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The Falcon/Xpress is intended for use in the noninvasive evaluation of peripheral vascular pathology in patients. The Falcon/Xpress is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications, and is not intended to be used inside the sterile field. The Falcon/Xpress is to be used only by trained medical personnel in hospitals, clinics and physicians' offices by prescription or doctor's orders

The Falcon/Xpress is intended for use in the noninvasive evaluation of peripheral vascular pathology in patients . The Falcon/Xpress is a new model that is added to the cleared Falcon product family (K111416), which already includes the Falcon/Pro, Falcon/Quad and Falcon/ABI+ models. The Falcon/Xpress is similar to the other Falcon models in terms of technology, operation, software, intended use, applications, and accessories. The main differences are that the Falcon/Xpress supports 2 independent pressure channels (compared to 10 for the Pro and 4 for the Falcon/Quad and Falcon/ABI+), 2 PPG sensors (compared to 5 for the Pro and 4 for the Quad and ABI+), 2 Doppler ports (compared to 3 for the Pro and Quad and 0 for the ABI+), and no temperature sensor (compared to 1 for the Pro, Quad and ABI+). In addition, the Falcon/Xpress supports operation with an external battery and supports an 8-channel pressure selector (not available with the other Falcon models). The Falcon/Xpress supports an optional tablet, and can be mounted on a cart or within a dedicated bag. The Falcon/Xpress system is smaller in size, with dimensions of roughly 27x20x5.5 cm, compared to the Falcon legacy models with dimensions of 34x31x9.5 cm. In addition, the Falcon/Xpress system weighs roughly 2 kg, compared to roughly 4 kg for the Falcon legacy models. Similar to the other Falcon models, the Falcon/Xpress is based on pneumatic technology to measure systolic blood pressures and Pulse Volume Recording waveforms (PVR) at various peripheral limb sites. Similarly, the Falcon/Xpress includes the same Continuous Wave (CW) Doppler technology as the other Falcon models to allow measurements of blood flow velocities in peripheral blood vessels. The Falcon/Xpress also supports the same Photo-Plethysmography technology (PPG) as the other cleared Falcon models. The above-mentioned technologies allow the Falcon/Xpress to perform peripheral vascular diagnosis measurements in a similar manner to the cleared Falcon models (K111416), including the measurements of segmental systolic blood pressures, the Ankle-Brachial pressure index, PVR measurement, PPG measurements, and blood flow velocity measurements. The measurements support dedicated specialty test protocols such as measurements under various stress conditions, thoracic outlet syndrome, raynaud's syndrome, pulse wave velocity, penile function, venous reflux, venous capacitance and outflow, palmar arch test, arterio-venous fistula, and similar. All of the specialty tests simply use the measurements according to dedicated protocols and display for the evaluation of specific medical conditions. The pressure cuffs are connected to the air tubes via "Bayonet" connectors or Viasonix Vfit connectors. Both of these options are designed to avoid potential misconnections by being incompatible with standard Luer connectors or other connectors used for nonvascular applications.

The provided text is an FDA 510(k) summary for the Falcon/Xpress device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for assessing performance against specific acceptance criteria for AI integration.

Therefore, many of the requested details, particularly regarding acceptance criteria for AI performance, sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone AI performance, and AI-specific training/ground truth, are not available in this document. The document explicitly states "No clinical study was conducted to support this application."

However, I can extract information related to the device's characteristics and the non-clinical testing performed to show its equivalence to the predicate device.

Here's an attempt to answer your questions based on the provided text, while acknowledging the limitations:

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

The document does not specify quantitative acceptance criteria in terms of AI model performance (e.g., AUC, sensitivity, specificity) because it's not a study of AI performance, but rather a submission for substantial equivalence based on device characteristics. Instead, the "acceptance criteria" are implied by the claim of substantial equivalence to the predicate device and compliance with relevant standards. The reported performance is an assertion of equivalency of the new model to the predicate device through non-clinical testing.

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

• Sample Size: Not applicable/not stated. The submission relies on non-clinical bench testing and substantial equivalence to a predicate device, not a clinical study with a specific test set of patient data for performance evaluation.
• Data Provenance: Not applicable, as there was no clinical data test set.

