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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 Medical Video Colonoscope EC34-i10T Series is compatible with the PENTAX Medical EPK-i7010 Video Processor (K150618) and PENTAX Medical EPK-i5010 Video Processor (K143727). They scopes are composed of three main components: an Insertion Portion, Control Body and PVE Connector. The Insertion Portion is inserted into the body cavity of patient. The Insertion Portion includes the Distal End and Bending Section. The Objective Lens, Light Guide, and Instrument Channel are located on the Distal End of the Insertion Portion. The Distal End also contains an Air/Water Nozzle and Water Jet Nozzle. The Bending Section of the Insertion Body is used to operate the endoscope angulation and is bent by the Angulation Control Knob on the Control Body. The Control Body is held by the user's hand. The Control Body includes the Angulation Control Knob, Angulation Lock Knob/Lever, Air/Water Cylinder, Suction Cylinder, Remote Button, and Instrument Channel Inlet. Endotherapy Device such as Biopsy Forceps may be inserted from the Instrument Channel Inlet into the body cavity through the instrument channel. The PVE Connector is connected to the Video Processor via an Electrical Contacts. The Light Guide of the Distal End is used to illuminate the body cavity by light that is carried through the Light Carrying Bundle. The Light Carrying Bundle guides the light from Light Guide Plug that 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 is converted into the image signal by the Video Processor, and the image inside the body cavity is displayed on the Monitor. The EC34-i10T series includes three models: EC34-i10TF, and EC34-i10TF, and EC34-i10TM. These models are identical in all parameters and only differ in length of the insertion of the scopes.

The provided text describes a 510(k) premarket notification for a new medical device, the PENTAX Medical Video Colonoscope EC34-i10T Series. The document focuses on demonstrating that this new device is substantially equivalent to a previously cleared predicate device (PENTAX Medical EC34-i10L Video Colonoscope).

The nature of this submission (demonstrating substantial equivalence to a predicate device) means that the testing performed largely confirms that the new device maintains the safety and effectiveness characteristics of the predicate, despite minor dimensional and material changes. It does not involve a study to "prove the device meets the acceptance criteria" in the way one might for a novel diagnostic algorithm or a therapy with specific performance metrics against a defined standard. Instead, the acceptance criteria are largely met by demonstrating performance comparable to the predicate and compliance with relevant safety and reprocessing standards.

Therefore, the requested information, particularly regarding "device performance," "sample sizes," "ground truth," "experts," and "MRMC comparative effectiveness study," is not directly applicable in the context of this 510(k) submission, as it relates to a colonoscope, not an AI/ML-based diagnostic tool. The document primarily focuses on validation of reprocessing, biocompatibility, electrical safety, EMC, software, and optical/usability performance against established standards or the predicate device.

However, I can extract the relevant information that is present in the document related to acceptance criteria and the studies performed:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Reprocessing Validation: The document states that "The following testing has been performed for the PENTAX Medical Video Colonoscope EC34-i10T Series." This implies specific units of the device were tested. Sample sizes are not explicitly provided (e.g., how many colonoscopes were subjected to cleaning or HLD efficacy testing), but it would typically involve a statistically relevant number of units as per reprocessing validation standards. Data provenance is not mentioned, but these types of studies are typically conducted by the manufacturer or accredited testing labs.
• Biocompatibility: Involves testing of patient-contacting materials. Sample sizes are not specified but would be dictated by ISO 10993-1.
• Electrical Safety and EMC: Involves testing of device units. Sample sizes are not specified but are typically one or a few units for compliance testing.
• Optical Testing: The document states "PENTAX Medical completed optical testing of the PENTAX Medical Video Colonoscope EC34-i10T compared to the predicate, PENTAX Medical Video Colonoscope EC34-i10L." This indicates at least one unit of each (subject and predicate) was used for comparison.
• Usability Testing: The document states "A comparison of the usability of the PENTAX Medical Video Colonoscope EC34-i10T to PENTAX Medical i10 and k10 series of scopes was conducted." Sample sizes for the tested scopes are not mentioned, nor are the number of users involved in the usability assessment.

All these studies appear to be prospective (conducted specifically for this submission) in nature, performed by the manufacturer or their designated testing facilities. No country of origin for the data is specified, but given the manufacturer's location (Montvale, New Jersey, USA) and the submission to the FDA, it's reasonable to infer a U.S. or international standard-compliant testing environment.

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

This is not applicable to this type of device and submission. Colonoscopes are physical instruments, and their performance is evaluated through engineering and biological testing, not by establishing "ground truth" through expert clinical interpretation in the context of a diagnostic AI.

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

This is not applicable as there is no "ground truth" adjudication process involving experts for a physical device like a colonoscope.

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:

This is not applicable. The device is a video colonoscope, not an AI-assisted diagnostic tool. No human reader studies with or without AI assistance were conducted or reported.

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

This is not applicable. The device is a video colonoscope, not an algorithm.

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

This is not applicable for the reasons outlined above. The "ground truth" for colonoscope performance is adherence to engineering specifications, safety standards, and functional equivalence to a predicate device, demonstrated through direct physical and electrical testing.

