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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 Medical Video Endoscope is designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney.

The image processor is used with the specified endoscope designed by SEPLOU during minimally invasive surgery.

The image processor provides power and processes the images for medical electronic endoscope.

The Medical Video Endoscope system is designed to provide image solution for endoscopy and endoscopic surgery, and perform procedures in the urinary tract and interior of the kidney using appropriate accessory devices (e.g. laser fibers, forceps baskets).

The Medical Video Endoscope is a sterile Medical Video Endoscope. The Image Processor for Endoscopy is a reusable monitor.

The Medical Video Endoscope is comprised of a control body with articulation controls and accessory access ports, and a flexible insertion tube with an on-tip camera module and LED lighting source. The Image Processor processes the images from the Endoscope and outputs video signals to a display.

This document describes the FDA 510(k) clearance for the Seplou (ZHUHAI) Co., Ltd. Medical Video Endoscope System. It is important to note that this is a medical device clearance, not an AI/ML device clearance. Therefore, the information regarding AI-specific criteria like training sets, expert ground truth, and MRMC studies will not be present in this document. The provided text does not describe an AI/ML device.

Here's an analysis based on the provided document for the Medical Video Endoscope System:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a medical device and not an AI/ML system, the "acceptance criteria" discussed are related to physical, electrical, and performance standards rather than metrics like sensitivity or specificity. The "reported device performance" refers to the device's adherence to these standards.

2. Sample Sizes Used for Test Set and Data Provenance

This is not applicable as the clearance is for a physical medical device (endoscope system) and not an AI/ML algorithm that processes data. The "test set" in this context refers to the physical units and their components undergoing various engineering and performance tests, not a dataset of medical images. The data provenance would be laboratory testing data generated during the device's development and validation.

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

This is not applicable for a non-AI medical device clearance. Ground truth, in the context of AI/ML, refers to definitively labeled data. For this device, "ground truth" would be established through adherence to engineering standards, validated measurement techniques, and industry best practices by qualified engineers and technicians.

4. Adjudication Method for the Test Set

Not applicable for a non-AI medical device clearance. Adjudication methods like 2+1 or 3+1 are used for reconciling expert disagreements in AI ground truth labeling. For a physical device, testing outcomes are typically definitive measurements against established standards.

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

Not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks. This device is an endoscope system, not an AI diagnostic tool.

6. Standalone (i.e. algorithm only without human-in-the loop performance) Study

Not applicable. This device is a physical endoscope system, not a standalone algorithm.

7. Type of Ground Truth Used

The "ground truth" for this medical device's performance is established by:

• International Standards: Adherence to ISO, ASTM, and IEC standards for biocompatibility, sterilization, electrical safety, EMC, optical performance, and packaging.
• Engineering Specifications: The device's measurable physical and optical properties meeting predefined design specifications.
• Comparison to Predicate Device: Demonstrating substantial equivalence to a legally marketed predicate device, implying similar performance characteristics.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable for the same reason as above.

Summary of Device and Performance:

The Seplou (ZHUHAI) Medical Video Endoscope System aims to provide an image solution for endoscopy and endoscopic surgery within the urinary tract and interior of the kidney. It consists of multiple models of flexible endoscopes and an image processor.

The device's performance has been demonstrated through a series of non-clinical tests to meet established regulatory and industry standards. This includes:

• Biocompatibility: Evaluated according to ISO 10993-1, covering cytotoxicity, sensitization, irritation, acute systemic toxicity, and material-mediated pyrogens.
• Sterilization and Shelf Life: Validated via ISO 11135:2014 for sterilization, ISO 10993-7:2008 for EO/ECH residuals, and ASTM F1980-21 for accelerated aging to support a 3-year shelf life. Package validation was also done per ISO and ASTM standards.
• Electrical Safety and EMC: Complies with IEC 60601-1 (general medical electrical equipment safety), IEC 60601-2-18 (endoscopic equipment specific safety), and IEC 60601-1-2 (electromagnetic compatibility).
• Software Verification and Validation: Conducted and documented as per FDA guidance.
• Bench Performance Testing: Included optical performance (according to ISO 8600 series, color reproduction, geometric distortion, resolution, depth of field, image intensity uniformity, noise, dynamic range compared to the predicate device) and mechanical tests (use-life of bending section, control knob, connection strength, tensile force, and corrosion resistance).

The conclusion states that these performance tests and compliance with voluntary standards confirm the substantial equivalence of the proposed Medical Video Endoscope system to its predicate device (K172098). No clinical studies were deemed necessary for this clearance.