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

• Not applicable. No clinical test set with expert ground truth was used for this 510(k) submission.

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

• Not applicable. No clinical test set.

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. The document explicitly states: "No clinical study was conducted to support this application." This device is not an AI-assisted diagnostic tool in the sense of image interpretation for which an MRMC study would typically be performed.

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

• Not applicable. This is not an AI algorithm submitting standalone performance data. The device itself is a diagnostic instrument, not solely an AI algorithm. Its performance is evaluated through its physical and software functionality as a whole unit, which is compared to its predicate.

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

• For the non-clinical testing, the "ground truth" would be established by validated test methods, reference standards, and specifications against which the device's components and integrated system are measured. For example:
  • Pressure measurements: Calibration against known pressure standards.
  • Doppler frequencies: Measurement against known frequency sources.
  • Software functionality: Verification and validation against software requirements and design specifications.
  • Safety/EMC: Compliance with international standards (IEC 60601 series).

8. The sample size for the training set

• Not applicable. This document does not describe the development or performance of an AI model that would require a "training set" in the machine learning sense. It's a medical device.

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

• Not applicable, as there was no AI training set as described in the context of this submission.

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The Dolphin/IQ, Dolphin/4D and Dolphin/MAX are medical Doppler devices intended for noninvasive measurements of blood flow velocities in arteries and veins in adults and Pediatric. The Dolphin systems can be used in hospitals, clinics and physician offices.

The Dolphin/XF robot accessory, when used with the Dolphin system, is a device which assists the user in the acquisition of cerebral blood flow velocity.

Contraindications: The Dolphin is not intended to be used in fetal or neonatal applications.

Note - The Dolphin is to be used only by trained medical personnel

Dolphin/IQ, Dolphin/4D and Dolphin/MAX systems are part of the Dolphin product family of transcranial Doppler systems. The Dolphin/IQ, Dolphin/4D and Dolphin/MAX are transcranial Doppler (TCD) systems for measurement of blood flow velocity intracranially, extracranially and in the peripheral circulation. All systems share identical Doppler hardware and software. The Dolphin/IQ is a module, that needs to connect to an external computer and display for its' operation while the Dolphin/4D is a complete integrated system that includes an integrated computer system with hard disk, and touch screen display. Dolphin/Max is similar to the Dolphin/4D system, except that it also has an internal rechargeable battery and an external power supply. The functionality and performance of Dolphin/IQ, Dolphin/4D and Dolphin/MAX systems is identical. Dolphin systems support the same Doppler probes: 1.6 MHz PW hand held probe, 2 MHz PW hand held probe, 2 MHz PW monitoring probe, 4 MHz CW/PW hand held probe and 8 MHz CW/PW hand held probe. Dolphin systems support the same accessories: IR wireless remote control, External Channels connection box, wired remote control, foot switch, monitoring head set and Dolphin/XF robot.

Wherever the term Dolphin is used in this document, it applies to the Dolphin/IQ, Dolphin/4D and Dolphin/MAX. Otherwise, each product is specifically by name. The Dolphin devices are based on Doppler technology and are designed for standard intended use for Transcranial Doppler systems operated only by experienced medical staff.

The Dolphin supports the Dolphin/XF robot accessory. The Dolphin/XF robot accessory, when used with the Dolphin system, is a device which assists the user in the acquisition of cerebral blood flow velocity. This accessory can be unilateral or bilateral, and is attached to the head with a dedicated headset. It is software controlled, and allows scanning in two angular directions in order to assists the user in the acquisition of the cerebral blood flow velocity.

The provided FDA 510(k) summary (K202742) for the Dolphin/IQ, Dolphin/4D, and Dolphin/MAX with Dolphin/XF Robot Accessory does not contain acceptance criteria or study data demonstrating device performance in a clinical context.

