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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Cardiac, Fetal (incl Obstetrics), Intraoperative, Transurethral, Neurosurgery, Pediatrics, Transrectal, Small Parts (organ

Flex Focus 1202 supports the following scanning modes and combinations thereof: B-mode (incl.Tissue Harmonic Imaging), M-mode, PWD 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 module 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. An optional RF wireless function with the ability to wireless transmit for printing and archive connectivity purpose.

Here's a breakdown of the acceptance criteria and study information for the B-K Medical Ultrasound Scanner Flex Focus 1202 (K132335), based on the provided text.

Important Note: This 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device, rather than a de novo approval requiring extensive clinical validation of novel performance characteristics. The "device performance" in this context mainly refers to adherence to safety and performance standards already established for ultrasound systems, and the new features (RF wireless, Vector Flow Imaging) are discussed in terms of their safety and equivalence, not necessarily extensive clinical efficacy trials.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Acoustic Output, Thermal, Mechanical, Electrical Safety: No specific "test set" sample size in terms of patient data or image data is mentioned. The testing was likely performed on the device hardware itself following established engineering and safety standards. The provenance is internal testing and certification by a recognized body.
• RF Wireless Function: Tested at "five (5) different sites." This refers to locations, and implies device testing rather than patient data.
• Clinical Measurement Accuracy: No sample size or provenance is provided in this document; it states details are in "User Information."

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

This type of information is generally not required or provided for a 510(k) submission seeking equivalence for an existing ultrasound system with minor modifications. The "ground truth" for the performance characteristics discussed (acoustic output, safety, electrical performance) is based on engineering measurements against recognized standards, not expert clinical interpretation of images.

4. Adjudication Method for the Test Set

Not applicable. The reported tests are primarily engineering and safety evaluations against predefined standards, not diagnostic performance assessments requiring clinical adjudication.

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

No, an MRMC comparative effectiveness study was not done. This 510(k) is aimed at demonstrating substantial equivalence for an updated ultrasound system, not to prove improved clinical effectiveness with or without AI assistance for a specific diagnostic task. The description of the device as an "Ultrasound Scanner" further indicates it's a general imaging tool, not an AI-powered diagnostic aide.

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

No, a standalone algorithm performance study was not done. This device is an ultrasound scanner, which is operated by a human. There is no indication of a standalone algorithm component that performs a diagnostic task without human interaction.

7. The Type of Ground Truth Used

• Acoustic Output, Thermal, Mechanical, Electrical Safety: Ground truth is established by adherence to international and national device safety and performance standards (e.g., AIUM/NEMA UD-2, UD-3, IEC 60601 series, ISO 14971, IEC 62304, IEC 62359). This involves physical measurements and engineering validation.
• RF Wireless Function: Ground truth is implied to be actual user requirements and freedom from interference, measured through testing scenarios.
• Clinical Measurement Accuracy: Not explicitly stated, but for a diagnostic ultrasound, this would typically involve phantoms with known dimensions or comparisons to gold standard clinical measurements. The document refers to "User Information" for these details.

8. The Sample Size for the Training Set

Not applicable. This is not a submission for an AI/CADe device that requires a training set. The device is a traditional ultrasound system.

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

Not applicable, as there is no training set for this device type.

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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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