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Plasdent Disposable Barrier Sleeves and Barrier Film are intended to be used as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient one time use only.

Plasdent Disposable Barrier Sleeves and Barrier Film are made of polyethylene film (PE), and come in various shapes and sizes as dental accessories intended to fit over and cover dental instruments and equipment. The Disposable Barrier Sleeves cover small hand-held dental instruments such as air/water syringes, curing lights, hand pieces, computers, sensors, dental instrument trays, and other similar handheld instruments to provide as a physical barrier or cover during a dental procedure. In other forms, the Disposable Barrier Film Covers are used to cover equipment, such as dental chairs, headrests, X-Ray heads, and other devices. The device is non-sterile, prepackaged, and is disposable, for single patient and one time use only.

This document is a 510(k) Premarket Notification from the FDA for a medical device: "Plasdent Disposable Barrier Sleeves and Barrier Film." It is primarily focused on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.

It is important to note that this document does NOT describe the validation of an AI/ML powered medical device. It describes the testing of a physical barrier device. Therefore, many of the requested elements for an AI/ML device validation (e.g., sample size for test set with data provenance, number of experts for ground truth, MRMC study, sample size for training set, ground truth for training set) are not applicable or present in this context.

However, I can extract the relevant information for the physical device based on the provided text, focusing on acceptance criteria and performance data from the non-clinical testing.

Acceptance Criteria and Device Performance (for a physical barrier device)

The document presents non-clinical testing results to demonstrate that the Plasdent Disposable Barrier Sleeves and Barrier Film are substantially equivalent to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not specify the exact sample sizes (N) for each performance test. It lists results for multiple "samples" (e.g., HL181201, HL20190601, HL20190605 for Tensile Strength) but doesn't quantify the total count per test.
• Data Provenance: The document does not specify the country of origin for the test data directly. It is inferred to be manufacturer-generated for regulatory submission. All tests appear to be retrospective in the sense that they were conducted in a lab setting, not in a live clinical environment, to characterize the device properties.

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):

• Not Applicable. This is a physical device (barrier sleeves/film), not an AI/ML device requiring expert interpretation of images or other data for ground truth establishment. The "ground truth" for these tests comes from objective measurements and standardized test methods (e.g., ASTM, ISO standards).

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

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used for human-reviewed data in clinical studies, typically for establishing ground truth in image analysis or diagnostic contexts. This is a physical device undergoing lab-based performance testing.

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 type of study relates to AI-assisted human performance, which is not relevant for a physical barrier device. The study is a comparison of the subject device to a predicate device based on material properties and barrier effectiveness.

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

• Not Applicable. This applies to AI algorithms. The device itself is a standalone physical product, and its performance was evaluated without human intervention in the loop of its function (i.e., its barrier properties were tested directly).

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

• The "ground truth" for this device is based on objective measurements and adherence to recognized industry standards (ASTM, ISO) for material properties (tensile strength, puncture resistance, tear resistance, thickness) and barrier performance (synthetic blood penetration, viral penetration), as well as biocompatibility assessments (cytotoxicity, sensitization, irritation). There isn't a "clinical ground truth" in the diagnostic sense.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device, 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 for an AI/ML device, this question is irrelevant.

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