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The ROSA® Hip System for use with the ROSA® RECON platform, is indicated as a fluoroscopic-guided system for total hip arthroplasty (THA). It is used to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of hip implant components provided that the points of interest can be identified from radiology images.

The intraoperative cup placement is performed relative to anatomical landmarks as recorded using the system intraoperatively, and based on preoperative planning values optionally determined using compatible X-Ray based surgical planning tools.

The ROSA® Hip System is designed for use on a skeletally mature patient population. The targeted population has the same characteristics as the population that is suitable for the implants compatible with the ROSA® Hip System. The ROSA® Hip System is not for primary image interpretation and is applicable for the direct anterior approach.

The ROSA® Hip System is to be used with the following hip replacement systems in accordance with their indications and contraindications: G7® Acetabular System, Avenir Complete™ Hip System, Taperloc® Complete Hip System, Echo® Hip System.

The ROSA® Hip System (RHS) (cleared via K210998) for use with the ROSA® RECON Platform is used to assist surgeons in performing Total Hip Arthroplasty (THA) with features to assist in acetabular shell impaction for the direct anterior approach, as well as assessing the leg length discrepancy and the femoral offset.

The system uses a Non-Device Medical Device Data System (MDDS) called the Zimmer Biomet Drive Portal, which manages the creation and tracking of surgical cases. The cases reside on the portal until they are uploaded to the ROSA® RECON Platform before surgeries.

The system uses fluoroscopic images to determine the instruments' orientation in relation to the patient anatomy and as a guide for acetabular component orientation. The system allows the surgeon to input the case's surgical preoperative planning values and preview the acetabular component orientation intra-operatively. Throughout the surgical workflow, fluoroscopic images are acquired with a C-arm device. Fluoroscopic images are then captured with the ROSA® Tablet digital camera and transferred onto the ROSA® RECON platform via a wireless connection. The current instruments' orientation is computed from the image capture and is adjusted to match the surgeon's planning values using the ROSA® RECON robotic arm. The robotic arm is maintained stationary to keep the instruments in a fixed orientation during acetabular component impaction. The system also provides component selection options based on leg length and offset changes measurements.

The proposed device provides additional compatibility that allows the ROSA® Hip System Software to display images from flat panel C-arm devices onto the Optical Unit monitor throughout the surgical workflow. Images are captured with the ROSA® Tablet digital camera and landmarks are selected to display the outline of either the Lesser or Greater Trochanter.

The intra-operative workflow and surgical concepts implemented in the system remain close to the conventional THA direct anterior approach workflow. As such, at the time of the surgery, the system mainly assists the surgeon in (1) determining reference alignment axes and cup orientation using image-to-image and robotic registration, (2) precisely orienting the cup inserter relative to the desired orthopedic implant angle by using a robotic arm, and (3) providing leg length and offset changes measurements based on fluoroscopic image references.

I'm sorry, but this document does not contain the detailed information necessary to fully answer your request regarding the acceptance criteria and the study that proves the device meets those criteria.

Specifically, the document is a 510(k) summary for the ROSA Hip System. While it states that "The performance testing conducted on the predicate is still applicable to the proposed device and remains unchanged" and that "Verification and validation activities including integration testing for the newly compatible Flat Panel C-arm, were performed using the same methods as the predicate device," it does not provide the acceptance criteria or detailed results of specific performance studies for either the predicate or the proposed device.

The document focuses on demonstrating substantial equivalence to a predicate device (K210998) primarily based on identical intended use, indications for use, and similar technological characteristics and principle of operation. It implies that the necessary performance data was presented to the FDA, but the specifics are not included in this publicly available summary.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set or data provenance.
3. Number of experts, their qualifications, or ground truth establishment for the test set.
4. Adjudication method for the test set.
5. If an MRMC study was done or its effect size.
6. If standalone performance was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How ground truth for the training set was established.

This information would typically be found in the full 510(k) submission, which is not publicly available in this detail, or in separate clinical/performance study reports.