Instead, the documentation focuses on demonstrating substantial equivalence to a predicate device (Dolphin/IQ, Dolphin/4D and Dolphin/MAX, K191023) and a reference device (EMS9UA, K122710) for the Dolphin/XF robot accessory, primarily through characteristic comparison and adherence to standards.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided document. The document states:

• "No clinical study was conducted to support this application." (Page 17)
• The comparison table (Pages 11-12) lists "Measurement accuracy: ± 10%" as a specification for the Dolphin devices, shared with the predicate device. However, this is a specification rather than acceptance criteria for a study demonstrating performance against a ground truth.

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

Not applicable. The document explicitly states: "No clinical study was conducted to support this application." (Page 17) Therefore, there is no test set or data provenance from a clinical study.

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

Not applicable. As no clinical study was conducted, there was no test set requiring expert-established ground truth.

4. Adjudication Method for the Test Set

Not applicable. As no clinical study was conducted, there was no test set or need for an adjudication method.

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

No. The document explicitly states: "No clinical study was conducted to support this application." (Page 17) Therefore, no MRMC study was performed.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. The document explicitly states: "No clinical study was conducted to support this application." (Page 17) The Dolphin/XF robot accessory "assists the user in the acquisition of cerebral blood flow velocity," implying a human-in-the-loop system, but no standalone performance data for the robotic assistance component is provided.

7. Type of Ground Truth Used

Not applicable regarding clinical performance. For demonstrating substantial equivalence, the "ground truth" implicitly used is the established performance and characteristics of the legally marketed predicate devices.

8. Sample Size for the Training Set

Not applicable, as this is related to clinical performance data which was not conducted. The submission focuses on device characteristics and adherence to standards rather than a machine learning model's training data.

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

Not applicable, as no clinical study with a training set for a machine learning model was conducted or reported.

Summary of Device Acceptance:

The device's acceptance (510(k) clearance) is based on demonstrating substantial equivalence to existing legally marketed predicate devices, not on a new clinical performance study. The core of the submission relies on:

• Identical Indications for Use (for the Dolphin/IQ, Dolphin/4D, and Dolphin/MAX systems).
• Similar Indications for Use for the Dolphin/XF robot accessory, comparing it to an extended indication of the existing Dolphin predicate (K191023) and a similar indication of a reference device (NeuralBot, K180455 under product code OQQ). The added accessory's function to "assists the user in the acquisition of cerebral blood flow velocity" is considered similar to a reference device with the same product code.
• Comparison of Technical Characteristics: A detailed table (Pages 11-12) outlines the specifications of the proposed device against the predicate and reference devices, highlighting similarities and discussing minor differences that do not impact safety or clinical performance (e.g., slight weight/dimensions of the robot, higher grid resolution).
• Compliance with Recognized Standards: The device meets several IEC and NEMA standards related to medical electrical equipment, electromagnetic disturbances, ultrasonic diagnostic equipment, acoustic output, and usability (Page 17).
• Non-Clinical Performance Testing: "The Dolphin/IQ, Dolphin/4D and Dolphin/MAX devices with Dolphin/XF robot accessory have been thoroughly tested through verification of specifications and validation, including software validation" (Page 17). These are bench tests and verification activities rather than clinical studies with performance metrics against a defined ground truth.

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The LiteWalk is intended for home and hospital use for temporary increase in local blood circulation in the lower extremities and temporary relief of minor muscle aches and pains where applied.

The LiteWalk is a pneumatic sequential foot compression device, designed primarily for temporary improvement in blood flow circulation in the lower limb. The system is based on a pneumatic unit that includes a pump, valves, pressure sensor and tubing, and is fed by an external power supply of 12V DC. The unit is connected through 2 sets of 4-tubes to 2 inflatable sandals. Each sandal has 4 inflatable pressure chambers, located to match the foot anatomy: heel, arch, metatarsals, and toes. The sandals come in a pair, for right and left feet, and in 3 sizes: small, medium, large. The operation is based on sequential inflation of the 4 chambers, from heel to toes.

The provided document is a 510(k) premarket notification letter from the FDA for a device called "LiteWalk." It focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics and non-clinical testing. Crucially, the document explicitly states there was "No clinical study was conducted to support this application." Therefore, there is no information in this document regarding acceptance criteria for device performance based on clinical outcomes, nor any study proving the device meets such criteria.

