(127 days)
RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indication and support of bone grafts in alveolar bony defect sites.
RPM™ Reinforced PTFE Mesh is placed between bone grafts and the periosteum in dental bone grafting procedures to stabilize and support the bone graft. The PTFE mesh helps create the space needed for bone-derived cells to repopulate and repair the defect. RPM™ Reinforced PTFE Mesh is composed of proprietary 100% polytetrafluoroethylene sheets reinforced with a titanium frame. The titanium frame is embedded between two layers of PTFE. PTFE is a biologically inert and tissue-compatible material. RPM™ Reinforced PTFE Mesh is manufactured with circular 0.66 mm diameter macropores to allow direct contact between the bone graft and the periosteum. Direct contact between the periosteum and bone graft allows naturally occurring revascularization and infiltration of cells. The PTFE mesh is designed to maintain space and conform to tissue contours. RPM™ Reinforced PTFE Mesh is provided pre-shaped in a variety of shapes and sizes.
The provided text describes a 510(k) premarket notification for the RPM™ Reinforced PTFE Mesh, a medical device for bone grafting. The document focuses on demonstrating substantial equivalence to predicate and reference devices through non-clinical testing.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Tensile Strength | Tensile strength ≥ reference device (Bio-Gide®) | Tensile strength ≥ reference device (Bio-Gide®) |
| Lamination Strength | Lamination strength ≥ reference device (Cytoplast™ Regentex™ Titanium 250) | Lamination strength ≥ reference device (Cytoplast™ Regentex™ Titanium 250) |
| Suture Retention Force | Suture retention force ≥ reference device (Cytoplast™ Regentex™ Titanium 250) | Suture retention force ≥ reference device (Cytoplast™ Regentex™ Titanium 250) |
| Cytotoxicity | Non-cytotoxic (passed ISO 10993-5) | Non-cytotoxic |
| Irritation | Non-irritant (passed ISO 10993-10) | Non-irritant |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the numerical sample sizes used for each in vitro bench test. It mentions that "in vitro product characterization testing was performed" and "A series of bench tests were conducted."
The data provenance is from non-clinical testing (in vitro characterization studies and biocompatibility studies). No information about country of origin for the data is provided, but it's generated as part of a US FDA submission. The studies are prospective in the sense that they were conducted specifically for this submission to evaluate the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
Not applicable. The "ground truth" in this context is established by the design and execution of the scientific tests based on recognized standards (ASTM, ISO). There are no human "experts" establishing ground truth in the way one would for image interpretation in AI. The testing itself is the ground truth.
4. Adjudication Method for the Test Set:
Not applicable. This is not a study involving human interpretation or subjective assessment that would require adjudication. The test results are objective measurements against established standards and comparisons to reference devices.
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:
Not applicable. This submission is for a physical medical device (reinforced PTFE mesh), not an AI/imaging diagnostic device. Therefore, no MRMC study was conducted or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used:
The ground truth used for these non-clinical tests is based on:
- Performance against established industry standards: ASTM D638-14 for tensile strength, and ISO 10993-5 and ISO 10993-10 for biocompatibility.
- Comparative performance against legally marketed predicate/reference devices: The specified predicate device (Osteo-Mesh™ TM-300) and reference devices (Cytoplast™ Regentex™ Titanium 250 and Bio-Gide® Resorbable Bilayer Membrane) serve as benchmarks for tensile strength, lamination strength, and suture retention force.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI device or a study involving a "training set" in that sense.
9. How the Ground Truth for the Training Set was Established:
Not applicable. Refer to point 8.
§ 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.