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The Corin OPS™ Femoral is intended to be used as a patient-specific surgical instrument to assist the surgeon in delivering a target femoral neck osteotomy, based on a pre-operative plan with implant sizing, type and placement.

The Corin OPS™ Femoral is intended to be used with OPS™ Plan and compatible components. The dislocating Femoral Guide is intended for use with the posterolateral surgical approach and the in-site Ferrorel. Guide is intended for use with the direct anterior surgical approach.

The Corin OPSTM Femoral PSI is intended for single use only.

The Corin Optimized Positioning System (OPS™) Femoral consists of Femoral Patient Specific Instruments (PSI) and reusable instrumentation. The Femoral Patient Specific Instruments include a Femoral Guide and an optional Trial Femoral Head (Bone Model).

The Femoral Guide is shape-matched to the patient's femoral anatomy and provides a guide for the femoral neck osteotomy during total hip arthroplasty. The planned femoral resection, or target osteotomy, is defined by a preoperative plan (either OPS™ Plan (K171847, K183038) or OPS™ Insight (K192656)). OPS™ Plan and OPS™ Insight are pre-operative tools used by the Surgeon for the selection, sizing and placement of implant components using anatomical landmarks of the femur and pelvis identified from pre-operative CT scan and AP X-ray.

Corin OPS™ Femoral was originally cleared under K181061. The purpose of this submission is to include OPS™ Insight (K192656) to the Indications for Use as an alternative compatible component. The design and manufacturing process of the device subject of this submission is identical to that of the predicate device K181061.

OPS™ Plan was previously cleared under K171847 and K183038; OPS™ Insight (K192656) is currently under review with FDA. OPS™ Plan (K171847, K183038) and OPS™ Insight (K192656) are not submitted for review in this 510k submission.

The provided text describes a 510(k) summary for the Corin Optimized Positioning System (OPS) Femoral. A 510(k) submission is typically for demonstrating substantial equivalence to a predicate device, and it often does not require new clinical studies for acceptance criteria in the same way a Premarket Approval (PMA) would.

Based on the provided document, here's an analysis of the acceptance criteria and the study (or lack thereof) that supports the device meeting those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a tabled format, nor does it present specific performance metrics from a study that would directly map to such criteria for the current 510(k) submission. Instead, it refers to "non-clinical testing" for safety and effectiveness.

The closest we get to performance assessment is the statement in Section 13: "Testing verified that the accuracy and performance of the device is adequate to perform as intended."

Given the nature of this 510(k):

• Acceptance Criteria (Implied): The device, Corin OPS™ Femoral, should exhibit sufficient "accuracy and performance" to assist in delivering a target femoral neck osteotomy, consistent with its intended use and equivalent to the predicate device (K181061). This implicitly means it should be able to guide the surgeon accurately and reliably for the pre-planned osteotomy. The non-clinical tests would have aimed to confirm this.
• Reported Device Performance: The document only provides a qualitative summary: "Testing verified that the accuracy and performance of the device is adequate to perform as intended." No specific accuracy values (e.g., in mm or degrees) are reported in this summary. The testing included "quantitative assessments of clinical accuracy," but the results of these quantitative assessments are not provided here.

2. Sample Size Used for the Test Set and Data Provenance

The document states in Section 14: "Clinical testing was not necessary for this Traditional 510(k)." This means there was no new clinical test set (i.e., patient data) generated for this specific submission with human subjects to evaluate the device's performance in a clinical setting.

The "non-clinical testing" mentioned in Section 13 would typically involve bench testing, mechanical tests, and potentially simulations, not patient data. Therefore, details like data provenance (country of origin, retrospective/prospective) and sample size for a test set based on human data are not applicable to the studies supporting this 510(k). The validation of the device relies on its substantial equivalence to a previously cleared device for which clinical or performance data might have been presented in its original 510(k).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

Since no new clinical test set with human patients was acquired for this 510(k) submission (as stated in Section 14), there is no information provided about experts establishing ground truth for such a test set.

For the non-clinical tests (e.g., accuracy of the guide), the "ground truth" would likely be established by engineering measurements against known specifications or designs, rather than expert consensus on patient data.

4. Adjudication Method for the Test Set

Not applicable, as no new clinical test set with human data was used for direct evaluation in this 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. The document explicitly states that "Clinical testing was not necessary for this Traditional 510(k)." An MRMC study would be a type of clinical study involving human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

The device is described as a "patient-specific surgical instrument to assist the surgeon". It is a physical guide, not an AI algorithm. Therefore, the concept of a "standalone" algorithm performance is not applicable. The core function relates to its physical accuracy and fit for guiding the osteotomy, which was assessed through "non-clinical testing."

7. The Type of Ground Truth Used

For the "quantitative assessments of clinical accuracy" during non-clinical testing (Section 13), the ground truth would likely refer to:

• Design Specifications: The accuracy of the guide compared to the pre-operative plan's target osteotomy.
• Physical Measurements: Using metrology tools to verify the dimensions and functional features of the manufactured surgical guides against the design.

It is not based on expert consensus, pathology, or outcomes data from human patients for this submission.

8. The Sample Size for the Training Set

The Corin OPS™ Femoral is a physical patient-specific instrument. It is not an AI/ML algorithm that requires a "training set" in the conventional sense of machine learning. The design and manufacturing process are validated, and the device's effectiveness is based on its physical accuracy and design principles, not on being trained on a dataset.

9. How the Ground Truth for the Training Set was Established

As explained in point 8, there is no "training set" for this device in the context of an AI/ML algorithm. The "ground truth" during its development would refer to engineering specifications, anatomical references from medical imaging (CT scans), and surgical principles validated through design controls and manufacturing processes.

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