8. The sample size for the training set:

This is not applicable. This is a hardware device, not a machine learning algorithm requiring a training set. The device does utilize software, but it is explicitly stated that "The subject devices utilize the same software as the predicate device," implying the software was previously
validated and no new training was performed for this submission.

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

This is not applicable. See points 7 and 8.

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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 upper digestive tract including the esophagus, stomach, and duodenum.

The PENTAX Medical Video Upper GI Scope EG34-i10 is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the upper gastrointestinal tract. The PENTAX Medical Video Upper GI Scope EG34-i10 is compatible with the PENTAX Medical EPK-i7010 Video Processor (K150618) and PENTAX Medical EPK-i5010 Video Processor (K143727).

The PENTAX Medical Video Upper GI Scope EG34-i10 is composed of three main components: an Insertion Portion, Control Body and PVE Connector. The Insertion is inserted into the body cavity of patient. The Insertion Portion includes the Distal End and Bending Section. The Distal End of the Insertion Portion includes the Objective Lens, Light Guide, Instrument Channel, Air/Water Nozzle, and Water Jet Nozzle.

The Air/Water Feeding System is used to deliver the air and water to the Objective Lens from the Air/Water Nozzle. The Air/Water Feeding Valve is attached to the Air/Water Cylinder. 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. A Water Jet System is used to stream forward the sterile water from the Water Jet Nozzle.

The Control Body is held by the user's hand. The Control Body includes the Angulation Control Knob, Angulation Lock Knob/Lever, Air/Water Cylinder, Suction Cylinder, Remote Control Button, and Instrument Channel Inlet. The Bending Section is bent by the Angulation Control Knob to operate the endoscope angulation Lock Knob/Lever is used to adjust the rotation torque of the Angulation Control Knob. The Remote Button is used to operate the function of video processor and external device from the control body, as necessary.

The Inlet Seal is attached to the Instrument Channel Inlet. Endotherapy Device such as Biopsy Forceps may be inserted from the Instrument Channel Inlet into the body cavity through the instrument channel.

The PVE Connector is connected to the Video Processor via an Electrical Contacts. The Light Guide of the Distal End is used to illuminate the body cavity by light that is carried through the Light Carrying Bundle. The Light Carrying Bundle guides the light from Light Guide Plug that 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 is converted into the image signal by the Video Processor, and the image inside the body cavity is displayed on the Monitor.

The PENTAX Medical Video Upper Gl Scope EG34-i10 is a reusable semi-critical device. Since it is packaged non-sterile, it must be high-level disinfected or sterilized before initial use. Prior to each subsequent procedure, it must be subjected to an appropriate cleaning and either highlevel disinfection or sterilization processes.

This FDA 510(k) summary describes the PENTAX Medical Video Upper GI Scope EG34-i10, a reusable semi-critical device intended for endoscopy and endoscopic surgery within the upper digestive tract. The submission primarily focuses on demonstrating substantial equivalence to its predicate device, the PENTAX Video Upper GI Scopes EG29-i10 (K131902), by showing that minor differences in dimensional specifications and materials do not adversely impact safety or effectiveness.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria and reported device performance in the format usually seen for AI/software-based medical devices with specific performance metrics like sensitivity, specificity, or AUC. Instead, it details various engineering and performance tests conducted to establish substantial equivalence. The "acceptance criteria" are implied by the successful completion and "passing results" of these engineering tests, confirming that the device meets relevant standards and performs comparably to the predicate.

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

The document describes device performance testing and validation, not a study with a traditional "test set" of clinical data for a diagnostic algorithm. The tests conducted (reprocessing, biocompatibility, electrical safety, EMC, optical, usability) involve physical samples of the device and its components, or measurements under controlled lab conditions.

• Sample Size: Not specified in terms of number of devices or units used for each test, but it is implied that a sufficient number was tested to demonstrate compliance and comparability. These are engineering tests, not statistical clinical trials with patient populations.
• Data Provenance: The data comes from internal testing conducted by PENTAX Medical, as implied by the "PENTAX Medical completed optical testing" and "Testing revealed..." statements. These are laboratory-based, prospective engineering tests rather than retrospective or prospective clinical data.

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

Not applicable. This device is not an AI/ML algorithm requiring expert ground truth or adjudication for diagnostic performance. Its validation is based on engineering standards and comparisons to a physical predicate device.

4. Adjudication method for the test set

Not applicable. As this is not a study requiring expert clinical adjudication for diagnostic outcomes, no such method was employed.

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, a hardware instrument, not an AI-assisted diagnostic tool. No MRMC study or AI assistance evaluation was performed.

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

Not applicable. This device does not involve a standalone algorithm for performance evaluation.

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

Not applicable in the context of clinical diagnostic ground truth. The "ground truth" for the engineering tests would be defined by the specifications, standards (e.g., IEC, ISO), and the performance characteristics of the predicate device. For example:

• For reprocessing: Standardized microbiological assays or chemical residue tests demonstrating inactivation/removal targets.
• For optical testing: Direct measurement of light properties and comparison to predicate's measured values, and adherence to photobiological safety standards.

8. The sample size for the training set

Not applicable. This device does not involve a training set as it is not an AI/ML system.

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

Not applicable. This device does not involve a training set.

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