(56 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.q., 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 II Rotational Core Biopsy System consists of a sticking needle, cutting cannula, fully integrated control unit and specimen container. The sticking needle is operated by the control unit and uses cold temperatures at its tip to engage the tissue to be sampled. The cutting cannula is coaxially mounted around the sticking needle and is used to core the tissue specimen. The cutting cannula will be available in several qauge sizes and lengths.
The provided text describes the Sanarus Centrica™ II Rotational Core Biopsy System and its substantial equivalence to a predicate device. However, it does not contain information on specific acceptance criteria and a study proving the device meets those criteria in the context of diagnostic accuracy, sensitivity, specificity, or other performance metrics typically associated with AI/software devices.
The document focuses on demonstrating substantial equivalence for a physical medical device (a biopsy system) based on similar indications for use, technological characteristics, and performance testing confirming equivalent sample quality. It does not involve AI or software performance evaluation as would be typical for the detailed questions asked.
Therefore, many of your requested points about acceptance criteria, sample sizes for test and training sets, expert consensus, MRMC studies, or standalone algorithm performance cannot be answered from the provided text.
Here's what can be extracted based on the information given:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Implicit Criteria: Equivalence in sample quality for histological examination. | "Performance testing confirms that the quality of samples obtained with the Sanarus Centrica II Rotational Core Biopsy System is equivalent to the predicate device." (Section 8) |
| Implicit Criteria: Substantial equivalence to predicate device in indications for use, technological characteristics, patient contact components, component materials, packaging, sterilization methods, and sterility assurance level. | The device "has the same indications for use and technological characteristics as the predicate device. The patient contact components and component materials... are the same. The packaging materials, packaging configurations, sterilization methods and sterility assurance level are also equivalent." (Section 7) |
Note: The document implies acceptance criteria by stating how the new device is equivalent to the predicate. Specific numerical targets (e.g., sensitivity, specificity, or specific tissue quality scores) are not provided.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The text only vaguely refers to "Performance testing."
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)
This information is not provided in the document. The evaluation focuses on sample quality for histological examination, presumably by pathologists, but no details are given.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported for this device, as it is a physical biopsy system, not an AI/software diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this device is not an algorithm, so a standalone performance study in that context is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" implicitly referred to is the histological examination of tissue samples, which would involve pathologists. The document states the device provides "breast tissue for histologic examination."
8. The sample size for the training set
This information is not provided in the document. As this is not an AI/ML device, a "training set" in the conventional sense is not applicable.
9. How the ground truth for the training set was established
This information is not provided in the document, and a "training set" is not relevant for this type of device submission.
§ 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.