(48 days)
The Stryker VariAx 2 System is intended for use in internal fixation, reconstruction and treatment of fractures in the foot and ankle in adult and adolescent (12-21 years) patients. Including: . Replantation . Joint fusions . Corrective osteotomies . Osteopenic bone
This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the new VariAx 2 System. The VariAx 2 System is an internal fixation device that consists of various plates used with compatible screws to fit different types of fractures in the foot and ankle. The subject components will be available sterile and non-sterile. The plates will be available in sizes ranging from 14-70mm in length.
The provided text does NOT describe acceptance criteria or a study that proves the device meets acceptance criteria related to clinical performance or diagnostic accuracy.
Instead, the document details a 510(k) premarket notification for a bone plate system (VariAx 2 System). This type of submission relies on demonstrating substantial equivalence to existing legally marketed predicate devices, primarily through non-clinical testing for mechanical performance, rather than clinical efficacy studies.
Here's a breakdown based on the information provided and what is absent:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Type | Acceptance Criteria (Specific Values/Thresholds) | Reported Device Performance (Specific Values/Results) |
|---|---|---|
| Non-clinical - Construct Fatigue Strength | Not explicitly stated in the document (implied to be similar to predicate devices) | Testing demonstrated substantial equivalence to predicate devices. (Specific values for fatigue strength are not provided in this summary). |
| Clinical Performance | Not applicable for this submission type; no clinical criteria were established or evaluated. | Not applicable; clinical testing was not required for this submission. |
2. Sample size used for the test set and the data provenance:
- Test Set (Non-clinical): The document states "Construct Fatigue Strength Testing" was performed. However, it does not specify the sample size of the constructs tested (e.g., number of plates/screws).
- Data Provenance: The document does not specify the country of origin for the non-clinical testing data. It only states "Non-clinical laboratory testing was performed on the VariAx 2 System components".
- Retrospective/Prospective: Non-clinical testing of this nature is neither retrospective nor prospective in the same sense as patient studies; it's laboratory-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable: This information is not relevant as no clinical test set or ground truth based on expert review was established or used for this submission. The "ground truth" for the non-clinical testing would be the physical properties and performance measured in the lab.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable: No clinical test set requiring expert adjudication was used.
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 device is a bone plate system, not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable: This device is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Non-clinical: The "ground truth" for the non-clinical testing would be the physical and mechanical properties of the device constructs (e.g., load to failure, cycles to failure) measured according to established engineering standards (though the specific standards are not detailed in this summary).
- Clinical: No clinical ground truth was established as no clinical testing was required.
8. The sample size for the training set:
- Not Applicable: As this is a medical implant and not a machine learning model, there is no "training set" in the context of AI.
9. How the ground truth for the training set was established:
- Not Applicable: See point 8.
In summary: The provided document is a regulatory submission for a physical medical device (bone plates) that relies on demonstrating substantial equivalence through non-clinical mechanical testing. It explicitly states "Clinical testing was not required for this submission." Therefore, most of the requested information pertaining to clinical studies, human readers, AI, or clinical ground truth is not present and not relevant to this specific regulatory pathway.
§ 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.