Search Results

OptiVu™ ROSA® MxR is indicated for displaying surgical workflow images from the ROSA® RECON platform in Mixed Reality. It includes functions for viewing the same surgical workflow steps and 2D visualizations as presented on the existing ROSA RECON platform user interface. When accessing ROSA® MxR from a stereoscopic head mounted display (HMD), images viewed are for informational purposes only and are not intended for diagnostic use.

OptiVu™ ROSA® Mixed Reality (ROSA® MxR) is indicated for displaying surgical workflow images from the ROSA® RECON Platform and the corresponding ROSA® clinical applications intra-operatively during orthopedic surgeries. It is intended to provide an additional means of display where the ROSA® RECON Platform user interface is duplicated into a Mixed Reality see-through environment. OptiVu™ ROSA® MxR allows the ROSA® RECON Platform user interface and corresponding ROSA® clinical applications (e.g. ROSA® Knee, ROSA® Partial, or ROSA® Hip) to be streamed through a compatible head-mounted display (HMD) (e.g. HoloLens 2).

The subject device's main purpose is to place the duplicated virtual ROSA® user interface at a convenient location to provide the following functionalities:

• Mixed Reality visualization solution
• Register hand gestures as inputs such as to touch, move and resize views
• Wireless connectivity between a HMD (e.g. HoloLens 2) and the ROSA® RECON Platform

The OptiVu™ ROSA® MxR device is designed to display surgical workflow images from the ROSA® RECON platform in Mixed Reality. It includes functions for viewing the same surgical workflow steps and 2D visualizations as presented on the existing ROSA RECON platform user interface via a head-mounted display (HMD) like the HoloLens 2. It's important to note that images viewed through the HMD are for informational purposes only and are not intended for diagnostic use.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list quantitative acceptance criteria in a typical tabular format. Instead, it describes general performance goals and verification activities. The overall acceptance criterion is demonstrating substantial equivalence to predicate devices without raising new questions of safety and effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a separate "test set" in the context of a clinical study with patient data. The performance evaluations described are primarily non-clinical device performance testing, engineering analysis, software verification and validation, and usability engineering. Therefore, the concept of sample size for patient data or data provenance (country of origin, retrospective/prospective) is not directly applicable in the information provided.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

As there is no mention of a clinical test set requiring expert-established ground truth related to patient data or diagnostic interpretations, this information is not provided. The device explicitly states that images viewed through the HMD are "for informational purposes only and are not intended for diagnostic use."

4. Adjudication Method for the Test Set

Given the absence of a clinical test set requiring expert interpretation of patient data, there is no mention of an adjudication method (e.g., 2+1, 3+1). The performance testing described focuses on the device's technical functionality and software integrity.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not mentioned in the provided document. The device's indications for use emphasize displaying surgical workflow information rather than diagnostic interpretation or AI-driven decision support for human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The document describes "Software Verification and Validation Testing" and "Device Performance Testing." While these are standalone tests of the algorithm's functional performance, they are not presented as a standalone clinical performance study in the sense of an algorithm making diagnostic or treatment decisions without human oversight. The device is an accessory for surgical workflow information display, not an autonomous diagnostic or therapeutic algorithm.

7. The Type of Ground Truth Used

For the software and device performance testing:

• Engineering specifications and design inputs served as the "ground truth" or reference for verification and validation activities. The tests aimed to ensure the device met these predefined requirements.
• Regulatory standards and guidance documents (e.g., FDA Guidance for Content Premarket Submissions for Software, IEC 62304) provided the "ground truth" for software quality and safety.

No "ground truth" in terms of expert consensus, pathology, or outcomes data for clinical decision-making is mentioned, consistent with its informational purpose.

8. The Sample Size for the Training Set

The document does not provide information on a "training set" in the context of machine learning. The device appears to be primarily an interface and display tool, integrating with existing ROSA® RECON Platform software, rather than a system that learns from a large dataset.

9. How the Ground Truth for the Training Set Was Established

As no training set (for machine learning) is discussed, the method for establishing its ground truth is not applicable or provided.

Ask a specific question about this device

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-overative 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.

Modifications have been made to some of the applications to improve the overall workflow: however, the patient specific guides and bone models remain unchanged from the predicate. In addition, modifications have been made to the user interface of the planning application.

