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The ultrasonic gastrovideoscope (hereinafter called endoscope) is intended to provide endoscopic images for the examination and diagnosis of the upper gastrointestinal tract and to perform the ultrasound examination and diagnosis of the upper gastrointestinal sub-mucosa and the surrounding organs.

The endoscope should be used in the medical institution. The operator of the endoscope should be a physician or a medical staff supervised by a physician, both of whom have received sufficient training in clinical endoscopy technology.

The subject device, Ultrasonic Gastrovideoscope, is consisting of insertion, control section and connector section. The insertion is consisting of a distal end, a bending section and an insertion tube. This Ultrasonic Gastrovideoscope is intended to use in conjunction with Endoscopic Image Processor (HD-550Exp, HD-550, HD-550Pro, HD-550S, HD-510 and HD-500Plus), light source (VLS-55Q, VLS-55T, VLS-51D and VLS-51T), ultrasound system (P60 Exp, P60, P60 Pro, P60 CV, P60S and P60 VO) and monitor to provide endoscopic images for the examination and diagnosis of the upper gastrointestinal tract and to perform the ultrasound examination and diagnosis of the upper gastrointestinal sub-mucosa and the surrounding organs.

The Ultrasonic Gastrovideoscope is a reusable device. The Ultrasonic Gastrovideoscope has only one model EG-UR5.

The prospective clinical value of the enhanced imaging modes (EWL, SFI, and VIST) has not been demonstrated, and no clinical claims are made.

The provided text describes the acceptance criteria and the study conducted for the Sonoscape Medical Corp. Ultrasonic Gastrovideoscope (EG-UR5).

Here's the information broken down as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by testing against recognized standards and comparing performance to a predicate device. The document repeatedly states that the device's performance is "similar" to or "meets the requirements" of the predicate device and relevant standards.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size for test sets (e.g., number of devices tested for each non-clinical test). The studies appear to be non-clinical bench testing rather than clinical studies on human subjects.

• Data Provenance: The tests were conducted by the manufacturer, Sonoscape Medical Corp., in China, as indicated by their address. The data is retrospective in the sense that it was collected as part of the device development and verification process before submission for FDA clearance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Not Applicable. As this was a non-clinical submission, the "test set" refers to physical device testing against standards and predicate devices, not clinical data requiring expert human interpretation for ground truth.

4. Adjudication Method for the Test Set

• None. Since there was no clinical test set requiring human interpretation, no adjudication method was used. The evaluation involved technical measurements and comparisons to established standards and the predicate device's specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. The document explicitly states: "No clinical study is included in this submission." Therefore, no MRMC study was performed.

6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) Was Done

• Not Applicable. The device is an endoscope, a hardware medical device that directly captures images and performs ultrasound. It is not an AI algorithm or software-only device, so the concept of "standalone algorithm performance" does not apply in this context. Its performance is intrinsically tied to human operation and interpretation.

7. The Type of Ground Truth Used

The ground truth for the non-clinical tests was established by:

• Technical Specifications and Performance of the Predicate Device (K130206): The subject device's performance was compared directly to that of the PENTAX EG-3670URK Ultrasound Video Gastroscope.
• International Standards: Compliance with standards such as ISO 10993 (biocompatibility), IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-2-18, IEC 60601-2-37 (particular requirements), and ISO 8600 (endoscope performance).
• FDA Guidance Documents: For example, "Mitigating the risk of Cross-Contamination from valves and Accessories Used for irrigation through Flexible Gastrointestinal Endoscopes" for backflow prevention.

8. The Sample Size for the Training Set

• Not Applicable. This device is a hardware endoscope, not an AI or machine learning system. Therefore, there is no "training set" in the context of algorithm development.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. See point 8.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Trans-rectal
Trans-urethral
Trans-esoph. (non-Card.)
Gastrointestinal tract, biliary, pancreatic duct and surrounding organs.
Intraluminal ultrasound for upper airways and tracheobronchial tree
3-D Imaging

The combination of the XEU-M60A Endoscopic Ultrasound Center, UM-2R/3R Ultrasonic Probes, UM-DP12/20-25R Ultrasonic Probes, GF-UM130 Ultrasonic Gastrovideoscope, GF-UM160 Ultrasonic Gastrovideoscope, XGF-UM180 Ultrasonic Gastrovideoscope, GF-UE160-AL5 Uftrasonic Gastrovideoscope, GF-UC140P-AL5 Ultrasonic Gastrovideoscope, and GF-UCT140-AL5 Ultrasonic Gastrovideoscope enables the acquisition and display of high-resolution and high-penetration, real-time ultrasound B-mode endoscopic images,

This is a premarket notification (510(k)) for the Olympus XEU-M60A Endoscopic Ultrasound Center and associated ultrasonic probes and gastrovideoscopes. A 510(k) submission primarily demonstrates substantial equivalence to a legally marketed predicate device rather than conducting a full clinical study to establish new acceptance criteria. Therefore, the document does not contain acceptance criteria or study results in the typical sense of a de novo clinical trial for a novel device.

