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510(k) Data Aggregation
(90 days)
The TMINI™ Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components.
The robotic device placement is performed relative to anatomical landmarks as recorded using the system intraoperatively and based on a surgical plan determined preoperatively using CT based surgical planning tools.
It includes a handheld robotic device, 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 implant(s) compatible with the TMINI™ Miniature Robotic System. The TMINI™ Miniature Robotic System is to be used with the following knee replacement system(s) in accordance with the indications and contraindications: Enovis™ EMPOWR Knee System®.
The TMINI™ Miniature Robotic System consists of three primary components: a three-dimensional, graphical, Preoperative Planning Workstation (TPLAN Planning Station), an Optical Tracking Navigation Console (TNav) and a Robotically Controlled Hand-held Tool (TMINI Robot) that assists the surgeon in preparing the bone for implantation of TKA components.
The TPLAN Planning Station uses preoperative CT scans of the operative leg to create 3D surface models for case templating and intraoperative registration purposes. The Planning Workstation contains a library of 510(k) cleared knee replacement implant(s). The surgeon can select an implant model from this library and manipulate the 3D representation of the implant in relation to the bone model to optimally place the implant. Once the surgeon is satisfied with the implant location and orientation, the data is written to a file that is used to guide the robotically controlled hand-held tool.
The handheld robotic tool is optically tracked relative to optical markers placed in both the femur and tibia and articulates in two degrees-of-freedom, allowing the user to place bone pins in a planar manner in both bones. Mechanical guides are clamped to the bone pins, resulting in subsequent placement of cut slots and drill guide holes such that the distal femoral and proximal tibial cuts can be made in the pre-planned positions and orientations, and such that the implant manufacturer's multi-planer cutting block can be placed relative to drilled distal femoral pilot holes.
The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the way described in the prompt. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Rosa Knee System) for FDA clearance.
However, I can extract the information related to performance testing that is mentioned as part of the substantial equivalence claim.
Here's an attempt to answer based on the available information, highlighting where details are missing:
The TMINI™ Miniature Robotic System (K230202) underwent performance testing to support its substantial equivalence to the legally marketed predicate, Rosa Knee System (K182964).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (from predicate) | Reported Device Performance (TMINI™) |
|---|---|---|
| Biocompatibility | Passed | Passed |
| Cutting Accuracy |
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(149 days)
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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(137 days)
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® Hip System, Avenir Complete™ Hip System, Taperloc® Complete Hip System, Echo® Hip System.
The ROSA® Hip System (RHS) 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 ROSA® Hip 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 ROSA® Hip System utilizes the robotic arm of the ROSA® RECON platform cleared in K182964, but does not add new stereotaxic or robotic components
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. Fluoroscopic images are then captured with the ROSA® Tablet and transferred onto ROSA®. 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 system provides pre, intra and post-operative measurements relative to patient anatomy and does not provide infrared-based stereotaxic navigation for implant placement. 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 discrepancies measurements.
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 discrepancies measurements based on fluoroscopic image references.
Based on the provided text, the ROSA® Hip System is a fluoroscopic-guided system for total hip arthroplasty (THA) that assists surgeons in component placement. Here's a breakdown of the acceptance criteria and study information:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a formal table of quantitative acceptance criteria with corresponding performance metrics like sensitivity, specificity, accuracy, or specific measurement tolerances. Instead, it describes various tests and analyses performed to ensure the device's acceptable performance and safety. The acceptance essentially comes from demonstrating that the device meets established regulatory standards and design inputs.
| Acceptance Criteria Category | Description of Acceptance | Reported Device Performance (Summary) |
|---|---|---|
| Biocompatibility | Meets biocompatibility requirements according to ISO 10993. | Evaluation reveals that the ROSA Hip device meets biocompatibility requirements. |
| Electrical Safety | Complies with recognized electrical safety standards (IEC 60601-1). | The device complies with IEC 60601-1 standard for electrical safety. |
| Electromagnetic Compatibility (EMC) | Complies with recognized EMC standards (IEC 60601-1-2). | The device complies with IEC 60601-1-2 standard for electromagnetic compatibility. |
| Device Performance | Performance of implemented features verified; design inputs verified; usability addressed; safe and effective under full simulated use. | Physical/Performance Tests, Engineering Analysis, Usability Engineering, and Validation Lab (on cadaveric specimens) were conducted to ensure performance, verify design inputs, address usability, and validate safety and effectiveness. |
| Software Verification & Validation | Satisfies requirements of FDA Guidance for Premarket Submissions for Software Contained in Medical Devices and IEC 62304; does not raise new safety/effectiveness issues. | Software tests were conducted, and the software was considered a "major" level of concern. Testing demonstrates that the ROSA Hip System does not raise any new issues of safety and effectiveness compared to predicate devices. |
2. Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: The document mentions "full simulated use on cadaveric specimens" for Validation Lab testing, but it does not specify the sample size (i.e., number of cadavers or individual surgical simulations).
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the data was retrospective or prospective. Given the nature of a 510(k) submission for a new device, it's highly probable that the testing, particularly the cadaveric studies, was prospective, and likely conducted in Canada (where Zimmer CAS is located) or the US.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not specify the number of experts used or their qualifications for establishing ground truth during the cadaveric testing. The phrase "full simulated use on cadaveric specimens" implies that the performance was likely assessed by experienced surgeons or researchers against predefined anatomical landmarks and implant placement targets, but the details are not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
The document does not describe any specific adjudication method for the test set, such as 2+1 or 3+1.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, the document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on demonstrating the device's technical performance and safety, rather than directly comparing human reader performance with and without AI assistance. The system assists the surgeon, rather than providing an AI-driven interpretation that human readers would then interpret or compare against.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The ROSA® Hip System is described as assisting the surgeon in a fluoroscopic-guided system where images are acquired, processed, and used to guide robotic arm movements for instrument orientation. It is explicitly stated that the "ROSA® Hip System is not for primary image interpretation." Therefore, no standalone (algorithm-only) performance evaluation would be applicable or relevant for this type of assistive surgical navigation device. Its function is inherently human-in-the-loop.
7. The type of ground truth used:
Based on the description of the device's function, the ground truth for performance testing (particularly the cadaveric studies) would likely involve:
- Anatomical landmarks: Verifying that the system accurately identifies and registers anatomical landmarks from fluoroscopic images.
- Surgical planning values: Comparing the intraoperative cup placement and component orientation achieved with the system against predefined preoperative planning values (which would serve as a form of ground truth for optimal placement).
- Measurements: Verifying the accuracy of leg length and offset discrepancies measurements compared to physical or pre-measured values on the cadavers.
- Expert Consensus/Observation: The outcome of the cadaveric studies (e.g., whether the system successfully assisted in accurate placement to a specified degree) would be assessed by surgical experts.
The ground truth is not pathology or clinical outcomes data, but rather adherence to surgical planning, anatomical accuracy, and positional precision in a simulated environment.
8. The sample size for the training set:
The document does not specify a sample size for a training set. Given that this is a surgical assistance system primarily using fluoroscopic image processing and robotic guidance logic, it's not described as a deep learning or AI model in the conventional sense that would require a large, labeled training dataset for image classification or prediction tasks. The "software" aspect refers more to control logic, image registration algorithms, and user interface elements, rather than a trainable AI model for image interpretation.
9. How the ground truth for the training set was established:
Since a training set with explicitly established ground truth (as in machine learning) is not described, this information is not provided. The development and verification of such a system would rely on mathematical models, engineering principles, and rigorous testing against known physical and anatomical parameters.
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