(29 days)
Non-cemented total joint replacement in cases of:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- Correction of functional deformity
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
- Revision of previously failed total hip arthroplasty
The X-Series Integral® femoral components are identical to the predicate Integral® femoral components in overall geometry. Both device series are manufactured from titanium alloy (Ti-6AI-4V) conforming to ASTM F-620. Additional stem diameters and lengths have been added to the product line. The insertion hole has been moved medially by 6mm.
The provided text describes a 510(k) premarket notification for a medical device, the X-Series Integral® Hip Femoral Components.
Here's an analysis of the acceptance criteria and the study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: Device design changes will not affect safety. | Non-Clinical Testing: Finite Element Analysis and engineering analysis were conducted to insure the design changes would not affect the safety of the device. |
| Effectiveness: Similar to or identical to predicate device in technological characteristics (materials, design, sizing and indications). | Summary of Technologies: The technological characteristics (materials, design, sizing and indications) of the X-Series Integral® femoral components are similar to or identical to the predicate device [Integral® Hip Femoral Component (K984296)]. |
Note: This submission primarily relies on demonstrating substantial equivalence to a predicate device rather than establishing new acceptance criteria based on novel performance targets. The "acceptance criteria" here are implicitly met by showing that the new device's changes (additional stem diameters and lengths, moved insertion hole) do not negatively impact safety or effectiveness when compared to the legally marketed predicate.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. No clinical testing with human subjects or a dedicated test set for performance evaluation was conducted.
- Data Provenance: Not applicable. The testing was non-clinical (Finite Element Analysis and engineering analysis).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. Ground truth was established through engineering analysis and Finite Element Analysis, not expert human review of a test set.
- Qualifications of Experts: Not specified, but would typically be biomedical engineers or similar professionals with expertise in biomechanics and materials science.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No human review test set was used.
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
- MRMC Study: No. This device is a hip 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
- Standalone Performance: Not applicable. This is a physical medical device (hip implant), not an algorithm. The "non-clinical testing" (Finite Element Analysis and engineering analysis) can be considered a form of standalone evaluation of the device's structural integrity and performance under simulated conditions.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this submission is implicitly based on the established safety and effectiveness profile of the predicate device (Integral® Hip Femoral Component, K984296). For the design changes, the "ground truth" for the non-clinical tests would be the established principles of biomechanics, material science, and engineering standards (e.g., ASTM F-620 for titanium alloy). The analyses aimed to demonstrate that the changes did not deviate negatively from these established principles or the performance of the predicate.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. No machine learning training set was used. The "training" for this device's development comes from established engineering design principles and the manufacturing history of similar devices.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable. As there was no machine learning training set, there was no ground truth to establish for it in this context. The underlying knowledge base for the device design and non-clinical testing is derived from established engineering principles, material science, and regulatory standards for orthopedic implants.
Summary of the Study:
The study proving the device meets its "acceptance criteria" (which in this 510(k) context means proving substantial equivalence and non-inferiority regarding design changes) was entirely non-clinical.
- It consisted of Finite Element Analysis (FEA) and engineering analysis.
- These analyses aimed to insure the design changes would not affect the safety of the device, specifically the added stem diameters and lengths, and the 6mm medial repositioning of the insertion hole.
- The comparison was implicitly made against the established performance characteristics and safety profile of the predicate device, the Integral® Hip Femoral Component (K984296).
- No clinical testing (human trials) was provided or required for this 510(k) submission, as the changes were minor and substantial equivalence could be demonstrated non-clinically.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.