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510(k) Data Aggregation
(241 days)
Porcine Mineral Collagen Composite is intended to be used for bone grafting in periodontal, oral and maxillofacial surgeries.
Porcine Mineral Collagen Composite 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 conjunction with products 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 (GBR).
Porcine Mineral Collagen Composite is an osteoconductive bone mineral with collagen composite for bone grafting in periodontal. oral and maxillofacial surgery. The device is composed of anorganic bone mineral granules derived from porcine cancellous bone and collagen from porcine Achilles tendon in compressed, formaldehyde-crosslinked, preformed sponge matrices designed to fit the size of the defect upon hydration. The product is supplied sterile, non-pvrogenic and for single use only.
The product is available in the following shape and sizes:
| Product Shape | Dimensions |
|---|---|
| Plug | 10mm (5mm dry) x 17mm (diameter x length) |
| Umbrella | 17mm (13mm dry) x 10mm (diameter x height) |
| Umbrella | 22mm (17mm dry) x 12mm (diameter x height) |
This document describes the performance data for a medical device called "Porcine Mineral Collagen Composite" in the context of its 510(k) premarket notification to the FDA. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence through various performance tests rather than against explicit numerical "acceptance criteria" in the way one might see for an AI algorithm's sensitivity/specificity. However, the outcomes of these tests effectively serve as the criteria for acceptance to demonstrate equivalence to the predicate device.
| Test Category | Specific Test (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity (ISO 10993-5) | Non-cytotoxic |
| Sensitization (ISO 10993-10) | No evidence of causing delayed dermal contact sensitization in the guinea pig | |
| Irritation Intracutaneous Reactivity (ISO 10993-10) | No evidence of irritation or toxicity | |
| Acute Systemic Toxicity (ISO 10993-3) | No mortality or evidence of systemic toxicity | |
| Pyrogenicity (USP 151, USP 85) | Non-pyrogenic | |
| Genotoxicity (Mouse Lymphoma Assay, ISO 10993-3) | No evidence of causing increase in the mean mutant frequency of the L5178Y/TK+/- cell line; not mutagenic | |
| Genotoxicity (Ames Assay) | Non-mutagenic to Salmonella typhimurium and to Escherichia coli strain WP2uvra | |
| Implantation (Canine Intrabony Defect Model, ISO 10993-6) | Minimum tissue reaction at 4, 8, and 13 weeks of implantation and no adverse tissue reaction to the host | |
| Subacute / Subchronic / Chronic Toxicity (Canine Intrabony Defect Model, ISO 10993-11) | Minimum tissue reaction at 4, 8, and 13 weeks of implantation and no adverse tissue reaction to the host | |
| Formaldehyde Residuals (Toxicology Risk Assessment) | Amount of formaldehyde residual for single product use has been addressed. No long-term toxicological effects are anticipated for single use. (Note: Risk of exposure to formaldehyde has not been addressed when multiple products are used.) | |
| Bench Testing | Mineral Content | Similar to predicate devices |
| Size | Similar to predicate devices | |
| Calcium to Phosphate Ratio (mineral only) | Similar to predicate device | |
| Scanning Electron Micrograph (SEM) - Morphologies | Similar to reference device | |
| X-Ray Diffraction - Diffraction Patterns | Similar to reference device | |
| IR Spectroscopy - Functional Groups | Similar to reference device | |
| Porosity | Similar to predicate | |
| pH | Similar to predicate device | |
| Absorbency | ≥ 5ml/g | |
| Pyrogenicity | Non-pyrogenic | |
| Animal Testing | Canine One-Wall Intrabony Defect Model (Radiographic, Micro CT, Histology, Histomorphometry analyses) | Performance substantially equivalent to the predicate device Bio-Oss® Collagen when used as intended. |
| Sterilization | Validation (ISO 11137-1, 11137-2, 11737) | Performed in accordance with standards |
| Pyrogenicity | Finished product release test (LAL endotoxin test, USP 85) | Non-pyrogenic (Each batch tested) |
| Shelf Life/Stability | Product and Packaging Stability (ASTM D4169, ISO 11607) | Determined using data; performance testing of packaging system performed in accordance with ASTM D4169; selection, qualification, and validation of packaging performed in accordance with ISO 11607. |
| Viral Inactivation | Studies (ISO 22442-3) | Performed to ensure viral safety of the product. |
2. Sample Size Used for the Test Set and the Data Provenance:
- Biocompatibility Testing: The specific sample sizes for each biocompatibility test (e.g., number of guinea pigs for sensitization, number of mice for acute systemic toxicity) are not explicitly stated in the summary. The tests were performed in vitro (e.g., L929 MEM Elution) and in vivo (e.g., Guinea Pig Maximization, Rabbit Intracutaneous Reactivity, mice for systemic toxicity, canine for implantation).
