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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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The Corin Optimized Positioning System Plan (OPS™ Plan) is indicated for pre-operative planning for primary total hip arthroplasty. OPS™ Plan is intended to be used as a pre-operative tool to assist the Surgeon in the selection (for example, lateralised or standard stem), sizing and positioning of components of primary total hip arthroplasty.

The Corin OPS™ Plan is intended to be used with the Corin TriFit TS (K121563, K153772), MetaFix (K082525, K121439, K131952, K153381), TaperFit (K142761, K153725), MiniHip (K083312, K11046, K131986) and TriFit CF (K173880) Femoral Hip Stems.

The Corin Optimized Positioning System™ Plan (OPS™ Plan) is a pre-operative templating tool to assist the Surgeon in the planning of primary total hip arthroplasty using any Corin femoral stem. The Corin OPS™ Plan assists in selection (for example, lateralised or standard stem), sizing and placement of implant components (stem, head, cup) using anatomical landmarks of the femur and pelvis obtained from pre-operative CT scan and AP X-ray. The OPS™ Plan consists of the OPS™ Plan Report and the OPS™ Plan Appendix. The OPS™ Plan report is a static report which displays the selection (for example, lateralised or standard stem), sizing and placement of implant components. OPS™ Plan Appendix presents the steps taken by the Engineer on behalf of the Surgeon during the preoperative planning process, which include the identification of anatomical landmarks as well as sizing and positioning of the implants.

The Corin OPS™ Plan process begins with booking the OPS case to final release of the OPS Plan Report. OPS™ case booking details and required CT and X-ray imaging in DICOM format are electronically transferred to the manufacturer via the online end-user interface, the OPS™ Portal. Image processing is completed by an Corin Simulation Engineer with results of the OPS™ analysis provided in the OPS™ Plan Report. The Surgeon does not actively interact with the image processing, implant positioning and/or report generation. Final acceptance of the OPS™ Plan by the Surgeon is confirmed following any modifications or clarifications of the reported results.

The OPS™ Plan was originally cleared in K171847. The purpose of this submission is to include TriFit CF (K173880) to the Femoral Hip systems intended to be used with the OPS™ Plan.

The design and all the other compatible components for use with the OPS™ Plan subject of this submission are identical to that of the predicate device K171847.

The provided text describes the Corin Optimized Positioning System (OPS) Plan, a pre-operative planning tool for total hip arthroplasty. However, it explicitly states that clinical testing was not necessary for this Traditional 510(k) submission. Instead, the submission relies on non-clinical testing to demonstrate safety and effectiveness.

Therefore, the following information, which typically relies on clinical or comparative studies, is either not applicable or not detailed in the provided document:

1. A table of acceptance criteria and the reported device performance: The document does not provide a table with specific acceptance criteria (e.g., minimum accuracy percentages, error margins) and reported performance against those criteria as would be found in a clinical study report. It generally states that "accuracy and performance of the system is adequate to perform as intended."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No details on sample size, data provenance, or whether data was retrospective or prospective from a test set for clinical performance are provided, as no clinical testing was performed for this submission.

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 external expert-validated test set for clinical performance is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical test set requiring adjudication is described.

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. The device is a planning tool, and a clinical MRMC study evaluating human reader improvement with AI assistance is not mentioned. The "Surgeon does not actively interact with the image processing, implant positioning and/or report generation" (page 4), suggesting a standalone planning process rather than an AI-assisted reading scenario for the surgeon.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document mentions "Image processing is completed by an Corin Simulation Engineer with results of the OPS™ analysis provided in the OPS™ Plan Report. The Surgeon does not actively interact with the image processing, implant positioning and/or report generation. Final acceptance of the OPS™ Plan by the Surgeon is confirmed..." This describes a process where the engineer uses the system to generate a plan, which the surgeon then approves. While not a fully automated 'algorithm only' in the sense of no human intervention, it is a standalone planning tool that an engineer operates, rather than direct human-in-the-loop diagnostic assistance. The non-clinical testing assessed the "processing of patient imaging to produce accurate, repeatable and reproducible implant selection, sizing and placement of components," which supports a standalone performance claim for the system's output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Since clinical testing was not performed and no direct ground truth for a clinical comparison is mentioned, the ground truth for the non-clinical testing would likely be based on engineering benchmarks, simulated scenarios, or established anatomical measurements against which the system's output (implant selection, sizing, placement) could be validated for accuracy, repeatability, and reproducibility. These details are not elaborated in the provided text.

