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The AllTest Urinary Tract Infection Test is 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.

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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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The Scanostics UTI Check Application test system consists of the Scanostics UTI Check Application and the URS-2L (UTI) Urine Test Strips. The test system is intended for the qualitative detection of nitrite and leukocytes in urine as an aid in the screening of urinary tract infections (UTI). It is intended for over-the-counter home use only.

The Scanostics UTI Check Application test system consists of the Scanostics UTI Check Application and the URS-2L (UTI) Urine Test Strips. The Scanostics UTI Check Application measures the colour developed in two reaction zones (leukocytes and nitrite pads) on the UTI test strip following application of a urine sample. The developed colors are then compared to calibration colours located on the Scanostics backing material and the result for each pad is determined based on the minimum colour distance between the developed colours and calibration colours.

The URS-2L UTI Test Strip comprises of two reagent pads areas, which are absorbent material saturated with chemically active substances, then dried and affixed to the plastic strip with double-sided adhesive.

The backing card comprises of thirty-two (32) calibration colour blocks and three (3) black and white alignment squares printed onto a rigid card stock and die cut to provide a groove for the strip (preventing strip misalignment). The use of the backing card is primarily to compensate for different lighting environments as it allows the calibration colours and the test strip to be subjected to the same conditions as the reagent pads for comparison - this would not be possible if the calibration colours were stored within the application itself.

The representative platform for the test system is the iPhone 6 with iOS 9. The application has been proven to be compatible on the iPhone 6S (iOS 9) and iPod touch (8th gen with iOS 8 and iOS 9). The application's core technology is based on four (4) patents held by Teco Diagnostics (US 8655009, 8877140, 8911679 and 8506901).

Here's an analysis of the provided text to extract the acceptance criteria and study details for the Scanostics UTI Check Application Test System.

Please note: The provided text is a 510(k) summary, which is a regulatory document. It summarizes the findings rather than presenting the full study report. Therefore, some information like specific statistical metrics for acceptance criteria and the exact number of participants in all study phases might not be explicitly detailed.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria (e.g., sensitivity > X%, specificity > Y%). Instead, it indicates that the device should perform "comparably" to the predicate device in the hands of lay users and "satisfactorily" in non-clinical studies. The ultimate acceptance criterion implicitly relies on the demonstration of substantial equivalence to the legally marketed predicate device, Clinistrip (URS-10).

Study Details

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated for specific metrics like sensitivity/specificity studies. The "lay user studies were performed at three sites," suggesting a multicenter approach, but the number of participants or urine samples is not provided in detail.
   • Data Provenance: The document does not specify the country of origin of the data. It seems to be a prospective study, as it describes "lay user studies were performed," implying new data collection rather than retrospective analysis.

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

   • The document implies a comparison against "a trained HCP using the Clinistrip (URS-10)" as a reference for the lay user study. However, it does not specify the number of HCPs, their qualifications, or how a definitive "ground truth" was established for each sample (e.g., if a definitive culture result was also used). Given the nature of a 510(k) submission focusing on substantial equivalence, the "ground truth" for the test set often stems from the established predicate device's performance.

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

   • Not described in the provided text.

4. 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, a multi-reader multi-case (MRMC) comparative effectiveness study in the traditional sense was not performed. This device is an AI-powered reader for a diagnostic strip, intended for over-the-counter home use only by lay users. The comparison was between the lay user with the Scanostics app and a "trained HCP using the Clinistrip (URS-10)" (the predicate device). The focus is on enabling accurate interpretation by lay users, not improving expert reader performance.
   • Therefore, an "effect size of how much human readers improve with AI vs without AI assistance" is not applicable in the context of this study design as presented.

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

   • The "Scanostics UTI Check Application test system" inherently involves the app (algorithm) reading the test strip. The "lay user studies" describe the performance when the human (lay user) operates the system. However, the non-clinical studies ("method comparison, precision, detection limit, interference, specificity, shelf life and stress studies as well as several flex studies") would largely assess the standalone performance of the algorithm's ability to read the strips under various controlled conditions, separate from a human's interpretation error. The document states these studies found the device performers "satisfactorily," implying the algorithm itself functions as intended.

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

   • The primary ground truth for comparison in the lay user study appears to be the results obtained by a "trained HCP using the Clinistrip (URS-10)" (the predicate device). For the non-clinical studies, the "ground truth" would likely be established through controlled laboratory testing with known concentrations for precision, detection limit, specificity, etc., but this is not explicitly detailed. It does not mention pathology or outcomes data as direct ground truth for this device's performance.

7. The sample size for the training set:

   • The document does not provide information about the sample size used for the training set of the Scanostics UTI Check Application's algorithm.

