(261 days)
Mixed Reality Spine Navigation is an accessory to the Spine & Trauma Navigation Medical Device. The software is intended to display 2D navigation screens as well as a floating 3D virtual representation and stereotactic information of tracked instruments on a virtual display using a Mixed Reality headset. The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed stereotaxic information.
The Subject device Mixed Reality Spine Navigation is an accessory to the Spine & Trauma Navigation System. It consists of the software Mixed Reality Spine Navigation 1.0 and the mixed reality headset Magic Leap 2 Medtech (ML2). The software application allows the display in the mixed reality headset of 2D navigation views and a 3D hovering model of the patient anatomy, including stereotactic information of tracked instruments to support the surgeon during pedicle screw placement procedures.
The software Mixed Reality Spine Navigation is installed and running on the Magic Leap 2 MedTech glasses and can only be used in combination with a Brainlab Image Guided Surgery (IGS) platform (Curve Navigation 17700, Kick 2 Navigation Station or Buzz Navigation Ceiling-Mounted), where the Spine & Trauma Navigation software is running. All required navigation data, such as the patient registration, is transferred over Wi-Fi from the IGS platform to the Magic Leap 2 MedTech. Based on these data, 2D views and a 3D model are rendered by the computing unit of the Magic Leap 2 MedTech and displayed stereoscopically in the headset. Thus, navigation information displayed on the screen(s) of the IGS platform can be simultaneously displayed on Magic Leap 2 MedTech during the surgery.
Magic Leap 2 MedTech is an optical see-through head-mounted display: images are projected on semi-transparent optical layers, giving the surgeons the possibility to have virtual content displayed around the patient while having a view of the real world. If needed, corrective lenses can be attached to the headset.
The provided FDA 510(k) clearance letter and summary for the "Mixed Reality Spine Navigation" device indicates that no clinical testing was required. This suggests that the substantial equivalence determination was primarily based on non-clinical performance data, comparisons to predicate devices, and the established safety and effectiveness of the underlying technology.
Therefore, the request for specific details about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of clinical performance, ground truth establishment, expert adjudication, sample sizes for test/training sets, and MRMC studies, cannot be fully answered using the provided text. The document explicitly states: "No clinical testing was required for the subject device."
However, based on the information provided, we can infer some "acceptance criteria" related to device performance as compared to the predicate, and how the device implicitly meets them through bench testing and verification/validation activities.
Here's an attempt to answer your questions based solely on the provided document, highlighting where information is absent due to the lack of clinical testing:
Acceptance Criteria and Device Performance for Mixed Reality Spine Navigation
The substantial equivalence of the Mixed Reality Spine Navigation device was established primarily through non-clinical testing and comparison to predicate devices, as no clinical testing was required. Therefore, the "acceptance criteria" are implicitly defined by the equivalence to the predicate device's performance characteristics, including accuracy and the successful execution of its intended function in a simulated environment.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category/Feature (Implicit from Predicate Comparison) | Specific Criterion (Based on Predicate) | Reported Device Performance (from Bench Testing/Verification) |
|---|---|---|
| Navigation Accuracy | Mean Positional Error of placed instrument's tip ≤ 2 mm | Mean Positional Error of placed instrument's tip ≤ 2 mm |
| Mean Angular Error of placed instrument's axis ≤ 2° | Mean Angular Error of placed instrument's axis ≤ 2° | |
| Functional Equivalence | Display 2D navigation screens | All views displayed in IGS platforms screen of the predicate can also be displayed. |
| Display floating 3D virtual representation | Floating 3D model (patient anatomy) available in ML2 Medtech. | |
| Display stereotaxic information of tracked instruments | Stereotaxic information of tracked instruments displayed. | |
| Usability/Workflow Compatibility | Support pedicle screw placement workflows | Usability testing validated pedicle screw placement workflow in a simulated OR environment. |
| Network Performance | Work as intended with minimum bandwidth requirements | Network performance benchmarking performed to ensure working as intended. |
| Safety and EMC | Compliance with IEC 60601-1 Ed 3.2 & IEC 60601-1-2 Ed 4.1 | Testing provided according to IEC 60601-1 Ed 3.2 2020-08 and IEC 60601-1-2 Ed 4.1 2020-09 (CONSOLIDATED VERSIONS). |
| Biocompatibility | Compliance with ISO 10993-1:2018 | Evaluation carried out in accordance with ISO 10993-1:2018. |
| Cleaning Validation | Compliance with FDA guidance | Cleaning validation in accordance with FDA´s guidance. |
| Optical Properties | Compliance with IEC 63145 standards | Testing in accordance with IEC 63145-20-10:2019 / 63145-20-20:2019 / 63145-22-10:2020 provided. |
| Software Verification & Validation | Compliance with FDA Guidance | Successful implementation of product specifications, incremental testing, risk control measures, compatibility, cybersecurity. Documentation for Enhanced Documentation level. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated in terms of patient data or clinical cases, as no clinical testing was required. Tests were primarily bench tests and usability tests in a simulated environment.
- Data Provenance: The document does not specify data provenance (country of origin, retrospective/prospective) because clinical data was not used for the clearance. Bench test data and simulated environment data would be internal to the manufacturer's testing labs.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable / Not Specified: For the required non-clinical testing, "ground truth" would be established by validated measurement systems for accuracy tests (e.g., optical tracking systems for positional/angular accuracy) and adherence to engineering specifications. Usability testing would involve trained personnel simulating surgical use, but the document doesn't specify a number of "experts" to establish ground truth in the sense of clinical reference.
4. Adjudication Method for the Test Set
- Not Applicable: Given the nature of bench testing and simulated environment usability tests, no multi-expert adjudication method (like 2+1, 3+1) would be necessary as it's not a diagnostic AI evaluating medical images.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No: The document explicitly states, "No clinical testing was required for the subject device." Therefore, no MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Partial/Indirect: The device is an accessory to a navigation system and displays information to a human user. Its core function relies on the underlying Spine & Trauma Navigation software. The "Navigation accuracy" metrics (positional and angular error) would reflect the algorithmic performance in conjunction with the optical tracking system in a controlled, non-human-in-the-loop setting for those specific measurements. However, the overall device function is human-in-the-loop as it's a navigation display.
7. The Type of Ground Truth Used
- Engineering Specifications and Simulated Performance Metrics: For accuracy, the ground truth would be based on precise measurement systems in a controlled environment to verify the device's ability to display instrument position and orientation within specified tolerances. For usability, the ground truth would be the successful completion of simulated surgical workflows as defined by the manufacturer's design specifications. No "expert consensus," "pathology," or "outcomes data" was used as ground truth for this device clearance.
8. The Sample Size for the Training Set
- Not Applicable: The document does not describe the use of any AI or machine learning models that would require a "training set" in the traditional sense of medical image analysis AI. The device is a mixed reality display system for an existing navigation platform.
9. How the Ground Truth for the Training Set was Established
- Not Applicable: As there's no mention of a "training set" for an AI model, this question is not relevant to the information provided.
In summary: The FDA clearance for "Mixed Reality Spine Navigation" was based on a combination of demonstrating substantial equivalence to a predicate device, comprehensive software verification and validation, hardware verification including safety and biocompatibility, and bench tests validating usability and network performance in a simulated environment. The absence of clinical testing means that acceptance criteria related to clinical efficacy studies, such as those involving human readers, expert ground truth, and patient outcome data, were not part of this specific 510(k) submission.
§ 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).