(165 days)
The SPINEART Navigation reusable instruments are intended to be used during the preparation and placement of SPINEART PERLA TL screws during thoracolumbar spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SPINEART Navigation reusable instruments are specifically designed for use with the eCential Op.n PERLA® TL Nav System. It is indicated for population with medical conditions requiring the placement of spinal screws and for which the use of stereotactic surgery may be considered to be appropriate and where reference to a rigid anatomical structure, such as a vertebra, can be identified. The quidance is based on an intra-operative surgical plan developed with Op.n PERLA® TL Nav Software and based on intraoperative 3D images provided by a compatible imaging system.
The Spineart® Navigation reusable instruments are surgical instruments to be used with a Navigation System to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants. Currently cleared Spineart® Navigation reusable instruments (K210472) feature a connecting area for the tracker compatible with the Navigated with the Medtronic® StealthStation® Navigation System. The purpose of this submission is to get clearance to include Spinear's eCential® Navigation Adapter (subject device) designed to enable navigation of Spineart Navigation Instruments with the eCential® Op.nº Navigation System to the cleared range of SPINEART® Natrument System.
Here's an analysis of the acceptance criteria and study information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state the numerical acceptance criteria from the ASTM F2554 protocol or the eCential protocol. However, it indicates that the device met these criteria.
| Acceptance Criteria (Not explicitly stated numerically, but implied) | Reported Device Performance |
|---|---|
| Accuracy Verification (ASTM F2554 Protocol) | Verification of the eCential Navigation Adaptor designed by Spineart used in a worst-case scenario, with the eCential Op.n Perla TL Nav system, according to the ASTM F2554 protocol. |
| Accuracy Verification (eCential Protocol) | Performance data showed that the Navigation of the SPINEART Navigation reusable instruments with the eCential Op.n Perla TL Nav system using the eCential Navigation adaptor provides an accuracy equivalent to the acceptance criteria initially defined for the SPINEART Navigation reusable instruments when used with the Medtronic Stealthstation System. |
| Absence of Accuracy Issues with Adaptor | It has been demonstrated that the SPINEART eCential Navigation Adaptor (subject device) on the SPINEART Navigation reusable instruments (predicate device) for a use with the eCential Op.n Perla TL Nav system does not raise accuracy issues. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size for the test set used in the ASTM F2554 verification or the eCential protocol accuracy verification.
The data provenance is not explicitly stated in terms of country of origin, but the company (Spineart SA) is based in Switzerland. The studies are non-clinical (verification and accuracy testing), so concepts like "retrospective" or "prospective" are not applicable in the same way they would be for clinical trials.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish a ground truth for the test set. The testing described (ASTM F2554 verification and eCential protocol accuracy verification) appears to be objective, physical testing of the device's accuracy and performance against defined technical standards and internal protocols, rather than relying on human expert interpretation of results.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the testing described does not involve human interpretation or subjective assessment that would require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The testing mentioned is non-clinical performance and accuracy verification of the device itself.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the testing described appears to be a standalone study of the device's performance. The "Verification of the eCential Navigation Adaptor designed by Spineart used in a worst case scenario, with the eCential® Op.n® Perla TL Nav system, according to the ASTM F2554 protocole" and "Accuracy Verification: Verification of the SPINEART Navigation reusable instruments with the eCential® Op.nº Peda TL Nav system, according a Protocole defined by eCential®" describe the device's inherent accuracy and technical performance without human intervention as part of the measured outcome. The device itself assists in navigation, but the testing focuses on the accuracy of the navigation system and instruments, not the accuracy of a human using it.
7. The Type of Ground Truth Used
The ground truth for the non-clinical testing would be the established technical specifications and measurements outlined in the ASTM F2554 standard and the eCential protocol. It's based on objective, measurable physical parameters such as precision, accuracy, and mechanical performance under specific test conditions.
8. The Sample Size for the Training Set
Not applicable. The described device is a navigation instrument system, not an AI/ML algorithm that requires a training set. The "eCential Op.n PERLA TL Nav System" includes software, but the provided text focuses on the instruments and adaptor and their performance with the navigation system, not the training of an AI component within the software itself.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned for this device.
§ 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).