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ELEOSTM Limb Salvage System with 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

ELEOS™ Limb Salvage System with 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:

l ) Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, 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 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 applications 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 femur, tibial hinge component, axial pin, tibial poly spacer, tibial baseplate, male-male mid-section, resurfacing femur, proximal tibia, tapered screws, patella, stem extension, tibial wedges and augments. Instrumentation is provided non-sterile in surgical trays which are to be re-processed per validated instructions.

This is an FDA 510(k) clearance letter for the ELEOS™ Limb Salvage System. Unfortunately, the provided document does not contain the kind of detailed information about acceptance criteria, device performance, study methodology (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance) that your request outlines.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device based primarily on mechanical testing.

Here's what can be extracted from the document regarding performance data, and an explanation of why the other information is not present:

Acceptance Criteria and Device Performance

Study Details (Not Applicable as per document content)

The document explicitly states: "Clinical data was not deemed necessary for the subject device." This means a clinical study, as you've described with human readers, ground truth, and statistical analysis for diagnostic performance, was not performed or required for this 510(k) clearance.

Therefore, the following information is not available in the provided text:

• Sample sized used for the test set and the data provenance: Not applicable, as a clinical test set for diagnostic performance was not used.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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. This device is a surgical implant, not an AI diagnostic tool.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Explanation:

The ELEOS™ Limb Salvage System is a physical medical device (orthopedic implant) used in reconstructive surgery. The FDA's 510(k) clearance pathway often relies on demonstrating substantial equivalence to an already legally marketed predicate device. For devices like this, substantial equivalence is primarily established through:

1. Technological Characteristics Comparison: Showing that the new device has similar design, materials, and intended use as the predicate.
2. Performance Data: This typically involves bench testing (mechanical, material, biocompatibility, etc.) to ensure the device performs safely and effectively as intended and is comparable to the predicate.

The type of detailed clinical study information you're asking for (sample sizes, expert ground truth, MRMC studies, AI performance metrics) is characteristic of submissions for diagnostic devices, particularly those involving artificial intelligence or image analysis, where the "performance" is about diagnostic accuracy or reader improvement. This is not applicable to a surgical implant like the ELEOS™ Limb Salvage System in the context of this 510(k) clearance.

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