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EPIQ:
The intended use of EPIQ Ultrasound Diagnostic 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), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), intra-luminal, intra-cardiac echo, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transvaginal, Lung.

The clinical environments where EPIQ Series 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 quidance 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. 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 your responsibility for sound clinical judgement and best clinical procedure.

Affiniti:
The intended use of Affiniti Series 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, Lung.

The clinical environments where the Affiniti diagnostic ultrasound systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.

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. 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 your responsibility for sound clinical judgement and best clinical procedure.

The purpose of this Traditional 510(k) Pre-Market Notification is to introduce the Smart Doppler View ID software feature onto the EPIQ and Affiniti Series Diagnostic Ultrasound Systems.

The purpose of the Smart Doppler View ID feature is to enhance the user's workflow through providing automation of the navigation of the touch screen groups on the Ultrasound System associated with Dopler Measurements. Without the Smart Doppler View ID feature, users must manually navigate to the desired Doppler Calculation Package Group on the Ultrasound System's various screens to perform a measurement. The Smart Doppler View ID feature automates this navigation and selects the associated calculation package group for the user based on the provided Doppler Spectrum acquired by the user using an artificial intelligence-based algorithm.

Smart Doppler View ID maps to six Doppler Calculations Package groups on the Ultrasound System screen:

• Aortic Valve
• Mitral Valve
• Tricuspid Valve
• Pulmonic Valve
• Venous Flow
• TDI Vel (Tissue Doppler Imaging Velocity) & Ratio

No hardware changes to the EPIQ or Affiniti systems are required when using the Smart Doppler View ID feature, and existing, commercialized Philips transducers are used for the Smart Doppler View ID feature.

The feature is supported by all EPIQ and Affiniti models running software version 11.0 or higher including EPIQ CVx/CVxi, EPIQ Elite Advanced, EPIQ 7, EPIQ 5, Affiniti CVx, Affiniti 70, Affiniti 50, and Affiniti 30. The Smart Doppler View ID feature is associated with the cardiac adult indication.

Here's a breakdown of the acceptance criteria and study details for the Smart Doppler View ID feature, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size (Test Set): 1100 TTE (transthoracic echo) cardiac clips
• Number of Subjects: 400 subjects
• Data Provenance: Retrospective, collected from a US-based hospital.

3. Number of Experts and Qualifications for Ground Truth Establishment

• Number of Experts: 16 cardiac sonographers, and board-certified cardiologists.
• Qualifications of Experts:
  • Cardiac Sonographers: Possessed a high level of expertise in acquiring Doppler TTE clips.
  • Board-Certified Cardiologists: Successfully passed the National Board of Echocardiography Examination and vetted and interpreted the studies.

4. Adjudication Method for the Test Set

The document does not explicitly describe a formal adjudication method (like 2+1 or 3+1). However, it states that the ground truth was "based on a group of measurements performed by intended users (i.e., Board certified cardiologists and cardiac sonographers) of the Ultrasound Systems as part of Standard of Care TTE exam per ASE guidelines at a large US-based hospital." This implies a consensus or expert-driven process for establishing the ground truth, but the specific mechanics of how disagreements were resolved are not detailed.

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

The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done to compare human readers with and without AI assistance. The study focuses solely on the standalone performance of the AI algorithm in automatically detecting touchscreens.

6. Standalone (Algorithm Only) Performance

Yes, a standalone (algorithm only) performance study was done. The study evaluated the accuracy with which the Smart Doppler View ID algorithm could automatically recommend the correct Doppler Calculation Package group. The reported accuracy of 97.5% (95% CI 96.3%, 98.3%) refers to this standalone performance.

7. Type of Ground Truth Used

The ground truth used was expert consensus based on the "Standard of Care obtained group of measurements (touch screens)" and "measurements performed by intended users (i.e., Board certified cardiologists and cardiac sonographers) of the Ultrasound Systems as part of Standard of Care TTE exam per ASE guidelines." This ground truth was mapped to the appropriate touchscreen groups.

8. Sample Size for the Training Set

The document explicitly states: "The 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.

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. It only mentions that the test set was distinct from the training set.

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The intended use of Philips EPIQ series 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. Intra-cardiac Echo. Intra-luminal, Intraoperative (Vascular). Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Transesophageal (Cardiac), Transrectal, Transvaginal, Lung,

The clinical environments where Philips 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. 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 your responsibility for sound clinical judgement and best clinical procedure.