8. How the ground truth for the training set was established:

   • This information is not provided in the 510(k) summary. Training set ground truth would typically be established through expertly-read images of a large number of test strips, potentially correlated with laboratory-confirmed analyte concentrations, but these details are absent.

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The Teco Diagnostics UTI Test Strips are intended for the qualitative detection of Nitrite and Leukocytes in urine as an aid in the screening of urinary tract infection (UTI). It is intended for over-the-counter home use only.

Teco Diagnostics UTI Test Strips provides tests for the qualitative determination of leukocytes and nitrite in urine. The product is a firm plastic strip to which is affixed two separate dry reagent pad areas that is used for urinalysis. The reagent pad areas are bibulous material saturated with chemically active substances. All UTI Test Strips are carefully packaged along with a desiccant in a sealed, foil pouch. The color chart for reading the strips is on the outside of the foil pouch. A package insert is packaged along with the foil pouch into a box. The package insert contains all the necessary product information. Results of each test are based on the color produced from the reaction of each reagent pad area once the Urine Reagent Strip comes into contact with a urine sample. Each parameter is color coded accordingly as described in the color chart. Results with Teco Diagnostics UTI Test Strips can be obtained in clinically meaningful units directly by comparison with the color chart. The color blocks represent nominal values will vary around the nominal values.

The Teco Diagnostics UTI Test Strips are intended for the qualitative detection of Nitrite and Leukocytes in urine as an aid in the screening of urinary tract infection (UTI). It is intended for over-the-counter home use only.

The device's performance was proven through a combination of laboratory and clinical studies demonstrating its substantial equivalence to the predicate device, Bayer Multistix 10 SG Reagent Strips for Urinalysis (K905396).

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The provided document does not explicitly state numerical acceptance criteria (e.g., specific sensitivity or specificity thresholds) or quantitative device performance metrics (e.g., exact percentages for accuracy, sensitivity, or specificity). Instead, the studies aim to demonstrate that the Teco Diagnostics UTI Test Strips "run well and met all required performance characteristics" and that lay users could "obtain comparable testing data compared to those obtained by the professionals" and to the predicate device.

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

The document does not explicitly state the sample size for the clinical test set or the laboratory test set.

• Data Provenance: The clinical studies were conducted at "Point of Care sites" and "with lay persons," implying the data was collected from human urine samples. The document does not specify the country of origin, but given the submitter is based in Anaheim, CA, USA, and the predicate device is from Elkhart, IN, USA, it's highly probable the data is from the US. The studies are prospective in nature, as they involve testing the device on samples collected for the purpose of the study.

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

The document states that clinical studies compared results from "inexperienced lay users" to "professionals." It does not specify the exact number of professionals or their specific qualifications (e.g., "radiologist with 10 years of experience"). However, given the context of urinalysis, these professionals would likely be trained medical technicians, nurses, or other healthcare providers familiar with performing and interpreting urine reagent strip tests in a clinical setting.

4. Adjudication method for the test set

The document does not mention a specific adjudication method like "2+1" or "3+1." It implies a direct comparison, stating "inexperienced lay users were able to obtain comparable testing data compared to those obtained by the professionals." This suggests that the professionals' readings or a more definitive lab result for the same sample served as the benchmark against which lay users' readings were compared.

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

• MRMC Study: A type of comparative effectiveness study was done comparing the performance of lay users and professionals using the Teco Diagnostics UTI Test Strips, and against the predicate device. This aligns with the spirit of an MRMC study in that it assesses different "readers" (lay vs. professional) on the same "cases" (urine samples).
• Effect Size/AI Assistance: This study does not involve AI assistance. The comparison is between human readers (lay vs. professional) and between two different manual test strips. Therefore, there is no effect size related to AI improvement.

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

No, a standalone (algorithm only) performance study was not done. This device is a manual urine reagent strip, requiring human-in-the-loop performance (visual interpretation of color changes).

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

The ground truth for the clinical study was based on the results obtained by "professionals" using either the Teco Diagnostics UTI Test Strips or the legally marketed Bayer Multistix 10 SG Reagent Strips for Urinalysis. This can be considered a form of expert reference or standard device comparison, where the predicate device's results and professional interpretation of the test strips serve as the benchmark. It is not explicitly stated if further confirmatory tests (e.g., urine culture for UTI) were used as the ultimate ground truth, but the focus is on the performance of the test strips themselves in aiding screening.

8. The sample size for the training set

The document does not specify a separate "training set" or its sample size. For medical devices, particularly those without complex algorithms that "learn," the concept of a distinct training set (as in machine learning) may not directly apply in the same way. The development and optimization of the test strip's chemical reagents and color chart would be an iterative process, but not typically referred to as "training" in the context of sample sizes in regulatory submissions like this.

