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The Bladder Scanner is B-mode pulsed-echo ultrasound device adopts a 3D mechanical fan scanning probe for the ultrasonic scanning for bladder and measures the bladder volume from the abdominal surface of ultrasonic imaging. The Bladder Scanner is intended to be used only in hospital and by qualified medical professionals.

The Bladder Scanner (Model: AS-2) is a hand-held battery-operated device, it provides non-invasive bladder volume measurement utilizing real-time ultrasound imaging. The proposed device consists of the main unit (include 3D probe), battery power adapter and USB charging cable.

This FDA 510(k) summary provides information for a device called "Bladder Scanner" (Model: AS-2) by Avantsonic Technology Co., Ltd. The document primarily focuses on establishing substantial equivalence to a predicate device (K201316 Bladder Scanner by Suzhou Peaksonic Medical Technology Co., Ltd.) rather than detailing an independent study against acceptance criteria. However, it does state the acceptance criteria for volume measurement accuracy and reports whether the device met these criteria through non-clinical testing.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance:

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The BVT02 Bladder Scanner is B-mode pulsed-echo ultrasound device. It is intended as a portable device. The BVT02 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 BVT02 Bladder Scanner is intended to be used only by qualified medical professionals. Intended use environment: Professional health care facilities.

The BVT02 Bladder Scanner manufactured by Xuzhou Kaixin Electronic Instrument Co., Ltd. provides real - time ultrasound imaging and measuring, and also provides non invasive volume measurement of the bladder. During image scanning, multiple 2D plane ultrasonic images are acquired in several seconds. It features: Expert operating mode and Lite operating mode. Portable. Combined power supply with AC adapter and a battery.

Here's an analysis of the acceptance criteria and study information for the BVT02 Bladder Scanner, based on the provided FDA 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

The primary performance criterion mentioned is the bladder volume accuracy.

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

• Test Set Sample Size: The document does not explicitly state the specific sample size used for the volume accuracy test set. It mentions that "All the test results comply with the pre-set acceptability criterion," but not the number of measurements or subjects involved.
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only states that the testing was done per the FDA Guidance document "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers."

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

This information is not provided in the document. The volume accuracy testing appears to be a bench test involving physical measurements rather than human interpretation of images, so expert consensus on bladder volume images might not have been directly applicable.

4. Adjudication Method for the Test Set

This information is not provided. Given that the volume accuracy test appears to be a bench test, an adjudication method in the context of human interpretation is unlikely and not described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not mentioned or performed. The device is a bladder scanner that automatically calculates volume, not an AI diagnostic aid for image interpretation by clinicians.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Yes, a standalone performance test for volume accuracy was conducted. The "Performance-Bench Testing" section explicitly states: "The BVT02 Bladder Scanner had been tested volume accuracy per the FDA Guidance document 'Marketing Clearance of Diagnostic Ultrasound Systems and Transducers' issued in June 27, 2019. All the test results comply with the pre-set acceptability criterion..." This indicates the algorithm's performance was evaluated independently on a test setup.

7. Type of Ground Truth Used

The type of ground truth used for the volume accuracy test would likely be precise physical measurements of known volumes (e.g., water in a phantom) or a highly accurate clinical measurement method against which the device's calculated volume is compared. While not explicitly stated, the context of "volume accuracy" in bench testing for medical devices typically relies on such objective physical ground truth.

8. Sample Size for the Training Set

This information is not applicable and not provided. As a medical device for non-invasive volume measurement using pulsed-echo ultrasound, it is a hardware-software system rather than a machine learning/AI algorithm that requires a "training set" in the conventional sense for deep learning. Its accuracy is based on the underlying physical principles of ultrasound and algorithms for volume calculation, which are validated through bench testing rather than trained on data.

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

This information is not applicable and not provided since there's no mention of a "training set" for an AI or machine learning model. The device's performance is established through validation against known values in bench testing.

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The Bladder Scanner (Model Name:MS) 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.

Mode of operation: B-mode.

Intended user population: Trained and qualified healthcare professionals.

