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The JTS® Extendible Implant is intended to be used for cemented limb sparing procedures in paediatric (between the ages of 2 and 21) cases where radical resection and replacement of the distal femur is required with the following conditions:

• . patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment,
• surgical intervention for severe trauma, revision knee arthroplasties, failed . previous prostheses and/or oncology indications; and malignant diseases (e.g., osteogenic sarcoma).
  The JTS® Extendible Implant and its components are for single use only.

The JTS® Extendible Implant is a patient specific system that is used to replace bone which is lacking or damaged or must be removed (e.g., due to tumor). The JTS® Extendible Implant is a distal femoral (passive hinge tibia) implant. The device consists of components (defined below) which are available in a range of sizes depending on the size and needs of the patient. Every configuration includes a telescoping shaft with a gearbox, magnet, and extension screw assembly for extending the implant when required by the patient.
Components available in patient specific sizes:

• Femoral Telescoping Shaft .
• Femoral Block .
• Extension Screw .
• Femoral Shaft .
• Passive Hinge .
• Passive Bearing .
• Tibial Passive Stem .
• HA Coated Extra-cortical Plate that is integral to the Femoral Shaft .
• Hydroxvapatite Collar that is integral to the Femoral Shaft .
• Bumper Pad ◆
• Bushes .
• Axles .
  The specific design of the implant is based on the surgeon's description of the case and patient radiological information. The key dimensions for each JTS® Extendible Implant are derived from the generic device specifications and by taking measurements from the patient's X-rays and/or CT scans. The implant is designed and manufactured for each patient.
  The JTS® External Drive Unit is used periodically to lengthen the prosthesis when the patient's limb length discrepancy needs to be addressed. The JTS® External Drive Unit creates a magnetic field which interacts with the magnet in the telescoping shaft to lengthen the implant.

The provided text describes a 510(k) summary for the JTS® Extendible Implant, a medical device. It focuses on the general description of the device, its intended use, and a list of performance tests conducted to establish substantial equivalence to predicate devices, rather than detailed acceptance criteria and the specifics of a study proving those criteria are met in the way one might expect for a diagnostic or AI-driven device.

Therefore, many of the requested items related to acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert ground truth, and comparative effectiveness studies are not present in the provided document. The performance tests listed are primarily engineering and mechanical evaluations of the implant itself, not clinical effectiveness studies in the typical sense for a diagnostic device.

Here's a breakdown based on the provided text, with "N/A" for information not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in a table format for the device's clinical performance or diagnostic accuracy. Instead, it lists various engineering and mechanical performance tests. The "reported device performance" is implicitly that the device passed these tests and was deemed "as safe and effective" as the predicate devices.

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

• Sample Size (Test Set): Not specified. The document only mentions "summary of clinical data of compassionate use patients and foreign patients." This suggests a compilation of existing patient data rather than a newly designed test set for a specific study.
• Data Provenance: "Compassionate use patients and foreign patients" (implicitly retrospective, no specific countries mentioned).

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

• Number of Experts: N/A. The document does not describe the establishment of a "ground truth" by experts for this clinical data. The clinical data mentioned appears to be real-world outcomes.
• Qualifications of Experts: N/A.

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

• Adjudication Method: N/A. Not applicable as no explicit 'test set' requiring expert adjudication for ground truth is described.

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

• MRMC Comparative Effectiveness Study: No. This type of study is typically for diagnostic imaging devices involving human interpretation, not for an orthopedic implant.
• Effect Size: N/A.

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

• Standalone Performance: N/A. This device is an implant, not an algorithm.

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

• Ground Truth Type: For the mentioned "summary of clinical data," it would primarily refer to outcomes data (implicitly, actual patient outcomes from use of the implant in real-world scenarios). There is no mention of expert consensus or pathology serving as ground truth for a study.

8. The sample size for the training set

• Sample Size (Training Set): N/A. This is an orthopedic implant, not a machine learning model, so there is no concept of a "training set" in this context.

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

• Ground Truth Establishment (Training Set): N/A. Not applicable.

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