(57 days)
The ELEOS™ Limb Salvage System is indicated for resection and replacement of the proximal femur; intercalary portion of the femur, total femur, distal femur, and proximal tibia 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.
The ELEOS Limb Salvage System is also indicated for procedures where resection and replacement of the proximal femur, intercalary portion of the femur, distal femur, and proximal tibia is required with the following conditions:
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Patients suffering from severe arthropathy of the hip and/or knee that does not respond to any conservative therapy or better alternative surgical treatment;
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Surgical intervention for severe trauma, revision hip or 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 are proximal femur, intercalary portion of the femur, distal femur, total femur, proximal tibia, and hinged knee. The ELEOS Limb Salvage components are femoral head, proximal femur, female stem, mid-section, segmental stem, distal femur, tibial hinge assembly, axial pin, tibial poly spacer, tibial baseplate, male-male mid section, resurfacing femur, proximal tibia, patella, stem extension, and tibial wedges and augments. Instrumentation is provided non-sterile in surgical trays which are to be re-processed per validated instructions.
The provided text is a 510(k) Summary for a medical device called the ELEOS™ Limb Salvage System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics like sensitivity, specificity, or accuracy.
Therefore, many of the requested details about acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment are not applicable or available in this type of submission.
Here's an analysis of the available information:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The 510(k) summary focuses on demonstrating substantial equivalence through a risk-based evaluation and comparison of technological characteristics, rather than reporting specific performance metrics against pre-defined acceptance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. As no new performance testing was required (see point 5.7), there was no "test set" in the context of typical AI/software performance studies. The evaluation was based on a risk assessment and comparison to existing predicate devices.
3. 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)
This information is not provided. Since no new performance testing with a ground truth was conducted, this is not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Not applicable for the reasons stated above.
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 provided. An MRMC comparative effectiveness study is not mentioned. The device is a "Limb Salvage System" (a physical implantable medical device), not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. This concept is not applicable as the device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided. Not applicable for the reasons stated above.
8. The sample size for the training set
This information is not provided. The device is an orthopedic implant, not an AI model that requires a "training set."
9. How the ground truth for the training set was established
This information is not provided. Not applicable as there is no training set for this type of device.
Summary of what is provided regarding the "study" for substantial equivalence:
- Device: ELEOS™ Limb Salvage System (K211677)
- Purpose of Submission: To add a new indication for use (intercalary replacement) to the existing ELEOS™ Limb Salvage System, consistent with the predicate DePuy LPS System, and to introduce a female stem component.
- Predicate Devices:
- Method of "Proof":
- Technological Characteristics Comparison: The submission compares the technological characteristics of the subject device (including the new female stem) to the predicate devices. It notes that the design of the female stem utilizes the same material, segmental taper, cement flutes, and length as the primary predicate.
- Risk-Based Evaluation: A risk-based evaluation determined that the addition of the female stem for intercalary replacement does not raise new concerns with respect to safety and/or effectiveness.
- Conclusion of Risk Evaluation: This evaluation demonstrated "no new or increased risks related to loosening, subsidence, fatigue, dissociation, and/or fretting corrosion compared to the primary predicate device."
- Performance Data: "additional performance testing was not required to support this submission" because the risk-based evaluation showed no new concerns.
- Clinical Data: "Clinical data was not deemed necessary for the subject device."
- Overall Conclusion (5.9): Based on the comparisons and risk assessment, the subject device is deemed substantially equivalent to the primary predicate and predicate devices, implying that any differences do not raise new questions of safety and effectiveness, and the proposed device is at least as safe and effective as the legally marketed predicate devices.
In essence, the "study" here is a design comparison and risk assessment against an already cleared device, demonstrating that the modifications (new indication and component) do not introduce new safety or effectiveness risks compared to the predicate devices. It relies on the prior clearance information of the predicate devices.
§ 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.