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Strauss Surgical Cystoscopes are intended to illuminate and visualize the male urethra, prostate, and bladder for the purpose of performing diagnostic and surgical procedures.

Strauss Surgical Hysteroscopes are intended to illuminate and visualize the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.

The cystoscopes/hysteroscopes described herein are rigid endoscopes for visualizing the urethra, the urinary bladder or uterus, fallopian tube ostium and the cervical canal during the performance of endoscopic procedures in urology or gynecology.

A rigid endoscope consists of a fiber optic cable and sensitive image transmission system with eyepiece. The fiber optic cable is used to illuminate the site inside the body. The connector for connecting the light guide to the light source is situated at the proximal end of the endoscope. The adapters required to connect the light guide are included in the scope of delivery.

The distal end of the endoscope features an objective lens that captures the image from inside the body. The image is sent through the image transmission system to the eyepiece.

The provided document is a 510(k) clearance letter from the FDA for a medical device called "Strauss Surgical Cystoscopes & Hysteroscopes." This type of document primarily focuses on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving those criteria are met for the newly cleared device itself.

Crucially, the document explicitly states under the "Non-Clinical and/or Clinical Tests Summary & Conclusions" section that:

"The subject and predicate devices have identical technological characteristics. Therefore, no performance testing was necessary to demonstrate that the subject device is equivalent to the predicate device in terms of safety and performance."

This means that a study proving the device meets individual acceptance criteria, as typically understood for new device performance validation, was not performed or not deemed necessary by the FDA for this 510(k) clearance due to the identical technological characteristics with a previously cleared predicate device.

Therefore, I cannot provide the requested information regarding specific acceptance criteria and the study that proves the device meets them because the document clearly states such testing was not performed for this clearance.

However, I can still address some of your points based on the information provided, even if it's to state the absence of the requested detail:

1. A table of acceptance criteria and the 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)

• Sample Size for Test Set: Not applicable, as no performance testing was conducted.
• Data Provenance: Not applicable, as no performance testing was conducted.

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, as no performance testing was conducted.

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

• Not applicable, as no performance testing was conducted.

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 a rigid endoscope for visualization, not an AI-powered diagnostic tool. Furthermore, no performance testing was conducted.

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

• Not applicable. This device is a rigid endoscope, not an algorithm. Furthermore, no performance testing was conducted.

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

• Not applicable, as no performance testing was conducted.

8. The sample size for the training set

• Not applicable, as no performance testing was conducted (and this is not an AI device that would typically have a training set).

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

• Not applicable, as no performance testing was conducted (and this is not an AI device that would typically have a training set).

Summary of Document's Key Information regarding Performance:

The FDA clearance for the Strauss Surgical Cystoscopes & Hysteroscopes (K251652) was based on substantial equivalence to existing predicate devices (K150158 Schoelly Cystoscopes/Hysteroscopes and accessories). The manufacturer asserted, and the FDA accepted, that the subject device and the predicate device have identical technological characteristics. Therefore, no new performance testing (non-clinical or clinical) was deemed necessary or performed to demonstrate safety and effectiveness for this specific 510(k) submission. The clearance relies on the established safety and performance of the predicate device.

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The HydroCision SpineSite System is intended to be used as a single-use endoscopic video camera in a variety of endoscopic diagnostic and surgical procedures for spine applications. The device is also intended to be used as an accessory for microscopic surgery.

The HydroCision SpineSite System is comprised of (i) sterile disposable endoscope and (ii) reusable Video Processing Unit (VPU). The HydroCision SpineSite System provides illumination, image processing and digital documentation for endoscopic procedures. The HydroCision SpineSite System is not suitable for use in the MR environment.

The SpineSite Endoscope provides distal LED illumination via LEDs surrounding a high-resolution video sensor. The SpineSite Endoscope contains a working channel for the passage of micro instrumentation to the surgical site. The SpineSite Endoscope is provided sterile, via ethylene oxide sterilization.

The SpineSite Endoscope is designed to be connected to the SpineSite VPU via a proprietary edge card connector which provides power to the endoscope and supports video processing capability. The SpineSite VPU is powered via connection to an external wall outlet via a 12V power adapter.

The provided text is a 510(k) clearance letter and a 510(k) summary for the HydroCision SpineSite System. It details the device's indications for use, its components, and various non-clinical performance tests conducted to meet regulatory requirements. However, this document does not contain any information about a study proving the device meets specific acceptance criteria related to its performance in a clinical or AI-assisted context.

