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This device is a self-help tool for individuals aged 18 or older with diagnosed depression. It is intended to be used in addition to usual care and not as a replacement for it.

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The provided FDA 510(k) Clearance Letter for the HJY VisualNext 3D Endoscopic Vision System focuses on the device's substantial equivalence to a predicate device, as opposed to a detailed standalone or comparative effectiveness study of an AI-powered diagnostic device. Therefore, many of the requested details, particularly those related to AI algorithm performance (e.g., sample size for test/training sets, data provenance, ground truth establishment, MRMC studies, and effect size of human reader improvement with AI assistance), are not present in this document.

However, based on the information available, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

Device Type: The HJY VisualNext 3D Endoscopic Vision System is an endoscopic vision system, not an AI-powered diagnostic device. Its primary function is to provide 3D visualization during surgical procedures, differentiating it from an AI-based system that might perform automated image analysis or diagnosis.

Acceptance Criteria and Reported Device Performance:

The document outlines acceptance criteria implicitly through the performance of various non-clinical tests. The criteria are met if the device "Pass[es]" the respective tests and demonstrates performance metrics comparable to predefined standards or the predicate device.

Study Details (for the Non-Clinical Performance Testing):

Since the device is a vision system and not an AI algorithm, the traditional "test set" and "training set" concepts as applied to AI models do not directly apply in the same way. The non-clinical testing evaluates the physical and functional performance of the device itself.

1. Sample size used for the Test Set and Data Provenance:

   • Bench Testing: The sample size is not explicitly stated, but it involved "aged and non-aged subject devices" and direct comparison to the predicate device. The data provenance would be laboratory-generated data from device performance measurements.
   • Animal Study Testing: "A porcine animal model" was used. The specific number of animals or trials within the animal study is not provided. The data provenance is described as being from a porcine animal model. This would be prospective data collection, specifically for this study.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

   • This metric is not applicable in the context of this device's testing. The "ground truth" for a vision system's performance is typically established by objective physical measurements (e.g., MTF for resolution, calibrated light meters for illumination) and expert subjective evaluation of visual quality in a controlled setting, rather than a consensus on diagnostic findings. The document does not specify the number or qualifications of any human evaluators involved in the image quality assessment during bench or animal testing, only that the data "met the predefined acceptance criteria."

3. Adjudication Method for the Test Set:

   • Not applicable as the testing involves objective performance measurements and comparison against predefined criteria, not diagnostic interpretations requiring adjudication.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No. An MRMC study is typically performed for diagnostic devices where human readers interpret medical images, often with and without AI assistance, to measure diagnostic accuracy and efficiency. This device is a surgical visualization tool, not a diagnostic imaging device.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • This is not an AI algorithm, so the concept of "standalone performance" of an algorithm is not applicable. The core function of the device is to provide images for human viewing. The non-clinical tests assess the device's ability to produce high-quality images and function as intended.

6. The Type of Ground Truth Used:

   • For Bench Testing: Objective physical measurements (e.g., resolution targets, light sensors, distortion grids) served as the "ground truth" for parameters like FOV, DOF, resolution, etc., along with comparison to the known performance of the predicate device.
   • For Animal Study Testing: The "ground truth" for image quality (resolution, illumination, color representation, contrast, noise) was likely based on objective evaluation against predefined standards and comparative assessment by skilled observers (e.g., surgeons, imaging specialists) who could judge the clarity and utility of the visualization in an anatomical context, compared to the predicate device's 2D view. Anatomical structures within the porcine model served as the "true" objects being visualized.

7. The Sample Size for the Training Set:

   • Not applicable. This device is a hardware system, not an AI algorithm trained on data. There is no "training set" in the context of machine learning.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable, as there is no training set.

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This 3D Visualization System is intended to compose the imaging signals from video system center and convert them into 3D signals displayed on the monitor.

The 3D Visualization System can convert 2D endoscopic images synchronously. It is equipped HD-SDI and HDMI outputs ports which are compatible with 3D monitors of various interfaces. The 3DVS-S100 series 3D Visualization System includes 5 models, which are 3DVS-S100A, 3DVS-S100B, 3DVS-S100C, 3DVS-S100D and 3DVS-S100E. The differences between the models are in the number and type of imaging modes supported (single-lens endoscope with enhanced or standard 3D effects, and dual-lens endoscope with enhanced or standard 3D effects). The system should be used with endoscopic image processors which have HDMI or SDI output interface, and monitors which have SDI, HDMI or DVI interface. The device is provided non-sterile and for repeat use, does not have patient-contact, and is intended for use by a qualified healthcare professional and is not for home use.

