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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, NexGen CR-Flex Gender, NexGen LPS, NexGen LPS-Flex, NexGen LPS-Flex Gender, Persona® CR, Persona PS, Persona Ti-Nidium® CR, Persona Ti-Nidium PS, Persona IQ®,Vanguard® CR, and Vanquard PS.

The ROSA® Knee System for use with the 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 (MDDS) called the Zimmer Biomet 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.

If the case is image-based, a 3D virtual bone model is generated pre-operatively by the PSI systems (X-PSI Knee System-K171269 or CAS PSI Knee System-K131409) to create a 3D model of the patient's femur/tibia and allows the preparation of a pre-operative surgical plan as well as visualization of planned cuts. The pre-operative plan is then matched to the landmarks taken intra-operatively on the patient's bony anatomy. 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 ROSA Knee System remain close to the conventional TKA workflow. As such, at the time of the surgery, the system mainly assists the surgeon 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) precisely positioning the cut guide relative to the planned orthopedic implant location by using a robotic arm.

The purpose of the submission is additional compatibility (Persona IQ 30 mm) with the FDA cleared tibial extension implant (stem), Canturio Smart Extension with Canary Health Implanted Reporting Processor (CHIRP) System, FDA 510(k) number K234056 to the subject device: ROSA Knee System.

This submission, K242864, is a Special 510(k) for the ROSA® Knee System. Special 510(k)s are typically used for modifications to a manufacturer's own legally marketed device, where the modification does not alter the fundamental scientific technology of the device and the performance data demonstrates that the modified device is as safe and effective as the predicate device. In such cases, the manufacturer generally relies on existing performance data of the predicate device and provides a rationale for how that data still applies to the modified device.

The provided document states: "The purpose of the submission is additional compatibility (Persona IQ 30 mm) with the FDA cleared tibial extension implant (stem), Canturio Smart Extension with Canary Health Implanted Reporting Processor (CHIRP) System, FDA 510(k) number K234056 to the subject device: ROSA Knee System."

It further states: "The existing performance data that was performed for the predicate device remains unchanged and is still applicable for the proposed device." and "The subject device, ROSA Knee System, has the same Intended Use, Indications for Use, technological characteristics, and performance data as its predicate device, ROSA Knee System (K230243) and the information provided demonstrates: In sum, any differences between the devices do not raise new questions of safety and effectiveness: and the proposed device is at least as safe and effective as the legally marketed predicate device."

Therefore, for this specific 510(k) submission (K242864), a new study was not performed, and the device's acceptance criteria and proven performance rely on the predicate device (ROSA® Knee System, K230243). The document does not provide details of the original study that supported the predicate device.

Based on the provided information, I cannot complete the requested tables and descriptions because the submission itself explicitly states that no new performance data was generated for K242864 beyond relying on the predicate device's data.

To provide the detailed information requested, I would need access to the original 510(k) submission for the predicate device, K230243, which would contain the performance data and study details.

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The ROSA® Shoulder System, for use with the ROSA RECON platform, is indicated as a stereotaxic instrumentation system for Total Shoulder Arthroplasty (TSA) surgery. It is used to assist the surgeon in providing software-defined spatial boundaries for orientation and reference to identifiable anatomical structures for the accurate placement of the shoulder implant components.

The robotic arm placement is performed relative to anatomical landmarks and bony anatomy as recorded using the system intraoperatively, and based on a three-dimensional representation of the bone structures determined pre-operatively using compatible CT based imaging technology.

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

The ROSA® Shoulder System is designed for use on a skeletally mature patient population. The target population has the same characteristics as the population targeted by the implants compatible with the ROSA® Shoulder System.

The ROSA® Shoulder System is to be used with the following shoulder replacement systems in accordance with their indications and contraindications:
• Humerus implants: Comprehensive® Total Shoulder System, Comprehensive® Reverse Shoulder System, Identity® Shoulder System and Identity® Reverse Shoulder System.
• Glenoid implants: Alliance™ Glenoid and Comprehensive® Reverse Shoulder System.

