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ELEOSTM Limb Salvage System Hip Components:

Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions :

1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli. and painful hip dysplasia;

2. Inflammatory degenerative joint disease such as rheumatoid arthritis;

3. Correction of functional deformity

4. Revision procedures where other treatments or devices have failed; and,

5. Treatment of fractures that are unmanageable using other techniques.

Limb salvage system is also indicated for procedures where radical resection and replacement of the proximal, distal and or total femur is required with the following conditions:

1. Patients suffering from severe arthropathy of the hip that does not respond to any conservative therapy or better alternative surgical treatment:

2. Surgical intervention for severe trauma, revision hip arthroplasties, and/or Oncology indications.

• 3. Metastatic diseases
     ELEOSTM Limb Salvage System Knee Components:

Indicated for cemented use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:

1. Non-inflammatory degenerative joint disease including osteoarthritis, or avascular necrosis;

2. Inflammatory degenerative joint disease including rheumatoid arthritis;

3. Correction of functional deformity;

4. Revision procedures where other treatments or devices have failed; and

5. Treatment of fractures that are unmanageable using other techniques.

Limb salvage system is also indicated for procedures where radical resection and replacement of the proximal tibia is required with the following conditions:

1. Patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment;

2. Surgical intervention for severe trauma, revision knee arthroplasties, and/or Oncology indications.

3. Metastatic diseases

The Onkos Surgical ELEOS™ Limb Salvage System consists of components that are used in the reconstruction of the lower limb. The reconstruction are proximal femur, distal femur, total femur, proximal tibia, and hinged knee. The ELEOS Limb Salvage components are femoral head, proximal femur, mid-section, stem, distal hinge femur, tibial hinge assembly, axial pin, tibial poly spacer, tibial sleeve, male mid-section, resurfacing hinge femur, and proximal tibia, optional components include modular collars, patella, stem extensions, tibial wedges and augments. Instrumentation is provided non-sterile in surgical trays which are to be re-processed per the validated instructions stated below.

The provided text is a 510(k) summary for a medical device (ELEOS Limb Salvage System with BioGrip) seeking FDA clearance. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel performance against specific acceptance criteria through a clinical study.

Therefore, the document does not contain the acceptance criteria or a study designed to prove the device meets those criteria in the way you've outlined for a clinical performance study of, for example, an AI algorithm.

Instead, the document details performance data provided in support of substantial equivalence to a predicate device. This data focuses on mechanical and biocompatibility testing to ensure the new device (a line extension with modular collars and porous technology) is as safe and effective as the existing, cleared predicate device.

Here's a breakdown of what is available based on your request, with an explanation of why other points are not applicable in this context:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission based on substantial equivalence, there isn't a direct "acceptance criteria" table with specific performance metrics (like sensitivity/specificity for an AI algorithm) that the device must meet to prove its clinical utility. Instead, the performance data provided demonstrates that the device performs similarly or better mechanically and is biocompatible compared to predicate devices, adhering to recognized standards.

Biocompatibility Testing:

Mechanical Testing:

2. Sample Size Used for the Test Set and Data Provenance

This information is not applicable in the context of this 510(k) submission. The "test set" in this case refers to the physical device components subjected to laboratory testing. The document does not describe a clinical study with patients or data from medical records.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable. Ground truth, in the sense of expert consensus on clinical diagnoses or outcomes, is not established for the mechanical and biocompatibility tests performed. These tests rely on standardized protocols and measurements, not expert interpretation of clinical data.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies to resolve discrepancies in expert interpretations of data. The performance analyses presented here are laboratory-based.

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 information is not applicable. This submission is for a physical orthopedic implant system, not an AI algorithm. No MRMC study or AI assistance is mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. This submission is for a physical orthopedic implant system, not an algorithm.

7. The Type of Ground Truth Used

For biocompatibility, the "ground truth" is defined by the toxicological characteristics and cellular responses measured against established ISO standards.
For mechanical testing, the "ground truth" is defined by the physical limits and properties established in the ASTM and ISO standards for orthopedic implants.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of this device's development as it is not an AI/machine learning device. The design and testing are based on engineering principles and material science.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as point 8.

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The JTS® Extendible Distal Femoral Implant is intended to be used for cemented limb salvage 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 prosthesis and/or oncology indications; and
• malignant diseases (e.g., osteogenic sarcoma).
  The JTS® Extendible Distal Femoral Implant and its components are for single use only.

The JTS® Extendible Distal Femoral 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 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
• Tibial configurations for knee joint including passive rotating hinge, rotating hinge (polyethylene), and metal cased tibia components
• Passive Bearing
• Tibial Passive Stem
• HA Coated Extra-cortical Plate that is integral to the Femoral Shaft
• Hydroxyapatite 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 Distal femoral 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 is a 510(k) summary for the JTS® Extendible Distal Femoral Implant. This document focuses on establishing substantial equivalence to predicate devices for a medical implant.

Based on the content, this document does not describe a study involving performance metrics like sensitivity, specificity, accuracy, or reader improvement in an AI context. Instead, it discusses the technical characteristics, intended use, and substantial equivalence of a physical medical device.

Therefore, many of the requested categories related to AI/algorithm performance studies cannot be filled from the given text.

Here's a breakdown of what can be extracted and explanations for what cannot:

Acceptance Criteria and Device Performance (as described for a physical implant)

The document primarily focuses on establishing substantial equivalence to predicate devices rather than defining specific performance acceptance criteria for a new, standalone study of the device's functional performance in a clinical setting. The "performance" here refers to its design and intended use matching existing cleared devices.

Information Not Applicable / Not Available from the Provided Text:

The following requested items are specific to the evaluation of AI/algorithm performance and are not found in this 510(k) summary for a physical medical implant.

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. This document does not describe a clinical study for performance testing of an algorithm.
2. 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): Not applicable. "Ground truth" in the AI sense is not established for this device.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. 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: Not applicable.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

In summary, the provided text is a regulatory filing for a physical medical device (an extendable distal femoral implant), not for an artificial intelligence or algorithm-based device. Therefore, the detailed questions about AI performance studies, ground truth establishment, and expert involvement are not applicable to this document.

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