The provided document describes the Scivita Medical Technology Co., Ltd. 3D Visualization System (K183675). The document clarifies that this device is intended to process imaging signals from a video system center and convert them into 3D signals for display on a monitor. The FDA's 510(k) clearance process focuses on substantial equivalence to a predicate device, rather than explicit acceptance criteria with numerical performance targets for the proposed device itself. However, the document does describe non-clinical testing conducted to demonstrate this equivalence and ensure the device meets design specifications.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

• IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012 (General requirements for basic safety and essential performance)
• IEC 60601-1-2:2014 (Electromagnetic compatibility)
• IEC 60601-2-18:2009 (Particular requirements for endoscopic equipment) |
  | Software Validation | The software was validated in accordance with FDA guidance documents:
• "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
• "Off-The-Shelf Software Use in Medical Devices"
• "Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software"
• "General Principles of Software Validation" |
  | Image Quality Equivalence (2D and 3D) | Image quality performance tests were conducted to quantitatively compare the proposed device and predicate devices for both 2D and 3D images.
  Parameters evaluated:
• Field of view
• Direction of view
• Depth of field
• Geometric distortion
• Noise and dynamic range
• Intensity uniformity
• Artifacts
• Image frame frequency and system delay

Result: The image quality of the proposed device was equivalent to that of the predicate device (OLYMPUS LTF-190-10-3D ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE, MAJ-YO154 3D PROCESSOR, OLYMPUS CV-190, EVIS EXERA III VIDEO SYSTEM CENTER - K123365). This equivalence was tested across all four modes of the proposed device in both described combinations. |
| Substantial Equivalence to Predicate Device (K123365) | The non-clinical performance testing summarized supported a substantial equivalence determination, demonstrating the subject device is as safe and as effective as the legally marketed predicate device. |

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

The document does not specify the sample size (e.g., number of images, cases, or videos) used for the image quality performance tests. It vaguely states "image quality performance tests were conducted to quantitatively compare the proposed device and predicate devices."

The data provenance (country of origin, retrospective/prospective) is also not mentioned. Given the manufacturer is based in China, it's plausible the testing was conducted there, but this is not explicitly stated.

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

The document does not mention the use of experts or any process for establishing ground truth as typically understood in a clinical study (e.g., for diagnostic accuracy). The testing described is purely technical and comparative against a predicate device's performance characteristics.

4. Adjudication Method for the Test Set

As no expert review or human assessment of diagnostic accuracy is mentioned, there is no adjudication method described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. The study described is a non-clinical, technical performance comparison between the proposed device and a predicate device, focusing on image quality characteristics, not on human reader performance with or without AI assistance. The device's function is to convert existing video signals into 3D signals, not to provide AI-assisted diagnostic capabilities.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a form of standalone performance was assessed. The "image quality performance tests" were conducted on the device itself, comparing its output directly to the predicate device's output based on various technical image parameters. This is an evaluation of the algorithm's output (3D visualization) in isolation from human interpretation for diagnostic purposes.

7. Type of Ground Truth Used

For the non-clinical image quality tests, the "ground truth" was implicitly derived from technical performance metrics of the predicate device and established engineering standards for image quality. It was a comparative measurement against the performance characteristics of the legally marketed predicate device, not against clinical outcomes, pathology, or expert consensus on a diagnostic task.

8. Sample Size for the Training Set

The document does not mention a training set. This device is a "3D Visualization System" that converts video signals. It does not appear to be an AI/ML-driven diagnostic or image analysis tool that would typically involve a "training set" in the machine learning sense. Its function is signal processing and conversion.

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

As no training set is mentioned, this section is not applicable.

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The GE EchoPAC workstation is indicated for diagnostic review and analysis of ultrasound images acquired under various modes of operation including B, M, Color M modes, Color, Power, Pulsed & CW Doppler modes, Coded Pulse, Harmonic and Realtime 3D. Clinical applications include: Fetal; Abdominal (including renal and GYN); Urology (including prostate); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Transesophageal (TEE); Musculo-skeletal Conventional; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).

The device may include EchoPliot reporting software which provides guidance to support the quality of the echocardiography examination and report. It compares patient data, user entered clinical data and measurements to generally accepted guidelines and studies, and helps to identify mismatches, inconsistencies and unusual or missing data. It can generate a preliminary data analysis that can be used as basis for the examination report.

GE EchoPAC provides image processing, annotation, analysis, measurement, report generation, communication, storage and retrieval of ultrasound images that are acquired via GE Vivid family of ultrasound scanners, primarily for cardiology ultrasound applications but also for general imaging. The EchoPAC software is an integral component of each Vivid system, providing the postacquisition image management and reporting functions of the scanner. EchoPAC will be offered as SW-only to be installed directly on customer PC hardware, or as an accessory to selected 3rd party image management workstations. EchoPAC is DICOM compliant, transferring images and data via LAN between scanners, hard copy devices, file servers and other workstations. The modified or added software features for GE EchoPAC are substantially equivalent to the predicate device and functionality cleared on GE EchoPAC K123894.

The provided document is a 510(k) Premarket Notification for the GE EchoPAC device. It outlines modifications to an existing device, rather than introducing a new software feature that necessitates a robust clinical study with specific acceptance criteria.

Based on the content of the document, the device did not require clinical studies to support its substantial equivalence. Therefore, there is no information provided regarding acceptance criteria for device performance, nor a study proving the device meets such criteria.

