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

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The provided text is a 510(k) premarket notification letter from the FDA regarding "Disposable Barrier Sleeves." This document is a regulatory clearance for a physical medical device (barrier sleeves), not an AI/software as a medical device (SaMD).

Therefore, the document does not contain any of the information requested in your prompt regarding acceptance criteria and study details for an AI/SaMD. Specifically:

• No AI/SaMD Performance: The device is a physical barrier sleeve, completely unrelated to AI performance metrics.
• No Test Set/Ground Truth: There is no mention of a test set, data provenance, expert ground truth, adjudication, or MRMC studies because these concepts are not applicable to the clearance of a disposable physical barrier.
• No Training Set: Similarly, there is no training set for a physical product.

The document indicates that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its 510(k) clearance. The focus of the regulatory review for this product would have been on material safety, physical dimensions, intended use, and substantial equivalence to existing devices, not on algorithmic performance.

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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:

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Disposable Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.

The proposed devices. Disposable Barrier Sleeves and Covers, are made of polyethylene film and are used as accessories to dental instruments and equipment used during dental procedures. These disposable barrier sleeves and covers are offered in various shapes and sizes to fit over and cover the intended dental instruments and equipment. The Disposable Barrier Sleeves slip over the ends of the respective devices, allowing for the attachment and/or protrusion (where applicable) of those parts of the devices used during dental procedures. The Disposable Barrier Cover is placed over equipment, such as dental chair head rests and trays, to cover those parts.

The proposed devices, Disposable Barrier Sleeves and Covers, act as a physical barrier, augmenting existing infection control techniques, and facilitate clean-up.

The document provided is a 510(k) premarket notification for "Disposable Barrier Sleeves and Covers" (K160232) by DENTSPLY International. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the safety and effectiveness of a novel device through extensive clinical trials. Therefore, the information requested regarding acceptance criteria and studies proving a device meets them for a complex AI/ML device is largely not applicable in this context.

However, I can extract the relevant information from the provided document as it pertains to the substantial equivalence determination for this non-AI medical device.

Here's a breakdown based on the provided document and the nature of a 510(k) submission for a non-AI device:

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

The acceptance criteria are generally established by recognized standards for medical device materials and performance. The document defines the "Proposed Device" as "Disposable Barrier Sleeves and Covers" and compares its performance against a "Predicate Device," "TIDIShield™ Curing Light Sleeve (K132953)".

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

The document does not explicitly state the sample sizes for the mechanical and performance tests. It refers to "samples" being tested. For biocompatibility, it states "the proposed devices, Disposable Barrier Sleeves and Covers" underwent testing.
The data provenance is not specified beyond "testing conducted to support substantial equivalence." It's common for such bench testing to be conducted in-house by the manufacturer or by contract labs. There is no indication of country of origin or whether it was retrospective or prospective, as these are typically not relevant for a 510(k) submission for this type of device.

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 is not applicable. For a physical barrier device like this, ground truth is established by standardized material and performance testing against recognized industry standards (e.g., ASTM, ISO). There are no "experts" establishing a subjective "ground truth" in the way one would for diagnostic imaging.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of images or data in clinical studies, typically for diagnostic devices. This device is a physical barrier, and its performance is evaluated by objective laboratory tests, not by expert adjudication of subjective assessments.

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 is entirely not applicable.
* This device is a disposable physical barrier, not an AI/ML-powered diagnostic device.
* No human "readers" are involved.
* No "cases" are being interpreted.
* No AI assistance is provided or claimed.
* No MRMC study was conducted or is relevant for this device.

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

This is entirely not applicable.
* This device is a physical product, not an algorithm.
* There is no "human-in-the-loop" concept for this device's function.

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

The "ground truth" for this device's performance is based on the objective outcomes of standardized laboratory tests as defined by international standards (e.g., ISO, ASTM). For example:

• Biocompatibility: Demonstrated non-cytotoxicity, non-sensitization, and non-irritation as per ISO 10993 series.
• Performance (Barrier): Demonstrated resistance to synthetic blood and viral penetration as per ASTM F1670/F1670M and ASTM F1671/F1671M.
• Mechanical Properties: Measured tensile strength, puncture resistance, and tear resistance as per ASTM D882, F1342/F1342M, and D1004.

These are quantitative measurements against defined criteria, not subjective expert consensus or clinical outcomes data.

8. The sample size for the training set

This is not applicable. This device is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set."

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

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

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