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The Philips Lumify Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, Combined (B+Color), Pulsed Wave Doppler (PWD), and M-modes.

It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Fetal/Obstetric, Abdominal, Pediatric, Cephalic, Urology, Gynecological, Cardiac Fetal Echo, Small Organ, Musculoskeletal, Peripheral Vessel, Carotid, Cardiac, Lung,

The Lumify system is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.

The Philips Lumify Diagnostic Ultrasound System (Lumify) is a mobile, durable, and reusable, software-controlled medical device, which is intended to acquire high-resolution ultrasound data and to display the data in B (2D), Pulsed Wave Doppler, Color Doppler, Combined (B+ Color), and M modes.

The Lumify Diagnostic Ultrasound System (Android) utilizes:

• A commercial off-the-shelf (COTS) Android mobile device (smart phone or tablet)
• The Philips Ultrasound Lumify software running as an application on the COTS device
• The Philips C5-2 Curved array USB transducer
• The Philips L12-4 Linear array USB transducer
• The Philips S4-1 Sector array USB transducer
• Lumify Micro B Transducer Cable
• Lumify Micro C Transducer Cable

The Lumify system is compatible with iOS or Android operating systems. The Lumify system software provides various imaging features, including an Android-specific feature with artificial intelligence (AI) based, Auto EF Quantification (ejection fraction) technology during cardiac imaging.

Here's a breakdown of the acceptance criteria and the study details for the Philips Lumify Diagnostic Ultrasound System with Auto EF Quantification, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: 80 patients' Apical 4 Chamber (A4CH) view clips.
• Data Provenance: The data were acquired with the Lumify Diagnostic Ultrasound System, specifically for this clinical performance study. Patients were selected based on eligibility, and data were acquired consecutively for patients with normal and impaired LV function. This suggests a prospective acquisition for the purpose of the study. The document does not specify the country of origin for the data.

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

The ground truth was established by "manual tracing performed by sonographers."

• Number of Experts: The document refers to "sonographers" in the plural, but does not specify the exact number of sonographers involved in the manual tracing.
• Qualifications of Experts: The document implies that these were qualified "sonographers" experienced in echocardiographic LV function evaluation, but does not provide specific qualifications (e.g., years of experience, board certification). It can be inferred that they are healthcare professionals who routinely perform this task.

4. Adjudication Method for the Test Set

The ground truth for EF, EDV, and ESV was established by the "average results by manual tracing." This implies that IF multiple sonographers performed the manual tracings, their results were averaged. However, it does not explicitly state an adjudication method like 2+1 or 3+1 (where discrepancies are resolved by a third expert or consensus). It refers to "the average results by manual tracing," suggesting a quantitative aggregation rather than a specific adjudicative consensus process if multiple readers were used. If only one sonographer performed the tracing for each case, no adjudication would be necessary.

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being done to evaluate how much human readers improve with AI vs. without AI assistance. The study focuses on the agreement between the AI's automated measurements and a "manual tracing" ground truth, not on reader performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance

Yes, a standalone study was done. The clinical performance study directly compared the "automated EF evaluation by LVivo EF" (the algorithm's performance) against "Ejection Fraction (EF) evaluation by manual tracing performed by sonographers" (the ground truth). The results (correlation coefficients) reflect the algorithm's performance without a human-in-the-loop scenario. The LVivo EF automatically processed 95% of the clips, indicating its standalone capability.

7. Type of Ground Truth Used

The ground truth used was expert consensus/manual tracing. Specifically, it was defined as "Ejection Fraction (EF) evaluation by manual tracing performed by sonographers" and "the average results by manual tracing" for EF, EDV, and ESV. This is considered an expert-derived ground truth based on conventional, established methods for echocardiographic LV function evaluation.

8. Sample Size for the Training Set

The document explicitly states: "The data used for clinical performance study were completely distinct from that used during training of the algorithm, and there was no overlap between the two data sets." However, it does not provide the sample size for the training set used to develop the LVivo EF algorithm.

