(13 days)
The Manan™ Liver Biopsy Kit is used for obtaining liver biopsies or for other biopsies of soft tissue.
The Manan Liver Biopsy Kit is composed of a cutting biopsy needle based upon the Menghini cutting tip geometry that is fitted to a locking syringe.
The provided text describes a 510(k) premarket notification for the Manan™ Liver Biopsy Kit, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria in the way an AI/ML medical device submission would.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set size) are not applicable to this type of device and submission.
Here's a breakdown of the available information based on your request, highlighting what is not applicable:
1. A table of acceptance criteria and the reported device performance
For a traditional medical device like a biopsy kit, acceptance criteria are generally related to its physical characteristics, functionality, material compatibility, and sterile packaging. The provided document, a 510(k) summary, does not detail these specific criteria or their performance validation tests. Instead, it relies on demonstrating substantial equivalence to a predicate device already on the market.
| Acceptance Criteria Category | Reported Device Performance (as implied by 510(k) submission) |
|---|---|
| Functionality | "used for obtaining liver biopsies or for other biopsies of soft tissue" (Indications for Use). Assumed to function similarly to the predicate device Manan Medical Products Liver Biopsy Kit (K943650). |
| Device Design | "composed of a cutting biopsy needle based upon the Menghini cutting tip geometry that is fitted to a locking syringe." Assumed to be sufficiently similar to the predicate device. |
| Materials | Not explicitly stated, but implied to be suitable for medical use and substantial equivalence. |
| Sterility | Not explicitly stated, but expected for a biopsy kit. Compliance with "general controls provisions of the Act" and "Good Manufacturing Practice requirements" (21 CFR Part 820) implies sterility considerations. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This 510(k) submission does not describe a clinical study with a test set of data in the context of an AI/ML device. Substantial equivalence for this type of device is typically demonstrated through engineering tests, biocompatibility assessments, and comparisons of physical characteristics and intended use to a legally marketed predicate device, rather than performance on a clinical "test set" of 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)
- Not Applicable. There is no "ground truth" establishment in the context of a clinical test set for this device as it's not an AI/ML diagnostic tool.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or expert adjudication in this context.
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
- Not Applicable. This is a physical biopsy kit, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. Not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No ground truth in the context of an AI/ML evaluation. The "ground truth" for a device like this is its physical and functional attributes meeting design specifications and being suitable for its intended use, which is assessed through bench testing and often comparison to an already approved predicate.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device, so no training set is involved.
9. How the ground truth for the training set was established
- Not Applicable. No training set or associated ground truth.
§ 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.