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The Quantisal™ Oral Fluid Collection Device is intended for the collection, preservation and transport of oral fluid specimens for drugs of abuse testing. This device is for prescription use only.

The Quantisal™ Oral Fluid Collection Device is intended for the collection, preservation, and transport of oral fluid specimens for drugs of abuse testing. The device is for prescription use only.

An oral fluid specimen is collected by placing a cellulose pad affixed to a polypropylene stem under the tongue of an individual until a defined volume of saliva has saturated the cellulose pad. The defined volume taken up by the cellulose pad is indicated by coloration (blue) in a window on the stem (volume adequacy). The collector is then transferred into a polypropylene tube (provided) containing 3 mL of preservative buffer. The tube is stoppered with provided cap. The specimen is ready for storage and transport.

The Quantisal™ Oral Fluid Collection Device collects 1 mL of neat oral fluid and dilutes it with 3 mL of preservative buffer contained in the provided transport tube. This results in a 1 to 4 dilution factor.

The Quantisal™ Oral Fluid Collection Device is intended for the collection, preservation, and transport of oral fluid specimens for drugs of abuse testing. The subject device is substantially equivalent to the predicate device (K200801) as they share the same design, materials, and functionality. The primary difference lies in the updated "Indications for Use" to broaden the scope beyond a specific list of drugs, relying on the established performance data of representative analytes from the predicate device.

Here's an analysis of the acceptance criteria and supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance is based on the substantial equivalence to a legally marketed predicate device (K200801) and the device's ability to maintain the stability of various drug analytes in oral fluid samples. The acceptance criteria are implicitly related to maintaining drug stability and collection efficiency demonstrated in the previous submission.

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

The document refers to performance studies submitted and cleared in K200801 for sample volume, collection time, drug recovery, and clinical specimen studies. For the extended refrigerated sample stability, the samples were low positive samples (+50% cutoff). The exact number of samples used for each test (sample size for the test set) is not explicitly stated in this document, as it refers back to the K200801 submission. The provenance of the data (country of origin, retrospective/prospective) and detailed sample sizes are also not provided in this document but would have been part of the K200801 submission.

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

This information is not provided in the current 510(k) summary. The ground truth for drug detection and quantification would typically be established by the analytical methods themselves (LC-MS/MS, GC-MS), which are considered definitive. Expert interpretation might come into play during method development or result validation, but details are not given here.

4. Adjudication Method for the Test Set

This information is not applicable in the context of analytical device performance studies where objective measurements (e.g., drug concentrations by LC-MS/MS or GC-MS) establish the "ground truth." Adjudication methods like 2+1 or 3+1 are typically used in image-based diagnostic studies involving human interpretation.

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

No, an MRMC comparative effectiveness study was not applicable and therefore not done. This device is an oral fluid collection device, not an AI-assisted diagnostic tool that requires human interpretation. The performance relates to its ability to collect and preserve samples for subsequent laboratory analysis.

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

This question is not applicable as the device is a collection device, not an algorithm. Its performance is evaluated based on its physical properties for collection, preservation, and chemical stability of the analytes.

7. The Type of Ground Truth Used

The ground truth for the performance evaluations (drug recovery, stability) was established using definitive analytical methods: Liquid chromatography-tandem mass spectrometry (LC-MS/MS) and Gas chromatography-mass spectrometry (GC-MS). These methods are considered the gold standard for identifying and quantifying drugs, serving as the "pathology" equivalent in this context.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this device. As a physical collection device, it does not rely on machine learning or algorithms that require training data. All mentioned studies are performance evaluations.

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

As there is no training set, this question is not applicable.

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The Quantisal™ II Oral Fluid Collection Device is intended for the collection, preservation and transport of oral fluid specimens for drugs of abuse testing. This device is for prescription use only.

The Quantisal II Oral Fluid Collection Device is intended for the collection, preservation, and transport of oral fluid specimens for drugs of abuse testing. The device is for prescription use only.

An oral fluid specimen is collected by placing a split collector containing two cellulose pads affixed to a polypropylene stem under the tongue of an individual until a defined volume of saliva has saturated the cellulose pad. The defined volume taken up by the cellulose pads is indicated by coloration (blue) in a window on the stem (volume adequacy). The collector is then separated into two specific pads/stems (Collector 1 and 2) and transferred into two separate polypropylene tubes (provided) both containing 3 mL of preservative buffer (Labelled A and B). The tubes are stoppered with provided caps. The specimen is ready for storage and transport.

