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The AIRO™ is intended to be used for non-contrast X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding pediatric patients weighing over 400 lbs (182 kg).

Airo is contraindicated as the principal means of guidance during surgical procedures. The physician must verify navigation accuracy using known anatomical landmarks or an equivalent verification method when used in surgical procedures.

The Mobius Airo is a mobile high resolution Computed Tomography (CT) System similar to the NL4000 BodyTom CT System. The Airo has a large-diameter bore designed for intra-operative use; the main features include a 107cm bore, with a 51.2cm field of view (FOV). The Airo has two modes of operation; transport and scanning mode, translation along the longitudinal axis is achieved through movement of the gantry along the length of the system base (rather than through movement of the patient support table).

The lightweight translating gantry consists of a rotating disk with a solid state x-ray generator, solid state detector array (that includes detector modules that consist of a layered Cadmium Tungstate (CdWO4) and Photodiode Array). Each detector module includes a 32 x 16 pixel scintillator array that produces scintillation events responsive to irradiation by X-rays. The Airo also includes a collimator, control computer, communications link, data acquisition system, reconstruction computer, power system, brushless DC servo drive system (disk rotation), and a DC brushless servo drive system (translation).

The power system consists of batteries which provide system power while unplugged from a standard power outlet (e.g., during transport of the System and also during scanning). The base has retractable rotating caster wheels and electrical drive system can be easily moved to different locations.

In addition, the System has the necessary safety features such as emergency stop button, X-ray indicators, interlocks, patient alignment lasers, and 110 percent X-ray timer. The software helical reconstruction is based on an exact filtered-back projection algorithm.

This 510(k) summary describes the Mobius Airo CT System, a mobile high-resolution Computed Tomography (CT) System. The submission establishes substantial equivalence to the Neurologica NL4000 BodyTom CT System (K102677). The information provided focuses on the device's technical characteristics, safety and effectiveness concerns, and a summary of non-clinical and clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of acceptance criteria with corresponding device performance for specific image quality metrics or clinical outcomes. Instead, it states that the device was evaluated against general safety and effectiveness concerns and regulatory standards, and that a "Non-Significant Risk (NSR) study was performed to determine the diagnostic image quality of the Airo CT System for typical intended use anatomy."

The implicit "acceptance criteria" appear to be:

• Compliance with recognized regulatory standards.
• Diagnostic image quality for typical intended use anatomy.
• Substantial equivalence to the predicate device (Neurologica BodyTom CT System).

The reported device performance is:

• "all images were independently and subjectively reviewed and found to be of diagnostic image quality."
• "the Airo CT System meets the acceptance criteria and is substantially equivalent to the currently cleared predicate device (Neurologica BodyTom CT System)."
• "the Airo CT System to be as safe, as effective, and performance is substantially equivalent to its predicate device."

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "all images" from a Non-Significant Risk (NSR) study were reviewed, but the number of images or cases is not specified.
• Data Provenance: Not explicitly stated. Given the general nature of a 510(k) summary focusing on device performance and substantial equivalence, and the lack of detail on the "NSR study" methodology, specific country of origin or whether the data was retrospective or prospective is not provided. It is presented as a clinical study (NSR study), suggesting prospective data collection, but no further details are given.

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

• Number of Experts: Not explicitly stated. The document mentions "all images were independently and subjectively reviewed." It does not specify the number of reviewers involved in this subjective review.
• Qualifications of Experts: Not explicitly stated. The document does not provide details on the qualifications (e.g., medical specialty, years of experience) of the experts who performed the subjective review of image quality.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. The document only mentions "all images were independently and subjectively reviewed." It does not describe any specific adjudication process (e.g., 2+1, 3+1, none) if there were multiple reviewers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve With AI vs. Without AI Assistance

• MRMC Study: No. The device submitted is a CT imaging system, not an AI-based diagnostic tool for interpretation. Therefore, a multi-reader multi-case comparative effectiveness study evaluating human reader improvement with or without AI assistance is not applicable and was not performed.

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

• Standalone Performance: Not applicable. The Mobius AIRO™ CT System is an imaging device, not an algorithm, so the concept of standalone algorithm performance is not relevant in this context.

7. The Type of Ground Truth Used

• Type of Ground Truth: The reported "ground truth" for the assessment of diagnostic image quality was based on expert subjective review. The document states, "all images were independently and subjectively reviewed and found to be of diagnostic image quality." It does not mention pathology, outcomes data, or a formal expert consensus process beyond this subjective review.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. The Mobius AIRO™ CT System is a hardware device for image acquisition and reconstruction, not an AI algorithm that requires a training set.

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

• Ground Truth for Training Set: Not applicable, as the device does not involve an AI algorithm with a training set in the context of this submission.

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