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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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The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular).
When Pinpoint™ GT Technology, from C.R. Bard, Inc., is included with the system, the Indications for Use include: Pinpoint GT Technology is intended to provide clinicians with visual tools for passive magnetic tracking of a needle with respect to ultrasound image data.

The LOGIQ P9; LOGIQ P7 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 53 cm wide, 74 cm deep and 157 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 21.5 inch LCD image display.

This document is a 510(k) Premarket Notification from GE Healthcare for their LOGIQ P9 and LOGIQ P7 diagnostic ultrasound systems. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a de novo clinical study with detailed performance metrics against specific acceptance criteria. Therefore, the information typically found in an AI/Software as a Medical Device (SaMD) study for performance reporting (such as ROC curves, sensitivity/specificity, sample sizes for test/training sets, or expert ground truth adjudication) is not present.

However, based on the provided text, we can infer and extracting relevant safety and effectiveness information as follows:

1. Table of Acceptance Criteria (Inferred from Compliance and Testing) and Reported Device Performance

2. Sample Sizes and Data Provenance for Test Set

The document explicitly states: "The subject of this premarket submission, LOGIQ P9; LOGIQ P7, did not require clinical studies to support substantial equivalence."

This means there wasn't a separate "test set" in the context of a prospective clinical trial or performance study against pre-defined metrics. The submission relies on bench testing, compliance with standards, and comparison to predicate devices to demonstrate substantial equivalence, rather than a clinical performance study with patient data.

• Sample Size for Test Set: Not applicable as a clinical test set was not used for this 510(k) submission.
• Data Provenance: Not applicable for clinical performance data. The data provenance discussed is related to compliance with engineering standards and existing clearances for predicate and reference devices (e.g., K163596, K170445, K160162, K173555).

3. Number of Experts and Qualifications for Ground Truth for the Test Set

• Not applicable, as a clinical test set requiring expert ground truth establishment for a performance study was not performed. The evaluation relies on technical performance and safety testing, and substantial equivalence to existing devices cleared through other means.

4. Adjudication Method for the Test Set

• Not applicable, as a clinical test set requiring adjudication was not utilized.

5. MRMC Comparative Effectiveness Study

• Not applicable. This submission is for a diagnostic ultrasound system, not an AI or imaging assistance device that would typically undergo an MRMC study to show human reader improvement with AI assistance. The focus is on the device's inherent safety and performance for imaging.

6. Standalone Performance (Algorithm Only)

• Not applicable in the context of an "algorithm only" performance typical for AI/SaMD. The device itself is an ultrasound imaging system. Its performance relates to its ability to generate diagnostic ultrasound images and fluid flow analysis, which is demonstrated through engineering and safety evaluations and comparison to predicate devices.
  • While new features like "Shear wave elastography" involve processing, their performance is demonstrated via technical validation and substantial equivalence, not a standalone algorithm efficacy study in the typical AI sense.

7. Type of Ground Truth Used

• Not applicable in the sense of 'ground truth' defined by expert consensus or pathology for a clinical performance study. The "ground truth" here is compliance with established engineering and safety standards, and the capabilities of the already cleared predicate devices.

8. Sample Size for the Training Set

• Not applicable. This is a hardware/software system, and the submission does not describe a machine learning model that was "trained" on a dataset in the way an AI/SaMD product would be. The "training" here refers to the device's design and engineering based on established physics and medical imaging principles.

9. How the Ground Truth for the Training Set was Established

• Not applicable, as no external "training set" with established ground truth was utilized for a machine learning model. The device's design and functionality are based on long-standing principles of ultrasound imaging and adherence to regulatory standards.

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The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; and Intraoperative (abdominal, thoracic, vascular).

When PinpointTM GT Technology, from C.R. Bard, Inc., is included with the system, the Indications for Use include: Pinpoint GT Technology is intended to provide clinicians with visual tools for passive magnetic tracking of a needle with respect to ultrasound image data.

The LOGIQ P9 and LOGIQ P7 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 53 cm wide, 69 cm deep and 157 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 21.5-inch LCD image display.

This document is a 510(k) premarket notification for the GE Healthcare LOGIQ P9 and LOGIQ P7 ultrasonic imaging systems. It asserts substantial equivalence to predicate devices, meaning that clinical studies were not required to demonstrate safety or effectiveness for the new device. Therefore, no acceptance criteria in terms of clinical performance metrics, sample sizes for test sets, data provenance, number or qualifications of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance studies are applicable or reported here.

The document focuses on non-clinical testing and comparison to predicate devices to establish substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) premarket notification establishing substantial equivalence based on non-clinical testing and comparison to predicate devices, there are no specific performance-based acceptance criteria or reported device performance in the format of a quantitative clinical study outcome table. The "performance" is implicitly deemed equivalent to the predicate devices through a qualitative comparison.

The acceptance criteria here would be compliance with recognized medical device safety standards and demonstration of technological equivalence to already cleared devices.

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

Not applicable. The document states: "The subject of this premarket submission, LOGIQ P9 and LOGIQ P7, did not require clinical studies to support substantial equivalence." Therefore, no test set data of patients or clinical images were collected, and no provenance information is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As no clinical studies were performed, no ground truth needed to be established by experts for a test set.

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

Not applicable. No clinical test set.

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

Not applicable. No clinical studies were carried out, and the device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool as described in the context of improving human reader performance.

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

Not applicable. The device is a diagnostic ultrasound system, not a standalone algorithm.

