(15 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.
This 510(k) summary provides information about the Neothermia Corporation's en-bloc Biopsy System™, a device for diagnostic sampling of breast tissue. However, it does not contain the specific acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for an AI/ML medical device submission.
This document describes a traditional medical device (electrosurgical generator and biopsy instrument), not an AI/ML powered device. The "Substantial Equivalence" section focuses on comparing its "intended use, principles of operation, and technological characteristics" to previously cleared predicate devices, specifically "Neothermia's cleared 10mm, 15mm and 20mm en-bloc probes," with an emphasis on a "material change" in the new probe.
Therefore, many of the requested categories for AI/ML device studies (like sample size for test sets, expert qualifications, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of 510(k) submission.
I will address the questions based on the information available and indicate when information is not present or not relevant to this type of device submission.
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria or specific reported device performance metrics in the way an AI/ML study would (e.g., sensitivity, specificity, AUC). Instead, the criterion for clearance is substantial equivalence to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to legally marketed predicate devices | - Same intended use |
| - Same principles of operation | |
| - Similar technological characteristics (despite material change) | |
| - Performs diagnostic sampling of breast tissue |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable or not provided. This 510(k) submission for a non-AI/ML device typically does not include a test set sample size or data provenance in the context of an accuracy study. Substantial equivalence is often demonstrated through engineering testing, biocompatibility, sterilization validation, and comparison of design features and intended use.
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. Ground truth, in the context of an AI/ML algorithm's performance on clinical data, is not established for this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are not described for this type of medical device submission.
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. An MRMC study is not relevant for this traditional electrosurgical biopsy system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm; it is a physical electrosurgical system requiring human operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The concept of "ground truth" for evaluating an algorithm's diagnostic performance is not applied in this type of 510(k) submission for a physical device. Performance is generally assessed through functional testing, safety testing, and comparative analysis against predicate device specifications.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/ML algorithm, ground truth establishment for a training set is not relevant.
§ 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.