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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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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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