(149 days)
The device is intended to be used for drawing osteomedullary substances and/or the explantation of bone marrow.
A manually operated biopsy needle used for aspiration or explantation of bony substance.
The provided document describes a medical device, the BIOMID® - Bone Marrow Biopsy Needle, and its safety and effectiveness based on a submission made in April 1996. The document details the physical characteristics and intended use of the device, comparing it to a predicate device (Promedical - Jamshidi style biopsy needle).
However, the provided text does not contain information related to acceptance criteria, device performance metrics (like sensitivity, specificity, AUC), or any study details that would typically be associated with evaluating an AI/ML-based medical device.
The "tests" mentioned are standard biocompatibility and safety tests for a physical medical instrument:
- Intracutaneous Reactivity: Passed
- Acute Systemic Toxicity: Passed
- Pyrogen Test: Passed
- Cytotoxicity: Passed
These tests demonstrate that the materials used in the BIOMID® needle are safe for contact with human tissue and do not cause adverse reactions. They do not involve "device performance" in the sense of diagnostic accuracy or a comparison against a clinical ground truth, which is what your request implies.
Therefore, I cannot provide the requested information, such as:
- A table of acceptance criteria and the reported device performance: No such criteria or performance metrics (e.g., sensitivity, specificity) are mentioned beyond the "Passed" status of the biocompatibility tests.
- Sample size used for the test set and the data provenance: Not applicable, as there's no diagnostic test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not conducted.
- Standalone (algorithm only) performance: Not applicable; this is a physical biopsy needle, not an algorithm.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document describes a traditional medical device submission focused on material safety and equivalence to a predicate device, not an AI/ML-driven diagnostic or assistive technology.
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NOV 27 1996
Image /page/0/Picture/1 description: The image is a logo for Gallini. The logo is a circle with the word "GALLINI" written across the top half of the circle. There is a cross shape inside the circle, with the vertical line of the cross going through the middle of the word "GALLINI". The logo is black and white.
Medical Products and Services
SUMMARY OF SAFETY AND EFFECTIVENESS
OWNER: Gallini s.r.l. 88/90 Via S. Faustino Mirandola, Italy 41037
CONTACT: Paul L. Hawthorne U.S. Representative C/O Coeurage Enterprises 3106 Bretton Court Glen Allen, VA 23060
April, 1996 SUBMISSION DATE:
DEVICE NAME: BIOMID® - Bone Marrow Biopsy Needle
PREDICATE DEVICE: Promedical - Jamshidi style biopsy needle
INTENDED USE: The device is intended to be used for drawing osteomedullary substances and/or the explantation of bone marrow.
DESCRIPTION OF A manually operated biopsy needle used for FUNCTION: aspiration or explantation of bony substance.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS The ACRI® needle is equivalent to the predicate device in terms of technological characteristics and function.
The following tests were performed to demonstrate the safety, performance and efficacy of the product;
| TEST | RESULT |
|---|---|
| Intracutaneous Reactivity | Passed |
| Acute Systemic Toxicity | Passed |
| Pyrogen Test | Passed |
| Cytotoxicity | Passed |
§ 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.