8. The sample size for the training set: The document does not mention a training set size, as it focuses on the regulatory submission and non-clinical testing, not on the underlying machine learning model development (if any, as the system predates this specific submission). The device was originally cleared in K171847, and this submission is for an expanded list of compatible femoral hip stems.

9. How the ground truth for the training set was established: Not applicable, as details on a training set are not provided.

Summary from the provided text regarding acceptance criteria and study:

• Acceptance Criteria (Implied / Stated Goals):

  • Accuracy: The system must produce accurate implant selection, sizing, and placement of components.
  • Repeatability: The system must produce repeatable results.
  • Reproducibility: The system must produce reproducible results.
  • Usability: The OPS™ Plan provided to the Surgeon must be usable.
  • Adequate Performance: The system's accuracy and performance must be adequate to perform its intended use as a pre-operative planning tool.

• Reported Device Performance (from Non-Clinical Testing):

  • "Non-clinical testing was performed to assess the safety and effectiveness of the device, to demonstrate the processing of patient imaging to produce accurate, repeatable and reproducible implant selection, sizing and placement of components, and the usability of the OPS™ Plan that is provided to the Surgeon. Testing verified that the accuracy and performance of the system is adequate to perform as intended." (Page 5)

• Study That Proves the Device Meets Acceptance Criteria:

  • Title/Type: Non-Clinical Testing.
  • Objective: To assess safety and effectiveness by demonstrating accurate, repeatable, and reproducible implant selection, sizing, and placement, and usability of the OPS™ Plan.
  • Sample Size (Test Set): Not specified.
  • Data Provenance: Not specified.
  • Number of Experts for Ground Truth: Not specified.
  • Qualifications of Experts: Not specified.
  • Adjudication Method: Not specified.
  • MRMC Comparative Effectiveness Study: No.
  • Standalone Performance: Yes (demonstrated through non-clinical testing assessing the system's processing of patient imaging to produce results).
  • Type of Ground Truth: Not explicitly stated but inferred to be engineering benchmarks, simulated scenarios, or established anatomical measurements for validating the accuracy, repeatability, and reproducibility of the system's output.
  • Training Set Sample Size: Not specified.
  • Ground Truth for Training Set: Not specified.

It is important to note that this submission (K183038) is for an update to an already cleared device (K171847) to include a new femoral hip stem. The non-clinical testing mentioned reaffirms the system's core functionalities in light of this update, rather than being a comprehensive clinical validation of a new or significantly altered device.

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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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The Corin Optimized Positioning System Plan (OPS™ Plan) is indicated for pre-operative planning for primary total hip arthroplasty. OPS™ Plan is intended to be used as a pre-operative tool to assist the Surgeon in the selection (for example, lateralised or standard stem), sizing and positioning of components of primary total hip arthroplasty.

The Corin OPS™ Plan is intended to be used with the Corin TriFit TS (K121563, K153772), MetaFix (K082525, K121439, K131952, K131952, K153381), TaperFit (K142761, K153725), MiniHip (K083312, K11046, K131986) Femoral Hip Stems.

The Corin Optimized Positioning System™ Plan (OPS™ Plan) is a pre-operative templating tool to assist the Surgeon in the planning of primary total hip arthroplasty using any Corin femoral stem. The Corin OPS™ Plan assists in selection (for example, lateralised or standard stem), sizing and placement of implant components (stem, head, cup) using anatomical landmarks of the femur and pelvis obtained from pre-operative CT scan and AP X-ray. The OPS™ Plan report is a static report which displays the selection (for example, lateralised or standard stem), sizing and placement of implant components.

