive Results).

For the Lay-user Study:

The acceptance criteria for the lay-user study would typically be a high percentage of correct results, especially for samples clearly negative or positive, and a reasonable proportion around the cutoff. The document shows the "percentage of correct results (%)" for each concentration level. The implied acceptance criteria for OTC urine drug screens are usually very high concordance (e.g., >90%) with the ground truth for samples away from the cutoff, and some level of agreement for near-cutoff samples (where variability is expected). The device performance meets these generally implied high standards, especially for samples clearly below or above the cutoff (100% for most categories). For samples near +/-25% of cutoff, the accuracy ranges from 85-95%, which is typical for qualitative tests and acceptable for over-the-counter use where confirmation is recommended for positive results.

2. Sample Size Used for the Test Set and Data Provenance

• Precision Studies (Test Set):
  • For each drug, device type (Dip Card/Cup), and each of the 9 concentration levels: 50 tests were performed per concentration.
  • This was repeated for 3 different lots for each device type.
  • Therefore, for a single drug and device type, the test set size for precision was: 9 concentrations * 50 tests/concentration * 3 lots = 1350 tests.
  • Data Provenance: The samples were prepared by "spiking drug in negative samples" and confirmed by LC/MS. This suggests controlled, prospective laboratory-prepared samples rather than retrospective clinical samples from specific countries. The testing was "in-house."
• Comparison Studies (Test Set):
  • For each drug and device type (Dip Card/Cup): 80 unaltered clinical samples (40 negative and 40 positive) were used.
  • Data Provenance: "unaltered clinical samples." The document does not specify the country of origin, but given the manufacturer (China) and submission to US FDA, the samples could be from various global sources or acquired for the study. It's a retrospective analysis against independently confirmed samples.
• Lay-user Study (Test Set):
  • For each device format (presumably Dip Card and Cup, though only combined results are shown in the given table): 300 lay persons participated.
  • The total number of samples processed for each drug across the different concentration levels in the lay-user study tables is: 20 + 20 + 160 + 20 + 20 + 40 + 20 = 300 samples. (It seems 300 samples were tested for each drug type, probably with each of the 300 lay users testing one sample)
  • Data Provenance: Urine samples were "prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens." These were laboratory-prepared samples. The study involved "three intended user sites."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Precision Studies: Ground truth was established by LC/MS (Liquid Chromatography-Mass Spectrometry), which is a definitive quantitative analytical method. It's an instrumental method, so human "experts" in interpretation are typically not specified in the same way as for imaging or clinical diagnosis. The samples were "blindly labeled by the person who prepared the samples," which indicates blinding to the LC/MS results during the device testing.
• Comparison Studies: Ground truth was established by LC/MS results. The document states, "The samples were blind labeled and compared to LC/MS results." These are definitive chemical analysis results.
• Lay-user Study: Ground truth for the samples was established by LC/MS confirmation of the spiked drug concentrations.

4. Adjudication Method for the Test Set

• Precision Studies: No explicit human adjudication method mentioned, as the device results are quantitative categories (positive/negative) and compared to definitive LC/MS values. The results are reported as counts (e.g., 25-/25+).
• Comparison Studies: The device results were read by "three laboratory assistants." For discordant results, the individual viewer's result is listed against the LC/MS truth, but no specific human adjudication process (e.g., 2+1 majority voting) is described for resolving discrepancies among the assistants or between the assistants and LC/MS. The LC/MS is the definitive ground truth here.
• Lay-user Study: The results are presented as aggregated counts of positive/negative readings by the lay users compared to the known ground truth (LC/MS confirmed concentrations). No human adjudication process is mentioned among the lay users.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices where human readers interpret images or complex data, and the AI serves as an aid.
• This device is a qualitative, over-the-counter urine drug test. Its performance is evaluated against chemical analytical ground truth, and its usability is assessed with lay users, not by evaluating how it assists expert readers.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

• This device is a physical, qualitative immunoassay test kit, not a standalone algorithm/AI for analysis. The "performance" of the device itself (the reaction on the dip card/cup) is evaluated.
• However, the Comparison Studies and Precision Studies could be considered the "standalone" performance of the device when read by trained laboratory personnel (3 laboratory assistants), as it's the device's output itself being compared to LC/MS.
• The Lay-user study evaluates the device performance when interpreted by the intended "human-in-the-loop" (a lay user).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• The primary ground truth used for all performance studies (Precision, Comparison, Lay-user) is quantitative chemical analysis by LC/MS (Liquid Chromatography-Mass Spectrometry). This is a highly accurate and widely accepted method for confirming drug concentrations in urine.
• For the precision and lay-user studies, urine samples were spiked with known concentrations of drugs, and these concentrations were confirmed by LC/MS.
• For the comparison studies, "unaltered clinical samples" were used, with LC/MS providing the definitive truth for the presence and concentration of drugs.

