Search Results
Found 1 results
510(k) Data Aggregation
(307 days)
CarnaLife® Holo is a software device for display of medical images and other healthcare data. It includes functions for image review, image manipulation, basic measurements, annotations, and 3D visualization.
Lossy compressed mammography images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA-cleared display that meets technical specifications reviewed and accepted by FDA or displays accepted by the appropriate regulatory agency for the country in which it is used.
Display monitors used for reading medical images for diagnostic purposes must comply with the applicable regulatory approvals and quality control requirements for their use and maintenance.
CarnaLife® Holo software is indicated for use by qualified healthcare professionals including, but not restricted to radiologists, non-radiology specialists, physicians, and technicians.
When accessing CarnaLife® Holo software from a wireless stereoscopic head-mounted display (HMD), images viewed are for informational purposes only and not intended for diagnostic use.
CarnaLife® Holo is a Software as a Medical Device (SaMD) to be used by qualified healthcare professionals including, but not restricted to radiologists, non-radiology specialists, physicians, and technicians for the visualization of medical images in 3D to allow for surgical planning activities. The device makes it possible to visualize 3D Digital Imaging and Communications in Medicine (DICOM) files using volume and surface rendering in 3D to be viewed on a classic display or on a stereoscopic, holographic display. CarnaLife® Holo is intended to be used in operating rooms; office environments within hospitals or at any other location with a computer; and for informational purposes only at any location using the head-mounted display (HMD). The images can be viewed on desktop PCs with a monitor allowing the interaction with CarnaLife® Holo to be performed with a mouse and/or keyboard; and on an HMD, where the interaction with CarnaLife® Holo is performed using hand gestures, voice commands and virtual menus.
CarnaLife® Holo is used to:
- Load patient DICOM data; ●
- . Image review, image manipulation, basic measurements, annotations, and 3D visualization; and
- . View DICOM data using a traditional computer monitor, display monitors used for reading medical images for diagnostic purposes, or in mixed reality (MR) using a head-mounted display (HMD).
The provided document is a 510(k) summary for the CarnaLife® Holo device. It outlines the device description, indications for use, comparison to a predicate device (SurgicalAR K190764), and performance data. However, it does not provide detailed acceptance criteria or extensive study information typically found in a clinical study report for proving performance.
The document focuses on demonstrating substantial equivalence to a predicate device, which is a different regulatory pathway than proving de novo clinical effectiveness. The "Performance Data" section describes design verification and validation activities, but these are primarily focused on software functionality and accuracy rather than clinical performance based on a substantial patient cohort.
Here's an attempt to extract and infer the requested information based on the provided text, heavily noting what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present acceptance criteria in a formal, quantifiable table with corresponding performance metrics like sensitivity, specificity, or reader agreement for diagnostic tasks. Instead, it describes functional accuracy tests.
| Acceptance Criteria (Inferred from testing description) | Reported Device Performance |
|---|---|
| Accuracy of Measuring Function: | "Measurement accuracy met specified requirements" for: |
| * X - distance of P1-P2 and P3-P4 | * X - distance of P1-P2 and P3-P4 |
| * Y - distance of P1-P3 and P2-P4 | * Y - distance of P1-P3 and P2-P4 |
| * Angles defined by points P1-P2-P3 | * Angles defined by points P1-P2-P3 |
| * Diagonals defined by P1-P4 and P3-P2 | * Diagonals defined by P1-P4 and P3-P2 |
| Accuracy of Volume Rendering: | "The accuracy of Volume Rendering meeting specified requirements was demonstrated by comparing the size and dimensions of resulting displayed holograms to the known size and dimensions of the two geometric objects." (Implicitly, it met the requirements) |
| * Comparison of displayed hologram size/dimensions to known object size | "Design validation was successfully completed, and testing met all predetermined acceptance criteria based on user needs and intended use." |
| General Design Validation: | "The design verification was successful in that the design output specifications satisfactorily met the design input requirements." |
| * Design output specifications met design input requirements |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Testing: The document mentions "two data sets characterized by different voxel sizes (isotropic and anisotropic data)" for the measuring function test, and "CT scans of two different geometric objects of known size and dimensions" for the volume rendering test. This implies a very small, controlled, and synthetic/phantom-based test set, not a clinical patient image dataset.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given the nature of the tests (geometric objects, voxel sizes), it's highly likely to be controlled lab data, possibly simulated or phantom studies. It is not indicated as a clinical patient dataset.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- The document describes functional accuracy testing against known geometric properties or defined points, implying a ground truth established by engineering specifications or measurement tools, not human expert consensus from medical professionals.
- Therefore, the number of experts and their qualifications are not applicable in the context of the described performance tests.
4. Adjudication Method for the Test Set
- Given that the ground truth establishment involves direct measurement or comparison to known geometric properties, and not human expert interpretation, an adjudication method like 2+1 or 3+1 is not applicable and is not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was done or reported. The document focuses on the device's functional accuracy (measurements, rendering) and its substantial equivalence to a predicate, not on a direct comparison of human reader performance with and without AI assistance using this specific device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- The described "Performance Data" section details tests of the software's accuracy in performing measurements and rendering. This can be considered a form of standalone performance assessment of these specific functionalities. However, it's not a standalone diagnostic accuracy study in the traditional sense (e.g., classifying disease vs. no disease). The device itself is described as an image display and manipulation tool, not an AI diagnostic algorithm.
7. Type of Ground Truth Used
- The ground truth used was based on known geometric properties/dimensions of objects or precise definitions for measurements (e.g., P1, P2, P3, P4 points for distance and angle calculations). It was not expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set
- The document does not mention a training set or any machine learning/AI model training. The described tests are for the accuracy of features like measurement and 3D rendering, which are typically based on deterministic algorithms, not learned models. Therefore, the concept of a training set is not applicable to the performance data presented.
9. How the Ground Truth for the Training Set Was Established
- Since no training set is mentioned or implied for the performance data provided, this information is not applicable.
Ask a specific question about this device
Page 1 of 1