(217 days)
LUMYS is intended for use as a software interface and image segmentation system, which is used to carry out presurgical planning tasks. LUMYS is intended to be used by clinicians with appropriate clinical judgement.
LUMYS is a medical display software intended for 3D image visualization and image interaction. The stereoscopic 3D images are generated from 3D volumetric data acquired from a CT scan source. The device is intended to provide visual information to be used by clinicians with appropriate clinical judgement for analysis of surgical options, and the intraoperative display of the images. The primary surgeon wears a Microsoft Hololens™ Head Mounted Display (HMD) and consults with external users who can perform pre-surgical tasks such as annotating 3D images, uploading files and speaking with the surgeon. The surgeon must cease communication once surgery begins.
LUMYS is intended to be used as an adjunct to the interpretation of images performed using diagnostic imaging systems and is not intended for primary diagnosis. LUMYS is intended to be used as a reference display consultation software, which assists the clinician with appropriate clinical judgement who is responsible for making all final patient management decisions.
LUMYS is a data visualization standalone software that is used during medical procedures to visualize medical data and share this visualization with other healthcare professionals attending remotely the procedure. Different components are involved:
- A Microsoft HoloLens 2 headset to access the data in the operating theater,
- A broadcasting computer to broadcast video from a medical imaging device in LUMYS,
- A web browser on a computer to access the data remotely.
LUMYS is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. LUMYS is intended to be used by clinician with appropriate clinical judgement.
The provided FDA 510(k) clearance letter for LUMYS (V1) does not contain detailed information about specific acceptance criteria, comprehensive device performance data, or a full study report. The document states that "The testing results that all specifications have met the acceptance criteria" and "LUMYS passed all the tests, and support the claims of substantial equivalence, safety and effectiveness for its intended use." However, it only provides a very limited detail on one specific test.
Therefore, the following information is extracted and inferred from the limited details provided in the document:
Acceptance Criteria and Device Performance Study for LUMYS (V1)
The FDA 510(k) clearance letter for LUMYS (V1) indicates that the device has undergone verification and validation testing to demonstrate its safety and effectiveness. While a detailed study report is not included, the document briefly mentions optical testing and segmentation algorithm validation.
1. Table of Acceptance Criteria and Reported Device Performance
The document provides very limited, specific acceptance criteria and reported performance data. Based on the available text, these are:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Optical Test: Well suited to visualize medical images such as DICOM in Microsoft Hololens™ Head Mounted Display (implied) | Results confirm that LUMYS is well suited to visualize medical images such as DICOM in Microsoft Hololens™ Head Mounted Display. |
| Segmentation Algorithm: Error lower than 0.9 mm (implied) | LUMYS' segmentation algorithm allows to segment DICOM from CT scan source with an error lower than 0.9 mm. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set for either the optical testing or the segmentation algorithm validation. It also does not explicitly state the provenance (e.g., country of origin, retrospective/prospective) of the data used for these tests. The only mention of data source is "DICOM from CT scan source."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide information on the number of experts used or their qualifications to establish ground truth for any of the described tests.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for establishing ground truth or evaluating the test set results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was conducted to evaluate how much human readers improve with AI vs. without AI assistance. The device is described as an "adjunct to the interpretation of images" and a "reference display consultation software," but no comparative study with human readers is mentioned.
6. Standalone Performance Study
Yes, a standalone performance of the algorithm (without human-in-the-loop performance) was performed for the segmentation algorithm. The document states, "Other tests, carried out to validate the segmentation algorithm, show that LUMYS' segmentation algorithm allows to segment DICOM from CT scan source with an error lower than 0.9 mm." This indicates a measurement of the algorithm's performance on its own.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for the segmentation algorithm validation (e.g., expert consensus, pathology, outcomes data). The "error lower than 0.9 mm" suggests a quantitative comparison against a known reference, but the origin of that reference is not detailed.
8. Sample Size for the Training Set
The document does not specify the sample size used for the training set for the segmentation algorithm or any other AI/ML components of LUMYS.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for the training set was established for the segmentation algorithm or any other AI/ML components.
Summary of Missing Information:
The FDA 510(k) clearance letter focuses on providing a high-level overview of regulatory compliance and substantial equivalence to a predicate device. It lacks specific technical details common in a full study report, such as:
- Detailed acceptance criteria for various functionalities beyond the two brief mentions.
- Specific quantitative performance metrics for all functions.
- Sample sizes for test and training datasets.
- Details on ground truth establishment, including expert qualifications and adjudication methods.
- Results from any human-reader performance studies.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).