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The Marrow Cellution Bone Marrow Aspiration Needle is intended for use for aspiration of bone marrow or autologous blood using a standard piston syringe.

The Marrow Cellution Bone Marrow Aspiration Needle consists of a Ranfac Aspiration Needle with Adjustable Guide as well as an additional Aspirator Cannula and a 10ml Syringe. The Marrow Cellution Bone Marrow Aspiration Needle is a single use disposable needle that allows the medical device professional the ability to aspirate from the sides of the needle without aspirating from the needle tip. This allows the needle to be retracted during aspiration ensuring aspirate will not be compromised by the end being open to an area that has already had aspirate removed.

The provided text is a 510(k) summary for a medical device called the "Marrow Cellution Bone Marrow Aspiration Needle." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving performance against specific acceptance criteria through a clinical study for a novel AI/software type of medical device.

Therefore, the information requested in your prompt regarding acceptance criteria, a specific study proving it, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for an AI/software device is not applicable to this document.

This document describes a traditional medical device (a bone marrow aspiration needle) and its substantial equivalence to previously cleared predicate devices based on:

1. Similar Indications for Use: The Marrow Cellution Bone Marrow Aspiration Needle is intended for aspiration of bone marrow or autologous blood using a standard piston syringe, which is similar to the predicate devices.
2. Similar Technological Characteristics: The document provides a table (Table 5.1) comparing design, performance characteristics, cannula configuration, stylet configuration, gauge size, handle configuration, materials, and sterilization methods.
3. Performance Data (Non-Clinical): Design verification tests were performed based on risk analysis and product requirements to demonstrate that the device performed equivalently to predicate devices and is safe and effective when used as intended. These are typically bench tests, not clinical studies in the sense of AI performance evaluation. Biocompatibility testing (ISO 10993-1) was also conducted.
4. No Clinical Data: The document explicitly states "Not applicable" for clinical data. This further confirms that a human-in-the-loop or standalone AI performance study was not conducted or required for this type of device submission.

In summary, this document does not contain the information requested because it pertains to a physical medical device seeking substantial equivalence to existing devices, not an AI or software-as-a-medical-device (SaMD) that would typically undergo the types of performance studies you inquire about.

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