(238 days)
The Libertas™ Hip Replacement System is intended for use in total hip arthroplasty. Total hip arthroplasty is intended to provide patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to fix and support the components.
Total hip replacement is indicated for the following conditions:
- · Non-inflammatory degenerative joint diseases including osteoarthritis, post traumatic arthritis and avascular necrosis.
- · Rheumatoid arthritis.
- · Congenital hip dysplasia.
- · Acute traumatic fracture of the femoral head or neck.
- · Certain cases of Ankylosis.
- Dislocation of the hip.
- · Correction of functional deformity.
- · Revision of failed joint reconstruction or treatment.
- · Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur.
NOTE:
- · The Modular Shell, Uncemented Stem and Taper uncemented stem are intended for press-fit, uncemented use only.
- · The Cemented stem is intended for cemented use only.
The Libertas™ - Taper uncemented femoral stem is fabricated from Ti6Al4V - ELI (Titanium-6Aluminum-4Vanadium Extra Low Interstitial) and it is intended to be used with Libertas Femoral heads, previously cleared under K180973. The proximal portion of stem is coated with commercially pure Titanium with plasma spray method. Libertas™ - Taper uncemented femoral stem is available in two designs (Standard i.e. full profile design and distally reduced design is available in different sizes with three neck angles (132° Standard, 132° Lateral, and 128° Standard).
The provided text is a 510(k) summary for the Libertas™ - Taper Uncemented Femoral Stem, a medical device used in hip arthroplasty. This document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical performance testing.
It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device, which would typically involve clinical performance metrics like sensitivity, specificity, or reader studies. The document describes mechanical and material testing for an orthopedic implant.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving those criteria are met, as the provided text pertains to a different type of medical device (a mechanical implant) and a different regulatory pathway (510(k) for substantial equivalence based on physical and material properties, not AI/ML performance).
To answer your prompt, imagine the prompt was for an AI/ML medical device submission. Here's how I would structure the answer if the provided text contained the relevant information for an AI/ML device:
Hypothetical Answer (if the provided text were about an AI/ML medical device):
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Metric) | Threshold/Target | Reported Device Performance | Outcome |
|---|---|---|---|
| Standalone Performance | |||
| Sensitivity for Condition X | ≥ 90% | 92.5% | Met |
| Specificity for Condition X | ≥ 85% | 88.2% | Met |
| AUC for Condition Y | ≥ 0.90 | 0.915 | Met |
| Human-in-the-Loop Performance (Reader Study) | |||
| Average Sensitivity (Reader + AI) vs. (Reader Only) | Improvement ≥ 5% | 7.2% improvement | Met |
| False Positive Rate (Reader + AI) vs. (Reader Only) | Reduction ≥ 10% | 12.1% reduction | Met |
| Inter-reader Agreement (Kappa) with AI assistance | Increase of ≥ 0.1 | Increase of 0.15 | Met |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: [Number, e.g., 500 cases]
- Data Provenance: [e.g., Retrospective cohort from hospitals in the USA and Europe]
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: [e.g., 3]
- Qualifications: [e.g., Board-certified radiologists with 10-15 years of experience specializing in [relevant specialty, e.g., musculoskeletal imaging]]
4. Adjudication Method for the Test Set
- Method: [e.g., 2+1 adjudication, where two experts independently labeled cases, and a third, senior expert resolved any disagreements. Or, consensus reading by all three experts.]
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.
- Was an MRMC study done? [Yes/No]
- Effect Size (if Yes): [e.g., Human readers showed an average improvement of 7.2% in sensitivity and a 12.1% reduction in false positives when assisted by the AI compared to reading without AI assistance. This translate to a statistically significant improvement in AUC of 0.05 (p
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.