(42 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.
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. The plates will be available in sizes ranging from 23-191mm in length.
The provided text describes a 510(k) submission for a medical device called the "VariAx 2 One-Third Tubular Plating System." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria and extensive performance studies.
Therefore, the requested information regarding acceptance criteria, a specific study proving the device meets those criteria, sample sizes for test and training sets, expert involvement, and adjudication methods is not applicable in this case.
Here's why and what information is available:
- Acceptance Criteria and Device Performance: Not applicable. For 510(k) submissions, the device's "performance" is assessed relative to predicate devices through non-clinical testing to demonstrate that it performs at least as safely and effectively. There are no pre-defined numerical performance metrics or acceptance criteria in the typical sense of a clinical study for a novel device.
- Study Proving Acceptance Criteria: Not applicable.
- Sample size for test set and data provenance: Not applicable. No clinical test set.
- Number of experts and qualifications: Not applicable. No ground truth established by experts.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance study: Not applicable, as this is a physical medical device, not an AI algorithm.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable. No training set as there is no AI algorithm.
- How the ground truth for the training set was established: Not applicable.
What was done (Non-Clinical Testing):
The submission states:
- Non-Clinical Testing was performed on the VariAx 2 One-Third Tubular Plating System components to determine substantial equivalence.
- Testing demonstrated that the VariAx 2 One-Third Tubular Plating System is substantially equivalent to the predicate devices currently cleared for marketing.
- The following testing was performed:
- 4-Point Bending Out of Plane Testing
- 4-Point Bending Construct Out of Plane Testing
This non-clinical testing would have involved mechanical tests to compare the strength and performance of the new device to the predicate devices under simulated physiological conditions. The "acceptance criteria" here implicitly would be that the new device's performance in these mechanical tests is equivalent to or better than the predicate devices, thereby supporting the claim of substantial equivalence. However, specific numerical thresholds are not provided in this document.
Summary Table (with N/A where information is not applicable to a 510(k) for a physical device):
| Information Category | Details from K141204 |
|---|---|
| Acceptance Criteria & Reported Device Performance | Acceptance Criteria: Implicitly, the device must perform as safely and effectively as the predicate devices in mechanical stress tests. Specific numerical criteria are not provided in this summary. |
| Reported Device Performance: "Testing demonstrated that the VariAx 2 One-Third Tubular Plating System is substantially equivalent to the predicate devices currently cleared for marketing." The tests conducted were "4-Point Bending Out of Plane Testing" and "4-Point Bending Construct Out of Plane Testing." | |
| Sample size (test set) & Data Provenance | Not applicable (no clinical test set). |
| Number & Qualifications of Experts (ground truth) | Not applicable (no ground truth established by experts for a clinical study). |
| Adjudication Method (test set) | Not applicable. |
| MRMC Comparative Effectiveness Study | Not applicable (this is a physical medical device, not an AI/software device). |
| Standalone (algorithm only) performance study | Not applicable (this is a physical medical device, not an AI/software device). |
| Type of Ground Truth Used | Not applicable. The "ground truth" equivalent would be the established performance characteristics of the predicate devices. |
| Sample size (training set) | Not applicable (no training set). |
| How ground truth for 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.