(25 days)
The Klassic HD™ Hip System is intended for prosthetic replacement without bone cement in treatment of the following:
- . Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis, osteoarthritis, ankylosis, protrusio acetabuli and painful hip dysplasia.
- Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis. ●
- Those patients with failed previous surgery where pain, deformity, or dysfunction ● persists.
- Revision of a previously failed hip arthroplasty.
- Patients who require a total hip replacement.
The Klassic HD™ Hip System employs a prosthesis designed to help surgeons restore hip joint biomechanics intraoperatively by independently addressing the size of the femur and acetabulum, leg length, offset and version. The Klassic HD™ Hip System can be mated with metal (CoCrMo) or ceramic femoral heads and UHMWPE acetabular components.
This document is a 510(k) summary for a medical device called the "Klassic HD™ Hip System." It describes the device, its intended use, and the testing conducted to demonstrate its substantial equivalence to a previously cleared device. However, it does NOT include the specific details needed to answer most of your detailed questions about acceptance criteria and study particulars for a standalone AI algorithm.
This document pertains to a physical orthopedic implant (hip system), not software, AI, or an imaging device. Therefore, many of your questions about AI study design, such as sample size for test/training sets, expert adjudication, MRMC studies, and ground truth types like pathology or outcomes data, are not applicable in this context.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (General Description) | Reported Device Performance (General Description) |
|---|---|
| Pre-determined acceptance criteria identified in the Design Control Activities Summary for burst strength, fatigue, post-fatigue burst strength, and pull-off testing. (Specific numerical/statistical criteria are not provided in this document). | The test results demonstrate that the pre-determined acceptance criteria... were met. (Specific numerical/statistical results are not provided in this document). |
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 document only mentions "the company performed burst strength testing, fatigue testing, post-fatigue burst strength testing and pull-off testing." It does not state how many units were tested for each.
- Data Provenance: Not applicable in the context of device performance testing. These are material/mechanical tests, not patient data trials.
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 question is not applicable. The "ground truth" here refers to the physical properties and mechanical performance of the femoral heads. These are established through standardized engineering tests, not expert consensus or clinical evaluation in the way an AI algorithm's ground truth would be.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This question is not applicable. Adjudication methods are relevant for subjective assessments or when multiple human readers interpret data. For mechanical testing, the "ground truth" is typically the measured value against a pre-defined engineering specification.
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 question is not applicable. This document describes the testing of a physical hip implant component, not an AI or imaging device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. The device is a physical hip system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" here is based on engineering specifications and measurements from mechanical testing (burst strength, fatigue, post-fatigue burst strength, and pull-off testing). This is not expert consensus, pathology, or outcomes data.
8. The sample size for the training set:
- This question is not applicable. There is no training set for a physical device being evaluated through mechanical testing.
9. How the ground truth for the training set was established:
- This question is not applicable. There is no training set mentioned in this document.
In summary: This 510(k) pertains to a physical medical device (hip implant) and its mechanical properties. The provided text outlines that mechanical tests were performed to demonstrate substantial equivalence, and those tests met pre-determined acceptance criteria. However, it lacks the specific numerical results of those tests and the detailed methodologies that would be required to answer questions typically asked about AI/software device studies.
§ 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.