(169 days)
The XV Ventilation Lung Analysis Software is software-based image processing technology that analyzes cinefluorograph images and a CT (can be a previously acquired CT that is representative of the patient's present lung envelope), to quantify ventilation of pulmonary tissue for use in adult patients.
The XV Ventilation Lung Analysis Software provides reproducible quantification for pulmonary tissue, which is essential for providing quantitative support for diagnosis and follow up examinations. For use by referral from a pulmonary specialist or equivalent, the Device can be used to provide the physician with additional clinical data in the diagnosis and documentation of inhomogeneties and defects in pulmonary ventilation. Quantification and statistics are provided in the form of a Report, including:
- · The tidal volume (i.e. total lung ventilation), presented as a single value;
- · Visualization of lung ventilation with color-defined specific ventilation ranges overlaid on the CT slices;
- · The heterogeneity of lung ventilation, presented as three values, which quantifies the regional variability of the ventilation: and
· Ventilation graph/ histogram of the classified lung voxel's relative frequencies showing the frequency distribution of regional specific ventilation measured across the entire lung, including ventilation defect percentage which shows the volume of lung with low ventilation.
The clinical study used to validate the Device was limited to patients selected to undergo Radiation Therapy (most commonly for breast cancer and esophageal cancer). In this study these patients were examined using the Device at four time-points over a 13-month period (twice prior and twice following radiation therapy).
The XV Lung Ventilation Analysis Software is a software-based image processing technology that analyzes cinefluorograph images in combination with a CT image to quantify ventilation of pulmonary tissue, thereby providing support to physicians in their assessment of patients with lung diseases.
The XV Lung Ventilation Analysis Software measures the tissue motion of the lung, at all locations throughout the lung, and at all phases of the breath. It uses these motion measurements to calculate the 4-dimensional (4D) ventilation of lung tissues. Quantification and statistics are provided in the form of a Report.
The key outputs are:
- The tidal volume (i.e. total lung ventilation), presented as a single value;
- Visualization of lung ventilation with color-defined specific ventilation ranges; .
- The heterogeneity of lung ventilation, presented as three values; and .
- . Ventilation graph/ histogram of the classified lung voxel's relative frequencies including ventilation defect percentage.
The provided document, a 510(k) premarket notification, describes the XV Lung Ventilation Analysis Software System. While it discusses the device's intended use, its comparison to predicate devices, and general safety and effectiveness concerns, it does not contain the specific details of acceptance criteria for performance metrics or a detailed clinical study demonstrating the device meets those criteria, as typically found in clinical trial reports.
The document refers to a "clinical study" but only provides a high-level summary and its overall conclusion regarding safety and efficacy, not the quantitative results against pre-defined acceptance criteria. Therefore, I cannot generate a table of acceptance criteria and reported device performance from the provided text.
Here is a breakdown of the information that cannot be extracted from the provided text, based on your request:
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A table of acceptance criteria and the reported device performance: This information is not present in the document. The document states "Testing for verification and validation of the device supports that all software specifications have met the acceptance criteria" in section 9, and in section 10, "it is considered that the XV Lung Ventilation Analysis Software presents no unacceptable clinical risks, is safe for clinical usage as indicated by the manufacturer and meets the manufacturer's intended performance criteria." However, the actual criteria and the quantitative performance measured against them are not provided.
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Sample size used for the test set and the data provenance: The document states, "The clinical study used to validate the Device was limited to patients selected to undergo Radiation Therapy (most commonly for breast cancer and esophageal cancer)." It mentions "Data from all four time points was analyzed," referring to four time points over a 13-month period. However, the exact sample size (number of patients or cases) for the test set is not specified. Data provenance (country of origin, retrospective/prospective) is also not specified, beyond the implication of a prospective study given the description of follow-up time points.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided. The document mentions the study "validated the consistency of outputs with gold-standard measures (CT and PFT)," implying these were used as a form of ground truth or reference, but it doesn't describe the process of establishing ground truth by experts.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not provided.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: This information is not provided. The document describes the device as a "software-based image processing technology" to quantify ventilation, implying it's a tool providing data to a physician, but there is no mention of a comparative effectiveness study involving human readers with and without AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document doesn't explicitly state "standalone performance." It validates "consistency of outputs with gold-standard measures (CT and PFT)," which implies a comparison of the algorithm's output to these measures. However, the specifics of how this comparison was quantified or what metrics were used are not detailed.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The document mentions "consistency of outputs with gold-standard measures (CT and PFT)." This suggests that quantitative data from CT and Pulmonary Function Tests (PFTs) were used as references. It does not explicitly state expert consensus or pathology data as ground truth.
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The sample size for the training set: This information is not provided. The document only details the clinical study used for validation, not the development or training of the AI model.
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How the ground truth for the training set was established: This information is not provided.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.