(78 days)
The MotoBAND™ CP Implant System is indication and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. When used for these indications, the MotoBAND™ CP Implant System with the execption of the MTP plates and 2-hole plate may be used with the MotoCLIP™ Implant System
The MotoBANDTM CP Implant System is comprised of implant plates, bone screws and instruments, having various features and sizes to accommodate differing patient anatomy. MotoBANDTM CP Implant System is compatible with MotoCLIPTM Implant System. The MotoBANDTM implants are manufactured from titanium alloy (ASTM F136). Each hole in the plate accepts locking or non-locking screws. Certain plates have a slot that accepts the MotoCLIPTM nitinol staple. MotoBANDTM CP Implant System is compatible with the MotoCLIPTM Implant System The MotoCLIPTM implants are made of biocompatible nitinol and are designed to exhibit superelastic properties.
MotoBAND™ CP Implant System
This document describes the acceptance criteria and study proving the MotoBAND™ CP Implant System meets these criteria. The device is intended for stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers, and toes.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text focuses on the biocompatibility and mechanical integrity of the device, particularly when the MotoBAND™ CP system is used in conjunction with the MotoCLIP™ nitinol compression staple. The acceptance criteria are implicitly tied to the absence of adverse galvanic corrosion and a maintained passive state of the nitinol component, along with mechanical stability under fatigue.
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Galvanic Corrosion | Nitinol component should remain in a passive condition and exhibit a breakdown potential sufficiently above the galvanic mixed potential, indicating no pit initiation due to galvanic interactions. Breakdown potentials pre- and post-fatigue should remain unchanged. | "The nitinol remains in a passive condition and exhibits a breakdown potential sufficiently above the galvanic mixed potential. Pit initiation due to galvanic interactions should not occur." |
| "Test results indicate that the pre and post fatigue breakdown potentials are unchanged." | ||
| "A comparison of the breakdown potentials of the pre and post-fatigue samples indicates no significant difference in the samples." | ||
| Mechanical Fatigue | The combined construct (plate and staple) should function without failure that would indicate a risk for clinical use, particularly demonstrating that the fatigue test of the MotoBAND™ titanium plates does not impart a failure mode to the MotoCLIP™ compression staple. Breakdown potentials pre- and post-fatigue should remain unchanged. | "Testing indicates that fatigue test of the MotoBAND™ titanium plates used with a MotoCLIP™ compression staple does not impart a failure mode to the staple that would indicate a risk for clinical use." |
| "Test results indicate that the pre and post fatigue breakdown potentials are unchanged." | ||
| Wear and Corrosion | Minimal wear and corrosion between the plate and staple constructs under cyclic loading. | "Pre and post fatigue analyses were conducted on the plate and staple constructs to evaluate the wear and corrosion between the two devices." (The successful outcome reported in the other categories implies acceptable wear and corrosion performance.) |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample size for the test set. The data provenance is described as performance testing conducted by the manufacturer, CrossRoads Extremity Systems, as part of their 510(k) submission. This is retrospective testing performed on manufactured devices. The country of origin of the data is implicitly the USA, given the FDA submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This study involves mechanical and electrochemical performance testing of a medical device's physical properties, not a diagnostic or AI-driven system requiring expert assessment of ground truth in medical images or conditions. The "ground truth" here is objective scientific measurement (e.g., breakdown potential, mechanical failure).
4. Adjudication method for the test set
Not applicable. As described in point 3, this is objective performance testing, not a study requiring adjudication of expert opinions.
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 is a performance study for a surgical implant system, not a diagnostic device or an AI assistant for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a surgical implant, not an algorithm or AI system.
7. The type of ground truth used
The ground truth used for this performance testing is established through objective scientific measurements and analyses in a laboratory setting. This includes:
- Electrochemical measurements for cyclic polarization and galvanic corrosion susceptibility.
- Mechanical testing for fatigue and structural integrity.
- Material science principles (e.g., passive condition of nitinol, breakdown potential).
8. The sample size for the training set
Not applicable. This is a performance study for a physical device, not a machine learning model, and therefore does not have a "training set."
9. How the ground truth for the training set was established
Not applicable. As described in point 8, there is no training set for this type of performance study.
§ 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.