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It is intended for use for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs. Not suitable for use for observation and treatment of the heart and must not contact the heart or its vicinity.

The SIRIUS Endoscope System as a robotic endoscope consists of Video Processor, Laparoscope Handle, Laparoscope Head and Joystick. The SIRIUS Endoscope System is developed for minimal invasive surgery application.

The SIRIUS Endoscope System is a fully integrated compact 3D laparoscopic camera system with a flexible tip that can change its viewing direction. The Laparoscope Head is made of biocompatible materials. The articulated tip has three degrees of freedom enabling C and S shaped bending. The insertion section is 10 mm diameter and 342 mm working length. Stereo camera with 1080 high-definition resolution. It has 90 degrees field of view, 10-100 mm depth of view.

The SIRIUS Endoscope System is to be used only under the supervision of a trained surgeon and professional clinical staff with trained use of the device.

The device is intended for use in Hospital operating theatres only.

This 510(k) clearance letter focuses on establishing substantial equivalence to a predicate device, rather than proving the device meets new acceptance criteria through a specific study design typically seen for AI/ML devices or novel technologies. The "acceptance criteria" here are implicitly linked to the performance of the predicate device and relevant international standards.

Therefore, many of the specific details you requested regarding acceptance criteria and study design (like sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training sets) are not present in this type of document because the submission is not presenting evidence of novel diagnostic or assistive AI performance. It's a submission for a new model of an endoscope system, demonstrating it performs as safely and effectively as a previously cleared version.

However, I can extract information related to product performance and testing where available, and explain why other details are absent based on the nature of this 510(k) submission.

Analysis of Acceptance Criteria and Device Performance for SIRIUS Endoscope System (K250939)

The SIRIUS Endoscope System (PR-SI-1230) received 510(k) clearance based on its substantial equivalence to a predicate device (K221642: SIRIUS Endoscope System). The "acceptance criteria" in this context are not defined as specific performance metrics for a novel AI algorithm, but rather as meeting the safety, effectiveness, and performance standards expected of an endoscope system, particularly in comparison to its predicate. The studies provided focus on verifying that the new model performs comparably to the predicate and adheres to relevant industry standards.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for an updated hardware device (endoscope system) rather than a novel AI diagnostic, the acceptance criteria are primarily aligned with regulatory standards, predicate device performance, and international product standards. There are no specific AI performance metrics like sensitivity, specificity, or AUC mentioned.

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

This document does not describe a clinical "test set" in the context of an AI/ML or diagnostic performance study. The "tests" mentioned are primarily bench tests, engineering validations, and usability evaluations, not clinical studies involving patient data or images. Therefore, details like data provenance or a specific test set sample size for diagnostic performance are not provided. The comparisons are against the predicate device's design and adherence to recognized performance standards.

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

Not applicable. This submission is about the physical endoscope system, not an AI diagnostic algorithm requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for the performance section refers to engineering specifications and compliance with international standards.

4. Adjudication Method for the Test Set

Not applicable, as there's no diagnostic test set requiring human adjudication.

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

No, an MRMC study was not conducted or reported. This type of study is typically done for AI algorithms that assist or augment human reading of medical images to demonstrate improvement in reader performance. The SIRIUS Endoscope System is a hardware device for visualization and surgery, not an AI-powered diagnostic tool in that sense.

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

Not applicable. There is no standalone algorithm being evaluated for performance independent of human operation for diagnostic purposes. The "software" referred to in the document relates to the device's operational software, not an AI for image analysis.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on:

• International Standards: e.g., ISO 10993 series for biocompatibility, ISO 11135 for sterility, IEC 60601 series for electrical safety/EMC, IEC 62471 for light source safety, ISO 8600 series for endoscope performance, and ANSI/AAMI IEC 62366-1 for usability.
• Engineering Specifications: The design and function of the device itself are validated against its own specifications and those of the predicate.
• Predicate Device Performance: The primary "ground truth" for substantial equivalence is that the new device performs "as well as the legally marketed predicate device."

8. The Sample Size for the Training Set

Not applicable. This document does not describe an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for an AI/ML algorithm mentioned.