The ROSA® Shoulder system (RSS) for use with ROSA® RECON Platform (cleared via K230243) is used to assist surgeons in performing Total Shoulder Arthroplasty (TSA) for both anatomic and reverse techniques. It features humeral resection and glenoid reaming capabilities to reproduce the preoperative plan intraoperatively with The RSS uses a Non-Device Medical Device Data System (MDDS) called the Zimmer Biomet Portal, which manages the creation and tracking of surgical cases. The cases with the pre-operative planning based on surgeon preferences reside on the portal until they are uploaded to the ROSA RECON Platform before surgeries.

The intra-operative workflow and surgical concepts implemented in the system remain close to the conventional TSA workflow. As such, at the time of the surgery, the system mainly assists the surgeon in (1) determining reference alignment axes in relation to anatomical landmarks, (2) planning the orthopedic implants location intra-operatively based on these reference alignment axes and orthopedic implant geometry, and (3) precisely position the humeral cut guide and glenoid reamer relative to the planned orthopedic implant location by using a robotic arm.

The ROSA® Shoulder System, a stereotaxic instrumentation system for Total Shoulder Arthroplasty (TSA) surgery, underwent various performance tests to ensure its safety and effectiveness.

1. Acceptance Criteria and Reported Device Performance

The provided document does not contain a specific table detailing acceptance criteria alongside reported device performance for specific metrics (e.g., accuracy, precision of implant placement). Instead, it broadly states that "Verification and Validation Testing for ROSA Shoulder System was conducted with the following aspects: Performance Tests- to ensure the performance of the implemented features and verify related design inputs."

However, the study overall aimed to demonstrate that the device is "at least as safe and effective as the legally marketed predicate devices." The successful outcome of the performance tests, engineering analysis, usability engineering, and validation lab on cadaveric specimens, coupled with software verification and validation, implies that the device met its internal acceptance criteria for these aspects.

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

The document mentions a "Validation Lab- performed to validate that using ROSA Shoulder System is safe and effective and that the performances of the system are acceptable under full simulated use on cadaveric specimens." However, it does not specify the sample size (number of cadaveric specimens) used for this test set nor the country of origin of the cadaveric data. The study appears to be prospective in nature, as it involved performing tests on cadaveric specimens specifically for the validation of the device.

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

The document does not provide details on the number of experts used to establish ground truth for the cadaveric test set, nor their specific qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for determining ground truth in the cadaveric test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done. The evaluation focuses on the device's performance in assisting surgeons, rather than comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The ROSA® Shoulder System is described as a system "to assist the surgeon" and involves an "intra-operative workflow and surgical concepts implemented in the system remain close to the conventional TSA workflow." It explicitly states the system "mainly assists the surgeon." This indicates that the device is designed to be used with a human in the loop, and therefore, a standalone (algorithm only without human-in-the-loop performance) study was likely not the primary focus or was not explicitly reported as such. The "Validation Lab" involved "full simulated use on cadaveric specimens," which would implicitly involve human interaction with the system.

7. Type of Ground Truth Used

Based on the "Validation Lab- performed to validate that using ROSA Shoulder System is safe and effective and that the performances of the system are acceptable under full simulated use on cadaveric specimens," the ground truth for evaluating the device's performance (e.g., accuracy of implant placement, effectiveness of guidance) would have been established through direct measurement and observation on the cadaveric specimens in comparison to the pre-operative plan. This would fall under a form of empirical or objective ground truth as determined by surgical best practices and the stated goals of the system. It is not specified if this involved pathology or outcomes data in the traditional sense, but rather the physical outcome of the surgical assistance provided by the device.

8. Sample Size for the Training Set

The document does not provide information on the sample size for the training set of the software or any underlying AI components. The ROSA® Shoulder System is described as using "software-defined spatial boundaries" and "a three-dimensional representation of the bone structures determined pre-operatively." While this implies computational components, the nature of their development and training data is not detailed.

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

Since the document does not mention details about a specific training set or the development of a machine learning model, it does not describe how the ground truth for any potential training set was established. The focus of the provided information is on the verification and validation of the final device system.

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The Signature™ ONE System is indicated, based on patient-specific radiological images with identifiable placement anatomical landmarks, to assist in pre-operative planning and/or intra-operative guiding of surgical instruments for shoulder replacement surgical procedures on patients not precluded from being radiologically scanned.

The Signature™ ONE 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 Signature™ ONE System.