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

The document states that the clinical performance study data were "completely distinct from that used during training of the algorithm," but it does not describe how the ground truth for the training set was established. It implies that such a training process occurred ("training of the algorithm"), but details on its ground truth are not provided in this summary.

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The S90 Exp Series Digital Color Doppler Ultrasound System (S90 Exp, S80 Exp, S80 Exp, S80 Plus, S80 Elite, S80 Senior, S80 Super, S70i, S100 Exp, P90i, P80, P80 Exp, P80 Plus, P80 Elite, P80 Senior, P80 Super, P70i, I80-Endo, I80-Surg, 175-Endo, 170-Endo) is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician or sonographer with sufficient clinical ultrasound training for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic. The system is applicable for people who need clinical ultrasound examination.

The system is intended for use in the following clinical applications: Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esophageal (Cardiac), Laparoscopic, OB/Gyn and Urology.

Modes of operation include: B, M, PW Doppler, CW Doppler, Color M Doppler, Power Doppler, Power Doppler, Directional Power Doppler, Tissue Harmonic Imaging, Tissue Doppler Imaging, 3D/4D Imaging mode, Strain Elastography, Shear Wave Elastography, Contrast and Combined modes: B/M, B/PWD, B/THI, M/Color M, B/Color Doppler, B/Color Doppler/PWD, B/Power Doppler/PWD.

This SonoScape S90 Exp Series Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.

The basic principle is that system transmits ultrasonic energy into patient body and implements post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body.

This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array.

This system consists of a mobile console with touch screen and keyboard control panel, power supply module, color LCD monitor and optional probes.

This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler, Power Doppler and Directional Power Doppler Imaging, or the combination of these modes, Contrast Imaging, Strain Elastography, Shear Wave Elastography (S-SWE, P-SWE), SonoFusion, 3D/4D.

The provided text describes the Sonoscape Medical Corp.'s S90 Exp Series Digital Color Doppler Ultrasound System and its substantial equivalence to predicate devices, but does not contain information about specific acceptance criteria related to a performance study for the device's clinical or algorithmic performance, nor does it detail a study that proves the device meets such criteria.

The document primarily focuses on:

• Indications for Use: What the device is intended for (various clinical applications and modes of operation).
• Comparison to Predicate Devices: Explaining how the S90 Exp Series is similar to previously cleared devices in terms of intended use, regulations, safety standards, acoustic output, probes, biopsy brackets, and technical characteristics.
• Non-Clinical Tests: Listing compliance with electrical safety, EMC, acoustic, and software verification standards.

Therefore, I cannot provide the requested information. The text explicitly states:

"No clinical testing was required."

This indicates that, for the purpose of this 510(k) submission, a clinical study demonstrating the device's performance against specific clinical acceptance criteria was not performed or submitted. The substantial equivalence argument is based on the device's similarity to predicate devices and compliance with non-clinical technical standards.

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syngo Dynamics is a multimodality, vendor agnostic Cardiology image and information system intended for medical image management and processing that provides capabilities relating to the review and digital processing of medical images.

syngo Dynamics supports clinicians by providing post image processing functions for image manipulation, and/or quantification that are intended for use in the interpretation and analysis of medical images for disease detection, diagnosis, and/or patient management within the healthcare institution's network.

syngo Dynamics is not intended to be used for display or diagnosis of digital mammography images in the U.S.

syngo Dynamics is a software only medical device which is used with common IT hardware. Recommended configurations are defined for the hardware required to run the device, and hardware is not considered as part of the medical device.

syngo Dynamics is intended to be used by trained healthcare professionals in a professional healthcare facility to review, edit, and manipulate image data, as well as to generate quantitative data, qualitative data, and diagnostic reports.

syngo Dynamics is a digital image display and reporting system with flexible deployment - it can function as a standalone medical device that includes a DICOM Server or as an integrated module within an Electronic Health Record (EHR) System with a DICOM Archive that receives images from digital image acquisition devices such as ultrasound and x-ray angiography machines. There are three deployments: Standalone, EHR/EHS Integrated, and Multi-Modality Cardiovascular (MMCV). MMCV deployment functions as a standalone medical device with capability of natively support 2D and 3D CT and MR image types.

