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For in vitro diagnostic workplace use. The LifePoint® IMPACT® Test System Saliva Test Module (STM) for Opiate is a professional use single-drug test for the rapid determination of Opiate in human saliva. It provides qualitative screening results for Opiate at a cut-off value of 40 ng/mL. The disposable STM is used exclusively with the LifePoint IMPACT Test System instrument.

This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation method.

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Here's an analysis of the provided text, focusing on the acceptance criteria and study information:

The provided text is a 510(k) summary for the LifePoint® IMPACT® Test System Saliva Test Module (STM) for Opiate. This type of document primarily focuses on establishing substantial equivalence to a predicate device, rather than presenting detailed performance studies against specific acceptance criteria. While it mentions the device's intended use and performance characteristics, it does not provide a dedicated section outlining specific acceptance criteria or a detailed study proving the device meets them in the manner typically seen for novel device approvals.

Therefore, many of the requested items cannot be directly extracted from this document. However, I will infer and present the information that is available or implicitly stated.

Inferred Acceptance Criteria & Reported Performance:

The primary "acceptance criteria" for a 510(k) device like this hinge on its ability to provide qualitative screening results for Opiate at a specific cut-off value and to do so reliably for its intended use and user group. The reported performance is primarily descriptive of its function rather than a quantitative measurement against a pre-defined threshold.

Detailed Breakdown for Study and Criteria:

Since the document is a 510(k) and not a full clinical study report, specific details regarding sample sizes, ground truth establishment, expert qualifications, and detailed statistical analyses are not included in the provided text.

1. A table of acceptance criteria and the reported device performance:
   (See table above)

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

   • Sample Size: Not specified in the provided text.
   • Data Provenance: Not specified in the provided text. (It's a 510(k), not a study report).

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

   • Not specified in the provided text.

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

   • Not specified in the provided text.

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/mentioned. This is an in vitro diagnostic device for substance detection, not an AI-assisted diagnostic imaging or interpretation tool.

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

   • The device is inherently a "standalone" test system (albeit with a required instrument). It provides a result based on chemical reaction detection. The "human-in-the-loop" aspect comes from the user performing the test and interpreting the preliminary result, but the device itself generates the screening result without human interpretation of raw data. The document does not describe separate algorithm-only performance testing beyond the intended use.

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

   • While not explicitly stated for a "test set," the document implicitly refers to Gas Chromatography/Mass Spectroscopy (GC/MS) as the "preferred confirmation method" for analytical results. This strongly suggests that GC/MS would be the gold standard or ground truth for confirming the presence and concentration of opiates in human saliva during validation studies for such a device.

8. The sample size for the training set:

   • Not applicable/specified. This type of device does not typically involve a "training set" in the machine learning sense. Its performance is based on chemical assay characteristics, not learned patterns.

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

   • Not applicable. (See #8).

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For in vitro diagnostic point-of-care prescription use. The LifePoint® IMPACT® Test System Saliva Test Module (STM) for Opiate is a professional use singledrug test for the rapid determination of Opiate in human saliva. It provides qualitative screening results for Opiate at a cut-off value of 40 ng/mL. The disposable STM is used exclusively with the LifePoint IMPACT Test System instrument.

This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation method.

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The provided text is a 510(k) clearance letter from the FDA for the "IMPACT Test System; Saliva Test Module- Opiate." It grants market clearance based on substantial equivalence to a predicate device. However, it does not include the detailed study or performance data that would typically contain acceptance criteria, sample sizes, ground truth establishment, or expert information as requested in your prompt.

Specifically, the document focuses on:

• Confirming the device name and regulation details.
• Stating that the device is substantially equivalent to a legally marketed predicate device.
• Outlining regulatory requirements and responsibilities for the manufacturer.
• Providing an "Indications For Use Statement" which describes what the device is intended for (in-vitro diagnostic, rapid determination of Opiate in human saliva at a cut-off of 40 ng/mL, professional/prescription use). It also mentions that the assay provides only a preliminary result and requires confirmation by more specific methods like GC/MS for a confirmed analytical result.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth, or expert qualifications based on the text provided. This information would typically be found in the 510(k) submission document itself, which is a much more extensive technical dossier than the FDA clearance letter.

Ask a specific question about this device