(21 days)
These devices are indicated for the following:
Femur:
- fractures in the femur shaft, proximal femoral fractures, and combinations of these fractures;
- proximal femoral fractures including stable and unstable pertrochanteric, intertrochanteric, and subtrochanteric (with and without break-off of the minor trochanter), high subtrochanteric fractures and combinations of these fractures;
- use in osteotomy, nonunions and malunions, bone reconstruction following tumor resection, grafting and pathological fractures, and revision procedures in the femur;
- mid shaft fractures in the femur (5 cm below the surgical neck to 5 cm proximal to the distal end of the medullar canal);
- comminuted shaft fractures;
- fixation of short distal or proximal fragments
Tibia:
- diaphyseal shaft fractures in the tibia;
- comminuted shaft fractures;
- fixation of short distal or proximal fragments
Humerus:
- diaphyseal shaft fractures in the humerus;
- comminuted shaft fractures:
- fixation of short distal or proximal fragments
Not Found
This 510(k) uses a "substantial equivalence" approach rather than performance criteria based on clinical studies. Therefore, much of the requested information regarding acceptance criteria, study details, and ground truth cannot be extracted directly from this document.
Here's what can be provided based on the given text:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present quantitative acceptance criteria or reported device performance in a typical clinical study format. Instead, it relies on demonstrating substantial equivalence to existing predicate devices. The "acceptance criteria" are effectively the characteristics that demonstrate this equivalence.
| Acceptance Criteria | Reported Device Performance (Demonstrated Equivalence) |
|---|---|
| Same intended use | Yes |
| Same operating principles | Yes |
| Same design principles | Yes |
| Same or similar materials (Stainless steel meeting ASTM F 138/ISO 5832-1, ASTM F 1314) | Yes (Materials specified) |
| Same packaging | Yes |
| Same sterilization processes and materials | Yes |
| Design meets ASTM F 565 | Yes |
2. Sample size used for the test set and the data provenance
Not applicable. This is not a clinical performance study with a test set of patient data. It's a submission for substantial equivalence based on technical and functional similarities to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth was established by experts for a test set in this context.
4. Adjudication method for the test set
Not applicable.
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 not an AI-assisted diagnostic tool, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm-only device.
7. The type of ground truth used
Not applicable. The "ground truth" in this context is the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
Not applicable. This device does not use machine learning or require a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.