The Signature™ ONE System is to be used with the glenoid components of the following shoulder implant systems in accordance with their indications: Zimmer® Trabecular Metal Reverse Plus® Shoulder. Comprehensive® Total Shoulder System, Comprehensive® Reverse Shoulder System, Comprehensive® Reverse Augmented Baseplates and Alliance® Glenoid System.

The Signature™ ONE System pre-operative planning is also compatible with the humeral components of the following shoulder implant systems in accordance with their indications: Comprehensive® Total Shoulder System, Comprehensive® Reverse Shoulder System, and Identity™ Shoulder System.

The Signature™ ONE System Guides and bone models are intended for single use only.

The Signature™ ONE System is developed to assist in preoperative planning (using the Signature™ ONE Planner) and to accurately transfer a pre-operative plan to orthopedic surgical procedures (using the Signature™ ONE Guides and bone model) if desired in skeletally mature individuals for Total Shoulder Arthroplasty. Both anatomic and reverse (TSA and RSA respectively) approaches are supported.

The Signature ONE Guides and Bone Models are designed and manufactured of polyamide (nylon) using additive manufacturing selective laser sintering (SLS), based on the approved/finalized pre-surgical plan and shipped prior to surgery. The guides and bone models are provided nonsterile and sterilized at the hospital. They are used intraoperatively to assist the surgeon in reproducing the plan on the scapula. The Signature ONE System surgical technique remains close to the conventional shoulder arthroplasty workflow.

The Signature™ ONE System uses a Non-Device Medical Device Data System (MDDS) called the Zimmer Biomet Portal for the interaction with external users (i.e. imaging technician and the surgeon). The internal users (i.e. the Zimmer Biomet operators) use manufacturing software applications to prepare the patient cases for the surgeon.

The purpose of this submission is to introduce new hardware kits for the existing compatible Comprehensive Reverse Augment implants and to include the addition of pre-operative planning of humeral components. A Rotational Guide component will be available as part of these two kits. Modifications have been made to the software applications to accommodate the new guide ordering option. The overall manufacturing process, materials, sterilization methods, have not changed from the previous primary predicate and principal of operation remains similar.

The provided text does not contain detailed acceptance criteria or a comprehensive study report with the specific performance metrics typically found in such documents. The "Summary of Performance Data (Nonclinical and/or Clinical)" section is quite generic, listing categories of tests rather than specific results or acceptance criteria.

Therefore, I cannot fulfill all components of your request with the information provided. However, I can extract what is available and highlight what is missing.

Here's a summary of the available information and what is absent:

Missing Information:

• Specific Acceptance Criteria and Reported Device Performance (Table): The document lists categories of tests (Performance Tests, Engineering Analysis, Usability Engineering, Validation, Software V&V) but does not provide quantitative acceptance criteria (e.g., accuracy thresholds, precision targets) or the actual reported performance values for the device against these criteria.
• Sample size for the test set and data provenance: The document mentions "Verification and Validation Testing" but does not specify the number of cases or subjects in the test set, nor the country of origin or whether the data was retrospective or prospective.
• Number of experts used to establish ground truth and their qualifications: No information is provided about the experts involved in establishing ground truth for any test sets.
• Adjudication method for the test set: No information is provided regarding adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness study: The document does not mention an MRMC study or any results regarding human reader improvement with AI assistance.
• Standalone (algorithm-only) performance: While software verification and validation are mentioned, specific standalone performance metrics (e.g., sensitivity, specificity, accuracy) for the algorithm are not provided.
• Type of ground truth used: The description of "Validation... to validate related user needs, intended use and safety and effectiveness" is generic and does not specify how ground truth was established (e.g., expert consensus, pathology, outcome data).
• Sample size for the training set: There is no mention of a training set or its size.
• How the ground truth for the training set was established: Since a training set is not mentioned, the method for establishing its ground truth is also not provided.

Available Information (Indirectly related to performance):

The document primarily focuses on establishing substantial equivalence to a predicate device (K212560 and K211359) by demonstrating that the new device, the Signature™ ONE System, does not raise new questions of safety or effectiveness despite new features.

