(257 days)
The ImmersiveTouch simulators are intended as pre-operative software for simulating and evaluating surgical treatment options.
The ImmersiveTouch is software based pre-surgical planning system. It is intended for use as a software interface. It is also intended as pre-operative software for simulation and evaluation of surgical treatment options.
The ImmersiveTouch software has the capability of displaying 3D models of patient data from 2D scan slices. Additionally, it provides the user with ability to input, display, color, and manipulate the 2D scan slices via a 3D representation.
The 3D models of patient data are combined with the use of haptics. This provides the user with ability to modify the haptic properties, creating the sensation of feeling specific tissues.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria in a quantitative table format. Instead, it relies on successful testing, verification, and validation against specifications, as well as adherence to established medical device standards. The performance is reported as meeting these standards.
| Acceptance Criteria Category | Acceptance Criteria (as implied) | Reported Device Performance |
|---|---|---|
| Safety and Effectiveness | Meets specifications to ensure device is safe and effective for its intended use. | "Successfully tested, verified and validated to ensure that it meets specifications." "Results of performance tests conducted on the pre-operative software clearly demonstrate the device is safe and effective for its intended use." |
| Electrical Safety | Compliance with electrical safety standards. | "CE certified by Underwriters Laboratories under the standard IEC 60950-1:2005 (2005 (2005); Am 1:2009." "Also been tested in accordance with IEC 60601-1 and IEC 60601-1-2 standards." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not provide details on the sample size used for any specific test set, nor does it mention the data provenance (e.g., country of origin, retrospective or prospective) for any clinical or performance data. It discusses general testing and validation, but not the specifics of a test set with patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not mention the use of experts to establish ground truth for a test set. The focus is on technical compliance with standards rather than clinical performance evaluated against expert-derived ground truth.
4. Adjudication Method for the Test Set:
Given that no experts or ground truth establishment are described, there is no mention of an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in the provided document. The document describes the device as a pre-operative software for simulating and evaluating surgical treatment options, and its substantial equivalence is based on technological characteristics compared to predicate devices, not on a human-in-the-loop performance study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The document describes the "ImmersiveTouch" as "software based pre-surgical planning system" and clarifies that it is "intended for use as a software interface." It focuses on its technical capabilities (displaying 3D models, manipulating 2D scan slices, haptic properties). While it implies standalone function for generating simulations, it does not explicitly detail a standalone performance study with metrics suitable for an algorithm-only evaluation (e.g., accuracy against a defined ground truth for specific tasks). The performance data cited refers to technical and electrical safety standards.
7. The Type of Ground Truth Used:
The document does not specify the type of ground truth used for performance evaluation in the context of clinical accuracy or decision-making. The "performance data" mentioned refers to compliance with safety and electrical standards (IEC 60950-1, IEC 60601-1, IEC 60601-1-2) which are general engineering and safety truths, not patient-specific clinical ground truths (like pathology, expert consensus, or outcomes data).
8. The Sample Size for the Training Set:
The document does not provide any information about a training set since it focuses on the device's technical specifications and safety standards rather than a machine learning or AI algorithm trained on data.
9. How the Ground Truth for the Training Set Was Established:
As no training set is mentioned or implied, there is no information on how ground truth for a training set was established.
§ 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).