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The Intra medullary endo-Transilluminating device (iMET), together with all its components, is for use in performing interlocking screw holes positioning during intra-medullary nailing procedure. It is designed to assist surgeons who need to fix fractured long bone , such as tibia, femur, or humerus by providing illumination intramedullary for rapid and precise screw holes positioning without using C-arms thus no extra radiation dosage was absorbed.

The intra medullary endo-transilluminating (iMET) device is designed to aid the positioning of interlocking nails distal screw hole while intra-medullary nailing procedure is performed. It is a device used to assist surgeons who need to fix the fractured bone more efficiently. It is single use and is disposable after the operation.

The whole system consists of a LED-embedded guide pin (iMET), connecting cable and a power control box. The iMET will provide essential light source and indicated the route for aiming and tightening interlocking screw.

The iMET consists of a LED lamp, a 304 stainless metal tube and a Polyetheretherketone (PEEK) head.

The connecting cable is a simple 2 lines cable with custom-made IP67 waterproof connectors for repeated usage under basic disinfection.

The power source, control box, provide electric power for LED. It is designed within a metal box. The voltage enhancement and circuit design were applied for controlling high efficiency LED. The power input is DC 4.5V provided by 3 AA batteries and the output is 30mA in maximum. The control box can be reused under basic cleaning process after the operation.

The provided document describes the intra medullary endo-transilluminating device (iMET device), a medical device designed to assist surgeons in positioning interlocking screw holes during intra-medullary nailing procedures. The document includes information on the device's performance tests and a clinical usability study.

Here's an analysis of the acceptance criteria and the study that proves the device meets these criteria, based on the provided text:

Acceptance Criteria and Reported Device Performance

The document describes specific performance tests conducted on the iMET device. The acceptance criteria and the results are summarized below:

Table of Acceptance Criteria and Reported Device Performance:

Study Details for Device Performance

The provided document describes both bench performance tests and a clinical usability study.

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

• Bench Performance Tests: 5 pieces of the iMET devices were used.
• Clinical Usability Study: A total of 19 consecutive tibia-fracture patients (11 males and 8 females) were recruited.
• Data Provenance: The clinical trial was conducted at Cheng Hsin Rehabilitation Medical Center, Beitou, Taipei, Taiwan. This indicates the data is prospective and from Taiwan.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Bench Performance Tests: The document does not specify the number or qualifications of experts for these tests. The criteria (e.g., "functionable," "light penetration observed," "red intensity value") suggest objective measurements rather than expert subjective assessment for ground truth.
• Clinical Usability Study: The "ground truth" for the clinical study was based on objective measures: "failure rate" (number of repeated drilling attempts) and "operation times." The study was led by surgeons performing the procedures (implied by the context of "assist surgeons"), but it doesn't specify if these surgeons were the "experts" establishing a ground truth for a diagnostic AI system, given that this device is a surgical aid rather than a diagnostic tool. No explicit mention of expert consensus for ground truth on patient outcomes related to device performance, beyond direct measurement of surgical efficiency and absence of re-drilling.

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

• No specific adjudication method is described for either the bench tests or the clinical usability study. The clinical outcome measures (failure rate, operation time) are direct measurements rather than subjective interpretations requiring 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:

• No, a typical MRMC comparative effectiveness study was not performed as described for AI-assisted diagnostic tools. This device is a transilluminating surgical aid, not an AI-based diagnostic image analysis system that human readers would interpret.
• Instead, the clinical study compared the observed performance using the iMET device (average time to finish inserting one distal interlocking screw was 4.1 ± 1.8 min) to historical reported times for "other types of TADs" (ranging from 16.7 to 19.1 min). This suggests an indirect comparison rather than a head-to-head MRMC study.
• Effect Size (from clinical usability study): The average time for distal interlocking screw insertion with iMET was 4.1 ± 1.8 min. This is significantly faster than the reported range of 16.7 to 19.1 min for other TADs (Transillumination Aiming Devices). This represents a substantial improvement in efficiency, though it's important to note this is a comparison to historical data, not a direct randomized controlled trial.

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

• This question is not applicable in the context of the iMET device. The iMET device is a physical surgical tool that provides illumination. It does not have a standalone algorithm for performance evaluation in the way an AI diagnostic or image processing algorithm would. Its function is inherently "human-in-the-loop" as it assists a surgeon directly.

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

• Bench Performance Tests: The ground truth was based on objective physical measurements (device functionality, light penetration observation, quantitative light intensity value).
• Clinical Usability Study: The ground truth was based on clinical outcome data (failure rate defined by repeated drilling attempts, and measured operation times).

8. The sample size for the training set:

• Not applicable. The provided document describes a medical device, not an AI or machine learning algorithm that requires a training set. The performance evaluation is for the physical device itself.

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

• Not applicable. As the device does not involve an AI algorithm with a training set, this question is irrelevant to the information provided.

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