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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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