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The EG-3670URK, Ultrasound Video Gastroscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to the organs, tissues, and subsystems: Esophagus, Stomach, Duodenum, Small Bowel, and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: Endoscopy with Mode of Operation B, M, PWD, Color Doppler, Amplitude Doppler.

PENTAX EG-3670URK Ultrasound Video Gastroscope + HI VISION PREIRUS are the endoscopic ultrasound system consists of an ultrasound endoscope with a radial array type ultrasound transducer, video processor, and Hitachi ultrasound scanner. This modified new system configuration is to work together with the already cleared latest Hitachi HI VISION PREIRUS Diagnostic Ultrasound Scanner (K093466).

The provided document is a 510(k) summary for a medical device modification. It states that the submission is a "Special 510(k)" for a system configuration change, specifically replacing an older ultrasound scanner (Hitachi HI VISION 900) with a newer one (Hitachi HI VISION PREIRUS) while keeping the same PENTAX EG-3670URK Ultrasound Video Gastroscope.

Since this is a Special 510(k) for a modification that does not impact intended use, safety, and/or effectiveness, a detailed clinical study proving device performance against acceptance criteria is generally not required in the same way as a new device submission. Instead, the document focuses on demonstrating substantial equivalence to the predicate device and verification and validation of compatibility.

Therefore, the document does not contain the information requested in your numbered points about acceptance criteria and detailed study results. It primarily focuses on regulatory compliance and the demonstration that the modified system is equivalent to the predicate device.

Here's a breakdown of what can be inferred or directly stated from the document, and what is explicitly missing:

1. Table of acceptance criteria and the reported device performance:

• Missing. The document does not provide a table of acceptance criteria or specific performance metrics for the device. As a Special 510(k) for a system configuration change, the focus is on maintaining existing performance, not establishing new performance.

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

• Missing. No information on a test set sample size or data provenance is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Missing. No information on experts or ground truth for a test set is provided.

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

• Missing. No information on an adjudication method is provided.

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:

• Missing. This device is an Endoscopic Ultrasound system, not an AI-assisted diagnostic tool. Therefore, an MRMC study or AI-related metrics are not applicable and not mentioned.

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

• Missing. This is not an AI algorithm, but a medical imaging system. Standalone performance as described is not applicable.

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

• Missing. No information on ground truth type is provided for a performance study.

8. The sample size for the training set:

• Missing. No information on a training set sample size is provided. This is not an AI/machine learning device.

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

• Missing. No information on how ground truth was established for a training set is provided.

Summary from the document regarding the study and acceptance:

The central 'study' mentioned in this Special 510(k) is the verification and validation (V&V) activities performed to ensure compatibility between the PENTAX EG-3670URK Ultrasound Video Gastroscope and the HITACHI HI VISION PREIRUS Ultrasound Scanner.

• Acceptance Criteria (Implied): The implied acceptance criterion for this submission is that the modified system configuration (Gastroscope + HI VISION PREIRUS) performs "as safe, as effective and substantially equivalent in performance to the above identified cleared predicate device/system" (Gastroscope + HI VISION 900). This is a regulatory acceptance criterion for a Special 510(k), not a clinical performance metric.
• Study/Proof: "The modified system configuration has been verified and validated according to the company's design control activities as certified in this Special 510(K) Submission's declaration of conformity with design control to ensure the compatibility between the PENTAX EG-3670URK Ultrasound Video Gastroscope and the HITACHI HI VISION PREIRUS Ultrasound Scanner."

In essence, for this specific type of submission, the "proof" is the successful execution of design control activities, including verification and validation, demonstrating that the new component (HI VISION PREIRUS) is compatible with the existing device (EG-3670URK) and that the overall system maintains its previous safety and effectiveness. No new clinical performance data is presented because the fundamental performance characteristics are not expected to change, and the change is limited to swapping one compatible component for another.

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The EG-3870UTK, Ultrasound Video Gastroscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to the organs, tissues, and subsystems: Esophagus, Stomach, Duodenum, Small Bowel, and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: Endoscopy

PENTAX EG-3870UTK Ultrasound Video Gastroscope + HI VISION PREIRUS are the endoscopic ultrasound system consists of an ultrasound endoscope with a curved linear array type ultrasound transducer, video processor, and Hitachi ultrasound scanner. This modified new system configuration is to work together with the already cleared latest Hitachi HI VISION PREIRUS Diagnostic Ultrasound Scanner (K093466).

The provided text is a 510(k) summary for a medical device called "PENTAX EG-3870UTK Ultrasound Video Gastroscope (Curved Linear Array Type) + HI VISION PREIRUS". It describes a modification to an already cleared system. This document is a regulatory submission for premarket notification, not a clinical study report detailing acceptance criteria and performance data for a device.

Therefore, I cannot provide the requested information about acceptance criteria and device performance based on the provided text for the following reasons:

• This is a Special 510(k) submission for a modification, not a de novo clearance or a typical 510(k) requiring detailed performance data against acceptance criteria. The submission explicitly states: "There are no software or hardware changes between the PENTAX EG-3870UTK Ultrasound Video Gastroscope subject and predicate device in connecting with the new Hitachi HI VISION PREIRUS Diagnostic Ultrasound Scanner. In addition, there are no change in technology, including features, materials, and principles of operation." The modification is simply a change in the ultrasound scanner used with the endoscope.
• The justification for clearance is "substantial equivalence" to a predicate device, not demonstration of meeting specific performance acceptance criteria through a clinical study. The document states: "The system configuration modification does not impact the intended use, safety and/or effectiveness. The modified system configuration has been verified and validated according to the company's design control activities as certified in this Special 510(K) Submission's declaration of conformity with design control to ensure the compatibility between the PENTAX EG-3870UTK Ultrasound Video Gastroscope and the HITACHI HI VISION PREIRUS Ultrasound Scanner." This implies compatibility testing, not a formal clinical trial with acceptance criteria for diagnostic performance.
• No clinical study to demonstrate "device performance" in terms of sensitivity, specificity, accuracy, etc., is described. The document focuses on the equivalence of the modified system.

In summary, the provided document does not contain the information required to populate the requested table and answer the questions about acceptance criteria, study details, sample sizes, ground truth, experts, or comparative effectiveness studies. This type of information is typically found in full clinical study reports, which are usually not part of a Special 510(k) for a system configuration change like this.

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