(30 days)
The Skeletal Dynamics Inc's 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 Inc's 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 allov. The system also includes 2.7mm, 3.5mm and 4.5mm locking and compression titanium alloy screws and 3.0mm polyaxial Cobalt Chrome locking screws which are provided in various lengths. The System is being modified to include additional lengths of existing screw options and new 3.5mm and 4.5mm locking and compression Titanium Alloy Screws. Additionally, minor modifications have been made to the plates to accept the new screws above mentioned. Also included in the system is specialized instrumentation. The System is provided nonsterile for 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
This document describes a medical device, the "Distal Humerus Plating System," which is a metallic bone fixation appliance. The FDA clearance is based on substantial equivalence to a predicate device, not on extensive clinical outcome studies typically associated with AI/software devices.
Therefore, many of the requested points, particularly those related to AI algorithm performance (acceptance criteria, ground truth, expert consensus, MRMC studies, etc.), are not applicable to this type of device clearance. The clearance is based on engineering analysis and mechanical testing, ensuring the device's physical properties are safe and effective.
Here's an analysis of the provided text in relation to your questions, highlighting what is present and what is absent:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria (for this type of device): The primary acceptance criterion for this type of medical device cleared through the 510(k) pathway is substantial equivalence to a predicate device. This means demonstrating that the new device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness. For metallic bone fixation, this typically involves material compatibility, mechanical strength, and design similarities.
- Reported Device Performance: The document states:
- "Engineering analysis and mechanical testing demonstrated that the Skeletal Dynamics Inc's Distal Humerus Plating System is equivalent to predicate devices currently marketed."
- "Static testing, which established equivalency included ASTM-F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws."
- "The subject device is as safe and effective as the legally marketed predicate device."
Table of Acceptance Criteria and Performance (as applicable to this device type):
| Acceptance Criteria Category | Specific Criteria (Implicitly Met for 510(k)) | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Equivalence in Intended Use, Indications for Use, Materials, Design (Fundamental Scientific Technology), Performance, Sterility, and Packaging. | "demonstrated that the Skeletal Dynamics Inc's Distal Humerus Plating System is equivalent to predicate devices currently marketed." |
| Material Properties | Biocompatibility, appropriate material strength and longevity (Titanium alloy, CoCr). | Made of "medical grade titanium alloy" and "CoCr." Implies meeting standard material specifications. |
| Mechanical Performance | Mechanical strength and stability sufficient for intended use (bone fixation). | "Engineering analysis and mechanical testing demonstrated...Static testing, which established equivalency included ASTM-F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws." |
| Safety & Effectiveness | No new issues of safety or effectiveness compared to predicate. | "does not present any new issues of safety or effectiveness." "The subject device is as safe and effective as the legally marketed predicate device." |
2. Sample sized used for the test set and the data provenance
- Not Applicable. This is a hardware device cleared through a 510(k) pathway, not an AI/software device requiring a test set of medical images or patient data in the sense of an algorithm. The "testing" refers to mechanical and engineering tests, not data sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. See point 2. Ground truth in the context of AI relates to expert labels on data. For this device, "ground truth" relates to engineering standards and validated test methods.
4. Adjudication method for the test set
- Not Applicable. See point 2.
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 physical implantable device, not an AI-assisted diagnostic tool. MRMC studies are used for evaluating the impact of AI on human interpretation of medical images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm.
7. The type of ground truth used
- Ground Truth (for this device type): Engineering specifications, validated mechanical testing standards (e.g., ASTM-F543-17), and material properties are the "ground truth" against which the device's performance is measured for substantial equivalence. There isn't "expert consensus" or "pathology" in the sense of clinical image interpretation for this specific clearance.
8. The sample size for the training set
- Not Applicable. This is a hardware device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
In summary: The provided FDA clearance document for the "Distal Humerus Plating System" pertains to a physical medical device. The regulatory pathway (510(k)) relies on demonstrating substantial equivalence to a predicate device, primarily through engineering analysis and mechanical testing. The questions you posed are highly relevant to AI/machine learning medical devices, but not to this specific hardware device clearance.
§ 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.