8. The Sample Size for the Training Set

• This document describes premarket notification (510(k)) for a drug test kit, which is a physical diagnostic device based on immunochromatography, not an AI/Machine Learning algorithm.
• Therefore, there is no "training set" in the context of machine learning model development. The device's performance relies on its physical and chemical design, not on a trained algorithm.

9. How the Ground Truth for the Training Set Was Established

• As there is no AI/ML algorithm or training set, this question is not applicable.

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SAFECARE® Multi-Drug Urine Test Dip Card is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Secobarbital and Methadone in human urine at the cutoff concentrations of:

Configuration of SAFECARE® Multi-Drug Urine Test Dip Card can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Oxazepam and Secobarbital when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. The tests are intended for over-the-counter use.

SAFECARE® Multi-Drug Urine Test Cup is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cannabinoids, Methamphetamine, Morphine, Secobarbital and Methadone in human urine at the cutoff concentrations of:

Configuration of SAFECARE® Multi-Drug Urine Test Cup combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Oxazepam and Secobarbital when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. The tests are intended for over-the-counter use.

The SAFECARE Dip Card Tests and SAFECARE Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Secobarbital and Methadone (target analytes) in human urine. The products are single-use in vitro diagnostic devices, which come in the formats of Dip Cards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.

The document describes the SAFECARE Multi-Drug Urine Test Dip Card and SAFECARE Multi-Drug Urine Test Cup devices, which are qualitative lateral flow immunochromatographic assays for detecting various drugs in human urine.

Here's an analysis of the acceptance criteria and study data provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of a minimum performance threshold (e.g., "sensitivity must be >90%"). Instead, it presents the results of precision, specificity, linearity, stability, interference, and comparison studies, implying that the observed performance across these studies is considered acceptable for substantial equivalence. For the qualitative tests, the key performance indicator is the ability to correctly identify samples both above and below the cut-off concentrations.

Below is a summary of the reported device performance for selected drugs based on "Precision" and "Lay-user study" data. The "Precision" study shows how consistently the device performs near the cut-off, while the "Lay-user study" assesses the device's accuracy when used by the intended over-the-counter users.

Acceptance Criteria (Implied for consistency and accuracy related to cut-off)

• Precision: High agreement (ideally 100% negative/positive) for samples far from the cutoff (e.g., -100%, -75%, +75%, +100% cutoff). Some variability (mixed positive/negative results) is expected and acceptable near the cutoff (e.g., -25%, cutoff, +25%).
• Lay-user Performance (Percentage of correct results): High percentage of correct results, especially for samples significantly above or below the cutoff. Some deviation might be acceptable near the cutoff.

Reported Device Performance (Excerpt for Secobarbital Dip Card and for all drugs in Lay-user study)

Precision Study - Secobarbital Dip Card (Illustrative Example from document, similar patterns for other drugs)

Interpretation for Precision (e.g., Secobarbital Dip Card):

• For samples far below the cutoff (-100%, -75%, -50%, -25%), all 50 tests consistently showed negative results (50-/0+), indicating perfect agreement for negative samples sufficiently below the cutoff.
• For samples far above the cutoff (+25%, +50%, +75%, +100%), all 50 tests consistently showed positive results (50+/0-), indicating perfect agreement for positive samples sufficiently above the cutoff.
• At the exact cutoff, there was an expected mix of positive and negative results (e.g., 25-/25+, 26-/24+), demonstrating the device's performance around the critical concentration.

Lay-user Study - Percentage of Correct Results (Summary across drugs for Dip Card)

Interpretation for Lay-user Study:
The lay-user study for both Dip Card and Cup formats consistently shows 100% correct results for samples well above (+50%, +75%) and well below (-50%, -75%, -100%) the cutoff. Near the cutoff point (-25% and +25%), the percentage of correct results typically drops to between 85% and 95%, which is expected given the concentrations are close to the detection threshold. The study indicates the devices perform as intended for over-the-counter use.

