(114 days)
PROFEMUR® GLADIATOR® Thin HA Classic Stems w/ Collar are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis;
- correction of functional deformity; and,
- revision procedures where other treatments or devices have failed
Hydroxyapatite coatings applied to implant surfaces are intended for uncemented arthroplasty.
The PROFEMUR® GLADIATOR® Thin Hydroxyapatite-coated (HA) Classic Stems with Collar present a monolithic, tapered-wedge design and a reduced distal stem tip. The 'Thin' description is a relative word MicroPort uses as an internal descriptor to clearly identify the difference in product between the currently cleared US-offered HA coating thickness (65um) and the coating thickness offered in outside US (OUS) markets. The subject stems are coated with a 65um HA coating (ASTM 1185), and the uncoated medial collar, proximal shoulder and neck regions of the stem possess a glass-beaded finish (Ra=0.8μm). The subject stems possess a proximal medial collar designed to assist in discouraging subsidence and maximizing rotational stability. The proximal anterior, posterior, and medial surfaces possess grooves perpendicular to the stem's longitudinal axis and parallel with each other. The proximal grooves are designed to provide a maximized bone-stem contact surface for bone apposition and assist in discouraging stem subsidence. The distal anterior and posterior surfaces of the subject stem possess vertical grooves parallel to the stem's longitudinal axis. The distal grooves are designed to assist the stem in resisting against rotational loads. The subject classic stems possess an oval impaction feature on the proximal shoulder for stem insertion into the femoral canal. The PROFEMUR® GLADIATOR® Thin HA Classic Stems w/ Collar are designed for use in total hip arthroplasty.
The PROFEMUR® GLADIATOR® Thin HA Classic Stems w/ Collar are manufactured from forged Ti6Al4V alloy (ASTM F620) and come in 10 sizes, with the stem length ranging from 125mm to 175mm. The subject stems features two different neck options: standard (with a CCD neck angle of 135°) and extended/Varus 8° (with a CCD angle of 127°). The PROFEMUR® GLADIATOR® Thin HA Classic Stems w/ Collar were designed to accommodate a wide range of patient anatomy and to provide an optimized fit to adequately restore the biomechanics of the respective hip (including restoration of the natural leg length and head center offset).
The provided document describes a 510(k) premarket notification for a medical device (PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar) and focuses on demonstrating its substantial equivalence to previously cleared predicate devices. It does not contain information about a study that proves the device meets acceptance criteria in the context of AI/ML device performance (e.g., diagnostic accuracy, sensitivity, specificity, or human-in-the-loop performance).
Instead, the document details nonclinical testing performed on the hip stem to demonstrate its mechanical properties, safety, and equivalence to existing devices. Therefore, I cannot provide all the requested information, particularly those related to AI/ML device performance studies like sample size for test sets, data provenance, expert ground truth, MRMC studies, or standalone algorithm performance.
Here's an analysis of the information available in the document regarding "acceptance criteria" and "study" in the context of this orthopedic implant:
1. A table of acceptance criteria and the reported device performance:
The document describes various nonclinical tests and their successful completion, implying that passing these tests served as the acceptance criteria for substantial equivalence. However, it does not present a formal table with specific quantitative acceptance criteria alongside exact reported performance values from the tests. Instead, it generally states that the device "met all mechanical testing requirements" and "were successfully performed."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Endurance properties (stem endurance) per ISO 7206-4 | Testing successfully completed, met requirements. |
| Endurance properties (neck region) per ISO 7206-6 | Testing successfully completed, met requirements. |
| Specific requirements for hip-joint replacement implants per EN ISO 21535 | Testing successfully completed, met requirements. |
| Magnetic Resonance (MR) Induced Displacement Force per ASTM F2052-15 | Magnetic Resonance Imaging Safety Analysis successfully completed. |
| MR Image Artifacts per ASTM F2119-07 | Magnetic Resonance Imaging Safety Analysis successfully completed. |
| MR Radio Frequency Induced Heating per ASTM F2182-11a | Magnetic Resonance Imaging Safety Analysis successfully completed. |
| Marking Medical Devices for MR Environment per ASTM F2503-13 | Magnetic Resonance Imaging Safety Analysis successfully completed. |
| Distal Fatigue Testing | Successfully completed, met all mechanical requirements. |
| Proximal Fatigue Testing | Successfully completed, met all mechanical requirements. |
| Range of Motion Analysis | Successfully completed, met all mechanical requirements. |
| Coating Characterization of Hydroxyapatite Coating | Successfully completed. |
| Bacterial Endotoxin Limit (20 EU/device) per ANSI/AAMI ST72 and USP | Testing successfully performed, worst-case implants meet the 20 EU/device limit. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact number of hip stems or components used for each nonclinical test (e.g., how many stems were subjected to fatigue testing). It refers to "worst-case construct testing" and "worst case implants" for endotoxin testing, suggesting a representative, but unspecified, sample size.
- Data Provenance: Not applicable in this context. The "tests" are laboratory-based mechanical and biological evaluations, not clinical studies with human patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the evaluation involved nonclinical laboratory testing against pre-defined engineering standards, not expert interpretation of clinical data to establish ground truth.
4. Adjudication method for the test set:
This information is not applicable for nonclinical laboratory testing. The evaluation is based on meeting the quantitative or qualitative criteria of the respective ISO, ASTM, and EN standards.
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:
This information is not applicable. The device is a hip implant, not an AI/ML-based diagnostic or assistive technology for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a hip implant, not an AI/ML algorithm.
7. The type of ground truth used:
The "ground truth" in this context refers to the established international and national standards (e.g., ISO 7206 series, EN ISO 21535, ASTM F2052, ASTM F2119, ASTM F2182, ASTM F2503, ANSI/AAMI ST72, USP ) against which the hip stem's mechanical, safety, and material properties were evaluated. Compliance with these standards indicates acceptable performance.
8. The sample size for the training set:
This information is not applicable as the device is a physical hip implant. There is no "training set" in the context of an AI/ML algorithm.
9. How the ground truth for the training set was established:
This information is not applicable for the same reason as point 8.
§ 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.