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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: endoscopic observation of the gastrointestinal tract (esophagus, stomach, duodenum, large intestine) and biliary system (pancreato-biliary ducts).

Device Description

The subject device consists of:

EUB-525/EUB-2000 Diagnostic Ultrasound Scanner
SP-711UA Ultrasonic Probe Connecting Unit
TL-1A Translator
Probe (PL Series or PL26-7.5 Series)
Balloon and Sheath

The Hitachi EUB-525/EUB-2000 operating controls and their associated functions do not change with the addition of the Fujinon SP-711 Sonoprobe system. The operating controls specific to the Fujinon SP-711 system are described in the operation manuals included with this document in Section 7.

The transducers subject to this submission are the same transducers described in the previously cleared 510(k) K011252. They are: PL1726-20, PL1726-15, PL1726-12, PL1726-7.5, PL1926-20, PL1926-15, PL1926-12, PL1926-7.5, PL2226-20, PL2226-15, PL2226-12, PL2220-20, PL2220-15, PL2220-12, PL2220-7.5.

The PL26-7.5 probe series includes one type for use with a balloon/sheath and the other type for use without a balloon. The only difference between probes is the structure of the tip. The probes made for use with a balloon/sheath have a groove on the tip to catch the balloon head. The probes made for use without a balloon are slightly shorter. The choice of the probe type is at the discretion of the physician. Since ultrasound waves are stronger in water, the physician may choose to use the balloon version to improve image quality. The probes made for use with a balloon/sheath are designated with a "B" (i.e. PL26B-7.5) and must be used with a balloon adapter, balloon sheath, and balloon as described in the operation manual.

AI/ML Overview

The provided text is a 510(k) summary for the Hitachi EUB-525/EUB-2000 Diagnostic Ultrasound Scanner with the Fujinon SP711UA/SP711 Sonoprobe System. It asserts substantial equivalence to a predicate device (Fujinon SP711 Sonoprobe system, K011252) and Hitachi EUB-525 (K981434).

The document states "Performance Data: Identical to device previously cleared by the FDA under 510(k) K011252." This indicates that the device's performance was not re-evaluated for this specific submission, but rather, reliance was placed on the performance data of the predicate device. Therefore, direct acceptance criteria and studies demonstrating the current device's compliance with those criteria are not detailed in this document, as the argument is based on equivalence.

However, based on the information provided, here's a breakdown of what can be inferred and what information is missing:

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

The document does not explicitly state acceptance criteria or provide a table of performance metrics for the current device. It relies on the "identical" performance of the predicate device. The performance of a diagnostic ultrasound system is generally evaluated based on image quality, penetration depth, resolution, accuracy of measurements, and safety (acoustic output).

Performance Metric (Inferred)	Acceptance Criteria (Not Explicitly Stated for this submission)	Reported Device Performance (Implied)
Diagnostic Ultrasound Imaging Quality	Performance equivalent to predicate device (K011252 & K981434)	Deemed substantially equivalent to predicate devices.
Fluid Flow Analysis	Performance equivalent to predicate device (K011252 & K981434)	Deemed substantially equivalent to predicate devices.
Safety (Acoustic Output, Electrical Safety, EMC)	Compliance with recognized standards and predicate device safety data	Deemed substantially equivalent to predicate devices, implying compliance.
Transducer Performance (e.g., specific frequencies, modes)	Performance equivalent to transducers cleared under K011252	Listed transducers (PL1726, PL1926, PL2226, PL2220 series) are identified as previously cleared or part of the existing system.

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

This information is not available in the provided text. Since the submission relies on substantial equivalence and "identical" performance to predicate devices, there is no mention of a new test set or associated data provenance for this specific 510(k).

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)

This information is not available in the provided text. As no new "test set" or independent performance study is described for this submission, there is no mention of experts establishing ground truth.

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

This information is not available in the provided text.

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

This information is not available in the provided text. The device described is a diagnostic ultrasound system with sonoprobes, not an AI-assisted diagnostic tool.

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

This information is not available in the provided text. The submission describes hardware for diagnostic ultrasound, not a standalone algorithm.

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

This information is not available in the provided text. In a substantial equivalence submission for a diagnostic imaging device, the "ground truth" for the predicate device's performance would typically refer to clinical diagnosis, pathology, or other established diagnostic methods used to validate the imaging capabilities. However, this is not detailed in the provided summary.

8. The sample size for the training set

This information is not available in the provided text. The document describes a medical device, not a machine learning algorithm requiring a "training set."

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

This information is not available in the provided text. This question is not applicable to the type of device described in the submission.

Summary of Device and Acceptance:

The device, a combination of the Hitachi EUB-525/EUB-2000 Diagnostic Ultrasound Scanner and the Fujinon SP711 Sonoprobe system, gained FDA clearance through the 510(k) pathway by demonstrating substantial equivalence to previously cleared predicate devices (Hitachi EUB-525, K981434, and Fujinon SP711 Sonoprobe system, K011252).

The acceptance criteria for this submission were implicitly met by asserting that the device's intended use, technological characteristics, and performance data are identical to those of its predicate devices. This means that formal, new clinical trials or performance studies were not conducted for this specific submission. Instead, the FDA accepted the manufacturer's claim that the new device does not introduce new questions of safety or effectiveness compared to the already cleared devices. The "Indications for Use Forms" for the system and various transducers confirm the clinical applications and modes of operation that are either "previously cleared" (P) or "new" (N) but are cleared based on the substantial equivalence.

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