(26 days)
Marrow Plus (M+™) is intended for use as a system for the aspiration of bone marrow, autologous blood, plasma or other blood components. Prior to use, the syringe is either pre-filled or filled with the surgeon's choice of bone void filler (allograft, autograft or synthetic bone graft material). This system provides the surgeon with a convenient way to syringe bone graft material and deliver the material to the orthopaedic surgical site.
M+ may be pre-filled with synthetic bone substitute (Bi-Ostetic, Cem-Ostetic, Tri-Ostetic, BioPlus, GenerOs) shaped as granules or blocks (cancellous, cortical or cortico-cancellous) that are intended to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The granules or blocks provide void filling material that acts as a temporary support medium. The granules or blocks are pressed into the void or into the surgical site by hand. The granules or blocks are not intended to provide structural support. The material is radio-opaque. It is biocompatible and resorbs in the body as bone ingrowth occurs.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to Berkeley Advanced Biomaterials, Inc. regarding their device, M+. This document outlines the FDA's determination of substantial equivalence for the device.
However, the furnished text DOES NOT contain the following information:
- Acceptance criteria and reported device performance.
- Details of any study (including sample size for test set, data provenance, number/qualifications of experts for ground truth, adjudication method, MRMC study, standalone performance study, type of ground truth used for test set, training set size, or how its ground truth was established).
The document is purely a regulatory approval letter. It states that the device is substantially equivalent to legally marketed predicate devices, but it does not detail the specific performance metrics or studies used to demonstrate that equivalence.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or describe the study that proves the device meets the acceptance criteria, as this information is not present in the provided text.
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.