(16 days)
The SenoCor 360™ Biopsy Device is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is intended 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 is a 510(k) premarket notification FDA letter for the "SenoCor 360™ Circumferential Vacuum-Assisted Biopsy Device." This document approves the device for marketing based on its substantial equivalence to a legally marketed predicate device.
Unfortunately, the letter does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.
This type of FDA letter typically refers to a submission made by the manufacturer (K023923 in this case), which would contain the specifics of any performance studies, acceptance criteria, and their results. The letter itself is primarily a regulatory approval and does not delve into the technical details of the validation studies.
Therefore, I cannot provide the requested information from the given text regarding:
- A table of acceptance criteria and the reported device performance
- Sample sizes used for the test set and data provenance
- Number of experts and their qualifications for ground truth
- Adjudication method
- MRMC comparative effectiveness study details (effect size)
- Standalone performance study details
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
To obtain this information, one would need to access the full K023923 premarket notification submission documents, which are not included in the provided text.
§ 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.