Search Results

Ask a specific question about this device

OptiVu™ Shoulder is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures (humerus and scapula), humerus resection, and aligning the endoprosthesis with the anatomical structures, provided that the required anatomical landmarks can be identified on the patient's preoperative CT scan.

OptiVu™ Shoulder utilizes pre-operative planning files provided by the Zimmer CAS Signature ONE™ System. OptiVu™ Shoulder is compatible with any humeral implants that are supported by the Signature ONE™ System.

OptiVu™ Shoulder is specifically indicated for total shoulder arthroplasty using the Zimmer Biomet Alliance® Glenoid system or reverse shoulder arthroplasty using the Comprehensive® Reverse Shoulder system, to aid the surgeon in locating anatomical structures (humerus and scapula), humerus resection, and aligning the glenoid component with the anatomical structures.

OptiVu Shoulder includes an augmented reality (AR) head-mounted display (HMD) (OptiVu Tilt with HoloLens 2) and trackers to register and optically track anatomical landmarks and surgical instruments in real-time during the procedure. The HMD should not be relied upon solely and should always be used in conjunction with traditional methods.

OptiVu Shoulder is a stereotaxic surgical navigation system designed to aid surgeons in locating anatomical structures and aligning the endoprosthesis in total or reverse shoulder arthroplasty procedures. The system includes an augmented reality (AR) head-mounted display (HMD) (OptiVu Tilt with HoloLens 2) and mixed reality trackers to register and optically track anatomical landmarks and surgical instruments in real-time during the procedure.

The OptiVu Shoulder system is intended to be used specifically with the Zimmer Biomet Alliance® Glenoid or Comprehensive® Reverse Shoulder system for total or reverse shoulder arthroplasty, respectively.

The OptiVu Shoulder system also utilizes pre-operative planning files provided by the Zimmer CAS Signature ONE™ System.

The intended users of the system are surgeons who are trained in performing shoulder arthroplasty procedures.

This 510(k) clearance letter pertains to a Special 510(k) submission for the OptiVu™ Shoulder system. A Special 510(k) is used when changes to a previously cleared device do not alter its fundamental scientific technology or indications for use, but rather involve specific modifications. In this case, the modifications are explicitly stated to be updates to packaging parameters and the site for contract sterilization, not changes to the software, functionality, or performance of the navigation system itself.

Therefore, the provided document does not contain the information requested about the acceptance criteria and study proving the device meets those criteria for the AI/software performance, as this type of study would have been part of the original 510(k) clearance for OptiVu™ Shoulder (K250108), not this Special 510(k) (K252170). The validation testing performed for this submission is limited to sterilization efficacy and packaging safety.

This document explicitly states:

• "The purpose of this Special 510(k) submission is to update both the packaging parameters for the instruments and the site for contract sterilization."
• "There are no differences in technological characteristics that raise questions of safety and efficacy."
• "With the updated packaging and sterilization parameters presented in this submission, there are no technological or design changes in the subcomponents of the OptiVu Shoulder system instruments themselves."
• "Validation testing was conducted according to written protocols with acceptance criteria that were based on established standards. This submission includes or references the following tests in support of a substantial equivalence determination:
  • Sterilization validation testing to confirm that there is no impact to the sterilization efficacy of the system
  • Packaging validation to confirm that the packaging of OptiVu Shoulder system is safe and effective"

Conclusion based on the provided document:

The provided 510(k) clearance letter for K252170 (OptiVu™ Shoulder) is a Special 510(k), which addresses changes only to the packaging and sterilization of the device, not its core functionality or software performance. As such, the document does not contain any information about acceptance criteria or performance studies related to the artificial intelligence/software accuracy, clinical effectiveness, human reader improvement with AI assistance, or the establishment of ground truth for such studies. This type of information would have been part of the original 510(k) submission (K250108) for the device's fundamental technology.

Therefore, I cannot populate the requested table or answer the specific questions about AI/software performance, ground truth, and study parameters based solely on the provided text.

Ask a specific question about this device

OptiVu Shoulder is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures (humerus and scapula), humerus resection, and aligning the endoprosthesis with the anatomical structures, provided that the required anatomical landmarks can be identified on the patient's preoperative CT scan.

OptiVu Shoulder utilizes pre-operative planning files provided by the Zimmer CAS Signature ONE™ System. OptiVu Shoulder is compatible with any humeral implants that are supported by the Signature ONE™ System.

OptiVu Shoulder is specifically indicated for total shoulder arthroplasty using the Zimmer Biomet Alliance® Glenoid system or reverse shoulder arthroplasty using the Comprehensive® Reverse Shoulder system, to aid the surgeon in locating anatomical structures (humerus and scapula), humerus resection, and aligning the glenoid component with the anatomical structures.

OptiVu Shoulder includes an augmented reality (AR) head-mounted display (HMD) (OptiVu Tilt with HoloLens 2) and trackers to register and optically track anatomical landmarks and surgical instruments in real-time during the procedure. The HMD should not be relied upon solely and should always be used in conjunction with traditional methods.

OptiVu Shoulder is a stereotaxic surgical navigation system designed to aid surgeons in locating anatomical structures and aligning the endoprosthesis in total or reverse shoulder arthroplasty procedures. The system includes an augmented reality (AR) head-mounted display (HMD) (OptiVu Tilt with HoloLens 2) and mixed reality trackers to register and optically track anatomical landmarks and surgical instruments in real-time during the procedure.