2. Sample size used for the test set and the data provenance

• Precision Study: For each drug and each device type (Dip Card/Cup), the samples were prepared at 9 different concentrations relative to the cut-off (-100%, -75%, -50%, -25%, cut-off, +25%, +50%, +75%, +100%). For each concentration, tests were performed "two runs per day for 25 days per device in a randomized order." This implies a total of 50 tests per concentration per drug per device, for each of the three lots.
  • Example for Secobarbital Dip Card: 9 concentrations * 50 tests/concentration * 3 lots = 1350 test results.
  • Data Provenance: "These samples were prepared by spiking drug in negative samples." The document specifies these are "spiked" samples into "negative samples" (presumably drug-free urine), and concentrations were confirmed by LC/MS. This suggests laboratory-controlled samples (retrospective fabrication) rather than patient-derived clinical samples.
• Comparison Studies (Lab Assistant/Clinical Performance): For each drug, "Operators ran 80 (40 negative and 40 positive) unaltered clinical samples for each drug."
  • This means 80 clinical samples per drug were used.
  • Data Provenance: "unaltered clinical samples." The document states this was "performed in-house," but does not specify the country of origin. Given the submitter is Safecare Biotech (Hangzhou) Co. Ltd. from China, the in-house clinical samples likely originated from China. The samples were compared to LC/MS results.
• Lay-user Study: "A lay user study was performed at three intended user sites with 240 lay persons for each device format."
  • The test set comprised urine samples prepared at 7 different concentrations relative to the cut-off (negative, +/-75%, +/-50%, +/-25% of the cutoff). The document indicates for each concentration, approximately 20 to 100 samples were tested for each drug (e.g., 20 at -100% cutoff, 100 at -50% cutoff, 40 at +50% cutoff, totaling around 20 * 5 + 100 * 2 = 300 test results per drug).
  • Data Provenance: "Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens." Concentrations confirmed by LC/MS. This implies laboratory-controlled spiked samples, similar to the precision study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Precision Studies & Lay-user Study: The ground truth (drug concentration) was established by LC/MS (Liquid Chromatography-Mass Spectrometry), which is a highly accurate analytical method. The document does not specify human experts for establishing ground truth for these studies, as the LC/MS directly provides quantitative measurements.
• Comparison Studies (Lab Assistant/Clinical Performance): The ground truth for the "unaltered clinical samples" was established by LC/MS results. The study mentions "three laboratory assistants" who "ran" the tests and "compared to LC/MS results," but these assistants are the operators of the device under test, not the ground truth experts.

4. Adjudication method for the test set

• Precision Studies & Lay-user Study: The ground truth was based on objective analytical measurements (LC/MS). There was no human "adjudication" in the sense of reconciling differing expert opinions. The comparison was directly between the device's qualitative result and the known quantitative drug concentration relative to the cut-off.
• Comparison Studies (Lab Assistant/Clinical Performance): The document does not describe an explicit adjudication method. The results from the device, interpreted by "three laboratory assistants," were directly compared to the LC/MS results, which served as the gold standard. Discordant results are individually reported (e.g., Viewer A found Positive, LC/MS was 289 ng/mL), but no adjudication of discrepant viewer readings against each other or a higher authority is mentioned. Each viewer's interpretation was compared against the LC/MS.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This device is a rapid diagnostic test (lateral flow immunochromatographic assay), not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers was not performed or described. The "readers" in the "Comparison Studies" are "three laboratory assistants" interpreting the visual lines on the test.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This device is a manual, visually interpreted lateral flow assay. It does not employ an algorithm for interpretation. The performance is inherently "standalone" in the sense that the device produces a visual result, but it requires human interpretation. The "Lay-user study" specifically assesses performance without expert human-in-the-loop, relying on typical users' interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The primary ground truth used in all analytical and comparative studies (Precision, Comparison, Lay-user) was Liquid Chromatography-Mass Spectrometry (LC/MS) results. This is a gold standard analytical method for precise and accurate quantification of drug concentrations.
• For the comparison studies, "unaltered clinical samples" were used, and their status (positive/negative relative to cutoff) was determined by LC/MS.

8. The sample size for the training set

• The document does not describe any "training set." These are diagnostic devices that do not involve machine learning or AI models requiring a training phase for their interpretation logic. Their "training" is in their manufacturing process and the inherent biochemical reactions.

9. How the ground truth for the training set was established

• Not Applicable as there is no training set described for this type of device.

