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The device is intended for use by a qualified physician for ultrasound evaluation of Gyneological, Fetal, Peripheral Vascular, Cardiac, Neonatal Cephalic, Small Parts, Intra-operative, Transrectal and Abdominal applications. The device is not indicated for Ophthalmic applications.

The Aloka Prosound 2 Diagnostic Ultrasound System is a light weight, full-digital portable imaging and analysis system. It consist of a high resolution LCD flat panel monitor that provides excellent image quality and processing. The user interface includes a computer type keyboard. specialized controls and a display.

The provided 510(k) summary for the Aloka Prosound 2 Diagnostic Ultrasound System states "Clinical Tests: None Required." Therefore, there is no study presented in this document that proves the device meets specific acceptance criteria based on clinical performance.

The submission focuses on demonstrating substantial equivalence to a predicate device (Aloka SSD-500, K900805) and other cleared Aloka systems. Substantial equivalence relies on comparing the technological characteristics, safety, effectiveness features, and intended uses of the new device to a legally marketed predicate. In this context, the "acceptance criteria" are implicitly met by demonstrating that the new device is as safe and effective as the predicate.

Here's a breakdown of the information requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance

Since no clinical studies were performed to establish performance against specific acceptance criteria, this table cannot be directly populated from the provided information. Instead, the acceptance criteria are implicitly that the device is substantially equivalent to the predicate device in terms of safety and effectiveness, and that it conforms to applicable medical device safety standards.

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, as no clinical tests or test sets were used for performance evaluation as part of this 510(k) submission.

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)

Not applicable, as no clinical tests or ground truth establishment by experts were described in this 510(k) summary.

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

Not applicable, as no clinical tests or adjudication methods were described in this 510(k) summary.

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 applicable, as this is an ultrasound imaging device, not an AI-assisted diagnostic tool, and no MRMC study was conducted or 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 algorithm that performs standalone analysis.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable, as no clinical tests requiring ground truth were conducted for this 510(k) submission. The "ground truth" for substantial equivalence is the safety and effectiveness of the legally marketed predicate device.

8. The sample size for the training set

Not applicable, as there is no mention of a training set for an algorithm. The device's design and development conform to quality systems rather than a data-driven training process for an AI.

9. How the ground truth for the training set was established

Not applicable, as there is no mention of a training set or its ground truth.

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