(105 days)
APTUS® Proximal Humerus System is indicated for fractures, osteotomies and non-unions of the proximal humerus.
APTUS Proximal Humerus System consists of titanium locking plates, locking and non-locking titanium screws, spiral blades left/ right and the corresponding screws for the spiral blades. The plates are used with TriLock locking screws and cortical screws. APTUS Proximal Humerus plates and spiral blades are made of commercially pure titanium, grade 4, conforming to ASTM F67. TriLock locking and cortical screws are made of titanium alloy conforming to ASTM F136.
This document pertains to the clearance of the APTUS® Proximal Humerus System, a medical device, and does not involve AI/ML software. Therefore, many of the requested sections regarding AI/ML performance metrics, ground truth establishment, and training/test sets are not applicable.
Here's an analysis of the provided information:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for this device are based on demonstrating substantial equivalence to legally marketed predicate devices. This is achieved through engineering and performance testing that shows the device has similar characteristics, intended use, operating principles, materials, and designs, and does not raise new issues of safety or efficacy.
| Acceptance Criteria Category | Reported Device Performance (APTUS® Proximal Humerus System) |
|---|---|
| Intended Use | Same as predicate devices: for fractures, osteotomies, and non-unions of the proximal humerus. |
| Technological Characteristics | Same as predicate devices, including design principles, materials (commercially pure titanium, grade 4, and titanium alloy conforming to ASTM F136), and functionality. Differences do not raise new safety/efficacy issues. |
| Materials | Commercially pure titanium, grade 4 (plates, spiral blades); Titanium alloy conforming to ASTM F136 (locking/cortical screws). Matches or is similar to predicate devices. |
| Design | Basic designs are the same as predicate devices. |
| Operating Principles | Same as predicate devices. |
| Physical Dimensions | Encompasses the same range as predicate devices. |
| Packaging & Sterilization | Same materials and methods as predicate devices. |
| Performance Data | Detailed dimensional and engineering analysis (including fatigue testing of subject device and predicate device plate and screw constructs) provided to demonstrate substantial equivalence. |
| Safety & Efficacy | No new issues of safety or efficacy are raised by the device's characteristics compared to predicates. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable (N/A) as the clearance is for a physical medical device (bone fixation system), not an AI/ML software. The "testing" refers to mechanical and engineering performance tests on the device and predicate devices, not on a dataset of patient data.
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)
N/A. Ground truth for an AI/ML model is not relevant here. The "ground truth" for this device's performance is established through engineering standards and testing methodologies for mechanical properties and biological compatibility.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. This refers to adjudication of expert labels for AI/ML validation, which is not relevant for this device.
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
N/A. This device does not involve AI assistance or human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
N/A. The "ground truth" for this device's performance is based on established engineering principles, materials science, and bio-compatibility standards (e.g., ASTM standards for materials, fatigue testing protocols). Performance is compared against predicate devices and relevant industry standards.
8. The sample size for the training set
N/A. This is not an AI/ML model.
9. How the ground truth for the training set was established
N/A. This is not an AI/ML model.
In summary, the APTUS® Proximal Humerus System achieved clearance by demonstrating substantial equivalence to several predicate devices through detailed dimensional, engineering, and fatigue testing, confirming that its materials, design, intended use, and performance characteristics are comparable and do not introduce new safety or efficacy concerns.
§ 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.