(199 days)
The implants of the Clavicle Locking Plating System are indicated for fixation of fractures, mal-unions, non-unions, and osteotomies of the clavicle.
The Clavicle Locking Plating System consists of a range of plates and screws for clavicle surgery. Each device is manufactured from titanium and color anodized. The Clavicle Locking Plating System will be provided non-sterile for steam sterilization by health care professional's prior use.
The provided text describes the 510(k) summary for the Newclip Clavicle Locking Plating System. This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical mechanical testing, rather than human-in-the-loop studies, standalone AI performance, or detailed clinical efficacy trials.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in terms of specific numerical thresholds that the Newclip device must meet beyond being "substantially equivalent" to predicate devices. Instead, the "acceptance criteria" are implicitly met by demonstrating comparable mechanical performance to established predicate devices under specific ASTM standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Comparative Bending Test on Clavicle plates (according to ASTM F 382-99 Annex A1) | The Newclip Clavicle Locking Plating System passed comparative bending tests on clavicle plates, demonstrating performance comparable to predicate devices. The exact numerical results are not provided, only the conclusion of successful comparison. |
| Comparative Fatigue Test on Lateral Clavicle plates (according to ASTM F 382-99 Annex A2) | The Newclip Clavicle Locking Plating System passed comparative fatigue tests on lateral clavicle plates, demonstrating performance comparable to predicate devices. The exact numerical results are not provided, only the conclusion of successful comparison. |
| Comparative Torsional Test on each type of screws (according to ASTM F543-07 Annex A1) | The Newclip Clavicle Locking Plating System passed comparative torsional tests on its screws, demonstrating performance comparable to predicate devices. The exact numerical results are not provided, only the conclusion of successful comparison. |
| Comparative Mechanical Pullout Test on each type of screws (according to ASTM F543-07 Annex A3) | The Newclip Clavicle Locking Plating System passed comparative mechanical pullout tests on its screws, demonstrating performance comparable to predicate devices. The exact numerical results are not provided, only the conclusion of successful comparison. |
| Material Equivalence (Titanium alloy Ti-6Al-4V ELI) | The device's materials (Titanium alloy Ti-6Al-4V ELI, conforming to ASTM F 136-02a and/or ISO 5832-3) are explicitly stated and implicitly determined to be equivalent or acceptable based on the predicate devices primarily using Titanium (or Stainless Steel in some cases for predicate components). |
| Intended Use Equivalence | The intended use ("fixation of fractures, mal-unions, non-unions, and osteotomies of the clavicle") is directly compared and found to be substantially equivalent to the predicate devices, which have similar indications for clavicle fixation. |
| Design Equivalence (Anatomic contour, pre-contoured, midshaft/distal clavicle plates, combination of locking and non-locking screws) | The design features (anatomic contour, pre-contoured, midshaft and distal clavicle plates, and combination locking/non-locking screws) are stated to be equivalent to those of the predicate devices. This equivalence in design, along with material and function, supports the substantial equivalence determination. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail the specific sample sizes (e.g., number of plates, screws) used for each mechanical test. It only states that "comparative" tests were conducted. The "data provenance" is derived from these non-clinical mechanical tests performed according to ASTM standards, not from human or animal data, and thus has no country of origin or retrospective/prospective nature in the typical clinical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a submission for a medical device (clavicle plating system) based on mechanical testing and substantial equivalence to predicate devices, not on a study involving diagnostic accuracy, therefore no "ground truth" established by human experts in the context of diagnostic interpretation is relevant. The "ground truth" for the mechanical tests would be the established performance characteristics of the predicate devices as defined by the ASTM standards.
4. Adjudication Method for the Test Set
Not applicable, as this is a non-clinical mechanical testing submission, not a study requiring adjudication of expert interpretations.
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 submission is for a physical medical device (clavicle plating system), not a diagnostic algorithm or AI-powered system that involves human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This submission is for a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by existing ASTM international standards for orthopaedic implants (ASTM F 382-99 for plate bending/fatigue and ASTM F543-07 for screw torsional/pullout strength) and comparison to the established mechanical performance of legally marketed predicate devices. The goal is to demonstrate that the Newclip system performs at least as well as these predicate devices under these standard tests.
8. The Sample Size for the Training Set
Not applicable. This is a mechanical device, not a machine learning model, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, for the same reason as above.
§ 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.