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• · The Intact® Gen2 System is indicated to provide tissue sampling of breast abnormalities.
• · The Intact® Gen2 System is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality.
• · The Intact · Gen2 System is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
• The Intact Gen2 System is intended to preserve lesion architecture in samples with a diameter of 12–30 mm. .

The intent of the device is to be a biopsy tool to capture a sample of breast tissue in one intact sample to preserve the tissue architecture for histologic examination. The device is a highfrequency, vacuum-assisted electrosurgical device used to remove tissue by electrosurgical cutting and simultaneous capture of an incised tissue volume. The device includes the following components:

1. Probe/Wand
   Intact® Gen2 Probe/wand (Sizes: 12mm, 15mm, 20mm and 30mm)
2. Handle
3. Gen2 Controller with Power Cord and Foot Pedal
4. Table Mount
5. Cart

The provided text describes a 510(k) premarket notification for the Intact Gen2 System, which is a biopsy instrument. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than a study proving the device meets specific acceptance criteria based on diagnostic performance metrics. Therefore, many of the requested details about acceptance criteria, performance metrics (like sensitivity, specificity), ground truth, and expert involvement are not available in this document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a "Verification Testing Summary Table" for comparing the proposed Intact Gen2 System with its predicate device (Intact BLES System). The acceptance criteria are generally "Pass," indicating that the device met the requirements of the specified standards. The performance is reported as "Pass" for both the proposed and predicate devices in most categories, with comments often stating "Equivalent."

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "extensive bench and animal testing" but does not specify the sample size used for these tests.
The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data provided. The testing appears to be primarily laboratory-based (bench and animal testing).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not available in the provided text. Since the study focuses on engineering and performance characteristics (like energy delivery and thermal artifacts) using bench and animal models, the concept of "ground truth" established by clinical experts (like radiologists) for diagnostic performance is not applicable in the context described.

4. Adjudication Method for the Test Set

This information is not available. Given the nature of the testing described (bench and animal studies for electrosurgical properties), an adjudication method in the context of clinical interpretation by multiple readers is not relevant.

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

There is no mention of an MRMC comparative effectiveness study in this document. The device is a biopsy instrument, not an AI-assisted diagnostic tool.

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

This is not applicable. The device is an electrosurgical biopsy instrument, not an algorithm, and it requires human operation.

7. The Type of Ground Truth Used

For the "Bench Performance Verification Test" and "Thermal Artifact Verification Testing," the ground truth implicitly refers to:

• Measurement of energy delivered to biopsy tissue samples.
• Assessment of thermal artifacts in biopsy tissue samples.
  These are objective, measurable physical properties, likely evaluated using standard laboratory techniques and instruments, rather than clinical ground truth like pathology or outcomes data. The document states the goal was to demonstrate equivalence to the predicate device in these aspects.

8. The Sample Size for the Training Set

This is not applicable. The device is a biopsy instrument and does not involve AI or machine learning models that require a "training set."

9. How the Ground Truth for the Training Set was Established

This is not applicable for the reasons stated above.

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