The "Performance Testing" section lists only non-clinical tests:

• Biocompatibility per ISO 10993-1
• Design verification/validation to mechanical and optical specifications
• Electrical, Mechanical and Thermal (EMT) safety testing per IEC 60601-1, IEC 60601-2-18
• Human Factors/ Usability per IEC 60601-1-6
• Electromagnetic compatibility testing per IEC 60601-1-2
• Software validation

The "Substantial Equivalence Summary" focuses on comparing the HydroCision SpineSite System to its predicate device (Arthrex Nanoscope System) on aspects like intended use, technological design, sterilization, electrical safety, materials, and technical features (optical resolution, field of view, depth of field, etc.). It states: "The safety and effectiveness of the HydroCision SpineSite System are adequately supported by the non-clinical performance data, substantial equivalence information, and comparison of design characteristics provided within this premarket notification."

Therefore, based solely on the provided text, I cannot answer the specific questions related to acceptance criteria and a study proving the device meets those criteria, particularly those concerning:

1. A table of acceptance criteria and reported device performance (in a clinical/AI context).
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study (AI vs. human).
6. Standalone algorithm performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The device described is an endoscopic video camera system, not an AI-powered diagnostic device, which is what the questions regarding "AI assistance," "effect size," "standalone algorithm performance," and "training set" typically refer to. The document suggests a traditional medical device clearance based on substantial equivalence and non-clinical performance testing for a physical device, not an AI/ML algorithm.

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a. Endoscope Model EB-710P
Endoscope Model EB-710P is a bronchoscope intended for the observation, diagnosis and endoscopic treatment of the trachea and bronchus at medical facilities under the management of physicians. Never use this product for any other purposes.

b. Processor EP-8000
The EP-8000 is an endoscopic processor with an integrated light source that is intended to provide illumination, process electronic signals transmitted from a video endoscope and enable image recording.

This product can be used in combination with compatible medical endoscope, a monitor, a recorder and various peripherals.

It is used for endoscopic observation, diagnosis and treatment.

a. Endoscope Model EB-710P
FUJIFILM Endoscope Model EB-710P is comprised of three general sections: an insertion portion, a control portion, and a connector portion to the peripherals. The insertion portion is flexible and contains glass fiber bundles, several channels, and a complementary metal-oxide semiconductor (CMOS) image sensor in its distal end. The glass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion portion to illuminate the body cavity. This provides enough light to the CMOS image sensor to capture an image and display it on the monitor. The channels in the insertion portion assist in delivering suction as well as endoscopic accessories. The control portion controls the angulation and rotation of the bending portion in the insertion portion. The connector portion consists of electronic components needed to operate the endoscope when connected to the video processor. The endoscopes are used in combination with FUJIFILM's video processors, light sources, and peripheral devices such as monitor, printer, foot switch, and cart.

b. Processor EP-8000
FUJIFILM Video Processor EP-8000 is intended to provide illumination, process electronic signals transmitted from a video endoscope and enable image recording.

FUJIFILM Video Processor EP-8000 relays the image from an endoscope to a video monitor. The projection can be either analog or digital at the user's preference. The processor employs fiber bundles to transmit light from four LED lamps (Violet, Blue, Green, and Amber), with a total power of 79.2W lamps, to the body cavity.

The device is AC operated at a power setting of 100-240V/50-60Hz/ 3.0-1.5A. The processor is housed in a steel-polycarbonate case measuring 395×210×515mm

The provided FDA 510(k) clearance letter pertains to the FUJIFILM Endoscope Model EB-710P and Processor EP-8000. It details the substantial equivalence of these devices to their predicates based on non-clinical testing.

However, the provided text does not contain information about acceptance criteria or a study that uses a test set to prove the device meets those criteria.

The document primarily focuses on:

• Product identification: Device names, regulation numbers, product codes.
• Regulatory details: FDA clearance status, general controls, and compliance requirements.
• Substantial equivalence justification: Comparison of intended use, technological characteristics, and principles of operation between the new devices and their predicates.
• Non-clinical testing: A list of engineering tests performed (e.g., electrical safety, software validation, color and optical performance, image quality assessments like reproduction, geometric distortion, resolution, depth of field, ISO-SNR, dynamic range, intensity uniformity, and field of view).

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided FDA clearance letter.

To answer your request, I would need a document (e.g., a summary of safety and effectiveness, or a clinical study report) that explicitly defines:

1. Acceptance criteria: Quantitative thresholds or qualitative statements that define successful device performance.
2. Reported device performance: The actual outcomes measured during the study.
3. Test set details: Sample size, data provenance, ground truth establishment (experts, adjudication, type of ground truth).
4. Training set details: Sample size, ground truth establishment.
5. MRMC study information: If applicable, whether human readers improved with AI assistance and by how much.
6. Stand-alone algorithm performance: If an algorithm-only study was conducted.