Summary of Study Type:

The submission focuses on design verification and validation testing to demonstrate that the new SIRIUS Endoscope System (PR-SI-1230) is safe, effective, and performs as well as its predicate. This includes ensuring compliance with a wide array of international standards (ISO, IEC, ANSI/AAMI) for medical device manufacturing, biocompatibility, electrical safety, sterility, and basic endoscope performance. The differences from the predicate (e.g., working length, joystick design, locking mechanism) were specifically verified through engineering and usability tests to ensure they did not negatively impact safety or effectiveness.

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The i-Cut system is indicated for morcellating and extracting tissue in laparoscopic, gynecologic surgical procedures.

The i-Cut is a single use laparoscopic power morcellator. It is provided sterile.

The i-Cut consists of a rotating cutting tube with a trocar that provides protection against the cutting blade when locked in the "CLOSED" position. The device comes with an obturator for placement into the patient's body and a locking clip that keeps the trocar in the "closed" position during insertion. The activation button must be pressed to cut tissue.

The lumen of the device is designed for use with a standard grasper or Tenaculum forceps with a diameter between 10 to 14 mm. The i-Cut is designed to be used with surgical instruments of diameters between 10 to 14 mm. The lumen is fitted with a silicone valve to prevent gas loss during use of the device.

The i-Cut is electrically operated by a DC Motor which is powered by a 24V AC/DC mains adapter. The non-sterile i-Cut Power Supply with power cord is supplied separately to power the device.

This 510(k) clearance letter pertains to the i-Cut, a single-use laparoscopic power morcellator. The provided text details regulatory information, device description, indications for use, and non-clinical performance testing. However, it does not include information about clinical studies with human participants, acceptance criteria tables, sample sizes for test sets (in the context of clinical performance), expert ground truth establishment, or multi-reader multi-case (MRMC) comparative effectiveness studies.

The document primarily focuses on non-clinical bench testing to demonstrate substantial equivalence to a predicate device (LiNA eXcise, K101458). Therefore, I cannot address most of the requested points related to clinical study acceptance criteria and performance as this information is not present in the provided text.

Here's an analysis of what can be extracted from the provided text, and where gaps exist:

Preamble:

The provided 510(k) clearance letter for the i-Cut device focuses on demonstrating substantial equivalence through non-clinical performance testing (bench testing) rather than clinical trials with human participants. Therefore, many of the requested details pertaining to clinical study design, human reader performance, and expert consensus for ground truth are not present in this document. The "acceptance criteria" and "device performance" discussed here apply to the bench testing conducted, not clinical outcomes in human subjects.

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

Based on the provided non-clinical performance testing section, we can infer some "acceptance criteria" as implied by the successful completion of each test. The "reported device performance" is generally stated as "passed" or "met requirements." No numerical data for specific criteria are provided beyond the stated specifications (e.g., cutting rate, speed).

2. Sample sizes used for the test set and the data provenance

• Sample Size: The document does not specify the sample sizes (e.g., number of devices, number of tests) for each of the non-clinical performance tests. It only states that the tests were performed and passed.
• Data Provenance: The data provenance is from non-clinical bench testing conducted by the manufacturer, A.M.I. Agency for Medical Innovations GmbH. The country of origin of the manufacturer is Austria. This data is inherently prospective as it involves new testing for the device's clearance.

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

Not applicable. This was a non-clinical bench testing study. "Ground truth" in this context pertains to engineering specifications and performance metrics rather than clinical diagnoses established by medical experts. Usability testing involved "surgeons of different experience with laparoscopic morcellators," but it was to assess device compatibility and integrity, not to establish a clinical ground truth for a diagnostic AI.

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

Not applicable. This was a non-clinical bench testing study. Adjudication methods are typically used in clinical studies where multiple human readers interpret data to establish a consensus ground truth.

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. No MRMC comparative effectiveness study was performed or described. The clearance is based on substantial equivalence demonstrated through non-clinical bench testing. The device is a physical surgical tool, not an AI.