Intended use environment:Professional health care facilities.

The Bladder Scanner (model:M5) designed and manufactured by SUZHOU PEAKSONIC MEDICAL TECHNOLOGY CO., LTD. is a kind of B mode noninvasive bladder volume measurement and bladder wall thickness measurement based on ultrasonic imaging and measurement principle. The Bladder Scanner (model:M5) is composed of main device, probe, trolley and upper computer software. The main device and probe measure bladder wall thickness, and thickness, and they can transmit the patient information and measurement result to upper computer running upper computer software by WIFI or USB to manage and process patient's data, and the main device include print function.

The provided 510(k) summary for the Bladder Scanner (Model Name: M5) by Suzhou Peaksonic Medical Technology Co., Ltd. does not include a specific study detailing acceptance criteria and reported device performance in the format requested.

The document focuses on demonstrating substantial equivalence to a predicate device (Wireless Probe Type Ultrasound Scanner, Model: BProbe, K172750) through a comparison of technological characteristics and compliance with various international standards for safety, EMC, biocompatibility, and software.

While there is a mention of "Performance verification" with an "Internal verification protocol," the details of this protocol, including specific acceptance criteria and the results of the performance are not explicitly provided in the summary. The summary states that there are "slight difference in measurement range, measurement accuracy, and acoustic output, the subject device has wider measurement range and more accurate measurement accuracy, the measurement range and accuracy were verified." However, the actual acceptance criteria and the verified performance values are not tabulated.

Therefore, many parts of your request for specific details of the acceptance criteria and the study that proves the device meets them cannot be fully answered from the provided text.

Based on the available information, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with "acceptance criteria" and "reported device performance" in the typical sense of a clinical or performance study with quantified metrics and thresholds. Instead, it refers to the device having a "wider measurement range" and "more accurate measurement accuracy" than the predicate, and states that these were "verified."

Measurement Accuracy (Compared to Predicate):

Measurement Range (Compared to Predicate):

Other Performance-Related Characteristics (not explicit acceptance criteria, but comparisons):

2. Sample Size for the Test Set and Data Provenance

The document states: "Clinical testing is not required" and mentions "Internal verification protocol 1" for performance verification. This implies that the performance data for the "more accurate measurement accuracy" was likely derived from internal testing, possibly using phantoms or simulated data, rather than a clinical human test set.

• Sample Size for Test Set: Not specified.
• Data Provenance: Likely internal verification, not specified as human clinical data. No country of origin is mentioned for specific test data, apart from the manufacturer being in China.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Given the statement "Clinical testing is not required," there is no indication of experts being used to establish ground truth for a clinical test set. If the performance verification involved phantoms or other non-clinical methods, the "ground truth" would be the known properties of those phantoms.

4. Adjudication Method

Not applicable, as no clinical test set with expert adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was conducted or presented. The submission focuses on substantial equivalence based on technical specifications and international standard compliance, not a comparative effectiveness study with human readers.

6. Standalone Performance

The claimed "measurement accuracy" of ±7%, ±7ml refers to the standalone performance of the device's volume calculation algorithm. Details of the study or verification that quantified this accuracy are not provided beyond the mention of an "Internal verification protocol."

7. Type of Ground Truth Used

For the accuracy claim, the ground truth would likely be the known volumes of phantoms or carefully measured fluid volumes if internal verification protocols were used. The document does not specify the exact nature of the ground truth used for this verification.

8. Sample Size for the Training Set

The document does not mention any machine learning or AI components that would require a dedicated training set. The device is described as operating based on "ultrasonic imaging and measurement principle" and "complex algorithm is used to calculate the bladder volume." If these algorithms involve learning, the training set size is not disclosed.

9. How Ground Truth for the Training Set Was Established

Not applicable, as no training set is explicitly mentioned for algorithm development.

