(60 days)
Genex® is indicated only for bony voids or defects/gaps that are not intrinsic to the stability of the bony structure. Genex® bone graft substitute resultant paste can be injected, digitally packed into the bone void to cure 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® provides a bone graft substitute that resorbs and is replaced with bone during the healing process.
Genex® Bone Graft Substitute consists of synthetic bioabsorbable calcium salts, premeasured mixing solution and tools necessary to mix the components into a paste. These products are provided sterile for singe patient use. When mixed according to directions, the Gonex® Bone Graft Substitute produces biodegradable, radiopaque paste/moulded blocks that resorb in approximately 6 -- 9 months when used according to labelling. After the granular powder is hydrated using all of the mixing solution supplied in each pack, the resultant paste can be injected, digitally packed into the bone void to cure in situ or moulded into solid implants that are gently paced into non-load bearing voids or gaps of the skeletal system (i.c. the extremitics, spinc and pelvis). These bone voids may be surgically created osseous defects or osscous defects created from traumatic injury to the hone. The implants provide a bone void filler that resorbs and is replaced with bone during the healing process.
The provided document is a 510(k) summary for the Genex® Bone Graft Substitute. It does not contain acceptance criteria or a detailed study proving the device meets specific performance metrics. Instead, it focuses on demonstrating substantial equivalence to predicate devices.
Therefore, many of the requested sections about acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, and direct performance data either cannot be answered or would be speculative based on this document.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not provided in the document. 510(k) summaries primarily demonstrate substantial equivalence, not the fulfillment of specific performance acceptance criteria from a pre-defined study protocol for a novel device.
- Reported Device Performance:
Performance Aspect Reported Statement Resorption "resorbs in approximately 6 – 9 months when used according to labelling." Replacement "resorbs and is replaced with bone during the healing process." Bone Void Filler "provides a bone void filler"
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not available in the provided 510(k) summary. The document states "Test results confirm that Genex® Bone Graft Substitute provides a bone void filler which, when placed in contact with healthy bone, resorbs and is replaced with bone during the healing process," but it does not detail the nature, size, or provenance of these "test results."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not available in the provided 510(k) summary. Given that it's a bone graft substitute, ground truth would likely be established by histological analysis or imaging read by clinical experts, but no details are given.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not available in the provided 510(k) summary.
5. 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
- This is not applicable. The device is a bone graft substitute, not an AI-powered diagnostic or imaging interpretation tool. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This is not applicable. The device is a physical bone graft substitute, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The document implies that "test results" confirmed the device's performance, specifically its resorption and replacement by bone. For a bone graft substitute, ground truth would typically involve histological evaluation (pathology) from tissue samples over time to confirm bone ingrowth and material resorption, potentially combined with imaging (radiological) assessment of defect filling and healing. However, the document does not explicitly state the type of ground truth used for its "test results."
8. The sample size for the training set
- This information is not available in the provided 510(k) summary. The document does not describe a "training set" as it would for a machine learning model; the "test results" mentioned are likely from a traditional preclinical or clinical study, but details are not given.
9. How the ground truth for the training set was established
- Not applicable as no training set is described. If referring to the "test results" in general, please refer to the answer for question 7.
§ 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.