Search Results

· Augmentation or reconstructive treatment of 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 maxillary sinus floor
· Filling of periodontal defects in conjuncts 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.

Device Description

Porcine Mineral Collagen Composite Moldable is an osteoconductive bone mineral with collagen composite for bone grafting in periodontal, oral and maxillofacial surgery. The device is composed of 90% anorqanic bone mineral granules derived from porcine cancellous bone and 10% collagen from porcine Achilles tendon in a composite matrix. The product is supplied sterile, non-pyrogenic and for single use only.
Porcine Mineral Collagen Composite Moldable is provided in a block form and is available in three sizes, 0.5cc, 1.0cc, and 2.0cc.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Device Name: Porcine Mineral Collagen Composite Moldable (K201859)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are based on demonstrating substantial equivalence to predicate devices (K140714 and K033815, K110600, K122115) through a series of non-clinical tests. The criteria used are the standards and expected outcomes for these tests.

Test Category	Acceptance Criteria (e.g., standard, expected outcome for equivalence)	Reported Device Performance (Results)
Biocompatibility	In accordance with ISO 10993-1 and FDA Guidance
Cytotoxicity	Non-cytotoxic	Non-cytotoxic
Genotoxicity (Mouse Lymphoma Assay)	No increase in mutant frequency / not mutagenic	No evidence of causing increase in the mean mutant frequency; not mutagenic
Genotoxicity (Ames Assay)	Non-mutagenic	Non-mutagenic to Salmonella typhimurium and Escherichia coli strain WP2uvra
Sensitization	No evidence of dermal contact sensitization	No evidence of causing delayed dermal contact sensitization in the guinea pig
Irritation Intracutaneous Reactivity	No evidence of irritation or toxicity	No evidence of irritation or toxicity
Acute Systemic Toxicity	No mortality or systemic toxicity	No mortality or evidence of systemic toxicity
Pyrogenicity	Non-pyrogenic	Non-pyrogenic
Implantation	Minimum tissue reaction, no adverse tissue reaction	Minimum tissue reaction up to 13 weeks of implantation and no adverse tissue reaction to the host
Subacute / Subchronic / Chronic Toxicity	Minimum tissue reaction, no adverse tissue reaction	Minimum tissue reaction up to 13 weeks of implantation and no adverse tissue reaction to the host
Bench Testing	Similar to predicate device, appropriate characteristics
Mineral Content	Similar to predicate device	Mineral content similar to predicate device
Size	Volumes similar to predicate device	Volumes similar to predicate device
Calcium to Phosphate Ratio (mineral only)	Similar to predicate device	Ratio similar to predicate device
Scanning Electron Micrograph (SEM)	Morphologies similar to reference device	Morphologies similar to reference device
X-Ray Diffraction	Similar diffraction patterns to reference device	Similar diffraction patterns to reference device
IR Spectroscopy	Similar functional groups to reference device	Similar functional groups to reference device
Density	Appropriate density for sufficient porosity	Appropriate density for sufficient porosity
pH	Similar to predicate device	pH similar to predicate device
Absorbency	Similar to predicate device	Absorbency similar to predicate device
Pyrogenicity	Non-pyrogenic	Non-pyrogenic
Animal Testing	Performance substantially equivalent to reference device	Performance substantially equivalent to the reference device Bio-Oss Collagen when used as intended (Radiographic, Micro CT, Histology and Histomorphometry analyses at 4, 8, and 13 weeks)
Sterilization	In accordance with ISO 11137-1	Sterilization validation performed in accordance with ISO 11137-1
Shelf Life & Stability	Determined using real-time aging data, performance testing of packaging	Product and packaging stability determined using real-time aging data. Packaging system tested per ASTM D4169.
Viral Inactivation	Performed in accordance with ISO 22442-3	Viral inactivation studies performed in accordance with ISO 22442-3

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

The document does not explicitly state numeric "sample sizes" in terms of "test sets" for many of the individual tests beyond the animal study.

Animal Study (Implantation/Toxicity/Performance): The text mentions "Implantation in Canine Intrabony Defect Model" and "performance of the device in a canine one-wall intrabony defect model." It refers to "the subject device, reference device and sham negative control." While it doesn't give an exact number of dogs or defects, it implies experimental groups were used for comparison.
Biocompatibility Tests: These tests typically use standardized biological samples (e.g., L929 cells for cytotoxicity, guinea pigs for sensitization, rabbits for irritation, mice for acute systemic toxicity). The specific sample numbers for each of these tests are not provided but are generally dictated by the referenced ISO standards.
Bench Testing: These tests assess material properties and are performed on samples of the device and predicate/reference devices. Specific sample numbers (e.g., how many units were tested for mineral content, density, pH) are not specified.
Data Provenance: The studies are described as non-clinical (in vitro, bench, and animal testing). The country of origin for the data is not specified, but the use of international standards (ISO, ASTM, USP) suggests these are likely standardized laboratory tests. The nature of these tests is prospective within the context of the study design for each specific test, as the device was manufactured and then subjected to these evaluations according to pre-defined protocols.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable in the conventional sense. This is a non-clinical device submission for a bone grafting material. The "ground truth" for these tests refers to the established scientific principles, standardized test methods (like ISO, ASTM, USP), and documented performance of predicate devices. There wouldn't be "experts" establishing a "ground truth" for a test set in the same way clinical image interpretation requires expert radiologists. The "truth" is determined by the objective measurements and observations defined by the test protocols and standards.
For the Animal Testing, the "ground truth" for efficacy (performance) would be established by objective measurements (Radiographic, Micro CT, Histology, Histomorphometry analyses) performed by trained scientists/pathologists in accordance with the study protocol. Their qualifications are not specified but would typically involve veterinary expertise, histology pathology, and imaging interpretation.

4. Adjudication Method for the Test Set

Not applicable. As this is a non-clinical submission relying on objective measurement and comparison to predicate devices and standards, there is no "adjudication" in the sense of resolving conflicting interpretations by multiple human readers. The results of the tests (e.g., non-cytotoxic, similar mineral content, substantially equivalent performance in canines) are based on pre-defined criteria within the test protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

No. This is a submission for a medical device (bone grafting material), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.

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

No. As explained above, this device is a physical bone grafting material, not a software algorithm. Therefore, "standalone" algorithm performance is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily based on:

Standardized Test Outcomes: Adherence to established international standards (ISO, ASTM, USP) for biocompatibility, material properties, sterility, etc. The results are compared against the pass/fail criteria or expected values defined by these standards.
Comparison to Predicate Device Performance: Demonstrating that the subject device's performance (e.g., physical, chemical, biological characteristics, and performance in animal models) is "substantially equivalent" to legally marketed predicate devices. This is achieved by showing similar results across various tests.
Histopathology/Imaging (for Animal Study): For the animal study, the ground truth for biological response and bone regeneration comes from objective analyses like radiography, Micro CT, histology, and histomorphometry of tissue samples, interpreted by experts in these fields.

8. The Sample Size for the Training Set

Not applicable. This submission describes the evaluation of a manufactured medical device. There is no concept of a "training set" in the context of machine learning for this type of product. The device itself is the product being tested, not an algorithm that learns from data.

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

Not applicable. Since there is no "training set," the establishment of its ground truth is not relevant.

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