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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:

1. 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.
2. Sample size used for the test set and the data provenance: Not applicable, as there's no diagnostic test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not conducted.
6. Standalone (algorithm only) performance: Not applicable; this is a physical biopsy needle, not an algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. 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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