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This instrument is intended to be used with a PENTAX Video Processor (including light source), documentation equipment, Monitor, Endotherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract including the anus, rectum, sigmoid colon, colon and ileocecal valve.

The PENTAX Video Colonoscopes (EC Family), Model Numbers: EC-3890TLK, EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC-3890LZi, EC34-i10L, EC38i10L are used with a Video Processor. The EC-3890TLK is composed of the following main parts: an Insertion Portion, Control Body and PVE Connector. The Insertion Portion is inserted into the body cavity of patient. The Insertion includes the Distal End and Bending Section. The Objective Lens, Light Guide, Instrument Channel, Air/Water Nozzle, and Water Jet Nozzle are located on the Distal End of the Insertion Portion. The Control Body is held by the user's hand. The Control Body includes the Angulation Control Knob, Angulation Lock Knob/Lever, Air/Water, Suction Cylinder, Remote Button, Suction Selector Cylinder, and Instrument Channel Inlet. The AirMater Feeding Valve is attached to the Air/Water Cylinder, and the Suction Control Valve is attached to the Suction Cylinder. The Suction Channel Selector is attached to the Suction Selector Cylinder. The Inlet Seal is attached to the Instrument Channel Inlet. The PVE Connector is connected to the Video Processor via an Electrical Contacts. The Bending Section is bent by the Angulation Control Knob to operate the endoscope anqulation. The Angulation Lock Knob/Lever is used to adjust the rotation torque of the Angulation Control Knob. The Air/Water Feeding System is used to deliver the air and water to the Objective Lens from the AirMater Nozzle. When the hole at the top of Air/Water Feeding Valve is covered, the air is delivered. When the Air/Water Feeding Valve is pushed, the water is delivered. The Suction Control System is used to suction the fluid and air in body cavity from the Instrument Channel. When the Suction Control Valve is pushed, the fluid and air are suctioned. The EC-3890TLK has two channels; the primary channel and secondary one. Suction Channel Selector is used to switch between the primary and secondary channels as necessary. The Remote Button is used to operate the function of video processor and external device from the control body, as necessary. Endotherapy Device such as Biopsy Forceps is inserted from the Instrument Channel Inlet into the body cavity through the instrument channel. The Water Jet System is used to stream forward the sterile water from Water Jet Nozzle. The Light Guide of the Distal End is used to illuminate the body cavity by light which is carried through the Light Carrying Bundle. The Light Carrying Bundle guides the light from Light Guide Plug which is connected to the Light Source inside the Video Processor. The CCD built into the Distal End receives reflected light (image data) from the body cavity, and sends the image data to the Video Processor through the video cable. The image data are converted into the image signal by the Video Processor, and the image inside the body cavity is displayed on the Monitor.

Here's an analysis of the provided text regarding the acceptance criteria and study for the PENTAX Video Colonoscopes (EC Family):

This document describes the safety and performance testing for a traditional medical device (colonoscope), not an AI/ML-enabled device. Therefore, many of the requested fields pertinent to AI/ML device studies (such as sample sizes for test/training sets, ground truth establishment methods, expert qualifications, adjudication methods, MRMC studies, and standalone performance) are not applicable or explicitly mentioned in the provided text.

The acceptance criteria are primarily related to general safety and performance standards for endoscopes and medical electrical equipment.

Acceptance Criteria and Device Performance for PENTAX Video Colonoscopes (EC Family)

1. Table of Acceptance Criteria and Reported Device Performance

Regarding AI/ML-Specific Information:

The provided text details the submission for PENTAX Video Colonoscopes (EC Family), which are traditional endoscopy devices. The safety and performance data presented are for the physical device itself (electrical safety, biocompatibility, reprocessing, etc.) as per various international standards. There is no mention of artificial intelligence (AI) or machine learning (ML) within this document. Therefore, the following AI/ML-specific points cannot be addressed from the given text:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is a physical device submission, not an AI/ML algorithm. Testing was on the physical device and its components.
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. Ground truth for AI/ML is usually related to disease presence/absence or other assessments by human experts. For this device, "ground truth" refers to compliance with engineering and biological standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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, as there is no AI component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this physical device, the "ground truth" or acceptance criteria are defined by recognized consensus standards (e.g., IEC, ISO, AAMI) regarding safety, performance, and functionality.
8. The sample size for the training set: Not applicable. There is no AI model to train.
9. How the ground truth for the training set was established: Not applicable.

