(48 days)
The Variax Clavicle System is intended for use in internal fixation in the clavicle.
The Variax Clavicle Anterior/Superior Lateral and Anterior/Superior Midshaft Plates are indicated for fixation of single, segmental and comminuted fractures, osteotomies, mal-unions, and non-unions of the clavicle.
The Variax Clavicle System consists of anatomically contoured Anterior and Superior Lateral Plates as well as Anterior and Superior Midshaft Plates which were previously cleared in K113760. The plates are manufactured from Titanium alloy per ASTM F136 and Commercially Pure Titanium per ASTM F 67. The plates are fixed to the clavicle using 3.5mm or 2.7mm locking or non-locking screws. This Special 510(k) submission is intended to introduce 145mm Superior Lateral Plates as a line extension to the currently marketed Superior Lateral Plates in the Variax Clavicle System. This will extend the range of plate sizes from 74mm-145mm in length.
Here's a breakdown of the acceptance criteria and the study details for the Variax Clavicle System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Study that Proves Device Meets Criteria |
|---|---|---|
| Material Equivalence | Plates are manufactured from Titanium alloy per ASTM F136 and Commercially Pure Titanium per ASTM F67. | Risk analysis per ISO 14971:2007; comparison to predicate device (K113760). |
| Design Equivalence | Anatomically contoured Anterior and Superior Lateral Plates, as well as Anterior and Superior Midshaft Plates. Extension of plate size range (74mm-145mm). | Risk analysis per ISO 14971:2007; comparison to predicate device (K113760). |
| Operational Principle Equivalence | Fixes to the clavicle using 3.5mm or 2.7mm locking or non-locking screws. | Risk analysis per ISO 14971:2007; comparison to predicate device (K113760). |
| Safety and Effectiveness Equivalence | The new plate length did not present a new worst case. Met performance requirements and are as safe and effective as their predicate devices. | Risk analysis per ISO 14971:2007; "same verification and validation methods were applied to the subject device in comparison to the previously cleared predicate (K113760)". |
| Intended Use Equivalence | Internal fixation in the clavicle for various fracture types, osteotomies, mal-unions, and non-unions. | Comparison to predicate device (K113760) (stated in Substantial Equivalence section). |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a patient-based "test set" or its sample size, nor data provenance (country of origin, retrospective/prospective). The evaluation appears to be based on an engineering risk analysis and comparison to a predicate device rather than a clinical study with patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as there is no mention of a clinical test set requiring expert ground truth establishment. The evaluation relies on engineering principles and comparison to a predicate.
4. Adjudication Method for the Test Set
This information is not applicable as there is no clinical test set requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence to a predicate device through non-clinical testing.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Not applicable. This device is a bone fixation system, not a software algorithm or AI-powered diagnostic tool. The submission details a medical device, not a digital health product that would have standalone performance.
7. The Type of Ground Truth Used
For this medical device, the "ground truth" is established through engineering principles, material standards (ASTM F136, ASTM F67), risk assessment (ISO 14971:2007), and direct comparison to the design and performance of a previously cleared predicate device (K113760).
8. The Sample Size for the Training Set
Not applicable. This submission describes a physical medical device (bone fixation system), not an AI/ML algorithm that would require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As established in point 8, there is no training set for this type of 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.