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Dental Barrier and 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) clearance letter from the FDA for a device named "Dental Barrier and Sleeves." It explicitly states that the device is a physical barrier and not an AI/software device. Therefore, the questions related to AI/software performance acceptance criteria, test sets, ground truth, expert opinions, and training sets are not applicable to this document.

The document discusses regulatory aspects of a Class II medical device, including:

• Trade/Device Name: Dental Barrier and Sleeves
• Regulation Number/Name: 21 CFR 878.4370, Surgical Drape And Drape Accessories
• Regulatory Class: Class II
• Product Code: PEM, PUI
• 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.

Since the device is a physical product and not an AI or software-based system, the acceptance criteria would relate to its physical properties, material safety, effectiveness as a barrier, and manufacturing quality, rather than algorithms or data performance. Such tests would typically involve:

• Material Biocompatibility: Testing to ensure the materials are not toxic or irritating when in contact with patients or users.
• Barrier Integrity/Effectiveness: Physical testing to confirm its ability to prevent the passage of fluids, microorganisms, or other contaminants.
• Physical Properties: Tensile strength, tear resistance, and dimensions to ensure it performs as intended under typical dental use conditions.
• Sterility (if applicable, though this device is noted as non-sterile): If it were a sterile barrier, testing would confirm the absence of viable microorganisms.
• Shelf Life: Stability testing to ensure the product remains effective and safe over its intended storage period.
• Manufacturing Quality Control: Adherence to Good Manufacturing Practices (GMP) to ensure consistent quality.

None of this information is detailed in the provided FDA clearance letter, as the letter primarily serves to confirm substantial equivalence to a predicate device and outlines regulatory obligations, not to present detailed study results for a non-AI/software device.

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Dental Barrier and 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.

Dental Barrier and Sleeves consist of various sizes and shapes of polyethylene covers which are positioned on various small hand-held dental instruments such as hand pieces, 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.

This document is a 510(k) premarket notification for a medical device called "Dental Barrier and Sleeves." It outlines the device's characteristics and compares them to a legally marketed predicate device to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Important Note: This submission is for a Class II medical device, "Dental Barrier and Sleeves," which are physical barriers (polyethylene covers) for dental instruments and equipment. The document does not describe an AI/Software as a Medical Device (SaMD) and therefore doesn't contain information related to AI model performance, expert consensus on image interpretation, or multi-reader multi-case studies. The performance criteria and studies described are for the physical properties and biocompatibility of the barrier sleeves themselves.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on demonstrating equivalence in physical properties and biocompatibility with the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Sizes Used for the Test Set and Data Provenance:

   • Test Set Sample Size: The document does not specify a specific "sample size" in terms of number of units for the performance tests (e.g., blood penetration, viral penetration, physical properties). It implies that standard testing procedures typical for medical devices of this type were followed.
   • Data Provenance: The studies are "Non-Clinical Testing" which means they were likely conducted in a laboratory setting. The country of origin for the tests or data is not explicitly stated. It is considered retrospective as the tests were performed to support the 510(k) submission.

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

   • This question is not applicable to this device. As a physical barrier, there is no "ground truth" to be established by experts in the context of image interpretation or diagnostic accuracy. The performance is based on measurable physical and biological properties.

4. Adjudication Method for the Test Set:

   • This question is not applicable to this device. Adjudication methods like "2+1" or "3+1" are relevant for expert review of medical images or clinical outcomes, which is not the nature of the testing for this device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:

   • No. This is a physical device, not an AI/SaMD. MRMC studies are not relevant to its evaluation.

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

   • No. This is a physical device, not an algorithm. Standalone performance is not relevant.

7. The Type of Ground Truth Used:

   • The "ground truth" for this device's performance is based on standardized test methods and material properties.
     • For performance properties (blood/viral penetration, tear, tensile, puncture), the ground truth is defined by the passing criteria of the respective ASTM standards (ASTM F1670, ASTM F1671, ASTM D882, ASTM F1342, ASTM D1004).
     • For biocompatibility, the ground truth is defined by the "non-cytotoxic, non-sensitizing, and non-irritating" outcomes determined by the ISO 10993 suite of standards (ISO 10993-5, ISO 10993-10, ISO 10993-23).
     • For X-ray device effectiveness, the ground truth is the continued proper function of dental X-ray devices when covered by the barriers.

8. The Sample Size for the Training Set:

   • Not applicable. This is a manufactured physical device, not an AI model. There is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set was Established:

   • Not applicable. As there is no training set, there is no ground truth to be established for it.

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