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The CUBEScan BioCon-1100 is a B-mode pulsed-echo ultrasound device. The BioCon-1100 projects ultrasonic energy through the lower abdomen of a patient to obtain images of the bladder to calculate the urine volume non-invasively. The BioCon-1100 is intended to be used by a qualified medical professional in hospitals and other healthcare facilities to non-invasively measure the urine volume in the bladder. Contraindications for the BioCon-1100 are fetal use on pregnant patients.

The CUBEScan BioCon-1100 (Bladder volume measurement system) is a safe, easy to use, noninvasive system for measuring bladder volume (residual volume). The CUBEScan BioCon-1100 is a B-mode ultrasound device, which consists of a probe that sends and receives ultrasonic waves, and a console that processes ultrasonic signals and converts them into the desired data. The 3Dmechanical sector transducer take the bladder in 12 sections and calculate the volume of the bladder based on the images which appear on the LCD screen. In addition, the pre-scan function allows users to easily locate the location of the bladder before scanning, making measurement easier. Measurement results can be transferred to a computer, and data can be managed using CubePro-1100.

The provided text is a 510(k) summary for the CUBEScan BioCon-1100, a medical device for non-invasive bladder volume measurement. It clarifies that no clinical studies were required or performed to support substantial equivalence for this specific submission (K201995). The changes in this submission relate to the operating system, graphical user interfaces, rolling cart dimensions, and IPX rating, which were deemed not to affect device performance or indications for use.

Therefore, many of the typical acceptance criteria and study details for an AI/ML device (like those related to ground truth, expert consensus, MRMC studies, effect sizes, etc.) are not applicable to this submission, as it is for a traditional ultrasound device with minor technical updates, not an AI/ML product.

Based on the provided text, here's what can be extracted:

Acceptance Criteria and Device Performance (Not applicable for AI/ML performance, but for general device safety and effectiveness)

The document primarily states that the specific changes (Linux OS, GUIs, cart dimensions, IPX rating) "do not affect the device performance characteristics and does not change the device Indication for use." The underlying performance relates to accuracy of urine volume measurement, which is inherent to this type of device.

Study Details (based on the provided 510(k) Summary)

1. Sample size used for the test set and the data provenance: Not applicable. The document explicitly states: "The subject of this premarket submission, CUBEScan BioCon-1100, did not require clinical studies to support substantial equivalence." The testing was non-clinical (acoustic, biocompatibility, electrical, thermal, electromagnetic, mechanical safety).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical studies were performed requiring independent ground truth establishment by experts.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical studies were performed.

4. 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. This is not an AI/ML device, and no MRMC study was performed.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical studies were performed. For non-clinical testing, ground truth would refer to engineering specifications and compliance with standards.

7. The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no "training set" in the context of machine learning.

8. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

Conclusion from the document:

The CUBEScan BioCon-1100, as described in K201995, is cleared based on demonstrating substantial equivalence to a predicate device (CUBEScan BioCon-1100, K200548) through non-clinical testing (acoustic output, biocompatibility, thermal, electrical, electromagnetic, and mechanical safety) and by asserting that the minor technical changes (OS, GUI, cart, IPX) do not alter the device's performance characteristics or indications for use. The document explicitly states that no clinical studies were required or performed for this submission. Therefore, information typically requested for AI/ML device studies (like expert adjudication, MRMC, training/test set details, ground truth methods) is not present because it's not relevant to this specific 510(k) clearance.

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

CUBEScan BioCon-900S is a safe and easy, non-invasive system to measure the bladder volume. The device consists of a probe and various components. The probe is a B-mode instrument, which is hand-held, wireless and battery-operated. A 3D-mechanical sector transducer provides crosssectional images of the bladder from up to 12 scan planes which users can check through the screen and bladder volume is calculated based upon those images. In addition, the Pre-scan function allows users to easily locate the bladder before scanning, making measurement easier. CUBEScan BioCon-900S consists of a probe and CUBEscan Charger or a probe and CUBEScan Docking Station, with an optional mobile cart and a barcode module.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. Instead, it is a 510(k) premarket notification summary for the CUBEScan BioCon-900S.

The summary states that "The subject of this premarket submission, CUBEScan BioCon-900S, did not require clinical studies to support substantial equivalence." This means that no clinical studies were performed to establish performance metrics like accuracy, sensitivity, or specificity against a ground truth.

The document primarily focuses on:

• Device Description and Intended Use: The CUBEScan BioCon-900S is a B-mode pulsed-echo ultrasound device for non-invasively measuring urine volume in the bladder, intended for use by qualified medical professionals in hospitals and healthcare facilities.
• Comparison to Predicate Device: The device is considered substantially equivalent to a previously cleared predicate device (CUBEScan BioCon-900, K171591) based on the same indications for use and fundamental scientific technology.
• Non-Clinical Testing: The device underwent non-clinical testing for acoustic output, biocompatibility, thermal, electrical, electromagnetic, and mechanical safety, conforming to applicable medical device safety standards.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, device performance, sample sizes, ground truth, or MRMC studies, as this information is not present in the provided text.