The use of syngo Dynamics is focused on cardiac ultrasound (echocardiography), angiography (x-ray), cardiac nuclear medicine (NM), CT and MR studies that cover both adult and pediatric medicine. Also supported is vascular ultrasound in Obstetrics/Gynecology and Maternal Fetal Medicine (fetal echocardiography during pregnancy).

syngo Dynamics is based on a client-server architecture. The syngo Dynamics server processes the data from the connected imaging modalities, and stores data and images to a DICOM server and routes them for permanent storage, printing, and review. The client provides the user interface for interactive image viewing, reporting, and processing; and can be installed on network connected workstations. syngo Dynamics provides various semi-automated anatomical visualization tools.

syngo Dynamics offers multiple access strategies: A Workplace that provides full functionality for reading and reporting; A Remote Workplace that provides additionally compressed images with access to full fidelity images for reading and reporting; and a browser based WebViewer that provides access to additionally compressed images and reports from compatible devices (including mobile devices).

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Device: syngo Dynamics (Version VA40F) - Specifically, the Auto EF algorithm.

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LVivo platform is intended for non-invasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters of structures and function of patients with suspected disease and Age >18.

The LVivo Seamless is a standalone application that extends the LVivo Platform and runs offline on a server in a healthcare environment. The system accepts echo examinations in DICOM format that are sent from an Ultrasound device and automatically selects the adequate clips for EF and GLS evaluation. After the clip selection, the LVivo Seamless activates the FDA cleared LVivo EF and LVivo Strain modules which perform automatic evaluation. The results are sent to the PACS and are evaluated by a healthcare professional.

Here's a breakdown of the acceptance criteria and study details for the LVivo Seamless v2.0 device, based on the provided document:

1. Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: 100 patient examinations.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. It mentions "measurements done routinely in the Echo lab by AFI," which suggests retrospective use of existing clinical data.

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

The document does not explicitly state the number of experts used to establish the ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience").
It states that "The measurements by LVivo Strain running offline on the automatically selected clips were compared to the measurements done routinely in the Echo lab by AFI." This implies that the ground truth was established by the "AFI" system (Automated Functional Imaging, GE), which is a commercially available and presumably validated automated measurement tool, as part of routine clinical practice. Since these were routine measurements, they would have been interpreted and validated by qualified medical professionals (e.g., sonographers, cardiologists) in the echo lab. However, the exact process of how the AFI measurements were considered "ground truth" (i.e., whether they were subject to expert review for this study) is not detailed.

4. Adjudication Method for the Test Set

The document does not mention a specific adjudication method (e.g., 2+1, 3+1). The comparison was made between the device's measurements and measurements performed by the AFI system as part of routine lab procedures.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The study described compares the algorithm's performance against an existing automated system (AFI) for GLS measurements and view identification. It does not evaluate the improvement of human readers with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone study was done. The performance evaluation compares the LVivo Seamless v2.0 device's automated capabilities (view recognition and GLS measurement) directly against another automated system (AFI) and against predefined acceptance criteria for view identification. There is no mention of human readers interacting with the device for the purpose of this performance evaluation. The device "runs offline on a server" and "automatically selects the adequate clips for EF and GLS evaluation."

7. The Type of Ground Truth Used

The ground truth for the GLS measurements was established by comparing the LVivo Seamless results to "measurements done routinely in the Echo lab by AFI" (Automated Functional Imaging, GE). For the view identification, the ground truth is implicitly based on the actual presence of 4CH, 2CH, and 3CH views in the patient examinations, likely determined by human assessment during the initial acquisition and processing of the images in the echo lab.

8. The Sample Size for the Training Set

The document does not provide the sample size used for the training set. It focuses solely on the performance evaluation using the test set.

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

The document does not provide information on how the ground truth for the training set was established, as the details of the training process are not included in this summary.

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