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The OMNIVision™ system is intended to be used as an intra-operative system to assist in the alignment of prosthetic components during Total Hip Arthroplasty, where a reference to a rigid anatomical structure can be identified. The system achieves this by displaying intra-operative measurements of the acetabular component to the user calculated from visual information from a camera detecting fiducial markers.

The OMNIVision™ system is compatible for use with the legally marketed products

• · OPSInsight™ and
• · the Corin TrinityTM Acetabular System,
• · Trinity-iTM Acetabular shells and
• · TrinityTM non-occluded titanium plasma sprayed (TPS) acetabular shells.

The OMNI Vision™ system is indicated for use with the posterior, anterior surgical approaches for primary Total Hip Arthroplasty.

The OMNIVision™ system is an image-based navigation system intended to assist the surgeon in delivering a target acetabular cup placement during Total Hip Arthroplasty (THA). The system consists of a Camera Assembly, OMNIVision™ software application installed onto the laptop, fiducial markers used to track the position of the surgical instruments, and a single use sterile drape. The fiducial markers and camera drape are supplied in packaged and EtO sterilized condition.

The OMNIVision™ system displays real-time intraoperative information, cup alignment and cup depth, with augmented and virtual reality views using a fixed reference attached to the patient's pelvis. The workflow of the OMNIVision™ system involves instrument calibration, registration of patient anatomy, and determination of cup alignment. The system uses image-based registration of the patient's anatomy and matches it to the pre-operative CT images of the patient's anatomy, the OMNIVision System to intra operatively calculate and display the information relative to the patient's anatomy, and independent of the patient's intra-operative pelvic position.

The OMNIVision™ System is designed for use with the Corin Trinity Acetabular System components and compatible with the Corin OPSInsight™ system for pre-operative planning.

The OMNIVision system is an image-based navigation system intended to assist the surgeon in delivering a target acetabular cup placement during Total Hip Arthroplasty (THA). The acceptance criteria for the OMNIVision system were evaluated through various studies, including cadaver surgeries and software bench testing.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Cadaver Studies: The document states "Surgeon-user verification studies of performance measures and accuracy performed by cadaver surgeries." The sample size for cadavers is not specified.
• Data Provenance: The cadaver studies are likely prospective, as they involve newly performed surgeries under controlled conditions to test the device. The country of origin of this data is not specified.
• Software Bench Testing: A "phantom device developed with guidance from ASTM-F2554" was used. The sample size for this testing is not specified (e.g., number of test runs or simulations).
• Data Provenance: This is a controlled laboratory environment testing, hence prospective. The country of origin is not specified, though the manufacturer is based in Australia.

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

• Cadaver Studies: "Surgeon-user verification studies" implies surgeons were involved in the testing and evaluation. However, the number of experts and their specific qualifications (e.g., years of experience, specialization) used to establish ground truth or assess performance in the cadaver studies are not specified.
• Software Bench Testing: Ground truth for software bench testing would likely be based on predefined precise phantom measurements. No human experts are explicitly mentioned for establishing ground truth in this context, only in performing the tests.

4. Adjudication Method for the Test Set

The document does not specify any formal adjudication method (e.g., 2+1, 3+1, none) for either the cadaver studies or the software bench testing. The "surgeon-user verification" suggests a direct assessment by the operating surgeons for the cadaver studies.

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

There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done. The studies described focus on the standalone performance of the device without explicit comparison to human readers with and without AI assistance for effect size quantification.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Yes, a standalone performance study was done through software bench testing. This testing "demonstrated mean positional accuracy of ±1° for angular position and ±1mm for linear position" using a phantom device. This represents the algorithm's performance in a controlled, non-human-interaction scenario.
• The cadaver studies represent a human-in-the-loop scenario, where surgeons used the device to achieve the reported accuracy.

7. Type of Ground Truth Used

• Cadaver Studies: The ground truth for the cadaver studies is implied to be actual measurements taken post-implantation, based on the stated "accuracy of the OMNIVision™ System in implanting an acetabular cup." This would be a direct measurement of the implanted component's position relative to known anatomical landmarks.
• Software Bench Testing: The ground truth for software bench testing was based on a "phantom device developed with guidance from ASTM-F2554." This is a precisely engineered physical model with known, accurate measurements.

