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The Bladder Scanner (Models: M2, M2-W, M1, M1-W) is B-mode pulsed-echo ultrasound device. It intended as a handheld battery-operated device. The M2, M2-W, M1, M1-W 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 M2, M2-W, M1, M1-W Bladder Scanner is intended to be used only by qualified medical professionals.

The M Series Bladder Scanner manufactured by Suzhou Lischka Medtech Co., Ltd. provides noninvasive volume bladder measurement utilizing real-time ultrasound imaging and measurement. The equipment consists of the main unit, 3D probe (M2, M2-W)/2D probe (M1, M1-W), battery and Charger. It features:

• Two Operation Modes: Expert Mode and Easy Mode .
• Non-invasive, comfortable, correct, reliable, fast and simple operation .
• Printouts with ultrasound images and various parameters through PC software .
• . Touch screen keyboard operation
• . Voice input and play functions
• Multi-language selection .
• Information storage •
• . Information printing
• . built-in battery
  The difference between these models is that the model of the probe is different. M2, M2-W is 3D probe .M1,M1-W is 2D probe. M2-W, M1-W have WIFI connection function, M2, M1 do not have WIFI connection function.

The provided document focuses on the FDA 510(k) clearance of the Suzhou Lischka Medtech Co., Ltd. Bladder Scanners (Models: M2, M2-W, M1, M1-W) and primarily outlines conformance to general standards rather than specific clinical performance studies with detailed acceptance criteria and expert reviews.

Based on the available text, here's an analysis:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The document states: "Clinical testing is not required."

Instead, the submission relies on non-clinical data, including:

• Safety Standards: Compliance with electrical safety (ES60601-1), EMC (IEC 60601-1-2), and specific ultrasound safety (IEC 60601-2-37).
• Performance Standards: Compliance with NEMA UD 2 for real-time display of thermal and mechanical acoustic output, and FDA guidelines for acoustic output testing.
• Biocompatibility Standards: Compliance with ISO 10993-1, -5, -10.
• Wireless Communication Standards: Compliance with FCC CFR TITLE 47 PART 15 SUBPART C SECTION 15.247 for WIFI and Bluetooth.

The comparison table on pages 7-8 explicitly notes that the subject device's volume measurement accuracy (±7%, ±7ml for M2/M2-W and ±14%, ±14ml for M1/M1-W) is "more accurate than the predicate device" (which was ±15%, ±15ml). This direct comparison constitutes a performance claim relative to the predicate.

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

Since the document explicitly states "Clinical testing is not required," there is no information provided about a "test set" in the context of human clinical data or diagnostic performance on a dataset of patient scans. The performance data discussed (e.g., volume measurement accuracy) is likely derived from phantom testing or in-vitro validation. The document does not specify the sample size for these non-clinical tests or their provenance.

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

Not applicable, as clinical testing and the establishment of ground truth by experts for a diagnostic performance test set are not described as part of this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring expert adjudication is mentioned.

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

Not applicable. The device is a bladder scanner for volume calculation, not an AI-assisted diagnostic imaging interpretation tool for human readers. No MRMC study is mentioned.

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

The device itself is an "algorithm only" device in the sense that it automatically calculates bladder volume. However, the FDA submission doesn't describe a formal "standalone performance study" in the way it might for a sophisticated AI algorithm interpreting medical images. The accuracy metrics (e.g., ±7%, ±7ml) represent the device's inherent performance.

7. The Type of Ground Truth Used

For the key performance metric (volume measurement accuracy), the ground truth for non-clinical testing would typically be established using precisely known volumes in phantoms or calibrated fluid measurements. The document does not explicitly state how the ground truth for their accuracy claims was established, but given it's a bladder volume device and clinical testing was not done, this would be the most common method.

8. The Sample Size for the Training Set

Not applicable. This device, as described, is a pulsed-echo ultrasound device for volume calculation, not a machine learning model that requires a distinct "training set." Its functionality is based on established ultrasound physics and algorithms, not trained on large datasets.

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

Not applicable, as there is no mention of a training set for a machine learning model.

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