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Palm Bladder Scanner - PBSV7.1 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 - PBSV7.1 is a medical device with high performance combined with modern B-mode ultrasound technology and computer technology. The PBSV7.1 is composed of data processing host, 3D ultrasonic probe and application software. The 3D ultrasonic probe will transmit the collected data to the host, which will process the received data into ultrasonic images and bladder volume data. Images and data will be transmitted to the running application software on the Android system PC tablet through the USB interface.

The provided text is a 510(k) Summary for the Palm Bladder Scanner - PBSV7.1, with a predicate device of Palm Bladder Scanner - PBSV5.1 (K191307). While it discusses safety and effectiveness, it does not include a detailed study with specific acceptance criteria and performance data for clinical use.

The document states: "Clinical testing was not performed for the subject device as part of the submission."

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes and data provenance for a test set.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results.
6. Standalone performance results.
7. Type of ground truth used from a clinical study.
8. Sample size for the training set (clinical data).
9. How ground truth for the training set was established (clinical data).

Based on the provided text, the device's substantial equivalence is primarily established through non-clinical testing and comparison of technological characteristics with the predicate device.

Here's what can be extracted from the document regarding performance and testing, without a clinical study:

Acceptance Criteria & Reported Performance (Based on Technical Specifications & Bench Testing):

Explanation of the Study and Why it Lacks Clinical Details:

1. A table of acceptance criteria and the reported device performance:

   • As shown above, the "acceptance criteria" appear to be derived from the performance of the predicate device (PBSV5.1), and the "reported device performance" is the improved specification of the PBSV7.1. This is a comparison of technical specifications, not results from a clinical trial.

2. Sample sized used for the test set and the data provenance:

   • Not applicable for clinical data. The document explicitly states "Clinical testing was not performed for the subject device as part of the submission."
   • For non-clinical testing, the sample sizes and data provenance are not detailed in this summary. The summary mentions "non-clinical design verification and validation testing" and "comprehensive software verification and validation."

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

   • Not applicable for clinical data. There was no clinical test set with a need for expert-established ground truth.

4. Adjudication method for the test set:

   • Not applicable for clinical data.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

   • No, an MRMC study was not done. Clinical testing was not performed.

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

   • Not explicitly stated for a clinical context. The device calculates bladder volume non-invasively using an image. While the algorithm performs the calculation, its standalone performance in a clinical setting without a human using the device on a patient was not evaluated per this summary. The "software verification and validation" tests would have assessed the algorithm's performance, but not on clinical data.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not applicable for clinical data. For the non-clinical and software validation, the ground truth would have been based on defined specifications, simulated data, or phantoms, rather than clinical outcomes or expert consensus on patient data.

8. The sample size for the training set:

   • Not applicable for clinical data. The document does not describe any training set using patient data, as no clinical testing was performed for this submission. The software was "developed and verified according to IEC 62304:2006," implying a software development process rather than a machine learning training process on a large dataset.

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

   • Not applicable for clinical data.

Summary of Device Substantiation (as explained in the document):

The manufacturer claims substantial equivalence based on:

• Identical intended use as the predicate device.
• Similar technological characteristics, despite some differences.
• Non-clinical testing: "The function and performance of Palm Bladder Scanner - PBSV7.1 has been evaluated through non-clinical design verification and validation testing." This includes:
  • Compliance with various IEC and ISO standards (e.g., IEC 60601-1, IEC 60601-2-37, IEC 60601-1-2, IEC 62133, IEC 62359, ISO 10993-5, ISO 10993-10).
  • "Comprehensive software verification and validation."
• The conclusion that "the design changes presented with the subject device do not raise new questions of safety and effectiveness, the subject device meets design specifications, and that the subject and predicate devices are substantially equivalent."
• Improved performance over the predicate device in several key metrics (accuracy, maximum measurement, dead zone, memory capacity).

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The Bladder Scanner (Models: M3, M4, M4-HD) is B-mode pulsed-echo ultrasound device. It intended as a handheld battery-operated device. The M3, M3-HD, M4, M4-HD 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 M3, M3-HD, M4, M4-HD Bladder Scanner is intended to be used only by qualified medical professionals.