8. Sample Size for the Training Set

The document does not provide information regarding the sample size for any training set for the OMNIVision system's software. The system uses "image-based registration of the patient's anatomy and matches it to the pre-operative CT images of the patient's anatomy," implying some form of image processing or machine learning, but no details on training are given.

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

As no information is provided about a training set or its sample size, there is no information on how the ground truth for any potential training set was established.

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OmniVision is intended to be used for the acquisition, storage, communication and viewing of medical Images.OmniVision receives images from imaging modalities via DICOM or imported directly. It archives and displays these images for the use of medical specialists who are qualified to operate radiological equipment and to record and diagnose medical images.

It provides the user with a range of tools to assist them in viewing the images, such as zoom, filters and measurements, and with facilities to exchange images with other specialists.

OmniVision is not intended for the acquisition of mammographic image data.

OmniVision is a Picture Archiving and Communications System (PACS), as is the predicate Device dicomPACS. All of them have been developed to acquire, store, communicate, display and process medical images. They offer features (e.g. window leveling, zoom, measurements, annotations etc.) routinely used by medical professionals, such as radiologists and orthopaedists, and required of all PACS solutions.

OmniVision has a modular system architecture, It consists of the basic application viewer for image viewing and processing, image storage and communication, and a number of other modules for database management, image acquisition, printing etc.

OmniVision conforms to the DICOM (Digital Image and Communications in Medicine) standard.

The provided text describes the OmniVision Picture Archiving and Communications System (PACS) and its substantial equivalence to the predicate device, dicomPACS. However, it does not explicitly detail specific acceptance criteria in a quantitative manner or describe a study that involves performance metrics such as accuracy, sensitivity, or specificity.

The document primarily focuses on demonstrating that OmniVision provides comparable functionality, technological characteristics, and intended use as its predicate device to prove substantial equivalence for regulatory clearance. It confirms that the device has been tested according to the specifications documented in this notification and conforms to the DICOM standard.

Therefore, based solely on the provided text, the answer will reflect the absence of such detailed information.

Here's an analysis based on the provided input:

1. Table of acceptance criteria and the reported device performance

The provided document does not explicitly state quantitative acceptance criteria (e.g., minimum accuracy, sensitivity, or specificity) or the direct results of a performance study against such criteria. The document claims "substantial equivalence" to the predicate device, dicomPACS, based on functional and technological comparisons.

Instead, the comparison table focuses on functional similarities between OmniVision and dicomPACS:

The "acceptance criteria" here appear to be primarily functional equivalence and adherence to DICOM standards, rather than specific performance metrics like diagnostic accuracy. The study described is essentially a comparison study against a predicate device.

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

The document does not specify a sample size for any test set or the provenance (e.g., country of origin, retrospective/prospective) of any data used for performance evaluation that would typically be described in clinical validation studies. The testing mentioned refers to conformity with DICOM standards and specifications in the notification, not independent clinical performance.

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

Not applicable. The document does not describe a study involving expert-established ground truth for a test set. The device is a PACS system for image handling and viewing, not a diagnostic AI tool that generates a finding requiring ground truth for validation. The premise is that "medical specialists who are qualified to operate radiological equipment and to record and diagnose medical images" will use the system, implying human experts will interpret the images.

4. Adjudication method for the test set

Not applicable, as no described test set required adjudication for ground truth.

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

There is no mention of an MRMC comparative effectiveness study or any study evaluating human reader improvement with or without AI assistance. OmniVision is described as a PACS system providing tools like zoom, filters, and measurements, which are standard functionalities, not an AI-driven diagnostic assistance tool in the context of an MRMC study.

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

Not applicable. OmniVision is a PACS system intended for human-in-the-loop use by medical specialists. It is not an algorithm designed to provide standalone diagnostic output.

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

Not applicable, as no described study involved establishing ground truth for diagnostic accuracy.

8. The sample size for the training set

Not applicable. OmniVision is a PACS system, not an AI algorithm that undergoes "training" in the machine learning sense with a dataset.

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

Not applicable, as there is no training set mentioned for an AI algorithm.

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