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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 Elfor L is intended for measuring micro-vascular perfusion in skin and muscle in humans. It is intended to be used for clinical research applications and pre clinical research applications.

The Elfor-L device is making use of Miniaturized Dynamic Light Scattering (mDLS) technology to non-invasively measure micro-vascular perfusion in the skin. The device is comprised of sensor and signal processing station. The device uses Vertical-Cavity Surface-Emitting Lasers (VCSEL) as the light source and two photodetectors for detection.

The Elfor-L design incorporates three major components:

1. Sensor - the sensor as its predicate includes a laser light source and two photo sensitive elements. The sensor transfers analog signal to the control unit.
2. Control unit - the control unit is connected to the sensor by cable and includes the control circuit for the sensor, microcontroller and communication interface for the PC.
3. Dedicated software that processes, displays and record data on the computer. The computer is not part of the system.

The FDA 510(k) clearance letter for the Elfor-L device mentions that performance testing was conducted, including a comparison to its predicate device and an accuracy evaluation. However, the provided document does not contain the specific details required to fully address your request, such as:

• A table of acceptance criteria and reported device performance values. While it states "The test passed and met the predefined acceptance criteria" for comparison testing and "The test passed" for accuracy, the actual numerical criteria and results are not listed.
• Sample sizes used for the test set.
• Data provenance (e.g., country of origin, retrospective/prospective).
• Number of experts and their qualifications for ground truth.
• Adjudication method for the test set.
• Details on Multi-Reader Multi-Case (MRMC) comparative effectiveness study (effect size, human improvement).
• Details on standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How ground truth for the training set was established.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on intended use, technological characteristics, and compliance with general safety and performance standards (biocompatibility, software validation, electrical safety, EMC). It implies that the performance was found to be acceptable but does not provide the granular data of the clinical study itself.

Therefore, for the specific questions related to acceptance criteria and study details (especially for an AI/machine learning context, which this device, being a physical measurement device, doesn't explicitly describe), the provided text is insufficient.

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

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

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

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• Not specified. The performance testing section describes "comparison testing of the Elfor-L to its predicate device" and evaluating accuracy using a "standardized Motility Standard solution." This suggests an objective, instrument-based ground truth (e.g., comparison to a validated device/standard) rather than expert human interpretation in the traditional sense of medical imaging.

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

• Not applicable/not specified, as the ground truth appears to be objective, instrument-based.

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 Elfor-L is a direct measurement device ("Cardiovascular Blood Flowmeter") not an AI-assisted diagnostic imaging interpretation system. Therefore, MRMC studies are not relevant to its type of performance evaluation.

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

• The device itself is a standalone measurement instrument. Its performance ("Accuracy of the Elfor-L device") was evaluated in comparison to a predicate and against a standard, which fits the concept of standalone performance for this type of device. There isn't an "algorithm" in the sense of AI interpreting an image; rather, it's a signal processing software function for a physical sensor.

7. The type of ground truth used:

• For "Accuracy of the Elfor-L device," the ground truth was established using a "standardized Motility Standard solution."
• For comparison testing, the ground truth was implied to be the performance of the predicate device.

8. The sample size for the training set:

• Not specified. The document doesn't explicitly mention "training sets" in the context of machine learning, as this device measures physical parameters rather than learning from large datasets to perform a classification or detection task. Its "software validation" refers to V&V for software functionality, not machine learning model training.

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

• Not applicable/not specified, as no machine learning training set is described.

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The Laminar P1 device is a wearable and disposable, ultrasound-based (4.5 MHz, continuous-wave) patch sensor designed to detect blood flow in peripheral vessels and assist in the detection of peripheral vascular disease. The Laminar P1 device is intended to be used by medical professionals, such as physicians and nurses, in hospitals, clinics and private offices and healthcare facilities. It is to be used on adults, ages 18 years and older.

The Laminar P1 is an ultrasound-based battery-powered sensor patch designed to detect blood flow in veins and arteries to assist in the detection of peripheral vascular disease. The Laminar P1 consists of a single use sensor patch, a single use patch frame, and a reusable processing unit. The sensor patch is designed to have the same performance characteristics as traditional ultrasound transducer probes (4.5 MHz frequency) but in a patch form factor that is easy to place on the patient's body for a given time period. The patch frame is a sticky frame that aids in the positioning and alignment of the processing unit. The processing unit controls the piezoelectric transducers in the sensor patch and has a built-in speaker with volume-control, like the traditional handheld Doppler devices, and operates in the Doppler continuous-wave mode (4.5 MHz frequency). The Processing Unit is battery-operated.

