(110 days)
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
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| For Cadaver Studies | ||
| Angular position | ±3° (Max. error) | ±3° |
| Linear position | ±3mm (Max. error) | ±3mm |
| For Software Bench Testing | ||
| Angular position | Not explicitly stated (bench testing implies higher precision than clinical use) | Mean ±1° |
| Linear position | Not explicitly stated (bench testing implies higher precision than clinical use) | Mean ±1mm |
| User Requirements | Established criteria for user requirements | Met established criteria |
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.
§ 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).