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The device is indicated for use in general surgery, gynecology and oncology. The system is designed to destroy tissue by the application of extreme cold temperatures. In addition the system is intended for use in the following indications:

General Surgery

• Ablation of breast fibroadenoma .
• Localization of breast lesions .

Gynecology

• Ablation of malignant neoplasia or benign dysplasia of the female genitalia .
  Oncology
• Ablation of cancerous or malignant tissue .
• Ablation of benign tumors ●
• Palliative intervention

The Visica Treatment System consists of a control unit that controls one single-use, disposable (Visica Treatment Device or "cryoprobe"). The system utilizes incrt argon gas as a cooling agent and helium for thawing. The cystem unit operates from standard 120/240 VAC wall power and is control by a CPLD (Complex Programmable Logic Device). An LED screen displays the status of the system. System control is accomplished directly through keys on the console itself.

The cryoprobe operates on the Joule-Thompson principle and the refrigerative capacity is limited only the distal tip of the probe. The cryoprobe incorporates a thermocouple to measure temperature near the probe tip. The thermocouple is mounted inside the cryoprobe tip and its signal is used to monitor and control some operations of the system. The control unit can also accommodate two independent on the ts manitant to monitor temperatures in the surrounding tissues. The temperature probes use standard T-type needle thermocouples.

The provided text is a 510(k) summary for the Sanarus Visica Treatment System, which is a cryosurgical unit. This document is a regulatory submission to the FDA, primarily focusing on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria in the way new AI/ML device submissions might.

Therefore, much of the requested information regarding acceptance criteria, performance metrics, sample sizes for test/training sets, ground truth establishment, expert qualifications, and human-in-the-loop studies is not present in this document. The 510(k) summary aims to show that the modified device has the "same indications for use and technological characteristics" as its predicate and that "performance testing confirms that modifications to the Instructions for Use meet applicable specifications and performance standards and are equivalent to the predicate device."

However, I can extract the available information and indicate what is not present.

Here's a breakdown of the available information based on your request:

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

This information is not present in the provided 510(k) summary. The document states that "Performance testing confirms that modifications to the Instructions for Use meet applicable specifications and performance standards and are equivalent to the predicate device," but it does not detail specific acceptance criteria or the reported performance metrics of those tests.

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

This information is not present in the provided 510(k) summary. The document does not describe a clinical study with a test set of data for performance evaluation in the context of AI/ML device assessment.

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)

This information is not present in the provided 510(k) summary. Since this is a cryosurgical device, and not an AI/ML diagnostic tool, the concept of "ground truth" derived from expert consensus on a test set (as typically seen in AI/ML performance studies) is not applicable here.

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

This information is not present in the provided 510(k) summary.

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

This information is not present in the provided 510(k) summary. This type of study is relevant for AI/ML diagnostic systems, not for a cryosurgical treatment device like the Sanarus Visica Treatment System.

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

This information is not present in the provided 510(k) summary. The device is a physical cryosurgical system, not a standalone algorithm.

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

This information is not present in the provided 510(k) summary.

8. The sample size for the training set

This information is not present in the provided 510(k) summary. Training sets are typically associated with AI/ML model development, which is not the focus of this 510(k) for a physical cryosurgical device.

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

This information is not present in the provided 510(k) summary.

Summary of Device and Regulatory Context (based on provided text):

• Device Name: Sanarus Visica® Treatment System
• Device Type: Cryosurgical unit and accessories (Class II, Product Code: GEH)
• Indications for Use:
  • General Surgery: Ablation of breast fibroadenoma, Localization of breast lesions.
  • Gynecology: Ablation of malignant neoplasia or benign dysplasia of the female genitalia.
  • Oncology: Ablation of cancerous or malignant tissue, Ablation of benign tumors, Palliative intervention.
• Predicate Device: Sanarus Visica Treatment System (K022314, Oct 15, 2002; K052861, Nov 15, 2005)
• Substantial Equivalence Claim: The current device has the "same indications for use and technological characteristics as the predicate device," including identical patient contact components, materials, packaging, sterilization methods, and sterility assurance level.
• Performance Testing Mention: "Performance testing confirms that modifications to the Instructions for Use meet applicable specifications and performance standards and are equivalent to the predicate device." This statement implies that engineering and functional tests were conducted to ensure the device performs as intended and equivalently to its predicate, but the details of these tests, acceptance criteria, and specific performance results are not included in this summary.

In essence, this 510(k) summary is for a traditional medical device demonstrating substantial equivalence, not for an AI/ML-driven device, which would typically involve the detailed performance study information you've requested.

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