The provided document only states that "EP-8000 demonstrated substantial equivalence to VP-7000 and BL-7000 in Image performance and color reproduction" for the listed non-clinical tests, implying that the new device performed as well as the predicate for these specific engineering parameters, but it does not provide the specific performance values or the acceptance thresholds for these parameters. It also makes no mention of AI assistance or human reader studies.

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FUJIFILM Endoscope Models EG-840T and EG-840TP is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.

FUJIFILM Endoscope Model EG-840N is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum. This product can be inserted orally or nasally.

Never use this product for any other purposes.

The insertion portion of the device has a mechanism (hereinafter "the bending portion") which bends the tip from right to left and up and down, and a flexible tube (hereinafter "the flexible portion") consists of the bending portion and operating portion with a knob which controls the bending portion. The forceps channel which runs through the operating portion to the tip is arranged inside the insertion portion for inserting the surgical instrument. The insertion portion of the endoscopes comes into contact with the mucosal membrane.

The tip of the insertion portion is called the "Distal end" which contains the Imaging section, Distal cap, Objective lens, Air/water nozzle, Water jet nozzle (Except EG-840N), Instrument channel outlet, and Light guide. The bending portion is controlled by knobs on the control portion/operation section to angulate the distal end to certain angles.

The Flexible portion refers to the long insertion area between the Bending portion and the Control portion (a part of Non-insertion portion). This portion contains light guides (glass fiber bundles), air/water channels, a forceps/suction channel, a CrOS image sensor, and cabling. The glass fiber bundles allow light to travel through the endoscope to illuminate the body cavity, thereby providing enough light to the CMOS image sensor to capture an image and display the image on a monitor. The forceps channel is used to introduce biopsy forceps and other endoscopic accessories, as well as providing suction.

The control portion/operating section provides a grip to grasp the endoscopes and contains mechanical parts to operate the endoscopes. This section includes a Forceps inlet, which allows endoscope accessories to be introduced. The Scope connector connects the endoscopes to the light source.

The provided FDA 510(k) clearance letter pertains to endoscopes, which are hardware devices, not AI/ML software. Therefore, the information requested regarding acceptance criteria, study details, and data provenance for an AI/ML device is not explicitly present in the provided text.

The document focuses on demonstrating substantial equivalence to a predicate device through various non-clinical tests (electrical safety, biocompatibility, endoscope-specific testing, software validation, and reprocessing validation) rather than a clinical effectiveness study involving human readers or AI performance metrics.

However, I can extract information about the device's performance specifications that were tested to prove its general functionality and safety, which can be interpreted as fulfilling certain "acceptance criteria" for a physical medical device.

Here's a breakdown of the available information based on your request, with the caveat that it does not directly address AI/ML performance:

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

The document lists various performance specifications that the device met. It does not provide specific numerical acceptance criteria alongside reported performance values in a table format. Instead, it states that "The subject device met performance specifications in the following additional testing." This implies that the device did meet predefined internal thresholds for these parameters.

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

• Sample Size: Not specified for any of the tests. The document mentions "testing" or "validation activities" without detailing the number of devices or trials involved.
• Data Provenance: Not specified. As this is a 510(k) for a physical medical device (endoscope), the testing would typically be conducted in a laboratory setting by the manufacturer, rather than involving patient data in the context of imaging performance.

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

Not applicable. The tests performed are engineering and safety validations. There is no mention of human expert involvement for establishing "ground truth" in the context of image interpretation or diagnosis, as this is not an AI/ML diagnostic tool.

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

Not applicable. This is a concept typically used in clinical studies involving interpretation by multiple readers, which is not described here.

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 is not an AI-assisted device. The document describes a traditional endoscope.

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

Not applicable. The device itself is an endoscope, not an algorithm. Software validation was conducted (IEC 62304:2015), but this relates to the software controlling the endoscope's functions, not a standalone diagnostic AI.

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

For the listed performance specifications (field of view, resolution, etc.), the "ground truth" would be established by objective physical measurements using calibrated equipment and engineering standards. For biocompatibility, it's based on biological response to materials, and for reprocessing, it's based on sterility and decontamination efficacy. There is no "ground truth" in the diagnostic sense as there would be for an AI/ML algorithm.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

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This product is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.

