(83 days)
The Osteo-G Bone Void Filler System, pellets or paste, are intended for filling of bony voids or gaps, i. e., of the extremities, spine or pelvis, that are not intrinsic to the stability of the bone structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The pellets or paste provide a bone void filler that is bioabsorbable and is replaced with bone during the healing process. Osteo-G Bone Void Filler System pellets or paste may be used at an infected site.
The Osteo-G Bone Void Filler System is an osteoconductive, bioabsorbable, calcium sulfate dihydrate implant for use as a bone graft substitute or bone void filler. The system consists of prefabricated calcium sulfate dihydrate pellets or a kit for fabricating calcium suffate dihydrate implants to custom shape and size or for in situ use. The device is radiopaque and is presterilized for single use.
The Osteo-G Bone Void Filler System pellets are provided in three sizes, each with cylindrical shape, as follows:
- a) 5 mm diameter, 5 mm high
- b) 5 mm diameter, 3 mm high
- c) 3 mm diameter, 3 mm high
The Osteo-G Bone Void Filler System kit is provided in one size: a ten gram quantity of calcium sulfate hemihydrate powder component with a three milliliter mixing solution component. Once mixed, the powder and solution produce a moldable paste that can be custom shaped.
This document describes the Osteo-G Bone Void Filler System, which is a medical device. Based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI medical device.
The document K031319 is a 510(k) premarket notification for a calcium sulfate bone void filler. This type of device is a physical biomaterial, not software or an AI system. The information provided relates to its classification, intended use, material composition, and equivalence to other legally marketed predicate devices, as required for a 510(k) submission.
Therefore, I cannot fulfill your request for the acceptance criteria and study details as they pertain to an AI device. The input text does not contain any reference to AI, machine learning, or software performance evaluation.
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§ 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.