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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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OPS™ Insight is intended for use as preoperative surgical planning software to aid orthopaedic surgeons in component selection, sizing and placement for primary total hip arthroplasty.

OPS™ Insight is an interactive software for preoperative planning of Total Hip Arthroplasty. It enables 3D sizing and placement of implants in the patient's anatomy, calculates biomechanical measurements and performs functional analysis based on landmarks and anatomical models derived from patient-specific radiographic imaging and the templated implants. The biomechanical measurements include measurements relating to leg length, offset and femoral version, and the functional analysis includes determination of pelvic parameters, cup orientation calculation during flexion and extension, and prosthetic impingement detection.

The software uses 2D and 3D patient-specific radiographic data. The implant data required by the software is contained within a controlled database. OPS™ Insight is a closed platform. Please refer to the Instructions for Use for compatible implant systems.

The provided text does not contain detailed information about the acceptance criteria and the study that proves the device meets those criteria, specifically in the format requested. The document is a 510(k) summary for the OPS™ Insight device, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed technical report of performance validation.

Here's what can be extracted and what is missing based on your request:

What can be extracted:

• Non-Clinical Testing: "Non-clinical testing was performed to assess the usability and performance of OPS™ Insight software device to demonstrate that the device functions as intended. Software verification and validation testing was conducted according ISO 62304 and documentation provided as recommended by FDA's Guidance for the Industry: 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.'"
• Clinical Testing: "Clinical testing was not necessary for this Traditional 510(k)."

Information Missing from the provided text:

1. Table of acceptance criteria and reported device performance: This detailed information is not present in the 510(k) summary. The summary only states that non-clinical testing was done to show the device "functions as intended" but does not quantify performance against specific criteria.
2. Sample size used for the test set and data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: The document explicitly states "Clinical testing was not necessary for this Traditional 510(k)," which implies no human reader studies (MRMC) were conducted for this submission.
6. Standalone (algorithm-only) performance: While non-clinical testing for "performance" was mentioned, the specific metrics, acceptance criteria, and results for standalone algorithmic performance are not detailed.
7. Type of ground truth used: Not mentioned.
8. Sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

Summary of available information:

• Acceptance Criteria and Reported Device Performance: Not explicitly stated or tabulated. The general statement is that non-clinical testing demonstrated the device "functions as intended."
• Study Type: Non-clinical verification and validation testing in accordance with ISO 62304 and FDA guidance for software in medical devices. No clinical testing was deemed necessary.
• Ground Truth: Not detailed.
• Sample Sizes/Expert Details: Not detailed for either test or training sets.
• Human-AI Comparative Effectiveness: No clinical study involved, thus no human-AI comparison.

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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 the Corin OPS™ Plan (K171847) and the compatible components. The dislocating Femoral Guide is intended for use with the posterolateral surgical approach and the in-situ Femoral 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 the previously cleared OPS™ Plan (K171847). The OPS™ Plan is a pre-operative tool 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. The OPS™ Plan was previously cleared under K171847 and is not submitted for review in this 510k submission.

The provided text does not contain detailed acceptance criteria and a study proving the device meets them in the format requested. The document is an FDA 510(k) clearance letter for the Corin Optimized Positioning System (OPS) Femoral. While it mentions non-clinical testing for accuracy and performance, it does not provide the specific metrics or the details of the study.

However, I can extract the information that is present and indicate where details are missing based on your request.

Missing Information:
The document does not provide:

• A table of actual acceptance criteria values.
• Specific reported device performance values against detailed criteria.
• Sample size used for the test set.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts, their qualifications, or adjudication method for ground truth establishment.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness study, including effect size.
• Details on standalone algorithm performance.
• Specific type of ground truth used (beyond "clinical accuracy").
• Sample size for the training set.
• Specifics on how ground truth for the training set was established.

Information Extracted from the Document:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not specified.
• Data Provenance: Not specified. The manufacturer (Optimized Ortho Pty Ltd) is based in Pymble NSW, Australia, which might suggest data could originate from Australia, but this is not confirmed. The document only mentions "Non-clinical testing was performed..." without detailing data sources.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not specified. The document refers to "quantitative assessments of clinical accuracy" but does not detail the method of ground truth establishment or the involvement of experts.

4. Adjudication method for the test set:

• Not specified.

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 specified. This document is for the "Corin Optimized Positioning System (OPS) Femoral", which is described as a patient-specific surgical instrument and planning system (OPS™ Plan). It does not explicitly involve an "AI" component in the context of diagnostic image analysis or human reader improvement, but rather an instrument to deliver a target osteotomy based on a pre-operative plan.

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

• The device (OPS™ Femoral) is described as a "patient-specific surgical instrument" that assists a surgeon in delivering a target osteotomy based on a pre-operative plan generated by the "OPS™ Plan". This implies a "human-in-the-loop" system where the instrument guides the surgeon. A "standalone" performance for the instrument itself (without human interaction) would not be directly applicable in the same way as a diagnostic AI algorithm. The accuracy of the instrument in performing its guiding function was tested, but details are not provided.

7. The type of ground truth used:

• The document mentions "quantitative assessments of clinical accuracy." This suggests a comparison against a reference standard or ideal measurement, but the specific nature of this ground truth (e.g., direct measurement, expert opinion, high-resolution imaging) is not detailed. It's implied to be related to the accuracy of the femoral neck osteotomy.

8. The sample size for the training set:

• Not specified. The document does not mention a "training set" in the context of an algorithm that learns from data. The system uses pre-operative CT scans and AP X-rays to plan.

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

• Not applicable as a "training set" for an algorithm, as traditionally understood, is not explicitly mentioned. The "OPS™ Plan" (K171847) is a pre-operative tool for implant selection, sizing, and placement based on anatomical landmarks. The details of its development and validation are outside the scope of this particular 510(k) summary (K181061).

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