(90 days)
The Skeletal Dynamics Ulnar Shortening Plating System is indicated for fractures and osteotomies, in particular for the ulna.
The Skeletal Dynamics Ulnar Shortening Plating System consists of Distal Ulnar Shortening Plates with left and right configurations in two lengths and Proximal Ulnar Shortening Plates in two lengths. The Ulnar Shortening Plates are from medical grade Titanium Allov (ASTM F136). Included within the Ulnar Shortening Plating System Set are 3,5mm cortical locking and non-locking bone screws as well as 2.3mm and 2.7mm locking and non-locking pegs from medical grade Titanium Alloy (ASTM F136) for fixation and class 1 surgical instrumentation.
The FDA 510(k) summary for the Skeletal Dynamics Ulnar Shortening Plating System (K201962) indicates that the device's acceptance criteria are based on its substantial equivalence to predicate devices, particularly in terms of performance. The study proving the device meets these criteria is primarily through performance testing, specifically static and dynamic bend strength tests.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide specific numerical acceptance criteria (e.g., minimum bend strength in Newtons) or exact reported device performance values. Instead, it states a qualitative acceptance criterion and confirms it was met.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence in performance to predicate devices for static and dynamic bend strength. | Performance testing and engineering analysis confirmed the device's performance to be substantially equivalent to the predicate devices. |
| No new issues of safety or effectiveness compared to predicate devices. | Confirmed within the premarket notification based on identical indications for use, materials, design, and performance. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a sample size for the tests. It refers to "performance test data" and "engineering analysis" but doesn't mention how many plates were tested or how many repetitions were performed.
The provenance of the data is implied to be laboratory testing (in vitro) conducted by Skeletal Dynamics, Inc., based on the mention of ASTM standards. It is not patient or clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable to this type of submission. The "ground truth" for the performance testing of a metallic bone fixation appliance is typically defined by established engineering and biomechanical standards (e.g., ASTM standards) and the performance of known predicate devices, not by expert medical opinion on a test set of clinical cases.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving interpretation of medical images or outcomes, not for in vitro mechanical performance testing of orthopedic hardware.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study would compare human readers' performance with and without AI assistance, which is not relevant for a metallic bone fixation appliance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, a standalone performance study in the context of an algorithm's performance was not done. This refers to algorithmic decision-making, which is not what this device is.
7. The Type of Ground Truth Used:
The ground truth for the performance study was based on established engineering standards (specifically ASTM F382, ASTM F2193, and ASTM F1541) and the performance characteristics of the identified predicate devices.
8. The Sample Size for the Training Set:
The concept of a "training set" is not applicable here. Training sets are used in machine learning and AI development. This submission is for a medical device (metal plate and screws) that does not involve machine learning.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable as there is no training set for this device submission.
§ 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.