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

Not applicable. This device is a physical surgical tool and does not employ a standalone algorithm for diagnostic or interpretative purposes.

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

For non-clinical bench testing, the "ground truth" is defined by engineering specifications, regulatory standards (e.g., ISO, ASTM, IEC), and predefined pass/fail criteria for device performance (e.g., measuring force, checking for wear, verifying electrical safety compliance). There is no "expert consensus" or "pathology" in the medical sense for these tests.

8. The sample size for the training set

Not applicable. This device is a mechanical/electrical surgical tool, not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for this device.

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It is intended for use for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs. Not suitable for use for observation and treatment of the heart and must not contact the heart or its vicinity.

The SIRIUS Endoscope System as a robotic endoscope consists of Video Processor, Laparoscope Handle, Laparoscope Head and Joystick. The SIRIUS Endoscope System is developed for minimal invasive surgery application. The SIRIUS Endoscope System is a fully integrated compact 3D laparoscopic camera system with a flexible tip that can change its viewing direction. The Laparoscope Head is made of biocompatible materials. The articulated tip has three degrees of freedom enabling C and S shaped bending. The insertion is 10 mm diameter and 340 mm working length. Stereo camera with 1080 high-definition resolution. It has 120 degrees field of view, 10-100mm depth of view and bright light with 300 lumen.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

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 primarily describes bench testing and compliance to international standards. It does not specify "test sets" in the context of patient data or clinical trials with specific sample sizes. The data provenance is not mentioned beyond the manufacturer being in Hong Kong. The testing appears to be primarily laboratory-based (bench testing) rather than clinical studies using patient data.

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 provided in the document. The document focuses on technical and regulatory compliance testing rather than expert-derived ground truth from clinical cases.

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

This information is not provided as the studies described are not clinical studies requiring adjudication of diagnostic outcomes.

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

There is no mention of an MRMC comparative effectiveness study, AI assistance, or human reader improvement. The device described is an endoscope system, not an AI-powered diagnostic tool.

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

There is no mention of an algorithm-only standalone performance study. The device is hardware (an endoscope system) with associated software, but not an AI algorithm performing diagnostic tasks independently.

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

For the performance testing, the "ground truth" is adherence to international standards (e.g., ISO 8600 series) and published specifications. For biocompatibility, sterility, electrical safety, etc., the ground truth is defined by the requirements of the respective international standards (e.g., ISO 10993, ISO 11135, IEC 60601, IEC 62471).

8. The sample size for the training set

This information is not applicable or not provided. The device is an endoscope system, and the testing described is not related to machine learning model training.

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

This information is not applicable or not provided for the same reasons as above.

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The Video Endoscopy System & 3D Video Endoscopy System are intended to be used to provide illumination and visualization of surgical field in a wide variety of diagnostic abdominal and thoracic minimally invasive procedures, including female reproductive organs (gynecology) and urological anatomy.

The proposed Video Endoscopy Systems include the Video Endoscopy System and 3D Video Endoscopy System, Video Endoscopy System supports 2D imaqe output, 3D Video Endoscopy System supports 2D/3D image output.

Video Endoscopy System is composed of Video Endoscope (LPS21000/LPS21030) and Video Endoscopy processor (EVS100).

The Video Endoscopy Processor is a video processor, which receives the electrical signals from the Video Endoscope and process it and output the final image to the monitor. Two models 2D Video Endoscope (LPS21000/LPS21030) are available, one image sensor is located at the distal of the endoscope (LPS21000/LPS21030), they are used in conjunction with Video Endoscopy Processor (EVS100) to output 2D images.

3D Video Endoscopy System is composed of Video Endoscope (LPS31000/LPS31030) and Video Endoscopy Processor (EVS200).

The Video Endoscopy Processor is a video processor, which receives the electrical signals from the Video Endoscope and process it and output the final image to the monitor. Two models 3D Video Endoscope (LPS31000/LPS31030) are available, two image sensors are located at the distal of the endoscope (LPS31000/LPS31030), they are used in conjunction with Video Endoscopy Processor (EVS200) to output 2D/3D images.

