(41 days)
The ISKD System intended for limb lengthening of the femur and tibia.
The ISKD System is an intramedullary limb lengthening system that provides gradual, controlled osteogenic distraction of the tibia and femur. The ISKD System consists of the telescoping internal limb lengthening device, titanium locking screws, instrumentation and an external handheld Monitor. As the patient performs rotational oscillations of the affected limb during normal ambulation, the ISKD distracts as the distal section of the implant gradually telescopes out of the proximal section. The distraction is controlled by a one-way clutch mechanism and a threaded rod. A small magnet sealed within the ISKD implant rotates simultaneously as the implant distracts. The hand-held external Monitor is similar to an electronic compass and communicates with the magnet by detecting a tracking changes in the magnet poles. The external Monitor enables both patients and physicians to monitor the daily limb lengthening progress. The addition of the 10.7mm lengthener will provide surgeons with a device option for patients requiring a smaller diameter implant.
The provided document is a 510(k) premarket notification for the Orthofix Inc. ISKD Internal Limb Lengthening System (10.7mm), seeking substantial equivalence to a previously cleared 12.5mm version of the same device. This type of regulatory submission focuses on demonstrating equivalence to a predicate device, rather than proving efficacy through clinical outcome studies with predefined acceptance criteria for device performance as would be seen in AI/ML device submissions.
Therefore, the study described is a biomechanical testing study demonstrating the mechanical properties of the new 10.7mm device are comparable to the predicate device, rather than a study evaluating diagnostic or prognostic performance of an AI/ML algorithm.
Here's a breakdown based on the provided input:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from predicate device performance) | Reported Device Performance (10.7mm ISKD) |
|---|---|
| Mechanical properties necessary to perform intended use as per ASTM 1264 for intramedullary fixation devices. | Successfully completed 4-point bend, fatigue, and torsion testing in accordance with ASTM 1264. |
| Performs as well as the 12.5mm ISKD lengthener (predicate device). | Performs as well as the 12.5mm ISKD lengthener. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of devices. The study refers to "mechanical and functional testing" of the 10.7mm lengthener. For biomechanical testing, samples typically refer to a defined number of devices or components tested.
- Data Provenance: The testing was conducted by Orthofix Inc. The document implies these were laboratory-based tests on the manufactured devices, not human or animal data. There is no information on country of origin of data beyond it being conducted by the submitter (Orthofix Inc. in McKinney, TX, USA). It is a prospective test in the sense that the new device was manufactured and then tested.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as this is a biomechanical engineering study, not one requiring expert review of data (e.g., medical images). The "ground truth" is defined by the ASTM standard 1264.
4. Adjudication method for the test set:
This information is not applicable for a biomechanical engineering study. The evaluation likely involved direct measurement against the ASTM standard.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. This document describes a medical device (internal limb lengthener), not an AI/ML diagnostic or assistive technology.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
The "ground truth" for this study is the ASTM 1264 Standard Specification and Test Methods for Intramedullary Fixation Devices. The performance of the 10.7mm device was evaluated against the requirements and performance established by this recognized standard, and comparatively against the performance of the 12.5mm predicate device.
8. The sample size for the training set:
There is no training set as this is not an AI/ML study.
9. How the ground truth for the training set was established:
There is no training set as this is not an AI/ML study.
§ 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.