(132 days)
The ExpressCore Full Core Biopsy Device is intended for use in obtaining biopsies from soft tissues.
The ExpressCore Device is a sterile, single patient use, hand held full core biopsy device comprised of a plastic handle and three stainless steel needle components that work in sequence to capture a full core biopsy sample. The device is capable of infinitely variable throw distance between 10 and 30mm and is equipped with multiple firing modes to accommodate procedural requirements and physician preference. Multiple device gauge size and needle option combinations have been developed from 12ga x 10cm to 18ga x 25cm.
This FDA 510(k) clearance letter pertains to a device, the ExpressCore Biopsy Device, not an AI/ML software. The provided text details the device's characteristics, intended use, and comparison to predicate devices, but it does not include information about a study that proves the device meets specific acceptance criteria in the context of an AI/ML algorithm.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance (for an AI/ML algorithm)
- Sample sized used for the test set and data provenance (for an AI/ML algorithm's test set)
- Number of experts used to establish ground truth and qualifications (for an AI/ML algorithm's ground truth)
- Adjudication method (for an AI/ML algorithm's test set)
- MRMC comparative effectiveness study (as this is a physical device, not an AI system assisting human readers)
- Standalone performance (as this is a physical device, not an AI algorithm)
- Type of ground truth used (for an AI/ML algorithm)
- Sample size for the training set (as this is a physical device, not an AI algorithm)
- How the ground truth for the training set was established (as this is a physical device, not an AI algorithm)
The document focuses on the physical and functional characteristics of the biopsy device and demonstrates substantial equivalence to existing predicate devices through bench performance testing, biocompatibility, sterilization, packaging, and shelf life data.
Key information from the provided text relevant to device testing (not AI/ML):
- Type of Study: Non-Clinical Bench Performance Testing, Biocompatibility, Sterilization, Packaging, Shelf Life.
- Purpose of Study: To confirm the device meets all system requirements and is substantially equivalent to the predicate device.
- Specific Tests Mentioned:
- Usability of the Device
- Biopsy Sample Collection
- Finger Cannula Tensile Test
- Spoon Cannula Tensile Test
- Stylet Tensile Test
- Representative Tissue Sampling
This document is a 510(k) clearance for a physical medical device, not a review of an AI/ML-based medical device.
§ 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.