(148 days)
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:
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Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli. and painful hip dysplasia;
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Inflammatory degenerative joint disease such as rheumatoid arthritis;
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Correction of functional deformity
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Revision procedures where other treatments or devices have failed; and,
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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:
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Patients suffering from severe arthropathy of the hip that does not respond to any conservative therapy or better alternative surgical treatment;
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Surgical intervention for severe trauma, revision hip arthroplasties, and/or Oncology indications.
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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:
- Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
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- Inflammatory degenerative joint disease including rheumatoid arthritis;
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- Correction of functional deformity;
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- Revision procedures where other treatments or devices have failed; and
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- 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:
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Patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment;
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Surgical intervention for severe trauma. revision knee arthroplasties, and/or Oncology indications.
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- 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, 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, patella. stem extension, 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) seeking FDA clearance based on substantial equivalence to a predicate device. It does not describe a study involving acceptance criteria for a device's performance in the context of an AI/algorithm-driven system. Therefore, I cannot extract the information required to answer your questions as they pertain to AI/algorithm performance studies.
The document states:
- "No performance data is provided." (Page 7, Section VII. Performance Data)
- "A copy of the full 510(k) for the predicate device (K013035) is provided because there are no technological differences between the subject and predicate devices." (Page 7, Section VII. Performance Data)
- The conclusion is based on the subject device being "identical with respect to fit, form, function and manufacturing processes as the predicate device" (Page 7, Section VIII. Conclusions).
This indicates that the clearance for the ELEOS Limb Salvage System was based on demonstrating substantial equivalence to a previously cleared device, not on independent performance testing against specific acceptance criteria for a new, AI-driven functionality.
Therefore, questions about acceptance criteria, reported device performance, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information are not applicable to this document.
§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.