The insertion portion of the device has a bending mechanism and a flexible tube consisting of the bending portion and an operating portion with a knob to control the bending. A forceps channel runs through the operating portion to the tip for inserting surgical instruments. The insertion portion's tip, called the "Distal end," contains the Imaging section, Distal cap, Objective lens, Air/water nozzle, Water jet nozzle, Instrument channel outlet, and Light guide. The bending portion is controlled by knobs on the control portion/operation section. The flexible portion, between the bending and control portions, contains light guides (glass fiber bundles), air/water channels, a forceps/suction channel, a CMOS image sensor, and cabling. The control portion/operating section provides a grip and mechanical parts to operate the endoscopes, including a Forceps inlet. The Scope connector links the endoscopes to the light source and video processor.

The provided FDA 510(k) clearance letter and summary for the FUJIFILM Endoscope Models EC-860P/M, EC-860P/L, and EC-860S/L primarily focus on demonstrating substantial equivalence to predicate devices through bench testing and compliance with various consensus standards. It does not describe a clinical study in the traditional sense, where device performance is measured against specific acceptance criteria in a human subject population using metrics like sensitivity, specificity, or accuracy, often seen with AI or diagnostic imaging devices.

Instead, the submission relies on demonstrating that the new endoscope models meet established performance specifications and safety standards through non-clinical testing.

Here's an analysis based on the provided text, addressing your questions where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for each item. Instead, it refers to the subject device meeting "performance specifications" or demonstrating "substantially equivalent in performance to the predicate devices" for various parameters.

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

No human or patient test set is described. The "test set" consists of the physical endoscope models themselves, subjected to various bench tests and standard compliance evaluations. The data provenance is derived from these non-clinical tests performed by the manufacturer, rather than patient data.

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

Not applicable. This is not a study requiring expert readers to establish ground truth for clinical performance. The "ground truth" for the non-clinical tests is established by the specifications and standards themselves, and verified by testing personnel.

4. Adjudication method for the test set

Not applicable. There is no expert adjudication process described for clinical interpretation. The compliance with standards and performance specifications is determined through objective measurements and validated test methods.

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 endoscope, not an AI-powered diagnostic system. No MRMC study or AI assistance is mentioned. The clearance is for the physical endoscope models.

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

Not applicable. There is no AI algorithm involved in this device submission.

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

For this submission, the "ground truth" is defined by:

• Consensus standards: e.g., electrical safety (ANSI/AAMI ES 60601-1), biocompatibility (ISO 10993-1), medical device software (IEC 62304), endoscope-specific standards (ISO 8600 series).
• Manufacturer's internal performance specifications: These are the benchmarks against which specific performance parameters (e.g., field of view, resolution, bending capability) are measured.
• Predicate device performance: The "bench testing data regarding 'Optical performance' demonstrated that the subject devices are substantially equivalent in performance to the predicate devices." This implies that the performance of the predicate devices serves as a comparative ground truth for equivalence.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. No training set is described.

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Indications remain unchanged from pre-pandemic COVID-19 vaccines for use in individuals 6 months of age and older.

HPE 8570B 50 Ohm Programmable Step Attenuator, DC to 18 GHz

This FDA clearance letter for the Arthrex Spine Endoscope (K243602) does not contain information about the development and validation of an AI/ML device. Instead, it describes a traditional medical device submission for an endoscope.

The letter explicitly states on Page 6: "The Arthrex Spine Endoscope did not require animal testing or human clinical studies to support the determination of substantial equivalence." and "All verification activities were successfully completed to confirm the subject device meets product requirements and design specifications established for the device." This indicates that the clearance was based on non-clinical bench testing and comparison to a predicate device, typical for traditional medical devices, rather than a novel AI/ML algorithm requiring extensive clinical validation with ground truth, expert readers, and comparative effectiveness studies.

Therefore, I cannot extract the requested information about acceptance criteria and study proving an AI/ML device meets those criteria from this document. The document pertains to a physical endoscope, not an AI/ML system.

If you have a different document pertaining to an AI/ML medical device, please provide it, and I will do my best to extract the requested information.

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The da Vinci SP Firefly Imaging System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci SP Firefly Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, using near-infrared imaging.

The da Vinci SP Firefly Imaging System is a fully integrated, adjunct imaging system for the da Vinci SP Surgical System. The da Vinci SP Surgical System is a robotic-assisted surgical device (RASD) that is designed to enable complex surgery using a minimally invasive approach. The system consists of three major subsystems: the Surgeon Console, the Vision Cart, and the Patient Cart.