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

As there's no explicitly defined "training set" in the machine learning sense, the concept of establishing ground truth for it is not applicable here. The development of the test strip's performance (e.g., sensitivity, reproducibility, stability) would have been established through internal laboratory studies where known concentrations of analytes and controlled conditions were used to assess and optimize the reagents' performance. This would involve established analytical methods as a form of reference.

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Urinalysis Reagent Strips provide tests for glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite and leucocytes in urine.

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The document provided is a 510(k) clearance letter from the FDA for "Urinalysis Reagent Strips (10 Parameters)". This type of document assesses substantial equivalence to a predicate device, rather than detailed performance reports or clinical study results as would be found in a Premarket Approval (PMA) application. Therefore, the information requested about acceptance criteria, study details, and ground truth establishment is not available in this document.

The primary function of a 510(k) notification is to demonstrate that the new device is as safe and effective as a legally marketed predicate device. This typically involves submitting information on design, materials, chemical composition, energy source, manufacturing process, and intended use, along with performance data demonstrating equivalence to the predicate device. However, the FDA letter itself does not contain the detailed performance data or study methodology that would typically be included in a scientific study report.

Here's a breakdown of why each requested piece of information cannot be provided based on the given text:

• 1. A table of acceptance criteria and the reported device performance: This document is the FDA's clearance letter, not the study report itself. It states that the device is "substantially equivalent" but does not provide specific performance metrics or acceptance criteria tables.
• 2. Sample size used for the test set and the data provenance: Not present in this regulatory clearance letter. The original 510(k) submission would have contained this information.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
• 4. Adjudication method for the test set: Not present.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable for a device like urinalysis reagent strips, which are not typically "read" by multiple human readers in the same way as, for example, medical images for diagnosis. Even if a comparative study was done to demonstrate equivalence to the predicate device, details are not in this letter.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. These are reagent strips that produce a visual color change interpreted by a human, not an algorithm.
• 7. The type of ground truth used: Not present. For a diagnostic device like reagent strips, ground truth would likely involve more definitive laboratory methods (e.g., standard chemical analysis) to confirm the presence and concentration of the analytes.
• 8. The sample size for the training set: Not present.
• 9. How the ground truth for the training set was established: Not present.

To obtain the detailed study information, one would typically need to refer to the original 510(k) submission documentation filed with the FDA, which is a much more extensive technical package than the clearance letter provided.

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dBest Urinary Tract Infection Test Kit for Home-Use is a simple one step urinalysis assay for rapid, semi-quantitative detection of the presence of Nitrite and Protein in human urine to aid in the diagnosis of urinary track infection. The dBest Urinary Tract Infection Kits are for home-use only.

dBest Urinary Tract Infection Test Kit for Home-Use is a simple one step urinalysis assay for rapid, semi-quantitative detection of the presence of Nitrite and Protein in human urine.

The provided document is a 510(k) clearance letter for the "dBest Urinary Track Infection Test Kit for Home-Use." It states that the FDA has determined the device to be substantially equivalent to legally marketed predicate devices. However, the document does not contain detailed information about acceptance criteria, specific device performance, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot provide the requested table and information based on the given text. The letter primarily focuses on regulatory approval and points to general controls provisions of the Act and other relevant FDA regulations.

To answer your request, I would need access to the actual 510(k) submission document or a summary of its contents, which would typically include the performance study details.

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UriTest- Nitrite in Urine is a nonquantitative test to identify nitrite in urine. Nitrite identification is used for the detection of Urinary Tract Infection.

UriTest - Nitrite in Urine is a reagent strip test used to measure the presence of Nitrite in urine. Nitrite is produced by most organisms commonly associated with urinary tract infection. Nitrite is used to detect urinary tract infection.

Here's a breakdown of the acceptance criteria and study details for the Uri-Test - Nitrite in Urine, based on the provided text:

Acceptance Criteria and Device Performance

The provided document does not explicitly state pre-defined acceptance criteria (e.g., "The device must achieve a sensitivity of at least X%"). Instead, it presents the performance of the UriTest and implies that these results are considered acceptable because they demonstrate substantial equivalence to the predicate device (Bayer Multistix).

Note: The "Spiked Samples" section also shows a 100% sensitivity and accuracy, but "Specificity = Not Valid" due to the nature of the artificial positive-only sample. This test appears to confirm the device's ability to detect nitrite when present.