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SAFECARE Urine Test Amphetamine Cassette is a rapid test for the qualitative detection of Amphetamine in human urine at a cutoff concentration of 1000 ng/mL.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

SAFECARE Urine Test Amphetamine Cup is a rapid test for the qualitative detection of Amphetamine in human urine at a cutoff concentration of 1000 ng/mL.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

SAFECARE Urine Test Amphetamine DipCard is a rapid test for the qualitative detection of Amphetamine in human urine at a cutoff concentration of 1000 ng/mL.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

SAFECARE Urine Test Cocaine Cassette is a rapid test for the qualitative detection of Benzoylecgonine in human urine at a cutoff concentration of 300 ng/ml.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

SAFECARE Urine Test Cocaine Cup is a rapid test for the qualitative detection of Benzoylecgonine in human urine at a cutoff concentration of 300 ng/ml.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

SAFECARE Urine Test Cocaine DipCard is a rapid test for the qualitative detection of Benzoylecgonine in human urine at a cutoff concentration of 300 ng/ml.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

SAFECARE Urine Test Marijuana Cassette is a rapid test for the qualitative detection of Cannabinoids in human urine at a cutoff concentration of 50 ng/mL.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

SAFECARE Urine Test Marijuana Cup is a rapid test for the qualitative detection of Cannabinoids in human urine at a cutoff concentration of 50 ng/mL.

The tests provide only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

SAFECARE Urine Test Marijuana DipCard is a rapid test for the qualitative detection of Cannabinoids in human urine at a cutoff concentration of 50 ng/mL.

The tests provide only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

SAFECARE Urine Test devices are immunochromatographic assays for cocaine, amphetamine and marijuana. Each assay test is a lateral flow, one step system for the qualitative detection of Benzoylecgonine, or D-amphetamine or 11-nor-A9-THC-9 COOH (target analyte) in human urine. The product is a single-use in vitro diagnostic device, which comes in the form of: DipCards, or Cups or Cassettes. It contains a Test Device (in one of the three formats), a package insert and a urine cup. Each test device is sealed with a desiccant in an aluminum pouch.

The provided document describes the acceptance criteria and study results for the SAFECARE Urine Test Amphetamine, Cocaine, and Marijuana devices.

Here's an organized summary of the information requested:

Acceptance Criteria and Device Performance Study

The SAFECARE Urine Test devices are qualitative tests for the detection of Amphetamine, Cocaine (Benzoylecgonine), and Marijuana (Cannabinoids) in human urine at specific cutoff concentrations. The study aims to demonstrate the device's accuracy and reliability through analytical performance and comparison studies.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets (e.g., Sensitivity > X%, Specificity > Y%). However, the study design implicitly establishes acceptance criteria through its reported performance, which demonstrates consistent and accurate results around the cutoff concentrations. Given that this is a 510(k) submission and the conclusion states "acceptable performance characteristics" and "substantially equivalent to the predicate," the presented performance implicitly meets the FDA's requirements for substantial equivalence.

Interpreted Acceptance Criteria (Implicitly met by study results):

• Precision: Consistent results across different lots and repeated testing at various concentrations relative to the cutoff. For concentrations well below the cutoff (-100%, -75%, -50% cutoff), results should be consistently negative. For concentrations well above the cutoff (+50%, +75%, +100% cutoff), results should be consistently positive. At concentrations near the cutoff (-25%, cutoff, +25% cutoff), there should be an expected distribution of positive and negative results, demonstrating appropriate cutoff sensitivity.
• Cut-off Verification: All samples at and above +50% cut-off are positive, and all samples at and below -50% cut-off are negative.
• Interference/Specificity: No interference from common physiological substances or cross-reactivity from specified compounds at tested concentrations should lead to false positives/negatives at 25% above cutoff.
• Method Comparison: High agreement with GC/MS results for both negative and positive clinical samples. Low rates of discordant results, particularly for samples well below or well above the cutoff.
• Lay-user Performance: High percentages of correct results when performed by lay users, indicating ease of understanding and use. This is especially critical for over-the-counter devices.

Reported Device Performance (Excerpt for Amphetamine Dip Card - Precision Study):

Self-correction made: The table in the document uses "50-/0+" format where 50- means 50 negative results and 0+ means 0 positive results. This was separated into two rows for clarity as "Negative" and "Positive".

Lay-User Performance (Excerpt for Amphetamine Cup):

2. Sample Size for the Test Set and Data Provenance

All test sets (precision, cut-off, interference, specificity, method comparison, and lay-user studies) appear to use data that is retrospective in nature, as samples were "prepared by spiking drug in negative samples" or "unaltered clinical samples" were "blind labeled and compared to GC/MS results". The provenance of the data is not explicitly stated as a country of origin but implies laboratory-prepared or collected clinical samples, likely within China where the manufacturer is located, or a contract lab.