The da Vinci SP Firefly Imaging System consists of the following components of the da Vinci SP Surgical System (refer to Figure 1):

o the Endoscope Controller (light source) on the Vision Cart
o the SP Endoscope, 0° (subject device), which is installed on the Patient Cart

The Endoscope Controller provides a light source, either visible light or a near-infrared (NIR) excitation laser.

The Endoscope transmits visible light or NIR light from the Endoscope Controller via optical fibers to illuminate the surgical site. The stereoscopic camera at the Endoscope tip images the surgical site in either visible light mode or fluorescence imaging mode.

The provided FDA clearance letter for the SP Endoscope, 0° (430600) does not contain detailed information about the acceptance criteria and study results in the format requested. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing comprehensive efficacy study results.

Specifically, the document states that "The successful completion of testing demonstrated that the subject device (SP Endoscope, PN 430600) design outputs meet the design inputs, and the design validation validated that the user needs are met." However, it does not provide specific quantitative acceptance criteria or detailed performance data against those criteria.

Therefore, many of the requested fields cannot be accurately populated from the provided text.

Here's a breakdown of what can and cannot be answered based on the input:

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

• Cannot be provided definitively. The document lists various tests performed (Design Verification, Reliability Testing, Cleaning Validation, Transit Verification, Biocompatibility, Design Validation, EMC Testing) and states that the device "successfully met the acceptance criteria" or "met all acceptance criteria." However, the specific quantitative acceptance criteria for each test and the corresponding reported performance values are not detailed. For example, for "Range of Motion" verification, the specific range of motion deemed acceptable and the actual measured range are not present.

2. Sample size used for the test set and the data provenance:

• Cannot be provided definitively. The document mentions "a series of tests" and "bench testing" but does not specify the sample sizes used for these tests. Data provenance (country of origin, retrospective/prospective) is also not mentioned.

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

• Not applicable / Cannot be provided. This type of information is typically relevant for studies involving human interpretation (e.g., imaging studies that require expert readings to establish ground truth). The tests described here are primarily engineering and performance verification tests for a physical endoscope, not studies requiring expert clinical judgment for ground truth establishment. Even for "Simulated clinical use testing," details about expert involvement for ground truth are absent.

4. Adjudication method for the test set:

• Not applicable / Cannot be provided. Similar to point 3, adjudication methods are typically used in clinical studies where multiple human readers assess cases and discrepancies need to be resolved to establish a robust ground truth. The tests mentioned here do not fit this context.

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 such study was described. The device is an endoscope and imaging system, not an AI-powered diagnostic tool intended to assist human readers in a comparative effectiveness study. The document focuses on the device's physical and functional performance, not its impact on human reader performance.

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

• Not applicable. This device is an endoscope, a physical instrument for visualization, not a standalone algorithm.

7. The type of ground truth used:

• Implicit: Engineering specifications and regulatory standards. For the various tests, the "ground truth" implicitly refers to the predefined engineering design inputs, performance specifications, and requirements outlined in relevant standards (e.g., ISO 10993-1 for biocompatibility, IEC 60601-1-2 for EMC, AAMI standards for cleaning). The document states that the device "met the acceptance criteria" for these standards and specifications.

8. The sample size for the training set:

• Not applicable. This device is a physical endoscope, not an AI model that requires a training set of data.

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

• Not applicable. As above, no training set is involved for this type of device.

Summary of available information regarding acceptance criteria and studies:

The document broadly outlines the types of studies performed as evidence for substantial equivalence, focusing on design and safety aspects:

• Design Verification:

  • Focus Areas: Design Properties, Range of Motion, PSC Interaction, Optical Performance, Electrical Properties, Firefly, Mechanical requirements (Crimp Strength, Window Strength, Extended Illumination, Tip Durability, and Manifold Air Permeability).
  • Acceptance Criteria: "Functional design outputs met the functional design inputs." (Specific criteria not detailed in the provided text).
  • Outcome: "Bench testing was performed to verify that the functional design outputs met the functional design inputs."

• Reliability Testing:

  • Focus: Impact of increased number of lives (uses) and reprocessing cycles (50 lives, 60 reprocessing cycles for subject device vs. 33 lives, 40 cycles for predicate).
  • Acceptance Criteria: That the device "is not adversely affected by the increased number of lives (uses) and reprocessing cycles." (Specific criteria not detailed).
  • Outcome: "Reliability Testing was performed to ensure that...the subject device...is not adversely affected..." (Implies successful outcome).

