(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.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).