(104 days)
APTUS® Distal Humerus System is indicated for fractures, osteotomies and non-unions of the distal humerus.
The APTUS Distal Humerus System consists of titanium locking plates, 2.5/2.8 biconcave washers, and locking and non-locking titanium alloy screws. APTUS Distal Humerus plates are anatomically pre-contoured and provided in six designs: medial plate left/right, lateral plate left/right and posterolateral plate left/right; each of the plates is available in two lengths. The plates are used with TriLock locking screws, cortical screws or lag screws. APTUS Distal Humerus plates and washers are made of commercially pure titanium, grade 4, conforming to ASTM F67. TriLock locking, cortical, and lag screws are made of titanium alloy conforming to ASTM F136.
Here's an analysis of the provided 510(k) summary, specifically focusing on the acceptance criteria and the study that proves the device meets them.
It's important to note that this 510(k) summary is for a medical device (bone fixation system), not a diagnostic AI algorithm. Therefore, many of the typical questions for AI algorithm studies (like sample size for test sets, ground truth methodology with experts, MRMC studies, or standalone performance for an algorithm) are not applicable in this context. Medical devices like this are typically cleared based on demonstrating substantial equivalence to a predicate device through mechanical testing and material compatibility, rather than clinical performance studies in the same way an AI might be.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria (Benchmarking / Comparison) | Reported Device Performance (APTUS® Distal Humerus System) |
|---|---|
| Intended Use Equivalence: | Same intended use as predicate devices: fractures, osteotomies, and non-unions of the distal humerus. |
| Technological Characteristics Equivalence: | Same technological characteristics as predicate devices. |
| Material Equivalence: | Made of the same or similar materials (commercially pure titanium, grade 4, conforming to ASTM F67 for plates/washers; titanium alloy conforming to ASTM F136 for screws) as predicate devices. |
| Design Principles Equivalence: | Same operating principles and basic designs as predicate devices. |
| Physical Dimensions Equivalence: | Encompasses the same range of physical dimensions as predicate devices. |
| Packaging & Sterilization Equivalence: | Packaged using the same materials and sterilized by the same methods as predicate devices. |
| Mechanical Performance (ASTM F543): | Performance data provided included engineering analysis and mechanical testing according to ASTM F543. |
| Fatigue Performance: | Performance data provided included fatigue testing of subject and predicate device plate and screw constructs. |
| No New Safety/Efficacy Issues: | Any differences in technological characteristics do not raise new issues of safety or efficacy. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. For mechanical testing of medical devices like bone plates and screws, "sample size" refers to the number of constructs or specimens tested in the lab, not a clinical patient dataset. The document does not specify the exact number of plates/screws or constructs tested for engineering analysis and mechanical/fatigue testing, but it implies standard testing procedures were followed.
- Data Provenance: Not applicable in the traditional sense of clinical data. The "data" here refers to mechanical test results generated in a laboratory setting, likely at Medartis AG or a contracted testing facility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The "ground truth" for this type of device is established through engineering standards (e.g., ASTM F543) and material specifications, demonstrated by objective mechanical testing, rather than expert clinical consensus.
4. Adjudication method for the test set
- Not applicable. No expert review or adjudication process is described or relevant for mechanical testing data.
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
- Not applicable. This is a bone fixation system, not a diagnostic AI algorithm. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for demonstrating substantial equivalence of this medical device is based on established engineering standards, material specifications, and comparative mechanical performance against legally marketed predicate devices. This includes demonstrating that the device meets mechanical strength, fatigue resistance, and material biocompatibility requirements inherent in the chosen ASTM standards.
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of a 510(k) submission for a bone fixation system.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set" or corresponding ground truth establishment process for this type of medical device. Product development involves design, material selection, and extensive mechanical testing to ensure performance against predefined engineering specifications.
§ 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.