(93 days)
The Arthrex Distal Radius System is intended for fixation of fractures, fusions, ostectomies and non-unions of the radius, ulna, olecranon, metacarpal, metatarsal, and malleolus.
The Arthrex Distal Radius System is a family of implantable titanium plates and screws intended to be used for fixation of fractures, fusions, osteotomies and non-unions of the radius, ulna, olecranon, metacarpal, metatarsal, and malleolus.
The subject plates are contoured and may be available in left and right configurations, ranging in length from 25mm to 166mm and feature both locking and non-locking holes.
The accompanying screws are solid, fully or partially threaded, and may be locking or non-locking. The proposed screw offering subject of this application are 2.4mm to 3.5mm in diameter and 8mm to 34mm in length and include the Arthrex Low Profile Screws previously cleared under the auspices of K131474.
The provided document is a 510(k) premarket notification for a medical device called the "Arthrex Distal Radius System". This type of submission focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing acceptance criteria and performance through clinical studies in the same way a novel AI or diagnostic device might.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth definitions for a "study that proves the device meets the acceptance criteria" is largely not applicable in the context of this specific document.
This document describes a medical device (bone fixation system) that is evaluated primarily through mechanical testing to demonstrate its substantial equivalence to predicate devices, rather than through studies involving human readers or expert consensus on diagnostic tasks.
However, I can extract the relevant information that is present in the document.
Here's a breakdown of what can be derived from the provided text:
1. A table of acceptance criteria and the reported device performance:
The document states that the device is "substantially equivalent" to predicate devices. The primary performance metric mentioned is related to mechanical strength.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical bending strength equivalent to predicate devices | "The submitted mechanical testing data demonstrates that the bending strength of the plates is substantially equivalent to that of the predicate devices." |
| Intended Use | "The Arthrex Distal Radius System is intended for fixation of fractures, fusions, osteotomies and non-unions of the radius, ulna, olecranon, metacarpal, metatarsal, and malleolus." (Matches predicate's intended use). |
| Technological Characteristics | Similar basic design features to predicate devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not explicitly stated in the document. The document mentions "mechanical testing data" but does not detail the sample size (e.g., number of plates/screws tested) or the provenance of this test data. It's safe to assume this is laboratory-based mechanical testing, not a clinical study on patients.
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. This document pertains to a bone fixation system and its mechanical properties, not a diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No adjudication method is mentioned as there are no human interpretations being evaluated.
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 device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI or algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the device's mechanical performance, the "ground truth" would be established by engineering standards and testing methodologies (e.g., ASTM standards for bone fixation devices) that define parameters like yield strength, ultimate tensile strength, fatigue life, etc. The document does not specify the exact standards but refers to "mechanical testing data." For the substantial equivalence argument, the reference point is the performance of the predicate devices.
8. The sample size for the training set:
- Not applicable. There is no "training set" in the context of mechanical testing for a hardware device.
9. How the ground truth for the training set was established:
- Not applicable. There is no "training set" or need to establish ground truth for it for this type of device.
In summary: The provided document is a 510(k) submission for a traditional Class II medical device (bone fixation system). The "study" referenced for meeting acceptance criteria is primarily mechanical testing to demonstrate substantial equivalence to predicate devices in terms of function and safety, particularly mechanical strength. The concepts of acceptance criteria, sample sizes, expert review, and ground truth as typically understood for AI/diagnostic devices are not directly applicable in this context.
§ 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.