(51 days)
The system is indicated for primary or revision surgery in skeletally mature individuals for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
The system is intended for use either with or without bone cement in total hip arthroplasty.
The Longevity IT Highly Crosslinked Polyethylene Elevated Liners are intended to be used with either Continuum or Trilogy IT Acetabular components in Total Hip Arthroplasty. The liners are available in 22, 28, 32 and 36mm articulation diameters.
Here's a breakdown of the acceptance criteria and the study information for the Longevity® IT Highly Crosslinked Polyethylene Elevated Liners based on the provided text:
Lack of Specific Acceptance Criteria and Detailed Study Information:
It's important to note that the provided document is a "Summary of Safety and Effectiveness" (510(k) Premarket Notification) for a medical device. This type of document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a full study report with statistical performance metrics like sensitivity, specificity, or AUC. The document states that "Non-Clinical testing demonstrated that the Longevity IT Highly Crosslinked Polyethylene Elevated Liners met performance requirements and are as safe and effective as their predicate." This general statement is the core finding presented without delving into specific numerical acceptance criteria or granular study results.
Therefore, many of the requested details, especially those related to AI algorithm performance (like sample sizes for test/training sets, ground truth establishment for AI, expert qualifications, adjudication methods, or MRMC studies), are not applicable to this type of device and document. This is a traditional medical device (hip prosthesis liner), not an AI-powered diagnostic or predictive algorithm.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance requirements, safety, and effectiveness equivalent to predicate device for Total Hip Arthroplasty. | Non-Clinical testing demonstrated that the Longevity IT Highly Crosslinked Polyethylene Elevated Liners met performance requirements and are as safe and effective as their predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document refers to "Non-Clinical testing" which would typically involve mechanical testing, material characterization, and wear studies, not clinical patient data in the typical sense of a "test set" for an AI algorithm.
- Data Provenance: Not explicitly stated, as it pertains to non-clinical laboratory testing rather than patient data from a specific country. The device sponsor is Zimmer, Inc. from Warsaw, IN, USA.
- Retrospective or Prospective: Not applicable for non-clinical bench testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not applicable. This device is a physical implant. "Ground truth" would be established through engineering specifications, material science standards, and performance benchmarks in non-clinical testing settings, not via expert interpretation of patient data.
4. Adjudication Method for the Test Set
- Not applicable. This is a physical device, not an AI model requiring adjudication of interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, an MRMC study was not done. This is not an AI-assisted diagnostic or imaging device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
- The implicit "ground truth" for this device's performance would be established through engineering specifications, material testing standards (e.g., ISO standards for orthopaedic implants), and performance benchmarks set by the predicate device. These would typically involve measures like wear rate, mechanical strength, fatigue resistance, and biocompatibility.
8. The Sample Size for the Training Set
- Not applicable. This is a physical device, not an AI model that undergoes a "training set" process.
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
§ 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.