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The implants of the Footmotion Plating System are intended for arthrodeses, fractures and osteotomies fixation and revision surgeries of the foot in adults.

Device Description

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.

AI/ML Overview

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.

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