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The GPS-XYZ device is a diagnostic ultrasound system which produces twodimensional diagnostic ultrasonic images. The following intended uses are identified for the transducer applications: General Radiology, Abdominal, Cardiac and Vascular, with the use of ultrasonic probes from 2.8-12.5 MHz. There is no transcranial application for this device.

The GPS-XYZ Diagnostic Ultrasound System device is a diagnostic ultrasound system which produces two-dimensional diagnostic ultrasonic images. The following intended uses are identified for the transducer applications: General Radiology, Abdominal, Cardiac and Vascular, with the use of ultrasonic probes from 2.8-12.5 MHz. There are no transcranial applications for this device.

User interface is via an alphanumeric keypad and integrated trackball. The Perception Inc. GPS-XYZ Diagnostic Ultrasound System may be operated in M and B modes of inspection. The Perception Inc. GPS -XYZ Diagnostic Ultrasound System supports M, B, M&B, Dual B and Quad B display modes.

All probes currently intended for use with the Perception Inc. GPS -XYZ Diagnostic Ultrasound System are either mechanical sector devices or electronic curved array, and make use of a fluid filled design.

Here's a breakdown of the acceptance criteria and study information for the Perception Inc. GPS-XYZ Diagnostic Ultrasound System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The document is a 510(k) summary for a pre-market notification, which focuses on demonstrating substantial equivalence to predicate devices rather than specific performance metrics against pre-defined acceptance criteria for a new, novel device. Therefore, explicit quantifiable "acceptance criteria" and "reported device performance" in the typical sense of a clinical trial are not presented.

Instead, the "acceptance criteria" for this device are implicitly met by demonstrating:

1. Substantial Equivalence: The device's intended use, technological characteristics, and safety/effectiveness are comparable to legally marketed predicate devices.
2. Compliance with Recognized Standards: The device meets applicable industry and regulatory standards for safety and acoustic output.

The document states:
"This 510(k) submission is intended as a Track 1 type submission. Acoustic Output Reporting was prepared utilizing the following documents.

• NEMA 1992, Acoustic output measurement standard for diagnostic ultrasound . equipment, NEMA Standard UD-21992.
• FDA Center for Devices and Radiological Health 1985 510(k) Guide for ● Measuring and Reporting and Acoustic Output of Diagnostic Ultrasound Medical Devices, December, 1985, Revised, 1989, 1990, 1991, 1993, 1994 and 1995. --"

And:
"The following testing was conducted by Intertec Testing Services:

• UL-544, Third Edition .
• Radiated and Conducted Emissions per CISPR 11 ●
• Magnetic Field Emission per MIL-STD-482D, method RE101 ●
• Electrostatic Discharge Immunity per IEC 801-2 .
• Radiated Field Immunity (3 V/m, 26 MHZ to 1 Ghz, 100% Square Wave Modulation)
• Steady State Voltage Fluctuations
• Line Voltage Dropouts
• Slow Line Voltage Sags and Surges .
• . Fast Transients Bursts per IEC 801-4
• . Fast Line Voltage Surges
• Conducted Energy Immunity per MIL-STD-462D, Method CS114 .
• Magnetic Field Immunity per MIL-STD-482D, Method RS101 ●
• Quasi-Static Electric Field Immunity

None of the testing demonstrated any design characteristics that violated the requirements of the "FDA November 1993 Draft Reviewer Guidance for Pre-Market notification submissions, DCRND" or resulted in any safety hazards. It was Intertec Testing Services' conclusion that the device tested met all relevant requirements of the aforementioned quidance testing requirements."

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

• Sample Size: Not Applicable. The document explicitly states "Discussion of Clinical Tests Performed: Not Applicable." This indicates that clinical trials with patient data were not conducted as part of this 510(k) submission. The evaluation was based on engineering and safety testing, and comparison to predicate devices.
• Data Provenance: Not Applicable. Since no clinical tests were performed, there is no patient data, and therefore no country of origin or retrospective/prospective classification.

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

• Not Applicable. No clinical studies were performed, thus no "test set" requiring ground truth established by experts.

4. Adjudication Method for the Test Set:

• Not Applicable. No clinical studies were performed.

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 is a submission for a diagnostic ultrasound system, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance was not conducted and is not relevant to this type of device.

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

• No. This device is a diagnostic ultrasound system, which is inherently operated by a human. It is not an algorithm performing a standalone task.

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

• Not Applicable. No clinical studies were performed, and no ground truth from patient data was established. The "ground truth" for this 510(k) submission primarily relies on the established safety and performance records of the predicate devices and compliance with recognized engineering and safety standards.

8. The sample size for the training set:

• Not Applicable. This device is a traditional ultrasound imaging system, not an artificial intelligence or machine learning algorithm that requires a "training set."

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

• Not Applicable. As it is not an AI/ML device, there is no training set and no ground truth for a training set.

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