(88 days)
The VariAx Distal Radius Locking System including the XXL Volar Distal Radius Plates is intended for internal fixation of small bone fractures, primarily including distal radius fractures.
Indications include:
- compression fractures .
- intra-articular and extra-articular fractures .
- displaced fractures .
Following additional indications apply only for the XXL Volar Distal Radius Plates:
Osteotomies, non-unions, and malunions.
This Traditional 510(k) submission is being supplied to the U.S. FDA to obtain authorization to market a line extension to the VariAx Distal Radius Plating System, which was cleared in K040022, as the Universal Distal Radius System. The VariAx Distal Radius Plating System Line Extension consists of multiple internal fixation plates in varying lengths and widths. The portfolio of plates is being extended to include new plate width (intermediate) and new plate length (extrashort). The plates will be used with the VariAx locking screws, non-locking screws, locking pegs, and partially threaded screws previously cleared in K040022, K080667, and K132502. The subject components will be available sterile and non-sterile.
The provided text is for a 510(k) submission for a medical device (VariAx Distal Radius Plating System Line Extension). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy or safety through clinical trials in the same way a new drug or novel medical device might.
Therefore, the document does not contain the specific information requested in the prompt regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, or MRMC studies. This is because these are more typical requirements for AI/ML-driven devices or those requiring extensive clinical evidence.
The relevant sections are "Non-Clinical Test" and "Clinical Testing".
Here's a breakdown of what is available:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The implicit acceptance criterion is "substantial equivalence" to the predicate devices (VariAx Distal Radius Plating System (K040022) and the VariAx Distal Radius Line Extension of XXL Plates (K100271)) in terms of intended use, design, materials, and operational principles. Specifically for mechanical performance, the standard "ASTM F382 - 99: 2008" serves as the benchmark.
- Reported Device Performance: "Testing demonstrated that the subject plates being added to the VariAx Distal Radius Plating System are substantially equivalent to the currently marketed predicate devices."
| Acceptance Criteria (Implicit from Substantial Equivalence Goal) | Reported Device Performance |
|---|---|
| Substantial equivalence in intended use, design, materials, and operational principles to predicate devices (K040022, K100271). | Demonstrated substantial equivalence in intended use, design, materials, and operational principles. |
| Compliance with "Standard Specification and Test Method for Metallic Bone Plates as per ASTM F382 - 99: 2008" for worst-case subject plates. | Testing performed per ASTM F382 - 99: 2008. Results indicated substantial equivalence. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: This device is a mechanical implant. The "test set" refers to physical samples of the device undergoing non-clinical mechanical testing. The document states "worst case subject plates" were tested but does not specify the exact number of plates or samples.
- Data Provenance: The testing was "Non-clinical laboratory testing," implying in-vitro or bench testing, not human patient data. Therefore, country of origin or retrospective/prospective does not apply in the typical sense.
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)
- Not Applicable. Ground truth, in the context of expert consensus, is not relevant for this type of mechanical device submission. The "ground truth" here is compliance with an engineering standard (ASTM F382).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This pertains to expert review of medical images or data. For mechanical testing, the "adjudication" is the pass/fail result according to the specified ASTM standard.
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
- No. This is not an AI/ML device. MRMC studies are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a mechanical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance is adherence to established engineering and material standards for metallic bone plates (ASTM F382 - 99: 2008). The comparison is against predicate devices that also met these standards.
8. The sample size for the training set
- Not Applicable. This is a mechanical device, not an AI/ML system. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not relevant.
§ 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.