(88 days)
ABCcolla® Bone Matrix is intended to fill bony voids or gaps of skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of bone structure. ABCcolla® Bone Matrix provides resorbs and is replaced by bone during the healing process.
ABCcolla® Bone Matrix is a bone mineral matrix of porcine origin. ABCcolla® Bone Matrx is physically and chemically comparable to the mineralized matrix of human bone.
This document (K212156) is a 510(k) premarket notification for a medical device called "ABCcolla® Bone Matrix." It concerns a resorbable calcium salt bone void filler.
Crucially, this document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device. The document is for a traditional medical device (bone matrix), not an AI/ML driven device.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and study data for an AI/ML device based on the provided text. The document focuses on demonstrating substantial equivalence to a predicate device based on material characteristics, manufacturing processes, and physical specifications.
To answer your request, I would need a document related to an AI/ML medical device and its validation study.
§ 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.