The OptiVu Shoulder system is intended to be used specifically with the Zimmer Biomet Alliance® Glenoid or Comprehensive® Reverse Shoulder system for total or reverse shoulder arthroplasty, respectively.

The OptiVu Shoulder system also utilizes pre-operative planning files provided by the Zimmer CAS Signature ONE™ System.

The intended users of the system are surgeons who are trained in performing shoulder arthroplasty procedures.

The provided FDA 510(k) clearance letter for OptiVu™ Shoulder describes the device and its intended use, but it does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and the specific study that proves the device meets those criteria.

The document states that non-clinical testing was conducted to demonstrate safety and effectiveness, including "Performance tests to ensure the performance of the implemented features and verify related design inputs" and "Validation lab to validate that the OptiVu Shoulder system is safe and effective and performance of the system is acceptable under full simulated use on cadaveric specimens." However, the specific acceptance criteria values and the quantitative results of these tests are not provided in this public clearance letter. This type of detailed performance data is typically found within the full 510(k) submission, which is a confidential document.

Therefore, I cannot populate the table or provide specific values for most of your questions. I can only infer what kind of studies would have been conducted based on the mention of "Validation lab" with "cadaveric specimens" and "Performance tests."

Here's what I can extract and infer from the provided text, along with clear indications of what information is missing:

While the complete details of the acceptance criteria and the specific study proving the device meets them are not fully contained within the provided FDA 510(k) clearance letter, the document does refer to non-clinical testing that was conducted to demonstrate safety and effectiveness.

The clearance letter mentions:

• "Performance tests to ensure the performance of the implemented features and verify related design inputs"
• "Validation lab to validate that the OptiVu Shoulder system is safe and effective and performance of the system is acceptable under full simulated use on cadaveric specimens"

Based on the nature of a stereotaxic surgical navigation system for shoulder arthroplasty, the acceptance criteria would typically revolve around the accuracy and precision of anatomical structure localization, humerus resection, and endoprosthesis alignment. The "Validation lab" study on cadaveric specimens strongly suggests a performance study was conducted to quantify these aspects.

However, the specific numerical acceptance criteria (e.g., target accuracy in mm and degrees) and the quantitative results (reported device performance) are not provided in this public document.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific numerical acceptance criteria and reported performance values are not present in the provided document. The table below represents typical acceptance criteria for such a device, and the "Reported Device Performance" column cannot be filled with concrete data from this document.

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

• Test Set Sample Size: Not specified in the provided document. The document mentions "full simulated use on cadaveric specimens," implying a test set that included multiple cadaveric specimens, but the exact number is missing.
• Data Provenance: The document explicitly states "cadaveric specimens." The geographic origin (country) is not specified. The study was likely prospective as it involved simulated use of the device for testing purposes.

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

• Number of Experts: Not specified in the provided document.
• Qualifications of Experts: Not specified in the provided document. For a device used in surgical navigation, these would typically be experienced orthopedic surgeons familiar with shoulder arthroplasty.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified in the provided document. Given the nature of a cadaveric study for surgical navigation accuracy, adjudication might refer to the method used to establish the "true" surgical plan or the "true" anatomical alignment against which the device performance is measured (e.g., independent measurements by a metrology expert, or consensus among multiple surgeons on the optimal plan).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was NOT mentioned or described in the provided document. This type of study typically assesses the impact of an AI algorithm on human reader performance (e.g., radiologists interpreting images). OptiVu™ Shoulder is a surgical navigation system with an Augmented Reality (AR) HMD for real-time guidance, not primarily an image interpretation AI tool. Its effectiveness study would focus on its guidance accuracy during simulated surgery, rather than assisting human readers in diagnostic interpretation.
• Effect Size of Human Reader Improvement: Not applicable, as an MRMC study was not described.

6. Standalone (Algorithm Only) Performance

• Standalone Performance: The document describes "Performance tests" and "Validation lab" studies. While the results are not quantified, these studies would inherently evaluate the "standalone" or "algorithm-only" performance of the navigation system (e.g., its accuracy in tracking, registration, and guidance output) in a controlled environment without active human intervention beyond operating the system as intended. The "HMD should not be relied upon solely and should always be used in conjunction with traditional methods" indicates that the device is intended for human-in-the-loop use, but its core performance metrics (accuracy of localization, resection, alignment) would be evaluated in a standalone manner.

7. Type of Ground Truth Used

• Type of Ground Truth: The document explicitly states "full simulated use on cadaveric specimens." Therefore, the ground truth would likely be established through:
  • Pre-operative CT scan planning: The "true" surgical plan (e.g., desired resection angles, implant position) is derived from the pre-operative CT scan using the Zimmer CAS Signature ONE™ System.
  • Post-hoc metrology/physical measurements: After using the OptiVu™ Shoulder system on the cadaver, the actual resections and implant placements would be measured using highly accurate metrology tools (e.g., CMM, industrial CT scanning) and compared against the planned values derived from the pre-operative CT. This comparison would quantify the accuracy of the device's guidance.

8. Sample Size for the Training Set

• Training Set Sample Size: Not specified in the provided document. The 510(k) clearance process primarily focuses on the safety and effectiveness of the final device, including its performance characteristics, rather than the details of the training data used for its development (unless it's a specific AI/ML medical device where the training data directly impacts performance).

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

• Training Set Ground Truth Establishment: Not specified in the provided document. As mentioned above, the details of the training process and data are typically not disclosed in the public 510(k) clearance letter.

Ask a specific question about this device