- Bench Testing: Sample sizes for each bench test are not specified. These tests are inherently in vitro.
- Animal Testing (Canine Study): The sample size (number of canines) for the intrabony defect model is not specified. The study was in vivo, involving implantation at 4, 8, and 13 weeks. Its provenance is not stated (e.g., specific country or institution), but it's an animal study conducted to demonstrate performance.
- Data Provenance: The document does not explicitly state the country of origin for the data for any of the studies, nor does it explicitly classify them as "retrospective" or "prospective" as one would for human clinical trials. However, given the nature of the studies (biocompatibility, bench, animal), they would generally be considered prospective studies designed to evaluate the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This level of detail is not provided for most tests.
- Animal Testing (Canine Study): Radiographic, Micro CT, Histology, and Histomorphometry analyses were conducted. While these analyses require expert interpretation (e.g., veterinary pathologists, radiologists), the number of experts and their specific qualifications are not specified in this summary. The "ground truth" here is derived from the scientific measurements and observations from these analyses compared to a predicate device and sham control.
- For in vitro and other standardized tests (e.g., cytotoxicity, pyrogenicity), the "ground truth" is typically the result of the standardized test itself, not expert consensus on interpretations.
4. Adjudication Method for the Test Set:
Not applicable or specified for the types of tests conducted. These are not studies requiring human expert adjudication of ambiguous cases, as would be common for AI in medical imaging. The studies focus on objective measurements and established biological responses.
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:
No. This type of study (MRMC for AI assistance) was not performed because:
- The device is a medical implant (bone graft material), not a software or AI-driven diagnostic tool.
- "Clinical performance data was not required to determine substantial equivalence" (Page 8), meaning human clinical trials comparing device performance or AI assistance were not deemed necessary for this 510(k) submission.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
No. This question is also specifically relevant for AI algorithms. The "Porcine Mineral Collagen Composite" is a physical device, so the concept of an "algorithm only" or "human-in-the-loop" performance study does not apply.
7. The Type of Ground Truth Used:
The ground truth for the performance evaluation of this device is established through a combination of:
- Standardized Test Results/Reference Values: For biocompatibility tests (e.g., non-cytotoxic, non-mutagenic), specific thresholds or qualitative outcomes defined by recognized standards (ISO, USP) serve as the ground truth.
- Predicate Device Equivalence: For many bench tests (e.g., mineral content, calcium to phosphate ratio, porosity, pH), the "ground truth" is similarity to the legally marketed predicate devices, as the goal is to demonstrate substantial equivalence.
- Pathological/Histological Findings: In the canine intrabony defect model, ground truth is derived from objective measurements (e.g., radiographic density, Micro CT analyses) and expert evaluation of tissue samples (histology, histomorphometry) for parameters like tissue reaction, new bone formation, etc.
8. The Sample Size for the Training Set:
This device does not involve a "training set" in the context of machine learning or AI models. Therefore, this question is not applicable.
9. How the Ground Truth for the Training Set was Established:
As there is no training set for an AI model, this question is not applicable. The device's characteristics are inherent to its manufacturing process and tested through established laboratory and animal study protocols.
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(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.
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