(199 days)
The Salvin CytoSurg™ Non-Resorbable PTFE Membrane is a temporarily implantable material (nonresorbable) for use as a space-making barrier in the treatment of periodontal defects.
The Salvin CytoSurg™ Non-Resorbable PTFE Membrane is composed of microporous PTFE material. It has a nominal thickness of 250 microns and is supplied in two sizes (25mm x 30mm and 12mm x 24mm). The membranes are single use and are supplied in sterile sealed pouches.
The provided document is a 510(k) Premarket Notification for a medical device called the Salvin CytoSurg™ Non-Resorbable PTFE Membrane. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a study proving performance against specific acceptance criteria in the context of an AI/ML device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth, and training set details for an AI/ML device cannot be extracted from this document.
However, I can extract the performance data and the conclusion related to the device's substantial equivalence to its predicate, as presented in the document.
Acceptance Criteria and Reported Device Performance (as related to substantial equivalence):
| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Physical Properties | Tensile Strength | Bench testing demonstrated substantial equivalence to the predicate device |
| Tear Resistance | Bench testing demonstrated substantial equivalence to the predicate device | |
| Geometric Comparisons | Demonstrated substantial equivalence to the predicate device | |
| Biocompatibility | ISO 10993-5 / Tests Cytotoxicity | Met their acceptance criteria |
| ISO 10993-6 / Tests Local Effects After Implantation | Met their acceptance criteria | |
| ISO 10993-10 / Tests for irritation and skin sensitization | Met their acceptance criteria | |
| ISO 10993-11 / Tests for Systemic Toxicity | Met their acceptance criteria | |
| Other Validations | Packaging Validation | Met their acceptance criteria |
| Sterilization Validation | Met their acceptance criteria |
Since this is not an AI/ML device, the following information is not applicable and cannot be extracted from the provided text:
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
§ 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.