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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Small Organ (Breast, Thyroid, Testes), Cardiac, Transrectal, Transvaginal, Peripheral Vascular, Musculo-skeletal Conventional.

The Perception's GPS-6TBMD Ultrasound System is a PC (computer) based and controlled real time. two dimensional, mechanical sector and electronic array diagnostic ultrasound and pulsed Doppler imaging system which produces diagnostic ultrasonic images and blood flow spectral analysis through user friendly operation. User interface is via an alphanumeric keypad, trackball and Icon-driven graphical interface. The Perception Inc. GPS-6TBMD Diagnostic Ultrasound System may be operated in M /B /D modes of inspection. The Perception GPS-6TBMD Diagnostic Ultrasound System supports M. B. M&B, Dual B, Quad B, D and D/B, display modes. All probes currently intended for use with the Perception GPS-6TBMD Diagnostic Ultrasound System are either mechanical sector devices or electronic linear and curve array, and make use of a fluid filled design.

This appears to be a 510(k) summary for the Perception Inc. GPS-6TBMD Diagnostic Ultrasound System, dated September 29, 1998. It details the device, its intended uses, and its substantial equivalence to predicate devices.

However, the provided document explicitly states:

• "8. Discussion of Clinical Test Performed: Not Applicable" (Page 3)

This means that no clinical study was performed to prove the device meets acceptance criteria in a clinical setting. Instead, the submission focuses on non-clinical tests to demonstrate substantial equivalence to legally marketed predicate devices.

Therefore, I cannot provide information on acceptance criteria related to clinical performance, how ground truth was established, sample sizes, or expert qualifications for a clinical study, as no such study is documented in this 510(k) summary.

Here's what I can extract regarding the non-clinical acceptance criteria and tests:

Acceptance Criteria and Device Performance (Non-Clinical)

• Radiated and Conducted Emissions per CISPR 11
• Magnetic Field Emissions per MIL-STD-482D, method RE101
  Immunity:
• 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 RS 101
• Quasi-Static Electric Field Immunity | Satisfactory testing results and compliance to applicable standards. No design characteristics were found that violated the requirements of the September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, Center for Devices and Radiological Health," or resulted in any safety hazards. The contract testing laboratory concluded that the device met all relevant requirements of the aforementioned guidance testing requirements. |
  | Biocompatibility | (Implicitly tested as stated in the conclusion.) | "Biocompatibility testing revealed no new questions of safety or effectiveness." (Specific standards or detailed results are not provided in this summary.) |
  | Substantial Equivalence | The device should have the same intended use, method of operation, materials, and design, or comparable without raising new questions of safety or effectiveness, as legally marketed predicate devices. | The Perception Inc. GPS-6TBMD Diagnostic Ultrasound System has the same intended use as a combination of all cited predicates. All non-clinical testing and biocompatibility testing revealed no new questions of safety or effectiveness. When compared to the predicate devices, the device "does not incorporated any significant changes in intended use, method of operations, material or design that could affect safety or effectiveness." |

Study Details (Non-Clinical Testing)

Since no clinical study was performed, the following points relate to the non-clinical testing described:

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

   • This information is not applicable for non-clinical testing of a diagnostic ultrasound system's technical specifications and safety. The "test set" in this context refers to the device itself and its components. The provenance would be the manufacturing site and testing laboratories.

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

   • Not applicable in the sense of clinical ground truth. The "experts" involved would be the contract testing laboratory personnel who conducted the engineering and safety tests, qualified to perform tests against the listed standards (e.g., UL, CISPR, IEC, MIL-STD, NEMA). Their specific number or qualifications are not detailed in this summary.

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

   • Not applicable for non-clinical engineering and safety testing. Compliance is determined by whether the device's measured performance meets the specified thresholds or requirements of the cited standards.

4. 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 diagnostic ultrasound system from 1998, which is a hardware device. There is no mention of AI or image analysis software that would involve human readers or MRMC studies.

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

   • No. Not applicable for this type of device.

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

   • For the non-clinical tests, the "ground truth" refers to the established technical standards and regulatory limits (e.g., maximum acoustic output levels, acceptable EMI/EMC performance thresholds).

7. The sample size for the training set:

   • Not applicable, as there is no algorithmic component requiring a training set for machine learning.

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

   • Not applicable.

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