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These devices are intended to be used to obtain percutaneous biopsy samples of Bone Marrow.

A. Intended Use: These devices are intended to be used to obtain percutaneous biopsy samples of Bone Marrow. B. Materials: 304 Stainless Steel and polycarbonate or similar material. For more detail about materials refer to Section I - Attachments A. C. Additional Features: Currently, Manan (Northbrook, IL) provides features such as: Luer fittings on Cannula and adjustable depth stop (Illinois style). Promex's products will incorporate these features as well. A listing of available needle dimensions is included in Section I - Attachment B.

Here's an analysis of the provided text regarding acceptance criteria and study details:

The provided documents do not contain information about acceptance criteria or a study that proves the device meets those criteria.

The documents are a 510(k) summary and an FDA clearance letter for a "Bone Marrow Aspiration Needle." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific performance acceptance criteria through a dedicated study with the details you've requested.

Here's a breakdown of why each point you asked for cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The 510(k) summary describes the device's intended use and materials, but no performance metrics or acceptance criteria are listed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set, sample size, or data provenance is mentioned.
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): No experts, ground truth establishment, or test set is discussed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: No adjudication method is mentioned as there's no test set 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 is completely irrelevant to a bone marrow aspiration needle. MRMC studies are typically for imaging devices or AI-assisted diagnostic tools.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable to this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is mentioned.
8. The sample size for the training set: No training set is mentioned.
9. How the ground truth for the training set was established: No training set or ground truth establishment is mentioned.

In summary: The provided 510(k) documents focus on demonstrating that the "Bone Marrow Aspiration Needle" is substantially equivalent to existing devices based on its intended use, materials, and design, rather than presenting a performance study against specific acceptance criteria. For devices like this, substantial equivalence is often established through comparison of design features, materials, and intended use, sometimes supported by basic engineering tests (e.g., strength, sterility), but not typically detailed clinical performance studies in the way you're asking for.

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