(14 days)
The en-bloc Biopsy System is intended for diagnostic sampling of breast tissue during a breast biopsy procedure.
The en-bloc is a percutaneous high frequency, automated, vacuum-assisted electrosurgical device used to remove tissue by automated electrosurgical cutting and simultaneous capture of an incised tissue volume. The Neothermia en-bloc ™ consists of a hand-held biopsy handle, upon which the single-use en-bloc Biopsy Probe is attached, with an integral cable to connect the handle to the control unit. 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. An outer plastic sleeve surrounds this stainless steel cannula and an annular gap between the sleeve and the cannula provides a conduit for vacuum-assisted 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 vacuum also helps maintain the required cutting arc during automated tissue capture.
The provided text is a 510(k) summary for the Neothermia Corporation's en-bloc Biopsy System and an FDA clearance letter. It focuses on demonstrating substantial equivalence to pre-existing, legally marketed devices. It does not contain information about acceptance criteria, detailed study designs, or performance metrics in the way a clinical trial report or a comprehensive validation study would.
Therefore, I cannot provide the requested information in the format you specified. The document explicitly states that "The dimensional change does not raise new questions of safety or efficacy. The modified probe is substantially equivalent to Neothermia's cleared en-bloc probes." This indicates that the clearance was based on equivalence to existing devices rather than new performance data against specific acceptance criteria.
Here's why each point you requested is not available in the provided text:
- A table of acceptance criteria and the reported device performance: Not present. The submission focuses on substantial equivalence based on intended use, principles of operation, and technological characteristics, not on quantitative performance metrics or acceptance criteria.
- Sample size used for the test set and the data provenance: Not present. No test set or associated data is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No ground truth establishment is described.
- Adjudication method for the test set: Not present. No adjudication is described.
- 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 present. This device is an electrosurgical biopsy system, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. This is a physical medical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not present.
- The sample size for the training set: Not present. No training set is mentioned as this is not an AI/ML device.
- How the ground truth for the training set was established: Not present.
In summary, the provided 510(k) summary and FDA clearance letter do not contain the type of detailed performance data and study information you requested because the clearance was granted based on substantial equivalence, not a de novo pathway requiring extensive new performance data against specific acceptance criteria.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.