Sample Sizes for Test Sets:

• Precision Study:
  • For each drug (Amphetamine, Cocaine, Marijuana) and each format (Dip Card, Cup, Cassette):
    • 9 concentration levels (-100% to +100% of cut-off).
    • Each concentration tested 50 times (2 runs per day for 25 days) for each of 3 lots.
    • Total observations per drug/format: 9 concentrations * 50 tests/concentration * 3 lots = 1350 observations.
• Cut-off Verification Study:
  • For each drug (Amphetamine, Cocaine, Marijuana) and each format (Dip Card, Cup, Cassette):
    • 5 concentration levels (-50%, -25%, cut-off, +25%, +50% of cut-off).
    • Total samples: 150 samples (equally distributed across 5 concentrations, so 30 samples per concentration) tested using 3 different lots by 3 different operators.
• Interference/Specificity Studies:
  • Urine samples (drug-free and spiked at +25% cut-off) tested for each interfering substance/cross-reactant compound. Number of tests per substance (e.g., 3 batches of each device for all formats) is not explicitly listed per substance but implied to be sufficient.
• Method Comparison Studies:
  • For each drug (Amphetamine, Cocaine, Marijuana) and each format (Dip Card, Cup, Cassette):
    • 80 unaltered clinical samples (40 negative, 40 positive).
    • Total samples per drug/format tested by 3 viewers: 80 samples * 3 viewers = 240 observations.
• Lay-user Study:
  • For Amphetamine devices: 420 lay persons.
  • For Cocaine devices: 420 lay persons.
  • For Marijuana devices: 420 lay persons.
  • Each person tested one blind labeled sample and a device.
  • Sample concentrations used: 7 levels (-100% to +75% of cut-off), 20 samples per level. Total samples per drug: 7 concentrations * 20 samples/concentration = 140 samples.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• For Analytical Performance (Precision, Cut-off, Interference, Specificity): The ground truth for spiked samples (negative samples spiked with known concentrations of drug) was established by GC/MS (Gas Chromatography/Mass Spectrometry), which is the "preferred confirmatory method" and considered the gold standard for drug detection and quantification in toxicology. No "experts" in the sense of clinicians or radiologists were used. The document doesn't specify the qualifications of the personnel performing GC/MS.
• For Method Comparison Studies: The ground truth for the 80 unaltered clinical samples was established by GC/MS. These GC/MS results are the reference against which the device's performance was compared.
• For Lay-user Study: The ground truth for the prepared urine samples was confirmed by GC/MS.

4. Adjudication Method for the Test Set

• For Precision Studies: The testing was "performed two runs per day for 25 days" (total 50 tests per concentration per lot). The results are presented as counts of positive/negative. There is no mention of an adjudication method among multiple readers for these analytical studies.
• For Cut-off Verification Study: Testing was performed by "three different operators." There is no explicit adjudication method stated for these observations. The results are presented as all positive or all negative for certain concentration ranges, which implies agreement or a predefined interpretation across operators.
• For Method Comparison Studies: "Three different laboratory assistants" were the "operators" or "viewers" (referred to as Viewer A, B, C) who read the device results. The document lists discordant results individually for each viewer, indicating that results were compared viewer-by-viewer against GC/MS. There is no explicit multi-reader adjudication method (e.g., majority vote like 2+1 or 3+1) mentioned for reaching a consensus device result; rather, individual reader agreement with GC/MS is analyzed.
• For Lay-user Study: Lay persons independently read the results. The comparison is between the lay person's reading and the GC/MS ground truth. No adjudication among lay persons is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. The study performed a method comparison where individual "viewers" (laboratory assistants) read the devices and their results were compared to GC/MS. There is no comparison of human readers' performance with AI assistance versus without AI assistance, as these are rapid qualitative test devices, not AI-powered diagnostic algorithms.

6. Standalone (Algorithm Only) Performance

The SAFECARE Urine Test devices are immunochromatographic assays, not software algorithms or AI-driven systems. Their performance is inherently standalone (device-only, interpreted by a human user). The reported precision, cut-off, interference, specificity, and method comparison data represent the standalone performance of these physical tests.

7. Type of Ground Truth Used

• GC/MS (Gas Chromatography/Mass Spectrometry): This is consistently stated as the ground truth method for confirming drug concentrations in all performance studies (precision, cut-off, interference, specificity, method comparison, and lay-user studies). GC/MS is a highly accurate analytical method considered the gold standard for drug testing.

8. Sample Size for the Training Set

These devices are immunochromatographic assays, not machine learning or AI models, therefore they do not have a "training set" in the computational sense. Their development typically involves chemical and biological optimization, with analytical and clinical validation serving as the equivalent of performance evaluation.

9. How the Ground Truth for the Training Set Was Established

As noted above, these devices do not involve a training set as they are not AI/ML-based. The development of such diagnostic tests relies on established immunochemistry principles and rigorous analytical validation to ensure sensitivity, specificity, and accuracy against a gold standard like GC/MS.

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