(28 days)
Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix is intended for use as a bone void filler for voids or gaps, that are not intrinsic to the stability of the bony structure. The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, intervertebral disc space, and posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process.
In the posterolateral spine and intervertebral disc space, Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix is combined with either autogenous bone marrow or autograft with saline and can also be used with autograft as a bone graft extender. When used in intervertebral body fusion procedures, Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix is composed of anorganic bone mineral, bioactive glass, and type I collagen that can be molded to fit the bone defect. It is an osteoconductive, bioactive, porous implant that allows for bony ingrowth across the graft site. The bone graft matrix is slowly resorbed and replaced by new bone tissue during the natural healing process.
The anorqanic bone mineral component of the bone graft matrix is a natural, porous bone graft material produced by removal of all organic components from bovine bone. The composition of the anorganic bone mineral meets ASTM F1581 standard specifications for composition of anorganic bone for surgical implants. The bioactive glass component of the device is made of 45S5 Bioactive Glass and meets ASTM F1538 standard specifications for glass and glass ceramics biomaterials for implantation. The purified type I collagen is derived from bovine Achilles tendon.
The product is available in various sizes and is provided sterile, non-pyrogenic, and for single use only.
This is a 510(k) premarket notification for a medical device called "Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix". The document confirms FDA clearance and discusses the device's indications for use and substantial equivalence to previously cleared devices.
Based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the traditional sense of a performance study with defined metrics for the device itself.
The document focuses on establishing substantial equivalence to predicate devices. This means that the FDA has determined the new device is as safe and effective as a legally marketed device that does not require premarket approval.
Here's a breakdown of why the requested information cannot be fully provided from this document:
- No "AI" or "Algorithm": This is a bone graft matrix, a physical medical device. It's not a software device or an AI-powered system, so concepts like "AI assistance," "human-in-the-loop," "ground truth," "training set," "test set," "experts," or "adjudication methods" are not applicable.
- Focus on Substantial Equivalence: The "study" mentioned is not a performance study against acceptance criteria for an AI or software device. Instead, it refers to the comparison of the subject device to predicate devices to demonstrate substantial equivalence.
However, I can extract the relevant information regarding the "study" (in the context of demonstrating substantial equivalence) and the "performance" as described:
1. A table of acceptance criteria and the reported device performance
Since this is not a software/AI device with performance metrics like sensitivity, specificity, or accuracy, a traditional acceptance criteria table is not present. The "performance" is primarily described by its material composition and functional characteristics, and its equivalence to predicate devices.
| Acceptance Criteria (Implied for Substantial Equivalence to Predicates) | Reported Device Performance (as described for substantial equivalence) |
|---|---|
| Material Composition Equivalence: The device's components (anorganic bone mineral, bioactive glass, type I collagen) should meet specified standards and be comparable to predicate devices. | Composed of anorganic bone mineral, bioactive glass, and type I collagen. |
| Anorganic bone mineral meets ASTM F1581 standard. | |
| Bioactive glass (45S5 Bioactive Glass) meets ASTM F1538 standard. | |
| Purified type I collagen is derived from bovine Achilles tendon. | |
| Same basic design characteristics and technological characteristics (design, material, chemical composition, principle of operation) as the secondary predicate device (K231942) and reference device (K182074). | |
| Same specification range as secondary predicate K231942 and reference device K182074. | |
| Functional Characteristics Equivalence: The device should be moldable, osteoconductive, bioactive, porous, allow bony ingrowth, and resorb over time to be replaced by new bone. These characteristics should be consistent with predicate devices. | Moldable to fit the bone defect. |
| Osteoconductive, bioactive, porous implant that allows for bony ingrowth across the graft site. | |
| Slowly resorbed and replaced by new bone tissue during the natural healing process. | |
| Intended Use/Indications for Use Equivalence & Expansion: The device's intended use should be substantially equivalent to predicate devices, with justified expansion of indications if applicable. | Original/Predicate Indications: Bone void filler for voids or gaps not intrinsic to bony structure (extremities, pelvis, posterolateral spine) for surgically created osseous defects or traumatic injury. Resorbs and is replaced by bone. |
| Expanded Indication (Subject of this 510(k)): Includes use in the intervertebral disc space with an intervertebral body fusion device cleared by FDA. | |
| Also combined with autogenous bone marrow or autograft with saline; can be used as a bone graft extender with autograft. | |
| Safety and Efficacy Equivalence: (Implied through non-clinical testing, sterilization, biocompatibility, and manufacturing controls) The device must be shown to be as safe and effective as the predicate devices. This includes demonstrating: * Sterilization: Maintains validated sterilization method and SAL. * Non-pyrogenic: Confirms non-pyrogenic status. * Biocompatibility: No changes to product requiring new biocompatibility testing. * Animal Testing: Existing animal testing from predicate devices is applicable. * Clinical Data: No new clinical data required due to demonstrated equivalence. | Performance Testing: Unchanged from secondary predicate (K231942) and reference device (K182074) as there are no changes to device characteristics, specifications, manufacturing, or composition due to expanded indications. |
| Sterilization: Validated sterilization method and SAL (1x10-6) remain the same as documented in K231942 and K182074. | |
| Non-pyrogenic: Subject device is non-pyrogenic; no changes to product. | |
| Biocompatibility: No new biocompatibility testing required as there are no changes to the product and performance data is from K231942 and K182074. | |
| Animal Testing: No additional animal testing required; animal testing from K231942 and K182074 is applicable. | |
| Clinical Performance Data: Not required to determine substantial equivalence. | |
| Absence of New Safety/Efficacy Issues: Differences in technological characteristics should not raise new issues. | Any differences in technological characteristics between subject and predicate devices do not raise new issues or concerns of safety or efficacy. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is not a study assessing performance of a diagnostic or AI device using a test set of data. The "testing" refers to non-clinical assessments, material characterization, and comparison to predicate devices, not data-driven performance metrics against a "test set."
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. This is not a study requiring expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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. This document is not about AI assistance or human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device's safety and effectiveness is established by its demonstrated equivalence in material, design, and performance characteristics to previously cleared predicate devices through non-clinical testing (e.g., material testing, sterilization validation, biocompatibility) and the absence of new safety/effectiveness concerns.
8. The sample size for the training set
Not applicable.
9. 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.