The design of the split collector allows for the simultaneous collection of 2 aliquot to be used for screening and confirmation testing and the other aliquot to be stored as retain sample for potential confirmation testing.

The Quantisal II Oral Fluid Collection Device collects 1 mL of neat oral fluid and dilutes it with 3 mL of preservative buffer contained in the provided transport tube. This results in a 1 to 4 dilution factor.

The provided document describes a 510(k) premarket notification for the Quantisal™ II Oral Fluid Collection Device. This device is intended for the collection, preservation, and transport of oral fluid specimens for drugs of abuse testing. The submission claims substantial equivalence to a predicate device (K183048).

The document does not describe an AI/ML device. It details the performance characteristics and studies for a medical device designed for specimen collection, specifically an oral fluid collection device. Therefore, many of the requested criteria related to AI/ML device evaluation (like sample size for test/training sets, expert ground truth establishment for AI, MRMC studies, or standalone algorithm performance) are not applicable or extractable from this document.

However, I can provide information based on the performance characteristics described for this physical device.

Device: Quantisal™ II Oral Fluid Collection Device
Intended Use: Collection, preservation, and transport of oral fluid specimens for drugs of abuse testing.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" as a pass/fail threshold in a tabular format for each study outcome. Instead, it describes various performance studies conducted and their positive findings, stating that the device is "substantially equivalent" to the predicate. The performance evaluation is based on demonstrating proper sample collection, preservation, and analytical comparability.

Since no explicit quantitative acceptance criteria are given for the studies, I will list the areas of performance evaluation and the conclusions drawn from the studies.

• Results: Most drugs stable for 10 days at 8-25°C and 12 months at 2-8°C in both A and B specimens. Cocaine stable for 5 days at 8-25°C and 1 month at 2-8°C. THC stable for 10 days at 8-25°C and 2 months at 2-8°C. Measured by comparing concentrations over time to initial concentration, with results within ±10% of initial concentration listed as stable intervals. |
  | Sample Transportation Stability | Performed on representative drug analytes and submitted/cleared in K183048. (Implies the device maintains sample integrity during transport). |
  | Clinical Specimens Equivalency | - Study demonstrated equivalency between the two collection pads (A and B) of the device.
• Forty deidentified, unaltered drug-free clinical oral fluid samples and up to forty deidentified, unaltered clinical oral fluid samples containing representative drugs were collected by expectoration and with the Quantisal II device.
• Results: Quantisal II Tube "A" and "B" results were compared to each other, and results from expectorated neat oral fluid and Quantisal II collected samples "matched 100%". |
  | Expectorated Oral Fluid Samples Processed Through Quantisal II (Dipping Study) | - Verified that drug concentrations in oral fluid samples collected by the device are analytically comparable to neat oral fluid samples collected by expectoration.
• At least 60 oral fluid samples for each representative drug (from self-reported drug user patients) collected by expectoration.
• An aliquot of each expectorated sample was processed through the device by dipping.
• Results: 899/900 Quantisal II Oral Fluid Collection Device samples had concentrations that were within ±20% of expectoration concentration. |

2. Sample Size and Data Provenance

Again, this is not an AI/ML device study. The provided data relates to a physical device for sample collection.

• Test Set Sample Size:
  • Oral Fluid Sample Stability: Not explicitly stated as a "test set" size, but samples were evaluated for each representative drug at low positive concentrations. The table shows initial concentrations for 14 drugs.
  • Clinical Specimens Equivalency: At least 40 deidentified, unaltered drug-free clinical oral fluid samples and up to 40 deidentified, unaltered clinical oral fluid samples containing representative drugs.
  • Dipping Study: At least 60 oral fluid samples for each of the 14 representative drugs listed in Table 5-2. (This implies a minimum of 14 drugs * 60 samples = 840 samples). The combined result mentioned "899/900 Quantisal II Oral Fluid Collection Device samples".
• Data Provenance: Clinical research facilities. The document does not specify the country of origin but implies clinical settings where drug users or drug-free individuals provide samples. The studies are retrospective in the sense that they analyze collected samples. The "Clinical Specimens Equivalency" study used "deidentified, unaltered clinical oral fluid samples" collected for comparison.

