(15 days)
Collagen Dental Membrane – Conformable 11 is intended for use in oral surgical Collegon Donal resorbable material for placement in the area of dental implant, bone defect, or ridge augmentation to aid in wound healing.
Collagen Dental Membrane-Conformable II is a white, nonfriable, conformable, resorbable, membrane matrix engineered from highly purified type I collagen derived from bovine Achilles tendon. It is flexible and conforms to the contours of the defect site. Collagen Dental Membrane-Conformable II is supplied sterile, non-pyrogenic, in various sizes, and for single use only.
This document is a 510(k) summary for a medical device called "Collagen Dental Membrane - Conformable II". This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving effectiveness through clinical studies with specific performance criteria in the way a new drug or novel medical device might. Therefore, the information typically requested regarding acceptance criteria, study design parameters like sample size, expert involvement, and ground truth establishment, is not present in this document.
The provided text focuses on demonstrating the new device's similarity to a previously cleared predicate device ("Collagen Dental Membrane, K011695") in terms of materials, intended use, and various physical characteristics, along with biocompatibility testing. It explicitly states: "The results of the in vitro product characterization studies show that the device... is safe and substantially equivalent to the original device."
Based on the provided text, the following information cannot be extracted:
- A table of acceptance criteria and reported device performance (in the context of clinical efficacy/accuracy)
- Sample size used for a test set or data provenance related to clinical performance
- Number of experts used to establish ground truth or their qualifications
- Adjudication method for a test set
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size
- Whether a standalone algorithm performance study was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Sample size for the training set (as this is not an AI/algorithm-driven device)
- How the ground truth for the training set was established.
However, here's what can be gathered, re-framing the "acceptance criteria" based on the nature of a 510(k) for a material device:
1. Table of Acceptance Criteria and Reported Device Performance (Re-framed for a 510(k) of a material device):
| Acceptance Criteria Category (Demonstrating Substantial Equivalence) | Reported Device Performance / Evidence Provided |
|---|---|
| Intended Use | "Collagen Dental Membrane-Conformable II is intended for use in dental surgery procedures as a material for placement in the area of dental implant, bone defect or ridge reconstruction to aid in wound healing post dental surgery." |
| (Identical to predicate's stated use, though not explicitly detailed in the provided text for the predicate) | |
| Material Composition | "engineered from highly purified type I collagen derived from bovine Achilles tendon." (Similar to predicate) |
| Form, Sizes & Thickness | "It is flexible and conforms to the contours of the defect site." "supplied sterile, non-pyrogenic, in various sizes". (Similar to predicate) |
| Physical Integrity | Not explicitly detailed, but implied by "similar technological characteristics" and "nonfriable." (Similar to predicate) |
| Permeability | "similar technological characteristics." (Similar to predicate) |
| Conformability | "flexible and conforms to the contours of the defect site." "similar technological characteristics." (Similar to predicate) |
| Biocompatibility/Safety | "The device passed all applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing for the biological evaluation of medical devices." |
| Sterility & Pyrogenicity | "supplied sterile, non-pyrogenic." (Standard for implantable devices) |
| Single Use Only | "for single use only." (Standard for implantable devices) |
2. Sample size used for the test set and the data provenance:
- Not applicable in the context of clinical performance data for this 510(k). The evaluation was primarily via in vitro testing for biocompatibility and characterization studies to demonstrate equivalence in physical properties. No clinical "test set" from patients is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. Ground truth for clinical performance was not established as there was no clinical study described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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:
- Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-driven device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the in vitro characterization and biocompatibility testing, the "ground truth" would be established by reference standards in analytical chemistry, mechanical engineering, and specific biological assays as per FDA Blue Book Memorandum G95-1 and ISO 10993-1. These are standardized, objective measures, not clinical "ground truth" derived from patient outcomes or expert consensus.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that uses a "training set."
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.