(131 days)
The Remi Robotic Navigation System is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of a tool holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous spinal procedures in reference to rigid patient anatomy and fiducials that can be identified on a 3D imaging scan or 2D fluoroscopic images. The Remi Robotic Navigation System is indicated for assisting the surgeon in placing pedicle screws in the posterior lumbar region (L1-S1). The system is designed for lumbar pedicle screw placement with the prone position and is compatible with the Accelus LineSider Spinal System.
The Remi Robotic Navigation System (Remi) is an image guided system primarily comprised of a computer workstation, software, a trajectory system, including a targeting platform, a camera, and various image guided instruments intended for assisting the surgeon in placing screws in the pedicles of the lumbar spine. The system operates in a similar manner to other optical-based image y systems.
The provided text describes a 510(k) premarket notification for the Remi Robotic Navigation System (K223350). The submission focuses on demonstrating substantial equivalence to its predicate devices, particularly an earlier version of the Remi Robotic Navigation System (K223070) and the EXCELSIUS GPS (K171651). The key change in the subject device is the addition of compatibility with 2D fluoroscopic imaging systems for pedicle screw placement in the posterior lumbar region (L1-S1).
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics for the tested device. It broadly states that "The testing shows that the use of the 2D fluoroscopic images with the Remi system is equivalent to the use of the validated 3D imaging systems." and that the device "continues to meet design requirements, is as safe and effective as the predicate device, and performs according to its intended use."
However, the "POSITIONING ACCURACY (BENCH)" for the Primary Predicate Device is listed as: 0.74 ± 0.36 mm (worst case); 95% CI: 1.46mm (worst case). Since the subject device "Same as Primary Predicate" for this characteristic and the testing was done to demonstrate equivalence, it can be inferred that the acceptance criterion for accuracy for the new functionality is to maintain this level of accuracy or be equivalent to it.
| Acceptance Criterion (Inferred from Predicate) | Reported Device Performance (Equivalent to Predicate) |
|---|---|
| Positioning Accuracy: ≤ 0.74 ± 0.36 mm (worst case), 95% CI: 1.46mm (worst case) | Maintained (Stated as "Same as Primary Predicate" and "equivalent to the use of the validated 3D imaging systems") |
| Software System Functionality | Met (Software System Test performed) |
| Navigation Accuracy | Verified (Navigation Accuracy Verification performed) |
| System Accuracy | Validated (System Accuracy Validation performed) |
| ASTM F2554 Compliance | Met (ASTM F2554 Accuracy Test performed) |
| Software Unit and Integration | Met (Software Unit and Integration Tests performed) |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Performance Testing - Bench" was conducted, including "Navigation Accuracy Verification," "System Accuracy Validation," "Software System Test," "ASTM F2554 Accuracy Test," and "Software Unit and Integration Tests." However, specific sample sizes for these tests (e.g., number of cases, images, or measurements) are not provided.
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given that it is bench testing, it is likely that the data was generated in a controlled laboratory or testing environment rather than being derived from patient cases.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided. The document describes bench testing, which typically uses defined physical standards or simulated scenarios to establish ground truth rather than expert consensus on clinical images/data.
4. Adjudication Method for the Test Set
This information is not provided. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation of clinical data and subsequent consensus determination. Since the testing described is bench testing, such an adjudication method is unlikely to apply.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The submission focuses on demonstrating substantial equivalence through bench testing, verifying that the added 2D fluoroscopy functionality maintains the device's accuracy and safety profiles compared to its predicate with 3D imaging. There is no information regarding human readers improving with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone (algorithm only) performance study was done. The performance testing described (Navigation Accuracy Verification, System Accuracy Validation, Software System Test, ASTM F2554 Accuracy Test, Software Unit and Integration Tests) are all characteristics of a standalone performance evaluation, focusing on the device's technical capabilities without human interaction determining performance outcomes within the tests themselves. The stated purpose was "to demonstrate that the updated requirement for this change was met and to ensure the risk profile of Remi was maintained," specifically concerning "the use of the 2D fluoroscopic images with the Remi system is equivalent to the use of the validated 3D imaging systems."
7. Type of Ground Truth Used
The ground truth for the bench testing would likely involve engineered physical phantoms, precisely manufactured test fixtures, and controlled experimental setups with known geometric parameters and validated measurements. For example, for "Navigation Accuracy Verification" and "System Accuracy Validation," physical measurements against a known standard or calibrated instruments would establish the ground truth. For "Software System Test" and "Software Unit and Integration Tests," the ground truth would be defined by the software's specified functional requirements and expected outputs.
8. Sample Size for the Training Set
The document does not provide information about a training set or its sample size. The submission is for a modification to an existing cleared device, specifically adding 2D fluoroscopic image compatibility. While the software was updated to support this, including an algorithm correcting distortion, the text implies that the evaluation focused on the performance of the system with the new capability rather than the development of a completely new AI algorithm requiring extensive training data. If machine learning was used for the distortion correction, details about its training would typically be in a separate section not provided here.
9. How the Ground Truth for the Training Set Was Established
As no training set is explicitly mentioned, this information is not provided.
§ 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).