(70 days)
CytoFlex® Resorb membranes are intended for use as a space-making barrier in the treatment of periodontal defects and maxillofacial guided tissue regeneration procedures, including preservation and regeneration of alveolar bone height and volume, ridge and extraction site augmentation, sinus lifts, and treatment of associated cystic defects. It is also intended for use as a grafting material containment matrix.
CytoFlex® Resorb barriers are made from polyglycolide, polylactide and poly(glycolide-co-lactide) copolymer. CytoFlex® Resorb is a resorbable barrier membrane and is supplied in a variety of shapes and sizes in sealed pouches. CytoFlex® Resorb membrane is tested, evaluated and found to be substantially equivalent to legally marketed predicate devices.
The provided text describes a 510(k) summary for the CytoFlex® Resorb device, which is an absorbable barrier membrane. However, it does not contain information about any specific study or acceptance criteria related to device performance.
The document primarily focuses on:
- Device Identification: Trade name, common name, classification.
- Predicate Devices: Listing of similar devices already on the market.
- Device Description: Material composition (polyglycolide, polylactide, poly(glycolide-co-lactide) copolymer), form factor (various shapes and sizes in sealed pouches).
- Intended Use/Indications for Use: Applications in periodontal defects, maxillofacial guided tissue regeneration, and as a grafting material containment matrix.
- FDA Communication: A letter from the FDA indicating that the device has been found substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.
Therefore, I cannot fulfill your request for the following sections as the information is not present in the provided text:
- A table of acceptance criteria and the reported device performance
- Sample sized 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
- If a standalone performance study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
This type of 510(k) submission, especially for a Class II device seeking substantial equivalence, often relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive new clinical performance studies with acceptance criteria in the manner you've described for AI/diagnostic devices. The "study" here is essentially the comparison to predicate devices based on material properties, manufacturing, and intended use.
§ 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.