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Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
N = new indication.
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler, Harmonic Imaging and 3D Imaging.
Additional Comments:
Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e": Includes imaging for guidance of transrectal biopsy.
Subscript "f": Includes imaging for guidance of transvaginal biopsy.
Subscript "g": For pediatric patients.
Subscript "h": Includes imaging for guidance of transrectal biopsy.

The Imagin 2011 0000 Diagnoons aging system capable of the following operating pulsed Doppler und palsed continuous Wave Doppler, Color Flow (including Amplitude Doppler). It is also intended for harmonic imaging, superficial musculoskeletal imaging, and 3D imaging.

The Hitachi EUB-8500 Diagnostic Ultrasound Scanner (K013722) received clearance as a general ultrasound imaging system.

The provided document describes the intended uses for the EUB-8500 system with various transducers, indicating where it has "new indications" (marked with "N") for specific clinical applications and modes of operation. However, it does not contain information about acceptance criteria or specific studies proving the device meets those criteria with performance metrics such as accuracy, sensitivity, or specificity.

This document is a 510(k) premarket notification letter from the FDA, which confirms substantial equivalence to legally marketed predicate devices. It focuses on device description, safety (acoustic output and general electrical safety standards), and lists the cleared transducers and their intended uses.

Therefore, I cannot provide the requested information for the following points based on the provided text:

1. A table of acceptance criteria and the reported device performance: This is not present in the document. The document lists the intended uses for each transducer, but not performance metrics or acceptance criteria for those uses.
2. Sample size used for the test set and the data provenance: No test set details are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No details on expert-established ground truth for a test set.
4. Adjudication method for the test set: No details on adjudication.
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 a device clearance for an ultrasound scanner, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a device clearance for an ultrasound scanner, not an algorithm.
7. The type of ground truth used: Not specified.
8. The sample size for the training set: Not specified.
9. How the ground truth for the training set was established: Not specified.

Summary of available information from the document:

• Device Description: The Hitachi EUB-8500 Diagnostic Ultrasound Scanner is a diagnostic imaging system capable of pulsed Doppler, continuous Wave Doppler, Color Flow (including Amplitude Doppler), harmonic imaging, superficial musculoskeletal imaging, and 3D imaging.
• Safety:
  • As a Track 3 ultrasound device, it includes real-time display of Thermal and Mechanical Acoustic Output Indices, complying with NEMA standards (OD 3) and FDA guidelines (April 14, 1994, Revision of 510(k) Diagnostic Ultrasound Guidance).
  • It also complies with general safety standard IEC 60601-1 (1998) Medical Electrical Equipment, Part 1, General Requirements for Safety.
• Intended Use: The document details the intended uses for the EUB-8500 system with various transducers (EUP-B314, EUP-C514, EUP-ES322, EUP-ES52M, EUP-ES533, EUP-F531, EUP-L54M, EUP-L53S, EUP-OL334, EUP-R53W, EUP-S50, EUP-TC3, EUP-U533, EUP-V53W) across different clinical applications and modes of operation (B, M, PWD, CWD, Color Doppler, Combined, and Other (Amplitude Doppler, Harmonic Imaging, 3D Imaging)). "N" indicates a new indication for a specific application/mode combination. Subscripted notes (a-h) provide further clarification on certain clinical applications (e.g., guidance for biopsy).

The substantial equivalence determination is based on the device's adherence to established safety standards and its demonstration of equivalent technology and intended uses to predicate devices. This type of clearance does not typically involve efficacy studies with detailed performance metrics or clinical study data like those requested for deep learning algorithms.

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