(110 days)
Collagen Dental Sponge Membranes are intended for use in patients with moderate to Sollagen Bontal disease as a resorbable material for placement in periodontal defects to aid in wound healing post periodontal surgery.
Description of the Dore." Conagen Domar Sponge recemsnufactured from crosslinked type I collagen derived from bovine Achilles tendon. The product is supplied sterile, non-pyrogenic, and for single use only.
This submission (K033729) is for a Collagen Dental Sponge Membrane, a medical device. The provided documents are a 510(k) Summary of Safety and Effectiveness and the FDA's decision letter. These documents do not contain information about acceptance criteria or a study proving that the device meets them in the way typically expected for performance claims (e.g., sensitivity, specificity, accuracy for an AI/diagnostic device).
Instead, this submission is for a material (Collagen Dental Sponge Membranes) and focuses on demonstrating substantial equivalence to predicate devices by assessing its safety and technical characteristics. The "acceptance criteria" here are implicitly the regulatory requirements for showing substantial equivalence.
Here's how to interpret the available information in the context of your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Device must pass applicable biocompatibility tests. | The device passed all applicable ISO 10993-1 testing for the biological evaluation of medical devices. |
| Substantial Equivalence: Device must have similar intended use, material, source, sterilization, etc., to predicate devices. | Collagen Dental Sponge Membranes and its predicates have similar technological characteristics with respect to intended use, material, source, sterilization, etc. |
| Absence of new safety/effectiveness questions: Device must not raise new questions of safety or effectiveness compared to predicates. | Not explicitly stated as "met," but implied by the conclusion of substantial equivalence. |
| Intended Use: Consistent with predicate devices. | The device's indications for use: "Collagen Dental Sponge Membranes are intended for use in patients with moderate to severe periodontal disease as a resorbable material for placement in periodontal defects to aid in wound healing post periodontal surgery." This matches discussions about similar intended uses to predicates. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. For device submissions focused on substantial equivalence based on material properties and biocompatibility, human clinical "test sets" in the context of diagnostic performance are typically not required unless there are novel claims or significant differences from predicates. The "test set" here refers to the samples used for the ISO 10993-1 testing.
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)
This information is not provided. The "ground truth" for biocompatibility testing (ISO 10993-1) is established by the standardized test methods themselves, which are performed by trained laboratory personnel. There is no mention of clinical experts establishing ground truth for a test set in this context.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are typically relevant for clinical studies involving human interpretation or subjective outcomes, which are not detailed here.
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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, which this Collagen Dental Sponge Membrane is not.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is a bio-material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the safety evaluation, the "ground truth" was established by standardized laboratory testing protocols (ISO 10993-1) for biocompatibility. These tests assess parameters like cytotoxicity, sensitization, irritation, etc., against predefined pass/fail criteria within the standard.
8. The sample size for the training set
This information is not provided. "Training set" is a concept for machine learning models, which is not applicable to this device submission.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for an algorithm.
In Summary:
The provided documents describe a 510(k) submission for a Collagen Dental Sponge Membrane. The "study" referenced is the biocompatibility testing according to ISO 10993-1, which serves as the evidence for the device's safety. The "acceptance criteria" are the predefined pass/fail thresholds within these ISO standards. The overall goal of the submission is to demonstrate substantial equivalence to existing predicate devices, rather than to prove performance against clinical outcome metrics through a typical clinical trial with human subjects. Thus, many of the questions related to AI/diagnostic device evaluation are not applicable here.
§ 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.