(30 days)
The AOS Proximal Humeral Nail is intended to treat stable and unstable proximal fractures of the humerus including two and three, and in some cases, four part humerus fractures.
The AOS Proximal Humeral Nail is a titanium humeral intramedullary nail that is designed to enter the humerus through the greater tuberosity. It consists of an intramedullary nail. proximal and distal locking screws, and an end cap.
The AOS Proximal Humeral Nail is a cannulated nail with a 6° proximal bend and a proximal diameter of 10mm. The Humeral Nail is produced in a 15cm length with a distal diameter of 8mm. The proximal end of the nail has six holes which accept the 5.0mm cancellous screw. The distal end of the nail contains four cross locking holes which are designed to accept a 3.5mm cortical screw. The proximal end of the nail is threaded to accept an end cap.
The provided text describes a 510(k) submission for a medical device, the AOS Proximal Humeral Nail. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study or detailed standalone algorithm performance.
Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth establishment are not applicable to the information contained in this document.
Here's what can be extracted based on the provided text, and where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate device (AOS Humeral Nail K050241) in: | Demonstrated substantial equivalence in: |
| - Design | - Design |
| - Materials | - Materials |
| - Intended Use | - Intended Use |
| - Geometry (when assembled) | - Geometry (virtually identical when assembled) |
| - Mechanical Testing | - Mechanical Testing |
2. Sample size used for the test set and the data provenance
- Not Applicable. The submission is primarily focused on demonstrating substantial equivalence through design comparison and mechanical testing, not through testing with a "test set" of patient data or images.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. There is no mention of a "test set" or human experts establishing ground truth in the context of this 510(k) submission.
4. Adjudication method for the test set
- Not Applicable. No test set or adjudication process is mentioned.
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 intramedullary nail for fracture fixation, not an AI or imaging diagnostic tool. Therefore, an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- Not Applicable. The "ground truth" equivalent in this context is the predicate device's established safety and effectiveness. The comparison is based on physical characteristics and mechanical properties.
8. The sample size for the training set
- Not Applicable. No training set for an algorithm is relevant here.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set mentioned, this question is not applicable.
Summary based on the provided text:
The AOS Proximal Humeral Nail demonstrated substantial equivalence to its predicate device, the AOS Humeral Nail (K050241), through a comparison of design, materials, intended use, assembled geometry, and mechanical testing. The FDA concurrence letter confirms this finding, allowing the device to be marketed. This is a traditional medical device submission, not one related to AI or diagnostic imaging, and therefore the criteria for such technologies (like clinical studies with test sets, ground truth, and expert review) are not present in this documentation.
§ 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.