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Joint replacement is indicated for patients suffering from disability due to:

• · noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
• rheumatoid arthritis:
• · correction of functional deformity;
• · femoral fracture.

This device may also be indicated in the salvage of previously failed surgical attempts.

This device is indicated for cementless use.

The DJO Acetabular System allows for the total replacement of the acetabulum. The system consists of porous coated titanium acetabular cups, bone screws for use with the cups, and acetabular liners manufactured from highly crossed linked polyethylene with Vitamin E. It is designed for compatibility with currently cleared DJO stems and femoral heads.

This looks like a 510(k) summary for a medical device that does not involve AI. Therefore, most of the questions about acceptance criteria, study design, ground truth, and expert involvement are not applicable in the context of AI/ML devices.

Here's a breakdown based on the provided document:

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

The provided document describes a traditional medical device (hip implant) and does not specify quantitative acceptance criteria in the way you would expect for an AI/ML device (e.g., sensitivity, specificity thresholds). Instead, the acceptance criteria are implicitly that the device performs equivalently to the predicates in non-clinical mechanical testing.

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

This device clearance did not involve clinical testing as stated: "Clinical Testing: Clinical testing was not required". Therefore, there is no "test set" of patient data in the context of an AI/ML study. The "testing" referred to is mechanical testing of the physical device components. The document does not specify sample sizes for these mechanical tests, nor is data provenance (country, retrospective/prospective) relevant here.

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)

Not applicable, as no clinical testing or AI/ML ground truth was established by experts.

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

Not applicable, as no clinical testing or AI/ML ground truth was established.

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

Not applicable. This is a physical hip implant device, not an AI/ML diagnostic or assistive tool.

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

Not applicable. There is no algorithm.

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

Not applicable. For mechanical testing, the "ground truth" is typically defined by engineering specifications, material properties, and comparison to predicate device performance under controlled laboratory conditions, rather than clinical outcomes or expert consensus on a diagnosis.

8. The sample size for the training set

Not applicable. There is no AI/ML model to train.

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

Not applicable. There is no AI/ML model to train.

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The CER-MET™ III Acetabular Cup System is intended for uncemented use for all types of arthrosis, such as advanced destruction of the hip joint due to degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to acetabular revisions.

The CER-MET™ III Acetabular Cup System is a non-cemented acetabular cup system with a complete assortment of neutral and 10° hooded poly inserts as well as acetabular screws and screw hole covers (screw hole occluders).

Here's an analysis of the provided text regarding the CER-MET™ III Acetabular Cup System, focusing on the acceptance criteria and the study that proves the device meets them:

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

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

The provided text does not specify the sample size used for the biomechanical tests. It only states that "Biomechanical tests have been performed."

The document also does not specify the country of origin of the data or whether the study was retrospective or prospective.

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)

The provided text does not mention the use of experts to establish ground truth for the biomechanical tests. The evaluation appears to be based on physical material and design testing rather than expert interpretation.

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

The provided text does not mention any adjudication method for the test set, as the study described is biomechanical testing, not a clinical study involving human interpretation.

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

A multi-reader, multi-case (MRMC) comparative effectiveness study was not performed. This document describes the premarket notification for a medical device (acetabular cup system), which primarily relies on biomechanical testing and equivalence to predicate devices, not AI assistance or human reader performance.

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

This question is not applicable. The device described is a physical implant (acetabular cup system), not an algorithm or AI system. Therefore, standalone algorithm performance testing was not performed.

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

For the biomechanical tests, the ground truth would be established by engineering standards and established performance metrics for acetabular cups, comparing the device's performance against these predetermined benchmarks and against the performance of the identified predicate devices. It is based on physical measurements and mechanical properties, not clinical or pathological outcomes directly.

8. The sample size for the training set

This question is not applicable. The device is a physical implant and does not involve a "training set" in the context of machine learning or AI.

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

This question is not applicable for the same reason as #8.

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