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The Corin Optimized Positioning System Functional Hip Analysis (OPS™ FHA) is indicated for preoperative analysis of primary total hip arthroplasty. Corin OPS™ FHA is intended to be used as a pre-operative tool which provides the Surgeon with functional acetabular cup orientations based on the patient pelvic kinematics and presents a visualisation of the patient's hemipelvis.

The Corin OPS™ FHA is intended for use with the Corin Trinity Acetabular System (K093472, K11481, K122305, K123705, K130128, K130343 and K131647) for total hip arthroplasty.

The Corin Optimized Positioning System Functional Hip Analysis (OPS™ FHA) consists of a pre-operative patient specific analysis and two patient specific reports: Functional Hip Analysis (FHA) report and Patient Specific Visualisation (PSV) report.

The Corin OPS™ FHA assists the surgeon in determining a patient specific target orientation for the acetabular cup using anatomical landmarks of the pelvis obtained from pre-operative CT scan and X-ray data and a subsequent functional pelvic kinematic analysis (FHA report), and visualisation of the patient's 3-dimensional anatomy (PSV report).

The provided text describes the Corin Optimized Positioning System Functional Hip Analysis (OPS™ FHA) and its substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study proving performance.

Here's a breakdown of what can be extracted and what is missing:

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

The document mentions a "Reproducibility and Repeatability study" was performed and that it demonstrated the process used to generate the FHA report is "reliable and repeatable." However, it does not provide specific numerical acceptance criteria or the reported performance metrics (e.g., specific values for reproducibility, repeatability, accuracy, precision).

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

The document mentions a "Reproducibility and Repeatability study" was performed but does not specify the sample size used, the country of origin of the data, or whether the data 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)

This information is not provided in the document.

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

This information is not provided in the document.

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

The document states, "Clinical testing was not necessary for this Traditional 510(k)." This implies that a MRMC comparative effectiveness study was not performed as part of this submission. The device is a pre-operative analysis tool to assist surgeons, not a diagnostic tool requiring human reader improvement comparison.

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

The "Reproducibility and Repeatability study" described likely assessed the standalone performance of the FHA report generation process. However, specific metrics of this standalone performance are not provided.

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

The document describes the device as providing "functional acetabular cup orientations based on the patient pelvic kinematics." The ground truth for the reproducibility and repeatability study would presumably relate to the consistency of these calculated orientations, but the specific method of establishing "ground truth" (e.g., comparing to a gold standard measurement, or internal consistency checks) is not detailed.

8. The sample size for the training set

The document describes the device as being substantially equivalent to a predicate and mentions "non-clinical testing" including a reproducibility and repeatability study. It does not provide information about a training set size, which is typically relevant for machine learning or AI-based devices. The OPS™ FHA seems to be based on anatomical landmark analysis and kinematic modeling rather than a deep learning model trained on a large dataset.

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

Since information regarding a training set is not provided, how its ground truth was established is also not available in the document.

Summary of available information regarding acceptance criteria and study:

• Study Type: Reproducibility and Repeatability study.
• Purpose: To demonstrate that the process used to generate the FHA report is reliable and repeatable.
• Outcome (general): The study demonstrated reliability and repeatability.
• Clinical Testing: Not deemed necessary for this 510(k).

Missing Information:

• Specific numerical acceptance criteria.
• Detailed reported device performance metrics/values.
• Sample size for the reproducibility and repeatability study.
• Data provenance for the study (country, retrospective/prospective).
• Number and qualifications of experts involved in any ground truth establishment.
• Adjudication method.
• Specific details on how "ground truth" was established for the non-clinical study.
• Information on training set size or ground truth establishment for a training set.

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