(49 days)
The implants of the Footmotion Plating System are intended for arthrodeses, fractures and osteotomies fixation and revision surgeries of the foot in adults.
The Footmotion Plating System consists of plates and screws, designed for arthrodeses, fractures and osteotomies fixation and revision surgeries of the foot in adults.
The implants of the Footmotion Plating System will be provided non sterile for sterilization by health care professionals prior to use, or provided sterile by gamma sterilization.
The instruments of the Footmotion Plating System will be provided non sterile for sterilization by health care professionals prior to use.
This FDA 510(k) summary is for a medical device called the Footmotion Plating System, which is a metallic bone fixation device. As such, the "acceptance criteria" and "device performance" are typically related to mechanical and material properties rather than diagnostic accuracy or clinical outcomes. The study described is a non-clinical, benchtop study.
Here's the breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | 4-point-bending (plates) | Performance comparable to predicates (ASTM F382 standards) | Subject device plates performance found to be comparable to predicates. |
| Mechanical Performance | Torsional testing (screws) | Performance aligned with predicate standards (ASTM F543) | Performed on subject screws (details not quantified but implies acceptable performance vs. predicates). |
| Mechanical Performance | Axial pull-out strength (screws) | Performance aligned with predicate standards (Equation described by Chapman, FDA-Guidance: Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway-2020) | Performed on subject screws (details not quantified but implies acceptable performance vs. predicates). |
| Biocompatibility | Endotoxin testing | Acceptable endotoxin levels (LAL quantitative kinetic chromogenic method) | Testing performed and results considered acceptable. |
| Material Equivalence | Material Composition | Conform to predicate materials (CP Titanium per ASTM F67/ISO 5832-2; Titanium alloy Ti-6Al-4V ELI per ASTM F136/ISO 5832-3) | Uses the same materials as the predicate devices. |
| Design Equivalence | Shape, Material, Operating Principles | Equivalent to predicate devices | Equivalent in terms of shape, material, and operating principles. |
| Dimensional Equivalence | Sizes | Equivalent to predicate devices | Equivalent in their dimensions. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the number of plates or screws tested. However, mechanical testing typically involves a sufficient number of samples to achieve statistical significance.
- Data Provenance: The studies are non-clinical (benchtop) tests performed by the manufacturer, Newclip Technics, as part of their 510(k) submission. There is no mention of country of origin for the data or if it's retrospective/prospective as these terms are not applicable to non-clinical bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. For mechanical and material testing of this nature, "ground truth" is established by adherence to recognized international and national standards (e.g., ASTM, ISO, FDA guidance documents) and the results of the physical tests themselves. Human experts are involved in designing and conducting the tests, interpreting the raw data, and comparing it to the performance of predicate devices, but they are not establishing a "ground truth" in the diagnostic sense.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods like "2+1" or "3+1" are relevant for clinical studies or studies involving human assessment of clinical data, especially in diagnostic accuracy claims. For benchtop mechanical testing, the results are typically quantitative and objective, directly compared against established standards or predicate device performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance
- Not Applicable. This device is a bone fixation system, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and the concept of "human readers improving with AI vs. without AI assistance" are not relevant to this submission.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not Applicable. This device is a physical medical implant (plating system), not a software algorithm. Therefore, "standalone algorithm performance" is not applicable.
7. The Type of Ground Truth Used
- The "ground truth" for the mechanical performance of the device is established by:
- Adherence to recognized industry standards: ASTM F382 (for plate bending), ASTM F543 (for screw torsion), and FDA Guidance "Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway-2020" (for screw axial pull-out).
- Comparison to predicate devices: The subject device's mechanical and material properties are demonstrated to be "substantially equivalent" to legally marketed predicate devices.
- Biocompatibility testing: Endotoxin levels assessed by LAL quantitative kinetic chromogenic method.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" in the context of this device because it is a physical hardware device, not a machine learning or AI algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for this type of device, this question is not relevant.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.