(140 days)
The CATALYSTEM Femoral Stems are intended for total and partial hip arthroplasty in skeletally mature patients for the following indications:
Hip components are indicated for individuals undergoing primary surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of degenerative joint disease or any of its composite diagnoses of osteoarthritis, avascular necrosis, and traumatic arthritis.
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, congenital dysplasia, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques, and fracture-dislocation of the hip.
The CATALYSTEM Femoral Stems are intended for use without bone cement.
The purpose of this Traditional 510(k) is to notify the FDA of our intent to market the Smith & Nephew CATALYSTEM Femoral Stems. The CATALYSTEM Femoral Stems consists of femoral stem implants intended for primary hip arthroplasty in skeletally mature patients. The CATALYSTEM Femoral Stems are provided sterile to the user via gamma irradiation.
The subject CATALYSTEM Femoral Stems are comprised of two variants: CATALYSTEM Collared and CATALYSTEM Collarless. Both variants are available in standard and high neck offset options. The CATALYSTEM Femoral Stems are non-cemented femoral hip stems manufactured from forged titanium alloy and feature a CP-Ti and HA coating.
The CATALYSTEM Femoral Stems are intended to be used with Smith & Nephew femoral heads and acetabular components for total hip arthroplasty and hip hemiarthroplasty.
This document is a 510(k) summary for the CATALYSTEM Femoral Stems. It describes a medical device, specifically hip joint components, and outlines the testing and analyses conducted to demonstrate its substantial equivalence to previously marketed devices. This type of submission does not typically involve AI/ML components or studies on diagnostic performance, but rather focuses on mechanical integrity, materials, and biocompatibility.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set information is not applicable in the context of this device and submission type. The device is a physical implant, not a diagnostic software or AI product.
However, I can provide the acceptance criteria and a summary of the studies that prove the device meets these criteria based on the non-clinical testing performed, as described in the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Distal Fatigue Testing (ISO 7206-4, ASTM F2996-20) | Meets or exceeds the fatigue strength requirements for its class (implied by meeting standards) | Device met the required acceptance criteria as per the standards. |
| Neck Fatigue Testing (ISO 7206-6, ASTM F2996-20) | Meets or exceeds the fatigue strength requirements for its class (implied by meeting standards) | Device met the required acceptance criteria as per the standards. |
| Range of Motion (ROM) Evaluation (ISO 21535) | Demonstrated acceptable range of motion performance (implied by meeting standards) | Device demonstrated acceptable range of motion performance. |
| Fretting and Corrosion Performance Rationale | Acceptable fretting and corrosion characteristics (established by rationale) | Performance deemed acceptable based on engineering rationale. |
| Femoral Head Disassembly Performance Rationale | Acceptable disassembly characteristics (established by rationale) | Performance deemed acceptable based on engineering rationale. |
| HA Chemical Characterization (ASTM F1980-21, ISO 13779-2, ISO 13779-3) | Chemical composition meets specified requirements for HA coating. | HA coating's chemical characterization met specified requirements. |
| HA Static Tensile Attachment Strength Testing (ASTM F1147-05, ISO 13779-4) | Meets or exceeds specified tensile attachment strength for HA coating. | HA coating met or exceeded the required tensile attachment strength. |
| HA Static Shear Attachment Testing (ASTM F1044-05R17e01) | Meets or exceeds specified shear attachment strength for HA coating. | HA coating met or exceeded the required shear attachment strength. |
| HA Shear Fatigue Strength Testing (ASTM F1044-05R17e01, ASTM F1160-14) | Meets or exceeds specified shear fatigue strength for HA coating. | HA coating met or exceeded the required shear fatigue strength. |
| HA Dissolution Rate and Solubility Product | Acceptable dissolution rate and solubility product for HA coating. | HA coating demonstrated acceptable dissolution rate and solubility product. |
| MR Compatibility (ASTM F2182-19e2, ASTM F2052-15, ASTM F2213-2017, ASTM F2119-07) | MR Safe/Conditional as per standards. | Device evaluated as MR compatible according to the standards. |
| Biocompatibility (ISO 10993-1) | Biocompatible for its intended use and contact duration. | Device was found to be biocompatible. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each mechanical or material test. These tests typically involve a defined number of samples according to the specific ASTM or ISO standard being followed. Data provenance is implied to be from Smith & Nephew's internal testing labs or contracted testing facilities, as these are non-clinical (laboratory) studies. The data is prospective in the sense that the tests were conducted specifically to support this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. For mechanical and material testing of implants, "ground truth" is established by the specifications defined in recognized national and international standards (e.g., ISO, ASTM). The "experts" are the engineers and material scientists conducting and interpreting these standardized tests, whose qualifications are inherent in their ability to perform such tests according to regulatory requirements. No clinical expert consensus is involved in establishing the "truth" for these non-clinical tests.
4. Adjudication method for the test set
Not applicable. Mechanical and material tests follow defined methodologies in their respective standards. The results are quantitative and directly measured against pre-defined acceptance criteria, not subject to subjective adjudication.
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
Not applicable, as this is not an AI/ML-driven diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/ML-driven diagnostic device.
7. The type of ground truth used
For the non-clinical tests, the "ground truth" is based on:
- Engineering specifications and design requirements: Derived from the predicate devices and industry best practices.
- Recognized national and international standards: Such as ISO (e.g., ISO 7206, ISO 21535, ISO 10993, ISO 13779) and ASTM (e.g., ASTM F2996, ASTM F1147, ASTM F1044, ASTM F1160, ASTM F2182, ASTM F2052, ASTM F2213, ASTM F2119). These standards define acceptable performance metrics for medical devices of this type.
8. The sample size for the training set
Not applicable, as this is not an AI/ML-driven diagnostic device.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML-driven diagnostic device.
§ 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.