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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.

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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 (DLR is limited for patient use 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 (for medium and large patients) 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 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 is an indication being added to the existing Arineta scanners for SpotLight and SpotLight Duo, previously cleared by the FDA (K230370, K213465).

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

This option includes scan protocols with CTDI that comply with AAPM's requirements for Low Dose Lung Cancer Screening.

No Hardware modifications and minor Software modifications (for compatibility with the Low-Dose Lung Cancer Screening protocols) are required for the subject device, which includes the following LD LCS protocol characteristics:

• Lung Cancer Screening protocols for medium and large patients according to AAPM's definitions.

· Lung Cancer Screening protocols option will be activated by service or production personnel (no need for additional installation, option activation only).

Here's a breakdown of the acceptance criteria and the study proving the device's performance, 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

• Test Set Sample Size:
  • Bench Testing: Not explicitly stated as a number of phantom scans, but described as "extensive bench testing" using "standard phantoms" and a "semi-anthropomorphic clinical simulation lung phantom."
  • Clinical Image Quality Assessment: Fourteen (14) cases.
• Data Provenance:
  • Bench Testing: Internal laboratory testing ("extensive bench testing").
  • Clinical Image Quality Assessment: Collected from two (2) U.S. sites. The text doesn't specify if it was retrospective or prospective, but the phrasing "were collected" often implies retrospective.

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

• Number of Experts: Two (2) U.S. board-certified radiologists.
• Qualifications: U.S. board-certified radiologists. No specific years of experience are mentioned.

4. Adjudication Method for the Test Set

The provided text only states "a clinical image quality assessment was performed by two U.S. board-certified radiologists." It does not specify an adjudication method (e.g., 2+1, 3+1, none). It implies both radiologists performed the assessment, but not how disagreements (if any) were resolved or if their readings were merged.

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

No MRMC comparative effectiveness study was mentioned. The study described focuses on whether the device's low-dose protocols produce diagnostic-quality images and maintain image quality compared to the predicate device, not on human reader performance with or without AI assistance.

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

The "device" in this context is the CT scanner itself with an added low-dose lung cancer screening option, which includes specific scan protocols and minor software modifications for compatibility. The "acceptance criteria" and "study" described are for the performance of the CT system under these low-dose conditions, as an image acquisition and reconstruction device. It is not an AI algorithm that provides diagnostic readings independently. Therefore, the concept of a "standalone" AI performance study is not directly applicable here. The performance evaluated is the image quality produced by the system.

7. The Type of Ground Truth Used

• Bench Testing: Phantom specifications or known values within the phantoms (e.g., specific nodule sizes, CT number values of materials). Comparison was also made against a "reference device" (GE Revolution CT).
• Clinical Image Quality Assessment: The "ground truth" for the clinical evaluation was the qualitative assessment by the two board-certified radiologists that the images were "diagnostic for the indications for use" and "enable the detection of findings relevant to LD LCS," including 2mm nodules. This is essentially expert consensus on clinical diagnostic utility. It does not refer to histopathological ground truth for nodules, for example.

8. The Sample Size for the Training Set

The document does not mention any training set size. This is because the submission describes an option for an existing CT system (SpotLight/SpotLight Duo) to perform Low Dose Lung Cancer Screening. It does not describe a new AI algorithm that requires a separate training set. The changes are primarily in scan protocols and minor software adjustments for compatibility. The core image reconstruction algorithms (Modified FDK, MBAF, MBAF2) are pre-existing.

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

As no training set is mentioned (since it's not a new AI algorithm being trained), this information is not applicable.

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