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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 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: Zimmer® Trabecular Metal™ Reverse Plus Shoulder, Comprehensive® Total Shoulder System, Comprehensive® Reverse Shoulder System and Comprehensive® Reverse Augmented Baseplates.

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

The Signature™ ONE System is developed to assist in pre-operative 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.

The provided text describes the 510(k) premarket notification for the Signature™ ONE System, a device intended to assist in pre-operative planning and intra-operative guiding for shoulder replacement surgery. However, the document does not contain specific acceptance criteria, detailed study results proving device performance against those criteria, or information regarding AI/algorithm performance metrics.

It primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and principles of operation, rather than providing a detailed performance study with quantitative acceptance criteria and results.

Therefore, many of the requested details cannot be extracted from this document.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not specified in the provided text.
• Data Provenance: Not specified, although testing on "cadaveric specimens" is mentioned. The country of origin of the data is not provided. It is presented as nonclinical performance data, and the general nature of such testing typically implies prospective testing on the device model.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not specified in the provided text.

4. Adjudication method for the test set

Not specified in 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

• MRMC Study: Not mentioned.
• Effect Size of Human Readers with AI vs. without AI assistance: Not applicable, as no MRMC study or AI performance improvement claims are detailed. The device is described as assisting in pre-operative planning and intra-operative guiding, not as an AI for reading or interpreting medical images in the context of improving human reader performance.

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

• The document implies a "human-in-the-loop" system where the surgeon reviews, modifies, and approves the plan. It states the system "assist[s] in pre-operative planning and/or intra-operative guiding" and surgeons "interact with to review, modify and approve the plan."
• No standalone algorithm-only performance is detailed.

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

The term "ground truth" is not explicitly used. However, the validation lab performed studies "under full simulated use on cadaveric specimens," implying that the performance was assessed against known anatomical structures and surgical targets within those specimens, likely guided by expert surgical opinion and established anatomical references for accuracy.

8. The sample size for the training set

Not applicable. The document describes a medical device for surgical planning and guidance, not an AI/machine learning algorithm with a distinct "training set."

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

Not applicable. See #8.

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