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The ROSA® Knee System for use with the ROSA® RECON platform is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components.

The robotic arm placement is performed relative to anatomical landmarks as recorded using the system intraoperatively, and based on a surgical plan optionally determined pre-operatively using compatible X-ray or MRI based surgical planning tools.

It includes a robotic arm, an optical tracking system and accessories, software system, surgical instruments and accessories.

The ROSA® Knee System is designed for use on skeletally mature patient population. The targeted population has the same characteristics as the population that is suitable for the implants compatible with the ROSA Knee System.

The ROSA® Knee System is to be used with the following fixed bearing knee replacement systems in accordance with their indications and contraindications: NexGen CR, NexGen CR-Flex Gender, NexGen CR-Flex Gender, NexGen LPS, NexGen LPS-Flex, NexGen LPS-Flex Gender, Persona® CR, Persona Ti-Nidium® CR, Persona Ti-Nidium PS, Persona IQ®, Vanguard® CR, and Vanguard PS.

The ROSA® Knee System for use with ROSA® RECON Platform is used to assist surgeons in performing Total Knee Arthroplasty (TKA) with features to assist with the bone resections as well as assessing the state of the soft tissues to facilitate implant positioning intra-operatively.

The ROSA® Knee System uses a Non-Device Medical Device Data System (Non-Device-MDDS) called the Zimmer Biomet Drive Portal which manages the creation and tracking of surgical cases. The cases reside on the portal until they are uploaded to the ROSA® Knee System before surgeries.

If the case is image-based, a 3D virtual bone model is generated pre-operatively by the PSI systems (X-PSI Knee System or CAS PSI Knee System) to create a model of the patient's femur/tibia and allows for the preparation of a pre-operative surgical plan. An imageless option is also available where landmarks taken intra-operatively on the patient's bony anatomy are used to create the surgical plan. Accuracy of resections, knee state evaluation, and soft tissue assessment are the same between image-based and imageless options as they are always based on intraoperative landmarks.

The intraoperative workflow and surgical concepts implemented in the system remain close to the conventional TKA workflow. As such, at the time of the surgery and based on the surgical plan, the system mainly assists the surgeon for in (1) determining reference alignment axes in relation to anatomical landmarks, (2) planning the orthopedic implants location based on these reference alignment axes and orthopedic implant geometry (planning optionally based on a pre-operative plan using pre-operative imaging), and (3), and precisely positioning the cut guide relative to the planned orthopedic implant location by using a robotic arm.

This document is a 510(k) premarket notification from Orthosoft, Inc. (d/b/a Zimmer CAS) for their ROSA® Knee System. The purpose of this submission is to add an additional compatible FDA-cleared knee implant system (Persona Personalized Knee System) to the device's labeling.

Based on the provided text, the ROSA® Knee System is a stereotaxic instrumentation system used to assist surgeons in Total Knee Arthroplasty (TKA) surgery. It provides software-defined spatial boundaries for orientation and reference information for accurate knee implant component placement.

Here's an analysis of the acceptance criteria and study information, keeping in mind that this document describes an update (to include a new compatible implant) to an already cleared device, not an initial clearance. Therefore, the performance data presented is focused on demonstrating that this change does not negatively impact the existing safety and effectiveness.

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

The document does not provide a table of acceptance criteria with specific numerical performance metrics for the device itself (e.g., accuracy in mm or degrees). This is because the submission is for a modification to an already cleared device (K221928), and the performance testing is framed as demonstrating that the modification (adding a new compatible implant) does not negatively impact the performance previously established.

Instead, the "Summary of Performance Data (Nonclinical and/or Clinical)" section states:

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

The document does not specify the sample size for any test set in terms of patient data or clinical trials. The "performance testing" mentioned is "non-clinical," meaning it likely involved bench testing, simulations, or phantom studies rather than patient data.

