(16 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 Special 510(k) submission is being supplied to the U.S. FDA seeking clearance for additional compatibility between the previously cleared VariAx 2 System (K140376) and previously cleared VariAx 2 System screws (K132502 and K140769). The previously cleared screws include the T8 Ø2.4mm, T10/T8 Ø2.7mm, and T10 Ø3.5mm screws. The VariAx 2 System is an internal fixation device that consists of various plates used with compatible screws to fit different types of fractures and corrective procedures in the foot and ankle.
This document is a 510(k) premarket notification for the Stryker VariAx 2 System, a device for internal fixation, reconstruction, and treatment of foot and ankle fractures. It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a de novo study with detailed acceptance criteria and performance data in the typical sense of a diagnostic or AI-driven device.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not directly applicable or available in this type of submission. This document describes a modification to an existing device rather than a new device that requires extensive clinical performance studies as an AI/diagnostic device would.
Here's an attempt to answer the questions based on the provided text, while acknowledging its limitations for this type of request:
1. A table of acceptance criteria and the reported device performance
Since this is a submission for a bone fixation system and not a diagnostic or AI device, the "acceptance criteria" are related to mechanical and material performance, and "device performance" refers to its ability to meet established safety and effectiveness standards, often through comparison with a predicate device. The document states that the evaluations demonstrated the device "met the performance requirements" and is "as safe and effective as the predicate device." Specific numerical criteria for mechanical performance (e.g., tensile strength, fatigue life) are not provided in this summary.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical integrity | Met performance requirements; as safe and effective as predicate. |
| Biocompatibility | (Implied by use of similar materials as predicate) |
| Functional equivalence | Compatible with previously cleared VariAx 2 System screws (K132502 and K140769). |
2. Sample size used for the test set and the data provenance
The document mentions "Non-Clinical Testing" which likely refers to bench testing (mechanical testing, materials characterization).
- Sample Size for Test Set: Not specified. This would typically be a number of physical device units tested, not a patient sample size.
- Data Provenance: Not explicitly stated as retrospective or prospective, but given it's non-clinical testing, it would be laboratory-generated data from newly manufactured devices. The country of origin for the sponsor is Switzerland (Stryker Trauma AG, Selzach, Switzerland).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept is not applicable here. Ground truth, in the context of device performance, typically refers to expert consensus for diagnostic accuracy or pathology for disease presence. For a mechanical device, performance is established through engineering and biomechanical testing, often against recognized standards. There are no "experts" establishing a "ground truth" in the diagnostic sense for this type of device submission.
4. Adjudication method for the test set
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are for resolving discrepancies in expert interpretations, primarily in diagnostic imaging or clinical trials. This is a mechanical device 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
Not applicable. This is not an AI or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used
For this type of device, "ground truth" would be defined by engineering specifications and established test standards (e.g., ISO, ASTM standards for bone fixation implants). The device's performance is measured against these objective criteria in a laboratory setting. Pathology or outcomes data are not used as "ground truth" for demonstrating substantial equivalence of a modified mechanical implant in a 510(k).
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning or AI device.
§ 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.