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MicroPort total hip systems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
2. inflammatory degenerative joint disease such as rheumatoid arthritis;
3. correction of functional deformity; and,
4. revision procedures where other treatments or devices have failed
   The MicroPort total hip systems devices are single use only devices.

The subject devices are a variety of hip joint replacement prostheses. The components for these systems include an acetabular shell, acetabular liner, fixation screws, femoral head, femoral stem, modular neck, proximal body, centralizers, bone plugs, and neck sleeves. These components can be utilized in a variety of configurations to assemble the final construct. The femoral and acetabular components are manufactured from a variety of materials which include cobalt-chromium-molybdenum alloy, titanium alloy, unalloyed titanium, alumina ceramic, Alumina Matrix Composite ceramic (Biolox Delta), polymethylmethacrylate (PMMA), and ultra high molecular weight polyethylene (UHMWPE), all of which conform to ASTM or ISO standards, or internal standards. The only changes to the subject hip systems are updates to the labeling of the devices. Specifically, the package inserts and package labels are being updated to include MR Conditional language and symbols. The subjects are identical to the predicates in all aspects except for the labeling updates.

The information provided is about the MicroPort Orthopedics Inc. Hip Systems MR Labeling, which involves updating the labeling of existing hip systems to include MR Conditional language and symbols. This submission is for a labeling change and not for a new medical device or a change in the device's fundamental design or intended use.

Here's an analysis of the acceptance criteria and study information based on the provided document:

1. A table of acceptance criteria and the reported device performance

Since this submission is a labeling change for existing predicate devices to include MR Conditional language and symbols, the "acceptance criteria" and "reported device performance" are related to satisfying the requirements for safe use in an MR environment. The performance is documented through non-clinical testing.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not explicitly state a numerical "sample size" for the test set or the "country of origin of the data." It mentions that "worst case components and constructs" were evaluated for non-clinical testing.

The data provenance is non-clinical testing, performed according to recognized ASTM standards (F2052-6, F2119-7, F2503-13, F2182-11a) and FDA guidance documents. This type of testing is generally performed in a controlled laboratory environment. It is not "retrospective or prospective" in the sense of clinical patient data.

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 information is not provided in the document. For non-clinical testing of MR compatibility, "ground truth" is typically established by adhering to standardized testing protocols and measurement methodologies, rather than expert consensus on patient data. The experts involved would be engineers and scientists specialized in MR safety testing.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable or not provided. Adjudication methods like "2+1" or "3+1" are relevant for clinical studies where multiple human readers interpret medical images and their interpretations need to be reconciled to establish a consensus ground truth. This submission is based on non-clinical, objective laboratory testing for MR safety and compatibility, not human interpretation of images.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is not for an AI device but for a labeling change for hip implant systems to ensure their safety and compatibility in an MR environment. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this submission.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

No, a standalone (algorithm only) performance study was not done. This submission is for mechanical implants and their MR compatibility, not for a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this submission's non-clinical testing is based on objective measurements and adherence to recognized industry standards (ASTM standards) for MR safety and compatibility. This includes physical measurements of magnetic field interaction, temperature changes due to RF heating, and visual/quantitative assessment of image artifacts in controlled laboratory settings. It's not based on expert consensus of clinical data, pathology, or outcomes data.

8. The sample size for the training set

Not applicable. This submission is for a labeling change for existing mechanical hip implant systems, not for a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As a non-AI device submission for labeling changes, there is no training set or ground truth in that context.

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