The M Series Bladder Scanner is a handheld battery-operated device, which is developed by SUZHOU PEAKSONIC MEDICAL TECHNOLOGY CO., LTD., and manufactured by Suzhou Lischka Medtech Co., Ltd., it provides non-invasive bladder volume measurement utilizing real-time ultrasound imaging. The device consists of the main unit, 3D probe (M4, M4-HD)/2D probe (M3, M3-HD), Data processing and storage modules, APP software, battery and Charger.

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in an "acceptance criteria" section. However, it does list the "Volume measurement accuracy" and implicitly sets the predicate device's performance as the benchmark for substantial equivalence.

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

The document explicitly states: "Clinical testing is not required." This implies that no clinical test set with human patients was used to prove the device meets these specific performance metrics. The performance metrics are likely derived from non-clinical phantom studies or internal validation processes that are not detailed in this summary. Therefore, there is no information on sample size or data provenance (country of origin, retrospective/prospective) for a clinical test set.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Since clinical testing was not required, there is no mention of experts being used to establish ground truth for a test set in the context of human patient data.

4. Adjudication Method

Not applicable, as no clinical test set with human data was used requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document clearly states that clinical testing was not required. Therefore, no MRMC study comparing human readers with and without AI assistance was performed.

6. Standalone (Algorithm Only) Performance Study

The document focuses on the device performance and states that "The M3,M3-HD,M4,M4-HD Bladder Scanner was evaluated with safety, EMC and Acoustic Output." It provides performance accuracy figures for volume measurement. This suggests that the algorithm's performance, as integrated into the device, was evaluated to achieve these accuracy figures. While the term "standalone study" in the context of an algorithm might imply a specific type of evaluation (e.g., using a separate dataset to test the algorithm's output without the full device), the volume measurement accuracy directly reflects the algorithm's capability.

7. Type of Ground Truth Used

Based on the lack of clinical testing, the ground truth for the stated performance accuracy (bladder volume measurement) was likely established through:

• Phantom studies: Using calibrated phantoms with known volumes. This is a common method for validating ultrasound device accuracy.
• Engineering measurements: Direct measurements of physical models.

The document does not specify the exact method for establishing ground truth for the performance metrics, but it is implied to be non-clinical.

8. Sample Size for the Training Set

The document does not provide any information regarding the training set size for the device's algorithms.

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

The document does not provide any information regarding how the ground truth for the training set (if any, as it could be rule-based or trained on phantom data) was established.

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Palm Bladder Scanner - PBSV5.1 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 - PBSV5.1 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.

The provided document is a 510(k) premarket notification for the Palm Bladder Scanner - PBSV5.1. It asserts substantial equivalence to a predicate device (PBSV4.1) rather than proving the device meets a set of acceptance criteria through a clinical study involving AI assistance.

Therefore, the document does not contain the information requested regarding acceptance criteria and the study proving the device meets those criteria for an AI/ML-driven device. Specifically:

• It states clearly under "7.1 Clinical Tests" that "Clinical testing was not performed for the subject device as part of the submission."
• The comparison focuses on hardware/software changes from a previous version of the same device, not a performance study against a defined ground truth with human readers or standalone AI performance metrics.
• The device is a bladder scanner that calculates bladder volume non-invasively, not explicitly an AI/ML system requiring extensive comparative effectiveness studies with human readers or complex ground truth establishment methods typically associated with AI.

The document focuses on non-clinical tests to demonstrate that the changes (housing, digital circuit, software UI optimization, battery) do not raise new questions of safety and effectiveness and that the device meets design specifications and relevant electrical safety, performance, and software standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2-2004, IEC 62304, ISO13485, IEC62133).

Therefore, I cannot provide the requested table and study details because the provided text does not describe such a study for this device.

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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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MD-6000P Bladder Scanner is intended to measure the urine volume in human bladder.

The device is intended to be used in medical and nursing care institutions. It should be operated by trained professionals. The device is not intended for use on pregnant women. It cannot be used on wounded skin.

