(10 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™. It focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting a study with specific acceptance criteria and performance metrics for a new device's efficacy or accuracy.
Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, efficacy studies (MRMC, standalone), and ground truth establishment cannot be extracted from this document. This document primarily describes the device, its intended use, and argues for its substantial equivalence based on technological characteristics and principles of operation.
Here's what can be extracted and a clear statement of what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. This document does not specify performance acceptance criteria or report performance data to meet such criteria. It focuses on demonstrating equivalence in design and intended use to existing devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document does not describe any specific test set or clinical study to evaluate the device's performance. It primarily discusses the manufacturing modification of the probe and its similarity to predicate devices.
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)
- Cannot be provided. No test set or ground truth establishment is described in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No test set or adjudication process 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
- Cannot be provided. This device is an electrosurgical biopsy system, not an AI-powered diagnostic tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. This device does not have an "algorithm only" component. It is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. No ground truth is mentioned as no performance study is detailed.
8. The sample size for the training set
- Cannot be provided. This document is for a physical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Cannot be provided. (Same reason as above).
Summary of available information from the document:
This 510(k) summary is for a modification to an existing device, specifically the Neothermia Corporation's en-bloc Biopsy System™. The submission argues for substantial equivalence to previously cleared versions of the device, rather than presenting new performance data for a novel device.
- Device Name: en-bloc Biopsy System™
- Intended Use: Diagnostic sampling of breast tissue during a breast biopsy procedure.
- Technological Characteristics: Percutaneous high frequency, automated, vacuum-assisted electrosurgical device used to remove tissue by automated electrosurgical cutting and simultaneous capture of incised tissue volume.
- Predicate Devices: Neothermia's cleared 10mm, 12mm, 15mm, and 20mm en-bloc probes.
- Basis for Substantial Equivalence: The probe with the manufacturing modification has the "same intended use, principles of operation, and technological characteristics" as the previously cleared predicate devices. Both the modified probe and predicate devices are electrosurgical devices used to biopsy breast tissue.
§ 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.