(24 days)
The Klassic HD® Hip System is intended for prosthetic replacement 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 prostheses designed to help surgeons restore hip joint biomechanics intra-operatively. The purpose of this Special 510(k) is to add larger sizes of the Klassic® Blade Femoral Stems and add a new material for previously cleared Klassic® Blade Femoral Stems and Klassic® Blade Offset Femoral Stems.
The provided text is a 510(k) summary for the Klassic HD® Hip System. It describes the device, its indications for use, and claims substantial equivalence to predicate devices based on design control activities. However, it does not contain the specific information required to complete the table and answer the study-related questions.
The document focuses on demonstrating substantial equivalence through design control activities and worst-case fatigue testing, rather than a clinical study measuring device performance against specific acceptance criteria in a patient population. It outlines that the "modified Klassic Blade Femoral Stems and modified Klassic® Blade Offset Femoral Stems met the pre-determined acceptance criteria for the verification activities" and that "The fatigue and characterization results demonstrated that the modified stems are substantially equivalent to the predicate components."
Therefore, I cannot extract the detailed information requested in your prompt regarding acceptance criteria, study design parameters (sample size, data provenance, expert truth, etc.), or comparative effectiveness studies.
Based on the provided text, here's what can be inferred and what is missing:
Acceptance Criteria and Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Pre-determined acceptance criteria for verification activities (specific criteria not detailed) | Modified Klassic Blade Femoral Stems and modified Klassic® Blade Offset Femoral Stems met these criteria. |
| Compliance with worst-case fatigue testing (specific thresholds not detailed) | Fatigue results demonstrated substantial equivalence. |
| Porous coating characterization (specific parameters not detailed) | Characterization results demonstrated substantial equivalence. |
| Compliance with LAL testing requirements for orthopedic implants | Klassic HD® Hip System is in compliance. |
Study Details (Information NOT present in the provided text):
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not present. The document refers to "verification activities" and "fatigue testing" but does not detail a test set of patient data, so no sample size or provenance is available.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No human expert ground truth is mentioned as this is not a study assessing diagnostic or prognostic performance of an AI/human-in-the-loop device.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not present. See above.
- 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 present. This is a hip implant, not an AI diagnostic tool. No MRMC study was conducted.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. This refers to a physical device (hip implant), not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the engineering tests would be the specific quantitative results of the fatigue and characterization tests compared against established engineering standards and predicate device performance. No patient-related ground truth (like pathology or outcomes) is mentioned.
- The sample size for the training set: Not applicable/Not present. This is a physical medical device, not an AI algorithm that requires a training set.
- How the ground truth for the training set was established: Not applicable/Not present. See above.
In summary: The provided document is a regulatory submission for a medical device (hip implant) seeking substantial equivalence, not a clinical study report for an AI/diagnostic device. As such, it details engineering tests and verification activities, but does not include the specific types of studies and data points (e.g., patient sample sizes, expert ground truth, MRMC studies) you've requested for AI device evaluations.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.