The intended use of the Affiniti Series 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), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.

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

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. Systems are to be operated only by appropriately trained healtheare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgment and best clinical procedure.

Philips EPIQ and Affiniti Series Diagnostic Ultrasound Systems are durable, reusable capital equipment medical devices intended for high-resolution general imaging; interventional radiology, cardiology, vascular, obstetrics, and gynecology 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.

The purpose of this Traditional 510(k) Pre-Market Notification is to introduce the Auto Measure software-only feature for use on the Philips EPIQ and Affiniti Series Diagnostic Ultrasound Systems. The Philips Auto Measure feature provides the end user with semiautomated functionality for a subset of 2D and Doppler measurements currently available on the Philips EPIQ and Affiniti systems when performing or reviewing an adult transthoracic echocardiography (TTE) with simultaneously acquired electrocardiogram (ECG). The AI/MLenabled algorithm is designed to produce semi-automated and editable measures.

The provided text is a 510(k) summary for the Philips EPIQ and Affiniti Ultrasound Systems with the new "Auto Measure" feature. It focuses on demonstrating substantial equivalence to predicate devices. However, the document does not contain the detailed performance data, acceptance criteria, sample sizes, expert qualifications, or ground truth establishment methods typically found in a clinical study report or a more comprehensive validation study.

The "Performance Data" section in the K211597 summary only broadly states that non-clinical testing included a "Performance Validation Study" and that "Software Verification and Validation testing were used to support substantial equivalence." It also mentions "adherence to the aforementioned Philips internal processes."

Therefore, I cannot extract the specific information requested in your prompt based on the provided text. The document clearly omits the granular details of the validation study.

Here's what the document does tell us about the study, albeit at a high level:

• Study Type: A "Performance Validation Study" was conducted for the Auto Measure software, alongside Software Verification and Validation testing.
• Purpose: To demonstrate that the Auto Measure feature meets defined requirements and performance claims, and to support substantial equivalence to the currently marketed manual measuring options.
• What was tested: The "Auto Measure" software-only feature, which provides semi-automated functionality for a subset of 2D and Doppler measurements during adult transthoracic echocardiography (TTE) with simultaneously acquired ECG. The end user can edit, accept, or reject the measurements.

Without the actual performance validation study report or more detailed information, I cannot fill in the table or answer most of your specific questions.

If this information were available, here's how I would attempt to reconstruct it:

Hypothetical Acceptance Criteria and Device Performance (Based on common FDA expectations for such devices, NOT from the provided text)

Missing Information from the Provided Document:

1. A table of acceptance criteria and the reported device performance: NOT PROVIDED. The document only states that testing demonstrated the feature "meets the defined requirements and performance claims" but does not enumerate these.
2. Sample sizes used for the test set and the data provenance: NOT PROVIDED.
   • Test Set Sample Size: Unknown
   • Data Provenance: Unknown (country of origin, retrospective or prospective)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: NOT PROVIDED. The document refers to "manual measuring options" as a comparison, implying human expert measurements, but doesn't detail the ground truth process.
   • Number of Experts: Unknown
   • Qualifications: Unknown
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: NOT PROVIDED.
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 PROVIDED. The document discusses "semi-automated and editable measures" which implies human-in-the-loop, but doesn't describe an MRMC study or effect size. It only states the AI offers "semi-automated functionality" compared to "manual" on predicate devices.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The "Auto Measure" feature is described as providing "semi-automated and editable measures," suggesting human oversight is intended. A purely standalone performance might have been part of the internal validation, but it's not explicitly detailed as a primary regulatory performance endpoint in this summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Based on the comparison to "manual measuring options," the ground truth likely involved expert human measurements (manual measurements by sonographers/cardiologists). Whether this was a single expert, consensus, or other method is NOT SPECIFIED.
8. The sample size for the training set: NOT PROVIDED.
9. How the ground truth for the training set was established: NOT PROVIDED.

In conclusion, while the document confirms that performance validation was conducted and software V&V was performed in accordance with FDA guidance, it lacks all the granular details about the study design and results that your prompt requested. This level of detail is typically found in the full 510(k) submission and supporting technical reports, not usually in the summary made publicly available.

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