3. Number of Experts and Qualifications for Ground Truth

Not applicable to this type of device study. The ground truth for drug concentrations was established using analytical gold standards (LC-MS/MS and GC-MS), not human expert consensus.

4. Adjudication Method for the Test Set

Not applicable, as this is not an AI/ML device study requiring human adjudication of results. Analytical methods (LC-MS/MS, GC-MS) were used for quantitative comparison.

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

Not applicable. This is not an AI/ML or imaging interpretation device. There are no "human readers" involved in the primary function or evaluation of this oral fluid collection device.

6. Standalone (Algorithm Only) Performance

Not applicable, as this is a physical medical device and not an algorithm or software. The performance assessed is the device's ability to collect and preserve samples reliably for subsequent laboratory analysis.

7. Type of Ground Truth Used

The ground truth for the performance studies was established through:

• Analytical Gold Standards: Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) and Gas Chromatography—Mass Spectrometry (GC-MS) were used to quantify drug concentrations in collected samples, serving as the "ground truth" for drug levels.
• Comparisons: "Analytical comparability" to neat oral fluid samples collected by expectoration was also used as a ground truth for assessing collection efficiency. The borosilicate glass vial was also verified to provide "analytical truth."

8. Sample Size for the Training Set

Not applicable, as this is a physical medical device and not an AI/ML algorithm that undergoes a training phase.

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

Not applicable, as there is no "training set" for this physical device.

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For In Vitro Diagnostic Use

The Quantisal Oral Fluid Collection Device is intended for the collection, preservation and transport of oral fluid specimens for tetrahydrocannabinol (THC), cocaine and its metabolite benzoylecgonine, morphine, codeine, oxycodone, hydrocodone, 6-acetylmorphine, phencyclidine, amphetamine, buprenorphine, methadone, benzodiazepines and tramadol.

The Quantisal Oral Fluid Collection Device is intended for the collection, preservation and transport of oral fluid specimens for tetrahydrocannabinol (THC), cocaine and its metabolite benzoylecgonine, morphine, codeine, oxycodone, 6-acetylmorphine, phencyclidine, amphetamine, methamphetamine, buprenorphine, methadone, benzodiazepines and tramadol. This device is for prescription use only.

An oral fluid specimen is collected by placing a cellulose pad affixed to a polypropylene stem (Collector) under the tongue of an individual until a defined volume of saliva has saturated the cellulose pad. The defined volume taken up by the cellulose pads is indicated by coloration (blue) in a window on the stem (volume adequacy). The collector is then transferred into a provided polypropylene tube containing a specific volume of preservative buffer. The tube is stoppered with provided caps. The specimen is ready for storage or transport.

The Quantisal Oral Fluid Collection System collects 1 mL of neat oral fluid and dilutes it with 3 mL of preservative buffer. This results in a 1 to 4 dilution factor.

Immunalysis Quantisal Oral Fluid Collection Device is sold as a stand-alone collection device.

Here's a breakdown of the acceptance criteria and study information for the Quantisal™ Oral Fluid Collection Device, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Volume Consistency: 75 oral fluid samples from known drug users. Data provenance is not specified beyond "known drug users." This sounds like prospective collection for the study.
• Sample Collection Time: 75 oral fluid samples from known drug users. Data provenance is not specified beyond "known drug users." This sounds like prospective collection for the study.
• Drug Recovery: Drug-free negative oral fluid spiked with drugs. This is an in vitro study using laboratory-prepared samples, not human subjects.
• Oral Fluid Sample Extraction Efficiency and Stability: Drug-free negative oral fluid spiked with drugs. This is an in vitro study using laboratory-prepared samples.
• Sample Transportation Stability: Drug-free negative oral fluid spiked with drugs. This is an in vitro study using laboratory-prepared samples.
• Borosilicate Glass Vial Stability: Drug-free expectorated oral fluid spiked with drugs. This is an in vitro study using laboratory-prepared samples.
• Expectorated Oral Fluid Samples Processed Through Quantisal (Dipping Study): At least 60 de-identified, unaltered drug-containing oral fluid samples. Provenance is "collected by expectoration (spitting) at clinical research facility." This indicates prospective collection of clinical samples.
• Drug Free Clinical Specimens: At least 40 de-identified, unaltered drug-free clinical oral fluid samples. Provenance is "obtained from clinical research facility." This indicates prospective collection of clinical samples.

