(90 days)
The Skeletal Dynamics Distal Humerus Plating System is indicated for intra-articular fractures of the distal humerus, comminuted supracondylar fractures, osteotomies, and non-unions of the distal humerus.
The Skeletal Dynamics Distal Humerus Plating System consists of five titanium bone plates in different shapes (medial direct, lateral direct, lateral capitellar, and supracondylar), in multiple lengths, and in left and right configurations to address distal humerus fractures. The plates are made of medical grade titanium alloy. Locking and compression screws in 2.7mm, 3.5mm and 4.5mm and 3.0mm polyaxial locking screws are provided in various lengths. Also included in the system is specialized instrumentation. The System is provided non-sterilization in the user facility.
The Distal Humerus Plating System is comprised of:
- . Titanium alloy plates, screws and fasteners
- CoCr Cannulated Polyaxial Locking Screws (PLS) .
- Stainless steel K-wires (for provisional fixation: not for implantation) ●
- System specific instrumentation ●
The provided text is a 510(k) summary for a medical device called the "Distal Humerus Plating System," which is a metallic bone fixation appliance. It describes the device, its indications for use, and how its substantial equivalence to predicate devices was demonstrated through mechanical testing.
However, the request asks for information related to "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/Software as a Medical Device (SaMD). The provided document does not describe an AI/SaMD device; instead, it describes a hardware device (bone plates and screws) and the performance testing (mechanical testing, specifically ASTM standards) done to demonstrate its equivalence to predicate devices.
Therefore, I cannot fulfill all aspects of your request because the document does not contain information about:
- A table of acceptance criteria and reported device performance related to AI metrics (e.g., sensitivity, specificity, AUC).
- Sample sizes for test sets in the context of AI (e.g., number of images).
- Data provenance for AI test sets.
- Number of experts and their qualifications for establishing ground truth for AI.
- Adjudication methods for AI test sets.
- MRMC studies for AI and human-in-the-loop performance.
- Standalone performance for an AI algorithm.
- Types of ground truth for AI (e.g., pathology, outcomes data).
- Sample size for AI training sets.
- How ground truth for AI training sets was established.
The document focuses on the mechanical and material equivalence of a physical implantable device.
Here's what can be extracted and inferred from the provided text, reinterpreted as much as possible for your request, but with the explicit understanding that it's not an AI/SaMD context:
Device Description:
The Skeletal Dynamics Distal Humerus Plating System is a physical medical device consisting of titanium bone plates, locking and compression screws, and specialized instrumentation, designed for fixing fractures of the distal humerus.
1. A table of acceptance criteria and the reported device performance:
Since this is a physical device, the "acceptance criteria" and "performance" are based on mechanical equivalency to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical properties equivalent to predicate devices | Demonstrated equivalency through ASTM F382 and ASTM F543 testing. |
| Safe and effective as legally marketed predicate devices | Subject device is concluded to be as safe and effective as predicate devices. |
| Compliance with ASTM F382 (Metallic Bone Plates) standards | Met (stated a study included this standard) |
| Compliance with ASTM F543 (Metallic Bone Screws) standards | Met (stated a study included this standard) |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as "sample size" in the context of a discrete number of tests on identical units, but indicated to be sufficient to demonstrate equivalency according to ASTM standards. ASTM standards define the number of samples typically required for such tests.
- Data Provenance: The "study" is an engineering analysis and mechanical testing performed to demonstrate equivalency. The data provenance would be laboratory testing conducted by the manufacturer or a third-party lab. No information on country of origin of "data" in a clinical/retrospective sense, as this is pre-market mechanical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of mechanical testing. The "ground truth" for mechanical testing is established by the specified parameters and methodologies within the ASTM standards themselves, interpreted and executed by qualified engineers and technicians. This is not about human labelers/readers.
4. Adjudication method for the test set:
- Not applicable. This is mechanical testing against defined engineering standards, not human expert adjudication.
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 device is a physical implant, not an AI or imaging device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. No algorithm is involved.
7. The type of ground truth used:
- The "ground truth" for the performance testing of this physical device is the mechanical and material specifications and performance parameters outlined in the referenced ASTM standards (ASTM F382 for plates and ASTM F543 for screws) and the performance characteristics of the legally marketed predicate devices.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable.
In summary, the provided document details the regulatory clearance of a physical orthopedic implant based on demonstrating mechanical equivalence to existing products, not an AI/SaMD product. Therefore, most of your specific questions related to AI/SaMD testing and ground truth cannot be answered from this text.
§ 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.