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510(k) Data Aggregation
(94 days)
EQUIMATRIX
EQUIMATRIX™ cancellous and cortical granules are recommended for:
- Augmentation or reconstructive treatment of the alveolar ridge.
- Filling of infrabony periodontal defects.
- Filling of defects after root resection, apicoectomy, and cystectomy.
- Filling of extraction sockets to enhance preservation of the alveolar ridge.
- Elevation of the maxillary sinus floor.
- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).
- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
EquiMatrix™ is a sterile, natural, non-antigenic, porous bone mineral matrix produced by the removal of organic compounds from equine bone. Due to its natural structure EquiMatrix™ is physically and chemically comparable to the mineralized matrix of human bone. The anorganic bone matrix of EquiMatrix™ has a macro and microporous structure similar to human bone. The formation and in-growth of new bone at the implantation site of EquiMatrix™ is favored due to its trabecular architecture, interconnecting macro and micro pores, and its natural consistency. It is supplied as cancellous (spongiosa) or cortical granules in a single use container, packaged in a secondary thermoform blister, and sterilized by v-irradiation.
The provided document is a 510(k) summary for the EquiMatrix™ Natural Bone Mineral Matrix. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device, Bio-Oss®.
Here's an analysis of the provided text in relation to your request about acceptance criteria and a study proving device conformance:
The document does not describe an AI/ML device. It is a regulatory submission for a medical device (bone grafting material) that is a physical product, not a software algorithm. Therefore, many of your specific questions related to AI/ML device performance (like sample sizes for test sets, data provenance, ground truth establishment by experts, MRMC studies, standalone performance, training sets) are not applicable to this document.
However, I can extract information related to the device's "performance" and "acceptance criteria" as understood in the context of this biological material.
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device, "acceptance criteria" are typically demonstrating equivalence to a recognized standard or predicate device in terms of material properties, biocompatibility, and intended biological function (e.g., bone formation). The document argues for substantial equivalence to Bio-Oss®.
| Item | Acceptance Criteria (based on equivalence to predicate/standards) | Reported Device Performance (EquiMatrix™) |
|---|---|---|
| Intended Use | Used as an adjunctive therapy in restoring bony defects (matching predicate) | Used as an adjunctive therapy in restoring bony defects. Applications include augmentation/reconstruction of alveolar ridge, filling various bone defects (periodontal, post-resection/cystectomy, extraction sockets), maxillary sinus floor elevation, and use with GTR/GBR products. |
| Target Population | Human oral, periodontal (matching predicate) | Human oral, periodontal |
| Dosage Form | Granules contained in single use container (matching predicate) | Granules contained in single use container |
| Granule Sizes | 0.25 mm to 1.0 mm or 1.0 mm to 2.0 mm granules (matching predicate) | 0.2 mm to 1.0 mm or 1.0 mm to 2.0 mm granules (Slight difference in lower bound of smaller size, but deemed equivalent) |
| Material | Anorganic naturally derived osteoconductive hydroxyapatite bone mineral (matching predicate) | Anorganic naturally derived osteoconductive hydroxyapatite bone mineral (from equine bone) |
| Source Bone | Biological source for anorganic bone mineral. Not explicitly an "acceptance criteria" beyond general material characteristics from xenograft, but the difference from predicate (equine vs. bovine) is a key point of comparison. | Equine bone |
| Physical Morphology | Trabecular, interconnecting macro and micro pores (matching predicate) | Trabecular, interconnecting macro and micro pores (similar to human bone) |
| Biocompatibility | Biocompatibility as per ISO 10993 and FDA's "Class II Special Controls Guidance Document: Dental Bone Grafting Devices" (matching predicate's inherent biocompatibility) | Biocompatible, demonstrated by: Genotoxicity, Intracutaneous reactivity, Maximization and sensitization, Pyrogen, Acute systemic injection, Cytotoxicity, Implantation, Preclinical safety and efficacy testing, Clinical case series. Confirmed product safety. |
| Performance (Bone Formation) | Osteoconductive and supports bone formation (matching predicate's known function) | Supports bone formation; "formation and in-growth of new bone at the implantation site of EquiMatrix™ is favored due to its trabecular architecture, interconnecting macro and micro pores, and its natural consistency." Animal studies showed both products (EquiMatrix™ and Bio-Oss®) grew new bone and resorbed at similar rates. Clinical case series resulted in "defect healing and formation of new bone of sufficient quality to obtain dental implant placement." |
| Chemical Composition | Similar to predicate's chemical composition (based on chemical analyses, XRD, FT-IR, and ICP analysis) | Similar to Bio-Oss® based on chemical analyses, XRD, FT-IR, and ICP analysis. Organic material removed, product specifications established to limit protein content. |
| Sterilization Process | Sterile by Gamma irradiation (matching predicate) | Sterile by Gamma irradiation (achieving SAL 1 x 10⁻⁶) |
| Chemical Safety | Biocompatible (matching predicate) | Biocompatible |
| Pyrogen Free | Yes (matching predicate) | Yes |
| Shelf Life | Acceptable shelf-life demonstrated. Predicate's shelf life is "determined by manufacturer," so the criteria is to have a valid, determined shelf life. | 3 years |
Since this is a non-AI/ML device, the following points are not applicable or cannot be extracted from the document:
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable as this is not an AI/ML device. The document mentions "several animal studies" and a "clinical case series" but does not provide sample sizes or data provenance details for these studies.
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)
- Not applicable as this is not an AI/ML device. Ground truth, in a clinical sense for this device, would be histological analysis of bone growth, clinical outcomes (implant placement success), and assessment of defect healing, typically done by attending clinicians or pathologists, but not "experts establishing ground truth for a test set" in the AI/ML context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as this is not an AI/ML device.
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
- Not applicable as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable as this is not an AI/ML device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For the biological performance of the device (bone formation), the document implies:
- Histological assessment: Implied by "formation and in-growth of new bone," likely from the animal studies.
- Clinical outcomes data: Mention of "defect healing and formation of new bone of sufficient quality to obtain dental implant placement" from the "clinical case series" suggests clinical assessment of surgical sites and successful subsequent treatment.
- Physico-chemical characterization: Ground truth for material properties (composition, morphology) is established through analytical techniques like XRD, FT-IR, ICP analysis.
8. The sample size for the training set
- Not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable as this is not an AI/ML device.
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