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Ultrasound images are acquired via B (2D), M, Color M modes, Color, Power, Pulsed and CW Doppler modes, Coded Pulse, Harmonic, 3D, and Real time (RT) 3D Mode (4D).

Clinical applications include: Fetal/Obstetrics; Abdominal (including renal and GYN); Urology (including prostate); Pediatric; Small organs (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Transesophageal (TEE); Musculo-skeletal Conventional; Musculo-skeletal Superficial; Transrectal (TR); Transvaginal (TV); Intraoperative (vascular); Intra-Cardiac; Thoracic/Pleural and Intra-Luminal.

Device Description

EchoPAC Software Only / EchoPAC Plug-in provides image processing, annotation, analysis, measurement, report generation, communication, storage and retrieval functionality to ultrasound images that are acquired via the GE Healthcare Vivid family of ultrasound systems, as well as DICOM images from other ultrasound systems. EchoPAC Software Only will be offered as SW only to be installed directly on customer PC hardware and EchoPAC Plug-in is intended to be hosted by a generalized PACS host workstation. EchoPAC Software Only / EchoPAC Plug-in is DICOM compliant, transferring images and data via LAN between systems, hard copy devices, file servers and other workstations.

AI/ML Overview

The provided 510(k) clearance letter and summary discuss the EchoPAC Software Only / EchoPAC Plug-in, including a new "AI Cardiac Auto Doppler" feature. The acceptance criteria and the study proving the device meets these criteria are primarily detailed for this AI-driven feature.

Here's an organized breakdown of the information:

1. Acceptance Criteria and Reported Device Performance (AI Cardiac Auto Doppler)

Acceptance Criteria	Reported Device Performance
Feasibility score of more than 95%	The verification requirement included a step to check for a feasibility score of more than 95%. (Implies this was met for the AI Cardiac Auto Doppler).
Expected accuracy threshold calculated as the mean absolute difference in percentage for each measured parameter.	The verification requirement included a step to check mean percent absolute error across all cardiac cycles against a threshold. All clinical parameters, as performed by AI Cardiac Auto Doppler without user edits, passed this check. These results indicate that observed accuracy of each of the individual clinical parameters met the acceptance criteria.
For Tissue Doppler performance metric: Threshold not explicitly stated, but comparative values for BMI groups are provided.	**BMI

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K Number

K220940

Device Name

EchoPAC Software Only, EchoPAC Plug-in

Manufacturer

GE Medical Systems Ultrasound and Primary Care Diagnostics,

Date Cleared

2022-07-22

(113 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K211488,K202658,K202132,K200852

Intended Use

Ultrasound images are acquired via B (2D), M, Color M modes, Color, Power, Pulsed and CW Doppler modes, Coded Pulse, Harmonic,3D, and Real time (RT) 3D Mode (4D).

Clinical applications include: Fetal/Obstetrics; Abdominal (including renal and GYN); Urology (including prostate); Pediatric; Small organs (breast, testes, thyroid); Neonatal and Adult and pediatric); Peripheral Vascular; Transesophageal (TEE); Musculo-skeletal Conventional; Musculo-skeletal Superficial; Transrectal (TR); Transvaginal (TV): Intraoperative ( vascular); Intra-Cardiac; Thoracic/Pleural and Intra-Luminal.

Device Description

AI/ML Overview

The provided FDA 510(k) summary for GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC's EchoPAC Software Only/EchoPAC Plug-in includes an "AI Summary of Testing" section for the Easy Auto EF and Easy AFI LV algorithms. This section provides information relevant to acceptance criteria and study details.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the reported performance figures, as they state the accuracy achieved.

Acceptance Criteria (Implied)	Reported Device Performance (Accuracy)
≥ 92% average Dice score (general)	92% or higher
≥ 91% average Dice score (different scanning views)	91% or higher
≥ 92% average Dice score (different left ventricle volumes)	92% or higher

Note: The document only provides Dice score for "accuracy." Other common performance metrics like sensitivity, specificity, or F1-score are not explicitly stated.

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

Sample Size for Test Set:
- Individual patients' images: 45 exams from assumed 45 patients (exact number of patients unknown due to anonymization).
- Number of samples (images): 135 images extracted from the 45 exams.
Data Provenance: Europe, Asia, US (retrospective, as indicated by anonymization and collection for testing).

