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The FloPatch FP120 is indicated for use for the noninvasive assessment of blood flow in the carotid artery. FloPatch FP120 operates in a single mode, the Continuous Wave (CW) mode, and is not capable of operating in any other mode.

The device is intended to be used by medical professionals, such as physicians and nurses, in hospitals and professional environments. The device is intended for prescription use on adults only.

The FloPatch (FP120) is a non-invasive blood flow detection device to be used in a medical/hospital setting for use by a medical professional. The device uses ultrasound and the Doppler effect to assess the flow of blood. The device consists of a signal processing unit and an adhesive strap. The device transmits ultrasonic waves from the ultrasonic transducer to a peripheral vessel such as the carotid artery. The Doppler shifted ultrasonic waves are reflected by moving blood cells back to the ultrasonic flow transducer. The reflected signal is received by the signal processing unit which outputs the Doppler signal wirelessly to a mobile medical application. The mobile medical application then processes the Doppler signal and displays a Max Velocity trace, Max VTI (Velocity Time Integral) and the Corrected Flow Time.

The provided text is a 510(k) summary for the FloPatch (FP120) and mainly focuses on showing substantial equivalence to predicate devices based on intended use, technology, and compliance with recognized standards. It lacks detailed information about specific acceptance criteria for device performance and the study that proves those criteria are met.

However, based on the information provided, here's what can be extracted and inferred:

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

The document does not explicitly state quantitative acceptance criteria for device performance (e.g., accuracy, precision) or provide a table with these criteria alongside reported performance data. It broadly mentions compliance with consensus standards and performance verification testing.

It states:

"The FloPatch has been evaluated to and found compliant with recognized consensus standards for EMC, electrical, thermal & mechanical safety. Additionally, the device has been evaluated to and complies with the requirements of the recognized consensus standard for basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment. Further testing was conducted to verify performance, labelling, packaging and shelf life. The results of the performance testing to recognized consensus standards demonstrate that the characteristics of the FloPatch FP120 are equivalent to the recognized predicate(s)."

This indicates that acceptance criteria are tied to:

• Compliance with electrical safety, EMC, thermal, and mechanical safety standards (e.g., ES60601-1, IEC 60601-1-2, IEC 60601-2-37).
• Biocompatibility (ISO 10993 standards).
• General performance verification (likely comparing its outputs like Max Velocity, VTI, and Corrected Flow Time to a reference method, though the specific targets and results are not detailed).

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the given text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided in the given text.

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

This information is not provided in the given text.

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

The FloPatch (FP120) is described as a "non-invasive blood flow detection device" that processes Doppler signals and displays metrics (Max Velocity trace, Max VTI, Corrected Flow Time) on a mobile medical application. It is used by medical professionals. The document does not describe an MRMC comparative effectiveness study comparing human readers with and without AI assistance or any AI components in its operation that would involve human "readers" or "interpretation" by AI beyond signal processing and data display. Its function appears to be a measurement device rather than an AI-assisted diagnostic interpretation tool.

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

While the device operates as an "algorithm only" in the sense that it processes signals and calculates metrics, the document does not specifically describe a "standalone" performance study in the context typically used for AI/CADe devices, which would involve evaluating its agreement with a ground truth independently of human intervention. It states that "the mobile medical application then processes the Doppler signal and displays a Max Velocity trace, Max VTI (Velocity Time Integral) and the Corrected Flow Time," indicating algorithm-driven data presentation. Therefore, it implicitly operates in a standalone manner to generate these outputs, but a formal "standalone study" with detailed metrics is not described.

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

This information is not explicitly stated in the provided text. For a blood flowmeter, ground truth would typically be established using a highly accurate, often invasive, or more complex reference method for blood flow measurement.

8. The sample size for the training set

This information is not provided in the given text.

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

This information is not provided in the given text.

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The FloPatch(FP110) is intended for the detection of blood flow in peripheral vasculature.

