(59 days)
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:
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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
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;
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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 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, proximal femur, mid-section, stem, distal hinge femur, tibial hinge assembly, axial pin, tibial poly spacer, tibial sleeve, male-male mid-section, resurfacing hinge femur, and proximal tibia, patella, stem extension, modular collar, tibial wedges and augments.
The ELEOS™ Limb Salvage System with BIOGRIP™ did not have specific quantitative acceptance criteria for performance metrics in a clinical or AI-assisted context. The substantial equivalence determination was based on demonstrating the safety and effectiveness of the device through biocompatibility and mechanical testing, comparing it to a predicate device.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993 standards and FDA guidance for: |
- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic Toxicity
- Material Mediated Pyrogenicity
- Genotoxicity
- Chemical Characterization
- Toxicological Risk Assessment
- Endotoxin limit of 20 EU/device | "Testing was successfully performed, and it was confirmed that the subject devices meet the 20 EU/device testing limit for general medical devices that are implanted."
"The following biocompatibility tests were performed on each material group to ensure biocompatibility." (Implies successful completion for all listed tests). |
| Mechanical Performance | Equivalence to predicate device based on bench tests per FDA guidance and ASTM/ISO standards: - Shear Testing of Coatings (ASTM F1044)
- Tension Testing of Coatings (ASTM F1147)
- Shear and Bending Fatigue Testing of Coatings (ASTM F1160)
- Stereological Evaluation of Porous Coatings (ASTM F1854)
- Abrasion Resistance (ASTM F1978)
- Knee Replacement Prosthesis Specification (ASTM F2083)
- Plasma sprayed unalloyed titanium coatings (ISO13179-1:2014) | "The following bench testing was completed and the results of support the subject devices are equivalent to the predicate device." (Implies successful demonstration of equivalence across all listed tests). |
| Design Validation | Function as intended and user needs met. | "Design Validation demonstrated the subject implant and existing instruments function as intended and user needs were met." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of clinical testing with human subjects. The testing was primarily bench testing (biocompatibility and mechanical) and a cadaver lab for design validation. The document does not specify the number of individual test articles or specimens used in the bench tests, only the types of tests performed.
- Data Provenance: The biocompatibility and mechanical testing were conducted in a laboratory setting (bench tests), not from patient data. The design validation used a cadaver lab.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable as the study did not involve human experts establishing ground truth on a test set (e.g., image interpretation for an AI device). The "ground truth" for the performance aspects was established through standardized laboratory testing protocols and design validation in a cadaver lab.
4. Adjudication Method for the Test Set (e.g., 2+1, 3+1, none)
- Not applicable. There was no expert adjudication process for a test set as the evaluation was based on laboratory testing and functional assessment in a cadaver lab rather than diagnostic interpretation.
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
- No, an MRMC comparative effectiveness study was not done. This device is a medical implant, 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
- Not applicable. This device is a physical medical implant (Limb Salvage System), not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for demonstrating the device's acceptable performance was based on:
- Validated laboratory testing standards (ISO and ASTM for biocompatibility and mechanical properties)
- Direct functional assessment in a cadaver lab for design validation.
- Comparison to a legally marketed predicate device to establish substantial equivalence.
8. The Sample Size for the Training Set
- Not applicable. This document describes the clearance of a medical device (implant), not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there was no AI algorithm or training set, there was no ground truth for a training set to be established.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.