(90 days)
In the presence of appropriate additional immobilization or fixation, indicated for maintaining the alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts, and, maintenance of relative position of weak bony tissue (e.g., bone grafts, bone graft subsitives, or bone fragments from comminuted fractures), in trauma and reconstructive procedures.
Specific indications include: I. Craniofacial skeleton, cranium, mid-face, maxilla, and mandible, 2. Metacarpus, proximal and middle phalangeal bones, 3. Long bones, flat bones, short bones, irregular bones, appendicular skeleton, and thorax.
The Re-Zorb™ Plating System consists of plates, fixation devices, and associated instrumentation. The plates are offered in lengths of 60 and 110mm, and widths of 14 and 20mm. All plates are 1.6mm thick with uniformly distributed fixation holes and a polished finished. Fixation devices included in the system consist of screws and tacks. The screws and tacks are offered in 2.7mm diameters and lengths ranging from 8 to 40mm. The plates, screws, and tacks are injection molded from poly (1-lactide-co-D, L-lactide) 70:30, which gradually lose strength in vivo and are provided sterile. Suture can also be used in conjunction with the plates.
The provided text describes a 510(k) summary for the ACUTE Innovations® LLC Re-Zorb™ Plating System. This document focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and mechanical properties, rather than presenting a study involving AI or human reader performance. Therefore, many of the requested criteria related to AI device performance evaluation, human reader studies, and ground truth establishment are not applicable or detailed in this submission.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not specify quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic or AI device. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device.
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Substantially equivalent intended use | Identical to predicate device (Inion FreedomPlate™ K063410) |
| Substantially equivalent scientific technology | Uses poly (1-lactide-co-D, L-lactide) 70:30, shown not to raise new safety/effectiveness questions compared to predicate's degradable material. |
| Substantially equivalent degradation profile | Shown through performance data and specifications. |
| Substantially equivalent mechanical properties | Shown through performance data and specifications. |
| Compliance to voluntary consensus standards | Listed in the application (details not provided in this extract). |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The submission describes a medical device (plating system) cleared through the 510(k) pathway, which primarily relies on technological comparison and non-clinical testing rather than clinical study data from a test set of patient cases. No test set in the context of diagnostic performance or AI evaluation is mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. There is no mention of a test set requiring expert ground truth establishment for a diagnostic or AI performance evaluation. The safety and effectiveness are established through comparison to a predicate and performance data on the device's material and mechanical properties.
4. Adjudication Method for the Test Set
Not applicable. No test set is described.
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 comparative effectiveness study was not done. The device is a bone plating system, not an AI diagnostic tool.
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. The device is a physical medical implant.
7. The Type of Ground Truth Used
Not applicable in the context of diagnostic or AI performance. The "ground truth" for the device's safety and effectiveness relies on established material science, mechanical testing standards, and a comparison to a legally marketed predicate device (Inion FreedomPlate™).
8. The Sample Size for the Training Set
Not applicable. This device is not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is involved.
§ 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.