The information provided primarily relates to comparisons with a predicate device and compliance with general safety standards.

Here's a breakdown of the specific points requested, based on the provided text:

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

No clinical performance acceptance criteria or reported device performance for clinical outcomes are mentioned, as no clinical study was conducted. The document focuses on demonstrating substantial equivalence to a predicate device based on technical specifications. A summary table of technical comparison is provided in the document:

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

Not applicable, as no clinical study or test set data for clinical performance was used. The evaluation was based on non-clinical performance (bench tests, verification of specifications, software validation) and comparison to a predicate device.

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)

Not applicable, as no clinical study that would require expert-established ground truth was conducted.

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

Not applicable, as no clinical study that would require adjudication was conducted.

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 LiteWalk is a pneumatic sequential foot compression device, not an AI-assisted diagnostic or imaging device. No MRMC study was mentioned.

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

Not applicable. The LiteWalk is a physical medical device, not an algorithm.

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

Not applicable, as no clinical study was conducted. The "ground truth" for the substantial equivalence determination relied on demonstrating that the device's technical specifications and safety performance (through non-clinical testing and standard compliance) are comparable to the legally marketed predicate device.

8. The sample size for the training set

Not applicable, as no clinical study involving training data was conducted.

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

Not applicable, as no clinical study involving training data was conducted.

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Dolphin/Q, Dolphin/4D and Dolphin/MAX are medical Doppler devices intended for noninvasive measurements of blood flow velocities in arteries and veins in adults and Pediatric. The Dolphin systems can be used in hospitals, clinics and physician offices.

Dolphin/IQ, Dolphin/4D and Dolphin/MAX systems are part of the Dolphin product family of non-invasive peripheral vascular diagnostic systems. The Dolphin/IQ, Dolphin/4D and Dolphin/MAX are transcranial Doppler (TCD) systems for measurement of blood flow velocity intracranially, extracranially and in the peripheral circulation. Both systems share identical Doppler hardware and software. The Dolphin/IQ is a module, that needs to connect to an external computer and display for its' operation while the Dolphin/4D is a complete integrated system that includes and integrated computer system with hard disk, and touch screen display. Dolphin/Max is similar to the Dolphin/4D system, except that it also has an internal rechargeable battery and an external power supply. The functionality and performance of Dolphin/4D and Dolphin/4D and Dolphin/MAX systems is identical. Dolphin systems support the same Doppler probes: 1.6 MHz PW hand held probe, 2 MHz PW hand held probe, 2 MHz PW monitoring probe, 4 MHz CW/PW hand held probe and 8 MHz CW/PW hand held probe. Dolphin systems support the same accessories: IR wireless remote control, External Channels connection box, wired remote control foot switch and monitoring head set.

Wherever the term Dolphin is used in this document, it applies to the Dolphin/IQ, Dolphin/4D and Dolphin/MAX. Otherwise, each product is specifically by name.

The Dolphin devices are based on Doppler technology and are designed for standard intended use for Transcranial Doppler systems operated only by experienced medical staff.

The provided text is a 510(k) summary for the Dolphin/IQ, Dolphin/4D, and Dolphin/MAX ultrasonic pulsed Doppler imaging systems. It asserts substantial equivalence to a previously cleared predicate device (Dolphin/IQ and Dolphin/4D, K170859).

Here's an analysis based on the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" against which specific "device performance" metrics are reported in a granular way that would be typical for an AI/ML device. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

However, based on the Comparison Table (Section 5.4.1), we can infer performance characteristics that are expected to be "identical" or "equivalent" to the predicate. The key performance criterion explicitly mentioned is Measurement Accuracy.

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

The document explicitly states: "No clinical study was conducted to support this application." Therefore, there is no test set in the context of clinical data, no sample size, and no data provenance for such a test set. This submission relies on "non-clinical performance testing" and comparison to a predicate device.

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

As no clinical study was conducted, there are no "experts used to establish the ground truth for the test set."

4. Adjudication Method for the Test Set

Not applicable, as no clinical study or test set was used.