The Corin OPS™ Plan process begins with booking the OPS case to final release of the OPS Plan Report. OPS™ case booking details and required CT and X-ray imaging in DICOM format are electronically transferred to the manufacturer via the online end-user interface, the OPS™ Portal. Image processing is completed by an OPS™ Simulation Engineer with results of the OPS™ analysis provided in the OPS™ Plan Report. The Surgeon does not actively interact with the image processing, implant positioning and/or report generation. Final acceptance of the OPS™ Plan by the Surgeon is confirmed following any modifications or clarifications of the reported results.

The provided text describes the Corin Optimized Positioning System (OPS™) Plan, which is a pre-operative templating tool for primary total hip arthroplasty. Here's a breakdown of the acceptance criteria and the study information based on the provided document:

Acceptance Criteria and Device Performance for Corin Optimized Positioning System (OPS™) Plan

The document does not explicitly state numerical acceptance criteria in a table format. However, it outlines the general performance aspects that were tested.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the sample size (number of cases or patients) used for the non-clinical testing.
• Data Provenance: Not explicitly stated. The manufacturer, Optimized Ortho Pty Ltd, is located in Pymble NSW, Australia, suggesting the data may originate from Australia or other regions where Corin operates. The document only mentions "patient imaging in DICOM format are electronically transferred to the manufacturer." It does not specify if these were retrospective or prospective studies.

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

The document does not specify the number of experts or their qualifications used to establish ground truth for the non-clinical testing. The process described for generating the OPS™ Plan states that "Image processing is completed by an OPS™ Simulation Engineer," and "Final acceptance of the OPS™ Plan by the Surgeon is confirmed following any modifications or clarifications of the reported results." This implies a Surgeon's clinical judgment is the ultimate arbiter, but detailed information about their role in establishing ground truth for testing is missing.

4. Adjudication Method for the Test Set

The document does not mention a formal adjudication method (e.g., 2+1, 3+1). The process involves an "OPS™ Simulation Engineer" generating the plan and the "Surgeon" confirming final acceptance. For testing purposes, the method by which ground truth was definitively established from multiple expert opinions is not detailed.

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

• No, a MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not necessary for this Traditional 510(k)." The testing described is "Non-Clinical testing."

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

The device is described as a "pre-operative templating tool" where "Image processing is completed by an OPS™ Simulation Engineer," and the "Surgeon does not actively interact with the image processing, implant positioning and/or report generation." This indicates a human (the OPS™ Simulation Engineer) is in the loop during the generation of the plan. Therefore, a purely standalone algorithm evaluation without human interaction is not explicitly described or implied for the final output generation. However, the "accuracy, repeatability and reproducibility" testing could have involved testing specific algorithmic components in a standalone manner, but the overall system performance evaluated includes human involvement.

7. The Type of Ground Truth Used

The type of ground truth used for non-clinical testing is implied to be based on established anatomical landmarks and surgical planning principles, likely validated by expert surgical opinion or established surgical methodology. The document mentions "selection (for example, lateralised or standard stem), sizing and placement of implant components (stem, head, cup) using anatomical landmarks of the femur and pelvis obtained from pre-operative CT scan and AP X-ray." However, it does not explicitly state whether this involved pathology, outcomes data, or a formal expert consensus process as the ground truth standard for the testing.

8. The Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set.

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

The document does not provide any information on how ground truth was established for a training set. Given that it's a 510(k) submission not requiring clinical trials, and the process involves human engineers and surgeon confirmation, it's possible that a formal machine learning training set with expert-labeled ground truth in the typical sense was not explicitly detailed or a primary focus of the submission documentation provided.

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The Corin Optimized Positioning System (OPS) is intended to be used as patient-specific surgical instrument to assist in the alignment of components during total hip arthroplasty. The Corin OPS is intended to assist in the orientation of the acetabular cup intra-operatively using anatomical landmarks of the pelvis that are clearly identifiable on preoperative X- rays and CT imaging scans.

