Search Results

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.

Ask a specific question about this device

Mineral Collagen Composite Bioactive 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 applications, Mineral Collagen Composite Bioactive 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 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 anorganic 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-pvrogenic, and for single use only.

The provided text is a 510(k) summary for the Mineral Collagen Composite Bioactive Moldable device. This document describes a medical device seeking regulatory clearance, not an AI/ML device study. Therefore, most of the requested information regarding acceptance criteria, study design for AI/ML performance, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance does not apply to this document.

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through non-clinical testing (biocompatibility, sterilization, pyrogen, packaging, shelf life, and animal studies). Clinical studies were explicitly not required for this determination.

Here's an attempt to answer the questions based on the provided document, highlighting where the requested information is not applicable:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria in a table format for performance. Instead, it relies on demonstrating that the device performs substantially equivalently to its predicate and reference devices, particularly for the expanded indications for use.

2. Sample size used for the test set and the data provenance

• Animal Study: The document mentions "a rabbit femoral condyle critical-sized defect model." It does not specify the number of rabbits or exact sample size used for this study.
• Data Provenance: The studies mentioned (biocompatibility, sterilization, pyrogen, packaging, shelf life) were completed under the original submission (K182074). The animal study appears to be part of the current submission, likely conducted for the expanded indications. The country of origin and whether the data was retrospective or prospective is not specified, but animal studies are typically prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as this is not an AI/ML device requiring human expert annotation for ground truth. Ground truth for a bone void filler would typically be established through histological analysis of tissue regeneration in the animal model. The document does not specify who conducted such analyses or their qualifications.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable for this type of device and study.

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 is not an AI/ML device that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the animal study, the "ground truth" for assessing device performance would primarily be based on pathology/histology of bone regeneration and integration within the rabbit femoral condyle defects, comparing the test device to the reference device. The document states "The results demonstrate performance substantially equivalent to the reference device with regards to the expansion of the indications for use," implying such an assessment was made.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Ask a specific question about this device

Mineral Collagen Composite Bioactive Moldable combined with either autogenous bone marrow or autograft with saline is indicated for bony voids or gaps, that are not intrinsic to the stability of the bony structure; Mineral Collagen Composite Bioactive Moldable can also be used with autograft as a bone graft extender.

The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., 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.

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 anorganic 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 deep flexor Achilles tendon.

The product is available in various sizes and is provided sterile, non-pyrogenic, and for single use only.

The provided text is a 510(k) Summary for a medical device called "Mineral Collagen Composite Bioactive Moldable." It describes the device, its intended use, and substantial equivalence to predicate devices, but it does not contain the specific information required to answer your request regarding acceptance criteria and a study proving the device meets them.

Here's why and what's missing:

• Acceptance Criteria and Reported Device Performance: This document states that in vivo and in vitro testing was conducted to demonstrate substantial equivalence, and "The results of the animal study demonstrate performance substantially equivalent to the predicate device Vitoss BA and performance substantially equivalent to autograft when used as an autograft extender." However, it does not explicitly list quantitative acceptance criteria for specific performance metrics (e.g., bone formation percentage, fusion rates, mechanical strength) or provide tables comparing the device's performance against these criteria. It only makes a general statement of "substantially equivalent."

• Sample Size for Test Set and Data Provenance: The document mentions "posterolateral spine fusion rabbit model" for the in vivo study, but does not specify the sample size (number of rabbits or test articles) used in this test set. It also doesn't explicitly state the country of origin or whether the data was retrospective or prospective, though animal studies are typically prospective.

• Number of Experts and Qualifications for Ground Truth: This information is not present in the document. Ground truth for animal studies often involves histological analysis by veterinary pathologists, but this detail is missing.

• Adjudication Method: This information is not present in the document.

• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: The document does not mention an MRMC study. The study described is an animal in vivo study comparing the device to a predicate and autograft, not a human reader study.

• Standalone (Algorithm Only) Performance: This device is a physical bone graft matrix, not an algorithm. Therefore, a "standalone algorithm performance" assessment is not applicable.

• Type of Ground Truth Used: For the animal study, the ground truth would likely be based on histological analysis and potentially imaging (e.g., X-rays, micro-CT) assessed by experts (e.g., veterinary pathologists, radiologists). While not explicitly stated, this is standard for such studies.

• Sample Size for Training Set: Since this is a physical device and not an AI/ML algorithm, there is no "training set" in the context of an algorithm's development. The "training" for the device would be its manufacturing process.

• How Ground Truth for Training Set Was Established: As above, this concept is not applicable to a physical medical device.

In summary, while the document confirms that studies were conducted to support the device's substantial equivalence, it lacks the detailed breakdown of acceptance criteria, specific performance metrics, sample sizes, and expert involvement that your request specifies for AI/ML or diagnostic device evaluations. The information provided is typical for a 510(k) summary for a physical implantable device, focusing on material composition, biocompatibility, and in vivo performance relative to predicates.

Ask a specific question about this device