(303 days)
The BellaFuse™ is an implant intended to fill bony voids or gaps of the skeletal system, i.e. posterolateral spine. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Bellafuse™ resorbs and is replaced with bone during the healing process.
Device Identification and Materials of Use:
BellaFuse™ is a resorbable bone void filler, combining Human Demineralized Bone Matrix (DBM) with gelatin. The primary component of this BVF product is demineralized particle bone, which is derived from human donor cortical bone. The additional porcine gelatin is a biocompatible component which maintains the shape and enhances flexibility.
Device Characteristics:
This product is provided in several flexible sheet sizes ranging from 10x10x2.5mm to 50x100x5.0mm. It is supplied sterile for single patient use.
Body Contact:
BellaFuse™ is a permanent resorbable device, implanted in bone tissue.
I am sorry, but the provided text does not contain the detailed information necessary to complete the table and answer the questions regarding acceptance criteria, device performance, and study specifics as outlined in your request.
The document is a 510(k) premarket notification summary for a medical device called BellaFuse™. It discusses the device's intended use, description, mechanism of action, and a summary of testing for serological, biocompatibility, osteoconduction, and osteoinductive potential. However, it does not provide:
- Specific numerical acceptance criteria for performance. It states the device "was tested successfully to fully assess the performance to grow bone" and "was shown to have osteoinductive potential," but doesn't quantify these successes with specific metrics or thresholds.
- Detailed reported device performance outcomes. While it mentions new bone growth, it doesn't provide statistical results like sensitivity, specificity, accuracy, or quantitative measures of bone growth in the context of specific acceptance criteria.
- Sample sizes for test sets, training sets, or data provenance. Only a sample size of "nude rat muscle pouch model" (n=?) is mentioned for osteoinductive potential, and no other sample sizes are given.
- Information about experts, ground truth establishment, adjudication methods, or MRMC studies.
- Specifics on how the ground truth for training or test sets was established.
Therefore, I cannot populate the table or answer most of the questions based on 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.