(84 days)
The Mathis Vertebral and Bone Biopsy Systems are intended for use by physicians performing bone marrow biopsy procedures.
The Mathis Vertebral and Bone Biopsy System is a standard bone marrow biopsy needle consisting of a cannula with a sharpened distal end and a stylet received coaxially in the cannula and having a sharpened distal end protruding from the distal end of the cannula. The cannula is insert molded to a hub with standard threadable lug tabs. The stylet is insert molded to a standard hub. When the stylet assembly is placed into the cannula assembly, the entire cannula/stylet unit can be threaded into a removable gripable handle.
The provided text describes a 510(k) submission for the Mathis Vertebral and Bone Biopsy System, which is a standard bone marrow biopsy needle. The submission aims to demonstrate substantial equivalence to a predicate device, the Manan Bone Marrow Aspiration / Biopsy Needle (K890925).
Based on the provided information, no specific acceptance criteria or an associated study proving the device meets those criteria are mentioned in the typical sense for a diagnostic or imaging device. This 510(k) summary focuses on demonstrating substantial equivalence based on technological characteristics and non-clinical data, rather than performance metrics.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Technological Characteristics: The device should not substantially differ its stylet and cannula point geometry from products currently available in the market to facilitate bone penetration. | "The Mathis Vertebral and Bone Biopsy System will not substantially differ its stylet and cannula point geometry from product currently available in the market." |
| Substantial Equivalence to Predicate Device: The device must be deemed substantially equivalent to the predicate device (Manan Bone Marrow Aspiration / Biopsy Needle K890925) based on its key technical performance characteristics. | "Part specification and prints for the Mathis Vertebral and Bone Biopsy System show it to be substantially equivalent to the Manan Bone Marrow Aspiration/Biopsy Needle." |
| "It is the conclusion of International Medical Systems that the Mathis Vertebral and Bone Biopsy System is substantially equivalent, relative to its key technical performance characteristics, to product already available in the market." | |
| "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent..." (FDA statement) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "Clinical Performance Data: None available at this time."
Therefore, no test set, sample size, or data provenance related to clinical performance is mentioned. The submission relies on non-clinical data (part specifications and prints) and comparison of technological characteristics.
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. No clinical test set was used, and thus no expert ground truth establishment for a test set is discussed. The "ground truth" for the substantial equivalence claim appears to be based on engineering specifications and comparison to the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set was used.
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 non-AI medical device (bone biopsy needle). No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a manual medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the substantial equivalence claim appears to be based on:
- Comparison of technological characteristics (point geometry of the cannula and stylet) to currently marketed devices.
- Part specifications and prints of the Mathis device demonstrating equivalence to the predicate device.
- The FDA's review and determination of substantial equivalence based on the provided engineering and descriptive information.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device. No training set was used.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
§ 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.