(529 days)
Lumina-PTFE Titanium is a temporarily implantable material (non-resorbable) indicated for use as a space-making barrier in the treatment of alveolar and periodontal bony defect sites.
Lumina-PTFE Titanium is a synthetic, biocompatible, single-use, sterile polymeric barrier composed of a 100% polytetrafluoroethylene (PTFE) reinforced by a titanium structure. The titanium frame is embedded between two layers of PTFE. This medical device is placed between bone grafts and the periosteum in dental bone grafting procedures to stabilize and support the bone graft. The PTFE membrane helps create the space needed for bone-derived cells to repopulate and repair the defect. The PTFE membranes are designed to maintain space and conform to tissue contours. Lumina-PTFE Titanium is provided in thicknesses of 0,25mm and different sizes.
The provided text is a 510(k) premarket notification for a medical device called "Lumina-PTFE Titanium." This document does not describe an AI or software device that requires acceptance criteria related to a study proving performance against a ground truth, or an MRMC study.
Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device (Cytoplast™ Titanium-Reinforced PTFE Membranes). This is achieved by comparing the device's technological characteristics and presenting non-clinical performance data (e.g., biocompatibility tests, sterilization validation, material property tests like absorption, wettability, tension break, elasticity, suture pullout strength, and peel resistance).
Therefore, I cannot provide the requested information about acceptance criteria, study design (sample size, data provenance, expert adjudication, MRMC, standalone performance), and ground truth establishment, as these are not relevant to the type of device and submission described in the input.
The entire submission is dedicated to proving that "Lumina-PTFE Titanium" shares the same indications for use, principle of operation, design, composition, and other technical characteristics as its predicate, and that any differences do not raise new questions of safety or effectiveness. No AI or algorithm performance metrics are discussed.
§ 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.