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

No MRMC study was conducted. The device is a diagnostic ultrasound system, not an AI-assisted interpretation tool for human readers in the way an AI/ML diagnostic software might be.

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

The device itself is a standalone medical Doppler device. The "performance" discussed relates to its physical and functional specifications. It is not an AI algorithm in the contemporary sense that would have separate standalone performance evaluated. The comparison is made against the performance of its predicate device, which is also a standalone medical device.

7. The Type of Ground Truth Used

For the key performance metric of "Measurement accuracy," the "ground truth" would implicitly be the established accuracy of the predicate device, which is stated as ± 10%. For the acoustic output criteria, the "ground truth" is compliance with FDA guidelines and standards (e.g., IEC 60601-2-37, NEMA UD 2 & 3). For the Dolphin/MAX battery, the stated 3-hour operating time would have been verified through internal testing.

8. The Sample Size for the Training Set

Not applicable, as no AI/ML algorithm was being developed or trained. This is a traditional medical device submission for an ultrasound system.

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

Not applicable, as there was no training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" to prove the device meets acceptance criteria primarily consists of non-clinical performance testing and a comparison to a legally marketed predicate device.

• Non-Clinical Performance Testing: The document states that the devices "have been thoroughly tested through verification of specifications and validation, including software validation." This would include engineering bench tests to verify parameters such as measurement accuracy, acoustic output, and electrical safety. The specific details of these non-clinical tests (e.g., the number of devices tested, the protocols, the exact results) are not provided in this 510(k) summary but would have been part of the full submission to the FDA. The compliance with standards such as IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2-2004, and UD 3-2004 indicates that specific tests related to electrical safety, electromagnetic compatibility, acoustic output, and diagnostic ultrasound equipment performance were conducted and successfully met.

• Predicate Device Comparison (Substantial Equivalence): The core of the submission is to demonstrate that the Dolphin/IQ, Dolphin/4D, and Dolphin/MAX systems are "substantially equivalent" to predicate devices (Dolphin/IQ and Dolphin/4D, K170859). The comparison table (Section 5.4.1) highlights that the new devices share identical or equivalent technical characteristics, indications for use, clinical applications, frequency modes, transducers, patient contact materials, user controls, display modes, various measurement parameters, and measurement accuracy to the predicate. The few differences (e.g., the addition of Dolphin/MAX with an internal battery, new accessories) are discussed and deemed not to impact product performance or effectiveness. The predicate device's existing clearance implies its performance already met FDA requirements, and by demonstrating equivalence, the new devices are considered to do the same.

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The Dolphin/IQ and Dolphin/4D are medical Doppler devices intended for noninvasive measurements of blood flow velocities in arteries and veins in adults and Pediatric. The Dolphin systems can be used in hospitals, clinics and physician offices.

Contraindications : The Dolphin is not intended to be used in fetal or neonatal applications.

Note : The Dolphin is to be used only by trained medical personnel.

Dolphin/IQ and Dolphin/4D systems are part of the Dolphin product family of noninvasive peripheral vascular diagnostic systems. The Dolphin/IQ and the Dolphin/4D are transcranial Doppler (TCD) systems for measurement of blood flow velocity intracranially, extracranially and in the peripheral circulation. Both systems share identical Doppler hardware and software. The Dolphin/IQ is a module, that needs to connect to an external computer and display for its' operation while the Dolphin/4D is a complete integrated system that includes and integrated computer system with hard disk, and touch screen display. The functionality and performance of both systems is identical. Both systems support the same Doppler probes: 1.6 MHz PW hand held probe, 2 MHz PW hand held probe, 2 MHz PW monitoring probe, 4 MHz CW/PW hand held probe and 8 MHz CW/PW hand held probe. Both support the same accessories: IR wireless remote control, foot switch and monitoring head set.

The provided text describes the Viasonix Ltd. Dolphin/IQ and Dolphin/4D medical devices, which are ultrasonic pulsed Doppler imaging systems. However, it explicitly states that no clinical study was conducted to support the application. Therefore, it is impossible to describe acceptance criteria and a study proving the device meets those criteria from the provided document.

The document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and adherence to standards.

