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Premium Plus Disposable Barrier Sleeve is 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.

Premium Plus Disposable Barrier Sleeves are made of polyethylene film and are used as accessories to dental instruments and equipment used during dental procedures. These barrier sleeves consist of various sizes and shapes 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 travs, x-ray heads, and others. The products are sold nonsterile, prepackaged, and are disposable, single use only.

The provided text is a 510(k) premarket notification from the FDA for a device called "Premium Plus Disposable Barrier Sleeve." This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a medical device's performance against specific acceptance criteria through a study involving diagnostic accuracy, human readers, or AI.

Therefore, the requested information about acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, as would be relevant for an AI/ML-driven diagnostic device, cannot be found in this document.

The document describes the physical and material characteristics of the barrier sleeves and confirms that they meet certain safety and performance standards for barrier efficacy, not diagnostic accuracy.

Here's what can be extracted from the document regarding the device's "performance" in its specific context:

Device: Premium Plus Disposable Barrier Sleeve
Indications for Use: Intended to be used as a disposable barrier for dental instruments and equipment. Non-sterile and intended for single patient use only.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present acceptance criteria in a quantitative diagnostic performance metric (e.g., sensitivity, specificity, AUC). Instead, it compares the new device to a predicate device ("Pac-Dent Barrier Sleeve") based on various physical and biological properties relevant to its function as a barrier. The "acceptance criteria" are implied by the "Comparison of Technological Characteristics and Performance" table, where the new device is stated to be "comparable" or "equivalent" to the predicate.

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

This document does not describe studies that would have "test sets" in the context of diagnostic performance (e.g., patient data for an AI model). The "tests" mentioned are for material properties and barrier efficacy.

• Sample Size: Not specified in terms of "test set" for diagnostic performance. For mechanical and barrier tests, samples of the material/product would have been tested according to relevant ASTM/ISO standards, but specific sample numbers are not provided.
• Data Provenance: Not applicable in the context of patient data. The tests are laboratory-based material property tests.

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

Not applicable. This is not a diagnostic device or an AI/ML device requiring expert ground truth for interpretation of medical images or patient data. The "ground truth" for this device relates to established material performance standards (e.g., a material either passes or fails a tear strength test as per an ASTM standard).

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication process is described as it's not a diagnostic study.

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

No. An MRMC study is relevant for evaluating the impact of a diagnostic tool (often AI-assisted) on human readers' performance. This device is a physical barrier, not a diagnostic tool, so an MRMC study is not applicable.

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

No. This device is not an algorithm or an AI system. Its performance relates to its physical properties as a barrier.

7. The Type of Ground Truth Used

The "ground truth" is based on:

• Physical and Chemical Properties: Material composition (polyethylene film), thickness.
• Biocompatibility Standards: ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and sensitization). These involve laboratory tests on cell cultures and animal models (though the document doesn't specify if human or animal data were used beyond stating "non-cytotoxic," etc.).
• Mechanical and Barrier Performance Standards: ASTM D882 (tensile strength), ASTM F1342 (puncture resistance), ASTM D1424 (tear resistance), ASTM F1670 (synthetic blood penetration), ASTM F1671 (viral penetration). These are well-defined laboratory test methods.
• Functional Testing: "Effectiveness of x-ray devices covered with Premium Plus Disposable Barrier Sleeves was performed to demonstrate the subject device does not impact the function of dental x-ray devices." This implies functional testing against a benchmark of an X-ray device operating without the barrier, but the specifics of this "ground truth" are not detailed.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. No training set is involved.

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