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Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows: Laparoscopic (Mode of Operation: B, M, PWD, Color Doppler, Other* (Amplitude Doppler)).

The Hitachi EUP-OL334 Laparoscopic Probe is a Track 3 diagnostic ultrasound transducer capable of the following operating modes: B, M., Pulsed Doppler, and Color Flow (including Amplitude Doppler). It is intended for laparoscopic clinical applications with the EUB-525, EUB-555, and EUB-8000 Hitachi Diagnostic Ultrasound Systems.

The provided text is a 510(k) premarket notification for the Hitachi EUP-OL334 Laparoscopic Probe. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through adherence to safety standards and the device's intended use. It does not contain information about specific performance acceptance criteria or a study designed to prove the device meets such criteria in terms of diagnostic accuracy or clinical effectiveness.

The document highlights the device's technical specifications and compliance with safety standards for ultrasound devices, such as acoustic output limits and general electrical safety standards (IEC 601-1). The "Indications for Use" forms list various clinical applications for which the device is cleared, including a new indication for laparoscopic use. However, these forms do not define quantitative performance criteria (e.g., sensitivity, specificity, resolution) or provide data from studies designed to measure these.

Therefore, based solely on the provided text, I cannot describe specific acceptance criteria and a study proving the device meets them in the way the request specifies (e.g., in terms of diagnostic performance). The document is a regulatory submission for substantial equivalence, not a report on clinical performance validation against specific diagnostic metrics.

Here's a breakdown of what can be inferred from the provided text, and what cannot be, based on your request:

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

• Cannot be provided: The document does not define quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) nor does it report such performance metrics for the device. The focus is on safety compliance and intended use.

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

• Cannot be provided: There is no mention of a test set, sample size, or study data provenance for evaluating diagnostic performance.

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):

• Cannot be provided: Ground truth establishment for a diagnostic performance study is not discussed.

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

• Cannot be provided: No adjudication method is mentioned as there's no diagnostic performance study described.

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:

• Cannot be provided: This document predates widespread AI in medical devices and does not describe AI assistance or MRMC comparative effectiveness studies.

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

• Cannot be provided: The device is a diagnostic ultrasound probe, which inherently requires human operation and interpretation. There is no mention of a standalone algorithm or its performance.

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

• Cannot be provided: No ground truth for diagnostic performance is discussed as there's no diagnostic performance study reported.

8. The sample size for the training set:

• Cannot be provided: The concept of a "training set" for an algorithm is not applicable or discussed in this 1998 regulatory submission for an ultrasound probe.

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

• Cannot be provided: As with point 8, the concept of a training set and its ground truth is not relevant to this document.

Summary of what the document does provide regarding "acceptance criteria" in a general sense:

The "acceptance criteria" presented in this document are primarily regulatory compliance criteria for a Class II medical device, focusing on:

• Acoustic Output Limits: The Hitachi EUP-OL334 Laparoscopic Probe "complies with the 'Standard for Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Instruments (1992)', published by the National Electrical Manufacturers Association as UD-3" and "complies with the guideline limits set in the April 14, 1994, Revision of 510(k) Diagnostic Ultrasound Guidance."
• General Safety Standards: The device is "designed to comply with IEC 601-1 (1988) Medical Electrical Equipment, Part 1, General Requirements for Safety."
• Intended Use Compatibility: The device is tested for its intended use in "Diagnostic ultrasound imaging or fluid flow analysis…for laparoscopic clinical applications with the EUB-525, EUB-555, and EUB-8000 Hitachi Diagnostic Ultrasound Systems." The "Indications for Use" forms confirm the new "N= new indication" for laparoscopic use in B, M, and PWD modes, and Color Doppler.

The "study that proves the device meets the acceptance criteria" in this context is the submission of documentation to the FDA demonstrating adherence to these standards and the substantial equivalence to predicate devices (EUB-555, EUB-525, EUB-8000 systems with previously cleared probes). The FDA's issuance of the 510(k) clearance letter (K981434) on July 27, 1998, indicates that the agency found the device to be substantially equivalent based on the provided information, which included compliance with these safety and performance standards for ultrasound devices of its type. The specific studies proving this are implicit in the manufacturer's internal testing and compliance documentation submitted to the FDA, but are not detailed within this public summary.

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