The performance data mentioned in the document is categorized as:

• Device Performance Testing:
  • Performance Tests: Documented to ensure performance of implemented features and verify related design inputs.
  • Engineering Analysis: Documented to ensure performance of implemented features and verify related design inputs.
  • Usability Engineering: Performance of the system in regards to human factors engineering.
  • Validation: Performed to validate related user needs, intended use, and safety and effectiveness.
• Software Verification and Validation Testing: Conducted to satisfy requirements of the "Content of Premarket Submissions for Device Software Functions Guidance" and IEC 62304. This testing aims to demonstrate the system "does not raise any new issues of safety and effectiveness as compared to the predicate devices."

Conclusion from the document:

The conclusion drawn by the submitter is that "any differences between the subject and predicate devices do not raise different questions of safety and effectiveness and the proposed device is at least as safe and effective as the legally marketed predicate devices." This implies that the performance data (though not detailed here) was sufficient to demonstrate this equivalence.

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OptiVu™ ROSA® MxR is indicated for displaying surgical workflow images from the ROSA® RECON platform in Mixed Reality. It includes functions for viewing the same surgical workflow steps and 2D visualizations as presented on the existing ROSA RECON platform user interface. When accessing ROSA® MxR from a stereoscopic head mounted display (HMD), images viewed are for informational purposes only and are not intended for diagnostic use.

OptiVu™ ROSA® Mixed Reality (ROSA® MxR) is indicated for displaying surgical workflow images from the ROSA® RECON Platform and the corresponding ROSA® clinical applications intra-operatively during orthopedic surgeries. It is intended to provide an additional means of display where the ROSA® RECON Platform user interface is duplicated into a Mixed Reality see-through environment. OptiVu™ ROSA® MxR allows the ROSA® RECON Platform user interface and corresponding ROSA® clinical applications (ROSA Knee, ROSA Partial or ROSA Hip) to be streamed through a compatible head-mounted display (HMD) (e.g. HoloLens 2). The subject device's main purpose is to place the duplicated virtual ROSA® user interface at a convenient location to provide the following functionalities: ● Mixed Reality visualization solution Wireless connectivity between a HMD (e.g. HoloLens 2) . and the ROSA® RECON Platform Interaction with the duplicated user interface and ● RECON Platform (e.g. voice, eye gaze and hand gestures)

The provided text describes a 510(k) premarket notification for the OptiVu™ ROSA® MxR device. However, it does not contain the specific details required to complete your request, such as a table of acceptance criteria, reported device performance, sample sizes, expert qualifications, or details of standalone or MRMC studies.

The document states that a "subsequent performance and integration test was performed regarding the active command functions and is described in the Section 11- Design Control Activities Summary," but this section is not included in the provided text.

Therefore, I cannot provide the requested information about acceptance criteria, study details, and performance metrics as they are not present in the given document.

Image /page/0/picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square are the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" below it.

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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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OptiVu™ ROSA® MxR is indicated for displaying surgical workflow images from the ROSA® RECON platform in Mixed Reality. It includes functions for viewing the same surgical workflow steps and 2D visualizations as presented on the existing ROSA RECON platform user interface. When accessing ROSA® MxR from a stereoscopic head mounted display (HMD), images viewed are for informational purposes only and are not intended for diagnostic use.

OptiVu™ ROSA® Mixed Reality (ROSA® MxR) is indicated for displaying surgical workflow images from the ROSA® RECON Platform and the corresponding ROSA® clinical applications intra-operatively during orthopedic surgeries. It is intended to provide an additional means of display where the ROSA® RECON Platform user interface is duplicated into a Mixed Reality see-through environment. OptiVu™ ROSA® MxR allows the ROSA® RECON Platform user interface and corresponding ROSA® clinical applications (e.g. ROSA® Knee, ROSA® Partial, or ROSA® Hip) to be streamed through a compatible head-mounted display (HMD) (e.g. HoloLens 2).

