Search Results

PBSV4.1 bladder scanner is intended to project ultrasound energy through the lower abdomen of the nonpregnant patient to obtain an image of the bladder and uses that image to calculate the bladder volume non-invasively. It is contraindicated for fetal use and for use on pregnant patients. And it should not be used by those who are allergic to coupling agent and who have abdomen wound and skin disease.

Palm bladder scanner is a medical device with high performance combined with modern B-mode ultrasound technology and computer technology. The device consists of host and probe, it can speedily complete the detection of bladder area through scan of probe connected with the device, and transmit B ultrasound echo signal detected to embedded computer system after processing before computer identifies the edge of image and volume calculation, realizes the measurement of bladder volume, displays and prints out the relative information through LED/built-in printer.

This document is a 510(k) summary for the Meike PBSV4.1 Palm Bladder Scanner. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves the device meets specific acceptance criteria in a clinical context.

However, based on the provided text, we can extract information regarding acceptance criteria and the claimed device performance, as well as the types of tests performed.

1. Table of Acceptance Criteria and Reported Device Performance

Notes on the Table:

• Acceptance Criteria Derivation: The "Acceptance Criteria" column is derived directly from the specifications of the predicate device (Verathon BladderScan BVI 9400 Ultrasound System, K071217), as the submission aims to show "substantial equivalence."
• Device Performance Derivation: The "Reported Device Performance" column directly reflects the specifications of the PBSV4.1 Palm Bladder Scanner as presented in the "Comparison of Required Technology Characteristics" table.
• Accuracy Discrepancy: It's noteworthy that the accuracy specification for the subject device is presented with two different thresholds based on volume, which differs from the single ±15%, ±15ml specification of the predicate. The overall accuracy of the subject device (±15% for volumes 150ml-999ml) aligns with the predicate for larger volumes, but has a wider margin for smaller volumes (60ml-150ml).
• Time and Penetration Depth Discrepancy: The subject device is slower and has less penetration depth than the predicate. The submission states, "Then though the subject device and the predicate device differ in the specific transducer specification and acoustic output parameters, such differences will not influence the major function of the subject device and cause safety and effectiveness concerns."

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

• Sample Size for Test Set: Not mentioned. No clinical tests were included.
• Data Provenance: The document does not specify the origin of any data that would constitute a "test set" for performance evaluation against the stated accuracy criteria. Since no clinical tests were performed, any performance data for accuracy would likely come from phantom testing or internal validation, but the details are not provided. The company is based in China.

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

• Not applicable/Not mentioned. No clinical tests were performed, and thus no expert-established ground truth for a test set is discussed.

4. Adjudication Method for the Test Set

• Not applicable/Not mentioned. No clinical tests were performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. The document explicitly states: "No clinical tests were included." Therefore, no MRMC study was performed.

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

• The document does not explicitly describe a "standalone" performance study in the context of an algorithm or AI. The device is a bladder scanner that calculates volume non-invasively. While it performs calculations automatically based on ultrasound images, the submission does not detail a separate "algorithm-only" performance study. The reported accuracy figures would implicitly be the standalone performance of the device's volumetric calculation.

7. The Type of Ground Truth Used

• Not explicitly stated for the device's accuracy performance. Since no clinical tests were performed, it is highly likely that any "ground truth" for accuracy measurements (e.g., for the ±25% and ±15% figures) would have been established using phantom studies or controlled laboratory settings with known volumes of fluid, rather than pathology or patient outcomes data. This is a common method for bladder scanners to validate volumetric accuracy.

8. The Sample Size for the Training Set

• Not applicable/Not mentioned. The device is described as utilizing "modern B-mode ultrasound technology and computer technology" to identify edges and calculate volume. This implies an underlying algorithm, but the document does not discuss a "training set" in the context of modern machine learning. It's likely the algorithms are based on established ultrasound image processing techniques developed through engineering principles rather than a large, labeled training dataset for AI in the contemporary sense.

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

• Not applicable/Not mentioned for the same reasons as point 8.

Ask a specific question about this device