(90 days)
This device is an automated, disposable biopsy needle and can be used in Fluoroscopic, CT and Mammographic procedures to obtain biopsies of various tissues including those from Prostate Kidney, Breast and Liver.
This device is an automated, disposable biopsy needle
This document is a 510(k) summary for the BIOSPEED™ Spring Loaded Biopsy Needle. It outlines the product, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information regarding clinical studies, acceptance criteria, or device performance data.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and the reported device performance: This document does not present any performance data or acceptance criteria.
- 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: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned. This type of study would not typically be applicable to a basic biopsy needle like this, which is a physical instrument rather than an AI-enabled diagnostic tool.
- If a standalone study was done: Not mentioned. Again, for a physical instrument, "standalone" performance (without human interaction) isn't a relevant concept in the same way it would be for an AI algorithm.
- The type of ground truth used: Not mentioned.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
Conclusion: The provided document is a regulatory submission summary primarily focused on establishing substantial equivalence for a medical device. It does not contain the detailed clinical study design, performance data, or ground truth establishment information required to answer your specific questions about acceptance criteria and device performance studies. Such information would typically be found in a separate, more comprehensive testing report or clinical study report, which is not part of this 510(k) summary.
§ 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.