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The FloPatch FP120 is indicated for use for the noninvasive assessment of blood flow in peripheral vasculature. FloPatch FP120 operates in a single mode, the Continuous Wave (CW) mode only.

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. 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.

I cannot provide a specific study that proves the device meets acceptance criteria, as the provided text is a 510(k) clearance letter and 510(k) summary, not a detailed clinical study report. The document describes the device, its intended use, comparison to predicates, and lists performance tests conducted. It asserts that these tests passed, but doesn't provide the detailed methodology, specific acceptance criteria values (beyond general descriptions like "≤720 mW/cm2"), or the results in a manner that would allow for a complete reconstruction of a clinical study or performance evaluation.

However, I can extract and infer information based on the typical content of a 510(k) submission and the provided text to address your points regarding acceptance criteria and the "study" (referring to the performance testing described).

It's crucial to understand that 510(k) clearance primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, not necessarily on new clinical efficacy studies. The "performance data" section in this document describes a series of engineering and bench tests, along with usability testing, to support this claim of substantial equivalence for the modifications made to the device.

Here's an attempt to answer your questions based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Device Performance (Inferred from 510(k) Summary)

The "acceptance criteria" for a 510(k) are generally defined by compliance with recognized standards (e.g., IEC, ISO) and demonstrating that the modified device performs as intended and is as safe and effective as the predicate. The document lists the specific tests and states that they "Pass." The table below summarizes the implied acceptance criteria based on industry standards and the reported (binary: Pass/Fail) device performance from the 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

Study Details (Inferred/Not Applicable)

The document refers to "Performance Data" which are a series of tests to demonstrate substantial equivalence, rather than a single, comprehensive "study" with a defined clinical protocol to prove efficacy or diagnostic accuracy in the way a clinical trial would.

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

• Sample Size: Not specified in the provided text. These tests are typically bench and engineering tests, and possibly a limited usability test. They are not clinical trials with large patient cohorts. For example, "Usability Testing" likely involves a small number of representative users, not a large patient sample.
• Data Provenance: The document does not specify the country of origin of the data for these performance tests. Given that Flosonics Medical is based in Canada and the submission is to the US FDA, the tests could have been conducted in Canada, the US, or other locations. These are primarily engineering/bench tests, not retrospective or prospective clinical data in the traditional sense, except possibly for the usability testing which would be prospective.

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

• For bench and engineering tests (Acoustic Output, Electrical Safety, EMC, etc.), "ground truth" is typically established by calibrated measurement devices and compliance with international standards, not by human experts.
• For "Usability Testing," it's implied that medical professionals (physicians and nurses) were involved as the intended users, but the specific number or their qualifications are not stated. They would provide feedback on the user interface and operation.

4. Adjudication Method for the Test Set

• For engineering and bench tests, adjudication methods (like 2+1, 3+1 consensus) are not typically applicable. The results are quantitative measurements against defined thresholds.
• For Usability Testing, the "adjudication" would involve assessment against predefined usability goals and heuristics, likely by product designers and human factors specialists. It's not a consensus reading of medical images.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• No, an MRMC comparative effectiveness study was not done or reported in this 510(k) summary. This type of study is more common for AI/ML-driven diagnostic imaging devices where human reading performance with and without AI assistance is being evaluated.
• The FloPatch FP120 is described as a "Cardiovascular blood flowmeter" that uses ultrasound and the Doppler effect to assess blood flow. While it has "Software including but not limited to: Algorithm changes," it's not presented as a device that assists human readers in interpreting complex medical images in the way an AI diagnostic algorithm would. Its purpose is to output calculated values (Max Velocity trace, Max VTI, Corrected Flow Time). Therefore, an MRMC study comparing human readers with AI assistance would not be applicable to this device's reported function.

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

• The software testing explicitly states: "Verified that the software application satisfies functional requirements and performs as intended. Algorithms and calculations were also verified." This constitutes a form of standalone performance evaluation for the algorithms and calculations embedded in the device/app.
• The device outputs quantitative values (Max Velocity trace, Max VTI, Corrected Flow Time), which implies its core function is to produce quantitative readings based on its algorithms, rather than requiring subjective human interpretation of raw data.

7. The Type of Ground Truth Used

• Benchmarking/Reference Standards: For the technical performance tests (acoustic output, electrical safety, EMC, etc.), the ground truth is established by adherence to recognized international standards (e.g., IEC 60601 series, ISO 10993) and comparison to calibrated reference instruments.
• Engineering Specifications: For hardware and software testing, the ground truth is adherence to the device's predefined engineering specifications and functional requirements.
• User Feedback/Expert Opinion: For usability testing, the 'ground truth' comes from medical professionals' feedback on the device's ease of use and ability to perform its function in a simulated environment, validating that it "meets new indications for use."

