(119 days)
The Arthrex Fracture System is intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and fibula. The Arthrex Fracture Plates are to be used with the 2.7mm-4.0mm Arthrex Low Profile Screws.
The Clavicle Plate Button is intended for use with the clavicle plates for clavicle indications such as for the treatment of syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruption, and this button may not be used alone. The button is intended to be used with #5 Fiber Wire or FiberTape.
The Arthrex Fracture System is a family of stainless steel plates, screws, and buttons. The plates may be contoured or straight and may be available in left and right configurations. The plates are to be used with the 2.7mm-4.0mm Low Profile Screws. The screws are solid and fully threaded and may be locking or non-locking. The button is stainless steel and designed to fit securely in the holes of the fracture plates. The button is intended to be used with the previously cleared suture, which is provided separately.
This document describes the Arthrex Fracture System, a device for internal bone fixation. Given the provided text, there is no information available regarding specific acceptance criteria, a study proving the device meets these criteria, or details about artificial intelligence (AI) in this context.
The document is a 510(k) summary for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data against specific, defined acceptance criteria. It primarily addresses the device's description, intended use, and a comparison to existing devices.
Therefore, many of the requested sections regarding acceptance criteria, study details, ground truth, and AI performance cannot be extracted from this text.
Here's a breakdown of what can be inferred or stated based on the provided information, and what cannot:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail criteria with numerical thresholds. The "acceptance" for this 510(k) submission is based on demonstrating substantial equivalence to predicate devices.
- Reported Device Performance:
"The submitted mechanical testing data demonstrated that the bending and pull-out strength of the proposed devices are substantially equivalent to the bending and pull-out strength of the predicate devices."- Comment: The document doesn't provide specific numerical values for bending and pull-out strength or detailed comparison data. It only states that the data demonstrated "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: Not specified.
- Data Provenance: Not specified, but the context implies laboratory mechanical testing rather than clinical data from a specific country. This would be prospective testing on manufactured devices to compare against predicates.
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 device is a bone fixation system, and the "ground truth" in this context would be physical/mechanical properties, not expert-interpreted diagnostic images or outcomes. The review of the 510(k) submission itself would involve regulatory experts (FDA staff).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is a physical device being evaluated for mechanical equivalence, not a diagnostic algorithm or image interpretation task requiring adjudication of expert opinions.
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, an MRMC study was NOT done. This document is for a physical medical device (fracture system) and does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was NOT done. This document is for a physical medical device and does not involve any algorithm or AI component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Mechanical properties of predicate devices. The "ground truth" for demonstrating substantial equivalence appears to be the established mechanical performance (bending and pull-out strength) of the predicate devices. The new device's performance is compared against these benchmarks.
8. The sample size for the training set
- Not applicable. This document describes a physical medical device. There is no mention of a "training set" in the context of an algorithm. If referring to the manufacturing process, quality control samples would be used, but not a "training set" as understood in AI/ML.
9. How the ground truth for the training set was established
- Not applicable. As above, there is no "training set" in the AI/ML sense for this 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.