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510(k) Data Aggregation
(28 days)
ROSA**®** Knee System
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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(58 days)
ROSA**®** Knee System
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 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 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 (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® 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 or CAS PSI Knee System) to create a 3D model of the patient's femur/tibia and allows the preparation of a preoperative 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, 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 preoperative plan using pre-operative imaging), and (3) precisely positioning the cut guide relative to the planned orthopedic implant location by using a robotic arm.
It includes a robotic arm, an optical tracking system and accessories, software system, surgical instruments and accessories.
This document, K230243, is a 510(k) premarket notification for the ROSA® Knee System. It specifically describes the addition of new disposable instruments (sterile checkpoint screws) to an already cleared device, K221928.
Therefore, the document does not contain the detailed acceptance criteria and study data typical for the initial clearance of a medical device or an AI/ML-driven device. Instead, it justifies substantial equivalence by stating that the existing performance testing for the predicate device (K221928) remains unchanged and applicable, and that the only modification (sterile packaging of checkpoint screws) does not raise new questions of safety or effectiveness.
Based on the provided text, I cannot extract the specific information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria, as this document focuses on a minor modification (sterilization of existing components) rather than the foundational performance of the "ROSA® Knee System" itself.
The document explicitly states:
- "The existing performance testing that was O performed for the predicate device remains unchanged and is still applicable for the proposed device." (Page 6)
- "The technological characteristics between the proposed device and predicate are identical with differences in the instrumentation where the proposed device checkpoint screws are sold in a sterile packaging to end users." (Page 6)
- "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." (Page 6)
To obtain the requested information about the performance and acceptance criteria of the ROSA® Knee System as a whole, one would need to refer to its predicate device's 510(k) submission (K221928) or potentially earlier submissions if K221928 was also a modification.
In summary, the provided text does not contain the study details you are asking for because this specific 510(k) is for a minor modification to an already cleared device, not for its initial performance validation.
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(95 days)
ROSA**®** Knee System
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 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 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 (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® 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 or CAS PSI Knee System) to create a 3D 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, 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 preoperative 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 ROSA® Knee System is a stereotaxic instrumentation system designed to assist surgeons in Total Knee Arthroplasty (TKA) surgery.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric/Aspect | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Functional Equivalence | The device should assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for accurate knee implant components. | The ROSA® Knee System assists the surgeon in (1) determining reference alignment axes in relation to anatomical landmarks, (2) planning orthopedic implant location based on these reference alignment axes and implant geometry, and (3) precisely positioning the cut guide relative to the planned implant location using a robotic arm. |
| Accuracy of Resections | Not explicitly stated, but implied to be sufficient for TKA procedures and equivalent to the predicate. | Accuracy of resections is stated to be the same between image-based and imageless options, as they are always based on intraoperative landmarks. The system is designed to facilitate accurate placement of knee implant components. |
| Knee State Evaluation | Not explicitly stated, but implied to be sufficient for TKA procedures and equivalent to the predicate. | Knee state evaluation is stated to be the same between image-based and imageless options. |
| Soft Tissue Assessment | Not explicitly stated, but implied to be sufficient for TKA procedures and equivalent to the predicate. | Soft tissue assessment is stated to be the same between image-based and imageless options. The system also assists in joint balancing techniques. |
| Software Safety | The software contained in the device should not raise new issues of safety and effectiveness and should comply with FDA Guidance for the Content Premarket Submissions for Software Contained in Medical Devices and IEC 62304. | Software tests were conducted to satisfy requirements of the FDA Guidance and IEC 62304. The software was considered a "major" level of concern. The testing demonstrates that the ROSA Knee System does not raise any new issues of safety and effectiveness as compared to the predicate device(s). |
| Substantial Equivalence | The device should be at least as safe and effective as the legally marketed predicate device, with any differences not raising new questions of safety and effectiveness. | The proposed device and predicate device have the same intended use and similar indications for use, utilize the same platform components, and share similar technological characteristics. Differences in the software application and new instrumentation do not raise new questions of safety and effectiveness, and the proposed device is at least as safe and effective. |
| Physical/Performance | Not explicitly stated, but implied as ensuring the performance of implemented features and verifying related design inputs. | Physical/Performance Tests were conducted to ensure the performance of the implemented features and verify related design inputs. |
| Usability | Not explicitly stated, but implied as ensuring user interactions with the system are acceptable. | Usability Engineering addressed user interactions with the ROSA Knee System. |
| Performance in Simulated Use | The performance of the system should be acceptable under full simulated use on cadaveric specimens and equivalent to the predicate. | A Validation Lab-performed study validated that using the ROSA Knee System is equivalent to the predicate and that the performances of the system are acceptable under full simulated use on cadaveric specimens. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Validation Lab-performed to validate that using ROSA Knee System is equivalent to the predicate 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 or any other "test set").
The data provenance is described as being generated from "cadaveric specimens," suggesting a controlled laboratory setting. The country of origin of the data is not specified. It is a prospective study as testing was performed on the device.
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 used or their qualifications for establishing ground truth in the "Validation Lab" studies or any other testing. Surgical planning can optionally be determined pre-operatively using compatible X-ray or MRI based surgical planning tools, but how this planning forms a "ground truth" and who defines it is not detailed.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it quantify any effect size of human readers improving with AI vs. without AI assistance. The focus is on the device's performance in assisting the surgeon, not on human-reader performance with or without the device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The document does not explicitly state if a standalone algorithm-only performance study was conducted. The description of the device's function and the "Validation Lab" studies imply the device is used "with the ROSA® RECON Platform" and "assists the surgeon," indicating a human-in-the-loop context. However, the software verification and validation testing would assess the algorithm's performance in isolation to some extent.
7. Type of Ground Truth Used
The ground truth for the "Validation Lab" studies appears to be based on:
- Intraoperative Landmarks: Accuracy of resections, knee state evaluation, and soft-tissue assessment are "always based on intraoperative landmarks."
- Surgical Plan: The system assists in precise positioning "relative to the planned orthopedic implant location." This plan can be optionally determined pre-operatively using X-ray or MRI-based surgical planning tools.
- Equivalence to Predicate: The validation also aimed to prove that the system is "equivalent to the predicate," implying the predicate's established performance as a benchmark for ground truth.
8. Sample Size for the Training Set
The document does not provide any information regarding the sample size used for the training set for the software or any AI/machine learning components.
9. How the Ground Truth for the Training Set Was Established
The document does not describe how the ground truth for any potential training set was established. Given the nature of the device (stereotaxic instrument for TKA), if machine learning is involved, ground truth for training would likely come from well-annotated anatomical landmarks, surgical plans, and intraoperative measurements from historical TKA cases. However, this is not mentioned in the provided text.
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(149 days)
ROSA**®** Knee System
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.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document, but followed similar criteria to the predicate device. | Demonstrated no impact on existing design inputs, user needs, or intended use. |
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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