• Sample Size: Not specified for non-clinical testing.
• Data Provenance: Not specified (e.g., country of origin). The testing is described as "non-clinical," implying laboratory or bench testing rather than patient data collection. The company is based in Canada.
• Retrospective/Prospective: Not applicable as it's non-clinical testing.

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

Not applicable. As the testing was "non-clinical," it would not involve expert human review of medical images or patient outcomes to establish ground truth in the traditional sense of an AI/human reader study. The ground truth would be based on engineering specifications and measurement tolerances.

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

Not applicable. There is no mention of human readers or an adjudication process for a test set, as the performance testing described is non-clinical.

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

No. An MRMC comparative effectiveness study was not done according to the provided text. The device is a stereotaxic instrumentation system, a robotic assistance system, not an AI imaging diagnostic aid designed to be interpreted by human readers. The purpose of this submission is to add a compatible implant, not to evaluate human reader performance with or without the system.

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

This is implicitly addressed by the "non-clinical performance testing." The device itself (the robotic system) has standalone performance metrics (e.g., accuracy of cuts, placement of guides). The document states that the analysis demonstrated that the subject device did not impact these existing performance characteristics. However, the specific metrics and results of such standalone performance are not detailed in this 510(k) summary, as it refers back to the original predicate device's clearance.

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

For a robotic surgical system, the ground truth for non-clinical testing would typically involve:

• Engineering Specifications: Pre-defined accuracy and precision targets (e.g., millimetric deviation for bone resections, rotational accuracy).
• Physical Measurements: Using metrology equipment to measure the actual cuts or placements on phantoms or cadaveric models against the planned surgical targets.
• Simulations: Computational models to predict performance based on design parameters.

The document does not explicitly state the specific type of ground truth but refers to "similar test methods and acceptance criteria to those used for the predicate device," which for this type of device would primarily be based on objective physical measurements against established engineering tolerances.

8. The sample size for the training set

Not applicable. The ROSA® Knee System is a robotic surgical assistance system, not an AI/Machine Learning diagnostic algorithm that requires a "training set" of data in the typical sense. Its functionality is based on established engineering principles, sensor data processing, and pre-programmed surgical workflows, not pattern recognition learned from a large dataset.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm. The "ground truth" for the device's development would be derived from anatomical studies, surgical principles, biomechanical modeling, and expert surgical input to define the desired outcomes and parameters for knee replacement.

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The ROSA® Knee System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon in providing software- defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components.

The robotic arm placement is performed relative to anatomical landmarks as recorded using the system intraoperatively, and based on a surgical plan, optionally determined pre-operatible X-ray or MRI based surgical planning tools.

It includes a robotic arm, an optical sensor navigation system and accessories, software system, surgical instruments and accessories.

The targeted population has the same characteristics as the population that is suitable for the implants compatible with the ROSA® Knee System. The ROSA® Knee System is to be used with the following fixed bearing knee replacement systems in accordance with their indications and contraindications: NexGen CR-Flex, NexGen CR-Flex Gender, NexGen LPS, NexGen LPS- Flex, NexGen LPS-Flex Gender, Persona® CR, Persona PS, Persona IQ, Vanguard® CR, and Vanguard PS.

The ROSA® Knee System is used to assist surgeons in performing Total Knee Arthroplasty (TKA) with features to assist with the bone resections as well as assessing the state of the soft tissues to facilitate implant positioning intra-operatively.

The ROSA® Knee System uses a Non-Device Medical Device Data System (Non-Device-MDDS) called the Zimmer Biomet Drive Portal which manages the creation and tracking of surgical cases. The cases reside on the portal until they are uploaded to the ROSA® Knee System before surgeries.

If the case is image-based, a 3D virtual bone model is generated pre-operatively by the PSI systems (X-PSI Knee System or CAS PSI Knee System) to create a model of the patient's femur/tibia and allows for the preparation of a pre-operative surgical plan. An image-free option is also available where landmarks taken intra-operatively on the patient's bony anatomy are used to create the surgical plan. Accuracy of resections, knee state evaluation, and soft tissue assessment are the same between image-based and image-free options as they are always based on intraoperative landmarks.

