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510(k) Data Aggregation
(73 days)
The PadScan HD series Bladder Scanner is B-mode pulsed-echo ultrasound device. It is intended as a portable battery-operated device. The PadScan HD series Bladder Scanner projects ultrasound energy through the lower abdomen of the patient to obtain images of the bladder which is used to calculate bladder volume noninvasively. The PadScan HD series Bladder Scanner is intended to be used only by qualified medical professionals.
The PadScan HD series Bladder Scanner manufactured by Caresono Technology Co., Ltd. provides real-time ultrasound imaging and measuring, and also provides non-invasive volume measurement of the bladder. During image scanning, multiple 2D plane ultrasonic images are acquired in several seconds.
It features:
- Expert operating mode and Easy operating mode. .
- Correct, reliable, fast, and simple operation. ●
- Printouts of ultrasound images with many parameters. ●
- . Portable
- . Combined power supply with AC adapter and a built-in battery.
The PadScan HD series Bladder Scanner (Models: PadScan HD 5, PadScan HD 3) is a diagnostic ultrasound system designed for non-invasive bladder volume calculation.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Range) | Reported Device Performance (Accuracy) |
|---|---|
| Bladder volume: 0-999ml | ±15%, ±15ml (0-999ml) |
The device performance, with an accuracy of ±15% or ±15ml (within the 0-999ml range), meets its own specified acceptance criteria.
The provided document, a 510(k) summary for the PadScan HD series Bladder Scanner, focuses on demonstrating substantial equivalence to a predicate device (CUBEscan BioCon-700) and compliance with various safety and performance standards. While it outlines the device's accuracy specifications, it does not include a detailed study proving the device meets these acceptance criteria.
The document mentions "Performance: The PadScan HD series Bladder Scanner have been tested as Track 1 device per the FDA Guidance document 'Information for Manufactures Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers' issued in September 2008. The acoustic output is measured and calculated per NEMA UD 2:2004 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment." This primarily relates to acoustic safety testing, not clinical accuracy in bladder volume measurement.
Therefore, many of the requested details about a clinical study demonstrating the device's accuracy are not available in the provided text.
Based on the provided document, the following information is not available:
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): No information on a specific clinical test set for accuracy.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable as no specific clinical test is described.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable, as this is an ultrasound device for volume calculation, not an AI-assisted diagnostic imaging interpretation system.
- If a standalone (i.e., algorithm only without human-in-the loop performance) was done: The device calculates bladder volume automatically, implying a standalone algorithmic performance. However, there is no detailed study methodology provided to confirm this or elaborate on its performance without human interaction within a clinical validation context. The document refers to "Expert operating mode and Easy operating mode," which suggests human interaction is part of its intended use.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned for any accuracy testing.
- The sample size for the training set: Not applicable, as no details of an AI/machine learning model training are provided.
- How the ground truth for the training set was established: Not applicable.
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