(435 days)
Needles can be used in MRI, Flouroscopic, CT and Mammographic procedures for obtaining biopsies of various tissues.
MRI Chiba Needle, MRI Spinal Needle, MRI Automatic Cutting Needle, MRI General Purpose Introducer Needle, MRI Techna-Cut Biopsy Needle, MRI Super-Core Biopsy Needle, MRI Breast Localization Needle, and MRI Simon Breast Localization Needle
The provided text is a 510(k) clearance letter from the FDA for a set of MRI-compatible needles. It states that the devices are substantially equivalent to devices marketed prior to May 28, 1976. This type of clearance does not require the submission of clinical study data demonstrating specific performance criteria or a study proving the device meets those criteria.
Therefore, based solely on the provided text, the following information cannot be extracted:
- A table of acceptance criteria and the reported device performance: Not provided. The 510(k) clearance simply asserts substantial equivalence, not specific performance metrics.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- 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: Not applicable. This is for medical devices, specifically needles, and not an AI or imaging diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for medical devices, specifically needles, and not an AI or imaging diagnostic device.
- The type of ground truth used: Not applicable, as there's no study described for performance evaluation.
- The sample size for the training set: Not applicable, as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.
Summary based on the provided document:
The document is an FDA 510(k) clearance letter confirming that the listed MRI needles are substantially equivalent to predicate devices already on the market. It does not contain information about specific acceptance criteria, performance studies, or clinical trial data that would be relevant to evaluating new performance claims for an AI or diagnostic device. The clearance is based on the devices being comparable to existing ones, rather than demonstrating novel performance against defined criteria through a study.
§ 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.