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The Ellipse Intramedullary Limb Lengthening System is indicated for limb lengthening of the tibia and femurs.

The Ellipse Intramedullary Limb Lengthening System is composed of a modular implantable intramedullary rod ("Distracting Rod"), locking screws, an external remote controller (ERC), and implantation tools and accessories. The modular implantable rod is available in different configurations, lengths, and diameters to accommodate a variety of patient anatomies. Likewise, the locking screws are available in two different diameters and a variety of lengths from 20 mm to 75 mm in 5 mm increments. The distracting rod is a modular system that includes the IMLL Actuator component and various configurations of IMLL Extension Rods. The IMLL Actuator includes an enclosed rare earth magnet, telescoping lead screw/nut assembly and gearing. The IMLL Actuator is supplied sterile by gamma sterilization while the IMLL Extension Rods, locking screws, and reusable accessories are supplied non-sterile and must be sterilized prior to use.

The provided text does not contain detailed acceptance criteria with numerical thresholds, nor does it present specific performance metrics from a study that directly proves the device meets such criteria to the extent that would typically be seen in a clinical trial or performance study report.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device through various forms of in vitro testing and a comparison of technological characteristics. The "performance" in this context refers to the device successfully passing a series of mechanical, sterilization, biocompatibility, and electrical safety tests, rather than a clinical performance measured against specific clinical acceptance criteria.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document lists several tests performed to establish substantial equivalence. While it doesn't explicitly state "acceptance criteria" with numerical values used in the studies, the implicit acceptance criterion for each test is successful completion and compliance with the specified standard.

2. Sample size used for the test set and the data provenance:

• Sample Size: The document does not specify the sample sizes used for each of the mechanical or other in vitro tests. It refers to "testing" performed.
• Data Provenance: The tests are in vitro tests performed on the device components, not on human or animal subjects. Therefore, there is no country of origin of data or distinction between retrospective/prospective in the clinical sense. These are laboratory tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This question is not applicable to the type of testing described. The "ground truth" here is the pass/fail criteria defined by the applicable test standards (e.g., ISO, ASTM, IEC). Evaluation of test results against these standards is typically done by engineers or quality control personnel, not medical experts establishing a clinical ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies where multiple experts independently evaluate cases and then resolve discrepancies. The tests mentioned are objective engineering and material science tests, not subjective interpretations requiring medical adjudication.

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:
This is not applicable. The device is a mechanical intramedullary limb lengthening system, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or AI assistance evaluation was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical medical implant with an external remote controller, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the tests performed is the compliance with recognized international and national standards (e.g., ISO, ASTM, IEC) for mechanical properties, sterility, biocompatibility, electrical safety, and software validation. For the magnetic field safety, it refers to "established safety guidelines." There is no clinical ground truth (like pathology or outcomes data) derived from human subjects for these substantial equivalence tests.

8. The sample size for the training set:
Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:
Not applicable, as there is no training set.

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