(267 days)
Cytoplast™ Titanium-Reinforced PTFE Membranes are a temporarily implantable material (non- resorbable) indicated for use as a space-making barrier in the treatment of alveolar and periodontal bony defect sites.
Cytoplast™ Titanium-Reinforced PTFE Membranes are 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.
Cytoplast™ Titanium-Reinforced PTFE Membranes are composed of proprietary 100% polytetrafluoroethylene sheets reinforced with a titanium frame. The titanium frame is embedded between two layers of PTFE. PTFE is biologically nearly inert and a tissue-compatible material.
The PTFE membranes are designed to maintain space and conform to tissue contours.
Cytoplast™ Titanium-Reinforced PTFE Membranes are provided in two different thicknesses (approximately 150 µm & 250 µm) and are pre-shaped in a variety of shapes and sizes.
The provided text describes a 510(k) summary for a medical device and does not contain information about an AI/ML powered device, a comparative effectiveness study, or details related to establishing ground truth for a test set in the context of an AI/ML device.
Therefore, I cannot provide the requested information in the format of a table for acceptance criteria and device performance as it pertains to AI/ML or a study that proves a device meets AI/ML specific acceptance criteria. The document describes a traditional medical device (Cytoplast™ Titanium-Reinforced PTFE Membranes) and its substantial equivalence to predicate devices based on non-clinical testing.
Here's a breakdown of what can be extracted in relation to the questions asked, adapted to the context of the provided document:
Acceptance Criteria and Device Performance (Non-AI/ML context)
| Acceptance Criteria (Bench Tests) | Reported Device Performance (Cytoplast™ Titanium-Reinforced PTFE Membranes) |
|---|---|
| Biocompatibility (per ISO 10993) | Confirmed (Cytotoxicity, Irritation, Toxicity, Implantation) |
| Sterility Assurance Level (per ISO 11135-1:2007) | Achieved 10⁻⁶ SAL |
| Shelf-life (per ISO 11607-1) | Met (4 years) |
| Tensile Strength (per ASTM D638-14) | Tensile strength ≥ reference device (Bio-Gide® Resorbable Bilayer Membrane) |
| Lamination Strength (Internal Test) | Lamination is acceptable |
Further Details (where applicable to the provided document):
- Sample size used for the test set and the data provenance: Not applicable in the context of AI/ML. The "test set" here refers to the samples of the Cytoplast™ Titanium-Reinforced PTFE Membranes subjected to various non-clinical bench tests (e.g., for tensile strength, lamination). Specific sample sizes for each test are not explicitly stated in the summary, but the tests were performed on the device itself.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/ML models (e.g., expert-labeled images) is not relevant here. The "truth" for these non-clinical tests is determined by standardized protocols (e.g., ASTM D638-14 for tensile strength) and material characterization.
- Adjudication method for the test set: Not applicable. This document describes physical and material property testing, not subjective assessment requiring adjudication.
- 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/ML device, and no MRMC study was conducted.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/ML device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI/ML sense. The "ground truth" for the non-clinical tests is established by industry standards, physical measurements, and chemical/biological assays. For instance, biocompatibility is evaluated against established ISO 10993 cytotoxicity, irritation, and toxicity standards. Tensile strength is objectively measured.
- The sample size for the training set: Not applicable. There is no AI/ML model involved, and therefore no training set.
- 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.