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The BioCon-700 is a B-mode pulsed-echo ultrasound device. The BioCon-700 is intended as a portable battery-operated device. The BioCon-700 projects ultrasonic energy through the abdomen of the patient obtaining images of the bladder in order to calculate the urine volume non-invasively. BioCon-700 is intended to be used by a qualified medical professional to non-invasively measure the urine volume in the bladder. Contraindications for the BioCon-700 are fetal use and use on pregnant patients.

The BioCon-700 is a portable ultrasound system for measuring the urine volume in a patient. BioCon-700 transmits ultrasound signals to the abdomen of a patient and receives the echoed signals. Using the echoed signals the system detects the bladder outlines and calculates the volume in bladder outlines.

BioCon-700 has a Pre-scan function, which shows the ultrasound images for a horizontal plane consisted of the echoed signals. The Pre-scan function helps a user locate the bladder easily and get more accurate results.

A user can print the results using a build-in thermal printer after measurements right away. Also using the optional CubePro software, a user can review the scan results.

The provided 510(k) summary only includes acceptance criteria for the CUBEscan BioCon-700 Diagnostic Ultrasound System. It references the fulfillment of these criteria through various tests but does not provide a detailed study or its results proving the device meets these criteria. Instead, it relies on substantial equivalence to predicate devices and adherence to regulatory standards.

Here's the information extracted and organized as requested, with explicit notes about what is not present in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "All test results were satisfactory" for safety, EMC, and performance, implying these criteria were met, but it does not provide the raw data or detailed performance outcomes of these tests. The "Reported Device Performance" column reflects the criteria it is stated to align with or achieve, rather than specific numerical results from a performance study.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified in the provided document. The document refers to "performance testing" but does not detail the methodology or sample size of any patient study for accuracy.
• Data Provenance: Not specified. It is unclear if any clinical data was used for testing, or if validation was purely technical. If clinical data was used, its origin (e.g., country, retrospective/prospective) is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable / Not Specified: The document does not describe a study involving expert-established ground truth for the device's performance (e.g., measuring urine volume). The approval is based on substantial equivalence to predicate devices and adherence to engineering and safety standards.

4. Adjudication method for the test set

• Not Applicable / Not Specified: As no study involving expert interpretation or "ground truth" establishment is detailed, there is no mention of an adjudication method.

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

• No: The device is a diagnostic ultrasound system for automated urine volume calculation, not an AI-assisted diagnostic tool that would typically involve human reader performance comparisons. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not described or performed.

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

• Yes (Implicitly): The device's primary function is to automatically calculate urine volume. The "Accuracy" specification (0~999: ±15%, ±15ml) is a standalone performance metric for the algorithm's output. While a human initiates the scan and locates the bladder using the pre-scan function, the final volume calculation is performed by the device's algorithm. The document mentions "performance testing" was conducted, and the stated accuracy is a direct measure of this standalone performance. However, the details of the study proving this accuracy are not provided.

7. The type of ground truth used

• Not explicitly stated for the accuracy claim: For a device measuring urine volume, the ground truth would typically be actual urine volume obtained via catheterization or another highly accurate measurement method. However, the document does not describe the specific ground truth method used to validate the stated ±15%, ±15ml accuracy.

8. The sample size for the training set

• Not Applicable / Not Specified: This document is a 510(k) summary for a medical device that calculates bladder volume based on ultrasound images; it does not explicitly describe an AI/machine learning model that would require a distinct "training set." The algorithm's development (if it involved data-driven methods) and any associated training data are not disclosed.

9. How the ground truth for the training set was established

• Not Applicable / Not Specified: As no training set is discussed, the method for establishing its ground truth is also not mentioned.

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