The intraoperative workflow and surgical concepts implemented in the system remain close to the conventional TKA workflow. As such, at the time of the surgery and based on the surgical plan, the system mainly assists the surgeon for in (1) determining reference alignment axes in relation to anatomical landmarks, (2) planning the orthopedic implants location based on these reference alignment axes and orthopedic implant geometry, assisting in joint balancing, and precisely positioning the cut guide relative to the planned orthopedic implant location by using a robotic arm.

The purpose of this submission is to add an additional compatible FDA cleared knee implant system, the Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System, also known as Persona IO. As a result of this change, the labeling and Indications for Use has been updated to include this compatibility with this additional knee implant system.

The provided text describes a 510(k) premarket notification for the ROSA® Knee System, which is a stereotaxic instrumentation system for total knee replacement (TKA) surgery. The submission's primary purpose is to add compatibility with an additional FDA-cleared knee implant system (Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System, also known as Persona IO).

The document states that the rationale for substantial equivalence is based on consideration of the following characteristics:

• Intended Use: Same as predicate device.
• Indications for Use: Identical to the predicate, with the exception of adding a new compatible implant.
• Technological Characteristics: Same as predicate device.
• Principle of Operation: Same as predicate device.

Performance Data and Acceptance Criteria:

The document mentions non-clinical tests were conducted. It states, "An analysis of the performance testing was conducted which followed similar test methods and acceptance criteria to those used for the predicate device. The analysis demonstrated that the subject device did not impact the existing design inputs, user needs, or intended use."

However, the document does not explicitly provide a table of acceptance criteria or specific reported device performance values. It only states that the performance testing followed similar test methods and acceptance criteria to those used for the predicate device, and the device met these.

Therefore, I cannot populate the table or provide detailed information for many of your questions from the given text.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Cannot provide specific values. The document states that the testing followed "similar test methods and acceptance criteria to those used for the predicate device," and that the analysis "demonstrated that the subject device did not impact the existing design inputs, user needs, or intended use." This indicates the device met its acceptance criteria, but the criteria themselves and the specific performance metrics are not detailed.

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

Cannot be determined from the provided text. The document only mentions "An analysis of the performance testing was conducted" but does not specify the sample size or whether the data was retrospective or prospective, or its country of origin.

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

Cannot be determined from the provided text. The document does not describe how ground truth was established for the performance testing.

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

Cannot be determined from the provided text.

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

No, a MRMC comparative effectiveness study is not mentioned. The device is a stereotaxic instrumentation system (robotic assistance for surgery), not an AI diagnostic tool primarily interpreted by human readers. The context given is about assisting surgeons in TKA surgery.

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

A standalone performance evaluation would be consistent with the nature of a stereotaxic instrumentation system. The system "assists the surgeon in providing software-defined spatial boundaries for orientation and reference information" and "precisely positioning the cut guide by using a robotic arm." The "performance testing" mentioned likely refers to the accuracy and precision of the robotic arm and navigation system, which would be evaluated without a human-in-the-loop for the core technical performance. However, the document does not explicitly state "standalone" testing.

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

Cannot be determined from the provided text. For a stereotaxic system, ground truth would likely refer to highly accurate measurements of actual bone cuts, implant placement, or alignment compared to a predefined plan, often using high-precision metrology. However, the document does not specify this.

8. The sample size for the training set

Not applicable/Cannot be determined. This device is a stereotaxic surgical navigation and robotic assistance system. While it uses software, the context does not suggest it's a machine learning algorithm that requires a "training set" in the sense of image recognition or diagnostic AI. The term "training set" is usually associated with AI models that learn from data. The system itself is based on pre-programmed algorithms for spatial guidance.

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

Not applicable/Cannot be determined for the reasons stated above.

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