(70 days)
Spine & Trauma Navigation is intended as an intraoperative image-guided localization system to enable open and minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or intraoperative 2D or 3D image data.
Spine & Trauma Navigation enables computer-assisted navigation of medical image data, which can either be acquired preoperatively or intraoperatively by an appropriate image acquisition system. The software offers screw and interbody device planning and navigation with surgical instruments.
The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to the acquired image (CT, MR, 3D fluoroscopic image reconstruction or 2D fluoroscopic image) and/or an image databased model of the anatomy.
The Spine & Trauma Navigation is an image quided surgery system for navigated treatments in the fields of spine and trauma surgery, whereas the user may use image data based on CT, MR, 3D fluoroscopic image reconstruction (cone beam CT) or 2D fluoroscopic images. It offers different patient image registration methods and instrument calibrations to allow surgical navigation by using optical tracking technology. To fulfil this purpose, it consists of software, Image Guided Surgery platforms and surgical instruments.
Modified Drill Guides and Drill Bits have been introduced as part of the Subject Device. The Drill Guide instruments are navigated instruments which support the surgeon in guiding drill bits and K-wires during spinal procedures. They consist of a guide tube, a trocar insert (both available in five different diameters), a body with two available handles, an array and a depth control (available in two different sizes for various drilling depths). The Drill Guide Tubes and Drill Guide Trocar Inserts have patient contact. All instruments are delivered unsterile and require end user sterilization.
The Drill Bits are used for drilling of bone. They are made of stainless steel and are delivered non-sterile. They require steam sterilization onsite before use. There are several variants in terms of diameter, length, and presence of a depth stop feature.
The provided text describes the regulatory clearance for the Brainlab AG Drill Guide, Drill Bit, and Spine & Trauma Navigation system. Here's a summary of the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature | Acceptance Criteria (Subject Device) | Reported Device Performance |
|---|---|---|
| Navigation Accuracy | Mean Positional Error of the placed instrument's tip ≤ 2 mm | Accuracy testing: Tip position deviation equal to or below 1.7 mm (95th percentile). |
| Mean Angular Error of the placed instrument's axis ≤ 2° | Accuracy testing: Angular deviation equal to or below 1.7° (95th percentile). | |
| Assembly Stability | Withstand unintended loads without losing accuracy or function. | The Drill Guide was able to withstand forces without losing accuracy or function. |
| Lifecycle Assessment | Maintain accuracy and label readability throughout product lifetime. | Accuracy as well as label readability requirements were met. |
| Skiving | Provide a stable hold. | The modified Drill Guide provides a more stable hold with the improved teeth design compared to the predicate Guide Tubes. |
| Handling and Interface | Acceptance criteria met for depth control and array attachment. | Acceptance criteria were met in all cases. |
| Usability | Safe and effective for use in defined scenarios. | The final design was proven safe and effective for use in the defined use scenarios. |
| Mechanical Failure | Strong enough to withstand expected torques and possible bending. | The new worst case drill bit (diameter 2 mm) was tested under different scenarios in order to ensure it is strong enough to withstand the expected torques and possible bending under worst case conditions. |
| Biocompatibility | Compliance with ISO 10993-1:2018. | Was evaluated according to ISO 10993-1:2018 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process." |
| Reprocessing Validation | Compliance with ISO 11737-1:2018, ANSI/AAMI ST98:2022, ISO 15883-5:2021-07. | Was evaluated according to ISO 11737-1:2018, ANSI/AAMI ST98:2022 and ISO 15883-5:2021-07. |
2. Sample Size Used for the Test Set and Data Provenance:
The document doesn't explicitly state sample sizes for all test sets.
- Usability Testing: 15 representative users.
- Other Testing (Accuracy, Assembly Stability, Lifecyle assessment, Skiving, Handling and interface analysis, Mechanical failure testing, Biocompatibility, Reprocessing validation): Sample sizes are not specified in the provided text.
- Data Provenance: Not specified, but generally, these types of performance tests are conducted in a controlled laboratory environment. The document does not mention the country of origin of data or whether it was retrospective or prospective, as clinical data was not required.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not provided in the document. The performance tests described (e.g., accuracy, mechanical failure) are typically assessed against engineering specifications rather than expert consensus on medical images or diagnoses.
- For usability testing, the 15 "representative users" likely served as the evaluators, but their specific qualifications beyond being "representative" are not detailed.
4. Adjudication Method for the Test Set:
- An adjudication method (like 2+1, 3+1) is not applicable for the reported performance testing, as these are engineering and functional tests.
- For usability testing, the document states "The final design was proven safe and effective," implying an overall assessment rather than a specific multi-reader adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
- No MRMC comparative effectiveness study was done. This device is a navigation system and surgical instruments, not an AI diagnostic or assistive tool that would typically be evaluated in an MRMC study comparing human reader performance with and without AI.
- The document explicitly states: "No clinical testing was required for the subject device."
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- The "Spine & Trauma Navigation" system is an image-guided surgery system that inherently involves a human surgeon in the loop. The performance tests (e.g., navigation accuracy) evaluate the system's ability to accurately guide instruments, which is a standalone function of the technology when used by a surgeon. It's not an "algorithm-only" performance in the sense of a fully automated diagnostic or interpretive AI.
7. The Type of Ground Truth Used:
- The ground truth for most of the performance tests (e.g., accuracy, mechanical failure, stability) is based on engineering specifications and metrology (precise measurements against known values).
- For biocompatibility and reprocessing, the ground truth is established by adherence to international standards (ISO 10993-1:2018, ISO 11737-1:2018, ANSI/AAMI ST98:2022, ISO 15883-5:2021-07).
- For usability, the ground truth is the satisfaction of predefined acceptance criteria by the representative users in a simulated scenario.
8. The Sample Size for the Training Set:
- This information is not applicable/not provided. The device is an image-guided surgery system and newly modified instruments, not a machine learning or AI model trained on data in the traditional sense that would have a "training set." The development of such physical devices and software systems involves rigorous engineering design, verification, and validation, but not typically a "training set" like that seen in deep learning applications.
9. How the Ground Truth for the Training Set Was Established:
- This information is not applicable, as there is no mention of a "training set" for an AI model.
§ 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).