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510(k) Data Aggregation
(151 days)
Olecranon Plating System
The MDS Olecranon Plating System is intended for internal fixation of fractures of the Olecranon.
The Olecranon Plating System is an internal fixation system to be used for the treatment of Olecranon fractures. The system consists of plates, screws, and locking caps, as well as single use and reusable instruments. The Olecranon plates are pre-contoured and side-specific, available in two different sizes; 2 hole and 4 hole. The Olecranon Plating System Screws are 2.7mm in diameter and available in various lengths.
The MDS implants are single-use ONLY.
Materials: Titanium alloy and stainless steel
Here's an analysis of the provided text regarding the acceptance criteria and study for the Olecranon Plating System:
It's important to note that the provided document is a 510(k) summary for a medical device, specifically an Olecranon Plating System. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This is not a study of an AI-powered device or a comparative effectiveness study in the typical sense of measuring algorithm performance. Instead, it focuses on the engineering and material characteristics of a physical implant.
Therefore, many of the requested categories related to AI performance, ground truth, expert adjudication, and MRMC studies will not be applicable to this document.
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Strength | Demonstrated to be as safe and effective as the predicate devices. | Engineering analysis and testing according to ASTM F382-99 (Standard Test Method for Metallic Medical Bone Plates) and ASTM F543-07 (Standard Specification and Test Method for Metallic Bone Screws) showed the device performs as well as predicate devices. |
| Material Compatibility | Materials (Titanium alloy and stainless steel) must be acceptable for medical implants. | Uses Titanium alloy and stainless steel, which are standard materials for bone fixation. |
| Design and Functionality | Similar design and functionality to predicate devices for internal fixation of olecranon fractures. | "The Olecranon Plating System has the same intended use, similar performance characteristics, and is similar in design and material to the predicate devices." Plates are pre-contoured and side-specific; screws are 2.7mm in diameter. |
| Intended Use | Intended for internal fixation of fractures of the Olecranon. | The MDS Olecranon Plating System is intended for internal fixation of fractures of the Olecranon. |
| Sterility/Reprocessing | Implants are single-use ONLY. Instruments may be reusable and require reprocessing instructions. | "The MDS implants are single-use ONLY." Reference to Paragon 28, Inc.; The Monster Screw System: Instrument Reprocessing Instructions for Reusable Instruments (K151418) for guidance on reusable instruments. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable in the context of a clinical test set. The performance data is based on non-clinical (laboratory/performance) testing and engineering analysis of the device itself (plates, screws). The sample size would relate to the number of physical components tested in the lab. The document does not specify the exact number of plates or screws physically tested.
- Data Provenance: Not applicable in terms of country of origin for a data set. The testing was non-clinical (laboratory) rather than using patient data. It involved materials and mechanical testing.
- Retrospective/Prospective: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This document describes the mechanical and material equivalence of a physical implant, not an AI or diagnostic device that requires expert-established ground truth from medical images or patient data. The "ground truth" here is the established mechanical performance standards (ASTM standards) and the characteristics of the predicate devices.
4. Adjudication method for the test set:
- Not Applicable. There was no human adjudication of results in the context of a diagnostic test set. The "adjudication" was through engineering analysis and comparison against established industry standards (ASTM) and predicate device specifications.
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:
- No. This was not an MRMC study. This device is a physical bone implant, not an AI software or diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm. It's a physical medical device.
7. The type of ground truth used:
- For mechanical properties: Established industry standards (ASTM F382-99 for bone plates, ASTM F543-07 for bone screws) and the specifications/performance of the predicate devices.
- For material composition: Accepted medical-grade titanium alloy and stainless steel (as verified against predicate devices).
8. The sample size for the training set:
- Not Applicable. There is no "training set" in the context of a physical medical device like this, which relies on engineering design, material science, and mechanical testing, not machine learning.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
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