The document states:

• "The subject of this premarket submission, EchoPAC, did not require clinical studies to support substantial equivalence." (Page 2, "Summary of Clinical Tests" section).
• "GE Healthcare considers the EchoPAC to be as safe, as effective, and performance is substantially equivalent to the predicate device." (Page 2, "Conclusion" section).

The focus of this 510(k) submission is on demonstrating "substantial equivalence" of the modified device to a previously cleared predicate device (K123894). The modifications are primarily related to existing features (e.g., 4D Strain, 2D Strain) and the introduction of a new plug-in feature that was "originally cleared in its own right by their OEM manufacturer."

Therefore, I cannot provide a table of acceptance criteria, reported device performance, or details about a clinical study as none were conducted or deemed necessary for this specific submission to demonstrate substantial equivalence.

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GE Vivid E9 ultrasound system is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of Fetal; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate), Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).

GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E9 incorporates a variety of electronic array transducers operating in linear, curved linear, sector/phased array or matrix array format, including two dedicated CW transducers and several real time 3D transducers. It consists of a mobile console with keyboard control panel; color LCD/TFT touch panel, LCD color video display and optional image storage and printing devices. It provides high performance ultrasound imaging and analysis and has comprehensive networking and DICOM capability.

The provided document, K131514, is a 510(k) Premarket Notification for the GE Vivid E9 Diagnostic Ultrasound System. This document does not describe a study proving a device meets specific performance acceptance criteria for a new AI or advanced algorithm feature. Instead, it is a submission for a modified ultrasound system, primarily focusing on the addition of new transducers and two optional plug-in features (TomTec 4D MV Assessment and StereoVision) that were previously cleared.

The core of the submission revolves around demonstrating substantial equivalence to predicate devices. This means that GE Healthcare is asserting the modified Vivid E9 is as safe and effective as existing legally marketed devices, and does not raise new questions of safety and effectiveness. This is fundamentally different from a study proving a novel device or AI algorithm meets specific performance acceptance criteria.

The document explicitly states: "The subject of this premarket submission, Vivid E9, did not require clinical studies to support substantial equivalence." This indicates that no specific clinical performance study was conducted to establish acceptance criteria for a new feature demonstrating its performance.

Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) from this document because it outlines a regulatory submission for device modifications based on substantial equivalence, rather than a clinical performance study for a new or significantly modified feature.

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LTF-190-10-3D: This instrument is intended to be used with Olympus video system center, light source, documentation equipment, 3D processor, monitor, hand instruments, electrosurgical unit and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the thoracic and abdominal cavities including female reproductive organs. This instrument must not be used for observation or treatment of the heart and must not contact the heart or any area near the heart. In addition, this instrument must not contact with any device or therapeutic accessory that contacts the heart or any area near the heart.
CV-190: This video system center is intended to be used with Olympus camera heads, endoscopes, light source, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
MAJ-Y0154: This 3D processor is intended to be used with 3D videoscope and video system center for 3D observation.

The subject system is intended for endoscopy and endoscopic surgery with three-dimensional view of endoscopic images and the system is mainly composed of following devices: LTF-190-10-3D (ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE), MAJ-Y0154 (3D PROCESSOR), CV-190 (EVIS EXERA III VIDEO SYSTEM CENTER). The ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-190-3D is a flexible video endoscope used for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs. The subject device, LTF-190-3D is utilized with the MAJ-Y0154, 3D Processor and the CV-190, EVIS EXERA III VIDEO SYSTEM CENTER. The connection of the devices enables the system for endoscopic observation in 3D view of the image. The 3D video observation of this system is implemented with following process. The captured signals from two CCDs which correspond to left and right eye incorporated in the distal end of the subject LTF-190-10-3D are transferred to the MAJ-Y0154 via two CV-190s convert the captured signals into video image signals, and transmits them to the MAJ-Y0154. The MAJ-Y0154 converts the video image signals into 3D video signal and transfers it to the LMD-2451MT, (K113203). On the LMD-2451MT, 3D video image is displayed as passive stereo type which has different polarizing angle in the left and right; therefore, the 3D glasses for LMD-2451MT are required to obtain 3D video image.

The provided text describes a 510(k) summary for Olympus medical devices, specifically an endoscope, a 3D processor, and a video system center. The summary focuses on demonstrating substantial equivalence to predicate devices through design verification and non-clinical testing. It does not include information about AI/ML models, clinical studies, or acceptance criteria related to diagnostic performance or accuracy of an AI model.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance related to an AI model.
2. Sample size and data provenance for an AI test set.
3. Number and qualifications of experts for AI ground truth.
4. Adjudication method for an AI test set.
5. MRMC comparative effectiveness study results for AI.
6. Standalone performance results for an AI algorithm.
7. Type of ground truth for an AI model.
8. Sample size for an AI training set.
9. How ground truth for an AI training set was established.

This document describes technical aspects and safety testing for endoscopic hardware, not an AI-powered diagnostic device.

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