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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Musculo-skeletal Conventional.

The AMB7 is compact, lightweight and completely self-contained (w12" x h10" x 120") portable multipurpose ultrasound scanning system as are the predicate devices. The device can be carried anywhere for diagnostic purposes. The unit may operate from either a power source of 110vac / 220vac or from its' internal battery. A fully charged battery is able to provide the unit with approximately 1.5 hours of continuous operation. The predicate devices do not provide a means for battery operation. The AMIB7 uses a multi-frequency probe technology to produce high quality images (256 grey scale). The operator can select the best frequency, depending on the probe in use, to optimize near field imaging resolution and far field imaging penetration. The operator can move the focal point deeper through the image to reach the complex focus zone, to provide a better image resolution. The system features several operating modes, as do the predicate devices, and offers the following exam capabilities: B-mode. It is designed to perform Abdominal, Cardiac, and peripheral vascular, Pediatric, Obstetrical/Gynecological, Musculo-skeletal and small parts. The AMIB7 also enables the user to print reports viewed on screen. The AMIB7 allows the user to set up a wide variety of default parameters for easy operation like the predicate devices mentioned above. A sophisticated package of measurements and calculations ( Distance, Area, Circumference, Volume, Heart Rate, Ejection Fraction) are available B and M modes. In obstetric measurements for example, one can use the system equations and pre-programmed comparison tables or can set-up the unit and apply his own tables. The operator of the AMB7 unit can adjust the deplayed echo The system master gain allows the operator to uniformly control the gain level for all parts of the displayed image. The system Time Gain Compensation (TGC) allows for level adjustment of the echo amplification in near and far field (upper and the lower part of the echographic image).

The provided text is a 510(k) summary for the AMIB7 Ultrasound Diagnostic System. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a specific study proving device performance against such criteria.

The document states that the AMIB7 ultrasound system "does not in any way raise new questions of safety or effectiveness, when used as labeled, in comparison to the predicate devices." It also mentions that the "AMIB7s are tested for compliance according to the Guide for Measuring and Reporting Acoustic Output of Diagnostic Ultrasound Medical Devices." This indicates compliance with a standard, but not a specific study with defined acceptance criteria and performance results directly linked to clinical outcomes or imaging quality metrics in the way a clinical trial or performance study would.

The FDA's response letter also primarily focuses on the determination of substantial equivalence and regulatory compliance, and requires a post-clearance special report for acoustic output measurements, but this is a condition of clearance, not a pre-market performance study outlined in the initial submission.

Therefore, for your request, the following information is not available in the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: Not applicable as a formal performance study against acceptance criteria is not described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is an ultrasound imaging device, not an AI algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document primarily focuses on establishing substantial equivalence to predicate devices (Hitachi EUB-405, Aloka SSD-500, Fukuda UE-4500) based on similar technological characteristics and intended use, rather than presenting a detailed performance study with acceptance criteria for a novel device.

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