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

Number of Experts: Two certified cardiologists initially, with a panel of experienced experts for adjudication.
Qualifications of Experts:
- Two certified cardiologists (for initial manual delineation and review).
- A panel of experienced experts (for reviewing annotations that the two cardiologists could not agree on). Specific years of experience are not mentioned beyond "experienced."

4. Adjudication Method

The adjudication method used was a 2+1 process (consensus followed by expert panel review):

Consensus Reading: Two certified cardiologists performed manual delineation and then reviewed each other's annotations. They discussed disagreements to reach a consensus.
Expert Panel Review: If the two cardiologists could not agree on an annotation, a panel of experienced experts further reviewed those annotations to establish the final ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. It focuses on the standalone performance of the AI algorithm. Therefore, no effect size of human readers improving with AI vs. without AI assistance is provided.

6. Standalone Performance Study

Yes, a standalone (i.e., algorithm-only without human-in-the-loop performance) study was done. The reported Dice scores directly evaluate the algorithm's accuracy in segmenting regions of interest, independent of human interaction during the measurement process.

7. Type of Ground Truth Used

The type of ground truth used was expert consensus. It was derived from manual delineations by certified cardiologists, with a further review and consensus by an expert panel for disagreements.

8. Sample Size for the Training Set

The document does not explicitly state the sample size for the training set. It only mentions that "datasets from different clinical sites for testing as compared to the clinical sites for training" were used.

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

The document does not explicitly state how the ground truth for the training set was established. It only describes the process for the test set's ground truth. However, it is generally assumed that similar expert-driven annotation processes would have been used for training data.

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K Number

K200852

Device Name

EchoPAC Software Only, EchoPAC Plug-In

Manufacturer

GE Medical Systems Ultrasound and Primary Care Diagnostics

Date Cleared

2020-09-18

(171 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K182450,K181685,K200743,K170847

Intended Use

EchoPAC Software Only / EchoPAC Plug-in is intended for diagnostic review and analysis of ultrasound images, patient record management and reporting, for use by, or on the order of a licensed physician. EchoPAC Software Only / EchoPAC Plug-in allows post-processing of raw data images from GE ultrasound scanners and DICOM ultrasound images.
Ultrasound images are acquired via B (2D), M, Color M modes, Color, Power, Pulsed and CW Doppler modes, Coded Pulse, Harmonic, 3D, and Real time (RT) 3D Mode (4D).
Clinical applications include: Fetal/Obstetrics; Abdominal (including renal and GYN), Urology (including prostate), Pediatric; Small organs (breast, testes, thyroid), Neonatal and Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Transesophageal (TEE), Musculo-skeletal Conventional, Musculo-skeletal Superficial, Transrectal (TR), Transvaginal (TV), Intraoperative (vascular), Intra-cardiac, and Intra-luminal.

Device Description

EchoPAC Software Only / EchoPAC Plug-in provides image processing, annotation, analysis, measurement, report generation, communication, storage and retrieval functionality to ultrasound images that are acquired via the Vivid family of ultrasound scanners by GE Healthcare. The EchoPAC Software Only / EchoPAC Plug-in software is an integral component of each Vivid system, providing the post-acquisition image management and reporting functions of the scanner. EchoPAC Software Only will be offered as SW-only to be installed directly on customer PC hardware, and EchoPAC Plug-in will be offered as an accessory to image management workstations. EchoPAC Software Only / EchoPAC Plug-in is DICOM compliant, transferring images and data via LAN between scanners, hard copy devices, file servers and other workstations.

AI/ML Overview

The provided text is a 510(k) Premarket Notification Submission for GE Healthcare's "EchoPAC Software Only / EchoPAC Plug-in." It describes the device, its intended use, and compares it to predicate devices. However, it explicitly states:

"The subject of this premarket submission, EchoPAC Software Only / EchoPAC Plug-in, did not require clinical studies to support substantial equivalence."

This means the document does not contain information about acceptance criteria, a study proving device performance against those criteria, sample sizes, expert involvement, or adjudication methods because clinical studies were not deemed necessary for this submission. The submission relies on non-clinical tests and comparison to previously cleared predicate devices.

