(161 days)
Genex® Bone Graft Substitute injectable paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process.
• Genex® Bone Graft Substitute is indicated only for bony voids or defects/gaps that are not intrinsic to the stability of the bony structure
• Genex® Bone Graft Substitute is indicated to be gently packed into voids or defects of the skeletal system (i.e long bones, extremities, posterolateral spine and pelvis)
• Genex® Bone Graft Substitute resultant paste can be injected, digitally packed into the bone in situ or moulded into solid implants that are to be gently packed into the defect
• The bony defects or cavities may be surgically created or the result of traumatic injury. Genex® Bone Graft Substitute provides a bone graft substitute that resorbs and is replaced with bone during the healing process
Genex® Bone Graft Substitute is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible. The kit contains a powder and mixing solution which, when combined, provides a mouldable cohesive paste. When injected the mixture sets to form Genex® Bone Graft substitute, a hard but resorbable matrix. Genex® Bone Graft Substitute is supplied sterile.
Genex® Bone Graft Substitute, accessories and packaging are not made from natural rubber latex.
The provided text is a 510(k) summary for the Genex® Bone Graft Substitute. It does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in terms of effectiveness or outcomes.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Genex® K082381) based on:
- Intended Use / Indications for Use: These are stated to be the same as the predicate device.
- Technological Differences: The subject device is presented as a closed mixing system with differences in the number of syringes and mixing method, but these are claimed not to raise safety and effectiveness concerns.
- Non-Clinical Testing: This includes "Biocompatibility testing, Shelf-Life validation studies and Porosity testing." The summary states that these tests demonstrate substantial equivalence and do not raise new safety or effectiveness concerns.
Therefore, I cannot provide the requested information regarding acceptance criteria and studies proving the device meets them because this information is not present in the provided text. The document is concerned with regulatory clearance via substantial equivalence, not with presenting a efficacy study.
Here's a breakdown of why each requested point cannot be answered:
- A table of acceptance criteria and the reported device performance: Not provided. The document mentions "non-clinical testing" like biocompatibility, shelf-life, and porosity, but it doesn't list specific acceptance criteria (e.g., a certain percentage of bone growth, time to resorption) or performance outcomes from these tests.
- Sample size used for the test set and the data provenance: Not provided. No efficacy or outcome study is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No human interpretation of results for an efficacy study is described.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a bone graft substitute, not an AI-powered diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided. No efficacy or outcome study is described.
- The sample size for the training set: Not applicable. This device is a medical product, not an AI algorithm requiring a training set.
- How the ground truth for the training set was established: Not applicable.
§ 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.