(28 days)
FootHold™ System is intended to be used for suture or tissue fixation in the foot, ankle, hand, and wrist. Specific indications are listed below:
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of Collateral Ligaments, Repair of Flexor and Extensor Tendons at the PIP, and MCP Joints for All Digits, Digital Tendon Transfers
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-Foot Reconstruction
The FootHold™System is a device which is preloaded with suture and is designed to attach soft tissues to bone. The device is deployed through a bicortical drill hole and secured on the far cortex.
The provided document is a 510(k) premarket notification for a medical device called the FootHold™ System, which is a metallic bone fixation fastener. The information contained within this document primarily focuses on demonstrating substantial equivalence to a predicate device through mechanical and materials testing, rather than clinical study results with human participants or a machine learning component.
Therefore, the requested information regarding acceptance criteria, study design for machine learning models, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies for AI devices is not applicable to this submission.
The "study" described in the document is a series of mechanical and materials tests to demonstrate the safety and effectiveness of the device.
Here's a summary of the relevant information provided:
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Table of Acceptance Criteria and Reported Device Performance:
Test Type Acceptance Criteria Reported Device Performance Abrasion Strength Suture does not present a new worst-case for abrasion strength. Mechanical testing demonstrated the suture does not present a new worst-case for abrasion strength. Pull-out Strength Performance substantially equivalent or improved compared to predicate device. Bench testing showed a statistically significant improvement of pull-out strength for the subject device as compared to the listed predicate. Sterilization Sterility Assurance Level (SAL) of $10^{-6}$ (in conformance with ANSI/AAMI/ISO 11135-1). SAL of $10^{-6}$ established. Residuals of ethylene oxide and ethylene chlorohydrin are below thresholds specified in ANSI/AAMI/ISO 10993-7. Packaging Shelf Life Meets acceptance criteria for labeling of 5-year shelf-life (ISO 11607-2). Packaging met all acceptance criteria for labeling a 5-year shelf life. Bacterial Endotoxin Meets established limits. Bacterial endotoxin testing meets the established limits. Biocompatibility Meets ISO 10993-1. Based on comparative analysis, the subject FootHold™System meets ISO 10993-1 for biocompatibility. The results demonstrate the performance is substantially equivalent to the predicate device. -
Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. This is a medical device application based on bench testing of physical properties, not a software device relying on clinical data.
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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 for mechanical testing is established by recognized standards and objective measurements (e.g., force, weight, material composition).
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Testing is against predefined mechanical and material standards.
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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 device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is established by engineering and biological standards (e.g., ASTM, ISO standards for material properties, sterility, and biocompatibility) and direct physical measurements of mechanical properties (pull-out strength, abrasion strength).
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The sample size for the training set:
- Not applicable. This is not a machine learning device; there is no "training set" in the context of AI.
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How the ground truth for the training set was established:
- Not applicable. No training set for an AI model.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.