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The intended use of the Affiniti 30, Affiniti 70 Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Transesophageal (Cardiac), Transrectal, Transvaginal.

The clinical environments where the Affiniti Diagnostic Ultrasound Systems can be used include Clinics, and clinical point-of-care for diagnosis of patients.

When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live Echo Guidance. The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information, and only for the purposes for which it was designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgment and best clinical procedure.

Philips CX50 Diagnostic Ultrasound Systems is intended for diagnostic ultrasound imaging in B (or 2- D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Doppler Imaging and Harmonics (Tissue and Contrast) modes.

It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Ophthalmic Intraoperative Laparoscopic Fetal Abdominal Pediatric Small Organ Adult Cephalic Neonatal Cephalic Trans-vaginal Musculo-skeletal Gynecological Cardiac Pediatric Trans-Esoph. (Cardiac) Intracardiac echo Peripheral Vessel Other (Carotid)

The intended use of the EPIQ, EPIQ 7 is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use: Abdominal, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal.

The clinical environments where the EPIQ Diagnostic Ultrasound Systems can be used include Clinics, Hospitals, and clinical point-of-care for diagnosis of patients.

When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live Echo Guidance. The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information, and only for the purposes for which it was designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgment and best clinical procedure.

Philips Lumify Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, Combined (B+Color), 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. Lumify is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.

QLAB Advanced Quantification Software is a software application package. It is designed to view and quantify image data acquired on Philips ultrasound systems.

Philips Sparq Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (or 2- D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Doppler Imaging and Harmonics (Tissue and Contrast) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Ophthalmic Fetal Abdominal Pediatric Small Organ Adult Cephalic Trans-vaginal Trans-rectal Musculo-skeletal Gynecological Cardiac Adult Trans-Esoph. (Cardiac) Peripheral Vessel.

Philip Diagnostic Ultrasound Systems are durable, reusable capital equipment medical devices which are intended for high-resolution general imaging, interventional radiology, cardiology, vascular and OB/GYN applications and fluid flow analysis. They are intended to be used by trained professionals at various settings of patient care such as clinical admission, periodic evaluations, prior to hospitalization discharge, and/or academic research, via maneuverable caster wheels or mobile handheld components.

Philips QLAB Advanced Quantification software (QLAB) is designed to view and quantify image data acquired on Philips ultrasound systems. QLAB is available either as a stand-alone product that can function on a standard PC, a dedicated workstation, and on-board Philips' Diagnostic Ultrasound Systems.

Software modes/applications, scanning protocols, and pre-installed settings or functionality to create dedicated settings for imaging of specific anatomy are available with the subject Philips Diagnostic Ultrasound Systems and QLAB software and may vary among model configurations.

The diagnostic ultrasound systems are manufactured with hardware components which consist of:

• a primary console (e.g., workstation, tablet) with built-in software components, features, and 1) various clinical applications, and
• 2. a range of compatible ultrasound transducers.

A suite of compatible transducer types are offered such as transesophageal echocardiography (TEE) transducers, non-imaging (pencil) probes, curved array, linear array and sector/ohased array transducer models which have a prefix "C" are designed to provide larger fields of view and penetration for e.g., consolidation between bone spaces while linear array transducer models, which can be identified with a "L" prefix model name are designed to provide shallow visualization which are optimal for tissue layer interfaces. Sector/phased array transducer models which usually have a "S" prefix model names are designed to be applied for difficult anatomical sites (e.g., cardiac intercostal space (ICS)). Other Philips ultrasound transducers may also start with the prefix "X" which is referring to the xMatrix technology for two full-resolution planes of imaging. Volumetric three-dimensional (3D) imaging functionality is also available when specific transducer models are connected to the primary console. Philips ultrasound transducers may be bagged into compatible transducer/probe cover sheaths, designed by other manufacturers, for each procedure to prevent cross-contamination and reduce the risk of healthcareassociated infections.

Some configurations may have additional previously-cleared accessories, components and software features which are manufactured by Philips Ultrasound, Inc. or other manufacturers.

This document is a 510(k) Premarket Notification from Philips Ultrasound, Inc. to the FDA regarding several of their diagnostic ultrasound systems and software. The primary purpose of this submission is not to present performance data for a new device that meets acceptance criteria, but rather to assert substantial equivalence to previously cleared predicate devices for expanded labeling related to COVID-19.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, including sample sizes, ground truth establishment, expert qualifications, and comparative effectiveness studies, does not apply in the traditional sense for a new device submission with novel performance claims.

