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510(k) Data Aggregation
(49 days)
Footmotion Plating System
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.
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(107 days)
Footmotion Plating System
The Footmotion Plating System is 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. Single use kits (Initial F MTP) contain implants and instruments or instruments only provided sterile by gamma sterilization.
This document is a 510(k) premarket notification for the Footmotion Plating System. As such, it does not contain the detailed information typically found in a study proving a device meets specific acceptance criteria in the context of AI/ML performance evaluation. This device is a medical implant system, not a software or AI-driven diagnostic tool.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable to this type of submission. The document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and mechanical safety, rather than evaluating performance against a specific clinical metric.
Here's a breakdown of the information that is applicable or discernible from the provided text, along with an explanation for why other points are not present:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present acceptance criteria for performance in the typical sense of accuracy, sensitivity, or specificity that would apply to an AI/ML device. Instead, "acceptance criteria" are implied through the demonstration of substantial equivalence to legally marketed predicate devices. The performance is assessed through engineering analyses and material testing to ensure the device is safe and effective for its intended use, similar to its predicates.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use: Similar to predicate devices. | "The Footmotion Plating System is substantially equivalent to the predicate devices in terms of intended use..." |
| "The Footmotion Plating System is intended for arthrodeses, fractures and osteotomies fixation and revision surgeries of the foot in adults." (Matches predicate's likely intended use implicitly) | |
| Design: Similar to predicate devices. | "The Footmotion Plating System is substantially equivalent to the predicate devices in terms of... design..." |
| "The Footmotion Plating System consists of plates and screws, designed for arthrodeses, fractures and osteotomies fixation and revision surgeries of the foot in adults." (Implies design is appropriate for stated use and therefore comparable to predicates) | |
| Materials: Biocompatible and mechanically suitable. | "Titanium alloy Ti-6Al-4V (conform to ASTM F136 and ISO 5832-3)." (Demonstrates use of a known, biocompatible, and mechanically sound material, equivalent to predicates.) |
| Mechanical Safety/Performance: Equivalent to predicate devices. | "Engineering analyses have been conducted in comparison with the predicate devices." (Implied acceptance is that these analyses demonstrate comparable mechanical performance and safety to predicates.) |
| Biocompatibility/Sterility: Meets relevant standards. | "LAL testing was performed to demonstrate that the subject device meets the endotoxin limit of |
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(159 days)
Footmotion Plating System
The Footmotion Plating System is intended for arthrodeses, fractures and osteotomies fixation surgeries of the foot in adults.
The Footmotion Plating System consists of a plate with as many screws as holes (slots) designed for arthrodeses, fractures and osteotomies fixation and revision surgeries of the foot in adults. The plates and screws are manufactured from titanium alloy and color anodized. The Footmotion Plating System will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization.
This document is a 510(k) summary for the Footmotion Plating System, a metallic bone fixation device. As such, it does not describe a study proving software performance against well-defined acceptance criteria for an AI/ML medical device. It's for a physical implantable device.
Therefore, many of the requested categories related to AI/ML device studies, such as sample size for test set and training set, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and how ground truth was established, are not applicable to this document.
However, I can extract the information relevant to this device's non-clinical testing and acceptance criteria as described:
1. A table of acceptance criteria and the reported device performance:
| Test Type | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Comparative Fatigue Compression Tests | ASTM F382 | Subject devices met the standard (implied by conclusion of substantial equivalence to predicates that meet this standard) |
| Comparative Static Tests | ASTM F382 | Subject devices met the standard |
| Torsional Tests | ASTM F543 | Subject devices met the standard |
| Endotoxin Testing | LAL quantitative kinetic chromogenic method; max 20 EU per device | Demonstrated devices meet the recommended maximum endotoxin level of 20 EU per device |
| Water Endotoxin Level (for cleaning) | Max limit 0.25 EU/mL | Never reached the maximum limit of 0.25 EU/mL |
| Bioburden, TOC, THC (for water) | Not explicitly stated | Testing performed, values not specified but implied to be acceptable for cleaning water |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. These are non-clinical mechanical and material tests, not a clinical study or AI/ML evaluation. The tests are performed on representative samples of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. Ground truth as typically understood for AI/ML devices is not relevant for these types of mechanical and material tests. Compliance with established ASTM standards and endotoxin limits forms the 'ground truth' or acceptance criteria for these tests. Engineering analysis is performed by qualified engineers, though their specific number and qualifications are not detailed here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not a study involving human interpretation or subjective assessment that would require adjudication.
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:
No. This document specifies "No clinical studies were performed." This is not an AI/ML device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No. This is not an algorithm or AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's non-clinical testing is based on:
- Compliance with recognized industry standards (ASTM F382, ASTM F543).
- Quantitative measurements against established limits (e.g., endotoxin levels).
- Engineering analysis.
8. The sample size for the training set:
Not applicable. No AI/ML component; therefore, no training set.
9. How the ground truth for the training set was established:
Not applicable. No AI/ML component; therefore, no training set or ground truth for one.
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