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The HOLOSCOPE-i is a medical display workstation intended for 3D image visualization and image interaction. The holograms are generated from 3D volumetric data acquired from CT and Ultrasound sources. The device is intended to provide visual information to be used by the health care professional for analysis of surgical options, and the intraoperative display of the images. The HOLOSCOPE-i 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. The HOLOSCOPE-i is intended to be used as a reference display for consultation to assist the clinician who is responsible for making all final patient management decisions.

The HOLOSCOPE-i is a software-controlled optical system that displays 3D holographic medical images. The system generates color 3D holograms from 3D volumetric imaging datasets acquired from standard imaging modalities such as CT and 3D ultrasound. The HOLOSCOPE-i is comprised of an Optical Unit that creates the optical path for the generation of the holographic image; a system computer and electronics supporting the Human Machine Interactions (HMI) and a graphical user interface (GUI) display; a cart and boom mechanical fixture that mechanically connects the Optical Unit and the system computer; and a 3D Control Device for interfacing with the hologram.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: HOLOSCOPE-i (Medical display workstation for 3D image visualization and interaction)

Intended Use: The HOLOSCOPE-i is a medical display workstation intended for 3D image visualization and image interaction. The holograms are generated from 3D volumetric data acquired from CT and Ultrasound sources. The device is intended to provide visual information to be used by the healthcare professional for analysis of surgical options, and the intraoperative display of the images. The HOLOSCOPE-i 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. The HOLOSCOPE-i is intended to be used as a reference display for consultation to assist the clinician who is responsible for making all final patient management decisions.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes two main clinical studies: an "Expert Evaluation study" primarily focusing on visualization and ease of identification, and a "comparative clinical study" establishing substantial equivalence through measurement agreement. While explicit "acceptance criteria" values are not presented in a table format with pass/fail thresholds, the outcomes of these studies serve as the "reported device performance" against implied clinical acceptance.

2. Sample Sizes Used for the Test Set and Data Provenance

• Expert Evaluation Study:
  • Sample Size: 10 adult 3DTEE images and 10 adult CT images.
  • Data Provenance: Not explicitly stated, but clinical studies are generally conducted with patient data. No indication of specific country or retrospective/prospective nature is provided.
• Comparative Clinical Study:
  • Sample Size: 41 adult Mitral Valve images (19 normal, 22 pathological).
  • Data Provenance: Not explicitly stated. Assumed to be retrospective clinical images for such a comparative measurement study. Nothing about country of origin is mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document refers to "expert evaluators" in the "Expert Evaluation study" but does not specify the number of experts or their qualifications (e.g., "radiologist with 10 years of experience"). For the comparative study, it refers to a "validated reference device" for ground truth comparison, implying an established, accurate measurement method rather than a panel of human experts directly establishing ground truth for the measurements themselves.

4. Adjudication Method for the Test Set

• Expert Evaluation Study: The document states that "All landmarks were identified for all images and ease of identification, as expected, was scored at least 3, with 99% of identifications scoring 5 (very easily)." This phrasing suggests consensus or high agreement, but an explicit adjudication method (e.g., 2+1, 3+1, majority vote) is not described.
• Comparative Clinical Study: For the measurement comparison, the "validated reference device" serves as the standard, so human adjudication of measurements is not the primary method for ground truth establishment. Agreement was measured against this reference.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• An MRMC study per se comparing human readers with and without AI assistance was not explicitly described.
• The "Expert Evaluation study" involved expert evaluators assessing the device's visualization capabilities, which is a form of human interaction with the device.
• The "Comparative clinical study" focused on the device's measurement agreement with a reference device, rather than human reader performance improvement.

Effect Size: Not applicable, as a direct MRMC comparative effectiveness study for human reader improvement with AI assistance was not detailed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device, HOLOSCOPE-i, is a display workstation for human users. Its intended use inherently involves human interaction ("visual information to be used by the health care professional," "assist the clinician"). Therefore, standalone algorithm-only performance metrics separate from human interaction are not directly relevant to its function and were not a focus of the described clinical evaluations. Performance tests cover resolution, sharpness, luminance, contrast, color, 3D fidelity, orientation, and measurement accuracy, which are technical standalone performance aspects, but these are assessed for the purpose of supporting the human user's visual perception and interaction.

7. The Type of Ground Truth Used

• Expert Evaluation Study: The ground truth for this study was the pre-identified anatomical landmarks. The experts' role was to identify these landmarks using the device and assess the ease of identification and spatial perception. The existence and location of these landmarks implicitly serve as the ground truth. This combines aspects of expert consensus (likely used to pre-identify the landmarks) and defined anatomical structures.
• Comparative Clinical Study: The ground truth for the measurements was established by a "validated reference device" (K132165 - Philips QLAB Quantification (MVN) Software). This is a previously cleared or established measurement tool, implying its measurements are considered accurate and reliable.

8. The Sample Size for the Training Set

The document focuses solely on the validation/test sets for demonstrating performance and substantial equivalence. It does not provide any information regarding the training set size for the algorithms that generate the holographic display or process the 3D data.

9. How the Ground Truth for the Training Set Was Established

As no information is provided about the training set, there is no information on how its ground truth was established.

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