• Cleaning Validation:

  • Focus: Efficacy of the manual cleaning process.
  • Acceptance Criteria: Compliance with FDA Guidance, AAMI ST98:2022, AAMI TIR 12:2020, AAMI TIR 30: 2011/(R)2016, ISO 17664-1:2022. "Successfully met the acceptance criteria for all markers."
  • Outcome: "demonstrate that the subject device can be cleaned using the manual cleaning process."

• Transit Verification Testing:

  • Focus: Performance during shipping and distribution.
  • Acceptance Criteria: Compliance with ASTM D4169-22. "Met all the acceptance criteria."
  • Outcome: "demonstrate that the subject device has been validated for use within the shipping and distribution environment."

• Biocompatibility:

  • Focus: Biological safety of patient-contacting materials.
  • Acceptance Criteria: Compliance with FDA Guidance: Use of International Standard ISO-10993 and ISO 10993-1:2018. "Met all acceptance criteria for biocompatibility testing."
  • Outcome: "Biological Safety Assessment...determined that there was negligible risk to patient safety under its intended use."

• Design Validation:

  • Focus: Product specifications meeting user's needs and intended use.
  • Acceptance Criteria: Implicitly, that "the product specifications meet the user's needs and intended use." (Specific details not provided).
  • Outcome: "Simulated clinical use testing was performed to validate that the product specifications meet the user's needs and intended use."

• EMC Testing:

  • Focus: Electromagnetic compatibility.
  • Acceptance Criteria: Compliance with IEC 60601-1-2 Edition 4.1 2020-09.
  • Outcome: "The test results demonstrate that the subject device meets the applicable requirements within this standard."

In conclusion, the provided text confirms that specific validation and verification activities were conducted to demonstrate the safety and effectiveness of the SP Endoscope, 0°. However, it does not offer the granular detail of quantitative acceptance criteria and reported performance values typically requested for a comprehensive study breakdown. This is common for 510(k) summaries where the primary goal is to establish substantial equivalence based on a comparison to a predicate device and adherence to recognized standards.

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a. Processor EP-8000

• The EP-8000 is an endoscopic processor with an integrated light source that is intended to provide illumination, process electronic signals transmitted from a video endoscope and enable image recording.
• This product can be used in combination with compatible medical endoscope, a monitor, a recorder and various peripherals.
• It supplies air through the endoscope, for obtaining clear visualization and is used for endoscopic observation, diagnosis and treatment.
• BLI (Blue Light Imaging), LCI (Linked Color Imaging), ACI (Amber-red Color Imaging) and FICE (Flexible spectral-Imaging Color Enhancement) are adjunctive tools for gastrointestinal endoscopic examinations which can be used to supplement Fujifilm white light endoscopy. BLI, LCI, ACI and FICE are not intended to replace histopathological sampling as a means of diagnosis.

b. Endoscope Model EG-860R

This product is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.

FUJIFILM Video Processor EP-8000 is intended to provide illumination, process electronic signals transmitted from a video endoscope and enable image recording.

FUJIFILM Video Processor EP-8000 relays the image from an endoscope to a video monitor. The projection can be either analog or digital at the user's preference. The processor employs fiber bundles to transmit light from four LED lamps (Violet, Blue, Green, and Amber), with a total power of 79.2W lamps, to the body cavity.

The EP-8000, like the VP-7000 and BL-7000, has additional image processing options called BLI, BLI-bright, and LCI that provide endoscopic assistance for white light imaging (WLI). There is also an additional image processing option called "ACI"(Amber-red Color Imaging).

ACI is an image processing function that simultaneously emphasizes the brightness and color difference of red information in endoscopic images and serves as an adjunct to white light imaging (WLI).

Compared to WLI mode, ACI relatively increases the ratio of amber red light and decreases the ratio of violet light.

Relatively high-saturation red information such as blood-like red in the image signal digitized by the camera unit is enhanced by signal processing.

The EP-8000 also has a Multi Observation option that allows endoscopic images to be displayed in the main screen area and sub-screen area by switching image processing options at every frame. This allows each image frame to be displayed in the main screen area and sub-screen area 1 with a different combination of image processing options applied [WLI+(LCI), LCI+(WLI), BLI+(WLI), WLI+(BLI)].

The device is AC operated at a power setting of 100-240V/50-60Hz/ 3.0-1.5A. The processor is housed in a steel-polycarbonate case measuring 395x210x515mm

The insertion portion of the device has a mechanism (hereinafter "the bending portion") which bends the tip from right to left and up and down, and a flexible tube (hereinafter "the flexible portion") consists of the bending portion and operating portion with a knob which controls the bending portion. The forceps channel which runs through the operating portion to the tip is arranged inside the insertion portion for inserting the surgical instrument.

