(232 days)
Bi-Ostetic Foam is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into 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. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. The bone graft can be mixed with autogenous bone marrow prior to use at the physician's discretion. In weight bearing situations, Bi-Ostetic Foam is to be used in conjunction with internal or external fixation devices. The fracture defect treated with Bi-Ostetic Foam should not exceed 30 mL.
Bi-Ostetic Foam is a bone void filler consisting of resorbable purified fibrillar collagen and resorbable hydroxyapatite/tri-calcium phosphate granules. The bovine fibrillar collagen component is biocompatible. The device provides a scaffold around which new bone can grow.
It appears that the provided text is a 510(k) summary statement for a medical device (Bi-Ostetic Foam) and the associated FDA clearance letter. This document describes a bone void filler and its intended use, but it does not contain the type of study data, acceptance criteria, and performance metrics typically found in AI/algorithm-based device submissions.
The document states: "The safety and effectiveness of Bi-Ostetic Foam are adequately supported by the substantial equivalence information provided within the Premarket Notification." This indicates that the device's clearance was based on its similarity to existing cleared devices (predicate devices), rather than a de novo clinical trial with specific performance acceptance criteria against a ground truth.
Therefore, many of the requested items (acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set information) are not applicable or available in this specific document.
However, I can extract the following relevant information from the provided text:
- Device Name: Bi-Ostetic Foam
- Intended Use: For use in bony voids or gaps that are not intrinsic to the stability of the bony structure (e.g., extremities, spine, pelvis). Acts as a bone void filler that resorbs and is replaced by new bone growth. Can be mixed with autogenous bone marrow. In weight-bearing situations, used with internal or external fixation. Fracture defect treated should not exceed 30 mL.
- Mechanism of Action: Provides a scaffold around which new bone can grow. Consists of resorbable purified fibrillar collagen and resorbable hydroxyapatite/tri-calcium phosphate granules.
Since the document focuses on substantial equivalence and does not detail a study proving specific performance metrics against acceptance criteria, I cannot fill out the requested table or answer most of the questions.
If you have a different document that describes an AI/algorithm-based device and its performance study, I would be able to provide a more complete answer.
§ 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.