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The CUBEScan BioCon-1100 is a B-mode pulsed-echo ultrasound device. The BioCon-1100 projects ultrasonic energy through the lower abdomen of a patient to obtain images of the bladder to calculate the urine volume non-invasively. The BioCon-1100 is intended to be used by a qualified medical professional in hospitals and other healthcare facilities to non-invasively measure the urine volume in the bladder. Contraindications for the BioCon-1100 are fetal use and use on pregnant patients.

The CUBEScan™ BioCon-1100 (Bladder volume measurement system) is a safe, easy to use, noninvasive system for measuring bladder volume (residual volume). The CUBEScan™ BioCon-1100 is a B-mode ultrasound device, which consists of a probe that sends and receives ultrasonic waves, and a console that processes ultrasonic signals and converts them into the desired data. The 3Dmechanical sector transducer take the bladder in 12 sections and calculate the volume of the bladder based on the images which appear on the LCD screen. In addition, the pre-scan function allows users to easily locate the location of the bladder before scanning, making measurement easier. Measurement results can be transferred to a computer, and data can be managed using CubePro-1100.

The provided FDA 510(k) summary for the CUBEScan™ BioCon-1100 does not contain detailed information about specific acceptance criteria for device performance, nor does it describe a clinical study conducted to prove the device meets such criteria.

Instead, the summary states:

"The subject of this premarket submission, CUBEScan™ BioCon-1100, did not require clinical studies to support substantial equivalence."

This indicates that the FDA granted clearance based on the device's substantial equivalence to a predicate device (CUBEScan™ BioCon-900, K171591) by demonstrating similar technological characteristics and adherence to non-clinical safety standards, rather than through a new clinical performance study for this specific model.

Therefore, I cannot provide the requested information regarding acceptance criteria and the study proving the device meets them because such a study was not presented in this document for the K200548 submission.

The document focuses on non-clinical testing for safety and compliance with various standards related to acoustic output, biocompatibility, electrical safety, and software, as summarized in Section 7: "Summary of Non-Clinical Testing Performed." However, these are not directly performance acceptance criteria related to accuracy of urine volume measurement in a clinical context.

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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.

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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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The BioCon-500 is a B-mode pulsed-echo ultrasound device. The BioCon-500 is intended to project ultrasound energy through the abdomen of the patient to obtain images of the bladder and to calculate the bladder volume non-invasively using these images. Contraindications for the BioCon-500 are fetal use and use on pregnant patients.

The BioCon-500™ is a portable ultrasound system for measuring the urine volume in a patient. BioCon-500™ 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-500™ 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 built-in thermal printer after measurements right away.

Also using the optional CubeScanPC software you can upload the saved data in a device's flash ROM to a computer for reviewing the scan results.

The document provided describes the BioCon-500, a portable ultrasound system for measuring urine volume. However, it does not include detailed acceptance criteria or a study proving the device meets specific performance metrics in a structured way that would be typical for clinical validation.

The information primarily focuses on:

• Device Description: The BioCon-500 transmits ultrasound signals to the abdomen to detect bladder outlines and calculate urine volume non-invasively. It has a Pre-Scan function for bladder location.
• Indications for Use: To obtain images of the bladder and calculate urine volume non-invasively, used by qualified medical professionals. Contraindicated for fetal use and pregnant patients.
• Comparison to Predicate Devices: States that BioCon-500 is substantially equivalent to VERATHON INCORPORATED's BVI 9400 and Mediwatch Ltd.'s Multiscan.
• Safety and Performance Data: Mentions electrical, mechanical, environmental safety, and EMC testing according to UL 60601-1, IEC 60601-2-37, and EN/IEC 60601-1-2(2001), with satisfactory results.
• FDA Clearance: Concludes the device is safe, effective, and substantially equivalent to predicate devices.

Missing Information:
Crucially, the provided text does not contain specific numerical acceptance criteria (e.g., accuracy, precision targets) for urine volume measurement, nor does it describe a study with performance data against such criteria. The "Safety, EMC and Performance Data" section refers to compliance with general safety and EMC standards, not a clinical performance study for its primary function (urine volume measurement accuracy).

Therefore, I cannot populate the requested tables and points directly from the given input. The document attests to substantial equivalence with predicate devices, which implies that the device's performance is expected to be comparable to those predicate devices, but it does not present the specific performance data for BioCon-500 itself that would allow us to fill in the requested details.

Based on the provided text, I can only state that the information requested regarding acceptance criteria and performance study details is not present. If such information were available, it would typically include a clinical study comparing the device's calculated bladder volume to a reference standard (e.g., catheterization or another validated method), along with defined accuracy or precision targets.

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