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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), 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 EPIQ and 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.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics for the device itself (e.g., accuracy, sensitivity, specificity for diagnostic tasks). Instead, it focuses on demonstrating compliance with recognized safety and performance standards for ultrasound devices, and equivalence to predicate devices. The "performance" described relates more to meeting these technical and regulatory standards.

However, based on the Safety Considerations and Nonclinical Performance Data sections, we can infer the following:

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

The document does not detail specific sample sizes for clinical test sets as it states that no clinical study was required. The non-clinical performance data appears to involve bench testing.

• Test Set Sample Size: Not applicable for clinical data. For non-clinical tests like ElastQ Imaging Measurement, X8-2t Transducer Verification, and Software Verification and Validation, the sample sizes are not specified but would typically refer to the number of tests performed on the physical hardware/software.
• Data Provenance: The data provenance is non-clinical performance and engineering testing conducted by Philips Ultrasound, Inc. The country of origin for this testing is not explicitly stated, but Philips Ultrasound, Inc. is located in Bothell, WA, USA. The data is prospective in the sense of being generated during the device development and validation process.

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

This information is not provided as the submission relies on non-clinical performance data and substantial equivalence to predicate devices, rather than a clinical study requiring expert ground truth for diagnostic accuracy.

4. Adjudication Method for the Test Set

This information is not provided, as no clinical study with human readers/interpreters needing adjudication was conducted or required.

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 mentioned or performed. The device, an ultrasound system, does not appear to incorporate AI for interpretation that would necessitate such a study in this submission. The new features (ElastQ Imaging and the X8-2t transducer) are extensions of existing ultrasound technology, not AI-driven diagnostic aids.

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

This is not applicable. The device is a diagnostic ultrasound system that requires a human operator and interpretation, not a standalone AI algorithm for diagnosis. The "ElastQ Imaging" is a quantitative measurement tool, not an autonomous diagnostic algorithm.

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

For the non-clinical tests, the "ground truth" would be established by:

• Acoustic Output: Reference measurements against standardized phantoms and measurement equipment.
• Safety Standards: Compliance with the specified IEC and ISO standards through documented testing procedures.
• ElastQ Imaging Measurement: Performance against known physical properties of test phantoms.
• Software V&V: Meeting predefined software requirements and specifications.
  This is a technical, engineering-based "ground truth" rather than a clinical one from expert consensus or pathology.

8. The Sample Size for the Training Set

Not applicable. This submission is for a diagnostic ultrasound system, not an AI/machine learning algorithm requiring a "training set."

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

Not applicable, as no training set for an algorithm was used.

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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), Transvaginal.

The clinical environments where the EPIQ 5, EPIQ 7, Affiniti 50 Diagnostic Ultrasound Systems can be used include Clinics, Hospitals, and clinical point-of-care for diagnosis of patients.

The proposed EPIO and Affiniti Diagnostic Ultrasound Systems, which includes EPIO 5. EPIQ 7, Affiniti 50 and Affiniti 70 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). 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. EPIO also has a QWERTY keyboard.

The removable transducers are connected to the system using a standard technology, multipin connectors. The proposed EPIQ and Affiniti systems use 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 industry-standard formats (e.g. 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 proposed EPIQ and Affiniti systems give the operator the ability to measure anatomical structures and offer analysis packages that provide information used by competent healthcare professionals to make a diagnosis. The proposed EPIQ and Affiniti systems enable image guided navigation and image fusion via the optional PercuNav feature (K121498).

The document describes the Philips EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems, and Affiniti 50 and Affiniti 70 Diagnostic Ultrasound Systems. It primarily details their indications for use and compares their technological characteristics to a previously cleared predicate device (Philips EPIQ Diagnostic Ultrasound System K132304).

Based on the provided text, a "study that proves the device meets the acceptance criteria" in terms of clinical performance or specific statistical metrics is not explicitly described. The document explicitly states: "Clinical data was not required to demonstrate safety and effectiveness of the proposed EPIQ and Affiniti Diagnostic Ultrasound Systems since the proposed EPIQ or Affiniti system introduces no new indications for use, modes or features that have not been previously cleared with the predicate device EPIQ system (K132304). The clinical safety and effectiveness of ultrasound systems with these characteristics are well accepted for both predicate and subject devices."

Therefore, the acceptance criteria are demonstrated through substantial equivalence to a predicate device, and compliance with recognized safety and performance standards, rather than a de novo clinical study for this specific submission.

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

1. Table of Acceptance Criteria (from Standards) and Reported Device Performance (Compliance Statement)

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

• Test Set Sample Size: Not applicable. No new clinical test set data from human subjects was used for this submission to demonstrate safety and effectiveness.
• Data Provenance: Not applicable for a new clinical test set. The submission relies on the established safety and effectiveness of the predicate device and compliance with recognized standards.

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

• Not applicable. As no new clinical study was required, there was no independent ground truth labeling process with experts described for a test set. The predicate device's clinical safety and effectiveness are considered "well accepted."

4. Adjudication Method for the Test Set:

• Not applicable. There was no new clinical test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, ... and its effect size:

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done as this submission states "Clinical data was not required". The device is considered substantially equivalent to a predicate.

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

• Not applicable in the context of device performance claims. The devices are general-purpose diagnostic ultrasound systems used by human operators. The document mentions "Integration of OLAB Heart Model software" and "PercuNav feature" as integrated software components, but their standalone performance is not detailed in this summary.

7. The Type of Ground Truth Used:

• Established Equivalence to Predicate Device: The primary "ground truth" or basis for acceptance is the substantial equivalence to the Philips EPIQ Diagnostic Ultrasound System (K132304), whose safety and effectiveness are considered "well accepted."
• Compliance with Recognized Standards: Compliance with various IEC and ISO standards for acoustic output, electrical safety, EMC, usability, and biological evaluation also serves as a "ground truth" for non-clinical performance aspects.

8. The Sample Size for the Training Set:

• Not applicable. This submission describes hardware and integrated software for an ultrasound system, not a machine learning algorithm requiring a separate training set. The software components mentioned (OLAB Heart Model, PercuNav) were previously cleared, implying their training and validation were addressed in prior submissions.

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

• Not applicable for this submission directly, as it does not detail the training of a new algorithm. For historical or integrated software components, the ground truth would have been established during their respective development and clearance processes, but this is not specified here.

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