(67 days)
Porcine Mineral Collagen Composite Moldable is indicated for:
- · 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.
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.
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.
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.