(11 days)
The ITST Intramedullary Nail is indicated for use in a variety of femoral fractures, such as:
- Subtrochanteric Fractures .
- Intertrochanteric Fractures .
- Comminuted Fractures ●
- Segmental Fractures ●
- Fractures with Bone Loss .
- Proximal and Distal Fractures .
- Nonunions ●
The ITST is used to provide reduction and internal fracture fixation of the femoral head and neck and has an intramedullary nail that is curved and tapered anatomically to accommodate the curvature of the intramedullary canal.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Zimmer ITST™ Intertrochanteric Subtrochanteric Intramedullary Femoral Nail:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance and Conclusions |
|---|---|
| Substantial Equivalence to Predicate Device (M/DN Intramedullary Fixation System, K965098) in terms of safety and effectiveness. | "Performance testing completed as part of the design assurance procedure demonstrated that this device is safe and effective and substantially equivalent to the predicate device." |
"Except for modifications to facilitate easier insertion, accommodate a larger lag screw and the addition of sliding and locking nail caps, ITST components are identical to the predicate device. The modifications do not change the intended use or the fundamental scientific technology. The device is packaged and sterilized using the same materials and processes." |
| No change in intended use. | "The modifications do not change the intended use..." |
| No change in fundamental scientific technology. | "...or the fundamental scientific technology." |
| Packaging and sterilization materials and processes are the same as the predicate device. | "The device is packaged and sterilized using the same materials and processes." |
2. Sample size used for the test set and the data provenance
- Sample size for the test set: Not applicable (N/A). The document explicitly states: "Clinical data and conclusions were not needed for this device." The evaluation was based on non-clinical performance testing.
- Data provenance: N/A, as clinical data was not used. The non-clinical performance testing would have been conducted by the manufacturer, Zimmer, Inc. The document doesn't specify country of origin for the non-clinical tests but implies it was internal to Zimmer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. Clinical data with expert-established ground truth was not utilized for this 510(k) submission.
4. Adjudication method for the test set
- N/A. Clinical data and expert adjudication were not part of this submission. The evaluation relied on non-clinical performance testing.
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
- N/A. This device is a physical medical implant (intramedullary nail), not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- The "ground truth" for this submission was the established performance and safety profile of the predicate device (M/DN Intramedullary Fixation System, K965098). The non-clinical performance testing (e.g., mechanical testing) aimed to demonstrate that the modified device performed equivalently to the predicate's known performance.
8. The sample size for the training set
- N/A. As this is not an AI/machine learning device, there is no "training set" in that context. The "training data" for the design of the device would broadly be engineering principles, material science data, and possibly clinical experience with similar devices, but this is not quantifiable as a "sample size" in the conventional sense for AI.
9. How the ground truth for the training set was established
- N/A. Given that this is not an AI/machine learning device, the concept of a "ground truth for a training set" as it applies to software or diagnostic algorithms is not applicable. The design and development would be informed by established engineering standards, biomechanical principles, and the performance characteristics of the predicate device.
§ 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.