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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:

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.

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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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