The provided text does not contain information about acceptance criteria for device performance nor a study that proves the device meets specific performance criteria. The document is an FDA 510(k) clearance letter and a 510(k) summary for a device called "Laminar P1".

This document primarily focuses on demonstrating substantial equivalence to a predicate device (FloPatch FP110), rather than outlining specific performance acceptance criteria and a study to meet those.

Here's a breakdown of why the requested information is absent and what is provided:

• Acceptance Criteria and Reported Device Performance: This information is not explicitly stated. The document focuses on comparing the Laminar P1 to a predicate device, noting "Main differences in technological characteristics" such as smaller form factor, transducer frequency, global maximum outputs, and volume/receiver options. It states that "These differences have undergone testing to ensure the subject device is as safe and effective as the predicate device," but details of those tests, specific acceptance thresholds, and quantitative results are not provided in this public summary.
• Study Proving Acceptance Criteria: No clinical study specifically designed to demonstrate the device meets acceptance criteria is described. The "Summary of Clinical Testing" section explicitly states: "No clinical testing was provided to support the demonstration of substantial equivalence." This means performance was evaluated through non-clinical means compared to the predicate.

What Glimpses of "Testing" are Provided (Non-Clinical):

The "SUMMARY OF NON-CLINICAL TESTING" section lists the types of tests performed:

• Biocompatibility per ISO 10993-1
• Software per IEC 62304
• Electrical and EMC safety per IEC 60601-1 and IEC 60601-1-2
• Acoustic output levels per IEC 60601-2-37 and IEC 62359
• Bench performance testing (functional testing, audio performance testing, mechanical testing)

The conclusion states: "The results of these tests indicate that the Laminar P1 is substantially equivalent to the predicate device." However, specific acceptance criteria for these non-clinical tests and the quantitative results are not included in this publicly available 510(k) summary.

Therefore, it is impossible to populate the requested table and answer the study-related questions based solely on the provided text. The information needed (performance metrics, thresholds, study design, sample sizes, ground truth establishment, expert qualifications, etc.) would typically be found in the full 510(k) submission, which is not included here.

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VascuChek® Kit, VascuChek® Transceiver, VascuChek® Clinical Probe, VascuChek® Charger: The VascuChek® device is intended for the non-invasive transcutaneous evaluation of blood flow in Peripheral Vasculature.

VascuChek® Kit, VascuChek® Transceiver, VascuChek® Surgical Probe, VascuChek® Charger: The VascuChek® device is intended for the intraoperative and transcutaneous evaluation of blood flow in the following clinical applications:

• Intraoperative (Microvascular and Vascular)
• Intraoperative Neurological
• Transrectal and Peripheral Vascular.

VascuChek® Surgical is a cardiovascular blood flowmeter comprised of two components: a sterile VascuChek™ Surgical Probe with sheath which connects to the reusable, nonsterile VascuChek™ Transceiver. The sheath is deployed over, and encapsulates the transceiver, allowing it to be used within the sterile field.

VascuChek® Clinical is a cardiovascular blood flowmeter comprised of two components: a sterile VascuChek™ Surgical Probe with sheath which connects to the reusable, nonsterile VascuChek™ Transceiver. The sheath is deployed over, and encapsulates the transceiver, allowing it to be used within the sterile field.

The VascuChek® device follows Track 1.

A transmitter in the transceiver drives the ultrasonic transmitting crystal located at the tip of the probe component. The ultrasonic waves generated by the sensor travel through the tissue just under the probe tip in a narrow beam. The reflected ultrasonic waves are received by the transducer and are converted via the piezoelectric effect into a high frequency electronic signal. band audio Doppler shifted signal which is filtered and converted to audio via a speaker. During the intervals when the unit is not transmitting, the device passes any reflected signals that it receives to a receiving circuit. This circuit amplifies the returning echoes, compares their frequency to that of the transmitted signal and converts any frequency differences into an audible tone.

