(28 days)
The Stryker VariAx 2 One-Third Tubular Plating System is intended for internal fixation of bones in adult patients.
The Stryker VariAx 2 One-Third Tubular Plating System is intended for internal fixation of fractures of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, small bones in the ankle, fore, mid- and hind foot in adult patients.
Indications include the following:
- . osteotomies, and non-unions
- . fixation of fractures
- normal bone density and osteopenic bone .
This Special 510(k) submission is being supplied to the U.S. FDA seeking clearance for a device modification of VariAx 2 One-Third Tubular Plates previously cleared in K141204 (VariAx 2 One-Third Tubular Plating System). Modification includes a change of plate thickness and addition of grooves to the waist part of the plate to improve mechanical behavior.
The VariAx 2 One-Third Tubular Plating System is an internal fixation device that consists of straight plates used with compatible screws to fit different types of fractures in the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, small bones in the ankle, fore, mid- and hind foot in adult patients. The subject components will be available sterile and non-sterile. The plates will be available in sizes ranging from 23-191mm in length.
The request asks for specific information regarding acceptance criteria and a study proving device performance, based on the provided document. However, the document is a 510(k) summary for a medical device (VariAx 2 One-Third Tubular Plating System) seeking clearance for a modification to a previously cleared device. It explicitly states that clinical testing was not required for this submission and focuses on non-clinical testing and comparison to a predicate device for substantial equivalence.
Therefore, many of the requested items, which relate to clinical studies, ground truth establishment, and expert involvement, are not present in this document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document mentions that a risk analysis was performed according to DIN EN ISO 14971 and "the subject device met the performance requirements." However, the specific numerical acceptance criteria (e.g., a specific tensile strength, fatigue life, or accuracy metric) are not explicitly stated in this summary. The "performance requirements" are only broadly referenced.
- Reported Device Performance: The document states that the "evaluation demonstrated that the subject device did not present a new worst case and that the same verification methods were applied to the subject device in comparison to the previously cleared predicate device (K141204)." It concludes that the device "is as safe and effective as the predicate device" based on non-clinical tests. Again, specific quantitative performance results are not provided.
| Acceptance Criteria (Not explicitly numbered/quantified in document) | Reported Device Performance (Summary) |
|---|---|
| Met performance requirements identified through risk analysis (DIN EN ISO 14971) | Did not present a new worst case compared to predicate. |
| Same verification methods as predicate applied. | Met performance requirements. |
| As safe and effective as predicate device. | Deemed as safe and effective as predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not provided. The document explicitly states "Clinical testing was not required for this submission" and focuses on non-clinical tests and comparison to a predicate device. Thus, there is no "test set" in the context of clinical data, no sample size, and no data provenance from clinical studies.
3. 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)
- This information is not provided. As explained above, no clinical test set requiring expert-established ground truth was performed for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not provided. No clinical test set requiring adjudication was performed for this submission.
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
- This information is not provided. This device is a bone fixation system, not an AI-assisted diagnostic tool. An MRMC study is irrelevant to this device type, and no such study was performed or mentioned.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- This information is not provided. This device is a mechanical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- This information is not provided. Given that no clinical studies were performed for this submission, there's no mention of ground truth types for a clinical test set. For non-clinical tests, "ground truth" would refer to measured physical properties, which are not detailed.
8. The sample size for the training set
- This information is not provided. No training set is mentioned as this is a non-clinical device modification submission.
9. How the ground truth for the training set was established
- This information is not provided. No training set is mentioned in the document.
In summary: The provided document is a 510(k) summary for a device modification focusing on non-clinical testing and substantial equivalence to a predicate device. It explicitly states that clinical testing was not required. Therefore, most questions related to clinical studies, test sets, ground truth establishment, and AI performance are not applicable or answerable from this document.
§ 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.