The submission focuses on comparing the new device's technical characteristics and intended use to existing, cleared devices.

Here's an analysis of the provided text in the context of your request:

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

The provided document, a 510(k) submission, does not specify explicit acceptance criteria (e.g., minimum sensitivity, specificity, accuracy) for device performance or present a table of such criteria against reported performance. This type of information is typically reserved for clinical trials designed to prove safety and effectiveness for novel devices, or for performance studies of AI/ML-enabled devices that introduce new diagnostic capabilities.

For a 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices. The performance is assessed by confirming that the new device operates similarly and performs as expected for its intended use, aligning with the performance of the predicate devices. The document implies that the device works by stating: "The XEU-M60A Endoscopic Ultrasound Center operates identically to the predicate devices in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as images. Doppler shift caused by blood flow is displayed as Color Flow, or as spectrum analysis."

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

The document does not describe a clinical test set with a specific sample size, data provenance, or retrospective/prospective design. This information is generally found in clinical performance studies, which are not typically part of a 510(k) that relies on substantial equivalence for an established technology.

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)

Since there is no described clinical test set, there is no mention of experts used to establish ground truth or their qualifications.

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

As there is no described clinical test set, there is no information on an adjudication method.

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

The document does not describe an MRMC comparative effectiveness study. This device is a diagnostic ultrasound system and associated components, not an AI/ML-enabled device, and therefore this type of study showing human readers' improvement with AI assistance would not be applicable.

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

This refers to the performance of an algorithm without human intervention, which is relevant for AI/ML devices. The XEU-M60A is a diagnostic ultrasound system, not an AI/ML algorithm, so a "standalone algorithm" performance study is not applicable or discussed. The device's performance is inherently tied to human operation and interpretation.

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

As there is no described clinical test set, there is no information on the type of ground truth used. The submission relies on the established performance of the predicate devices.

8. The sample size for the training set

The document does not refer to a training set. This is typically applicable for AI/ML devices, where a model is trained on a specific dataset. This device is a traditional diagnostic ultrasound system.

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

As there is no described training set, there is no information on how its ground truth would have been established.

Summary of what the document implies about meeting acceptance criteria:

The "acceptance criteria" in the context of this 510(k) submission are met by demonstrating that the Olympus XEU-M60A Endoscopic Ultrasound Center and its associated ultrasonic probes and gastrovideoscopes are substantially equivalent to legally marketed predicate devices.

Study/Evidence that proves the device meets the acceptance criteria (Substantial Equivalence):

The document explicitly states:

• Identical Mode of Operation: "The XEU-M60A Endoscopic Ultrasound Center operates identically to the predicate devices in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body."
• Identical Technological Characteristics: "Technological Characteristics of this device is identical to the predicate devices identified in item 3."
• Predicate Device Comparison: The submission includes a table of predicate devices for comparison (listed in Section 3, titled "Predicate Device Information"). For both the Ultrasound System and Ultrasonic Gastrovideoscopes and Probes, specific predicate devices with control numbers (K-numbers) are cited.
  • XEU-M60A Endoscopic Ultrasound Center is compared to EU-M60 (K043275) and EU-C60 (K010591).
  • Various Ultrasonic Probes and Gastrovideoscopes (UM-2R/3R, UM-DP12/20-25R, GF-UM130, GF-UM160, XGF-UM180, GF-UE160-AL5, GF-UC140P-AL5, GF-UCT140-AL5) are compared to their respective previously cleared versions, often citing multiple K-numbers. For some, like UM-DP12/20-25R, it's mentioned that Olympus determined no new 510(k) was required for device changes based on earlier clearances.
• Indications for Use: The document outlines the intended uses (e.g., Transrectal, Transurethral, Transesophageal, Gastrointestinal tract, biliary, pancreatic duct and surrounding organs, Intraluminal ultrasound for upper airways and tracheobronchial tree, 3-D Imaging) in sections 4.3.1 through 4.3.9, noting which are "new indications" (N) but implying they fall within the scope of predicate devices or generally accepted ultrasound diagnostic capabilities. The new indications appear to be for specific anatomical sites (e.g., Trans-rectal, Trans-urethral, Trans-esoph. (non-Card.) and "Other" (e.g., Gastrointestinal tract, biliary, pancreatic duct and surrounding organs. Intraluminal ultrasound for upper airways and tracheobronchial tree), and 3-D Imaging capabilities.

