(152 days)
BoneSave™ Calcium phosphate granules (20cc) are indicated for osseous defect filling of bones not intrinsic to stability of the bony structure.
- BoneSave™ Calcium phosphate granules are indicated to be gently packed into osseous defects (i.e. bony voids or gaps) of the skeletal system (i.e., the extremities, spine, and pelvis).
- These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
Both the subject device and the predicate Mastergraft™ Resorbable Ceramic Pellets (Medtronic Sofamor Danek) are granular bone void fillers consisting of TCP and HA. The subject device is 80wt.%TCP and 20wt.%HA, while the predicate device can be either 60%HA/40%TCP or 15%HA/85%TCP. The TCP/HA ratio for the subject device falls in between the TCP/HA ratios cleared for the predicate device. Therefore, with regard to materials, the subject and predicate devices are substantially equivalent.
The provided text is a 510(k) summary for the BoneSave™ Bone Void Filler and does not contain information about acceptance criteria or a study proving device performance against such criteria in the context of AI/algorithm performance.
The document describes the device's materials, intended use, and design, and states that "Laboratory testing and animal testing were provided to characterize the subject device and to allow comparison of its characteristics to predicate devices." However, it does not detail the specifics of these tests, any acceptance criteria, or the results that would allow for the completion of the requested table and answers regarding AI/algorithm performance.
Therefore, I cannot provide the requested information based on the given text. The provided text is a regulatory submission for a medical device (bone void filler), not a study report on the performance of an AI or algorithm.
§ 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.