Therefore, I cannot provide the requested information from the given text.

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K Number

K170847

Device Name

EchoPAC Software Only, EchoPAC Plug-in

Manufacturer

GE Medical Systems Ultrasound and Primary Care Diagnostics

Date Cleared

2017-06-14

(86 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K150085,K150122,K161706

Intended Use

Ultrasound images are acquired via B (2D), M, Color M modes, Color, Power, Pulsed and CW Doppler modes, Coded Pulse, Harmonic and Real time 3D.

Clinical applications include: Fetal; Abdominal (including renal and GYN); Urology (including prostate); Pediatric; Small organs (breast, testes, thyroid); Neonatal and Adult and pediatric); Peripheral Vascular; Transesophageal (TEE); Musculo-sketal Conventional; Musculo-skeletal Superficial; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic and vascular).

Device Description

EchoPAC Software Only / EchoPAC Plug-in provides image processing, annotation, analysis, measurement, report generation, communication, storage and retrieval functionality to ultrasound images that are acquired via the Vivid family of ultrasound scanners by GE Healthcare. The EchoPAC Software Only / EchoPAC Plug-in software is an integral component of each Vivid system, providing the post-acquisition image management and reporting functions of the scanner. EchoPAC Software Only will be offered as SW-only to be installed directly on customer PC hardware, and EchoPAC Plug-in will be offered as an accessory to selected 3rd party image management workstations. EchoPAC Software Only / EchoPAC Plug-in is DICOM compliant, transferring images and data via LAN between scanners, hard copy devices, file servers and other workstations.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the EchoPAC Software Only / EchoPAC Plug-in:

Important Note: The provided document is a 510(k) Premarket Notification Summary. This type of submission often focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive new clinical studies to prove the device meets specific, novel acceptance criteria defined by the manufacturer. Therefore, "acceptance criteria" in this context refers more to the demonstration of meeting the established performance of the predicate device and relevant standards.

Acceptance Criteria and Study Overview for EchoPAC Software Only / EchoPAC Plug-in

Based on the provided 510(k) summary, the device EchoPAC Software Only / EchoPAC Plug-in did not undergo a clinical study to establish new acceptance criteria or prove device performance through a clinical trial. Instead, the submission relies on demonstrating substantial equivalence to predicate devices and adherence to relevant non-clinical standards and software development processes.

Therefore, the table below will reflect the comparative approach taken in a 510(k) summary. The "Reported Device Performance" for the new features is described in relation to existing functionalities or predicate devices.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied from Substantial Equivalence and Standards)	Reported Device Performance (as described in 510(k) for new features/changes)
Functional Equivalence: Device performs diagnostic review, analysis, patient record management, and reporting of ultrasound images.	The device maintains the same intended use for diagnostic review, analysis, patient record management, and reporting of ultrasound images.
Imaging Capabilities Equivalence: Supports current ultrasound imaging modes (B, M, Color M, Color, Power, Pulsed, CW Doppler, Coded Pulse, Harmonic, Real time 3D).	The device uses ultrasound images acquired via the same imaging modes as the predicate device.
Processing and Display Features Equivalence: Maintains similar processing and display features.	The device has the same processing and display features as the predicate device.
Clinical Applications Equivalence: Covers specified clinical applications (Fetal, Abdominal, Urology, etc.).	The device has the same indications and clinical applications as the predicate, with the addition of Musculo-skeletal Superficial (which was cleared with predicate K161706 – Vivid iq).
"Myocardial Work" Functionality: Builds on existing "2D-Strain" functionality.	The new "Myocardial Work" feature builds on the functionality of the existing "2D-Strain" functionality available with the predicate EchoPAC Software Only / EchoPAC Plug-in (K150085). (Implies it performs similarly or as an enhancement to the established 2D-Strain).
"4D Auto RVQ" and "4D Auto MVQ" Functionality: Alternative implementation of features offered by predicate K150122 (TomTec Arena TTA2).	The new features "4D Auto RVQ" and "4D Auto MVQ" are both alternative implementations of functionality offered with TomTec Arena (K150122) as available on the predicate EchoPAC Software Only / EchoPAC Plug-in (K150085). (Implies performing equivalent functions to a cleared predicate's features).
"Cardiac AutoDoppler" Functionality: Represents workflow improvements for existing functionality.	"Cardiac AutoDoppler" is a workflow improvement of functionality already available on the predicate EchoPAC Software Only / EchoPAC Plug-in (K150085). (Implies it delivers the same core functionality with enhanced efficiency).
"3rd party DICOM SR Read" Functionality: Builds on existing DICOM SR support.	"3rd party DICOM SR Read" builds on the capability of the existing DICOM SR support available with the predicate EchoPAC Software Only / EchoPAC Plug-in (K150085). (Implies enhancement or expansion of existing DICOM capabilities).
Compliance with Voluntary Standards: (IEC 62366, IEC 62304, NEMA PS 3.1-3.20, ISO 14971)	The device and its applications comply with these voluntary standards.
Quality Assurance Measures Adherence: Risk Analysis, Requirements Reviews, Design Reviews, Unit Testing, Integration Testing, Performance Testing, Safety Testing.	These quality assurance measures were and are applied to the development of the system. (Ensures software development process rigor, intending to produce a safe and effective product without adverse events or significant performance issues).
Safety and Effectiveness: As safe and effective as predicate devices.	GE Healthcare considers the EchoPAC Software Only / EchoPAC Plug-in to be as safe, as effective, and performance is substantially equivalent to the predicate devices. (This is the overarching conclusion of the 510(k) submission based on the comparisons and non-clinical tests).

