(219 days)
The indications for use for the Generation 4® Polished Femoral Hip Prosthesis with Proximal Cement Spacer include:
- 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 using other techniques.
- Revision of previously failed total hip arthroplasty.
The Generation 4® Polished Femoral Hip Prosthesis with Proximal Cement Spacer is intended for cemented use only and may be used in partial and total hip arthroplasties.
The Generation 4® Polished Femoral Hip Prosthesis with Proximal Cement Spacer is designed to replace the patient's natural hip femoral neck and head damaged due to disease or accident. The femoral hip prosthesis is made from forged Co-Cr-Mo per ASTM F799, and the proximal cement spacers are made from polymethylmethacrylate (PMMA). The implants are designed for use with bone cement. General implant surfaces are highly polished. In addition to the proximal cement spacer, an optional distal cement centralizer (cleared in K942479) is available for optimum stem placement within the canal.
Here's an analysis of the provided 510(k) summary regarding acceptance criteria and supporting studies for the Generation 4® Polished Femoral Hip System with Proximal Cement Spacer:
This device is not an AI/ML powered device, hence information regarding "AI/ML" is not applicable/not found.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., specific thresholds for strength, durability, or clinical outcomes). Instead, the acceptance criteria are implicitly met through the demonstration of substantial equivalence to legally marketed predicate devices.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary of Evidence) |
|---|---|
| Substantial Equivalence to legally marketed predicate devices in: | - Materials: Manufactured from the same materials (forged Co-Cr-Mo per ASTM F799 for femoral component, PMMA for cement spacers) as other cleared femoral hip prostheses. |
| - Manufacturing Practices: Utilizes the same manufacturing practices as other cleared femoral hip prostheses. | |
| - Conforms to Standards: Conforms to the same standards as other cleared femoral hip prostheses. | |
| - Intended Use/Functionality: Non-clinical laboratory testing indicated the device was functional within its intended use. | |
| Safety and Effectiveness (demonstrated through substantial equivalence) | - No adverse safety or effectiveness concerns raised by the FDA (as indicated by 510(k) clearance). |
| Indications for Use: The stated indications for use are similar to those of predicate devices. | - The device is indicated for non-inflammatory degenerative joint disease, Rheumatoid Arthritis, correction of functional deformity, treatment of certain femoral fractures, and revision of failed total hip arthroplasty, for cemented use only. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "test set" in the context of clinical data, as no clinical testing was necessary for the determination of substantial equivalence (as stated in the "Clinical Testing" section).
- Data Provenance: The primary "data" for demonstrating substantial equivalence comes from comparisons with existing, legally marketed predicate devices, and non-clinical laboratory testing. The provenance of this non-clinical data is not detailed (e.g., country of origin, retrospective/prospective), but it would have been conducted internally or by a contracted lab.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This is not applicable as no clinical test set requiring expert ground truth establishment was used for the 510(k) submission. The FDA review process itself involves expert evaluation by agency staff, but this is distinct from experts establishing ground truth for a device's specific test set.
4. Adjudication Method for the Test Set
- This is not applicable as no clinical test set requiring adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. The submission explicitly states "No clinical testing was necessary for determination of substantial equivalence."
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
- This is not applicable as the device is a physical hip prosthesis, not an algorithm or AI-powered system.
7. The Type of Ground Truth Used
- The "ground truth" for this device, in the context of a 510(k) submission, is effectively the established safety and effectiveness of the identified predicate devices, combined with the results of non-clinical laboratory testing demonstrating the device's functional performance and equivalence in materials and manufacturing.
- Predicate Device Performance: Historical clinical performance and regulatory clearances of the predicate devices (Generation 4® Polished Femoral Hip Prosthesis, A Rx-90™ Femoral Stems, A Rx-90™ Femoral Component) serve as the primary benchmark.
- Non-Clinical Testing: Laboratory tests (e.g., mechanical testing, materials characterization) provide the ground truth for the physical and mechanical properties of the new device itself.
8. The Sample Size for the Training Set
- This is not applicable. As a physical medical device and not an AI/ML system, it does not involve a "training set" in the computational sense. The design and manufacturing processes are informed by engineering principles, material science, and the existing knowledge base from previous device designs (predicate devices).
9. How the Ground Truth for the Training Set Was Established
- This is not applicable for the reasons stated in point 8.
§ 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.