(27 days)
The indications for use of the "Generation 4" Polished Femoral Hip Prosthesis 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 procedures where other treatments or devices have failed.
The "Generation 4" Polished Femoral Hip Prosthesis is intended for total hip arthroplasty, and is intended for cemented use only.
The Generation 4 Polished Femoral Hip Prosthesis is a series of implants meant to replace the patient's natural hip femoral neck and head due to disease or accident. The material is forged Co-Cr-Mo per ASTM F 799. They are designed for use with bone cement. General implant surfaces are highly polished and proximal and distal cement centralizers are offered for optimum stem placement within the canal. Stability within the cement mantle is enhanced by both a 4 mm medial collar designed to rest upon the calcar, and the bi-planer stem geometry which creates a wedge within the canal.
Implant sizing is graduated for different patient anatomies. Stem geometry is undersized to stated stem and instrument sizing so as to include a cement mantle. A trapezoidal neck design is offered on all sizes for increased range of motion. These devices accept a modular head used with associated acetabular reconstructive shells and liners. Contraindications are similar to comparable devices designed for replacement of the patient's natural hip femoral neck due to arthritic diseases or accident.
Acceptance Criteria and Study for "Generation 4" Polished Femoral Hip Prosthesis
This submission details the "Generation 4" Polished Femoral Hip Prosthesis, a femoral component for cemented use in total hip arthroplasty. The device is claimed to be substantially equivalent to the RX-90 Cemented Hip Prosthesis - Biomet Inc. (K023085).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study Type |
|---|---|---|---|
| Materials | Forged Co-Cr-Mo per ASTM F 799 | Manufactured from the same materials as other cleared femoral hip prostheses. | Non-Clinical Testing |
| Manufacturing Practices | Same manufacturing practices as predicate devices. | Utilizes the same manufacturing practices as other cleared femoral hip prostheses. | Non-Clinical Testing |
| Standards Conformance | Conforms to relevant ISO/ASTM standards. | "All 10 tested stems passed available ISO / ASTM as well as in house parameters." | Non-Clinical Testing |
| Biomechanical Performance | (Implied) Mechanical stability and durability for intended use (e.g., stem placement, cement mantle enhancement, range of motion). | Bi-planer stem geometry for wedge stability, 4mm medial collar for calcar rest, trapezoidal neck for increased range of motion. | Device Description (design features supporting performance) & Non-Clinical Testing (conformance to standards addresses this indirectly) |
Note: Specific quantitative acceptance criteria (e.g., minimum fatigue cycles, maximum wear rates) are not explicitly stated in the provided text for individual device performance metrics. Rather, the acceptance criteria are based on conformance to established standards and similarity to a predicate device.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 10 stems were tested.
- Data Provenance: The testing was "in house," implying that the data was generated within Biomet Orthopedics, Inc. The exact country of origin is not specified, but the applicant's address is Warsaw, Indiana, USA. The testing is non-clinical, meaning it's conducted in a laboratory setting, not on human subjects. This is a form of retrospective data in that it's performed on manufactured devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This device relied on non-clinical testing against ISO/ASTM standards and internal parameters. Therefore, no human experts were used to establish ground truth for a test set in the traditional sense of clinical opinion or diagnosis. The "ground truth" for non-clinical testing is compliance with established engineering and material standards and internal specifications, which would have been determined by engineers and material scientists. The document does not specify the number or qualifications of these internal experts.
4. Adjudication Method for the Test Set
The concept of an adjudication method (like 2+1 or 3+1) is typically applied in clinical studies where expert consensus is needed to establish a "ground truth" for patient cases. Since this study involved non-clinical, laboratory testing against predetermined standards, no adjudication method was used. The results of the mechanical tests were objectively measured against the established ISO/ASTM and internal parameters.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The submission explicitly states: "Clinical Testing: No clinical testing was necessary for determination of substantial equivalence." This type of study would involve human readers (e.g., surgeons evaluating X-rays or clinical outcomes) both with and without AI assistance, which is not relevant to this device's regulatory pathway.
6. Standalone (Algorithm Only) Performance Study
No standalone performance study of an algorithm was done. This is a medical device (hip prosthesis), not an AI algorithm. The performance evaluation was based on non-clinical, mechanical testing of the physical implant itself.
7. Type of Ground Truth Used
The ground truth used for the non-clinical testing was conformance to established ISO/ASTM standards and internal parameters for material properties and manufacturing. Specific examples mentioned are "ISO / ASTM" and "in house parameters."
8. Sample Size for the Training Set
No training set was used. This device is a physical implant, not an AI or machine learning model that requires a training set. The development of the device would have involved engineering design and testing, but not in the sense of a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
As there was no training set for an AI algorithm (as this is a physical device), this question is not applicable. The "ground truth" for the device's design and manufacturing processes would be based on established engineering principles, material science, and prior knowledge from predicate devices and industry standards.
§ 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.