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

• No specific information is provided regarding the number or qualifications of experts for establishing ground truth.
• For spiked samples, the "ground truth" is the known concentration of the spiked drugs, as determined by laboratory methods.
• For clinical samples (Dipping Study and Drug-Free Clinical Specimens), the ground truth was established by LC-MS/MS or GC-MS analysis of the expectorated (neat) oral fluid samples, which are high-accuracy analytical methods typically used in forensic or clinical toxicology laboratories. This is considered an analytical ground truth rather than an expert consensus based on visual assessment or interpretation.

4. Adjudication Method for the Test Set

• Not applicable as this is a device for specimen collection and preservation, with performance evaluated by objective analytical methods (LC-MS/MS, GC-MS) rather than subjective human assessment requiring adjudication.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging or interpretation devices where human readers are involved in making decisions, and the AI's impact on human performance is assessed. This device is a collection tool, not an interpretive one.

6. Standalone (Algorithm Only) Performance

• This device is not an algorithm or AI in the traditional sense. It's a physical collection device. Its "standalone" performance refers to its ability to collect, preserve, and transport samples effectively, and this was evaluated by the various laboratory performance studies (e.g., drug recovery, stability, comparison to expectorated samples). The analytical tests (LC-MS/MS, GC-MS) were performed on the collected samples to determine the device's performance.

7. The Type of Ground Truth Used

• Analytical Ground Truth:
  • For spiked samples and stability studies: The known concentration of drugs in the prepared solutions.
  • For clinical samples (Dipping Study and Drug Free Clinical Specimens): The drug concentrations (or absence of drugs) as determined by Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) and Gas Chromatography-Mass Spectrometry (GC-MS) of the neat/expectorated oral fluid. These are highly accurate, gold-standard analytical methods for drug quantification and identification.

8. The Sample Size for the Training Set

• This device does not involve a "training set" in the context of machine learning or algorithms. It is a physical device, and its performance is evaluated through a series of analytical and clinical studies as described.

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

• Not applicable, as there is no training set for this type of device.

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The Quantisal II Oral Fluid Collection Device is intended for the collection, preservation and transport of oral fluid specimens for tetrahydrocannabinol (THC), benzoylecgonine, cocaine, oxycodone, hydrocodone, bacetylmorphine, phencyclidine, amphetamine, buprenorphine, methadone, benzodiazepines and tramadol. This device is for prescription use only.

The Quantisal II Oral Fluid Collection Device is intended for the collection, preservation and transport of oral fluid. An oral fluid specimen is collected by placing two cellulose pads affixed to a polypropylene stem (Collector) under the tongue of an individual until a defined volume of saliva has saturated the cellulose pads. The defined volume taken up by the cellulose pads is indicated by coloration (blue) in a window on the stem (volume adequacy). The collector is then separated into two specific pads/stems and transferred into two separate polypropylene tubes (provided) both containing a specific volume of preservative buffer. The tubes are stoppered with provided caps. The specimens are then ready for storage or transport. The design of two specific pads/stems allows for one aliquot to be used for screening and confirmation testing and the other aliquot to be stored as retain sample for potential second chance testing. The Quantisal II Oral Fluid Collection System collects 1 mL of neat oral fluid and dilutes it with 3 mL of preservative buffer. This results in a 1 to 4 dilution factor. Immunalysis Quantisal II Oral Fluid Collection Device is sold as a stand-alone collection device.

This document describes product testing for the Immunalysis Quantisal II Oral Fluid Collection Device, a medical device for collecting and preserving oral fluid samples for drug testing. This is not an AI/ML device, and therefore the details usually associated with an AI/ML device's acceptance criteria and study (such as MRMC studies, human reader improvement with AI assistance, or sample sizes for training sets) are not applicable.

However, based on the provided text, we can extract details regarding the device's performance characteristics and how its acceptance was established.

