(47 days)
Variable Angle technology in MTP, TMT, MFT, MXL, DFX, and EDL plates are indicated for fractures, fusions and osteotomies for small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.
Variable Angle Technology in MXL and CLA plates are indicated for the fractures, fusions, and osteotomies of the clavicle and small bones in the hand, wrist, foot and ankle.
This special 510(K) submission is a modification to the previously cleared Modular Foot and Clavicle systems to add a variable angle locking screw construct. No changes have been made to the current locking plates; this addition will be compatible with all plates currently in the system. The OrthoHelix variable angle construct consists of a polymer ring which mates with the locking plate and allows for a specially designed locking screw to be inserted at angles up to 15° in any direction while maintaining angular stability.
The provided text describes a medical device, the MaxLock Extreme® Extremity Plating System with Variable Angle Technology, and its substantial equivalence to predicate devices. It does not contain information about a study proving the device meets acceptance criteria in the typical sense of a clinical trial or a performance study with metrics like sensitivity, specificity, or accuracy.
Instead, the acceptance criteria and proof of their fulfillment for this type of device (bone fixation system) are primarily based on mechanical testing demonstrating substantial equivalence to previously cleared devices.
Here's the breakdown based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Dynamic mechanical testing (e.g., fatigue, stability) | Dynamic mechanical testing confirmed substantial equivalence to predicate devices. |
| Static mechanical testing (e.g., strength, stiffness) | Static mechanical testing confirmed substantial equivalence to predicate devices. | |
| Material Equivalence | Materials are equivalent to predicate devices. | "No changes have been made to the current locking plates." (Implies material consistency with cleared plates). Introduction of a "polymer ring" and "specially designed locking screw" implies these new components also meet relevant material and performance standards, though specific data is not detailed here. |
| Performance vs. Predicate | Performance is substantially equivalent to predicate devices for intended use. | "Dynamic and static mechanical testing confirm that the MaxLock Extreme® implants with Variable Angle Technology are substantially equivalent to their predicate and meet the specified requirements for their intended use." |
| Safety and Efficacy | No new issues of safety and efficacy are raised. | "No new issues of safety and efficacy have been raised during the development of this system." |
Study Details (Mechanical Testing)
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Sample size used for the test set and the data provenance:
- The text does not specify the exact sample size (number of implants tested) for the dynamic and static mechanical testing.
- Data Provenance: The testing was conducted by OrthoHelix Surgical Designs Inc., a US-based company, as part of their development process for this modification. This would be considered prospective data generation for the purpose of demonstrating device performance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of mechanical testing does not typically involve "experts" establishing a "ground truth" in the same way clinical or diagnostic studies do. The "ground truth" here is adherence to established engineering and mechanical testing standards (e.g., ASTM standards for orthopedic implants), which are often industry-accepted benchmarks for performance. Product engineers and test lab personnel would conduct and assess these tests.
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Adjudication method for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on clinical or image-based ground truth, not for mechanical testing results. Mechanical test results are quantitative and compared directly to specified performance metrics or predicate device performance.
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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 a bone fixation system, not a diagnostic or AI-assisted device. Therefore, no MRMC study involving human readers or AI assistance would have been conducted or is relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a mechanical implant, not an algorithm.
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The type of ground truth used:
- For mechanical testing, the "ground truth" is defined by established engineering standards and the performance of the predicate devices. The new device's performance is compared against these benchmarks to establish substantial equivalence.
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The sample size for the training set:
- Not applicable. This is not a machine learning or AI device.
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How the ground truth for the training set was established:
- Not applicable.
§ 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.