The provided text is a 510(k) summary for a medical device called VascuChek®. It outlines the device description, indications for use, comparison to predicate devices, and a summary of non-clinical performance testing.

However, it does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML-based device. Specifically, it lacks:

• A table of acceptance criteria and reported device performance: While it mentions electrical safety, EMC, firmware verification, and biocompatibility testing, these are general device safety and performance criteria, not specific performance metrics for an AI/ML algorithm (e.g., sensitivity, specificity, AUC).
• Sample size and data provenance for a test set: No information regarding a test set, its size, or where the data came from (country, retrospective/prospective) is provided.
• Number and qualifications of experts for ground truth: There's no mention of experts, how many, or their qualifications, as the device doesn't appear to rely on such ground truth establishment for its performance claims.
• Adjudication method: Not applicable as there's no mention of expert review or ground truth establishment in this context.
• MRMC comparative effectiveness study: There is no indication of such a study being performed or any effect size for human reader improvement with AI assistance.
• Standalone (algorithm only) performance: The device described is a blood flowmeter, a hardware device with firmware, not an AI/ML algorithm that would have standalone performance metrics like sensitivity/specificity.
• Type of ground truth used: Not applicable for a non-AI/ML device that measures physiological parameters.
• Sample size for training set: Not applicable as it's not an AI/ML device.
• How ground truth for training set was established: Not applicable.

Explanation Based on the Provided Document:

The VascuChek® device is a cardiovascular blood flowmeter that uses ultrasonic technology to detect blood flow and convert frequency differences into an audible tone. It's a hardware device with integrated firmware, not an AI/ML-driven diagnostic or assistive tool. The performance studies mentioned are related to:

• Electrical Safety Testing (ANSI AAMI ES60601-1): Ensures the device is electrically safe.
• EMC Testing (IEC 60601-1-2, IEC 60601-2-37): Ensures the device operates correctly in its electromagnetic environment and doesn't interfere with other devices.
• Firmware Verification Testing: Confirms the embedded software functions as intended.
• Biocompatibility information: Addresses the safety of the materials in contact with the patient.

These are standard regulatory requirements for medical devices but are not related to the performance evaluation of an AI/ML algorithm. The document explicitly states that the device employs "identical technology" and "identical firmware requirements and performance" to its predicate devices, indicating that its performance is established through equivalence to existing, cleared devices, rather than through complex AI/ML validation studies.

Conclusion:

The provided 510(k) summary does not contain the information requested regarding acceptance criteria and study details for an AI/ML device because the VascuChek® device is an ultrasonic blood flowmeter and not an AI/ML-based medical device. Therefore, a study demonstrating AI/ML performance metrics (e.g., sensitivity, specificity, reader studies) was not conducted or reported for this submission.

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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.

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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.

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.

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The FLOW COUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FLOW COUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FLOW COUPLER Device is used in conjunction with the FLOW COUPLER Monitor, the FLOW COUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site. Post-operatively, blood flow can be detected on an as needed basis for up to 7 days. The FLOW COUPLER Doppler probe is not intended to be a permanent implant and should be removed 3 to 14 days post-operatively.

The GEM FLOW COUPLER System is designed for the detection of blood flow in vessels. The GEM FLOW COUPLER System consists of components as described below:

1. FLOW COUPLER Device (Product Code MVR) - single-use implantable rings used to secure anastomosis of small vessels. This includes a 20MHz ultrasonic Doppler transducer (probe) which attaches to one of the FLOW COUPLER rings, and an external lead.
2. FLOW COUPLER Monitor (Product Code DPW) - portable monitor that provides the audible output of the FLOW COUPLER Device's pulsed Doppler ultrasound signal. A varying audible signal is produced when the FLOW COUPLER Device (probe) detects flow.

The medical device in question is the GEM FLOW COUPLER Monitor (GEM1020M-2).

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for each specific test set (e.g., how many monitors were tested for cleaning, how many for audio quality). However, the tests described are primarily non-clinical performance tests of the device's hardware, firmware, and cleaning protocols. Therefore, the "data provenance" is typically within a controlled laboratory or manufacturing environment, rather than clinical patient data. There is no information regarding country of origin of data or whether it was retrospective or prospective, as these are not relevant to these types of engineering/performance tests.