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

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

• Sample Volume: 50 oral fluid samples from volunteers (country not specified, likely US since FDA submission), 75 oral fluid samples from known drug users (country not specified, likely US since FDA submission). Retrospective.
• Sample Collection Time: 50 oral fluid samples from volunteers, 75 oral fluid samples from known drug users. Retrospective.
• Drug Recovery (In Vitro): Oral fluid spiked with drugs at specific concentrations. Number of samples not explicitly stated but implied to be sufficient for LC-MS/MS or GC-MS testing. This is an in-vitro study.
• Oral Fluid Sample Extraction Efficiency and Stability: Oral fluid spiked with drugs. Number of samples not explicitly stated. This is an in-vitro study.
• Sample Transportation Stability: Oral fluid spiked with drugs. Number of replicates not explicitly stated for each condition, but tested in "replicates of two" within the variable temperature range. This is an in-vitro study with simulated transport conditions.
• Borosilicate Glass Vial Stability: Oral fluid spiked with drugs, initial concentration analyzed, then tested with three vials sequentially. This is an in-vitro study.
• Clinical Specimens:
  • Drug-Free: 40 deidentified, unaltered clinical oral fluid samples collected by expectoration and Quantisal II for each drug class/analyte. (Total 40 drug-free per drug x 15 drugs = 600 samples for the device, and 600 for expectoration).
  • Containing Drug: 40 deidentified, unaltered clinical oral fluid samples (except for Hydrocodone with 18 samples) obtained from clinical research facility, collected by expectoration and Quantisal II for each drug class/analyte. (Total ~578 samples for the device, and ~578 for expectoration).
  • Provenance: Clinical research facility, "deidentified, unaltered" samples. Country of origin not explicitly stated but implied to be within the US given FDA submission. Retrospective (samples "obtained").
• Expectorated Oral Fluid Samples Processed Through Quantisal II (Dipping Study): At least 60 deidentified, unaltered drug-containing oral fluid samples collected by expectoration from a clinical research facility. A minimum of 10 samples for each drug were within ±50% of the confirmation cutoffs. Total of 900 paired results were analyzed (Implied: 60 samples x 15 drugs = 900 measurements, or 60 samples for an undisclosed mix of drugs). Retrospective (samples "collected").

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

This is not applicable as this is a device for collecting samples for chemical analysis, not an AI/ML diagnostic interpretation. The "ground truth" for the drug concentrations was established through quantitative laboratory methods (LC-MS/MS or GC-MS), which are considered objective analytical techniques rather than expert consensus.

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

Not applicable. Ground truth was established by laboratory instrumentation (LC-MS/MS or GC-MS), not human adjudication.

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 diagnostic device that involves human readers or interpretation of medical images.

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

Not applicable. This is a collection device, not an algorithm. The reported performance is the device's ability to collect, preserve, and transport samples for subsequent laboratory analysis.

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

The ground truth for the presence and concentration of drugs in oral fluid samples was established using quantitative analytical methods: Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) and Gas Chromatography-Mass Spectrometry (GC-MS). These are highly sensitive and specific laboratory techniques considered gold standards for drug detection and quantification in biological matrices. For the clinical specimens, the "clinical truth" was defined by the expectorated neat oral fluid sample analyzed by LC-MS/MS or GC-MS.

8. The sample size for the training set

Not applicable. This is not an AI/ML device; there is no "training set." The studies were designed to validate the physical and chemical performance of the collection device.

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

Not applicable, as there is no training set for this type of device.

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The Intercept™ Oral Fluid Drug Test Oral Specimen Collection Device is intended for use in the collection, preservation, and transport of oral specimens. Oral specimens collected with the Intercept™ Oral Specimen Collection Device can be used to detect cocaine and cocaine metabolites, cannabinoids, phencyclidine, amphetamine, methamphetamine, opiates, barbiturates and methadone with the OraSure Technologies Intercept™ MICRO-PLATE EIAs.

The Intercept™ Oral Fluid Drug Test Oral Specimen Collection Device consists of a treated absorbent cotton fiber pad affixed to a nylon stick (Collection Pad) and a preservative solution in a plastic container (Specimen Vial). The Collection Pad is impregnated with a mixture of common salts and gelatin, creating a hypertonic environment which produces an osmotic gradient across the buccal and gingival mucosae. The Pad is placed in contact with the gingival mucosa (between the lower cheek and gum) which enhances the flow of mucosal transudate onto the absorptive cotton fibers of the Pad. Following the collection period, the Collection Pad is removed from the mouth and placed into a Specimen Vial. The vial contains a preservative solution which serves to inhibit the growth of oral microorganisms recovered on the Collection Pad. The vial is sealed with a plastic cap and transported to a laboratory for processing and testing.