Detailed Study Information (Based on the Provided Text):

Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated. The document indicates that no clinical studies were required to support substantial equivalence. The "tests" mentioned are primarily non-clinical software verification and validation activities (unit testing, integration testing, performance testing, safety testing). The size of the test sets for these software verification activities is not provided in this summary.
- Data Provenance: Not applicable for a clinical test set, as no clinical studies were performed. The "data" being tested in non-clinical scenarios would be simulated or internal developmental data.
Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not applicable. Since no clinical studies were conducted to generate a new test set requiring expert ground truth, this information is not provided. The performance comparison is against the established functionality of predicate devices.
Adjudication Method for the Test Set:
- Not applicable. No clinical test set requiring expert adjudication was described.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not performed or referenced. The document explicitly states: "The subject of this premarket submission, EchoPAC Software Only / EchoPAC Plug-in, did not require clinical studies to support substantial equivalence."
- Effect Size of Human Reader Improvement: Not applicable, as no MRMC study was conducted.
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Not applicable in the context of a separate "standalone" study for novel algorithm performance. The device itself is software that provides image processing, annotation, analysis, and measurement tools for diagnostic review by a physician. Its performance is inherent to its functionality and how it supports a human user in interpreting specific ultrasound findings. The performance of its new features (Myocardial Work, 4D Auto RVQ/MVQ, Cardiac AutoDoppler, 3rd party DICOM SR Read) is assessed through comparison to existing or predicate functionalities and non-clinical testing.
Type of Ground Truth Used:
- Not applicable for a clinical ground truth in the context of a new efficacy study. For the non-clinical software testing, the "ground truth" would be defined by explicit software requirements and expected outputs based on the predicate device's behavior or industry standards. The new features ("Myocardial Work", "4D Auto RVQ/MVQ") are described as building on or being alternative implementations of existing functionalities, implying their performance aligns with the established behavior of those predicate features.
Sample Size for the Training Set:
- Not applicable / Not provided. The document describes software that provides analysis, measurement, and reporting functions. It is not an AI/ML algorithm that typically requires a distinct "training set" in the sense of supervised learning from labeled clinical data. Its development would involve software engineering best practices and testing against defined specifications.
How Ground Truth for the Training Set Was Established:
- Not applicable. As indicated above, this device description does not align with a typical AI/ML device requiring a training set with established ground truth.

In summary, the 510(k) submission for the EchoPAC Software Only / EchoPAC Plug-in demonstrates substantial equivalence primarily through non-clinical testing, adherence to software development lifecycle standards, and direct comparisons of its features and intended use to legally marketed predicate devices. It does not involve new clinical studies to establish and meet novel performance criteria or to conduct head-to-head comparisons of human reader performance with and without AI assistance.

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