Here's a breakdown of what can be extracted and what cannot based on your request and the provided text:

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

Since no clinical study was performed, there are no specific performance-based acceptance criteria related to clinical efficacy or accuracy that can be directly reported for the device’s performance in a clinical setting. The document only provides a "Measurement accuracy" specification of "± 10% accuracy" as a technical characteristic compared to predicate devices (page 10). This is a technical specification, not clinical acceptance criteria derived from a study.

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

Not applicable, as no clinical study was conducted.

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)

Not applicable, as no clinical study was conducted.

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

Not applicable, as no clinical study was conducted.

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, as no clinical study was conducted, and the device is a diagnostic ultrasound system, not explicitly an AI-driven tool for human reader improvement.

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

Not applicable, as no clinical study defining standalone performance was conducted. The device itself is a diagnostic tool operated by trained medical personnel.

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

Not applicable, as no clinical study was conducted. The "Measurement accuracy" of ± 10% mentioned on page 10 would typically be assessed against a known standard or reference value in a bench test, not against a clinical ground truth.

8. The sample size for the training set

Not applicable, as no clinical study was conducted.

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

Not applicable, as no clinical study was conducted.

Information from the document related to "acceptance criteria" and "testing" (but not clinical trials):

• Non-Clinical Performance Testing (page 12):
  • "The Dolphin/IQ and Dolphin/4D devices have been thoroughly tested through verification of specifications and validation, including software validation."
  • "The following performance verification testing were applied to the development of the system: Acoustic output Measurement, temperature rise and velocity accuracy testing."
• Standards Compliance (page 11 & 12): The device meets several IEC and NEMA standards related to medical electrical equipment, electromagnetic disturbances, essential performance of ultrasonic diagnostic equipment, acoustic output measurement, and real-time display of thermal and mechanical acoustic output indices. These standards define the "acceptance criteria" for the safety and technical performance of the device, rather than its clinical diagnostic accuracy.

In summary, based solely on the provided document, it is not possible to answer most of your questions because the submission explicitly states: "No clinical study was conducted to support this application." The document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with relevant safety and technical standards.

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The Falcon/Pro, Falcon/Quad, and Falcon/ABI+ are intended for use in the noninvasive evaluation of peripheral vascular pathology in patients.

The devices are not intended to replace other means of evaluating vital patient physiological processes, are not intended to be used in fetal applications, and are not intended to be used inside the sterile field.

They are to be used by trained medical personnel in hospitals, clinics and physicians offices by prescription or doctor's orders.

The Falcon/Pro, Falcon/Quad, and Falcon/ABI+ systems are part of the Falcon product family of non-invasive peripheral vascular diagnostic systems. The Falcon/Pro is a complete peripheral vascular system that supports 10 independent pressure channels, 5 PPG sensors, 3 Doppler frequencies, and a temperature sensor. The Falcon/Quad and the Falcon/ABI+ systems are merely sub-assemblies of the Falcon/Pro system. Both support only 4 pressure channels, 4 PPG sensors and a temperature sensor. The Falcon/Quad also includes support for the 3 Doppler frequencies, while the Falcon/ABI+ does not support any Doppler features.

The Falcon/Pro and its' sub-assemblies Falcon/Quad and Falcon/ABI+ share the same hardware and software. While the main printed circuit board (PCB) is identical, the pneumatic components such as pumps, valves, sensors and check valves are assembled in the Falcon/Quad and Falcon/ABI+ to support only 4 pressure channels. In addition, one PPG sensor is omitted from the assembly of these systems. Furthermore, the Doppler board with its' PCB mount probe connectors is not assembled in the Falcon/ABI+ system. The same metal enclosure and connectors are used for the Falcon/Pro. Falcon/Quad, and Falcon/ABI+. The only difference lies in the front panel which is adapted according to the number of PPG sensors and Doppler probes.

