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The en-bloc Biopsy System is intended for diagnostic sampling of breast tissue during a breast biopsy procedure.

The en-bloc is a high frequency, vacuum-assisted electrosurgical device used to remove and simultaneous capture of an incised tissue volume. The Neothermia en-bloc TM consists of a hand-held biopsy handle, upon which the single use disposable Probe is attached, with an integral cable to connect the handle to the en-bloc Electrosurgical Generator. The Probe contains two sets of active electrodes at its distal end - a precursor electrode and cutting/capture electrodes. The shaft of the Probe™ is encased in a stainless steel cannula. A plastic sleeve surrounds this stainless steel cannula and an annular gap between the sleeve and the cannula provides a conduit for vacuumassisted removal of the gaseous products of electrosurgical cutting and any liquids (e.g., blood) that may accumulate at the distal end of the Probe during the biopsy procedure.

The provided text is a 510(k) summary for the Neothermia Corporation's en-bloc Biopsy System™. It discusses the device's intended use, technological characteristics, and a performance study. However, it does not provide specific acceptance criteria in a quantifiable manner, nor does it detail a study that explicitly "proves the device meets acceptance criteria" with the level of detail requested in your prompt (e.g., sample sizes, expert qualifications, ground truth methodology as typically seen in AI/diagnostic device studies).

This submission focuses on demonstrating substantial equivalence to predicate devices, particularly the ability to obtain viable tissue samples for pathology, rather than statistical performance against predefined clinical metrics.

Here's an attempt to extract the information you requested based on the limited data, acknowledging where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are inferred from the stated purpose of the performance testing and the general concept of substantial equivalence for a biopsy device. No quantitative thresholds (e.g., "capture rate > 95%", "fragmentation rate < 2%") are provided in this summary.

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

• Sample Size for Test Set: Not explicitly stated, but the testing was conducted "on porcine tissue."
• Data Provenance: Porcine tissue (animal model). The data is likely prospective as it was collected for the purpose of this evaluation. The country of origin of the porcine tissue is not mentioned.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. However, the evaluation mentions "pathology evaluation" and "histopathologic examination," implying that pathologists or histotechnicians would have been involved in assessing the suitability of the specimens.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. Given the nature of the "pathology evaluation," it likely involved one or more experts assessing the tissue samples.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This document describes a device for tissue extraction, not an interpretation aid for diagnostic imaging, which is where MRMC studies are typically employed for AI products.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: Not applicable. This is a physical biopsy device, not a diagnostic algorithm or AI system.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth was based on the histopathologic examination of the excised porcine tissue. This assessed whether the specimens were "intact, unfragmented," had a "predictable diameter and length," and were generally "suitable for post-biopsy histopathologic examination."

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is not an AI/algorithm that requires a training set. The performance testing was for the physical device's cutting and capture capabilities.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this type of device.

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