(452 days)
Signature Orthopaedics' Evolve UniPolar Head and BiPolar Head are intended for hemilhip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head are indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as:
- · Acute femoral head or neck fracture
- · Fracture dislocation of the hip
- Avascular necrosis of the femoral head
- · Non-union of femoral neck fractures
- · Certain high subcapital and femoral neck fractures in the elderly
- · Degenerative arthritis involving only the femoral head
The BiPolar Head consists of a stainless steel outer shell (per ISO5832-9) and a UHMWPE insert (per ASTM F648). The outer shell is highly polished to articulate against the patient's natural acetabulum. The insert articulates against a Signature Orthopaedics 22 or 28mm cobalt-chrome femoral head (K121297). The femoral head connects to a femoral stem from Signature Orthopaedics' range to complete the hip hemiarthroplasty.
The provided text is a 510(k) Premarket Notification from the FDA regarding a medical device, specifically a BiPolar Head and a Femoral Head for hip hemiarthroplasty.
This document describes the device, its indications for use, and the basis for its substantial equivalence to previously cleared devices. It does not present a study proving the device meets acceptance criteria in the way an AI/ML algorithm or a diagnostic tool would be evaluated. Instead, it describes performance testing for a mechanical orthopedic implant.
Therefore, many of the requested elements for an AI/ML model acceptance criteria study are not applicable or cannot be extracted from this document, such as:
- Table of acceptance criteria and reported device performance (in the context of AI/ML metrics): The document lists performance testing but not in terms of AI metrics like sensitivity, specificity, or AUC against specific thresholds.
- Sample size for test set and data provenance: Not applicable as this is a mechanical test rather than a data-driven model evaluation.
- Number of experts and qualifications for ground truth: Not applicable.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth: Not applicable in the AI/ML sense. "Ground truth" here refers to established engineering standards and physical performance.
- Sample size for training set/how ground truth for training set was established: Not applicable.
What can be extracted or inferred regarding "acceptance criteria" and "study" for this device:
1. Acceptance Criteria and Reported Device Performance (Mechanical Testing Context):
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Bacterial Endotoxin Levels | Evaluated on the finished form using the LAL method. Implies meeting regulatory limits for endotoxins. |
| Range of Motion Analysis | Conducted to verify adequate performance for anticipated in-vivo use. (Specific values not provided, but implicitly met if cleared). |
| Component Connection Strength and Fretting Corrosion Testing | Conducted to verify adequate performance for anticipated in-vivo use. (Specific values not provided, but implicitly met if cleared). |
| BiPolar Head Disclamping Resistance Testing | Conducted to verify adequate performance for anticipated in-vivo use. (Specific values not provided, but implicitly met if cleared). |
Note: The document states these tests were conducted to "verify that the performance of the 40-42mm BiPolar Heads are adequate for anticipated in-vivo use." The exact acceptance thresholds (e.g., minimum torque, maximum fretting, specific range of motion degrees) are not detailed in this FDA letter, but presumably, they were defined by the manufacturer based on relevant ASTM/ISO standards and validated as part of their submission.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The testing would involve a physical sample of the manufactured devices. The number of units tested for each specific performance criterion (e.g., how many heads for disclamping resistance) is not provided in this summary.
- Data Provenance: Not applicable in the geographic data sense. This involves non-clinical testing and engineering evaluations of physical devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable in the context of expert review of images/data for ground truth. This is engineering-based performance testing. The "experts" would be the engineers, technicians, and quality control personnel performing and interpreting the mechanical tests according to established standards.
4. Adjudication Method for the Test Set:
- Not applicable. This is not a human reader study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No, this is not applicable to a mechanical medical device submission of this nature.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:
- Not applicable. This is not an algorithm.
7. The Type of Ground Truth Used:
- In the context of a mechanical device, "ground truth" is defined by established engineering standards, material specifications (e.g., ISO5832-9 for stainless steel, ASTM F648 for UHMWPE), and validated test methods (e.g., for range of motion, connection strength, disclamping resistance). The performance of the device is measured against these objective physical and mechanical criteria.
8. The Sample Size for the Training Set:
- Not applicable. There is no "training set" in the context of an AI/ML model for this mechanical device.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable given the non-AI/ML nature of the product and testing described.
§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.