The Optimized Positioning System including the Patient Specific Guides is intended for use with the Corin Trinity Acetabular System (K093472, K110087, K111481, K122305, K123705, K130128, K130343 and K131647) for total hip arthroplasty.

The Corin Optimized Positioning System is intended for use with the Direct Anterior or Posterolateral surgical approaches.

The Patient Specific Guides are intended for single use only.

The Corin Optimized Positioning System (OPS) consists of software and hardware components to assist the surgeon in the alignment of components during Total Hip Arthroplasty.

The software component assists the surgeon in determining a patient specific target orientation for the acetabular cup through a pre-operative patient specific analysis and two patient specific reports: Functional Hip Analysis (FHA) report and Patient Specific Visualisation (PSV) report.

The hardware components assist the surgeon in delivering the target orientation through the use of a Patient Specific Guide and bone model (replica of the patient's acetabulum, into which the guide fits), and associated reusable instrumentation.

The Corin OPS can be used with the Trinity Acetabular System and the respective compatible components.

Here's a breakdown of the acceptance criteria and study information for the Corin Optimized Positioning System (OPS), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The text explicitly mentions a cadaver study for device performance verification. However, it does not specify the sample size (i.e., number of cadavers) used. The data provenance is implied to be a laboratory setting (cadaver study). No information is given about the country of origin. The study was conducted retrospectively or prospectively on cadavers for device verification.

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

The text does not specify the number of experts used or their qualifications for establishing ground truth in the cadaver study. It states that the study measured "repeatability (intra-observer variability) and reproducibility (inter-observer variability) of the system," which suggests that multiple individuals (likely experts like surgeons or trained technicians) performed measurements to assess variability, but their specific roles in establishing a definitive "ground truth" for the test set are not detailed in the provided summary.

4. Adjudication Method for the Test Set

The text does not explicitly state an adjudication method (e.g., 2+1, 3+1, none). The mention of "repeatability (intra-observer variability) and reproducibility (inter-observer variability)" suggests a comparison among observers' measurements, but how discrepancies or a final "ground truth" were resolved is not described.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states, "Clinical testing was not necessary for this Traditional 510(k)." The described studies focus on the device's technical performance and accuracy, not its comparative effectiveness with human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance evaluation of the algorithm (software component) was done. The text says:

• "Software verification and validation was completed in accordance with FDA guidance..."
• "Testing was also performed to verify that the FHA software module and acetabular quide design is reproducible and repeatable when processed by multiple operators."
• The system itself is described as assisting in "determining a patient specific target orientation for the acetabular cup through a pre-operative patient specific analysis and two patient specific reports: Functional Hip Analysis (FHA) report and Patient Specific Visualisation (PSV) report." This implies the software's ability to generate these outputs on its own.

7. The Type of Ground Truth Used

For the cadaver study, the ground truth was based on the accuracy of the implanted cup orientation relative to the pre-operative plan. This implies that a pre-operative plan (generated by the device's software) served as the target, and the actual physical implantation in the cadaver was measured against this plan. The details of how this "actual" implantation was precisely measured and considered the "ground truth" are not expanded upon (e.g., whether it was through high-precision imaging, direct measurement, etc.).

For the software validation, the ground truth would typically be established through predefined specifications, expected outputs, and comparison against known correct computations or reference data.

8. The Sample Size for the Training Set

The document does not provide information regarding a specific "training set" or its size. This device's purpose (patient-specific surgical instrument based on pre-operative scans) suggests it might not rely on a conventional machine learning model that requires a distinct training/validation/test split of patient data in the typical sense. Instead, its software likely employs computational geometry and image processing algorithms.

If there was an underlying machine learning component used to develop parts of the software (e.g., for automated anatomical landmark identification), this information is not disclosed in the summary.

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

Since no training set information is provided, the method for establishing its ground truth is also not available in this document.

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