(87 days)
Synthes Olecranon Osteotomy Nailing (OleON) System is intended to treat olecranon osteotomies as well as simple fractures of the olecranon.
Synthes Olecranon Osteotomy Nailing System consists of machined metallic olecranon nails, end caps and screws which are designed for use in fixation of fractures and osteotomies of the olecranon process of the ulna. Synthes Olecranon Osteotomy Nailing System offers a unique alternative to current techniques for olecranon fracture and olecranon osteotomy fixation. The system allows for quick realignment of the olecranon fragment following procedures which
This document is a 510(k) summary for the Synthes Olecranon Osteotomy Nailing System. It is a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices. As such, it does not detail acceptance criteria and a study proving device performance in the way a clinical trial report for an AI/ML device would.
The information provided describes a medical device (intramedullary fixation rod used for olecranon fractures and osteotomies), not an AI/ML device. Therefore, the questions related to AI/ML device performance (like multi-reader multi-case studies, standalone algorithm performance, training/test set data, expert ground truth adjudication) are not applicable to this document.
The document primarily focuses on establishing substantial equivalence to existing predicate devices, which is the regulatory pathway for this type of medical device.
Here's a breakdown of the relevant information from the provided text, addressed for a non-AI/ML medical device submission:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission for a non-AI/ML device, the concept of "acceptance criteria" and "reported device performance" typically refers to demonstrating substantial equivalence to predicate devices based on design, materials, indications for use, and technological characteristics. There isn't a direct table like you might find for an AI/ML diagnostic's sensitivity/specificity.
The "performance" is implicitly demonstrated through comparison to the predicate devices and the summary states:
| Criterion | Description / Performance |
|---|---|
| Device Name | Synthes Olecranon Osteotomy Nailing System |
| Intended Use | Synthes Olecranon Osteotomy Nailing (OleON) System is intended to treat olecranon osteotomies as well as simple fractures of the olecranon. This matches the intended use of the predicate devices. |
| Device Description | Consists of machined metallic olecranon nails, end caps, and screws designed for fixation of fractures and osteotomies of the olecranon process of the ulna. It offers a "unique alternative to current techniques" allowing for "quick realignment of the olecranon fragment." |
| Predicate Devices | Pioneer Surgical Technology SS Cables with Crimp, Synthes Kirschner Wires, Synthes 6.5mm Cancellous Screws, Acumed Small Bone Locking Rod System II, Biomet S.S.T. Small Bone Locking Forearm Nail. The new device is compared to these on technological characteristics, materials, and intended use to establish equivalence. |
| Substantial Equivalence | "Information presented supports substantial equivalence." This is the ultimate "acceptance" for a 510(k) pathway. The FDA's letter states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...". |
| Classification | Class II, 21 CFR 888.3020 - Intramedullary fixation rod. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable in the context of this 510(k) summary. For traditional medical devices like this, "test sets" in the context of clinical trials (with sample sizes, data provenance, etc.) are typically not required for 510(k) submissions unless the device introduces new technology or raises new questions of safety and effectiveness that cannot be addressed by comparison to predicates. The focus here is on engineering, material, and design equivalence to already marketed devices. Pre-clinical bench testing for mechanical properties (e.g., strength, fatigue) would have been performed, but specific "sample sizes" of clinical patient data are not detailed here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. See point #2. Ground truth, expert consensus, and reader qualifications are relevant for diagnostic AI systems, not for a bone fixation device's 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point #2 and #3.
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 hardware implantable device, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware implantable device, not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. For this type of device, the "ground truth" for demonstrating safety and effectiveness for a 510(k) submission largely relies on established clinical practice for the predicate devices, engineering principles, biocompatibility testing, and mechanical testing, rather than patient outcomes or pathology data in a comparative study mentioned within this summary.
8. The sample size for the training set
- Not Applicable. There is no "training set" for this non-AI medical device.
9. How the ground truth for the training set was established
- Not Applicable. There is no "training set" for this non-AI medical device.
In summary: The provided document is a 510(k) summary for a traditional medical device (an intramedullary fixation rod). The "acceptance criteria" and "proof" in this context revolve around demonstrating substantial equivalence to predicate devices already on the market, based on manufacturing, materials, design, and intended use. The questions posed are highly relevant for AI/ML-enabled diagnostic devices, but not for this type of submission.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.