The device is intended to be used by medical professionals, such as physicians and nurses, in hospitals and professional environments. The device is intended for prescription use only.

The FloPatch (FP110) is a non-invasive blood flow detection device intended to be used in a medical/hospital setting for use by medical professionals. The device uses ultrasound and the Doppler effect to evaluate the flow of blood. The device consists of signal processing box (main unit) and an ultrasonic vascular flow transducer. The device transmits ultrasonic waves from the vascular flow transducer to a peripheral vessel such as the carotid artery. The Doppler shifted ultrasonic waves are reflected by moving blood cells back to the ultrasonic flow transducer. The reflected signal is received by the signal processing box (main unit) which outputs the doppler signal to the device speaker.

I understand that you're asking for details about the acceptance criteria and the study that proves a device meets those criteria, specifically concerning the FloPatch (FP110) based on the provided FDA 510(k) summary.

However, after carefully reviewing the provided text, I can determine the following:

• Trade/Device Name: FloPatch (FP110)
• Regulation Number: 21 CFR 870.2100
• Regulation Name: Cardiovascular blood flowmeter
• Regulatory Class: Class II
• Product Code: DPW
• Intended Use: The FloPatch (FP110) is intended for the detection of blood flow in peripheral vasculature. It is intended to be used by medical professionals (physicians and nurses) in hospitals and professional environments and is for prescription use only.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Edan SD3 Vascular Doppler, K140579) based on design features, intended use, and compliance with various non-clinical performance standards (EMC, electrical, thermal & mechanical safety, biocompatibility, acoustic output, etc.).

The provided text does not contain the following information:

1. A table of acceptance criteria and the reported device performance. While it mentions "performance verification testing" and that the device "complies with the requirements of the recognized consensus standard for basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment," specific quantitative acceptance criteria and the FloPatch's performance against them are not detailed.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs. without AI assistance. (This device does not appear to involve AI/algorithms for "human improvement" as it's a basic blood flow detection device).
6. If a standalone study (i.e., algorithm only without human-in-the-loop performance) was done. (Again, not applicable to the type of device described).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for any performance studies.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

Conclusion based on the provided text:

The 510(k) summary indicates that the FloPatch (FP110) was deemed substantially equivalent to its predicate device (Edan SD3 Vascular Doppler) based on the following:

• Non-clinical Performance Data: The device was tested and found compliant with relevant recognized consensus standards for:

  • ES60601-1:2005/(R)2012 (Medical Electrical Equipment - Basic Safety and Essential Performance)
  • IEC 60601-2-37 Edition 2.1 2015 (Ultrasonic Medical Diagnostic and Monitoring Equipment)
  • IEC 60601-1-2 Edition 4.0 2014-02 (Electromagnetic Disturbances)
  • ISO 10993-1, -5, -10 (Biocompatibility: cytotoxicity, sensitization, skin irritation)
  • IEC 62127-1 Edition 1.1 2013-02 (Ultrasonics - Measurement and Characterization of Medical Ultrasonic Fields)
  • IEC 61161:2013 (Ultrasonics - Power measurement)
  • IEC 62359 Edition 2.1 2017-09 (Ultrasonics - Field characterization - Thermal and mechanical indices)
  • IEC 62304:2006 (Software Life Cycle Process)

• Performance Verification Testing: The summary generally states that "performance testing to compare the performance of the device to predicate was conducted besides verification of performance, packaging and labelling." It concludes that "The results of the performance testing and testing to recognized consensus standards demonstrate that the characteristics of the FloPatch FP110 are equivalent to the recognized predicate in terms of acoustic output and performance."

Without further documentation (e.g., specific test reports linked in the 510(k) submission), the detailed acceptance criteria and the specific performance results from clinical or comprehensive bench performance studies are not available in this summary. The substantial equivalence argument relies heavily on adherence to recognized safety and performance standards for similar devices and a comparison of features to the predicate.

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