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

For the types of tests conducted (e.g., cleaning, design, audio quality, EMC), the "ground truth" is established by industry standards (e.g., IEC 60601-1:2005, IEC 60601-1-2 Edition 4.1: 2020, 47 CFR, Part 15:2022) and the manufacturer's internal design and functional specifications. These are objective measures rather than subjective expert consensus. Therefore, the concept of "experts establishing ground truth" in the manner of medical image interpretation is not directly applicable here. The "experts" would be the engineers and technicians performing the tests and verifying compliance with the established standards and specifications. Their qualifications are implicitly in their ability to perform such tests and interpret the standards.

4. Adjudication Method for the Test Set

Not applicable in the conventional sense for non-clinical performance and engineering tests. The tests are designed with objective acceptance criteria, and the results (e.g., measured values, pass/fail based on a threshold) are typically directly compared against these criteria.

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. This document describes a 510(k) Pre-market Notification for modifications to an existing device, the GEM FLOW COUPLER Monitor. The changes are primarily hardware and firmware updates (power management, power button, audio system, remote monitoring disabling) and labeling updates (cleaning solutions). The device itself (a cardiovascular blood flowmeter) provides audible output to a human user to detect blood flow and confirm vessel patency. It does not involve AI or image interpretation, and therefore, an MRMC study or an assessment of human reader improvement with AI assistance is not applicable.

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

No. This device is a monitor that provides audible output to a human user (surgeon, nurse) for the detection of blood flow. It is intrinsically a "human-in-the-loop" device in its intended use. It does not operate as a standalone algorithm for diagnosis or decision-making.

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

The ground truth for the performance tests is based on:

• International and Federal Standards: e.g., IEC 60601-1, IEC 60601-1-2, 47 CFR Part 15.
• Manufacturer's Design and Functional Specifications: These are internal objective criteria derived from engineering requirements.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm or a diagnostic tool that requires a "training set" in the machine learning sense. The performance tests are for hardware and software functionality, not for training a model.

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

Not applicable, as there is no training set for this device.

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Remington Medical, Inc. VascuChek™ device is intended for the intraoperative and transcutaneous evaluation of blood flow in the following clinical applications:

• · Intraoperative (Microvascular and Vascular)
• · Intraoperative Neurological
• · Transrectal and Peripheral Vascular

VascuChek™ is a cardiovascular blood flowmeter comprised of two components: a sterile VascuChek™ Surgical Probe with sheath which connects to the reusable, nonsterile VascuChek™ Transceiver. The sheath is deployed over, and encapsulates the transceiver, allowing it to be used within the sterile field.

The VascuChek™ device follows Track 1.

A transmitter in the transceiver drives the ultrasonic transmitting crystal located at the tip of the probe component. The ultrasonic waves generated by the sensor travel through the tissue just under the probe tip in a narrow beam. The reflected ultrasonic waves are received by the transducer and are converted via the piezoelectric effect into a high frequency electronic signal. The received electronic signal is amplified and detected. The result is a base band audio Doppler shifted signal which is filtered and converted to audio via a speaker. During the intervals when the unit is not transmitting, the device passes any reflected signals that it receiving circuit. This circuit amplifies the returning echoes, compares their frequency to that of the transmitted signal and converts any frequency differences into an audible tone.

Here's a summary of the acceptance criteria and study information for the VascuChek™ device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than explicitly listing acceptance criteria with numerical performance targets and reported values. Instead, it describes a series of non-clinical and in vivo tests performed. The "reported device performance" is essentially that the device passed these tests and was found to be "substantially equivalent" to the predicate.

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

• Sample Size: Not explicitly stated for each test beyond "the subject device and predicate device" for the in vivo test. It implies a sufficient number of units or test scenarios were used to generate data for each performance test.
• Data Provenance: Not specified (e.g., country of origin). The studies appear to be non-clinical (laboratory/engineering) and in vivo (likely animal or simulated human models for the blood flow assessment, although this is not explicitly stated). The report does not mention human clinical trials. All studies are presumably prospective as they were conducted to support the 510(k) submission.

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

This information is not provided in the document. For the in vivo simulated use test comparing audio quality, it would typically involve trained personnel for evaluation, but their number and qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the tests (engineering, biocompatibility, in vivo simulation), formal adjudication methods like 2+1 or 3+1 typically used in image interpretation studies are unlikely to be directly applicable. The test results would be assessed against pre-defined engineering or biological standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical testing was required." The in vivo test was a "simulated use" assessment comparing the subject device to the predicate in terms of audio quality for blood flow measurement, not a clinical study involving human readers/interpreters.