The subject device's main purpose is to place the duplicated virtual ROSA® user interface at a convenient location to provide the following functionalities:

• Mixed Reality visualization solution
• Register hand gestures as inputs such as to touch, move and resize views
• Wireless connectivity between a HMD (e.g. HoloLens 2) and the ROSA® RECON Platform

The OptiVu™ ROSA® MxR device is designed to display surgical workflow images from the ROSA® RECON platform in Mixed Reality. It includes functions for viewing the same surgical workflow steps and 2D visualizations as presented on the existing ROSA RECON platform user interface via a head-mounted display (HMD) like the HoloLens 2. It's important to note that images viewed through the HMD are for informational purposes only and are not intended for diagnostic use.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list quantitative acceptance criteria in a typical tabular format. Instead, it describes general performance goals and verification activities. The overall acceptance criterion is demonstrating substantial equivalence to predicate devices without raising new questions of safety and effectiveness.

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

The document does not specify a separate "test set" in the context of a clinical study with patient data. The performance evaluations described are primarily non-clinical device performance testing, engineering analysis, software verification and validation, and usability engineering. Therefore, the concept of sample size for patient data or data provenance (country of origin, retrospective/prospective) is not directly applicable in the information provided.

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

As there is no mention of a clinical test set requiring expert-established ground truth related to patient data or diagnostic interpretations, this information is not provided. The device explicitly states that images viewed through the HMD are "for informational purposes only and are not intended for diagnostic use."

4. Adjudication Method for the Test Set

Given the absence of a clinical test set requiring expert interpretation of patient data, there is no mention of an adjudication method (e.g., 2+1, 3+1). The performance testing described focuses on the device's technical functionality and software integrity.

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

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not mentioned in the provided document. The device's indications for use emphasize displaying surgical workflow information rather than diagnostic interpretation or AI-driven decision support for human readers.

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

The document describes "Software Verification and Validation Testing" and "Device Performance Testing." While these are standalone tests of the algorithm's functional performance, they are not presented as a standalone clinical performance study in the sense of an algorithm making diagnostic or treatment decisions without human oversight. The device is an accessory for surgical workflow information display, not an autonomous diagnostic or therapeutic algorithm.

7. The Type of Ground Truth Used

For the software and device performance testing:

• Engineering specifications and design inputs served as the "ground truth" or reference for verification and validation activities. The tests aimed to ensure the device met these predefined requirements.
• Regulatory standards and guidance documents (e.g., FDA Guidance for Content Premarket Submissions for Software, IEC 62304) provided the "ground truth" for software quality and safety.

No "ground truth" in terms of expert consensus, pathology, or outcomes data for clinical decision-making is mentioned, consistent with its informational purpose.

8. The Sample Size for the Training Set

The document does not provide information on a "training set" in the context of machine learning. The device appears to be primarily an interface and display tool, integrating with existing ROSA® RECON Platform software, rather than a system that learns from a large dataset.

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

As no training set (for machine learning) is discussed, the method for establishing its ground truth is not applicable or provided.

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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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The Signature™ ONE System is indicated, based on patient-specific radiological images with identifiable placement anatomical landmarks, to assist in pre-operative planning and/or intra-operative guiding of surgical instruments for shoulder replacement surgical procedures on patients not precluded from being radiologically scanned.

The Signature™ ONE System is to be used with the glenoid components of the following shoulder implant systems in accordance with their indications and contraindications: Zimmer® Trabecular Metal™ Reverse Plus Shoulder, Comprehensive® Total Shoulder System, Comprehensive® Reverse Shoulder System, Comprehensive® Reverse Augmented Baseplates and Alliance™ Glenoid System.

The Signature™ ONE Guides and bone models are intended for single use only.

The Signature™ ONE System is developed to assist in preoperative planning of the glenoid component for Total Shoulder Arthroplasty (using the Signature™ ONE Planner) and to accurately transfer a pre-operative plan to orthopedic surgical procedures (using the Signature™ ONE Guides) if desired. Both anatomic and reverse (TSA and RSA respectively) approaches are supported.

The Signature ONE Guides and Bone Model are designed and manufactured of polyamide (nylon) using additive manufacturing (selective laser sintering), based on the approved/finalized pre-surgical plan and shipped prior to surgery. The guides and bone models are provide nonsterile and sterilized at the hospital. They are used intraoperatively to assist the surgeon in reproducing the plan. The Signature ONE System surgical technique remains close to the conventional shoulder arthroplasty to allow converting to standard surgical technique at any time if needed during the operation.

