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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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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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PBSV4.1 bladder scanner 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 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.

This document is a 510(k) summary for the Meike PBSV4.1 Palm Bladder Scanner. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves the device meets specific acceptance criteria in a clinical context.

However, based on the provided text, we can extract information regarding acceptance criteria and the claimed device performance, as well as the types of tests performed.

1. Table of Acceptance Criteria and Reported Device Performance

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