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

This concept is not directly applicable in the context of the VascuChek™ device. This device is a cardiovascular blood flowmeter that produces an audible tone based on the Doppler effect. Its performance is evaluated on its ability to generate an accurate audible signal representing blood flow, which is inherently designed for human interpretation (listening to the audio). There is no "algorithm only" component that would operate without human input in its intended use.

7. The Type of Ground Truth Used

The ground truth for the various non-clinical tests would be established by:

• Engineering Standards/Specifications: For mechanical, electrical, EMC, and software performance.
• Regulatory Standards/Guidelines: For biocompatibility (e.g., ISO 10993), pyrogenicity, sterility, and reprocessing.
• Predicate Device Performance: For the in vivo simulated use test, the performance of the predicate device serves as the comparative "ground truth" or benchmark, implying that the subject device should produce similar (substantially equivalent) audio quality and blood flow detection capabilities.

8. The Sample Size for the Training Set

This information is not applicable as the VascuChek™ device, as described, does not appear to be an AI/machine learning device that requires a "training set." It is a hardware device based on the Doppler effect for real-time blood flow detection.

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

This information is not applicable for the same reason as point 8; there is no "training set" for this type of device.

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The Remington Medical, Inc. VascuChek™ Clinical Device is intended for the non-invasive transcutaneous evaluation of blood flow in Peripheral Vasculature.

VascuChek™ is a cardiovascular blood flowmeter comprised of two components: a nonsterile, single-use VascuChek™ Clinical Probe which connects to the reusable, nonsterile VascuChek™ Transceiver.

The VascuChek™ device follows Track 1.

A transmitter in the transceiver drives the ultrasonic transmitting crystal located at the tip of the probe component. The ultrasonic waves generated by the sensor travel through the tissue just under the probe tip in a narrow beam. The reflected ultrasonic waves are received by the transducer and are converted via the piezoelectric effect into a high frequency electronic signal. The received electronic signal is amplified and detected. The result is a base band audio Doppler shifted signal which is filtered and converted to audio via a speaker. During the intervals when the unit is not transmitting, the device passes any reflected signals that it receives to a receiving circuit. This circuit amplifies the returning echoes, compares their frequency to that of the transmitted signal and converts any frequency differences into an audible tone.

The provided document is a 510(k) summary for the Remington Medical, Inc. VascuChek™ Clinical Device. The product is a cardiovascular blood flowmeter intended for non-invasive transcutaneous evaluation of blood flow in peripheral vasculature. The submission demonstrates substantial equivalence to the predicate device, Vascular Technology Incorporated (VTI) Surgical Doppler (K082870).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" for performance metrics in a quantitative manner (e.g., minimum sensitivity or specificity). Instead, the performance evaluation is based on demonstrating substantial equivalence to a predicate device through various non-clinical and an in vivo simulated use test. The criteria for acceptance are implied by the successful completion of these tests and a conclusion of substantial equivalence.

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

The document mentions an "in vivo Simulated Use" test. However, it does not specify the sample size used for this test (e.g., number of subjects, number of measurements). It also does not provide details about the data provenance beyond stating it was an in vivo test. Therefore, information regarding country of origin of the data or whether it was retrospective or prospective is not available in the provided text.

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

The document does not mention the use of experts to establish ground truth for any test set. The in vivo simulated use test focused on assessing audio quality and comparing performance to the predicate device, implying that the predicate's output or a direct measurement was used as a reference rather than expert consensus on a diagnostic outcome.

4. Adjudication Method for the Test Set:

Since the document does not describe the use of multiple experts or a diagnostic task requiring consensus, there is no mention of an adjudication method (e.g., 2+1, 3+1).

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported. The study focused on demonstrating substantial equivalence of the device's technical characteristics and performance to a predicate device, not on how human readers' performance might improve with or without AI assistance. The device itself is a blood flowmeter, not an AI-assisted diagnostic tool for interpretation by human readers in the traditional sense of an MRMC study.

