(261 days)
Sorrento Bone Graft Substitutes are intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities and pelvis not intrinsic to the bony structure. Sorrento Bone Graft Substitutes are also indicated for use in the treatment of surgically created osseous defects created from traumatic injury to the bone. Sorrento Bone Graft Substitutes must be wetted with bone marrow aspirate. Following placement in the bony void or gap (defect), Sorrento Bone Graft Substitutes are resorbed and replaced with bone during the healing process
Sorrento BioGlass Bone Graft Substitute is a resorbable bone void filler made from a matrix of highly purified collagen (ASTM F2212) that has high porosity beta tricalcium phosphate (TCP) granules (ASTM F1088) and Bioglass 45S5 (ASTM F1538) dispersed throughout. The implant is provided as sterile, for single-use in double peel packages.
The document is a 510(k) summary for the Sorrento™ Bioglass Bone Graft Substitute. It does NOT describe an AI/ML powered device, nor does it detail an AI/ML study.
Therefore, I cannot provide the requested information about acceptance criteria or a study proving an AI device meets acceptance criteria. The document focuses on demonstrating substantial equivalence of a bone graft substitute to predicate devices through biocompatibility, bench testing, and animal studies.
Here's an analysis of what the document does provide, structured to address your points, though many will be flagged as "Not Applicable (N/A)" for an AI device:
1. Table of Acceptance Criteria and Reported Device Performance
As this is not an AI/ML device, the acceptance criteria and performance are related to the material properties and biological response of the bone graft substitute, not AI model metrics.
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1:2009 for biological evaluation; Acceptable biological safety profiles (Material-Mediated Pyrogenicity, Cytotoxicity, Irritation, Sensitization, Implantation); Endotoxin level within established acceptance criteria. | Biocompatibility testing performed according to ISO 10993-1:2009 and FDA Guidance. Showed acceptable biological safety profiles for Material-Mediated Pyrogenicity, Cytotoxicity, Irritation, Sensitization, and Implantation. Bacterial endotoxin testing confirmed an endotoxin level within the established acceptance criteria. |
| Bench Testing | Compliance with ASTM F1088 (beta tricalcium phosphate), ASTM F2212 (collagen), and ASTM F1538 (Bioglass). Ability to form an in vitro layer of apatite. | Substantial equivalence supported by evaluation per ASTM F1088, ASTM F2212, and ASTM F1538. Bioactivity evaluated by SEM and FTIR confirmed the ability of the subject device to form an in vitro layer of apatite. |
| Animal Study | Demonstrate substantial equivalence to predicate and reference devices in terms of performance (radiographically and histomorphometrically) at 3, 6, and 12 weeks post-implantation. | A distal femoral defect model in rabbits compared the subject device to the predicate (Sorrento Bone Graft Substitute K141429) and reference (Vitoss Foam Bone Graft Substitute K083033) at 3, 6, and 12 weeks. Study data demonstrated that the subject device is substantially equivalent with the predicate and reference devices. Also supported by evaluation per ASTM F1088 (beta tricalcium phosphate), ASTM F2212 (collagen), and ASTM F1538 (Bioglass). |
| Material Composition | Bioglass 45S5 per ASTM F1538, Highly purified collagen (ASTM F2212), high porosity beta tricalcium phosphate (TCP) granules (ASTM F1088). Chemical Composition: Calcium salt with Type I bovine collagen and Bioglass (~90:5:5 w/w). Mineral Phase: Beta-Tricalcium Phosphate Ca3(PO4)2. Porosity: >80% (beta-TCP), 64-78% (Bioglass). Pore Size: ~1-732 μm (312 ± 140 μm) bioglass. Resorption: Resorbable. | Subject device meets these specifications as described in the "Technological Characteristics" table. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: For the animal study, the document mentions "rabbits" but does not specify the exact number of animals used.
- Data Provenance: The animal study was conducted to compare the device with predicate and reference devices. No country of origin is specified. It is a prospective animal study.
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)
- N/A. This device does not involve expert-established ground truth in the context of AI/ML. The evaluation involved radiographic and histomorphometric analysis in an animal model, which would typically be performed by trained veterinary pathologists or researchers, but no specific number or qualifications are provided in this regulatory summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. This is not relevant for the type of study described (biocompatibility, bench testing, animal study for a bone graft).
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
- N/A. This document describes a bone graft substitute, not an AI device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This document describes a bone graft substitute, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the animal study, "performance was evaluated radiographically and histomorphometrically." Histopathological and radiographic findings in animal models serve as the "ground truth" to assess bone regeneration and material integration.
8. The sample size for the training set
- N/A. This document describes a bone graft substitute. There is no AI model, and therefore no training set.
9. How the ground truth for the training set was established
- N/A. This document describes a bone graft substitute. There is no AI model, and therefore no training set or ground truth establishment method for it.
§ 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.