Video Endoscopy processor is non-sterile device. The Video Endoscope is terminallysterilized device. The Video Endoscope must be sterilized by users before being used in surgery.

This submission describes the Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. Video Endoscopy System & 3D Video Endoscopy System (K210116).

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list quantitative acceptance criteria for optical performance. Instead, it states that "The device met all acceptance criteria for optical performance testing and was shown to have equivalent image quality to the predicate." This implies a comparative standard rather than absolute numerical targets.

The reported device performance is qualitative for equivalence.

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 provide details on sample sizes for the "test set" in terms of images or data points for the individual optical performance tests. The testing described is non-clinical bench testing rather than a study involving clinical data from patients. Therefore, terms like "country of origin of the data," "retrospective or prospective," or "test set" in the context of patient data do not apply here. The testing was performed on the device prototypes or production units.

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

Not applicable. The performance evaluation was based on bench testing against established standards and comparison to a predicate device's specifications, not on human expert review of clinical images to establish ground truth such as disease presence/absence.

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

Not applicable. There was no adjudication method used, as the testing involved objective measurements and comparisons against technical specifications and standards, not subjective expert reviews requiring consensus.

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

No MRMC comparative effectiveness study was done. This submission is for a video endoscopy system as a medical device for visualization, not an AI-powered diagnostic or assistive tool.

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

Yes, the primary evaluation was standalone performance simulation/bench testing of the device's optical and functional characteristics. The device itself (the video endoscopy system) is essentially the "algorithm only" in this context, as its performance is independently measured without human operators for the technical specifications listed.

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

The "ground truth" for the non-clinical testing was based on:

• Established engineering and performance standards: e.g., IEC 60601 series, ISO 10993 series, IEC 62471.
• Predicate device specifications: The comparison table explicitly states characteristics like resolution, field angle, and depth of field that are identical or comparable to the predicate.
• Objective measurements: The various optical performance tests (Resolution, Brightness, White Balance, Color Performance, etc.) would have involved objective measurement techniques with specific targets or ranges derived from industry standards or performance requirements for such devices.

8. The sample size for the training set

Not applicable. This device is a video endoscopy system, not an AI or machine learning algorithm that requires a training set of data.

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

Not applicable, as there is no training set for this type of medical device submission.

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This instrument is intended to be used with a video system center, light source, documentation equipment, monitor. hand instruments, electrosurgical unit, and other ancillary equipment for endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs.

The LTF-S190-5 is a video endoscope consisting of three parts: the control section, the insertion section, and the connector section. The device uses an objective lens and light guide lens for capturing images/videos from the distal end of the endoscope.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-S190-5:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

The provided text describes various engineering and performance tests (reprocessing, biocompatibility, software V&V, electrical safety, EMC, and bench performance). These types of tests typically do not involve "test sets" in the clinical sense with human data. Instead, they involve testing the physical device, its materials, and its software against established technical and safety standards.

• No "sample size" for a clinical test set is mentioned.
• No "data provenance" (e.g., country of origin, retrospective/prospective) for clinical data is mentioned, as clinical data was not part of this submission's performance data section. The submission focuses on substantial equivalence based on technical characteristics and non-clinical performance data.

3. Number of Experts and Qualifications for Ground Truth Establishment

Not applicable. The performance data presented are based on engineering tests and adherence to recognized standards, not on expert-established ground truth from clinical cases.

4. Adjudication Method for Test Set

Not applicable. There is no clinical test set requiring adjudication in the provided performance data.

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

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. This evaluation focuses on the safety and effectiveness of the device itself, rather than comparing human reader performance with and without AI assistance. The device is a videoscope, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical videoscope, not an algorithm, so a standalone algorithm-only performance study is not relevant.

7. Type of Ground Truth Used

The "ground truth" for the various performance tests is defined by:

• Established national and international standards (e.g., FDA guidance documents, ISO 10993, ANSI/AAMI ES 60601-1, IEC 60601-1-2)
• Manufacturer's design specifications and requirements.

