(23 days)
The EnCapsule Breast Biopsy Device 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.
The EnCapsule Breast Biopsy Device 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 document describes a Rubicor EnCapsule™ Breast Biopsy Device and its 510(k) submission to the FDA. Unfortunately, the document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria.
Here's an analysis based on the available text:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided text. The document states: "Results of in-vitro testing demonstrate that the Rubicor EnCapsule Breast Biopsy Device is safe and effective for its intended function." However, it does not provide specific acceptance criteria or quantitative performance metrics.
2. Sample Size Used for the Test Set and Data Provenance
Not available in the provided text. The document only mentions "in-vitro testing" without detailing the sample size or the nature of the test set (e.g., human tissue samples, phantom, animal models). There is no information on data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable/available. Since the document only refers to "in-vitro testing" and does not describe a human-read or human-interpreted test set, there is no mention of experts establishing ground truth for such a set.
4. Adjudication Method for the Test Set
Not applicable/available. As there's no mention of a human-interpreted test set, an adjudication method is not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of Human Reader Improvement with AI vs. Without AI Assistance
Not applicable. The device described is a physical breast biopsy device, not an AI or software-as-a-medical-device (SaMD) that assists human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device type.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm, so a standalone algorithm performance study is not relevant.
7. The Type of Ground Truth Used
Not explicitly stated due to limited information on the "in-vitro testing." For a physical biopsy device, the ground truth for performance would typically relate to the quality and adequacy of tissue samples obtained (e.g., tissue quantity, integrity, diagnostic yield). The document vaguely refers to "safe and effective for its intended function," implying that the in-vitro tests confirmed the device's ability to collect tissue for histologic examination.
8. The Sample Size for the Training Set
Not applicable/available. This is a physical device, not an algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. As above, this is a physical device, not an algorithm.
In summary, the provided 510(k) summary is very high-level and only states that in-vitro testing was performed to demonstrate safety and effectiveness. It lacks specific details about the study design, acceptance criteria, sample sizes, ground truth establishment, or any human-reader involvement that would be needed to answer your questions comprehensively. The document focuses on establishing substantial equivalence to a predicate device (K023601 & K030049) based on intended use and method of operation, rather than providing detailed performance metrics of a novel study.
§ 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.