The software level of concern for the Falcon products is determined as Moderate. The software of the Falcon/Pro, Falcon/Quad, and Falcon/ABI+ systems is practically identical. The only software differences are as follows: the Falcon/Pro supports 10 pressure cuffs (tubing marked in red, blue, green, yellow, orange, and white with lines in red. blue, green, yellow, and orange), while the sub-assemblies support only 4 pressure cuffs (tubing marked in red, blue, green, yellow); the Falcon/Pro supports 5 color coded PPG sensors (red, blue, green, vellow and black) while the sub-assemblies support only 4 such sensors (red, blue, green, yellow); the default examination protocols are adapted according to the supported sensors and probes; the maximal protocol group allowed with the Falcon/Pro is 10. while the maximal allowed group for the sub-assemblies is 9: and the Falcon/ABI+ does not support any of the Doppler options and features.

All other software features are identical for the Falcon/Pro and the 2 sub-assemblies Falcon/Quad and Falcon/ABI+. Some of the main features include patient details and patient database management; Dicom connectivity; printing configuration and printing options; writing examination reports; summary screen support; configuration and management of examination protocols: measurement site configuration: export in various formats: import of VSX files; backup features; restoring backup data: online help options: and review stations. All of the standard signal control options and signal display options. as well as measurement calculations, are identical for all 3 systems (excluding Doppler related options for the Falcon/ABI+ system).

The quantitative measurements are the same for Falcon/Pro and the 2 sub-assemblies Falcon/Quad and Falcon/ABI+. The main measurement of the 3 systems is segmental systolic blood pressures. In general, the measurement is conducted by applying an appropriately sized cuff to the measured segment, obtaining a reference PPG or a Doppler signal in a location distal to the cuff placement, and then inflating the cuff to such a pressure that will occlude the blood vessels and prevent blood flow distal to the cuff location, which will result in disappearance of the reference signal. Then, a slow cuff deflation begins, and the instantaneous cuff pressure at which the reference signal reappears is typically defined as the segmental systolic blood pressure. While the software automatically places a cursor at the time location which is suspected as being the systolic pressure, it is the total responsibility of the system operator and the medical staff to modify the cursor location according to their medical training, and define the correct segmental pressure.

Based on the segmental pressures, the pressure indices are calculated, as the ratio between the systolic segmental pressure, and the higher of the 2 brachial systolic pressures. The ABI index is a commonly used index, which is a specific case of the above, calculated as the systolic right or left ankle pressure, divided by the higher of the right or left brachial systolic pressure.

The standard main Doppler parameters that are calculated (not for the Falcon/ABI+ system), include: Mean, representing the time-average value of the envelope (maximal velocity/frequency) over one cardiac cycle; Peak, representing the maximal systolic velocity/frequency during a cardiac cycle, in units of cm/sec or KHz; Diast, representing the minimal diastolic velocity/frequency during a cardiac cycle, in units of cm/sec or KHz; PI, representing the Gosling Pulsatility Index, calculated based on the peak envelope as (peak systolic velocity - minimal diastolic velocity) / mean velocity; RI. representing the Pourcelot Resistance Index. calculated based on the peak envelope as (peak systolic velocity - minimal diastolic velocity) / peak systolic velocity; S/D. representing the systolic to diastolic flow ratio, and is calculated based on the peak envelope as: (peak systolic velocity / minimal diastolic velocity); and HR, representing heart rate in beats (number of cardiac cycles) per minute.

Additional parameters that are displayed are related to the specialty tests. During stress testing, a digital timer indicates the duration of the exposure to stress (for example the total time the patient exercised), and the recovery time for each measurement (the time that passed since the end of stress exercise and the current measurement). During venous reflux testing the system automatically places vertical cursors that denote the minimal PPG signal after sequential leg dorsiflexions and the point in time that the PPG signal returns to pre-dorsiflexion baseline. The time difference between these 2 cursors is calculated and referenced as the VRT (venous refill time). It is the responsibility of the examiner to determine the correct vertical cursor position, hence adjusting the VRT parameter. Likewise, the MVO/SVC ratio is based on the horizontal baseline and plateau signals, and the rate of signal drop immediately after rapid deflation of the thigh cuff. Again, it is the responsibility of the examiner to determine the correct cursor positions for the parameter calculation.

