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The Wi-3 HAL-RAR System is a Bluetooth-enabled, pulsed Doppler, ultrasound system intended to be used for detecting hemorrhoidal arteries, manually ligating these arteries, and subsequently carrying out a mucopexy of hemorrhoidal prolapse if necessary.

The Wi-3 HAL-RAR System is a Bluetooth-enabled, pulsed Doppler, ultrasound system intended to be used for detecting hemorrhoidal arteries, manually ligating these arteries, and subsequently carrying out a mucopexy of hemorrhoidal prolapse if necessary. "HAL" is an acronym referring to "Hemorrhoidal Arteries Ligation", and "RAR" is an acronym referring to "Recto Anal Repair." The Wi-3 HAL-RAR System is designed for use in a surgical suite or operating room.

The Wi-3 HAL-RAR System includes components that come in contact with the patient during use. The RAR Probes (made of acrylic-based multipolymer) and Sleeve (PBT) are external communicating devices having limited contact duration (< 24 hours) with tissue. The Wi-3 Arm (made of Aluminum Alloy) and Wi-3 Fixation Nut (made of polyphenylsulfone and acetal) are surface devices having limited contact duration (< 24 hours) with skin.

This document is a 510(k) premarket notification for the Wi-3 HAL-RAR System and primarily focuses on establishing substantial equivalence to predicate devices, rather than presenting a detailed study proving the device meets specific acceptance criteria in the manner requested. The document outlines non-clinical testing performed, but does not provide specific acceptance criteria or performance results in a quantifiable way for clinical efficacy.

Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance cannot be extracted from this document.

Here's what can be extracted:

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

This information is not provided in the document. The document states that "non-clinical testing" was performed, but does not specify acceptance criteria or quantitative performance results for clinical efficacy. The types of non-clinical tests mentioned are:

• Biocompatibility: Compliant to ISO 10993-1.
• Software Verification: Compliant to IEC 60601-1 and IEC 60601-1-4.
• Electromagnetic Compatibility and Electrical Safety: Compliant to IEC 60601-1-2 and IEC 60601-2-37.

For these non-clinical tests, the "reported device performance" is simply that the device was found to be "in compliance" or "tested in compliance" with the stated standards. No specific performance metrics or quantitative results are given.

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. The document discusses non-clinical testing of the device itself (biocompatibility, software, electrical safety) rather than clinical performance data from a test set of patient data.

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. This document does not describe a study involving expert review for ground truth establishment.

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

Not applicable. This document does not describe a study involving adjudication of a test set.

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. The device described, the Wi-3 HAL-RAR System, is a surgical tool for detecting and ligating hemorrhoidal arteries. It is not an AI-based diagnostic tool, and therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device or document.

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

Not applicable. The Wi-3 HAL-RAR System is a physical medical device (ultrasound system for surgery) used by a human operator, not a standalone algorithm.

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

Not applicable. As noted, the testing described is non-clinical and related to device safety and compliance with standards, not diagnostic or therapeutic efficacy requiring ground truth from clinical data.

8. The sample size for the training set

Not applicable. This document does not describe the development or training of an algorithm using a training set.

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

Not applicable. This document does not describe the development or training of an algorithm using a training set.

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