(128 days)
For spinal use the CIRQ Robotic Alignment Module is an accessory to the compatible Brainlab IGS Spinal software applications and is intended to be an intraoperative image guided localization system to achieve pre-planned trajectories with surgical instruments.
The medical indications for use of the CIRQ Robotic Alignment Module for spinal use is the treatment of diseases where the placement of spinal screws is indicated.
The device is an accessory to the compatible Brainlab IGS Spinal software applications (K183605) and is intended to be an intraoperative image guided localization system to support the surgeon to achieve pre-planned trajectories with surgical instruments.
The device consists of the Cirq Robotic Alignment Module which is connected to the Surgical Base System from Medineering. It serves to align instruments to a pre-planned trajectory during surgical procedures using the Cirq Robotic Application Software together with the Brainlab IGS Spinal software applications.
Infrared passive marker based tracking as provided by the optical tracking camera unit of the navigation platform is used to determine the instrument's and patient's position. The relation between the patient and the reference attached to the patient is realized with a registration (manually or automatically).
The device is manually pre-aligned roughly to the region of interest by opening the brakes of the Surgical Base System using its 7 degrees of freedom. Following this, the tracking information is used to automatically fine align a tracked guide attached to the Cirq Robotic Alignment Module to achieve a pre-planned trajectory controlled by the CIRQ Robotic Application Software. After finishing the alignment, the device remains in this position and the surgical instruments through the provided guide to perform the surgical steps intended without losing the trajectory.
The provided FDA 510(k) summary for the CIRQ Robotic Alignment Module outlines various tests conducted to demonstrate the device's safety and effectiveness. However, it does not contain specific details regarding acceptance criteria for quantitative performance metrics, nor does it describe a clinical study of the device against a defined ground truth, a multi-reader multi-case (MRMC) study, or statistical analyses of AI performance.
The information provided focuses on engineering and usability verification, with conclusions stating "successful" or "met." It confirms that the device is an accessory for achieving pre-planned surgical trajectories but does not present quantifiable performance data (e.g., accuracy, precision) against specific acceptance criteria for robotic alignment.
Therefore, based on the provided text, I cannot answer sections 1, 2, 3, 5, 6, 7, 8, and 9 of your request as they relate to quantitative device performance, clinical study design, and ground truth establishment in a medical AI context. The document describes a device (hardware/software integration for robotic alignment) rather than a diagnostic AI algorithm.
However, I can extract information relevant to the types of tests performed that would typically lead to acceptance criteria, even if the criteria themselves are not explicitly numeric in this summary:
Summary of Device Performance and Testing (Based on provided 510(k) summary):
The provided document describes engineering verification and validation activities for the CIRQ Robotic Alignment Module. It does not detail a study proving the device meets quantitative performance acceptance criteria in the way one would expect for an AI diagnostic device (e.g., sensitivity, specificity, or AUC). Instead, it focuses on functional, safety, and integration testing.
Here's a breakdown of the relevant information from the document, acknowledging that it doesn't fit the typical "acceptance criteria for an AI study" format:
1. A table of functional/safety criteria and reported device performance (interpreted from the "Test" table):
| Acceptance Criteria (Inferred from Test Description) | Reported Device Performance (Conclusion/Result) |
|---|---|
| Functional: Accurate positioning of surgical instruments to planned trajectory and maintenance of position during procedure. Usefulness in open/percutaneous, minimally invasive approaches. | Verification of general functions successful. All requirements met. (Tested on a MIS Spine Training Model in a simulated clinical environment by spinal surgeons). |
| Design: Conformance to overall design, layout, and general behavior. | Verification of general design requirements successful. |
| Safety: Implementation and effectiveness of all specified risk control measures. | Risk control measures are effective and mitigate the associated risks. |
| Human Factors/Usability: Safe and effective use by surgeons and OR nurses. | System is safe and effective to use. (Usability tests with surgeons and OR nurses performed in a simulated clinical environment covering complete clinical workflow). |
| Product Safety (Standards Compliance): Compliance with AAMI/ANSI ES60601-1:2005, IEC 60601-1-2, IEC 80601-2-77, AIM standard 7351731. | Compliance with standards requirements demonstrated, no deviations. |
| Biocompatibility/Reprocessing: Material properties assessed for biocompatibility and response to cleaning/disinfection/sterilization. | Biocompatibility assessment and reprocessing tests successful. |
| Environmental: Adherence to RoHS, REACH, and WEEE directives. | Environmental tests successful. |
| Compatibility: Integration into spinal workflow and compatibility with spinal navigation applications and Brainlab navigation platforms. | Integration and compatibility tests successful. |
| Mechanical: Mechanical stability, lifecycle, and interface of components (e.g., fixating to OR table, holding surgical instruments). | Mechanical tests successful. |
| Integration (Robotic Application, Surgical Base System, Cirq Robotic Alignment Module, instruments): Tested integration incl. cybersecurity, braking concept, and alignment to desired position. | Integration tests Robotic Application with other components successful. |
| Software Verification (Surgical Base System firmware & Robotic Application): Compliance with IEC 62304 and FDA Guidance for Premarket Submissions for Software. | Surgical Base System software verification successful. |
| Robotic Application software verification successful. | |
| Sterile Drape Integration: Match in form, fit, function, sterile barrier, and navigation compatibility. | Drape integration tests successful. |
| Stabilization Brace Integration: Match in form, fit, function with Surgical Base System mechanical dimensions. | Stabilization brace integration tests successful. |
2. Sample size used for the test set and the data provenance:
- For the "Verification of general functions" and "Human factors / Usability Testing," the testing involved a "MIS Spine Training Model in a simulated clinical environment." The number of models or simulated cases is not specified.
- The "data provenance" is not explicitly mentioned as per country of origin. The tests were simulated clinical environments or engineering tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For "Verification of general functions," "spinal surgeons" were involved.
- For "Human factors / Usability Testing," "surgeons and OR nurses" were involved.
- The specific number or detailed qualifications (e.g., years of experience) for these experts are not provided. The "ground truth" here is effective and safe usage in a simulated environment, rather than a clinical diagnosis ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- No adjudication method is described for the "test set" as this was not a diagnostic study with ambiguous interpretations requiring adjudication.
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:
- No MRMC or comparative effectiveness study comparing human performance with and without AI assistance is described. This device is a robotic alignment module, an accessory for surgical guidance, not a diagnostic AI tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The device is designed as a human-in-the-loop system (an accessory supporting the surgeon). Standalone performance in the diagnostic AI sense is not applicable or described. The tests described are on the functionality and safety of the integrated system including the robotic module.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For functional and human factors testing, the "ground truth" was operational success and safety as evaluated by the users (spinal surgeons, OR nurses) in a simulated environment (MIS Spine Training Model for functional tests). This is a performance-based ground truth related to task execution and user experience, rather than a diagnostic accuracy ground truth based on pathology or clinical outcomes.
8. The sample size for the training set:
- This document describes the verification and validation of a medical device, not the development or training of a machine learning model. Therefore, no "training set" or "sample size for training set" is applicable in the context of an AI model's development.
9. How the ground truth for the training set was established:
- Not applicable, as this is not an AI model requiring a training set with established ground truth.
§ 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).