The Signature™ ONE System uses the Zimmer Biomet Drive Portal for the interaction with external users (i.e. imaging technician and the surgeon). The internal users (i.e. the Zimmer Biomet operators) use manufacturing software applications to prepare the patient cases for the surgeon.

Modifications have been made to include guides and bone models for the Alliance Glenoid System, to the planning application and user interface, and the inclusion of an additional glenosphere size for the Comprehensive Reverse Implant System within the Signature™ ONE planning software application. The overall planning process, manufacturing process, materials, sterilization methods, principal of operation, have not changed from previous predicates.

The provided text describes a 510(k) premarket notification for the Signature™ ONE System, a device used for pre-operative planning and intra-operative guiding in shoulder replacement surgery. However, the text does not contain the specific details required to answer all parts of your request regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the document lacks a table of acceptance criteria with reported device performance metrics, sample sizes for test and training sets, details about ground truth establishment (number/qualifications of experts, adjudication methods), and information about MRMC studies or standalone algorithm performance.

The document primarily focuses on explaining the device's indications for use, its substantial equivalence to predicate devices, and the general types of testing performed (engineering analysis, performance tests, system validation, and software verification/validation).

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

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

• Missing. The document states that "Performance Tests- Design verification tests were O documented to ensure the performance of the implemented features and verify related design inputs" but does not provide specific acceptance criteria or the measured performance outcomes.

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

• Missing sample size for the test set.
• Missing data provenance details. The document mentions "Cadaveric validation performed" but doesn't specify the number of cadavers or their origin. It also doesn't specify if other data used for software testing was retrospective or prospective, or its geographic origin.

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):

• Missing. The document does not describe how ground truth was established for any performance testing, nor does it mention the involvement of experts in defining a gold standard.

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

• Missing. No information on adjudication methods for establishing ground truth is provided.

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:

• Missing. The document does not mention any MRMC studies or comparative effectiveness studies involving human readers with and without AI assistance. The device is described as assisting in planning and guiding, implying human interaction, but no such study details are provided.

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

• Implicitly yes, partially, but no metrics are provided. The software verification and validation would involve algorithm-only testing to ensure its functionality. However, specific standalone performance metrics (e.g., accuracy of anatomical landmark identification by the algorithm alone) are not reported. The device's function is to "assist" which suggests a human-in-the-loop system.

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

• Not explicitly stated. For the "Cadaveric validation," the ground truth would likely be based on physical measurements or surgical outcomes on the cadavers, but this is not detailed. For software testing, the ground truth for image processing tasks would typically be pre-annotated data, but the source or method of annotation is not mentioned.

8. The sample size for the training set:

• Missing. The document does not provide any information about a training set since it focuses on verification and validation of a cleared device, not the development or training phase of an AI model per se. While the device has "planning application" and "user interface" modifications, and "overall workflow remains unchanged from the predicate devices," it isn't explicitly stated that a "training set" in the machine learning sense was used for this particular submission.

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

• Missing. As no training set information is provided, no details on how its ground truth was established are present.

In summary, the provided document is a regulatory approval letter and a summary of the 510(k) submission, confirming substantial equivalence. It outlines the device's purpose and general testing activities but does not delve into the detailed performance study methodology, acceptance criteria, and specific results you've requested for an AI/ML device. This level of detail is often found in the full 510(k) submission or associated study reports, which are typically not included in the public-facing FDA clearance letter.

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The Signature™ ONE System is indicated, based on patient-specific radiological images with identifiable placement anatomical landmarks, to assist in pre-operative planning and/or intra-operative guiding of surgical instruments for shoulder replacement surgical procedures on patients not precluded from being radiologically scanned.

The Signature™ ONE System is to be used with the glenoid components of the following shoulder implant systems in accordance with their indications and contraindications: Zimmer® Trabecular Metal™ Reverse Plus Shoulder, Comprehensive® Total Shoulder System, Comprehensive® Reverse Shoulder System, Comprehensive® Reverse Augmented Baseplates and Alliance™ Glenoid System.

The Signature™ ONE Guides and bone models are intended for single use only.

The Signature™ ONE System is developed to assist in preoperative planning of the glenoid component for Total Shoulder Arthroplasty (using the Signature™M ONE Planner) and to accurately transfer a pre-operative plan to orthopedic surgical procedures (using the Signature™ ONE Guides) if desired. Both anatomic and reverse (TSA and RSA respectively) approaches are supported.