8. Sample Size for Training Set

Not applicable. This device is a physical videoscope, not a machine learning model, so there is no concept of a "training set."

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no training set mentioned or implied for this device.

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The SurroundScope System is designed to be used with documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities, including the female reproductive organs.

The SurroundScope System (SS) is an endoscopic platform for visualization during surgery. The SS System is a modification of the previously cleared WV1 Endoscope (K190190) developed by 270Surgical. The SS System is designed to be used with documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment. The SS System features two viewing capabilities: standard and extended. The standard view uses one lens and displays a 90 degree field of view while the extended view uses two additional lenses on the side of the tip and displays a 270 degree field of view. Each lens has its own set of LEDs for illumination.

The SS System is comprised of two main components:

• SS endoscope (Video endoscope)
• Camera Controller Unit (CCU) (Video Processor)

The SS endoscope is a reusable, rigid video endoscope. It is a reusable (autoclavable) endoscope and is intended to be used in a sterile environment. It is initially supplied non-sterile to the user and requires the user to process (i.e., clean and sterilize) the device for initial use, as well as to reprocess the device after each use. The SS endoscope main components are the video and illumination system, the endoscope body, and the endoscope main connector. The endoscope consists of a camera head at the distal tip, insertion tube, control handle, umbilical cable, and main connector. The insertion tube and distal tip are made of gold coated stainless steel. The distal tip contains sapphire for the optical components. The required illumination for the endoscope is supplied by integrated LEDs, located on the endoscope's distal tip. The endoscope video system is controlled by the video processor which collects the video signal produced by the image sensors (CMOS).

The SurroundScope Camera Control Unit (CCU) processes and manages the images/video signal from the endoscope and transfers them to the monitor. The CCU video center also powers and controls the CMOS located in the SS endoscope.

The SurroundScope System is a rigid video endoscope designed for endoscopy and endoscopic surgery within the thoracic and abdominal cavities, including female reproductive organs. It supports both standard (90-degree field of view) and extended (270-degree field of view) viewing capabilities. The system comprises an SS endoscope (reusable, rigid video endoscope) and a Camera Controller Unit (CCU).

Here's an analysis of the acceptance criteria and the studies performed to demonstrate the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of acceptance criteria with corresponding performance results in a consolidated format. However, it states that "All tests met the predefined acceptance criteria" for various bench tests. The performance data section describes the tests performed and their successful outcomes. For the purpose of this response, I will synthesize the information regarding "acceptance criteria" from the fact that studies were conducted to industry standards and FDA guidance, and "reported device performance" from the statement that the devices met these criteria.

2. Sample Size for the Test Set and Data Provenance

The document describes various bench tests, but it does not specify the sample sizes used for these tests. For cleaning, drying, and sterilization, it mentions "multiple reprocessing cycles." For biocompatibility, it refers to standard ISO test methods, which have their own sample size requirements, but these are not enumerated here.

The data provenance is from bench testing and conducted by an independent lab (Wuxi AppTec) for specified tests (cleaning, drying, sterilization). There is no indication of human subject data, country of origin is not specified for the test set, and it is entirely retrospective as it's a pre-market submission for a device.

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

Since the studies described are primarily bench testing (physical, electrical, optical, and chemical properties, as well as software validation), the concept of "ground truth" derived from human experts in a clinical context (e.g., radiologists, pathologists) does not directly apply here.

The "ground truth" for these performance tests is established by the relevant industry standards (ISO, IEC, AAMI, USP) and FDA guidance documents, which define the expected performance metrics and acceptable thresholds. The "experts" involved would be the testing engineers and scientists at the independent labs or internally, who are qualified to conduct these specific technical tests according to the standards. No specific number or qualifications of these technical experts are provided in the document.

4. Adjudication Method for the Test Set

Not applicable. The tests described are objective, quantitative bench tests against established engineering and scientific standards, not subjective interpretations requiring adjudication by human experts.

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

No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence through bench testing, safety, and performance against a predicate device and established standards. This type of study would typically be performed for AI-driven diagnostic or interpretative devices to assess human performance with and without AI assistance, which is outside the scope of this endoscope system's pre-market submission description.