This document pertains to the Intercept™ Oral Fluid Drug Test Oral Specimen Collection Device. It is a collection device, so the performance criteria focuses on the ability to collect and preserve samples for subsequent drug testing, rather than direct diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly list quantitative acceptance criteria for the device's performance in a table format, nor does it present specific performance data from a study.

However, the core of the submission (K011057) is a claim of substantial equivalence to a predicate device (OraSure® Oral Specimen Collection Device; K970357). The "performance" in this context is implicitly tied to demonstrating that the new device can effectively collect and preserve samples for the same range of drug detection as the predicate and extend this capability to additional drugs when paired with specific assays.

Implicit Acceptance Criteria (derived from the text):

• Preservation Capability: Ability to preserve the collected specimen.
• Transport Capability: Ability to transport the specimen securely to a laboratory. | "Both devices share major components (collection apparatus and transport containing a preservative solution) and are intended for collecting an oral fluid specimen, and for containing and transporting that specimen." This implies the new device performs these core functions comparably to the predicate. |
  | II. Compatibility with Downstream Assays (Extended Use) | - Detection of Cocaine & Metabolites: Compatibility with assays for these substances.
• Detection of Cannabinoids: Compatibility with assays for these substances.
• Detection of Phencyclidine: Compatibility with assays for this substance.
• Detection of Amphetamine: Compatibility with assays for this substance.
• Detection of Methamphetamine: Compatibility with assays for this substance.
• Detection of Opiates: Compatibility with assays for these substances.
• Detection of Barbiturates: Compatibility with assays for these substances.
• Detection of Methadone: Compatibility with assays for these substances. | "The oral specimens collected with the Intercept™ device, however, can be used to detect cocaine and cocaine metabolites, cannabinoids, phencyclidine, amphetamine, methamphetamine, opiates, barbiturates and methadone with the OraSure Technologies Intercept™ MICRO-PLATE EIAs as demonstrated in the premarket notifications for the assays (K001197, K000399, K992918, K002375, K993208, K981341, K001976, K002010)." This indicates successful validation of compatibility with specific assays. |

2. Sample Size and Data Provenance for Test Set:

The provided 510(k) summary does not detail a specific "test set" sample size or data provenance for a direct clinical performance study of the collection device itself.

Instead, the submission relies on:

• Substantial Equivalence: By claiming substantial equivalence to the OraSure® Oral Specimen Collection Device (K970357), it implicitly asserts that the new device performs similarly for its core functions.
• Referenced PMA/510(k)s for Assays: For the extended detection capabilities, the document refers to multiple separate premarket notifications (K001197, K000399, K992918, K002375, K993208, K981341, K001976, K002010) for the OraSure Technologies Intercept™ MICRO-PLATE EIAs. The performance data for detecting the specific drugs with oral specimens collected by this device would be detailed within those referenced assay submissions.

Therefore, without access to those referenced documents, we cannot provide details on the test set sample size or data provenance for the drug detection capabilities.

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

The document does not mention the use of experts to establish ground truth specifically for the collection device's performance in this 510(k) summary. This is consistent with a substantial equivalence claim for a collection device, where the focus is on physical and functional similarity to an already cleared device, and the analytical performance (e.g., drug detection accuracy) is tied to the separate assays.

4. Adjudication Method for Test Set:

Not applicable, as no direct "test set" and ground truth establishment by experts for the collection device itself is described.

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

Not applicable. The Intercept™ Oral Fluid Drug Test Oral Specimen Collection Device is a collection device, not an AI-assisted diagnostic tool or a device that requires human interpretation in the way an imaging AI might. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

6. Standalone Performance Study (Algorithm Only):

Not applicable. This device is a manual specimen collection device and does not involve an algorithm for standalone performance. Its "performance" is its ability to successfully collect and preserve an oral fluid specimen for laboratory analysis.

7. Type of Ground Truth Used:

For the collection device's core functionality, the "ground truth" is implied by its functional equivalence to the predicate device and its ability to deliver a specimen suitable for subsequent laboratory analysis.

