(30 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 (NIDJ): 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 prostheses designed to help surgeons restore hip joint biomechanics intra-operatively. The purpose of this Special 510(k) is to add smaller sizes of the Acetabular Cups, Acetabular Inserts, and Ceramic Femoral Heads and to add both smaller and predicate sizes of Hooded and Low Profile Acetabular Inserts with XLPE material.
This document is a 510(k) Summary for the Klassic HD® Hip System, a medical device for hip replacement. It generally outlines the device's indications for use, description, predicate devices, and a statement of substantial equivalence to previously cleared devices.
However, the document does not describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the way requested in the prompt. It states that "all results met the pre-determined acceptance criteria identified in the Design Control Activities" and that the "information summarized in the Design Control Activities Summary demonstrates that the modified Klassic HD® Hip System met the pre-determined acceptance criteria for the verification activities." It also lists the types of testing performed (e.g., burst strength testing, fatigue testing, wear testing, etc.) and the relevant ISO and ASTM standards.
Crucially, the document explicitly says that the details of the acceptance criteria and the study results are "summarized in the Design Control Activities Summary," which is not provided in the input text.
Therefore, I cannot provide the specific details requested in your prompt based solely on the provided text. The document acts as a summary and refers to another internal document for the detailed evidence of compliance.
Key Missing Information:
- Specific Acceptance Criteria: The document mentions "pre-determined acceptance criteria" but does not list them.
- Reported Device Performance: While it states the device "met" the criteria, the actual performance values are not provided.
- Sample Sizes: No sample sizes are mentioned for any of the tests.
- Data Provenance: No information on the origin of data (country, retrospective/prospective).
- Experts/Ground Truth: This type of medical device (hip implant) does not typically involve "experts establishing ground truth" in the diagnostic AI sense. Its acceptance criteria relate to mechanical and material performance, not diagnostic accuracy. Therefore, questions about expert numbers, qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types are not applicable in this context.
- Training Set Sample Size/Ground Truth: Not applicable for this type of device.
What the document does state regarding testing:
- Engineering analysis and testing included: burst strength testing, fatigue testing, post-fatigue burst strength testing, pull-off testing of ceramic femoral heads (per ISO 7206-10), push-out, lever-out, axial torque disassembly (per ASTM F1820), Range of Motion (per ISO 21535), impingement testing (per ASTM F2852), and wear testing (per ISO 14242).
- LAL testing requirements: The device is in compliance with LAL testing requirements for orthopedic implants per AAMI ST-72.
- Conclusion: "all results met the pre-determined acceptance criteria identified in the Design Control Activities."
In summary, while the document confirms that testing was done and acceptance criteria were met, it does not provide the details of those criteria or the results, stating they are in the "Design Control Activities Summary."
§ 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.