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The SpotLight / SpotLight Duo is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission projection data taken at different angles. The system has the capability to image cardiovascular and thoracic anatomies, including the heart, in a single rotation. The system may acquire data using Axial, Cine and Cardiac scan techniques from patients of all ages (DLIR is limited for patient use above the age of 2 years). These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. The system is indicated for x-ray Computed Tomography imaging of cardiovascular and thoracic anatomies that fit in the scan field-of-view.

The Low Dose CT Lung Cancer Screening Option for SpotLight / SpotLight Duo is indicated for using low dose CT for lung cancer screening. The screening must be conducted with the established program criteria and protocols that have been approved and published by a governmental body or a professional medical society. Information from professional societies related to lung cancer screening can be found but is not limited to: American College of Radiology® (ACR) – resources and technical specification; accreditation American Association of Physicists in Medicine (AAPM) – Lung Cancer Screening Protocols; radiation management. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. The DLIR and ASIR-CV algorithms are not compatible with the Low Dose Lung Cancer Screening option.

The device output is useful for diagnosis of disease or abnormality and for planning of therapy procedures.

The Low Dose Lung Cancer Screening (LD LCS) option indication for Arineta's SpotLight and SpotLight Duo scanners is being expanded to include small patients, as defined by AAPM (American Association of Physicists in Medicine). This expansion ensures comprehensive coverage of the intended lung cancer screening population, following the previous clearance of the LD LCS option for medium and large patients under K241200.

The proposed LD LCS option for the SpotLight and SpotLight Duo includes scan protocols with CTDI that comply with AAPM's requirements for the whole LD LCS population patient size groups, as detailed in the following table:

There are not any functional, performance, feature, or design changes required for the CT systems to which the option is applied.

The proposed full LD LCS protocols option, as the cleared K241200, will be activated by service or production personnel, with no additional installation required (option activation only).

This FDA 510(k) clearance letter describes the acceptance criteria and study proving the SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option (specifically for small patients) meets these criteria.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the device are largely based on image quality and nodule detectability being maintained at low dose levels, specifically for small patients (50-70 kg) within the AAPM guidelines for CTDI. The reported performance confirms these criteria are met.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: 10 additional small patient exams. This supplements 14 larger patient datasets (7 medium and 7 large-size patient cases) from the predicate device (K241200) study. So, in total, 24 cases (10 small, 7 medium, 7 large) were assessed across the full patient size range.
• Data Provenance: The data was collected from 3 U.S. sites and included Low-Dose lung screening exams. The study was a clinical image quality assessment, implying it was based on real patient scans, likely retrospective based on the description of evaluating existing data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Two (2)
• Qualifications of Experts: U.S. board-certified radiologists.

4. Adjudication method for the test set

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). It only mentions that the image quality assessment was "performed by two U.S. board-certified radiologists" and that "all 10 cases... were evaluated as diagnostic." This implies a consensus or agreement was reached, or potentially individual evaluations were sufficient, but a formal adjudication process is not detailed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Comparative Effectiveness Study: No, a multi-reader multi-case comparative effectiveness study comparing human readers with and without AI assistance was not conducted or reported in this document. This submission is for a CT system itself and its low-dose lung cancer screening option, not an AI-assisted reading tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Not applicable. This submission is for a CT imaging system, not an algorithm that performs image analysis autonomously. The "device output is useful for diagnosis," implying human interpretation.

7. The type of ground truth used

• Type of Ground Truth: Expert consensus for diagnostic acceptability and reporting of pathologies. The radiologists' evaluations of image quality and their ability to detect pathologies (including 2mm nodules) served as the ground truth for the clinical acceptability of the images for diagnosis.

8. The sample size for the training set

The document does not provide information about a specific "training set" in the context of machine learning or AI. The device being cleared is a CT scanner, and the expansion of its low-dose screening option. The discussion refers to "bench testing" and "clinical testing data" but not a training set for an algorithm.

9. How the ground truth for the training set was established

As no specific "training set" for an algorithm is mentioned, the method for establishing its ground truth is not applicable. The device's performance is validated through physical phantom testing (bench testing) and clinical evaluation of images by expert radiologists.

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