For the drug detection claims, the ground truth would be established during the development and validation of the specific EIAs (Enzyme Immunoassays) as detailed in the referenced K numbers. This type of ground truth typically involves:

• Analytical Standards: Known concentrations of drugs and their metabolites.
• Spiked Samples: Oral fluid samples to which known amounts of drugs have been added.
• Clinical Samples with Confirmed Results: Oral fluid samples from actual subjects, where drug presence/absence and concentration have been independently confirmed by more definitive methods (e.g., GC/MS or LC/MS-MS, considered the gold standard for drug testing).

8. Sample Size for the Training Set:

The document does not specify a training set sample size. As a collection device, it does not typically involve traditional machine learning "training sets" in the same way an AI diagnostic algorithm would. Its design and functional validation would be based on engineering principles, materials science, and compatibility testing with chemical assays.

9. How Ground Truth for Training Set Was Established:

Not applicable, as a traditional "training set" with ground truth in the context of an algorithm or machine learning is not described or relevant for this type of device. The "ground truth" for the device's design and functionality would be based on:

• Established methods for oral fluid collection.
• Chemical stability validation for the preservative solution ensuring drug integrity.
• Compatibility testing with the OraSure Technologies Intercept™ MICRO-PLATE EIAs (which themselves would have their own established ground truth).

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The Oral-Eze Oral Fluid Collection System is a prescription device, intended for use by a person under the supervision of a trained health care professional to collect oral fluid specimens, contain these specimens, and preserve the specimens after collection and during transport from the collection area to the laboratory.

The Oral-Eze Oral Fluid Collection System is a device used by a person under the supervision of a trained health care professional to obtain an oral fluid specimen and have the specimen contained for transport to a laboratory. The device consists of the following:

• A collector pad holder/handle with a collector pad, contained in a sealed "peel-apart" plastic envelope. . The collector pad holder/ handle itself consists of two parts, a collector pad holder and a collector pad slider. The collector pad is held in the holder/handle by a pin in the slider that fits into a hole in the collector pad, and by the holder, which keeps the pad from falling off the pin. The slider has a round indicator port in it. A blue color appears in this indicator port when a predetermined amount of oral fluid has been collected.
• An Oral Fluid Collection Tube with a screw-on lid, containing preservative fluid. ..
• A clear plastic sealed envelope that contains all three of the above items. .

The provided text describes the "Osborn Laboratories Oral-Eze™ Oral Fluid Collection System." Since this is a collection device and not a diagnostic or AI-powered system, the typical acceptance criteria and study designs (like MRMC studies) for such devices are not applicable in the same way they would be for an AI algorithm interpreting medical images.

Instead, the performance evaluation focuses on direct comparison to predicate devices and ensuring the practical utility and stability of the collected specimens.

Here's an analysis based on the provided text, adapted for a medical device that collects biological samples:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The text explicitly states "The test results demonstrated that the Oral-Eze device is substantially equivalent to the Saliva-Sampler predicate device" for characteristics like collection time and volume. For environmental stability, it states "The test results were considered to be within acceptable accuracy limits." The specific quantitative thresholds for these metrics are not provided in the summary.

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

• Sample Size: Not explicitly stated. The text only mentions "To assess the suitability... both the Oral-Eze device and the Saliva · Sampler predicate device were tested for a number of characteristics." For environmental testing, it notes "Oral-Eze collection tubes with collector pads containing oral fluid specimens were subjected to environmental testing."
• Data Provenance: Not explicitly stated. The testing seems to be internal to Osborn Laboratories. Given it's a pre-market submission, it would typically be conducted under controlled laboratory conditions, possibly drawing from a pool of healthy volunteers for initial collection tests.

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

This level of detail is not provided. For a device like this, "ground truth" would likely involve objective measurements (e.g., volume collected, chemical analysis of preservative efficacy, stability of drugs/analytes in collected samples, if relevant, although not detailed here). The "suitability" and "acceptable accuracy limits" would be determined by laboratory professionals or engineers with expertise in medical device testing and quality control.

4. Adjudication Method for the Test Set:

Not applicable or provided. This is typically for subjective assessments (e.g., image interpretation). Performance for this device would rely on objective measurement against pre-defined engineering or performance specifications.