The provided text is a 510(k) summary for the Signature™ ONE System, a device for pre-operative planning and intra-operative guiding for shoulder replacement surgery. It discusses the device's indications for use, its similarity to a predicate device, and modifications made. However, the document does not contain the specific information requested regarding acceptance criteria, detailed study results (like sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance), or the ground truth establishment process.

The section "Summary of Performance Data (Nonclinical and/or Clinical)" only states:

• "Addition of a landmark to the Signature ONE Planner to display the location of the deepest glenoid point"
• "A feature is added to the Signature ONE Planner to display the medial/lateral translation between the backside on the implant and a reference landmark located on the most lateral point of the glenoid"
• "A feature is added to the Signature ONE Planner to display the percentage of contact between the selected implant and the glenoid surface"
• "All of the test steps passed successfully."

This is a very high-level summary and does not provide the detailed study information needed to answer your questions. This type of FDA clearance (510(k)) often relies on demonstrating substantial equivalence to a predicate device rather than presenting extensive, complex clinical trial data as might be seen for novel technologies or PMA (premarket approval) applications.

Therefore, I cannot provide the requested information from the given text. The document indicates that tests were performed and passed, but the specifics of those tests, the acceptance criteria, and how they proved the device meets those criteria are not detailed in this summary.

Ask a specific question about this device

Efficient Care 3D Planning is software indicated for assisting orthopedic surgeons in preoperative planning of knee orthopedic surgeries. The software allows for the overlaying of 3D/2D implant models and for the visualization of the radiological images and 3D reconstruction of bones, and includes tools for performing measurements on the images or 3D model of bones, and for selecting and positioning the implant model. Clinical judgments and experience are required to properly use the software.

Efficient Care 3D Planning 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 CR-Flex Gender, NexGen LPS, NexGen LPS-Flex, NexGen LPS-Flex Gender, Persona® CR, Persona PS, Vanguard® CR, and Vanguard PS.

Efficient Care 3D Templating is software application that is intended to assist in the preoperative sizing of femoral and tibial implants. The software solution allows for the processing of multiple 2D X-rays to create 3D bone models that scales to patient bones and compensates for patient leg rotation in the X-rays images. The 3D bone models allow implant sizing to occur and output a template report, which includes overlays of prostheses, in respect to leg orientations on the X-ray images. Final implant sizing is based on intraoperative surgeon assessment.

The provided text describes the regulatory clearance of a medical device called "Efficient Care 3D Planning" but does not contain detailed information about a comprehensive study that establishes specific acceptance criteria and rigorously proves the device meets those criteria with detailed performance metrics.

However, based on the snippet provided under "Summary of Performance Data (Nonclinical and/or Clinical)", we can infer some information relevant to acceptance criteria and a study:

Inferred Acceptance Criteria and Reported Device Performance

Missing Information:

The provided text lacks specific details for most of the requested points. Below is a breakdown of what is not present in the document for a complete description of the study and acceptance criteria:

1. Sample sized used for the test set and the data provenance: Not specified.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not specified.
4. 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: Not indicated beyond the statement that "Clinical judgments and experience are required to properly use the software." This implies human involvement, but no MRMC study details are given.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The "Implant Predictability Tests" seem to describe an algorithm-only performance assessment against post-operative results. However, the exact methodology (standalone vs. assisted) isn't explicitly detailed.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the "Implant Predictability Tests," the ground truth was the "post-op implant size."
7. The sample size for the training set: Not specified.
8. How the ground truth for the training set was established: Not specified.

Additional Information from the text regarding device validation:

• Biocompatibility Testing: Conducted in accordance with ISO 10993. The device meets biocompatibility requirements.
• Software Verification & Validation Testing: Conducted and documented as recommended by FDA guidance. The software was considered a "moderate level of concern" meaning a failure could lead to "Minor Injury."

In summary, while the document mentions "Implant Predictability Tests" to confirm performance related to implant sizing accuracy, it does not provide the comprehensive study details, sample sizes, expert qualifications, or ground truth establishment methodologies that would typically be expected for a detailed description of device validation against acceptance criteria.

Ask a specific question about this device