Instead, the submission states:

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

• There is no specific table of acceptance criteria or reported device performance for novel features in this submission.
• The document focuses on establishing technological characteristic equivalence between the subject devices and their respective predicate devices.
• Table 1, Table 2, Table 3, Table 4, Table 5, and Table 6 (spanning pages 13-25) provide a technological comparison for each subject device (Philips Lumify, EPIQ, Affiniti, CX50, Sparq, and QLAB software) against its predicate device. For all listed "Standard Features" (Indications for Use, Reusable?, Duration of Use, Scientific Technology, Operating principles, Type of Previously-cleared Transducers, Acoustic Outputs Within Range?, Previously cleared Imaging Modes?, Biocompatibility), the comparison consistently states "Identical." This indicates that no new performance metrics or acceptance criteria beyond those already established for the predicate devices are being introduced for new functionalities.

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

• Not applicable. The submission does not describe a new performance study requiring a test set. It relies on the equivalence of the subject devices to their predicate devices, which would have undergone performance testing for their initial clearances.

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. No new ground truth establishment is described in this submission.

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

• Not applicable. No new performance study or test set requiring adjudication is 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:

• Not applicable. No MRMC study is mentioned. The submission is for existing ultrasound systems and software with expanded labeling, not for AI-assisted diagnostic tools requiring such studies for comparative effectiveness.

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

• Not applicable. While QLAB is software, the submission primarily focuses on maintaining substantial equivalence in its current functionality and expanding labeling. No new standalone algorithm performance is detailed.

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

• Not applicable. No new ground truth is described. The established safety and effectiveness of the predicate devices implicitly relied on various forms of ground truth relevant to diagnostic ultrasound at the time of their clearance.

8. The sample size for the training set:

• Not applicable. This submission does not involve a new machine learning algorithm or a training set.

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

• Not applicable. This submission does not involve a new machine learning algorithm or a training set.

Summary of the Submission's Approach:

The core of this 510(k) submission is to assert that the subject devices (various Philips Diagnostic Ultrasound Systems and QLAB software) are substantially equivalent to their respective predicate devices. The significant change being addressed is the "Expanded Labeling" to include information about lung and cardiac ultrasound imaging for COVID-19 patients, based on established methods or the latest society guidelines. The submission explicitly states:

• "Relevant performance data does not apply to this submission." (Page 26)
• "There are no changes in software, hardware, and intended uses of the subject devices comparing to the predicates." (Page 26)
• "The results of the design controls activity support a determination that the subject devices do not raise new questions of safety or effectiveness and are substantially equivalent to the predicate devices." (Page 26)

Therefore, the "study" proving the device meets "acceptance criteria" is essentially the argument of identical technological characteristics and unchanged intended uses compared to the already cleared predicate devices, with the new labeling information being based on general clinical practice and guidelines rather than new device-specific performance data.

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The intended use of the EPIQ Diagnostic Ultrasound System is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use:

Abdominal, Cardiac Adult, Cardiac other (Fetal Echo), Cardiac Pediatric, Cerebral Vascular, Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal.

The clinical environments where the Philips EPIO Diagnostic Ultrasound Systems and Philips Affiniti Diagnostic Ultrasound Systems can be used include Clinics, Hospitals, and clinical point-of-care for diagnosis of patients.

When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live Echo Guidance.

The systems are intended to be installed and used only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces user responsibility for sound clinical judgement and best clinical procedure.

The proposed Philips EPIQ Series Diagnostic Ultrasound Systems are general purpose, software controlled, diagnostic ultrasound systems. Their function is to acquire ultrasound data and to display the data in various modes of operation. The devices consist of two parts: the system console and the transducers. The system console contains the user interface, a display, system electronics and optional peripherals (ECG, printers).

Transducers are connected to the system using a plug in electrical connection. Other than the introductions of the new mC12-3 Transducer, the device description, accessories and components are unchanged.

The provided text is a 510(k) summary for the Philips EPIQ Series Diagnostic Ultrasound System and mainly focuses on demonstrating substantial equivalence to a predicate device. It contains very limited information regarding acceptance criteria and performance studies in the way typically expected for an AI/ML medical device.

Specifically, the document does not describe:

• A table of acceptance criteria for algorithm performance and reported device performance.
• Sample sizes used for a test set or its provenance.
• The number or qualifications of experts used for ground truth establishment.
• Adjudication methods for a test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or the effect size of AI assistance for human readers.
• Whether a standalone (algorithm only) performance study was done.
• The type of ground truth used (e.g., pathology, outcomes data).
• The sample size for a training set or how its ground truth was established.

