(112 days)
The ORTHOLOC™ SPS is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.
ORTHOLOC™ SPS is a plating system designed to provide anatomical reduction and stable primary fixation of the proximal humerus using implanted plates and screws. The plates are available in three designs: Standard, Posterior, and Greater Tuberosity (GT) and are manufactured from stainless steel per ASTM F138. The system also includes locking cortical and cancellous screws manufactured from stainless steel per ASTM F2229 and non-locking cortical screws manufactured from stainless steel per ASTM F138. The system is provided non-sterile and requires steam sterilization prior to use.
This document describes acceptance criteria and outlines performance testing for the ORTHOLOC™ SPS Shoulder Plating System. However, it does not describe a study involving an AI/algorithmic device or its performance against acceptance criteria. Instead, it describes non-clinical bench testing for a physical medical device (bone plating system).
Therefore, I cannot populate the requested table and answer the study-specific questions (2-9) about AI device performance, sample sizes, ground truth, experts, or MRMC studies.
Here's the information that can be extracted from the provided text regarding the physical device and its testing:
Acceptance Criteria and Device Performance (Based on Non-Clinical Bench Testing):
| Acceptance Criteria Category | Specific Test Performed | Reported Device Performance / Conclusion |
|---|---|---|
| Mechanical Performance | Plate Bending and Fatigue (to ASTM F382-17) | Supports substantial equivalence to predicate devices. |
| Screw Torsion, Driving Torque, and Axial Pullout (to ASTM F543-17) | Supports substantial equivalence to predicate devices. | |
| Engineering Analysis of the Greater Tuberosity Plate | Supports substantial equivalence to predicate devices. | |
| Cross Sectional Analysis comparing the subject and predicate plates | Supports substantial equivalence to predicate devices. | |
| Safety and Effectiveness | N/A (addressed by performance testing and comparison to predicates) | Does not raise new questions of safety or effectiveness. |
| Substantial Equivalence | Comparison of technological characteristics with predicate devices | Substantially equivalent in intended use, materials, design, and sterilization method to the predicate devices. Design differences do not raise new issues and are supported by performance testing. |
Regarding the study, based on the provided text:
- Sample size used for the test set and the data provenance: Not applicable. The testing described is non-clinical bench testing of a physical device, not an AI model.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed."
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device.
- The type of ground truth used: Not applicable for an AI device. For the physical device testing, the "ground truth" would be established engineering standards (ASTM F382-17, ASTM F543-17) and comparative physical properties with predicate devices.
- The sample size for the training set: Not applicable. This is not an AI/algorithmic device.
- How the ground truth for the training set was established: Not applicable.
§ 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.