(23 days)
The Modified Shoulder Fixation System is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal Humerus.
The Modified Shoulder Fixation System is a set of orthopedic plates and fasteners supplied in a sterilization tray together with several reusable and disposable tools. The set of orthopedic plates and fasteners provided in the sterilization tray consists of the following implantable devices: • Shoulder Plates • Multidirectional and 90° Lock Screws • 90° Set Screws • Pegs Also, provided in the sterilization tray are the re-useable instruments
- Table of Acceptance Criteria and Reported Device Performance:
The provided document does not contain explicit acceptance criteria and device performance metrics in the format of a table. Instead, it describes a "Summary of Substantial Equivalence" and states that "The equivalence was confirmed through pre-clinical testing."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantially equivalent to predicate device (Shoulder Fixation System, K042059) | Equivalence confirmed through pre-clinical testing. |
- Sample size used for the test set and the data provenance:
The document does not specify a distinct "test set" or its sample size. The substantial equivalence was confirmed through "pre-clinical testing," which typically involves mechanical and/or bench testing rather than studies with patient data. Therefore, data provenance in terms of country of origin or retrospective/prospective is not applicable as patient data was not used.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. Given that the equivalence was based on "pre-clinical testing," ground truth would likely be established through engineering specifications and test standards, not expert medical consensus on a test set.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided. As mentioned, the evaluation was based on pre-clinical testing, making formal adjudication methods for a medical test set irrelevant.
- 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:
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a physical orthopedic implant (Shoulder Fixation System) and not an AI-powered diagnostic or assistive tool for human readers. Therefore, there is no discussion of human reader improvement with or without AI assistance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
A "standalone" performance study in the context of an algorithm or AI was not done. The device is a physical orthopedic implant, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for demonstrating substantial equivalence was based on pre-clinical testing which would involve engineering and mechanical performance data, often compared against established standards for material properties and mechanical strength of similar devices. It is not based on expert consensus, pathology, or outcomes data in the clinical sense.
- The sample size for the training set:
The concept of a "training set" is not applicable as this is a medical device (implant) clearance, not an AI or machine learning model.
- How the ground truth for the training set was established:
Not applicable, as 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.