(211 days)
The APR Hip System with Calcitite-Coated CST is indicated for noncemented use in skeletally mature individuals undergoing primary surgery for rehabilitating hips damaged as a result of Inflammatory Joint Disease (e.g., theumatoid arthritis) or Noninflammatory Degenerative Joint Disease (e.g., osteoarthritis, avascular necrosis, traumatic arthritis, fracture dislocation of the hip and femoral neck fracture).
The APR Total Hip System consists of four basic components: anatomically shaped APR II and APR II-T femoral stems. Cobalt Chrome (CoCr) and ceramic femoral heads. APR acctabular metal shells, and Ultra-High Molecular Weight Polyethyiene (UHMWPe) acetabular inserts. The porous surfaces of the femoral and acetabular components are coated with Calcitite® coating.
This is a 510(k) summary for a hip implant system, not a device that uses artificial intelligence or machine learning. Therefore, the requested information (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) related to AI/ML device performance and validation is not present in the provided text.
The document describes the APR® Hip System with Calcitite®-Coated Cancellous-Structured Titanium (CSTi), a medical device for hip replacement. It focuses on the physical components, materials, indications for use, and a few high-level performance tests.
Here's a breakdown of what is available in the text, and why the other requested information is not applicable:
1. A table of acceptance criteria and the reported device performance:
The document does not present a formal table of acceptance criteria for specific performance metrics in the way an AI/ML device validation would. Instead, it mentions general performance assessments:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Femoral Stem Durability | Fatigue analysis and stem strain gauge analysis indicated that both the APR II-T femoral stems should survive physiologic loading. |
| Acetabular Insert/Shell Fixation | Axial push-out, and lever-out testing performed on the APR acetabular insert and shell indicated that the device should perform favorably in-vivo. |
| Coating Bond Strength | Fatigue, tensile and shear test of the bond between the Calcitite-porous surface coating and the substrate indicate that the costing bond strength should be adequate for the intended use of the device. |
| Bone-Porous Coating Interface Strength | Additionally, in vivo studies showed that the interface between the bone and porqus coating exhibited strength over time. |
| Clinical Outcomes (General) | A clinical study conducted under an approved IDE showed that good to excellent clinical results can be expected in noncemented use of this prosthesis provided that stable initial fixstion can be achieved. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not specified. The clinical study is mentioned but details about patient numbers are absent.
- Data Provenance: Not specified for the clinical study. It states "A clinical study conducted under an approved IDE," which implies prospective data collection, but no country of origin is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This is not applicable as the device is a physical implant, not an AI/ML diagnostic or predictive tool that requires expert-established ground truth for image analysis or similar tasks. The "ground truth" for a hip implant is its physical and biological performance in a body, assessed through mechanical testing and clinical observation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable for a physical implant study. Adjudication methods like 2+1 are typically used in AI/ML studies where multiple human readers disagree on a diagnosis and a tie-breaker is needed.
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. This is a physical implant, not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For this type of device, the "ground truth" is implicitly related to:
- Mechanical testing results: Demonstrating physical strength, fatigue resistance, and bond integrity (e.g., "Fatigue analysis and stem strain gauge analysis," "Axial push-out, and lever-out testing," "Fatigue, tensile and shear test of the bond").
- In vivo biological observations: Demonstrating integration with bone (e.g., "in vivo studies showed that the interface between the bone and porqus coating exhibited strength over time").
- Clinical outcomes data: Patient rehabilitation status and overall clinical results (e.g., "good to excellent clinical results can be expected").
8. The sample size for the training set:
Not applicable. This is a physical implant, not an AI/ML device trained on data.
9. How the ground truth for the training set was established:
Not applicable.
§ 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.