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 fluid collection system, not an AI diagnostic or assistance tool, so MRMC studies are not relevant.

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

Not applicable. This device does not involve an algorithm.

7. The Type of Ground Truth Used:

For the performance testing mentioned:

• Comparison to Predicate Performance: The "ground truth" for collection time and volume was likely the observed performance of the predicate device (Saliva-Sampler).
• Defined Acceptable Limits: For environmental stability, the "ground truth" would be pre-defined "acceptable accuracy limits" for the integrity and chemical stability of the oral fluid specimens after exposure to extreme temperatures. This would usually be based on established laboratory standards or regulatory guidance for specimen transport.

8. The Sample Size for the Training Set:

Not applicable. This device does not use machine learning or AI, so there is no "training set."

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

Not applicable, as there is no training set.

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EpiScreen is intended to collect oral fluid specimens, contain those specimens, and preserve the specimens after collection and during transport from the collection area to the laboratory.

The EpiScreen device consists of a treated absorbent cotton fiber pad affixed to a nylon stick (Collection Pad) and a preservative solution in a plastic container (Specimen Vial). The Collection Pad is impregnated with a mixture of common (Specifical vial). The Generativertonic environment which produces an osmotic sails and gelain, ereating a my perival mucosae. The pad is placed in contact with the gingival mucosa (between the lower gum and cheek) which enhances the flow the gingival macoba (between was sorptive cotton fibers of the pad. Following the of Indecourt the Collection Pad is removed from the mouth and placed into a conection period, the Concession a preservative solution which serves to inhibit the Specifical The The Tim connect on the Collection Pad. The vial is sealed with a plastic cap and transported to a laboratory for processing and testing.

The provided text does not contain information about acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria.

The document is a 510(k) summary for the EpiScreen™ Oral Specimen Collection Device. It describes the device, its intended use, classification, and states that a modification was made to the package insert of an already cleared device (K970357). The core claim is that the modified device is identical to the currently cleared device and therefore does not raise new questions of safety and efficacy.

Consequently, none of the requested information (acceptance criteria table, sample size, data provenance, expert details, adjudication method, MRMC study, standalone performance, ground truth types, training set size, or ground truth establishment for training set) can be extracted from the provided text. The document focuses on regulatory equivalence rather than performance studies against defined acceptance criteria.

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EpiScreen is intended to collect oral fluid specimens, contain those specimens, and preserve the specimens after collection and during transport from the collection area to the laboratory.
EpiScreen is intended for use in the collection, preservation, and transport of oral fluid specimens.

The EpiScreen device consists of a treated absorbent cotton fiber pad affixed to a nylon stick (Collection Pad) and a preservative solution in a plastic container (Specimen Vial). The Collection Pad is impregnated with a mixture of common salts and gelatin, creating a hypertonic environment which produces an osmotic gradient across the buccal and gingival mucosa. The pad is placed in contact with the gingival mucosa (between the lower gum and cheek) which enhances the flow of mucosal transudate onto the absorptive cotton fibers of the pad. Following the collection period, the Collection Pad is removed from the mouth and placed into a Specimen Vial. The vial contains a preservative solution which serves to inhibit the growth of oral microorganisms recovered on the Collection Pad. The vial is sealed with a plastic cap and transported to a laboratory for processing and testing.

The provided text doesn't contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for the EpiScreen Oral Specimen Collection Device, which primarily focuses on establishing substantial equivalence to existing predicate devices.

Here's what the document does include, which is related to the request but doesn't directly answer it:

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

• The document provides a "Comparison Table: EpiScreen, Saliva Sampler, Saliva Sac, and Salivette" which compares the indications and components of the EpiScreen device to three predicate devices. This table doesn't list acceptance criteria or performance metrics, but rather technological characteristics.

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

• This information is not provided. The document focuses on regulatory classification and substantial equivalence, not a performance study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This information is not provided.

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

• This information is not provided.

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

• This device is a specimen collection device, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI-related metrics are irrelevant and not mentioned.

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

• This is not applicable to a specimen collection device.

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

• This information is not provided.

8. The sample size for the training set

• This information is not provided. There is no mention of a training set as this is not an AI-driven device.

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

• This information is not provided.

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