(77 days)
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:
- 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.
- 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.
- 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.
- 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.
§ 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.