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The Ranfac FLEX Bone Marrow Aspiration (BMA) Needle is intended for aspiration of bone marrow or autologous blood using a standard piston syringe.

The Ranfac FLEX BMA Needle subject of this premarket notification is a manual, sterile disposable needle intended for the purpose of aspirating bone marrow or autologous blood. The device consists of an Access Needle for bone marrow penetration and an Aspirator Cannula through which the aspirate is obtained. The Access Needle is provided with an integral threaded Adjustable Guide which acts as a depth stop for control of needle penetration depth and when turned counterclockwise allows for the Aspiration Cannula to be withdrawn backwards through the bone marrow needle tract in a controlled manner (as opposed to manually pulling back the needle or Aspiration Cannula). The distal tip of the Aspiration Cannula is closed and provided with side holes to allow the physician to aspirate from the sides of the needle (to minimize blood within the aspirate). The Aspiration Cannula has a flexed tip which will redirect if the tip encounters the wall of the marrow cavity. The Access Needle is 8 gauge with an effective length of 3 inches. An exchangeable Drillable Stylet is provided for use with the device which can mate to a standard surgical drill to aid bone penetration if needed.

The provided text describes the 510(k) submission for the Ranfac FLEX BMA Needle, asserting its substantial equivalence to a predicate device. However, this submission does not contain information about a study that assesses AI/algorithm performance or human reader performance with AI assistance.

Therefore, I cannot fill in the table or provide details for most of the requested points related to AI/algorithm performance, multi-reader multi-case studies, or the specifics of training and test sets and their ground truth.

The document focuses on demonstrating the device's physical and functional equivalence through engineering and biological testing, not through clinical performance data relevant to AI model validation.

Here's a breakdown of what can be extracted from the document based on your request, and where information is missing:

Acceptance Criteria and Device Performance (as far as applicable to this document)

Detailed Study Information (Based on Document Content)

This document describes the 510(k) submission for a physical medical device (a bone marrow aspiration needle), not an AI-powered diagnostic or assistive tool. Therefore, most of the requested information, which pertains to AI/algorithm development and validation, is not present in the provided text.

1. Sample size used for the test set and data provenance:

   • Not applicable for AI/algorithm testing. The document mentions "Structural integrity testing," "simulated use and cadaver testing," "biocompatibility testing," "sterility validation," and "shelf life studies." Specific sample sizes for these engineering and biological tests are not detailed beyond "All samples" for structural integrity.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable for AI/algorithm testing. Ground truth, in the context of an AI model, typically refers to expert labels on a dataset. This concept does not apply to the validation of a physical medical device as described here.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable for AI/algorithm testing. Adjudication is a process to resolve disagreements among human labelers, which is not relevant to the physical device validation described.

4. 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:

   • No. Not applicable. This document pertains to clearances for a physical device, not an AI system that assists human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This device is a manual, physical instrument. There is no algorithm to test in standalone mode.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not applicable for AI/algorithm testing. For the physical device, "ground truth" would be the success of a mechanical test, sterility validation result, or biocompatibility outcome. These are defined by established standards (e.g., ISO 11135 for sterility).

7. The sample size for the training set:

   • Not applicable for AI/algorithm training. There is no AI model being trained for this physical device.

8. How the ground truth for the training set was established:

   • Not applicable for AI/algorithm training. There is no AI model being trained for this physical device.

Summary: The provided FDA 510(k) submission describes the substantial equivalence of a physical medical device (bone marrow aspiration needle) to a predicate device. The performance data shared relates to the manufacturing, material, and mechanical properties of the needle, and does not involve AI algorithms or human reader performance studies. Therefore, most of the requested details concerning acceptance criteria and studies for AI-based devices cannot be extracted from this document.

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