(176 days)
Geotek Disposable Core Biopsy Needles (Three Models: Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, and Maxicore-M Automatic Biopsy Needle and Instrument) are intended 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.
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The provided text is related to an FDA 510(k) clearance letter for "Geotek Disposable Core Biopsy Needles." This document does not contain information regarding acceptance criteria or the study that proves the device meets those criteria.
The FDA letter confirms that the device is "substantially equivalent" to legally marketed predicate devices. This determination of substantial equivalence is based on a comparison of the new device to an existing predicate device, considering aspects like indications for use, technological characteristics, and safety and effectiveness information.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and the reported device performance: This document only states the device's intended use and FDA clearance.
- Sample size used for the test set and the data provenance: No performance study details are included.
- Number of experts used to establish the ground truth and their qualifications: No ground truth establishment details are included.
- Adjudication method for the test set: No adjudication method details are included.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No such study is mentioned.
- If a standalone performance was done: No standalone performance study is mentioned.
- The type of ground truth used: Not specified.
- The sample size for the training set: Not applicable as no AI/machine learning device is described.
- How the ground truth for the training set was established: Not applicable.
To obtain such details, one would typically need to refer to the full 510(k) submission, which is not provided here, or other regulatory documents detailing the specific performance studies conducted for the 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.