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510(k) Data Aggregation
(276 days)
Synthetic Mineral – Collagen Bone Graft Matrix, combined with autogenous bone marrow, is intended for orthopaedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Synthetic Mineral - Collagen Bone Graft Matrix is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e., extremities and pelvis. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
Synthetic Mineral – Collagen Bone Graft Matrix is a composite of synthetic calcium phosphate based granules and type I collagen. The calcium phosphate mineral has an apatite structure similar to that of natural bone. The type I collagen is derived from bovine Achilles tendon. The composite material is a resorbable, porous, osteoconductive bone graft matrix. The product is supplied dry in granular (putty) or block/strip form that is hydrated with autogenous bone marrow at the point of use. The product is sterile, non-pyrogenic, and for single use only.
The provided text describes a 510(k) summary for the "Synthetic Mineral – Collagen Bone Graft Matrix" device. This is a medical device submission, and the "acceptance criteria" and "device performance" in this context refer to demonstrating substantial equivalence to a predicate device, rather than a quantifiable performance metric against a specific threshold as might be found in a diagnostic AI study.
Therefore, the requested table of acceptance criteria and reported device performance will be structured to reflect the substantial equivalence claim.
Here's the breakdown of the information based on your request:
Description of the Acceptance Criteria and Study
The "Synthetic Mineral – Collagen Bone Graft Matrix" is a Class II medical device, granted 510(k) clearance by demonstrating substantial equivalence to a predicate device (OssiMend™ Bone Graft Material, K052812). The "acceptance criteria" for this type of submission are not presented as numerical thresholds for specific performance metrics (like sensitivity/specificity for an AI device) but rather as an assurance that the new device is as safe and effective as the predicate device based on similar technological characteristics, materials, and intended use. The "study" described focuses on non-clinical performance data (animal studies) and comparison of technological characteristics.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Criterion for Substantial Equivalence | Acceptance Method/Comparison | Reported Device Performance/Conclusion |
|---|---|---|
| Intended Use | Comparison with predicate device's intended use. | Intended use is the same: "for orthopaedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure... indicated to be packed gently into bony voids or gaps of the skeletal system, i.e., extremities and pelvis. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone." |
| Technological Characteristics | Comparison of design, materials, material characterization, and product forms with predicate device. Bench tests included mineral structure analysis, collagen purity, and resorption studies. | "Synthetic Mineral - Collagen Bone Graft Matrix and its predicates have the same key technological characteristics. In particular, the Synthetic Mineral – Collagen Bone Graft Matrix and its predicates are the same with respect to intended use, design, materials, material characterization, and product forms." |
| Biocompatibility | Evaluation using selected FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing. | "The device passed all selected FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing for the biological evaluation of medical devices." |
| Performance (Bone Ingrowth) | Animal studies: a rabbit round femur defect model and a segmental radial defect model. Endpoint measurements included radiographs and histology. Comparison was made "with respect to predicate device." | "These studies demonstrated with respect to predicate device the safety and performance of the Synthetic Mineral and Mineral - Collagen Composite materials in supporting bone ingrowth in orthopaedic applications." |
| Safety and Effectiveness | Overall conclusion based on in vitro product characterization, in vitro and in vivo biocompatibility studies, animal performance studies, and clinical experience with predicate devices. | "The results... show that the Synthetic Mineral - Collagen Bone Graft Matrix is safe with respect to predicate device and substantially equivalent to its predicate device." |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: The document mentions "a rabbit round femur defect model and a segmental radial defect model." Specific numbers of animals per model are not provided in the summary.
- Data Provenance: The animal studies were likely conducted within the US, as is common for submissions to the FDA, but the country of origin is not explicitly stated. The studies are prospective in nature, as they involve performing procedures on animals and observing outcomes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- The document does not specify the number of experts or their qualifications for establishing ground truth in the animal studies.
- For histological and radiological evaluations, it is implied that qualified personnel (e.g., veterinary pathologists, radiologists) would have interpreted the results, but no details are given.
4. Adjudication method for the test set
- The document does not mention any explicit adjudication method for the interpretation of the animal study results (e.g., 2+1, 3+1 consensus). It's typically assumed that such reports are generated by a single qualified expert in each domain (histology, radiology).
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
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices. The submission concerns a bone graft matrix, not an AI diagnostic algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This concept is not applicable to a physical medical device like a bone graft matrix.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the animal studies, the "ground truth" and endpoint measurements included:
- Radiographs (imaging evidence of bone formation/repair).
- Histology (microscopic examination of tissue to assess bone ingrowth, material resorption, and tissue response).
- These are considered objective biological and imaging markers.
8. The sample size for the training set
- This concept is not applicable to this submission. "Training set" refers to data used to train an AI model. This device is a physical bone graft, not an AI algorithm.
9. How the ground truth for the training set was established
- This concept is not applicable to this submission, as there is no "training set" for a physical medical device.
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