MD-6000P Bladder Scanner is a hand-held device which utilizes ultrasonic distance measuring principle to calculate urine volume in the bladder.

The device takes mechanical sector scan by 2.5MHz ultrasonic waves and recognizes the reflected waves of the front and back walls of bladder to get the area of bladder section; then it makes 12 scans at an interval of 15° and calculates the urine volume in human bladder with volume integral algorithm.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes bench testing for accuracy using a phantom and a water sac. It does not specify a "test set" in the context of human subjects or a clinical study.

• Test Set Sample Size: Not explicitly stated as a number of measurements, but refers to "scan on the phantom" and "scan on the test object of water sac with known volume." This implies a series of measurements were performed.
• Data Provenance: The document does not provide information on data provenance (e.g., country of origin, retrospective/prospective) for these bench tests.

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

• Number of Experts: Not applicable. The ground truth for the bench tests was established by "nominal value" for the phantom and "known volume" for the water sac.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Ground truth was based on physical properties (nominal value, known volume) rather than expert consensus requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The document states: "The MD-6000P Bladder Scanner, subject of this submission, did not require clinical studies to support the determination of substantial equivalence."

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

• Standalone Performance: The accuracy reported (±15% or ±15ml) is from bench testing of the device's measurement capabilities. This can be considered a standalone performance assessment in the sense that it evaluates the device's ability to measure a known volume without a human interpreter influencing the measurement outcome. However, it's not "algorithm-only" performance in the context of AI, as this is a physical measurement device.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the bench testing, the ground truth was based on:
  • Nominal value (for the phantom in the 100-999ml range).
  • Known volume (for the water sac in the 20-100ml range).

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. The document describes a medical device (bladder scanner) that utilizes ultrasonic distance measuring principles and a volume integral algorithm. It does not mention any machine learning or AI components that would require a "training set" in the conventional sense. The "algorithm" here refers to a deterministic calculation method, not a learned model.

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

• Ground Truth for Training Set: Not applicable, as there is no mention of a training set or a machine learning algorithm.

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The Bladder Scanner (model: PadScan Z3, PadScan Z3, PadScan Z5) is B-mode pulsed-echo ultrasound device. It intended as a handheld battery-operated device. The 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 Bladder Scanner is intended to be used only by qualified medical professionals.

The PadScan Series manufactured by AvantSonic Technology Co., Ltd. provides non-invasive volume bladder measurement utilizing real-time ultrasound imaging and measurement. The equipment consists of the main unit, 3D probe, battery and adapter. 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, Urine volume setting and alarm setting, Multi-language selection, Combined power supply with AC adapter and a built-in battery. The difference between these models is the size of the LCD screen and enclosure structure. PadScan DS3 is provided 7-inch LCD screen. PadScan Z3 is provided 7-inch LCD screen and LCD screen stand. PadScan Z5 is provided 8-inch LCD screen and LCD screen which has a handle.

Here's a breakdown of the acceptance criteria and study information for the AvantSonic Bladder Scanner, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states: "Clinical testing is not required." This indicates that no clinical test set was used for the substantial equivalence determination. The performance criteria were based on comparisons to the predicate device's specifications.

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

Not applicable, as no clinical testing with a test set requiring expert ground truth was conducted. Performance was based on device specifications and non-clinical testing.

4. Adjudication Method for the Test Set

Not applicable, as no clinical testing with a test set requiring adjudication was conducted.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned or performed. The submission relies on demonstrating substantial equivalence to a predicate device through non-clinical testing and shared intended use/technological characteristics.

6. Standalone (Algorithm Only) Performance Study

While the device calculates bladder volume non-invasively, the provided information does not detail a standalone algorithm performance study. The performance is assessed based on the device's ability to measure bladder volume within specified accuracy against a reference.

7. Type of Ground Truth Used

For the reported device performance regarding volume measurement accuracy, the ground truth would have been established through a controlled measurement method (e.g., using known volumes of liquid in a phantom or other controlled environment) to calibrate and verify the device's calculations. This is implied by the accuracy specification but not explicitly described as "pathology" or "outcomes data."