The Signature ONE Guides and Bone Model are designed and manufactured of polyamide (nylon) using additive manufacturing (selective laser sintering), based on the approved/finalized pre-surgical plan and shipped prior to surgery. The guides and bone models are provide nonsterile and sterilized at the hospital. They are used intraoperatively to assist the surgeon in reproducing the plan. The Signature ONE System surgical technique remains close to the conventional shoulder arthroplasty to allow converting to standard surgical technique at any time if needed during the operation.

The Signature™ ONE System uses the Zimmer Biomet Drive Portal for the interaction with external users (i.e. imaging technician and the surgeon). The internal users (i.e. the Zimmer Biomet operators) use manufacturing software applications to prepare the patient cases for the surgeon.

Modifications have been made to Planning application to include Alliance™ Glenoid implant system as a Pure Planning option (i.e. no Guides and Bone Models). In addition, modifications have been made to the user interface of the overall planning application. The planning process, manufacturing process, materials, sterilization methods, principal of operation, have not changed from previous predicates.

This FDA 510(k) premarket notification for the Signature™ ONE System does not contain the specific acceptance criteria, detailed study results, and statistical information typically required to fully answer your request regarding device performance and its proof. This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a standalone study proving the device meets predefined clinical acceptance criteria.

However, based on the provided text, here's what can be extracted and inferred:

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

The document does not explicitly state quantitative acceptance criteria (e.g., accuracy thresholds, precision ranges) or corresponding reported device performance metrics in a table format for clinical efficacy. The "Device Performance Testing" section mentions "Engineering Analysis" to "ensure the performance of the implemented features and verify related design inputs" but does not provide details on what these performance metrics were or their targets.

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

The document does not specify any sample size for a test set for clinical performance evaluation. It mentions "patient-specific radiological images" are used for planning, but no details about a dedicated test set of patients or images for validation are provided. Therefore, data provenance (country of origin, retrospective/prospective) is also not available here.

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. The application is for a planning and guiding system, where the ground truth regarding surgical accuracy would typically be established by comparing the planned outcome to the actual intraoperative or post-operative outcome, often involving expert surgeons. However, no such study details are present.

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

This information is not provided as there is no described test set of clinical images or cases requiring ground truth adjudication.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. The device is a planning and guiding system, not an AI diagnostic tool where human reader performance would typically be enhanced.

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

The document describes the Signature™ ONE System as assisting in "pre-operative planning and/or intra-operative guiding of surgical instruments." This inherently implies a human-in-the-loop system (the surgeon). The "planning application" is a software component, but its performance is not described in a standalone, algorithm-only context of clinical efficacy in this document. The "Software Verification and Validation Testing" addresses the software's compliance with regulations like IEC 62304 and its concern level ("moderate"), implying testing of its functionality and reliability, but not its clinical performance as a standalone entity in terms of accuracy against ground truth.

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

This information is not provided. For a surgical planning and guidance system, ground truth would ideally come from direct measurements of surgical accuracy and alignment post-procedure, or potentially surrogate measures confirmed by expert assessment.

8. The sample size for the training set

This information is not provided. While the system uses "patient-specific radiological images" for planning, the document does not discuss a "training set" in the context of an AI/ML model where a large dataset is used to train an algorithm. The system appears to be based on computational algorithms for planning rather than a deep learning model trained on a vast image dataset.

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

This information is not provided as there is no discussed training set.

Summary of what is present:

• Software Verification and Validation Testing: This was conducted to satisfy FDA guidance and IEC 62304 for medical device software. The software is classified as "moderate" level of concern.
• Engineering Analysis: Performed to ensure performance of implemented features and verify design inputs.
• Usability Engineering: Addressed user interactions.

In conclusion, this 510(k) notification focuses on the substantial equivalence of the Signature™ ONE System to previously cleared predicate devices, asserting that its modifications (like adding Alliance™ Glenoid system compatibility) do not raise new questions of safety and effectiveness. It provides a general overview of verification and validation activities (software, engineering, usability) but lacks the detailed performance study results and specific acceptance criteria that you requested for a comprehensive understanding of the device's proven clinical effectiveness.

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