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The AcuCam® Intraoral Camera Sheath is a single-use device intended for use with the various intraoral camera systems to prevent contamination of the camera handpiece with saliva and other bodily fluids.

The AcuCam Intraoral Camera Sheath is a single-use device intended for use with intraoral camera systems. The intraoral camera handpiece is inserted into the sheath prior to use.

The provided text is a 510(k) summary for the AcuCam® Intraoral Camera Sheath. This document describes a medical device and its substantial equivalence to a predicate device, rather than presenting a study proving a device meets specific acceptance criteria based on performance data.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, and comparative effectiveness studies cannot be extracted from this document, as it focuses on regulatory submission for a simple medical device, not a performance-based study as typically seen with AI/ML devices or complex diagnostic tools.

Here's an analysis based on the available information:

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

Not applicable. The document does not describe acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) or report device performance against such criteria. The device is a "surgical drape and drape accessory" (specifically, an intraoral camera sheath) whose primary function is to prevent contamination. The rationale for substantial equivalence focuses on material, manufacturing, and dimensions, not diagnostic performance.

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

Not applicable. There is no mention of a "test set" or data provenance as would be relevant for a performance study.

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. Ground truth for a test set is not relevant for this type of device submission.

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

Not applicable.

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 device is a physical sheath, not an AI-powered diagnostic tool, so an MRMC study is irrelevant.

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

Not applicable. The device is a physical product, not an algorithm.

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

Not applicable.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as would be relevant for an algorithm.

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

Not applicable.

Summary of Relevant Information from the Document:

While most of your questions are not applicable to this type of regulatory submission, here's what can be extracted that is tangentially related:

• Device Purpose and Rationale for Equivalence: The AcuCam® Intraoral Camera Sheath is a single-use device intended to prevent contamination of intraoral camera systems with saliva and other bodily fluids. Its safety and effectiveness are established by demonstrating substantial equivalence to a predicate device (Sanitherm Oral Disposable Thermometer Sheath, K983406).
• Key Equivalence Factors:
  • Identical Indications for Use: Both devices are used to prevent contamination.
  • Identical Materials: The AcuCam sheath is manufactured with the same materials as the predicate.
  • Identical Manufacturing Process: The manufacturing process is the same.
  • Identical Inspection and Test Procedures: The procedures used for quality control are the same.
  • Difference: The only noted difference between the AcuCam sheath and the predicate device is its size, to accommodate intraoral camera handpieces.
• Biocompatibility Testing: Biocompatibility of the materials used in the AcuCam sheath was demonstrated in accordance with ISO 10993-5. This is a common "acceptance criterion" for materials in contact with the body, ensuring the material itself does not cause harm. However, no specific test results (e.g., cytotoxicity scores) are provided, only that it "was conducted in accordance with" the standard.
• Conclusion of Substantial Equivalence: The FDA's letter (K994211) indicates that the device has been found substantially equivalent to the legally marketed predicate. This substantial equivalence determination serves as the "proof" that the device meets regulatory requirements for marketing.

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