6. Standalone Performance:

The primary focus of the performance data section is on the standalone performance of the VascuChek™ Clinical Device, both through non-clinical bench testing and the in vivo simulated use test. The purpose was to show that the device itself performs comparably to the predicate device.

7. Type of Ground Truth Used:

For the in vivo simulated use test, the ground truth appears to be established by comparison to the predicate device in terms of measuring the velocity of blood flow. The phrasing "compare performance of the new device to its predicate" suggests the predicate's output served as the reference for evaluating the subject device's audio quality in measuring blood flow velocity. There is no indication of pathology, outcomes data, or expert consensus being used as ground truth for this device's specific function.

8. Sample Size for the Training Set:

The document does not mention a training set because the VascuChek™ Clinical Device is a cardiovascular blood flowmeter, not a device that employs machine learning or artificial intelligence requiring a training set in the typical sense.

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

As there is no mention of a training set, there is no information on how its ground truth might have been established.

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The Bidop 7 is intended for the detection of arterial and venous blood flow in the extremities as well as fetal heart sounds. The Bidop 7 displays bi-directional velocity waverical data and fetal heart rate with heartbeat indicator. The Bidop 7 probe selection is 2, 5, 8, and 10 MHz.

The Bidop 7 is designed to provide both qualitative and quantitative information. The qualitative information mainly includes color visual display of waveform's shapes, including qualitative analysis of Photoplethysmography (PPG) and Doppler waveforms. The quantitative information is focused primarily on aiding the examiners in obtaining systolic segmental blood pressures, including the ABI (ankle-brachial index) and TBI (toe-brachial index). Additional quantitative measurements relate to the Doppler blood flow velocity waveforms.

Here's an analysis based on the provided document regarding the acceptance criteria and study for the Bidop 7:

It's important to note that the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It typically does not contain detailed clinical study data for establishing sensitivity, specificity, or detailed performance metrics against a clinical ground truth for a novel AI/ML device. The "study" here refers to the testing performed to demonstrate compliance with standards and equivalence to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, or accuracy derived from a clinical efficacy study. Instead, the "acceptance criteria" are implied by compliance with recognized standards and the demonstration of substantial equivalence to a predicate device (Smartdop 45, K050601).

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

The document does not describe a clinical "test set" in the context of an efficacy study with a specified sample size or data provenance (e.g., country of origin, retrospective/prospective). The testing described relates to engineering and regulatory compliance with standards, and comparison to the predicate device in terms of technology and indications for use. No patient data or clinical study data is detailed for an independent test set.

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

Not applicable. As no clinical test set for efficacy is described, there's no mention of experts or their qualifications for establishing ground truth.

4. Adjudication method for the test set

Not applicable. No clinical test set or adjudication method is described.

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 Bidop 7 is a cardiovascular blood flowmeter, not an AI-assisted diagnostic imaging device for which MRMC studies comparing human readers with and without AI assistance would typically be conducted. The document does not mention any AI components or MRMC studies.

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

Not applicable. The Bidop 7 is a medical device that produces diagnostic information (waveforms, numerical data, fetal heart rate) for interpretation by a human clinician. It is not an algorithm performing a standalone diagnostic task without human involvement. The document describes laboratory and engineering tests for compliance with standards and equivalence.

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

The concept of "ground truth" as typically applied in AI/ML performance evaluation (e.g., against pathology or clinical outcomes) is not discussed in this 510(k) summary. The comparison is primarily against specifications in standards and the performance characteristics of an existing predicate device. The underlying principle of operation (Doppler effect, photoplethysmography) itself is the "truth" that the device is designed to measure.

8. The sample size for the training set

Not applicable. This device is not an AI/ML product developed with training data.

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

Not applicable. This device is not an AI/ML product developed with training data.

Summary of the Study (as described in the document):

The "study" presented in this 510(k) summary primarily consists of engineering verification and validation testing to ensure the Bidop 7 complies with relevant medical device standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, ISO 14971) and FDA guidance for ultrasound systems and cybersecurity. The core of the submission demonstrates substantial equivalence to the predicate device, the Smartdop 45 (K050601), rather than a de novo clinical efficacy study. The document asserts that the general method of device construction and technology are identical, leading to the conclusion that the Bidop 7 is equivalent in safety and efficacy. No clinical trial data or performance metrics on a patient cohort are provided here; the focus is on technical compliance and equivalence.

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