In essence, the "study" demonstrating the device meets "acceptance criteria" here is the analysis of substantial equivalence conducted by Olympus and reviewed by the FDA, concluding that the new device has the same technological characteristics and intended use, or minor differences that do not raise new questions of safety or effectiveness, as its predicates. No independent clinical performance study data would typically be presented in such a 510(k) unless a new indication or technology significantly deviated from predicates.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Trans-esophageal(non-cardiac) Other 1) Gastrointestinal tract and the surrounding organs

These subject devices have been designed to be used with the HDI5000 Ultrasound system (Philips Ultrasound), Olympus video system center, light Source, documentation equipment, video monitor, endo-therapy accessories such as an aspiration biopsy needle and electrosurgical unit except for endoscopic ultrasound (EUS) guided electrosurgery. These subject devices are designed for endoscopic real-time ultrasonic imaging, for performing endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within the upper gastrointestinal tract and surrounding orgains.

The provided text is a 510(k) summary for the Olympus Ultrasonic Gastrovideoscope. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than detailing comprehensive clinical studies with acceptance criteria and specific performance metrics in the way a PMA or a de novo submission would.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment is not available in this document.

Here's a breakdown of what can be extracted or inferred:

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

• Acceptance Criteria: Not explicitly stated as numerical performance metrics (e.g., sensitivity, specificity, accuracy). The acceptance criteria implicitly are that the device performs similarly to the predicate device and meets safety standards.
• Reported Device Performance: Not reported in terms of quantitative clinical performance. The document focuses on demonstrating that the technological characteristics and intended use are equivalent to the predicate.

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

• Not Available. The document does not describe a clinical test set or patient data. The evaluation primarily relies on technical specifications and comparisons to existing devices.

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 / Not Available. There is no mention of a test set requiring expert ground truth establishment for clinical performance evaluation. The review is focused on engineering and regulatory equivalence.

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

• Not Applicable / Not Available. No test set or adjudication method is 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

• Not Applicable. This device is an ultrasonic gastrovideoscope, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device and was not performed.

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

• Not Applicable. This is a hardware medical device (endoscope), not a standalone algorithm.

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

• Not Applicable / Not Available. As no clinical performance study involving a test set is detailed, no ground truth type is specified. The "ground truth" for this submission is regulatory compliance and substantial equivalence to predicate devices, which is demonstrated through technical standards compliance and comparative analysis of design and intended use.

8. The sample size for the training set

• Not Applicable / Not Available. There is no mention of a "training set" as this is not an AI/machine learning device.

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

• Not Applicable / Not Available. See point 8.

Summary of the Study:

The "study" presented is a 510(k) premarket notification which aims to demonstrate that the Ultrasonic Gastrovideoscope OLYMPUS GF Type UC160P-AT8 and UCT160-AT8 are substantially equivalent to legally marketed predicate devices. This involves comparing the new device's intended use, technological characteristics, and safety to existing devices.

The evidence provided includes:

• Comparison of Intended Use: The intended use (Trans-esophageal (non-cardiac) and for the gastrointestinal tract and surrounding organs) is stated to be consistent with predicate devices. The "Diagnostic Ultrasound Indications for Use Form" lists specific modes of operation (B, M, PWD, Color Doppler, Amplitude Doppler, Combined) for various clinical applications, noting which are "new" (N) for this specific device but are established modes generally.
• Comparison of Technological Characteristics: The document states the device "operate identically to the predicate device in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body."
• Compliance with Standards: The device is designed to comply with several IEC and CISPR standards (IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-18, CISPR11).
• Biocompatibility Testing: For a new patient-contacting material in the distal tip, biocompatibility tests were conducted, concluding the material is safe.

The "study" is not a clinical trial in the traditional sense designed to quantify diagnostic performance metrics. Instead, it's a regulatory submission affirming that the device design, materials, and function align with pre-existing, legally marketed devices.

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The Olympus GF-UC140P-D05 Ultrasonic Gastrovideoscope has been designed to be used with the AI5200S and Envision Plus Ultrasound Imaging Systems (Dornier Surgical Products, Inc.), Olympus EVIS Video System Center, Olympus Light Sources, Olympus Endo-Therapy Accessories (such as Aspiration Biopsy Needles) and Olympus Electrosurgical Units (except for the case of Endoscopic Ultrasound (EUS) guided Electrosurgery) for performing real-time endoscopic ultrasound imaging, EUS guided Fine Needle Aspiration (FNA), and for endoscopic ultrasound guided or assisted intervention within the upper digestive tract.

