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The Aaron 910 handpiece Sheath is intended to be used as an accessory to electrosurgical handpieces. The sheath is placed over the handpiece and provides a barrier to minimize contamination. The Handpiece Sheath is non-sterile and is intended for single patient use only.

The Aaron A910 Handpiece Sheath is a non-sterile, disposable electrosurgical handpiece cover that is designed to fit over an electrosurgical handpiece to provide a barrier between the handpiece and the patient, thus prevent contamination of the handpiece.

The provided text is a 510(k) summary for the Aaron A910 Handpiece Sheath. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding specific acceptance criteria, detailed study design, sample sizes, expert involvement, and ground truth types is not applicable to this type of regulatory submission.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device 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. This submission is based on demonstrating substantial equivalence to predicate devices, not on a clinical performance study with a test set. This means no specific sample size for a test set or data provenance from a prospective/retrospective study is reported. The "test" in this context refers to a hazard analysis, not 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. As no clinical performance study was conducted on a test set requiring expert-established ground truth, this information is not provided. The evaluation was primarily engineering and regulatory in nature, comparing the device to existing predicate devices.

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

• Not Applicable. No clinical performance study requiring adjudication of a test set was performed.

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 an electrosurgical handpiece sheath, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI-related effect size are entirely irrelevant to its submission.

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

• Not Applicable. This is a medical device accessory (a sheath), not an algorithm or AI system.

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

• Not Applicable. The "ground truth" in this context is the established safety and effectiveness of the legally marketed predicate devices, against which the new device is compared. There is no biological or clinical "ground truth" generated for the Aaron A910 itself in this submission.

8. The sample size for the training set

• Not Applicable. This is not a machine learning or AI device, so there is no concept of a "training set" in this submission.

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

• Not Applicable. As there is no training set, there is no ground truth established for it.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" described in the 510(k) summary is not a clinical trial or a performance study in the traditional sense. Instead, it is a demonstration of substantial equivalence to legally marketed predicate devices. The evidence for equivalence includes:

• Hazard Analysis: Evaluations were performed to confirm that the Aaron A910 presents "no new hazards" compared to the predicate devices.
• Comparative Analysis: The submission asserts that the Aaron A910 Handpiece Sheath is "substantially equivalent" in:
  • Design
  • Intended Use
  • Materials
  • Method of Preparation
  • Performance Claims
• Predicate Device Identification: Specific predicate devices are listed and referenced (Geiger Medical Technologies Handpiece Sheath K-992149, Banta Healthcare Sanitherm Thermometer Sheath K983406, Aspen Laboratories/Conmed Handpiece Sheath K-963088, and Aaron Medical High Temperature Replacement Tip drape K-945758). The regulatory process assumes that if the new device is sufficiently similar to a device already deemed safe and effective, then the new device is also safe and effective.

In conclusion, for this type of device and regulatory submission (510(k) for substantial equivalence), a formal clinical study with detailed acceptance criteria, sample sizes, and expert adjudication as typically seen for novel diagnostic or therapeutic devices is not required or presented. The "proof" lies in the successful comparison to established, legally marketed predicate devices.

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