The document states:

• "Non-Clinical verification testing has been performed addressing system level requirements according to system and design specifications, and risk control measures." (Page 6)
• "The proposed Philips EPIQ Series Diagnostic Ultrasound System did not require clinical data for determination of substantial equivalence." (Page 6)
• "For testing, all pre-determined acceptance criteria were met. Results of these tests show that the proposed Philips EPIQ Series Diagnostic Ultrasound Systems with the new mC12-3 transducer meet their intended use." (Page 7)

This suggests that the "testing" mentioned refers primarily to non-clinical performance data related to the safety and fundamental operation of the ultrasound system and its new transducer (mC12-3), rather than the performance of an AI/ML algorithm that predicts or classifies outcomes. The acceptance criteria met were likely related to electrical safety, electromagnetic compatibility, acoustic output, and biocompatibility, as listed under "Nonclinical Performance Data" on page 6.

Therefore, based solely on the provided text, it is not possible to answer the detailed questions about acceptance criteria and study design for an AI/ML component, as the submission appears to be for a traditional ultrasound system and transducer, not an AI/ML-driven diagnostic device.

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The intended use of the EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 70 Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal.

The proposed Philips EPIQ Diagnostic Ultrasound Systems and Philips Affiniti Diagnostic Ultrasound Systems are general purpose, software controlled, diagnostic ultrasound systems. Their function is to acquire ultrasound data and to display the data in various modes of operation. The devices consist of two parts: the system console and the transducers. The system console contains the user interface, a display, system electronics and optional peripherals (ECG, printers).

The removable transducers are connected to the system using a standard technology, multi-pin connectors. Other than the introductions of the two new transducers, the device description, accessories and components are unchanged, reference table 1.

Here's the breakdown of the acceptance criteria and supporting studies for the Philips EPIQ and Affiniti Diagnostic Ultrasound Systems based on the provided text:

Important Note: The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for the device's original clearance. Therefore, information regarding specific clinical performance metrics (like sensitivity, specificity, accuracy) from a de novo study is not present. Instead, the document emphasizes compliance with standards and equivalence to a previously cleared device.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the device meeting safety and performance standards rather than specific clinical performance metrics like sensitivity/specificity for a novel algorithm.

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

The document does not explicitly state a "test set" in the context of clinical performance data for a novel algorithm being evaluated against a ground truth. The testing mentioned is primarily non-clinical, focusing on compliance with safety and performance standards, and demonstrating substantial equivalence to a predicate device. Therefore, a sample size for a separate test set of patient data is not provided. The data provenance is also not applicable in this context as no clinical study for a new performance claim was conducted.

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

This information is not provided as the submission is for substantial equivalence and mainly relies on non-clinical testing and comparison to predicate devices, rather than a de novo clinical study with expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not provided as no clinical study with a test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

An MRMC comparative effectiveness study is not mentioned in this 510(k) summary. The submission focuses on the safety and effectiveness of the ultrasound system and its transducers, not on an AI-assisted diagnostic workflow affecting human reader performance.

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

The document describes an ultrasound system and transducers, not a standalone algorithm. Therefore, "standalone" performance in the context of an algorithm is not applicable or discussed.

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

For the non-clinical performance data, the "ground truth" implicitly refers to the specified values and requirements within the cited technical standards (e.g., acoustic output limits, electrical safety standards). No clinical ground truth (like pathology or outcomes data) is referenced for performance evaluation.

8. The Sample Size for the Training Set

This information is not applicable as the submission describes an ultrasound system, not an AI/algorithm that would require a training set.

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

This information is not applicable, as there is no training set for an AI/algorithm mentioned in this submission.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetabl/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal. The clinical environments where the EPIQ Diagnostic Ultrasound System can be used include Clinics, Hospitals, and clinical point-of-care for diagnosis of patients.

