Search Results

The ROSA® Partial Knee System, for use with the ROSA® RECON platform, is indicated as a stereotaxic instrumentation system for Partial Knee replacement (PKA) 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 the knee implant components.

The robotic arm placement is performed relative to anatomical landmarks as recorded using the system intraoperatively, and based on a three-dimensional representation of the bone structures determined preoperatively using compatible X-ray or MRI based imaging technologies.

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

The ROSA® Partial Knee 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® Partial Knee System.

The ROSA® Partial Knee System is to be used with Persona Partial Knee (PPK) fixed bearing knee replacement system in accordance with its indications and contraindications.

The ROSA® Partial Knee System for use with the ROSA® RECON Platform is used to assist surgeons in performing Partial Knee Arthroplasty (PKA) with features to assist with the bone resections as well as assessing the state of the soft tissues to facilitate implant positions intraoperatively.

The system uses a Non-Device Medical Device Data System (MDDS) called the Zimmer Biomet Drive Portal which manages the creation and tracking of the surgical cases. The cases resides on the portal until it is 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 pre-operative ROSA® Total Knee System (TKA) surgical plan. However, the pre-operative surgical plan is not provided in the ROSA® Partial Knee System and is only made available if a switch is performed intra-operatively from ROSA® Partial Knee System to the ROSA® Knee System. Landmarks taken intra-operatively on the patient's bony anatomy are used to create the intraoperative surgical plan.

An image-less 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 intra-operative landmarks.

The intra-operative workflow and surgical concepts implemented in the system remain close to the conventional PKA 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 using pre-operative imaging), and (3) precisely positioning the cut guide relative to the planned orthopedic implant location by using a robotic arm and (4) using the Zimmer Biomet Persona Partial Knee (PPK) spacer block to perform the femoral distal cut

The provided text describes the ROSA® Partial Knee System's 510(k) submission, confirming its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria or a detailed study proving the device meets said criteria. The document mentions performance data was provided, but the specifics of that data are not included in the excerpt.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance
• Sample sizes used for the test set
• Data provenance for the test set
• Number of experts used to establish ground truth for the test set and their qualifications
• Adjudication method for the test set
• Whether an MRMC comparative effectiveness study was done, or its effect size
• Whether a standalone (algorithm only) performance study was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

What can be extracted is:

Summary of Performance Data (Nonclinical and/or Clinical) - General Statements:

The submission states that the following performance data was provided in support of the substantial equivalence determination (though the details of the results are not given):

1. Biocompatibility Testing: No additional testing was deemed necessary. Existing testing for the Persona Partial Knee instrumentation and ROSA® Partial Knee instruments remains valid.
2. Electrical Safety and Electromagnetic Compatibility (EMC): No additional testing was deemed necessary on the ROSA® RECON Platform. Existing EMC testing is still applicable.
3. Device Performance Testing:
   • Physical/Performance Tests: To ensure the performance of implemented features and verify related design inputs.
   • Engineering Analysis: To ensure the performance of implemented features and verify related design inputs.
   • Validation Lab: Performed to validate that using the ROSA® Partial Knee System is equivalently safe and effective, and that the performances of the system are acceptable under full simulated use on cadaveric specimens.
4. Software Verification and Validation Testing:
   • Tests were conducted to satisfy requirements of the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304 (Medical Device Software- Life Cycle Process).
   • The software was considered a "major" level of concern.
   • The documentation provided suggests that a failure of any device software function could present a hazardous situation with a probable risk of death or serious injury.
   • The testing demonstrates that the ROSA® Partial Knee System does not raise any new issues of safety and effectiveness as compared to the predicate device.

Ask a specific question about this device

The ROSA® Partial Knee System, for use with the ROSA® RECON platform, is indicated as a stereotaxic instrumentation system for Partial Knee replacement (PKA) 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 the knee implant components.

The robotic arm placement is performed relative to anatomical landmarks as recorded using the system intraoperatively, and optionally based on a three-dimensional representation of the bone structures determined preoperatively using compatible X-ray or MRI based imaging technologies.

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

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

The ROSA® Partial Knee System is to be used with Persona Partial Knee (PPK) fixed bearing knee replacement system in accordance with its indications and contraindications.

The ROSA® Partial Knee System for use with the ROSA® RECON Platform is used to assist surgeons in performing Partial Knee Arthroplasty (PKA) on the medial compartment with features to assist with the bone resections as well as assessing the state of the soft tissues to facilitate implant positioning intraoperatively.

The ROSA® Partial Knee System uses a Non-Device Medical Device Data System (MDDS) called the Zimmer Biomet Drive Portal which manages the creation and tracking of the surgical cases. The cases reside on the portal until it is 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 pre-operative ROSA Total Knee System (TKA) surgical plan. However, the pre-operative surgical plan is not provided in the ROSA® Partial Knee System and is only made available if a switch is performed intra-operatively from ROSA® Partial Knee System to the ROSA® Knee System. Landmarks taken intra-operatively on the patient's bony anatomy are used to create the intraoperative 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 intra-operative workflow and surgical concepts implemented in the system remain close to the conventional PKA 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 using pre-operative imaging), and (3) precisely positioning the cut guide relative to the planned orthopedic implant location by using a robotic arm.

The provided text is a 510(k) summary for the ROSA® Partial Knee System. While it describes the device, its intended use, and general performance testing (biocompatibility, electrical safety, software verification and validation), it 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.

The document states:

• "Verification and Validation Testing for ROSA® Partial was conducted with the following aspects: Physical/Performance Tests- to ensure the performance of the implemented features and verify related design inputs"
• "Validation Lab- performed to validate that using ROSA® Partial Knee 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 provide:

• A table of specific acceptance criteria (e.g., accuracy thresholds for bone cuts, alignment targets) and the quantitative reported device performance against these criteria.
• The sample size for a test set used for performance validation.
• Data provenance (country of origin, retrospective/prospective).
• Details on expert involvement for ground truth (number, qualifications, adjudication method).
• Whether an MRMC comparative effectiveness study was done involving human readers and AI assistance. Robotic surgical systems often focus on robotic accuracy and surgeon assistance, not typically AI-driven image interpretation in the same way an AI diagnostic tool would.
• Specific standalone algorithm performance (as it's a robotic system with a human-in-the-loop, not a purely AI diagnostic algorithm).
• The type of specific ground truth used for quantifying the performance (e.g., CT measurements post-cut, direct measurements, etc.).
• The sample size for the training set (if any machine learning was explicitly involved in training a model for decision-making, separate from software verification).
• How ground truth for the training set was established.

Based on the provided text, I cannot generate the table or provide detailed answers to most of your questions. The document focuses on regulatory compliance and substantial equivalence, not the detailed results of a performance study with specific quantitative acceptance criteria and outcomes.

Therefore, many parts of your request will be answered with "Not available in the provided text."

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device