(266 days)
The CPT Hip System is indicated for cemented use in:
- Patients suffering from severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur.
- Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis.
- Patients suffering from disability due to previous fusion.
- Patients with previously failed endoprostheses and/or total hip components in the affected extremity.
- Patients with acute femoral neck fractures.
The CPT (Collarless Polished Taper) Hip System is designed for cement fixation into the intramedullary canal for pathological or degenerative conditions involving the femur that merit total hip arthroplasty.
This document is a 510(k) premarket notification for the CPT Hip System, a medical device for cemented hip arthroplasty. The submission claims substantial equivalence to previously marketed predicate devices.
Here's the breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present "acceptance criteria" in the typical sense of quantitative benchmarks, but rather demonstrates substantial equivalence to predicate devices through various non-clinical tests. The "reported device performance" refers to the results of these tests, which support the claim of substantial equivalence.
| Acceptance Criteria Category (Implied) | Specific Tests Performed and Reported Performance (Supporting Substantial Equivalence) |
|---|---|
| Intended Use | Identical to predicates |
| Indications for Use | Substantially equivalent to predicates. The listed indications (severe hip pain due to various arthritis types, avascular necrosis, nonunion of fractures, congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, disability from previous fusion, failed endoprostheses, acute femoral neck fractures) align with the predicates. |
| Materials | Identical to predicates |
| Design Features | Substantially equivalent to predicates |
| Sterilization | Identical to predicates |
| Mechanical Performance | Non-Clinical Tests: |
- Proximal fatigue testing per internal requirements
- Distal fatigue testing per internal requirements
- Finite Element Analysis for worst-case proximal fatigue strength per ISO 7206-6
- Finite Element Analysis for worst-case in distal fatigue per ISO 7206-4
- Range of Motion analysis per ISO 21535 and internal requirements
- Fretting/Corrosion testing per ASTM F1875
- Anatomic fatigue testing and accelerated corrosion fatigue testing per internal requirements
- Load to failure, insertion force, and stem subsidence testing for distal stem centralizers.
(The implicit performance is that these tests demonstrated safety and functionality comparable to the predicate devices). |
| Clinical Performance | No clinical test data provided; reliance on substantial equivalence to predicates as the basis for safety and effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "Clinical test data is not provided for the subject device." Therefore, there is no clinical test set, sample size, or patient data provenance to report. The evaluation is based on non-clinical (bench) testing and comparison to predicate devices.
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)
Not applicable. As no clinical test data was provided, there was no need for experts to establish ground truth for a clinical test set. The ground truth for the substantial equivalence claim relies on the established performance and safety profiles of the predicate devices and the non-clinical engineering tests conducted on the subject device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Without a clinical test set requiring human interpretation of data, there is no adjudication method implemented or described.
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 submission for a hip prosthesis, not an AI-powered diagnostic or assistive device. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (hip prosthesis), not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the purpose of this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is established through:
- Engineering specifications and regulatory standards: The non-clinical tests (e.g., fatigue testing, FEA, ROM analysis, fretting/corrosion) are evaluated against established internal requirements, ISO standards (ISO 7206-6, ISO 7206-4, ISO 21535), and ASTM standards (ASTM F1875).
- Performance of legally marketed predicate devices: The "ground truth" for the subject device's safety and effectiveness is largely benchmarked against the known performance and safety profiles of the already cleared predicate devices (K960658 COLLARLESS POLISHED TAPER HIP PROSTHESIS and K030265 CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00), to which it claims substantial equivalence.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
§ 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.