Summary of the Study for PENTAX Video Colonoscopes (EC Family):

The study was a comprehensive non-clinical design verification and validation testing program focused on ensuring the device meets established safety and performance standards for endoscopes. The testing confirmed:

• Design Compliance: Adherence to 21 CFR Part 820.30 (Design Control).
• Safety (Electrical & Mechanical): Compliance with IEC 60601 series for basic safety, essential performance, and specific requirements for endoscopic equipment (IEC 60601-1, IEC 60601-1-1, IEC 60601-2-18, IEC 60601-1-4).
• Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2.
• Biocompatibility: Confirmation that materials are safe for patient contact, tested according to ISO 10993 series for cytotoxicity, sensitization, and intracutaneous reactivity.
• Reprocessing Validation: Validation of cleaning and high-level disinfection procedures through simulated use conditioned test samples, adhering to FDA draft guidance and AAMI TIR standards to ensure the device can be effectively reprocessed for reuse. User comprehensibility of reprocessing instructions was also validated.
• Usability: Compliance with IEC 60601-1-6 and IEC 62366.
• Software Life Cycle: Compliance with IEC 62304 (if applicable to the device's embedded software).
• Optical Characteristics: Compliance with ISO 8600 series for field of view, direction of view, and insertion portion dimensions.
• Quality Management and Risk Management: Compliance with ISO 13485 and ISO 14971.
• Labeling and Symbols: Compliance with relevant IEC and ISO standards for graphical symbols.

The "Master Device (EC-3890TLK)" was used for testing, and its results were stated to satisfy the acceptance criteria of all applicable standards, indicating the entire EC Family is substantially equivalent and safe/effective.

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The XTJF-160AF has been designed to be used with an Olympus EVIS video system center, light source, Documentation Equipment, Video Monitor, Endo-Therapy accessories (such as a Forceps, Electrosurgical Accessories, etc.), Electrosurgical Unit, and other Ancillary Equipment for endoscopy and endoscopic surgery within the duodenum.

Do not use these instruments for any purpose other than their intended uses.

This premarket notification is proposed to establish the safety and effectiveness of the variable stiffness scope that is intended for endoscopy and endoscopic surgery, including electrocautery application, within the duodenum. The intended use of the XTJF-160AF is identical to that of previously cleared device, the TJF-140R and JF-V10. The mechanical structure of variable stiffness is identical to that of another predicate device, the EVIS EXERA Colonovideoendoscopes. While the variable stiffness scope is brand new device in the duodenum, endoscopy and endoscopic surgery, including electrocautery, within the duodenum is popular and the mechanical structure of variable stiffness has been confirmed to be safe by the EVIS EXERA Colonovideoendoscopes. Any new insertion method or techniques in consequence of the added mechanical structure of variable stiffness are not considered. Therefore, this modification does not affect the safety and effectiveness of the proposed device,

XTJF-160AF has been designed, manufactured and tested in compliance with voluntary safety standards. It meets the requirement of IEC60601-1, IEC60601-1-2 and IEC60601-2-18.

There are no new patient contacting materials. All of patient contacting materials is cleared by previous 510(k). And all materials have been confirmed with ISO 10993-1.

The provided document is a 510(k) summary for the Olympus XTJF-160AF Duodenovideoscope. It discusses the device's substantial equivalence to previously marketed devices. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC comparative effectiveness studies.

The document primarily focuses on establishing substantial equivalence based on:

1. Intended Use: The intended use of the XTJF-160AF is identical to previously cleared devices (TJF-140R and JF-V10).
2. Mechanical Structure: The variable stiffness mechanism is identical to another predicate device (EVIS EXERA Colonovideoendoscopes), which has already been deemed safe.
3. Materials: No new patient-contacting materials are used, and all materials have been cleared by previous 510(k)s and confirmed with ISO 10993-1.
4. Safety Standards: The device complies with IEC60601-1, IEC60601-1-2, and IEC60601-2-18.

Therefore, I cannot populate the requested table or answer the specific questions about studying device performance as this information is not present in the provided text.

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