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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.

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.

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Mineral Collagen Composite Bioactive Extra Moldable 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, 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.

For spine application Mineral Collagen Composite Bioactive Extra Moldable is combined with either autogenous bone marrow or autograft with saline and can also be used with autograft as a bone graft extender.

Mineral Collagen Composite Bioactive Extra 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 osteroconductive, 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 anorganic bone mineral component of the bone graft matrix is a natural, porous bone graft material of all organic components from bovine bone. The anorganic bone mineral meets ASTM F1581 standard specifications for the composition of anorganic bone for surgical implants. The bioactive glass component of the device is made of 45S5 Bioactive Glass and meeting ASTM F1538 standard specifications for malantation. 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.

The provided 510(k) summary for the "Mineral Collagen Composite Bioactive Extra Moldable" device indicates that no new acceptance criteria or specific studies proving the device meets these criteria were conducted for this submission (K231942).

Instead, the submission relies on the substantial equivalence to predicate devices (K221735 and K182074) and states that the performance data, including sterilization, pyrogenicity, biocompatibility, and animal testing results, remain the same as those previously submitted for the predicate devices. No new clinical studies were required.

Therefore, many of the requested details about acceptance criteria and study particulars for this specific submission are not explicitly provided because the device's performance is asserted to be equivalent to previously cleared devices, and thus relies on their past demonstrations of meeting acceptance criteria.

However, based on the information provided, we can infer some details:

1. Table of Acceptance Criteria and Reported Device Performance:

Since new performance criteria are not explicitly stated for this submission, the "acceptance criteria" here refer to the standards that the predicate devices met, which are then carried over to the current device due to substantial equivalence.

2. Sample Size for the Test Set and Data Provenance:

• Sample Size for Test Set: Not applicable for this submission as no new testing was conducted to establish acceptance criteria for K231942. The "test set" and corresponding sample sizes would have been part of the predicate device submissions (K221735 and K182074). The document states, "In vivo and in vitro testing of the subject device was conducted to demonstrate substantial equivalence of the subject device and remains the same as that submitted for the primary predicate device (K221735) and the secondary predicate device (K182074)."
• Data Provenance: Not specified for this submission, as it relies on previous submissions. It's not stated whether the original predicate studies were retrospective or prospective, or their country of origin.

3. Number of Experts and Qualifications for Ground Truth:

• Not applicable as no new specific ground truth establishment for a test set was detailed for this submission.

4. Adjudication Method for the Test Set:

• Not applicable as no new specific test set and adjudication method were detailed for this submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, an MRMC comparative effectiveness study was NOT done. The device is a "Resorbable Calcium Salt Bone Void Filler Device," which is a physical implant, not an AI or imaging diagnostic device that would typically involve human reader studies.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Performance:

• No, a standalone performance study was NOT done. This is not an algorithmic or AI device.

7. Type of Ground Truth Used:

• Not explicitly defined for this submission in the context of a new test set. For the predicate devices, the "ground truth" for demonstrating performance would likely involve histopathology (for bone ingrowth and resorption in animal studies), material characterization data (for biocompatibility and physical properties), and microbiological testing (for sterility).

8. Sample Size for the Training Set:

• Not applicable as this is a physical medical device, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable as this is a physical medical device, not a machine learning model.

In summary, this 510(k) relies entirely on the demonstration of substantial equivalence to previously cleared predicate devices, asserting that the change (improved moldability) does not alter the fundamental performance as previously established. Therefore, no new primary studies to define and meet acceptance criteria were conducted or reported in this specific submission.

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