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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:
Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, Color Doppler, Vector Flow Imaging and combined mode imaging.
Signal analysis and display.
Guidance of biopsy needles, geometrical measurements and calculation of parameters.
Non monitoring ECG for superimposing the ultrasound information.
An optional 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.
An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.

Flex Focus 1202 supports the following scanning modes and combinations thereof: B-mode (incl. Tissue Harmonic Imaging), M-mode. CFM mode. Amplitude (Power) Doppler mode
The system can perform simple geometric measurements, and perform calculations in the areas of Vascular, Urology, Cardiology and OB/GYN applications.
The system can guide biopsy- and puncture needles.
An optional 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.
An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.
Transducers are linear arrays, convex arrays, phased arrays and mechanical sector.

The provided 510(k) summary for the B-K Medical Ultrasound Scanner Flex Focus 1202 focuses primarily on demonstrating substantial equivalence to predicate devices, rather than detailing a specific study to prove device performance against acceptance criteria. The document explicitly states:

"This submission introduces no new indications for use, modes, features or technologies relative to the predicate devices that require clinical testing. The clinical safety and effectiveness of ultrasound system with these characteristics are well accepted for both predicate and subject devices."

Therefore, it does not contain the information required to answer most of the questions about acceptance criteria and a specific study proving device performance. The submission relies on the established safety and effectiveness of the predicate devices and the fact that its technological characteristics are comparable.

However, based on the document, we can extract some information:

1. A table of acceptance criteria and the reported device performance
   The document doesn't provide a specific table of acceptance criteria with corresponding performance results from a dedicated study. Instead, it highlights that the device's technical specifications and intended use are comparable to legally marketed predicate devices.

   Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (Implied by Comparability)
   Compliance with medical device regulations	Device is considered substantially equivalent
   Acoustic output limits	Ispta ≤ 720 mW/cm² and MI ≤ 1.9 (Track 3, non ophthalmic); TI ≤ 6.0
   Biocompatibility of patient contact materials	Complies with ISO10993-1
   Thermal, mechanical, and electrical safety	Tested according to IEC 60601-1
   Clinical measurement accuracy	Described and accuracies provided in User Guide
   Intended use and indications for clinical applications	Comparable to predicate devices, including new "Neonatal Cephalic" application considered the same as predicates for that application.

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 (N/A). The submission explicitly states that "no new indications for use, modes, features or technologies" required clinical testing. Therefore, there is no specific test set of cases or related data provenance information provided.

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)
   N/A. No specific test set requiring expert ground truth establishment was conducted.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
   N/A. No specific test set requiring adjudication was conducted.

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
   N/A. This device is a diagnostic ultrasound system and does not involve AI assistance for human readers in the context of an MRMC study. The submission focuses on the system's inherent diagnostic capabilities as comparable to predicate devices.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
   N/A. This is a diagnostic ultrasound system, not an algorithm being validated in a standalone manner. Its performance is intrinsically linked to human operation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
   N/A. No new clinical studies were performed that would require establishing a "ground truth" for novel features or diagnostic claims. The ground truth for ultrasound systems is implicitly established through long-standing clinical practice and the validation of predicate devices.

8. The sample size for the training set
   N/A. As this submission describes a diagnostic ultrasound system and not an AI/ML algorithm, there is no concept of a "training set" for the device's core functionality.

9. How the ground truth for the training set was established
   N/A. See explanation for point 8.

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