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

Yes, standalone performance (in the context of a medical device's technical capabilities without human interaction) was assessed for various parameters of the SurroundScope System. For example:

• Optical Performance: Field of view, depth of field, signal-noise ratio, non-uniformity, distortion were measured objectively.
• Color Accuracy: Tested against colorimetry standards.
• System Functionality and Latency: Assessed as objective system performance.
• Electrical Safety and Electromagnetic Compatibility: Tested to ensure compliance with standards regardless of human interaction during use.
• Software Validation: The software itself was validated.

These are all measures of the device's inherent technical performance without considering how a human user might interact with or interpret the output in a clinical scenario.

7. The Type of Ground Truth Used

The ground truth used for these studies is based on:

• Industry and International Standards: Such as ISO 8600 series for endoscopes, IEC 60601 series for electrical safety, ISO 10993 series for biocompatibility, AAMI TIRs for reprocessing, and various CIE ISO standards for colorimetry. These standards define the acceptable range and methodology for measuring performance.
• FDA Guidance Documents: For reprocessing and software validation, these documents outline the expected validation methods and content for pre-market submissions.
• Specifications: Predefined acceptance criteria for the device itself, derived from these standards and the manufacturer's own design specifications (e.g., 90°/270° field of view, 17-200mm depth of field).

8. The Sample Size for the Training Set

Not applicable. The SurroundScope System is a hardware endoscope with integrated software for image processing and control. It is not an AI/ML device that requires a "training set" of data in the sense of machine learning. The term "software validation" refers to verifying that the software performs its intended functions correctly and reliably, not to training an algorithm.

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

Not applicable, as there is no "training set" for this device. The software validation is based on requirements and specifications defined by the developer and adherence to FDA guidance.

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The TipVision™ 0°/30° Videoscopes and EleVision™ HD 2 CCU are indicated for visualization during general laparoscopy, gynecological laparoscopy, urological laparoscopy, and video-assisted minimally invasive thoracic procedures.

The Tip Vision™ Videoscope System, consisting of the Tip Vision 0° / 30° Videoscope and the EleVision™ HD 2 Camera Control Unit (CCU), is used for 2D visualization of anatomical structures of the human body during endoscopic surgery including general laparoscopy, gynecological laparoscopy, urological laparoscopy, and video-assisted minimally invasive thoracic surgical procedures. The TipVision™ Videoscope can only be used with the EleVision™ HD 2 CCU; this combination of videoscope and camera controller results in a camera based on complementary metal-oxide-semiconductor (CMOS) technology with LED illumination. When used with a compatible monitor, the camera delivers a native full HD image resolution using progressive scanning (1080p). All parameters that can be adjusted through the user interface of the CCU (magnification, illumination brightness, saturation, selective color enhancement, color shift, image storage, etc.) can also be controlled by the buttons on the TipVision™ Videoscope.

The Tip Vision™ Videoscope is connected to the Ele Vision™ HD 2 CCU by means of a cable attached to the scope handpiece. The user has the ability to adjust videoscope imaging parameters using the buttons on the videoscope handle, or via the CCU. The EleVision™ HD 2 CCU is available in two configurations: image recording only, or image and video recording.

The provided text is a 510(k) summary for the TipVision Videoscope System. It describes the device, its indications for use, comparison to predicate devices, and a summary of non-clinical performance testing. However, it does not contain information about acceptance criteria and a study that proves an AI/ML device meets those criteria.

The document details testing related to:

• Reprocessing: Cleaning and sterilization validations per FDA guidance and AAMI/ISO standards.
• Biocompatibility: Evaluation and testing according to ISO 10993 series and USP .
• Performance Testing (Optical and Mechanical): Optical characteristics (field of view, resolution, color, etc.), photobiological safety, thermal safety, usability, noise/dynamic range, and tip rotation per ISO and IEC standards.
• Software Documentation: Adherence to FDA guidance for Moderate Level of Concern devices and IEC 62304.
• Electrical Safety and Electromagnetic Compatibility (EMC): Compliance with IEC 60601 series.

