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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 s), Transvaginal, Peripheral vascular, Muskulo-skeletal (conventional and superficial).

Pro Focus 2202 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. An optional ECG signal can be superimposed the ultrasound information in all modes and mode combinations. 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 purpose.

The provided text pertains to a 510(k) summary for an Ultrasound Scanner Pro Focus 2202. This document details the device's technical specifications, compared to predicate devices, and an FDA clearance letter. It is a regulatory submission for a diagnostic ultrasound system, not a study evaluating an AI device's performance.

Therefore, most of the information requested in your prompt (acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not present in the provided text.

The text focuses on demonstrating substantial equivalence to previously cleared devices based on:

• Technical characteristics: Modes of operation, intended use, indications for use, and features (ECG, VFI, RF wireless).
• Safety standards compliance: Acoustic output, thermal, electrical, electromagnetic, and mechanical safety, and biocompatibility of patient contact materials.

The only "testing" mentioned that marginally relates to performance is:

"Additional testing of the RF wireless function was performed at five (5) different sites representing actual user requirements. Several test scenarios was performed and no interference was measured."

This statement is very high-level and does not provide quantified acceptance criteria or performance metrics as typically expected for proving a device meets specific criteria for accuracy, sensitivity, or specificity. It merely states that "no interference was measured," which implies a pass/fail outcome for the RF wireless function's basic operational integrity, but not diagnostic performance.

In summary, as per the provided document, I cannot fulfill your request for detailed acceptance criteria and a study proving device performance because the document does not contain this information for diagnostic performance. It is a regulatory submission for a traditional medical device, not an AI/ML-driven device with performance metrics based on clinical outcomes or expert labels.

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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, CWD, 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.

Clinical applications:
Ultrasound Scanner Pro Focus 2202:
Fetal, Obstetrics, Abdominal, Intraoperative, Neurosurgery, Small organ, Pediatric, Neonatal Cephalic, Adult Cephalic, Cardiac, Transrectal, Transvaginal, Transurethral. Peripheral Vascular, Musculoskeletal.
Ultrasound Transducer N13C5, Type 8862: Neonatal Cephalic.

2202 supports the following scanning modes and combinations thereof:
B-mode. M-mode. CWD-mode, PWD mode and CFM mode. Tissue harmonic imaging. Contrast harmonic imaging.
An optional ECG signal can be superimposed the ultrasound information in all modes and mode combinations.
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.
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 Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.

Here's a breakdown of the acceptance criteria and study information based on the provided text, using the requested format:

Acceptance Criteria and Device Performance

Study Information

The provided document describes a 510(k) Pre-market Notification for an Ultrasound Scanner (Pro Focus 2202) and a specific transducer (N13C5 Type 8862). This submission primarily focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than conducting new clinical studies to prove device performance against specific novel acceptance criteria.

Therefore, many of the requested study details (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies) are not applicable (N/A) because the core of this submission is a comparison to established devices and their existing performance and safety profiles.

Here's a breakdown of what can be gleaned:

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

   • N/A. The submission states: "This submission introduces no new indications for use, modes, features or technologies relative to the predicate devices that require clinical testing." This indicates that no new clinical test sets were generated or utilized to prove performance in the traditional sense of a clinical trial for a novel device. The "test set" in this context is implicitly the historical data and established clinical performance of the predicate devices.

2. 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. As no new explicit clinical test set was used for this submission, there was no need for a new "ground truth" establishment by experts specifically for this device's performance claims. The substantial equivalence relies on the established ground truth and clinical acceptance of the predicate devices.

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

   • N/A. No new clinical test set requiring adjudication was performed as part of this substantial equivalence submission.

4. 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. The device is a diagnostic ultrasound system. There is no mention of AI or machine learning components, nor any MRMC study.

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

   • No. This is a diagnostic ultrasound system with human-in-the-loop operation. No standalone algorithm performance is reported.

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

   • N/A. For this substantial equivalence submission, the "ground truth" for the device's acceptable performance and safety is implicitly tied to the established and accepted clinical performance, safety profiles, and regulatory clearances of the predicate devices. New ground truth for a novel claim was not established as part of this submission.

7. The sample size for the training set:

   • N/A. This is not an AI/ML device, so there is no training set in that context.

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

   • N/A. As above, not an AI/ML device.

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