UHR Bipolar:
· Femoral head/neck fractures or non-unions.
· Aseptic necrosis of the femoral head.
· Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.
Other Considerations:
· Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
• Salvage of failed total hip arthroplasty.
Restoration GAP II Acetabular Shell:
· Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatic arthritis or late stage avascular necrosis.
· Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
· Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
· Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
· Segmental and/or cavitary acetabular defects which make it difficult to restore normal hip biomechanics or to reconstitute the normal structural continuity and integrity of the acetabulum, using standard total hip replacement acetabular components and procedures.
The devices covered by this submission are Stryker Hip System components:
- UHR Bipolar femoral head
- Restoration GAP II Acetabular Shell
These devices have been previously determined substantially equivalent in prior 510(k) submissions and are commercially available.
The purpose of this submission is to modify the labeling of these Stryker Hip System components to add MR Conditional labeling.
This document is a 510(k) summary for medical devices (UHR Bipolar Implants and Restoration GAP II Implants) and focuses on the modification of labeling to include MR Conditional information. It does not describe an AI medical device or a study involving human readers or ground truth determination in the context one would typically find for AI/diagnostic devices.
Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, expert qualifications, and study designs are not applicable to the content of this document.
Here's an attempt to answer the questions based only on the provided text, highlighting what is not applicable:
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Table of acceptance criteria and the reported device performance
This document is a 510(k) submission for an existing medical device, primarily focused on updating labeling to include MR Conditional information. It does not describe performance metrics in the way an AI diagnostic device would (e.g., sensitivity, specificity). The "acceptance criteria" here are related to proving safety in an MR environment.
Acceptance Criteria (for MR Safety) Reported Device Performance (Compliance) Magnetically Induced Displacement Force (per ASTM F2052-15) Tests performed, results indicate MR Conditional status is appropriate Magnetically Induced Torque (per ASTM F2213-17) Tests performed, results indicate MR Conditional status is appropriate Image Artifact (per ASTM F2119-07) Tests performed, results indicate MR Conditional status is appropriate Heating by RF Fields (per ASTM F2182-19) Tests performed, results indicate MR Conditional status is appropriate Note: The document states "The labeling has been modified to include the MR conditional symbol, and to provide the parameters under which a patient who has the device can be safely scanned," implying that the devices met the acceptance criteria for the MR safety tests performed.
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Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This document describes non-clinical laboratory testing on the device itself for MR compatibility. It does not involve a "test set" of patient data or clinical images. Therefore, questions of sample size for a test set, country of origin, or retrospective/prospective nature are not applicable. The tests were performed on the device components.
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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. No "ground truth" establishment by experts is described as this is non-clinical device testing, not a diagnostic or AI performance study.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No "test set" of cases or adjudication of expert opinions is described.
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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 not a study involving human readers or AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document does not describe an algorithm or AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" in this context is the physical properties and behavior of the device components under MR conditions, as measured by standardized tests (e.g., compliance with ASTM standards).
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The sample size for the training set
Not applicable. There is no training set mentioned as this is not an AI/machine learning device.
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How the ground truth for the training set was established
Not applicable. There is no training set and therefore no ground truth described for a training set.
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.