The EPIQ Diagnostic Ultrasound System is a general purpose, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation. The device consists of two parts: the system console and the transducers. The system console contains the user interface, a display, system electronics and optional peripherals (ECG, printers). In addition to the physical knobs and buttons of the main control panel, the user interface consists of a touch screen with soft key controls, and a QWERTY keyboard. The removable transducers are connected to the system using a standard technology, multi-pin connectors. The EPIQ system uses standard transducer technology, and supports phased, linear, curved linear array, TEE, motorized 3D curved linear arrays as well as non-imaging (pencil) probes. Clinical data storage consists of a local repository as well as off-line image storage via the network, DVR, DVD, and USB storage devices. The images are stored in industrystandard formats (Ex: JPEG, AVI, DICOM) and are intended to be readable using industry-standard hardware and software. On-line review of the images is available. Secure access tools are provided to restrict and log access to the clinical data repository according to HIPAA. The system circuitry generates an electronic voltage pulse, which is transmitted to the transducer. In the transducer, a piezo electric array converts the electronic pulse into an ultrasonic pressure wave. When coupled to the body, the pressure wave transmits through body tissues. The Doppler functions of the system process the Doppler shift frequencies from the echoes of moving targets such as blood to detect and graphically display the Doppler shifts of these tissues as flow. The EPIQ system gives the operator the ability to measure anatomical structures and offers analysis packages that provide information used by competent healthcare professionals to make a diagnosis. The EPIQ system enables image guided navigation and image fusion via the optional PercuNav feature.

The Philips EPIQ Diagnostic Ultrasound System, K132304, is a general-purpose, software-controlled diagnostic ultrasound system. It is designed to acquire ultrasound data and display it in various modes for diagnostic purposes across a wide range of clinical applications. Its acceptance for marketing was primarily based on substantial equivalence to predicate devices, rather than new clinical trials demonstrating de novo safety and effectiveness.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the EPIQ Diagnostic Ultrasound System are not presented as a direct performance table with numerical targets. Instead, acceptance is based on demonstrating substantial equivalence to previously cleared devices (Philips iU22 Diagnostic Ultrasound System, K130499, K121498, K093563, K042540, K030455) and compliance with relevant safety standards.

The reported device performance, in terms of meeting acceptance criteria for substantial equivalence, is articulated as follows:

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

The document explicitly states: "A clinical trial was not required to demonstrate safety and effectiveness of the EPIQ Diagnostic Ultrasound System." This means there was no specific "test set" of patient data in the context of a clinical study to evaluate the device's diagnostic performance against a ground truth. The device's acceptance was based on non-clinical performance data and its substantial equivalence to previously cleared devices.

Therefore, there is no sample size for a test set of patient data as part of this 510(k) submission, and consequently, no data provenance regarding country of origin or retrospective/prospective nature of such a clinical test set.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Since no clinical trial or test set with patient data was utilized for performance evaluation against a ground truth, there were no experts used to establish ground truth for a test set. The evaluation focused on engineering and regulatory compliance, and comparison to the predicate device's established performance.

4. Adjudication Method for the Test Set

As there was no clinical test set for performance evaluation, there was no adjudication method applied.

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

No, an MRMC comparative effectiveness study was not done. The submission relies on substantial equivalence to demonstrate safety and effectiveness, rather than a direct comparison of human readers with and without AI assistance. The device is purely a diagnostic imaging system, not an AI-assisted diagnostic tool in the sense of improving human reader performance.

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

The device is a diagnostic ultrasound system. Its "performance" is inherent in its ability to acquire and display ultrasound data accurately according to its specifications and the standards it complies with. It is not an "algorithm only" device that provides interpretations or diagnoses. Its performance is fundamentally linked to human operation and interpretation. Therefore, the concept of "standalone performance" as it might apply to an AI algorithm providing diagnostic outputs (e.g., sensitivity/specificity) is not relevant or applicable here. The non-clinical performance data (e.g., phantom imaging, acoustic output measurements) would be a form of standalone testing of the system's technical capabilities.

7. The Type of Ground Truth Used

For non-clinical performance data validation, the "ground truth" would be established by technical standards and physical measurements (e.g., phantom studies for image quality, calibrated sensors for acoustic output, engineering specifications for software and hardware functionality). There was no "expert consensus, pathology, or outcomes data" ground truth used for determining the device's diagnostic accuracy in a clinical context within this submission, as a clinical trial was not performed.

8. The Sample Size for the Training Set

The document does not describe the development of a specific "training set" in the context of machine learning or AI models. The EPIQ Diagnostic Ultrasound System is presented as an evolution of existing ultrasound technology (Track 3 system and identical fundamental scientific technology to the predicate device). Therefore, there is no stated sample size for a training set as this is not a submission for an AI/ML-driven device that requires such training data to establish its core functionality.

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

Since no training set for an AI/ML model is mentioned or appears to be relevant to this submission, the question of how its ground truth was established is not applicable. The ground truth for validating the system's performance would relate to engineering and regulatory standards, and established metrics for ultrasound image quality and safety.

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