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SpectoMed (v1.0) provides real-time spatial-visualization of medical imaging the manipulation, processing, review, analysis, communication and media interchange of multi-dimages of several modalities as defined by the DICOM standard, such as CT or MRI imaging datasets. Furthermore, SpectoMed (v1.0) aids the clinician in the preparation of a surgical intervention with measurements and import of compatible objects within the realistic spatial visuals of the patient's anatomy as well as their intraoperative display. SpectoMed (v1.0) is intended as an aid for assessing patient images.

SpectoMed (v1.0) is a software-only device that allows trained medical professionals to review CT and MRI image data in three-dimensional (3D) format and/or in virtual reality (VR) and/or Augmented reality (AR) interfaces. The 3D rendered images are accessible through the software desktop application and, if desired, through compatible VR and AR headsets which are used by users for preoperative surgical planning and for display during intervention/surgery.

SpectoMed (v1.0) product is to be used to assist in medical image review. Intended users are trained medical professionals, including imaging technicians, clinicians and surgeons.

The 3D images generated using SpectoMed (v1.0) are intended as an aid for assessing CT or MR images that are used for diagnosis, preoperative planning and/or during intervention/surgery. SpectoMed (v1.0) is intended to be used in environments where the usage of a computer display or an XR system is safe such as:

• Office spaces
• · Operating rooms under these two scenarios:
  • · Display of the SpectoMed (v1.0) visual output on existing monitors/screens in the operating room
  • Use of XR displays in a non-sterile situation as e.g. before draping the patient or outside the sterility area, and thus strictly in compliance with sterility protocols.

SpectoMed (v1.0) is not meant to:

• · be used in a sterile environment,
• · to register 3D images to patients,
• · to be used with the user's hands on the patient during an interventional or surgical procedure.

Here's a breakdown of the acceptance criteria and study information for SpectoMed (v1.0) based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "reference digital phantoms" and "varying reference CT phantom scan resolutions" for performance testing. It does not specify a numerical sample size for the test set or the country of origin of the data directly. The data is implied to be synthetic or standardized (phantoms) rather than from real patient cases. It is also not specified if it was retrospective or prospective.

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

The document does not explicitly state the number of experts used to establish the ground truth for the test set or their qualifications. The ground truth for measurement performance was established by comparing to a "cleared device (Osirix MD K101342)."

4. Adjudication Method for the Test Set:

The document does not describe an adjudication method for the test set in the traditional sense, as the ground truth for measurements was established by comparison to a cleared device (Osirix MD K101342) and statistical analysis (t-test). It does not mention human adjudication of results.

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

No, an MRMC comparative effectiveness study was not done. The performance testing described focuses on the accuracy of measurements compared to a reference device.

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

Yes, the performance testing described for measurements (distance and angle) appears to be a standalone (algorithm only) performance evaluation. The device's measurements were compared against those of a reference device on digital phantoms, without mentioning human intervention during the measurement process for the test.

7. The Type of Ground Truth Used:

The ground truth used for measurement performance was based on the measurements provided by a previously cleared medical device (Osirix MD K101342), applied to "reference digital phantoms."

8. The Sample Size for the Training Set:

The document does not mention a training set or its sample size. The SpectoMed (v1.0) is described as a software-only device for manipulating, processing, reviewing, and analyzing imaging data and aiding in surgical intervention preparation. This description suggests it might not be an AI/ML-driven device requiring extensive training data in the typical sense for classification or detection tasks, but rather a tool for visualization and measurement.

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

As no training set is mentioned, the method for establishing its ground truth is not applicable/provided in the document.

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