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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:

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