The Falcon complies with Class B EMC requirements. Therefore, the Falcon is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

The provided text describes the Falcon/Pro, Falcon/Quad, and Falcon/ABI+ systems, which are non-invasive peripheral vascular diagnostic systems. However, it does not contain information about specific acceptance criteria or a study proving that the device meets those criteria with statistical measures of performance like accuracy, sensitivity, or specificity. Instead, it focuses on demonstrating substantial equivalence to predicate devices.

The document indicates that the devices have undergone "extensive safety, performance testing, and validation" and that "various performance testing" was conducted to ensure they meet their functional specifications. It also mentions compliance with several international safety and electrical standards (EN 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, ISO 14971).

Since explicit acceptance criteria and corresponding performance data are not provided, the following table and subsequent sections highlight what is mentioned and what is missing.

Table of Acceptance Criteria and Reported Device Performance

Detailed Breakdown of Missing Information as Per Request:

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

   • As shown above, the document largely refers to compliance with safety and functional specifications broadly. There are no explicit, quantifiable acceptance criteria related to diagnostic performance (e.g., accuracy thresholds for ABI, Doppler velocity measurements) and no reported device performance data against such criteria. The submission states that "the devices meet all of their functional specifications," but these specifications are not detailed or quantified in terms of diagnostic output validity or reliability.

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

   • Not provided. The submission does not describe any specific clinical test set, its size, or its provenance.

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):

   • Not provided. Since no specific test set or clinical study demonstrating diagnostic performance is described, there's no mention of experts establishing ground truth. The document mentions that it is the "total responsibility of the system operator and the medical staff to modify the cursor location according to their medical training" for segmental blood pressure and other parameters, indicating the device relies on expert interpretation during use.

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

   • Not applicable/Not provided. No specific test set for diagnostic performance is detailed in this submission.

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/Not provided. The device described is a non-invasive peripheral vascular diagnostic system, not an AI-assisted diagnostic tool for human readers in the typical sense of imaging review. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device's description. The submission focuses on substantial equivalence based on device features and general function to predicate devices, not on a human-AI interaction study.

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

   • Not applicable/Not provided. The Falcon devices are diagnostic instruments that capture physiological signals (pressure, PPG, Doppler) and perform calculations based on these signals. While the software automatically places cursors for certain measurements, the submission explicitly states that "it is the total responsibility of the system operator and the medical staff to modify the cursor location according to their medical training." This indicates intended human-in-the-loop operation, and no mention of a standalone algorithm-only performance study is made.

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

   • Not provided. No specific ground truth methodology is described in relation to a study proving diagnostic accuracy. The device produces quantitative measurements (segmental systolic blood pressures, ABI, Doppler parameters, VRT, MVO/SVC ratio) that are then interpreted by medical staff. The document focuses on the correct functioning and calculation capabilities of the device itself, not on its diagnostic accuracy against a clinical gold standard.

8. The sample size for the training set:

   • Not applicable/Not provided. The device does not appear to be an AI/machine learning device that requires a "training set" in the conventional sense. It's a measurement and calculation device for physiological signals.

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

   • Not applicable/Not provided. As above, there is no mention of a training set or its associated ground truth establishment.

Summary of the Document's Focus:

This 510(k) submission primarily emphasizes:

• Device Description: Detailing the hardware and software components and functionality of the Falcon/Pro, Falcon/Quad, and Falcon/ABI+ systems.
• Substantial Equivalence: Comparing the new devices to legally marketed predicate devices (Vasoguard and Multilab Series II) based on features, intended use, performance capabilities (e.g., number of pressure channels, PPG sensors, Doppler frequencies, specialty tests), and compliance with general safety and performance standards.
• Safety and Standards Compliance: Stating that the devices meet various electrical and medical device standards (EN, IEC, ISO).
• User Responsibility: Highlighting that medical staff are ultimately responsible for interpreting the data and adjusting cursors for measurements.

The submission does not include data from clinical trials or performance studies that would typically provide specific acceptance criteria and detailed quantitative diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) against a defined ground truth for conditions like peripheral vascular pathology. The approval is based on demonstrating substantial equivalence to existing devices already on the market rather than on new clinical performance data.

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