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The ISKD System intended for limb lengthening of the femur and tibia.
The ISKD is indicated for limb lengthening of the tibia and femur.

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 the implant is controlled by a one-way clutch mechanism and a threaded and. 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 and tracking changes in the magnet poles. The external Monitor enables both trationing and physicians to monitor the daily limb lengthening progress. Titanium locking screws (2 proximal and 2 distal) secure the device in place in the intramedullary canal.

The provided text describes the Orthodyne ISKD System, an intramedullary limb lengthening system. However, it does not detail specific acceptance criteria with quantitative targets for device performance or a formal study designed to "prove the device meets acceptance criteria" in the way one might typically expect for a software or AI-driven medical device. Instead, the document presents a summary of biomechanical, animal, and clinical testing to demonstrate the device's safety, effectiveness, and substantial equivalence to predicate devices.

Let's break down what is available in the text according to your requested categories:

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

The document does not explicitly state "acceptance criteria" with numerical thresholds for performance. Instead, it describes performance in relation to predicate devices and the intended use.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document describes clinical studies rather than a "test set" in the context of an algorithm or AI.

• Pilot Study (Clinical): 9 patients. "Compassionate use" indicates these were likely very severe or difficult cases, possibly without strict prospective protocol adherence given their "last stage option" nature. Data provenance is not specified (e.g., country), but implied to be from a clinical setting.
• Feasibility Study (Clinical): 10 patients (11 lengthening procedures). This study appears to be prospective due to enrollment and follow-up. Data provenance is not specified (e.g., country).
• Animal Testing: 1 female sheep. This was a prospective animal study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable to the provided document. The clinical studies describe patient outcomes and physician assessments rather than a "ground truth" established by an expert panel for a test set (as would be relevant for an AI algorithm). The animal study involved radiographic evaluation and surgical removal of bone, implying veterinary and possibly pathology expertise, but no specific number or qualifications are given.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. The studies described are clinical trials and animal studies, not an adjudication process for an AI algorithm's test set. Clinical outcomes were assessed by treating physicians and followed up clinically and radiographically.

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

No MRMC comparative effectiveness study was done as the device is a mechanical implant, not an AI or imaging diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. The ISKD is a mechanical device with an external monitor for tracking, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the studies presented:

• Biomechanical Testing: Physical measurements and comparisons against established engineering standards and predicate devices (e.g., yield strength, stiffness, fatigue cycles).
• Animal Testing: Direct observation, radiographic evaluation of bone formation and distraction, and post-mortem pathological evaluation of the bone and implant site. The "ground truth" for lengthening was determined by counting threads on successive radiographs.
• Clinical Testing: Patient outcomes, including achieved limb length (measured clinically and radiographically), healing status (radiographic evaluation), adverse events, and physician assessment.

8. The sample size for the training set

Not applicable. The device is not an AI algorithm, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable.

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