(78 days)
This device is an automated, disposable and adjustable biopsy instrument designed for ultimate accuracy in obtaining high quality histological core samples, with three different choice of penetration depth and obtaining histological samples from 0.8 to 1.9 mm length.
This device is an automatic disposable biopsy Needle developed for taking a range of tissue specimens, including those from the prostate, kidney and liver.
The provided text for K962905, "TX® Biopsy Needle," does not contain information regarding detailed acceptance criteria, a study proving the device meets those criteria, or most of the other requested information. The submission is from 1996, and the regulatory requirements and expectations for performance studies were significantly different from today's standards, especially for AI/ML-driven devices.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided text does not define specific quantitative acceptance criteria or performance metrics such as sensitivity, specificity, accuracy, or other performance characteristics for the biopsy needle beyond basic functional and safety tests.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Gun Firing Test | passed |
| Pyrogen Test (LAL) | passed |
| Biocompatibility | Passed (based on supplier data) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the summary. The "Gun Firing Test" and "Pyrogen Test" are likely laboratory tests, not clinical studies involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the device is a biopsy needle, not an AI or diagnostic imaging device that requires expert interpretation for ground truth. The tests mentioned are mechanical and biological safety tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the type of tests described.
5. 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
This information is not applicable. The device is a biopsy needle, not an AI-based diagnostic tool. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the "Gun Firing Test" and "Pyrogen Test," the "ground truth" would be the predefined pass/fail criteria for those specific laboratory tests, not expert consensus or pathology. For biocompatibility, the ground truth would be established by standard biological safety testing protocols.
8. The sample size for the training set
This information is not applicable. The device is not an AI/ML model, so there is no training set in the conventional sense.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as above.
Summary of what is present:
The K962905 summary focuses on establishing substantial equivalence to a predicate device (Promedical Ltd. - PRO-B Biopsy Needle, K951598) based on technological characteristics and basic safety/performance tests. The tests listed are:
- Gun Firing Test (TX/F/T): Passed. This likely assesses the mechanical function of the automated biopsy mechanism.
- Pyrogen Test (LAL): Passed. This tests for the presence of bacterial endotoxins, indicating the sterility aspect of the disposable device.
- Biocompatibility tests: Performed by the supplier of the raw material and implicitly passed since the device was cleared. These tests ensure the materials used are safe for contact with human tissue.
The document does not delve into clinical efficacy studies, diagnostic performance metrics, or AI/ML-specific details, as these were not relevant to the device's nature or the regulatory context of 1996 for this type of product.
§ 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.