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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."

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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:

Study Details (Information NOT present in the provided text):

1. 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.
2. 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.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not present. See above.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.

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