(79 days)
The Stryker VariAx 2 Compression Plating System is intended for internal fixation of bones in adult patients.
The Stryker VariAx 2 Compression Plating System is indicated for internal fixation of fractures in the Radius, Ulna, Humerus, Clavicle, Distal tibia and Fibula for the following indications:
- osteotomies, mal-unions, and non-unions
- single, segmental, and comminuted fractures
- normal bone density and osteopenic bone
The VariAx 2 Compression Plating System is an internal fixation device that consists of various plates used with compatible screws to fit different types of fractures in the radius, ulna, humerus, clavicle, distal tibia and fibula. The subject components will be available sterile and non-sterile. The plates will be available in sizes ranging from 30-246mm in length.
The provided document is a 510(k) summary for the VariAx 2 Compression Plating System, which is a medical device for internal fixation of bone fractures. This type of submission focuses on demonstrating "substantial equivalence" to a predicate device already on the market, rather than conducting new clinical studies with detailed acceptance criteria and performance metrics for the new device as would be the case for a novel AI/software medical device.
Therefore, many of the specific questions regarding acceptance criteria, study design, expert involvement, and ground truth, as typically applied to AI/ML device evaluations, are not directly applicable or available in this document.
Here's an attempt to address your questions based on the provided text, highlighting where information is not present or not relevant to this type of device submission:
Acceptance Criteria and Device Performance (Based on provided text)
| Criterion | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | Demonstrated through non-clinical laboratory testing |
| Dynamic Fatigue Testing Performance | Not explicitly detailed, but part of non-clinical testing to demonstrate substantial equivalence. |
| Intended Use | Internal fixation of bones in adult patients. |
| Indications for Use | Internal fixation of fractures in Radius, Ulna, Humerus, Clavicle, Distal tibia, and Fibula for osteotomies, mal-unions, non-unions, single, segmental, and comminuted fractures, and in normal and osteopenic bone. |
Study Details (Based on provided text)
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. The submission relies on non-clinical laboratory testing (dynamic fatigue testing) to demonstrate substantial equivalence, not a clinical test set with patient data.
- Data Provenance: Not applicable for a clinical test set. The non-clinical testing was performed for the VariAx 2 Compression Plating System components.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device underwent non-clinical testing, not a clinical study involving expert-established ground truth on a test set.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set.
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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:
- No. This is a traditional medical device (bone plating system), not an AI/ML powered device. Therefore, no MRMC study or AI-related effectiveness was assessed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a hardware medical device; there is no algorithm or software for standalone performance evaluation in the context of AI.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the sense of clinical ground truth for AI/ML devices. The "ground truth" for this submission would be engineering standards and requirements for mechanical performance and materials, verified through non-clinical testing.
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The sample size for the training set:
- Not applicable. There is no training set for this traditional medical device.
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How the ground truth for the training set was established:
- Not applicable. There is no training set.
§ 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.