(149 days)
Collagen Dental Membrane – Porcine Type I Collagen is intended for use in oral surgical procedures as a resorbable material for placement in the area of dental implant, bone defect, or ridge augmentation to aid in wound healing.
Collagen Dental Membrane-Porcine Type I Collagen is a white, nonfriable, conformable, resorbable, membrane matrix engineered from highly purified type I collagen derived from porcine Achilles tendon. It is flexible and conforms to the contours of the defect site. Collagen Dental Membrane-Porcine Type I Collagen is supplied sterile, non-pyrogenic, in various sizes, and for single use only.
The provided text is a 510(k) summary for the Collagen Dental Membrane - Porcine Type I Collagen. This device is a resorbable membrane for use in oral surgical procedures. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than a standalone performance study with specific acceptance criteria in the context of AI/software device evaluation.
Therefore, many of the requested sections (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance measures like AUC, sensitivity, specificity, FROC curves) are not applicable to this type of device and submission.
Here's an analysis based on the information available in the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (resorbable collagen membrane), acceptance criteria and performance are typically related to material properties, biocompatibility, and substantial equivalence to legally marketed devices. The document does not explicitly present a table of quantitative acceptance criteria as would be seen for a diagnostic or AI-driven device. Instead, it states that the device was evaluated against various standards and compared to predicate devices for similar characteristics.
| Criterion | Reported Device Performance (as per submission) |
|---|---|
| Substantial Equivalence to Predicates | Device found substantially equivalent in intended use, purified starting material (type I collagen), form, sizes, thickness, physical integrity, permeability, and conformability to K062881 (Collagen Dental Membrane-Conformable II) and K053260 (Ossix Plus). |
| Material Properties | Evaluated through in vitro characterization studies; results support substantial equivalence. (Specific metrics not provided) |
| Biological Properties | Evaluated through in vitro characterization studies; results support substantial equivalence. (Specific metrics not provided) |
| Chemical and Physical Properties | Evaluated through in vitro characterization studies; results support substantial equivalence. (Specific metrics not provided) |
| Safety/Biocompatibility | Passed all applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing. |
| Viral Inactivation | Viral inactivation studies were performed to ensure viral safety. (Specific metrics not provided, just successful completion) |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This submission relies on in-vitro characterization, biocompatibility testing, and comparison to the clinical history of predicate devices, not a 'test set' of patient data in the typical sense of an AI/diagnostic device study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth, in the context of this device, refers to the scientific validation of material properties and biocompatibility, not expert interpretation of diagnostic images or patient outcomes for a specific clinical condition using the device.
4. Adjudication Method for the Test Set
Not applicable. No "test set" requiring adjudication by experts was described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This is not an AI/software device and therefore an MRMC study is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/software device requiring standalone algorithm performance evaluation.
7. The Type of Ground Truth Used
The 'ground truth' in this submission is established through:
- In vitro characterization studies: Demonstrating material, chemical, and physical properties.
- Biocompatibility studies (in vitro and in vivo): Conforming to FDA Blue Book Memorandum G95-1 and ISO 10993-1 standards.
- Viral inactivation studies: Demonstrating viral safety.
- Clinical history of predicate devices: Used to infer expected performance and safety in a clinical setting by demonstrating substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. There is no 'training set' as this is not an AI/machine learning device. The design and validation are based on established engineering principles, material science, and regulatory standards.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no 'training set' for this medical device. The 'ground truth' for the device's design and fundamental properties is based on scientific and regulatory standards for collagen-based resorbable membranes, as evaluated in the in vitro and in vivo (biocompatibility) studies.
§ 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.