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

Not applicable. No clinical ground truth was established for a test set. The ground truth for proving substantial equivalence was based on regulatory compliance and comparison to existing cleared devices.

8. The sample size for the training set

Not applicable. No machine learning algorithm or training set is mentioned in the context of this 510(k) submission for demonstrating substantial equivalence. The "training" of the device refers to its engineering and verification processes in compliance with standards, not a machine learning training set.

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

Not applicable. No machine learning algorithm or training set with associated ground truth is referenced.

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The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; and Intraoperative (abdominal, thoracic, vascular).

The LOGIQ P9 and LOGIQ P7 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 53 cm wide, 69 cm deep and 157 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 21.5-inch LCD image display.

The provided text does not contain detailed acceptance criteria and a study proving the device meets those criteria in the traditional sense of a clinical performance study for an AI/ML device.

Instead, the document is a 510(k) premarket notification for a diagnostic ultrasound system (GE LOGIQ P9 and LOGIQ P7) and its various transducers. The "study" described is a non-clinical comparison to predicate devices to establish substantial equivalence, rather than a clinical trial demonstrating performance against specific metrics.

Here's a breakdown of the information that can be extracted, and where limitations exist based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of specific quantitative acceptance criteria or reported performance metrics in terms of accuracy, sensitivity, specificity, or other performance measures typically associated with AI/ML devices.

Instead, the "acceptance criteria" are implied by the comparison to legally marketed predicate devices and compliance with voluntary safety and performance standards. The "reported device performance" is framed as its "substantial equivalence" to these predicates.

Implied Acceptance Criteria (based on comparison to predicate and standards):

• Intended Use Equivalence: Same clinical intended uses as predicate devices.
• Imaging Capabilities Equivalence: Same imaging modes and similar capabilities (measurements, digital image capture, reviewing/reporting).
• Technological Equivalence: Employs the same fundamental scientific technology as predicate devices.
• Safety Standards Compliance: Acoustic output below FDA limits, compliance with AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, NEMA UD 2, ISO10993-1, ISO14971, and NEMA PS 3.1 3.20 (DICOM).
• Biocompatibility: Transducer materials and other patient contact materials are biocompatible.
• Quality Assurance: Adherence to risk analysis, requirements reviews, design reviews, unit testing, integration testing, performance testing, and safety testing.

Reported Device Performance (as stated in the document):

The LOGIQ P9 and P7 systems are "substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness."

Specific new features or transducers are noted to be "previously cleared by FDA" on other GE Healthcare devices, implicitly demonstrating their performance was already deemed acceptable.

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

The document explicitly states: "The subject of this premarket submission, LOGIO P9 and LOGIO P7, did not require clinical studies to support substantial equivalence."

Therefore, there is no test set of patient data of a specific sample size used for performance evaluation in the context of an AI/ML study, nor is there information on data provenance (country of origin, retrospective/prospective). The substantiation is primarily based on engineering and performance testing against standards, and comparison to already cleared predicate devices.

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

Since no clinical studies or test sets with patient data were required for this submission, there is no mention of experts used to establish ground truth for such a test set.

4. Adjudication Method for the Test Set

As no clinical test set was required, there is no adjudication method described.

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 MRMC comparative effectiveness study was done or reported in this document. The device is a diagnostic ultrasound system, not explicitly an AI-assisted diagnostic tool, and the submission focuses on substantial equivalence to existing ultrasound devices.

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

Not applicable. This submission is for an ultrasound imaging system. While it includes "software features" like STIC and OmniView, and a "general measurement tool" called Cardiac AFI, these are presented as capabilities of the ultrasound system itself, not as standalone AI algorithms whose performance is evaluated independently. The primary focus is the imaging hardware and its integrated software relative to predicate ultrasound devices.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the new features or specific transducers mentioned as "previously cleared," their original submissions would have involved appropriate ground truth methods relevant to specific clinical applications (e.g., phantom studies for image quality, clinical data for specific measurements). However, for this specific 510(k) submission, since no new clinical studies were required, there is no ground truth established using patient data for the purpose of demonstrating performance of the LOGIQ P9/P7 as a complete system. The ground truth for proving safety and effectiveness here relies on compliance with engineering standards and demonstrated performance of predicate devices.

8. The Sample Size for the Training Set

Not applicable. This document describes a diagnostic ultrasound system, not an AI/ML algorithm that would undergo specific training on a data set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no AI/ML training set explicitly discussed, the establishment of ground truth for such a set is not detailed.

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The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; and Intraoperative (abdominal, thoracic, vascular).

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal / Obstetrics; Abdominal; Pediatric; Small Organ; Neonatal Cephalic; Adult Cephalic; Cardiac Adult & Pediatric; Peripheral Vascular; Musculo-skeletal Conventional; Musculo-skeletal Superficial; Other (Urology/Prostate); Transrectal; Transvaginal; Intraoperative.

The LOGIQ P9 and LOGIQ P7 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 53 cm wide, 69 cm deep and 157 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 21.5-inch LCD image display.

This document is a 510(k) Premarket Notification Submission for the GE LOGIQ P9 and LOGIQ P7 ultrasound systems. It does not contain information about an AI/ML device or its performance criteria. Instead, it describes a conventional diagnostic ultrasound system and its equivalence to predicate devices, focusing on regulatory compliance and safety standards.

Therefore, I cannot provide a response based on the requested information regarding acceptance criteria and study details for an AI/ML device.

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