(39 days)
The Rubicor Flexible Loop Electrosurgical Electrode is intended for diagnostic sampling of breast tissue during breast biopsy procedures. It is to be used for diagnostic purposes only and is not intended for therapeutic uses. It is also intended to be used to cut soft tissue.
The Rubicor Flexible Loop Electrosurgical Electrode is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
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The provided text describes a 510(k) premarket notification for the Rubicor Flexible Loop Electrosurgical Electrode. It details the device's intended use and claims substantial equivalence to predicate devices based on in-vitro testing. However, it does not contain the detailed information necessary to complete all sections of your request regarding acceptance criteria and study specifics.
Here's a breakdown of what can and cannot be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "Results of in-vitro testing demonstrate that the Flexible Loop Electrosurgical Electrode is safe and effective for its intended function." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified (other than "in-vitro testing"). The document does not mention country of origin, nor whether the data was retrospective or prospective.
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 specified. The document only mentions "in-vitro testing," which typically doesn't involve human experts establishing ground truth in the same way clinical imaging studies do.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified as it was in-vitro testing.
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
- No. This document describes an electrosurgical electrode and its safety/effectiveness for tissue sampling. It is not an AI-assisted diagnostic device, and therefore, an MRMC comparative effectiveness study involving human readers and AI is not relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This device is a surgical instrument, not a standalone diagnostic algorithm. Its performance is tied to its physical function in tissue sampling.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For "in-vitro testing," ground truth would typically refer to established physical or chemical properties, measurements, or the ability to perform the intended function (e.g., cut soft tissue, collect samples for subsequent histologic examination). The document implies the ability to provide tissue samples for histologic examination, but the specific "ground truth" for the in-vitro performance itself is not detailed.
8. The sample size for the training set
- Not applicable/Not specified. This is a conventional medical device, not an AI/machine learning model that would require a "training set."
9. How the ground truth for the training set was established
- Not applicable, as there is no "training set" for this type of device.
Summary of Study:
The document states that "Results of in-vitro testing demonstrate that the Flexible Loop Electrosurgical Electrode is safe and effective for its intended function." This indicates a study was conducted in a laboratory setting, likely involving tests to assess the device's ability to cut soft tissue and collect samples, as per its intended use for diagnostic sampling of breast tissue. The study aimed to show substantial equivalence to predicate devices like the Rubicor EnCapsule™ Breast Biopsy Device, SenoRx Shape Select Scalpel, Wallach LOOP Electrodes, and Megadyne Electrosurgical Electrode. However, no specific details about the methods, sample sizes, or precise outcomes of this in-vitro testing are provided beyond the general statement of safety and effectiveness.
§ 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.