The Olympus GF-UC30P Ultrasonic Gastrofiberscope has been designed to be used with the AI5200S and Envision Plus Ultrasound Imaging Systems (Dornier Surgical Products, Inc.), Olympus Light Source, Olympus Endo-Therapy Accessories (such as Aspiration Biopsy Needles) and Olympus Electrosurgical Units (except for the case of Endoscopic Ultrasound (EUS) guided Electrosurgery) for performing real-time endoscopic ultrasound imaging, EUS guided Fine Needle Aspiration (FNA), and for endoscopic ultrasound guided or assisted intervention within the upper digestive tract.

The Olympus GF-UC140P-D05 Ultrasonic Gastrovideoscope has been designed to be used with the AI5200S and Envision Plus Ultrasound Imaging Systems (Domier Surgical Products, Inc.) Olympus EVIS Video System Center, Light Source, Endo-Therapy Accessories (such as Aspiration Biopsy Needles) and Electrosurgical Unit (except for the case of Endoscopic Ultrasound (EUS) guided Electrosurgery) for endoscopic ultrasonic imaging and treatment in the gastrointestinal wall, biliary and pancreatic ducts, and surrounding organs. These instruments also provide for Endoscopic Ultrasound (EUS) guided fine needle aspiration (FNA) of submucosal and extramural lesions of the gastrointestinal tract, i.e., pancreatic masses, mediastinal masses, and lymph nodes).

The Olympus GF-UC30P Ultrasonic Gastrofiberscope has been designed to be used with the AI5200S and Envision Plus Ultrasound Imaging Systems (Dornier Surgical Products, Inc.) Olympus EVIS Video System Center, Light Source, Endo-Therapy Accessories (such as Aspiration Biopsy Needles) and Electrosurgical Unit (except for the case of Endoscopic Ultrasound (EUS) guided Electrosurgery) for endoscopic ultrasonic imaging and treatment in the gastrointestinal wall, biliary and pancreatic ducts, and surrounding organs. These instruments also provide for Endoscopic Ultrasound (EUS) guided fine needle aspiration (FNA) of submucosal and extramural lesions of the gastrointestinal tract, i.e., pancreatic masses, mediastinal masses, and lymph nodes).

The provided text is a 510(k) summary for the Olympus Ultrasonic Gastrovideoscope GF TYPE UC140P-DO5 and Olympus Ultrasonic Gastrofiberscope GF TYPE UC30P. It describes the devices and their intended use but does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

The document is a regulatory submission for premarket notification, focusing on demonstrating substantial equivalence to predicate devices, rather than presenting detailed clinical study results. It is likely that such study details would be found in other accompanying documents that are not included here, if they were required for this type of device.

Therefore, I cannot provide the requested table and information based on the given text.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Transesophageal
Transrectal
Transvaginal
Transurethral
Other
1)Gastrointestinal tract, biliary, pancreatic duct and the surrounding Organs
2)Intraluminal ultrasound for upper airways and tracheobronchial tree
3)Urinary tract
4)Female reproductive tract

The combination of OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER, Ultrasonic Gastrovideoscope OLYMPUS GF TYPE UM160, and Ultrasonic probe OLYMPUS UM-DP12/20-35R makes a endoscopic ultrasound imaging system used to acquire and to display high-resolution and high-penetration, real-time ultrasound B-mode images.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or training set details.

The text describes:

• A 510(k) premarket notification for the Olympus EU-M60 EUS Exera Endoscopic Ultrasound Center and its associated components (ultrasonic gastrovideoscope and probes).
• The FDA's determination that the device is substantially equivalent to legally marketed predicate devices.
• The intended uses for the device, including various clinical applications in B-mode operation (transesophageal, transrectal, transvaginal, transurethral, and "other" applications such as gastrointestinal tract, biliary, pancreatic duct, upper airways, tracheobronchial tree, urinary tract, and female reproductive tract).
• Details about the manufacturer, initial importer, contact person, device names, and classification.
• A list of predicate devices used for comparison.
• A brief device description and technological characteristics, stating that it operates identically to predicate devices in how it acquires and displays ultrasound images.

The document is a clearance letter from the FDA, and as such, it focuses on demonstrating substantial equivalence to pre-existing devices rather than presenting the detailed performance study results that would typically include acceptance criteria and a description of the study to prove those criteria were met.

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