Study Details

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

• Sample Size:
  • Professional User & Lay User Tests: 101 samples (derived from the sum of positives and negatives in the Bayer arm: 16+7+0+78 for professional, 16+9+0+76 for lay user, though the tables are not identical, it sums to 101. The discrepancies in specific cells between professional and lay user suggest separate analyses or slightly different interpretations of the same base data for the negative group).
  • Spiked Samples: 33 samples (all positive).
• Data Provenance: Not explicitly stated. However, given the context of a 510(k) submission, it is highly likely that these were prospective clinical samples collected for the purpose of this comparison study. The document does not specify the country of origin.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The "ground truth" for the comparison studies was established by the predicate device, Bayer Multistix, itself. For the "Professional User" test, a professional presumably read both the UriTest and Bayer Multistix. For the "Lay User" test, a lay user read the UriTest, and a professional likely read the Bayer Multistix as the reference.

4. Adjudication method for the test set

• Adjudication Method: Not applicable or not specified. In this comparison study, the Bayer Multistix serves as the reference standard (the "ground truth"). The UriTest's results are compared directly to the results obtained from the Bayer Multistix for the same samples. There's no indication of an independent adjudication process for discrepancies between the two devices, as the predicate device's reading is assumed to be correct.

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

• MRMC Study: No, this was not an MRMC study and does not involve AI assistance. The study compares a new device (UriTest) to a predicate device (Bayer Multistix) for detecting nitrite in urine. The users are either "Professional User" or "Lay User" directly interpreting the test strips.

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

• Standalone Study: No, this is not an algorithm-only device. It's a reagent strip that requires human interpretation (either professional or lay user) to read the color change.

7. The type of ground truth used

• Type of Ground Truth: The ground truth for the comparison studies was established by the predicate device, Bayer Multistix, on the same urine samples. For the spiked samples, the ground truth was the known presence of bacteria (leading to nitrite production) in the spiked urine.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This type of device (reagent strip) does not typically involve a "training set" in the machine learning sense. The performance data is derived from clinical comparison and spiked sample testing.

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

• Ground Truth for Training Set: Not applicable, as there is no training set in the machine learning sense. The performance of the device is assessed against a predicate device and known positive (spiked) samples.

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CHEK-STIX U.T.I. Test Strips for the Detection of Urinary Tract Infection is an O.T.C. home use test for nitrite and leukocytes (WBC's) in urine. It is intended to be used by lay persons to detect urinary tract infections.

CHEK-STIX U.T.I. Test Strips for the Detection of Urinary Tract Infection is a plastic strip to which is affixed two reagent pads to test for nitrite and leukocytes (WBC's) in a urine specimen. The product is provided as a carton containing a bottle of five strips and a package insert.

The provided text describes the CHEK-STIX U.T.I. Test Strips, an over-the-counter (OTC) home use test for detecting urinary tract infections by testing for nitrite and leukocytes in urine.

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

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation of Implied Acceptance Criteria: The document directly states that the study was conducted "to demonstrate that lay persons can obtain results with CHEK-STIX U.T.I. comparable to results obtained by health care professionals." While no specific numerical threshold for "comparable" is given as an explicit acceptance criteria before the study, the reported agreement percentages (97% and 85%) are presented as evidence that this criterion was met.

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

The document does not explicitly state the sample size used for the test set. It mentions a "study was conducted in clinical settings," implying a prospective study involving human participants. However, the country of origin of the data is not specified.

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

The "ground truth" in this context appears to be the results obtained by "health care professionals." The document does not specify the number of healthcare professionals involved or their specific qualifications (e.g., physician, nurse, medical technologist, years of experience).

4. Adjudication Method for the Test Set:

The document does not describe an adjudication method. It simply refers to "agreement between the two groups" (lay persons and healthcare professionals), implying a direct comparison of results without a formal adjudication process for discrepancies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study, in the typical sense of evaluating human readers' improvement with AI vs. without AI assistance, was not conducted. This device is a biochemical test strip, not an AI-powered diagnostic system requiring human interpretation in conjunction with AI. The comparison is between lay users and healthcare professionals for interpreting the test strip's results.

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

This question is not applicable in the traditional sense of an "algorithm only" performance for an AI device. The CHEK-STIX U.T.I. Test Strips are a standalone device that provides a visual result. The "performance" being evaluated is the ability of human users (lay persons) to correctly interpret the results compared to human experts (healthcare professionals). The device itself is not an algorithm for which standalone performance (without human interpretation) would be relevant in this context.

7. The Type of Ground Truth Used:

The ground truth used was expert assessment/interpretation. Specifically, it was the results obtained by "health care professionals" using the same type of test pads.

8. The Sample Size for the Training Set:

This information is not provided. The document does not describe a separate training set. The study detailed appears to be a single evaluation, not a training/testing paradigm as would be seen for machine learning models.

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

As there is no mention of a training set, the process of establishing its ground truth is not described.

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