(13 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 document is a 510(k) Pre-market Notification for the Neothermia Corporation's en-bloc Biopsy System™. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a new device or algorithm.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not directly applicable or available in this type of submission.
Here's an analysis based on the provided text, highlighting what is and isn't present:
Key Takeaway: This 510(k) submission is for a modified version of an already cleared device ("modified cradle") and aims to show it has the "same intended use, principles of operation, and technological characteristics as the previously cleared predicate devices." It explicitly states, "The change does not raise new questions of safety or efficacy." This type of submission does not typically include new performance studies with specific acceptance criteria in the way a novel device or AI algorithm would.
1. A table of acceptance criteria and the reported device performance
- Not Applicable. This submission is based on substantial equivalence to predicate devices, not on proving new performance against defined acceptance criteria with reported metrics. The document asserts that the modified device has the "same intended use, principles of operation, and technological characteristics" as existing cleared predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No specific test set data is described for performance evaluation in this 510(k) summary. Given it's a "modified cradle" and not a fundamentally new device, performance testing (if any) would likely be limited to verification and validation of the modification's impact, not a full-scale clinical or diagnostic accuracy study.
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. No test set requiring expert-established ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set is described.
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. This is an electrosurgical biopsy system, not an AI-based diagnostic tool. Therefore, an MRMC study related to AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware device (electrosurgical biopsy system). There is no "algorithm only" component to test for standalone performance in the context of diagnostic accuracy.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. No specific ground truth establishment for a performance study is mentioned in this submission. The device itself is intended for diagnostic sampling of breast tissue, implying that the tissue samples it yields would then be subject to pathology for definitive diagnosis.
8. The sample size for the training set
- Not Applicable. This is an electrosurgical device, not a machine learning algorithm. Therefore, there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. No training set is involved.
Summary regarding acceptance criteria and studies:
The provided text from the 510(k) summary emphasizes substantial equivalence to predicate devices. The core argument is that the "modified cradle" of the en-bloc Biopsy System™ retains the "same intended use, principles of operation, and technological characteristics" as previously cleared devices, and that the modification "does not raise new questions of safety or efficacy."
Therefore, this document does not contain information about:
- Specific quantitative acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy).
- Clinical studies or diagnostic accuracy studies with sample sizes, data provenance, ground truth establishment, or reader performance metrics.
- Any AI-related performance metrics or studies.
The "study" implicitly referenced is the comparison to predicate devices, demonstrating that the modified device is similar enough not to warrant new, extensive performance studies typically required for novel devices.
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.