All these tests are for the physical and software aspects of a traditional medical device (a videoscope system), not for an AI/ML-driven device that would have "acceptance criteria" related to its algorithm's performance (e.g., accuracy, sensitivity, specificity, AUC) and requiring a "test set" with "ground truth" established by experts.

Therefore, I cannot fulfill the request for a table of acceptance criteria and the study proving an AI/ML device meets them, as the provided text does not describe an AI/ML device or its associated performance studies. The request specifically asks for details related to "AI vs without AI assistance," "standalone (algorithm only) performance," and "ground truth" establishment, which are concepts relevant to AI/ML device validation and are entirely absent from this 510(k) summary.

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4K UHD Camera System is used to provide imaging of the operative area in endoscopic surgery.

4K Camera Control Unit
The 4K camera control unit has been designed to be used with endoscopes, 4K camera head, light source, monitors, and other ancillary equipment for endoscopic diagnosis, treatment, and observation. The 4K camera head is compatible with the 4K camera control unit only.

4K Camera Head
The 4K camera head has been designed to be used with endoscopes, 4K camera control unit, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.

The proposed system, 4K UHD Camera System, comprises the 4K camera head, objective lens and power cable and video cables. The proposed system is reusable device, and provided non-sterile. The proposed camera head and should be cleaned and disinfected after each use.

The video cables include an SDI video cable and an HDMI video cable. The 4K camera control unit has two models (ES-CS4K100 and ES-CS4K200) with the only difference on signal output terminals, the detail difference refers to Table 3 of this document; the 4K camera head only has one model (ES-CS4K100C). Therefore, the 4K UHD Camera System is available in two models in combination of the 4K camera control unit and 4K camera head.

The Scivita Medical Technology Co., Ltd. 4K UHD Camera System (K200216) is designed to provide imaging for endoscopic surgery. My analysis of the provided text did not reveal a detailed acceptance criteria table nor a specific study demonstrating the device's fulfillment of those criteria. Instead, the document focuses on non-clinical performance testing and substantial equivalence to a predicate device.

Here's an analysis of the available information regarding acceptance criteria and performance:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that "the subject device met all predefined acceptance criteria" for various performance tests, but it does not provide specific numerical acceptance criteria or the numerical results (i.e., the reported device performance) for these tests.

The document details the general specifications of the device, which can be seen as implicit performance benchmarks:

2. Sample Size for the Test Set and Data Provenance

The document does not mention a "test set" in the context of clinical images or patient data. The performance tests mentioned (Depth of Field, Resolution, etc.) appear to be non-clinical engineering/technical evaluations of the device hardware and software, likely using test targets and technical measurements rather than patient data. Therefore, information on sample size and data provenance (country of origin, retrospective/prospective) for a test set of medical data is not applicable based on the provided text.

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

Since the tests described are non-clinical technical performance tests, the concept of "ground truth" derived from expert review of medical images is not applicable here. The ground truth for these tests would be objective technical standards and measurements.

4. Adjudication Method for the Test Set

Not applicable, as the tests described are non-clinical technical performance tests, not studies involving human interpretation of medical images.

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

No MRMC study was performed or mentioned in this document. The submission focuses on demonstrating substantial equivalence through technical performance verification and comparison to a predicate device.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The device described is a 4K UHD Camera System, which is a hardware system for image acquisition, not an AI algorithm for image analysis. The "software" mentioned as a "Moderate level of concern (LoC)" refers to the device's operational software, not an AI for diagnostic interpretation.

7. Type of Ground Truth Used

For the non-clinical performance tests mentioned ("Depth of Field Test," "Resolution Test," etc.), the "ground truth" would be established by predefined engineering specifications, standardized test methods, and objective measurements. The document does not specify how these performance criteria were set or verified beyond stating that "the subject device met all predefined acceptance criteria."

8. Sample Size for the Training Set

Not applicable. The device is a camera system, not an AI model that requires a training set of data.

9. How Ground Truth for the Training Set Was Established

Not applicable, as the device is a camera system, not an AI model.

