(78 days)
The device is indicated for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
The device is also 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.
The Sanarus Centrica™ Core Tissue Biopsy System consists of a sticking probe, tissue cutter, control unit and specimen container. The sticking probe is operated by the control unit and utilizes cold temperatures at its tip to engage the tissue to be sampled. The tissue cutter is coaxially mounted around the sticking probe and is used to core the tissue specimen. The tissue cutter will be available in several gauge sizes and lengths.
The provided text describes the Sanarus Centrica™ Core Tissue Biopsy System and its substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria or a study that definitively "proves" the device meets these criteria in the way described by the prompt's request for performance metrics, ground truth establishment, or sample sizes for testing.
Instead, the document states that the new device has "the same indications for use and technological characteristics as the predicate device" and that "Testing confirms that the quality of samples obtained with the Sanarus Centrica™ Core Tissue Biopsy System is equivalent to the predicate device and that the use of a cooled probe to engage the tissue does not affect the histological evaluation." This indicates a substantial equivalence (SE) pathway, which primarily relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring a detailed clinical study demonstrating specific performance metrics against pre-defined acceptance criteria.
Therefore, many of the requested fields cannot be directly extracted from the provided text.
Here's a breakdown of what can and cannot be answered based on the provided input:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Implicit: Quality of samples is equivalent to predicate device. | "Testing confirms that the quality of samples obtained with the Sanarus Centrica™ Core Tissue Biopsy System is equivalent to the predicate device." |
| Implicit: Use of cooled probe does not affect histological evaluation. | "Testing confirms... that the use of a cooled probe to engage the tissue does not affect the histological evaluation." |
| Implicit: Same indications for use as predicate. | "The Sanarus Centrica™ Core Tissue Biopsy System has the same indications for use... as the predicate device." |
| Implicit: Same technological characteristics as predicate. | "The Sanarus Centrica™ Core Tissue Biopsy System has the same... technological characteristics as the predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not specified.
- Data provenance: Not specified.
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 globally refers to "histological evaluation" without detailing the process or personnel involved in ground truth establishment for a specific test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
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 MRMC comparative effectiveness study is described. The device is a biopsy system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable, as this is a physical biopsy device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The document mentions "histological evaluation," implying pathology as the ground truth for tissue sample quality.
8. The sample size for the training set
- Not applicable/not specified. The device is not an AI algorithm that requires a training set in the typical sense. The "testing" mentioned is likely engineering or preclinical testing to demonstrate equivalence.
9. How the ground truth for the training set was established
- Not applicable/not specified.
§ 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.