Search Results

BioCon-900 is a B-mode pulsed-echo ultrasound device. The BioCon-900 projects ultrasonic energy through the lower of a patient to obtain images of the bladder to calculate the urine volume non-invasively. BioCon-900 is intended to be used by a qualified medical professional to non-invasively measure the urine in the bladder. Contraindications for the BioCon-900 are fetal use and use on pregnant patients.

CUBEScan™ BioCon-900 (bladder volume measurement system) is a safe and easy, non-invasive system to measure the bladder volume. CUBEScan™ BioCon-900 is a B-mode instrument, hand-held, wireless and battery-operated. A 3D-mechnical sector transducer provides cross-sectional images of the bladder from up to 12 scan planes and bladder volume is calculated based upon those images and displays 12 scan planes on a screen. Furthermore, a live image of the bladder during Pre-Scan makes it easier to detect the bladder before scanning. Measurements are transmitted to a personal computer running CubePro software via a wireless connection. CubePro allows the user to print measurements, archive data and so on.

The provided document is limited to the 510(k) Summary for the CUBEScan™ BioCon-900 (Bladder Volume Measurement System). While it discusses safety and some performance testing, it does not contain a detailed study proving the device meets specific acceptance criteria in the way typically found in clinical validation studies for AI/algorithm performance.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (CUBEScan™ BioCon-700) and compliance with various regulatory standards for medical devices (biocompatibility, electrical safety, acoustic output, software validation).

Therefore, I can only extract limited information relevant to your request, primarily regarding the "Volume Measuring Testing." The other requested items (ground truth, expert consensus, MRMC studies, training set details) are not present in this 510(k) Summary.

Here's an analysis based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions "Volume Measuring Testing" to demonstrate accuracy but does not explicitly state numerical acceptance criteria (e.g., specific accuracy thresholds) or detailed quantitative performance results (e.g., mean absolute error, agreement with reference). It only states that "the accuracy has been demonstrated."

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

• Sample Size for Test Set: Not specified. The document only mentions "a tissue-equivalent bladder phantom with a balloon which has a designated volume is used." It doesn't indicate how many different designated volumes were tested or how many measurements were taken for each.
• Data Provenance: The test was conducted using a "tissue-equivalent bladder phantom," which means it was an in vitro (laboratory-based) study, not involving human subjects. Therefore, it's neither retrospective nor prospective in a clinical sense, and country of origin for human data is not applicable.

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

• Number of Experts: Not applicable. The ground truth ("designated volume of the balloon") was established by the physical properties of the phantom, not by human experts.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The ground truth was a "designated volume" of a phantom, not subject to expert interpretation or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• MRMC Study: No, an MRMC study was not done. This 510(k) summary describes a standalone device (BioCon-900) which is an ultrasound device to measure bladder volume. It is not an AI/algorithm that assists human readers/clinicians, but rather an instrument for measurement. The concept of "human readers improving with AI assistance" does not apply to the testing described.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, a standalone performance test was done for the device's ability to measure volume from a phantom. The "Volume Measuring Testing" describes the device (CUBEScan™ BioCon-900) directly measuring the volume of a bladder phantom and comparing it to the "designated volume." This is a standalone performance test for the device itself.

7. The Type of Ground Truth Used

• Ground Truth Type: "Designated volume" of a balloon within a tissue-equivalent bladder phantom. This is an engineered physical truth.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not specified in this document. The CUBEScan™ BioCon-900 is described as a "B-mode pulsed-echo ultrasound device" with a "3D-mechanical sector transducer." While it uses images to calculate volume, the document does not indicate that it is a machine learning or AI-driven algorithm that requires a "training set" in the conventional sense. The volume calculation is likely based on established ultrasound principles and internal algorithms that may have been developed and refined, but the concept of a separate "training set" as in deep learning is not mentioned or implied.

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

• How Ground Truth for Training Set Was Established: Not applicable, as detailed training set information is not provided nor explicitly relevant to the device as described.

Summary of Limitations as per the provided document:

The provided document is an FDA 510(k) summary primarily focused on demonstrating substantial equivalence and regulatory compliance (safety, EMC, software validation) for a medical device. It offers very limited detail on the specific performance study for bladder volume measurement accuracy, particularly regarding numerical acceptance criteria, detailed results, human subject data, or AI/algorithm-specific validation metrics like those typically requested. The "Volume Measuring Testing" only mentions the type of test (phantom-based comparison to designated volume) without quantifiable outcomes.

Ask a specific question about this device