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The LAP-iX Suction Irrigation provides suction or irrigation to a surgical site during laparoscopic and endoscopic procedures.

The LAP-iX Suction Irrigation provides suction or irrigation to a surgical site during laparoscopic and endoscopic procedures. It delivers sterile irrigation fluids to surgical site and evacuates blood and body fluids from the surgical site to aid visualization. It consists of 4.50 diameter shaft, suction/irrigation buttons and suction/irrigation tubes with hand piece. It has two types of hand piece, pistol and trumpet grip. The subject device is compatible with all suction and irrigation pumps in the market which have the connecting tubes or connectors of Ø10mm (Suction) or Ø7mm(Irrigation). All equipment conforming to this specs can be used. It is provided sterile, for Rx only and single use.

The provided text does not contain information about the acceptance criteria and the study that proves the device meets those criteria in the context of an AI/ML-driven medical device.

The document is a 510(k) clearance letter for a LAP-iX Suction Irrigation device. This is a conventional medical device used in laparoscopic and endoscopic procedures for surgical suction and irrigation.

The "Performance Data" section (page 4, point 7) lists general verification, validation, and testing activities, including:

• Sterilization Validation Test in accordance with ISO11737-1
• Shelf Life Validation Test in accordance with ASTM F 1980
• Biocompatibility Tests in accordance with ISO 10993 (specifically ISO 10993-5 for Cytotoxicity, and ISO 10993-7 for Ethylene Oxide Sterilization Residuals, ISO 10993-10 for Skin Sensitization and Irritation)
• Performance Tests: Air tightness, Suction and Irrigation Test

It states that "The device passed all of the tests based on pre-determined pass/fail criteria." However, it does not provide the specific acceptance criteria that were pre-determined, nor does it detail the results of these tests (e.g., specific values for air tightness, suction, or irrigation performance).

Therefore, I cannot provide the requested information regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details, as these are typically relevant for AI/ML device evaluations and are not present in this document for a traditional physical medical device.

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The WV1 endoscope is a reusable, rigid, video endoscope, designed to be used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs.

The WV1 System is comprised of two main components: WV1 endoscope (Video endoscope) and FuseBox (Video Processor, cleared under (K132839). The WV1 endoscope is a reusable, rigid, video endoscope. The device has been designed to be used with a compatible video system, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery. It is a reusable (autoclavable) endoscope and is intended to be used in a sterile environment. It is initially supplied non-sterile to the user and requires the user to process (i.e., clean and sterilize) the device for initial use, as well as after each use. The WV1 endoscope main components are the distal tip, the endoscope body and the endoscope main connector. The required illumination for the endoscope is supplied by integrated LEDs, located on the endoscope's distal tip. The endoscope video system is controlled by the video processor which collects a video signal produced by the CCD (Charge Couple Device). The video assembly that controls the field view and image characteristics, including video resolution and brightness, is located in the endoscope's distal tip. The WV1 Distal Tip is equipped with a color CCD and covers a 90° field of view. The extended field of view is achieved by use of additional 2 lenses located behind the endoscope's distal tip, each attached to a separate CCD. The geometrical location of the lenses allows for image overlap that results in the extended field of view (enabled by operation of the Fusebox). Each view on the distal tip has its own dedicated illumination source (LEDs). The images are presented side by side on a display monitor.

This document describes the 510(k) premarket notification for the WV1 Endoscope. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that an AI-driven device meets specific performance acceptance criteria for a diagnostic task.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study that proves an AI-driven device meets those criteria, specifically:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number of experts, adjudication methods for a test set.
• Information on MRMC studies, standalone performance.
• Types of ground truth used or how it was established for training and test sets.

The document discusses non-clinical performance testing for a medical device (an endoscope), not a software or AI-driven diagnostic system. The "bench testing" mentioned refers to physical characteristics and optical performance of the endoscope, not diagnostic accuracy.

In summary, the provided document is a 510(k) submission for an endoscope and does not contain the information necessary to address the prompt's request regarding acceptance criteria and study results for an AI-driven diagnostic device.

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