The insertion portion of the endoscopes comes into contact with the mucosal membrane.

The tip of the insertion portion is called the "Distal end" which contains the Imaging section, Distal cap, Objective lens, Air/water nozzle, Water jet nozzle, Instrument channel outlet, Objective lens, and Light guide.

The bending portion is controlled by knobs on the control portion/operation section to angulate the distal end to certain angles.

The Flexible portion refers to the long insertion area between the Bending portion and the Control portion (a part of Non-insertion portion). This portion contains light guides (glass fiber bundles), air/water channels, a forceps/suction channel, a CMOS image sensor, and cabling. The glass fiber bundles allow light to travel through the endoscope to illuminate the body cavity, thereby providing enough light to the CMOS image sensor to capture an image and display the image on a monitor. The forceps channel is used to introduce biopsy forceps and other endoscopic accessories, as well as providing suction.

The control portion/operating section provides a grip to grasp the endoscopes and contains mechanical parts to operate the endoscopes. This section includes a Forceps inlet, which allows endoscope accessories to be introduced. The Scope connector connects the endoscopes to the light source and video processor, respectively.

The provided FDA 510(k) clearance letter and summary for FUJIFILM Processor EP-8000 and FUJIFILM Endoscope Model EG-860R focus on establishing substantial equivalence to predicate devices, primarily through engineering performance testing rather than clinical study data involving human readers or AI algorithms. The document explicitly states that the various imaging modes (BLI, LCI, ACI, FICE) are "adjunctive tools" and "not intended to replace histopathological sampling as a means of diagnosis." This indicates that the device operates as an image enhancement and visualization tool, not a diagnostic AI that makes independent claims.

Therefore, the study described in the document is a non-clinical engineering performance evaluation comparing the new device's image quality and functional parameters to those of existing predicate devices. It is not a clinical study involving an AI algorithm and human readers.

Here's an attempt to answer the questions based on the provided text, recognizing that many details typically requested for AI/human reader studies are not applicable or not provided in this type of 510(k) submission:

Acceptance Criteria and Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format typical of standalone AI performance studies. Instead, it states that "the devices met the pre-defined acceptance criteria for the test" for the EG-860R, and for the EP-8000, "EP-8000 demonstrated substantial equivalence to VP-7000 and BL-7000 in Image performance and color reproduction." The acceptance criteria were "engineering requirements listed in this section" and "identical to those assessed for the predicate devices."

The "performance (of) Image and the performance of the WLI, FICE, BLI, BLI-bright, LCI and ACI imaging modes" was evaluated for the EP-8000. For the EG-860R, a range of performance characteristics was evaluated.

Table of Performance Evaluation (Based on provided text, not explicit acceptance criteria):

Study Details:

1. Sample size used for the test set and the data provenance:
   This section describes engineering performance testing, not a clinical test set with patient data. The "test set" would refer to the physical devices and various test setups (e.g., optical phantoms, standardized targets) used to evaluate the specified engineering parameters. The document does not specify a "sample size" in terms of number of patient cases or images, as it is evaluating hardware and its image generation capabilities directly through engineering tests.

   • Provenance: Not applicable in the context of patient data. The tests were "conducted in combination with representative FUJIFILM gastroscopes."

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

   • Not applicable. Ground truth in this context is established by the engineering specifications and calibrated measurement equipment, not clinical expert consensus. The device produces images; it does not make a diagnosis that would require expert ground truth.

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

   • Not applicable. This relates to clinical interpretation and consensus, which is not part of this engineering performance evaluation.

4. 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. An MRMC study was not performed. The submission describes engineering performance comparisons to predicate devices, not an evaluation of human reader performance with or without AI assistance. The new imaging modes (BLI, LCI, ACI, FICE) are explicitly stated as "adjunctive tools...not intended to replace histopathological sampling as a means of diagnosis."

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

   • No. This is not an AI algorithm making independent diagnostic claims. The performance evaluated is that of the hardware (processor and endoscope) and its image enhancement capabilities.

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

   • Engineering specifications and measurements. The "ground truth" for the performance tests (e.g., resolution, color reproduction, geometric distortion) would be derived from precisely known physical targets, measurement instruments, and established engineering standards. It is not clinical ground truth (e.g., pathology, clinical outcomes, or expert consensus) because the device's function is image generation and enhancement, not diagnostic interpretation.

7. The sample size for the training set:

   • Not applicable. This device is an endoscope and processor system, not a machine learning model that requires a training set in the conventional sense.

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

   • Not applicable. As above, there is no "training set" for this hardware device.

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