(232 days)
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:
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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."
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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.
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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.
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Adjudication Method: This information is not present in the document.
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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.
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Standalone (Algorithm Only) Performance: This device is a physical bone graft matrix, not an algorithm. Therefore, a "standalone algorithm performance" assessment is not applicable.
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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.
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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.
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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.
§ 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.