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The LOGIQ P&P9/P10 is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal; Pediatric; Small Organ(Breast, Testes, Thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac(adult and pediatric); Peripheral Vascular; Musculo-skeletal Converticial; Urology(including Prostate); Transrectar, Transvaginal; Transesophageal and Intraoperative(Abdominal, Vascular).

Modes of operation include: B, M, PW, Doppler, CW Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography, Attenuation Imaging and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD. The LOGIQ P8/P9/P10 is intended to be used in a hospital or medical clinic.

The LOGIQ P10, LOGIQ P9 and LOGIQ P8 are full featured, Track 3 device, primarily intended for general purpose diagnostic ultrasound system which consists of a mobile console approximately 55 cm wide, 74 cm deep and 160 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10.4-inch LCD touch screen and color 23.8-inch LCD image display with HDMI audio function. All probes on the subject device have been previously cleared on the predicate K203114 with the exception of the E7C8L-RS which was previously cleared on predicate K210438. All probes available as accessories for the subject systems LOGIQ P Series uses are unchanged from the cleared predicates. They are made of the same materials and their shape is unchanged.

The provided FDA 510(k) premarket notification for the GE LOGIQ P10, LOGIQ P9, and LOGIQ P8 ultrasound systems does not contain information about acceptance criteria or a study proving the device meets specific performance criteria for an AI/CAD product.

This document is primarily concerned with demonstrating substantial equivalence to previously cleared predicate devices (K203114 LOGIQ P10/P9/P8 Diagnostic Ultrasound System and K210438 Versana Premier). The focus is on the general diagnostic ultrasound system and its various imaging modes, not a specific AI or computer-aided detection (CAD) application with distinct performance metrics.

The "modifications" mentioned, such as the addition of the E7C8L-RS transducer, Stepper Volume Measurement support, "EZ DICOM Viewer," "Probe Health Test," and the KOIOS SW (KOIOS Breast) connectivity, are described as either hardware additions, software features for workflow/data management, or connectivity to a separate cleared CAD system (KOIOS DS for Breast, K190442).

Therefore, it is explicitly stated in the "Summary of Clinical Tests" section:

"The subject of this premarket submission, LOGIQ P10, LOGIQ P9 and LOGIQ P8, did not require clinical studies to support substantial equivalence."

Without a specific clinical study detailed in this document to demonstrate the performance of an AI/CAD component against acceptance criteria, I cannot provide the requested information. The document focuses on demonstrating safety and effectiveness through compliance with standards and comparing the new device's features to those of cleared predicate devices.

If this were a submission for a new AI/CAD specific algorithm, the information you requested would typically be required and detailed within the 510(k) submission, often in sections dedicated to performance testing, clinical validation, or human factors studies.

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The LOGIQ P10, LOGIQ P9, LOGIQ P8 are general purpose diagnostic ultrasound system intended for use by a qualified and trained healthcare professional physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The LOGIO P10, LOGIO P9 and LOGIO P8 clinical applications include: evaluation of Fetal/Obstetrics; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectar, Transvaginal; Transesophageal and Intraoperative (abdominal, vascular).

Modes of operation include: B, M, PW, Doppler, CW Doppler, Color M Doppler, Power Doppler, Power Doppler, Harmonic Imaging, Coded pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography, Attenuation Imaging and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD. The LOGIQ P10, LOGIQ P9 and LOGIQ P8 are intended to be used in a hospital or medical clinic.

The LOGIQ P10, LOGIQ P9 and LOGIQ P8 are full featured, Track 3 device, primarily intended for general purpose diagnostic ultrasound system which consists of a mobile console approximately 55 cm wide, 74 cm deep and 160 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10.4-inch LCD touch screen and color 23.8-inch LCD image display.

The provided text describes a 510(k) premarket notification for the LOGIQ P10, LOGIQ P9, and LOGIQ P8 diagnostic ultrasound systems. It details the device's intended use, comparison to predicate devices, and a summary of non-clinical tests. However, the document explicitly states in "Summary of Clinical Tests" that "The subject of this premarket submission, LOGIQ P10, LOGIQ P9 and LOGIQ P8, did not require clinical studies to support substantial equivalence."

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and a study that proves the device meets those criteria, as no such clinical study was conducted or reported in this 510(k) submission.

The document focuses on demonstrating substantial equivalence through:

• Comparison to Predicate Devices: Showing the new devices use the same fundamental scientific technology, have the same clinical intended uses (with minor additions), similar imaging modes (with some new modes migrated from other cleared devices like UGAP), and similar capabilities for measurements, image capture, review, and reporting.
• Non-Clinical Tests: Verifying acoustic output, biocompatibility, cleaning and disinfection effectiveness, and compliance with thermal, electrical, electromagnetic, and mechanical safety standards (e.g., AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, ISO10993-1, ISO14971, NEMA PS 3.1 - 3.20 (2016) DICOM Set, IEC 62359).
• Quality Assurance Measures: Including risk analysis, requirements reviews, design reviews, unit level testing, integration testing, performance testing, and safety testing.

There is no mention of acceptance criteria based on performance metrics that would typically arise from a clinical study (e.g., sensitivity, specificity, AUC) or any study that evaluated human reader performance with or without AI assistance, as these are not AI/ML-enabled devices described here, but rather general diagnostic ultrasound systems.

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