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Pac-Dent Barrier Sleeve and Cover-It Barrier Film are intended to be used as a barrier to cover dental instruments. This device is non-sterile and is intended for single patient use only.

Pac-Dent Barrier Sleeve and Cover-It™ Barrier Film consist of various sizes and shapes of clear polyethylene covers which are positioned on various small hand-held dental instruments such as handpieces, curing lights, air/water syringes and similar hand instruments. In other forms, they are used to cover various devices such as dental chairs, dental instrument trays, x-ray heads, and others. The products are sold non-sterile, prepackaged, and are disposable, single use only.

Based on the provided document, here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:

Device Name: Pac-Dent Barrier Sleeve, Cover-It™ Barrier Film

1. Table of Acceptance Criteria and Reported Device Performance:

Study Details:

2. Sample sizes used for the test set and data provenance:
   The document does not explicitly state the specific sample sizes for each test in terms of the number of individual barrier sleeves or films tested. It mentions "Performance test including resistance to penetration, tear strength, tensile properties, resistance to puncture was performed in comparison to the predicate device." Similarly, it notes "Biocompatibility test in accordance with ISO10993-5, ISO10993-10 has been performed" and "Effectiveness of X-Ray Devices Covered with Barrier Sleeves was performed".

   The data provenance is not specified. It's typical for premarket notifications to be based on studies conducted by the manufacturer or third-party labs on behalf of the manufacturer, likely in the country of manufacture or where testing facilities are located. The document implies these were non-clinical tests (lab-based, not involving human patients), so the concept of "retrospective or prospective" as it applies to patient data is not directly relevant here.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
   This question is not applicable to the type of studies described. The "ground truth" here is based on objective, standardized laboratory test methods (e.g., ASTM, ISO standards) and comparison with a predicate device, not on expert human interpretation of results like in medical image analysis.

4. Adjudication method for the test set:
   This is not applicable. The tests performed are objective, quantitative laboratory tests with defined pass/fail criteria or comparative measurements against a predicate device. There is no element of human judgment or adjudication in the sense of consensus building for a diagnosis or interpretation.

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 device is a physical barrier (barrier sleeve/film), not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   No, a standalone algorithm performance study was not done. Again, this is not an AI/software device. The studies focused on the physical and protective properties of the barrier sleeves and films.

7. The type of ground truth used:
   The "ground truth" for this device's performance is established by:

   • Adherence to recognized standards: ASTM F1670, ASTM F1671, ASTM D1424, ASTM D882, ASTM F1342, ISO 10993-5, ISO 10993-10. These standards define the test methodologies and often the performance thresholds.
   • Comparison to predicate device: The subject device's performance characteristics (e.g., tear strength, tensile properties, resistance to puncture) were shown to be "equivalent" to the predicate device (TiDiShield Curing Light Sleeve - K132953). This implies that the predicate's established performance serves as a benchmark for substantial equivalence.
   • Functional demonstration: For the x-ray sleeves, the "ground truth" was that the barrier did not negatively impact the function of the dental x-ray devices, which is a functional test.

8. The sample size for the training set:
   This question is not applicable. This device is not an AI/machine learning device, so there is no concept of a "training set" in the context of data used for algorithm development. The tests are physical and biological property evaluations of the manufactured product.

9. How the ground truth for the training set was established:
   This question is not applicable as there is no training set for this type of device.

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