8. Sample Size for the Training Set

Not applicable, as this is a medical device submission based on substantial equivalence, not a machine learning model requiring a training set in the typical sense. The device's "training" is inherent in its design and calibration processes to meet the specified accuracy.

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

Not applicable. See point 8. The device's volume calculation mechanism is based on ultrasound physics and established algorithms for bladder volume estimation, not trained on a distinct dataset with "ground truth" labels in the context of machine learning. The accuracy is verified through metrological testing.

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The Bladder Scanner(model: PadScan HD2) is B-mode pulsed-echo ultrasound device. It intended as a handheld batteryoperated device. The PadScan HD2 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 PadScan HD2 Bladder Scanner is intended to be used only by qualified medical professionals.

The PadScan HD2 Bladder Scanner manufactured by Caresono Technology provides real-time ultrasound imaging and measuring, and also provides non-invasive volume measurement of the bladder. It is a handheld bladder scanner, the main unit and the probe are all-in-one.

It features:

• · Expert operating mode and Easy operating mode
• · Non-invasive, comfortable, correct, reliable, fast and simple operation
• SD card storage
• Voice recording function
• Urine volume setting and alarm setting
• Multi-language selection
• · Injection molded shell, the main unit and the probe are all-in-one, 2.5-inch LCD screen(240x320pixels)
• Power supply with built-in battery.

The provided document is a 510(k) summary for the Caresono Technology Co., Ltd. PadScan HD2 Bladder Scanner. It details the device's indications for use, its comparison to a predicate device, and the non-clinical testing performed to establish substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

1. Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:
The document states: "The PadScan HD2 Bladder Scanner had been tested volume accuracy per the FDA Guidance document 'Information for Manufactures Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers' issued in September 2008. All the test results comply with the pre-set acceptability criterion, which is the same as predicate device."

Additional Information:

Since this is a 510(k) summary focused on establishing substantial equivalence through non-clinical testing, it primarily details engineering and performance benchmarks against an existing predicate device rather than comprehensive clinical study data. Many of the requested details related to human reader studies, ground truth establishment, and sample sizes for clinical trials are not typically found in this type of submission for a device like a bladder scanner, which primarily relies on established physical principles and performance accuracy.

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

• Sample Size: Not specified in the provided document for volume accuracy testing. The testing mentioned is "Bench Testing."
• Data Provenance: Not specified, but given it's bench testing, it's likely conducted in a controlled lab environment by the manufacturer in China.

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 volume accuracy testing described is mechanical or phantom-based bench testing, not reliant on expert interpretation of clinical data in the same way an AI diagnostic algorithm might be.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable/not specified. This term typically refers to the resolution of discrepancies among human readers in clinical studies, which is not described for this bench testing.

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, an MRMC comparative effectiveness study is not mentioned. This type of study would be more relevant for an AI-powered diagnostic imaging interpretation tool, not a bladder volume measurement device based on pulsed-echo ultrasound. The device calculates bladder volume non-invasively, not assisting human readers in interpreting complex images to improve diagnostic accuracy.

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

• Yes, the performance testing for volume accuracy described (10.3 Performance-Bench Testing) appears to be a standalone evaluation of the device's ability to measure volume against a known standard. The device "projects ultrasound energy...to calculate bladder Volume noninvasively," implying an algorithmic calculation of volume based on the ultrasound data, without human interpretation of the final volume number.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the volume accuracy testing, the ground truth would likely be a precisely measured phantom or known volume of fluid, as typically used in bench testing for such devices. The document does not explicitly state the specific ground truth, but refers to "pre-set acceptability criterion."

8. The sample size for the training set:

• Not applicable/not specified. The document does not describe an AI or machine learning component that would require a distinct training set in the context of diagnostic performance testing. The device is described as a "B-mode pulsed-echo ultrasound device" that calculates volume, implying traditional signal processing and measurement algorithms rather than machine learning models that are "trained."

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

• Not applicable/not specified, as no training set for an AI/ML algorithm is described.

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