8. The Sample Size for the Training Set

• Not Applicable / Not Provided. This document describes a 510(k) for a medical device that uses "Algorithm changes," but it does not specify if these algorithms are machine learning/AI algorithms that require a "training set" in the typical sense. Even if ML components are present, information on training sets is not commonly disclosed in the high-level 510(k) summary provided in a clearance letter. The focus here is on demonstrating the device's overall performance and safety after modifications, not on describing its underlying ML development process.

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

• Not Applicable / Not Provided. As the existence and nature of a "training set" are not specified, neither is the method for establishing its ground truth.

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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 device, focusing on modifications related to reprocessing of "Single-Use Only" devices. It refers to a previous 510(k) submission (K222242) for the original device. This document primarily details performance data for the reprocessing capabilities of the device, rather than the initial clinical performance or diagnostic accuracy of the device itself.

Therefore, much of the requested information regarding acceptance criteria for device performance and the study proving it (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, type of ground truth) is not directly available in the provided document. The document focuses on demonstrating that reprocessing does not degrade the device's technical characteristics, assuming its original performance was already established in K222242.

However, I can extract the information related to the acceptance criteria and the study for the reprocessing modifications.

Here's a summary based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance (for reprocessing modifications):

The acceptance criteria for the reprocessing modifications were that repeated reprocessing does not adversely affect specific device characteristics. The reported performance confirms that these criteria were met.

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

• Test Set Sample Size: Not explicitly stated in this document. The description only mentions "repeated reprocessing" and "up to six cycles," implying a limited number of devices were tested for these engineering/validation tests.
• Data Provenance: Not specified. These are likely internal validation studies conducted by Flosonics Medical.

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

• Not applicable for these engineering/reprocessing validation tests. Ground truth would be based on objective measurements and established standards for cleaning, disinfection, and device performance specifications.

4. Adjudication method for the test set:

• Not applicable. The tests described are objective engineering and validation tests, not subjective expert reviews.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:

• No, an MRMC comparative effectiveness study was not done, as this submission is for reprocessing modifications, not the initial clinical efficacy of the device's diagnostic capabilities.

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

• No, this refers to the effects of reprocessing on the physical device and its components, not the performance of an algorithm. The device "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 performance of this application and its underlying algorithm would have been assessed in the K222242 submission, not in this document.

7. The type of ground truth used:

• For these reprocessing tests, the "ground truth" would be the pre-reprocessing performance specifications of the device and established engineering/biomedical standards for cleaning, disinfection, acoustic output, and physical integrity.

8. The sample size for the training set:

• Not applicable. These are validation tests for reprocessing, not machine learning model training.

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

• Not applicable.

Ask a specific question about this device

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.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the FloPatch FP120 device, structured to answer your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

The submission describes product modifications to an already cleared device and demonstrates substantial equivalence through various tests. The acceptance criteria, while not explicitly stated as numerical values for all tests, are implied by a "Pass" result for each test performed.

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

The document does not provide specific sample sizes for the test sets for the various engineering validation and verification tests. The data provenance (e.g., country of origin, retrospective/prospective) is also not specified in this summary. These tests appear to be laboratory-based engineering and software validation tests rather than clinical studies with patient data.

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

This information is not provided in the document. Given that the tests are primarily engineering and software verification, the "ground truth" would likely be established by technical specifications and standards rather than expert clinical consensus.

4. Adjudication Method for the Test Set

This information is not provided. For engineering and software tests, adjudication usually involves technical review against predefined specifications rather than a multi-expert clinical review process.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not mentioned or described in this document. The device, FloPatch FP120, is a cardiovascular blood flowmeter that directly assesses blood flow and does not appear to involve human interpretation of images or data that would typically necessitate such a study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The "Software Testing" mentioned includes verification that "Algorithms and calculations were also verified." This implies that the algorithms were tested for their accuracy in isolation (standalone), but the details of this testing (e.g., specific metrics, dataset) are not provided. The device itself is user-operated by medical professionals, so an entirely "standalone" clinical performance might not be applicable in the same way it would be for an AI-powered diagnostic image analysis tool.

7. The Type of Ground Truth Used

For the engineering tests (EMC, Biocompatibility, Material/Shelf Life, Packaging, Electrical Safety, Dust Ingress, Emergency Services Equipment, Acoustic Output, Ultrasound Safety), the ground truth is based on regulatory standards and recognized industry specifications (e.g., Class B requirements, ISTA3, applied part BF requirements, IP6X, IEC 60601-1, IEC 60601-2-37, global maximum derated ISPTA, global maximum MI limits).

For "Software Testing," the ground truth for "Algorithms and calculations" would be based on mathematical correctness and predefined functional requirements of the device's calculations (Max Velocity trace, Max VTI, Corrected Flow Time).

8. The Sample Size for the Training Set

The document does not mention any training sets. This submission is for modifications to a previously cleared device, not for the development of a new AI model that typically requires a training set. The "Software Testing" focuses on verification of existing algorithms and calculations rather than training a new machine learning model.

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

As no training set is mentioned, this information is not applicable.

Ask a specific question about this device

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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