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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 subject device is identical to the predicate device. There are no changes to the design, specifications, or technological characteristics of the PENTAX Medical Video Upper GI Scopes as described in K131902. The PENTAX Medical Video Upper G.I. scopes (EG Family) are used with Video Processors. They are composed of three main components: 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, 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. This Air/Water Feeding System is used to deliver the air and water to the Objective Lens. The Control Body is held by the user's hand. The Control Body includes the Angulation Control lever used to operate the endoscope angulation; Suction Cylinder and Suction Nipple for suctioning fluid and air in the body cavity; Remote Button used to operate the function of video processor; and Instrument Channel Inlet used to insert endotherapy devices, such as biopsy forceps, into the body cavity. The GI Family of scopes also contains a Magnification Control Lever used to magnify the image on the video monitor, as necessary. As this magnification is performed electrically, focus and depth of field are not changed. The PVE Connector is connected to the Video Processor via an Electrical Contacts. The PVE Connector includes the Electrical Contacts and Light Guide Plug. The Light Guide Plug is connected to the Light Source inside the Video Processor. 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. 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. The PENTAX Medical Video Upper G.I. scopes are reusable semi-critical devices. Since they are packaged non-sterile, they must be high-level disinfected or sterilized before initial use. Prior to each subsequent procedure, they must be subjected to an appropriate cleaning and either highlevel disinfection or sterilization processes.

This document is a 510(k) Premarket Notification for the PENTAX Medical Video Upper GI Scopes (EG Family), primarily seeking clearance for revised reprocessing instructions. It is not an AI/ML device, and as such, the typical acceptance criteria and study designs for such devices (e.g., accuracy, sensitivity, specificity, reader studies, etc.) are not applicable here.

The "study" in this context is a reprocessing validation study to demonstrate that the revised cleaning instructions maintain the safety and effectiveness of the endoscopes.

Here's how the provided information relates to acceptance criteria and the "study":

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

Since this is not an AI/ML device or a device with performance metrics like sensitivity/specificity, the acceptance criteria are related to the effectiveness of the reprocessing instructions in ensuring the device remains safe for reuse.

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

• Sample Size for Test Set: The document does not specify the exact number of endoscopes or cleaning cycles used in the reprocessing validation study. It only mentions "reprocessing validation data" and "soil accumulation and cleaning efficiency studies." For medical device reprocessing validation, this typically involves a defined number of cycles on a set of devices to demonstrate reproducibility and effectiveness.
• Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing conducted by or for PENTAX. It would be prospective (purpose-designed experiments) to validate the new instructions. The country of origin is not specified but would likely be where the manufacturing or R&D validation takes place.

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 isn't applicable. For reprocessing validation, "ground truth" is established through standardized laboratory methods (e.g., measuring residual protein, hemoglobin, or other markers after cleaning; visual inspection; microbial load testing). It does not involve expert interpretation of images or clinical outcomes in the same way an AI diagnostic device would. Experts in this context would be reprocessing validation engineers and microbiologists, adhering to relevant standards.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used in reader studies for diagnostic performance where human interpretation is the primary outcome. Here, the "outcomes" are quantitative measurements of cleaning effectiveness. Quality control and statistical analysis methods would be used to ensure the validity of the reprocessing study results.

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 diagnostic device, nor does it involve human readers interpreting cases.

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

Not applicable. This is a medical device (endoscope) with revised instructions for use, not an algorithm.

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

The "ground truth" (or more accurately, the validation methodology) for reprocessing effectiveness is based on scientific and regulatory standards for cleaning validation. This typically involves:

• Quantitative analytical methods: Measuring the removal of simulated soil (e.g., protein, hemoglobin, carbohydrates) using validated assays.
• Microbiological methods: Demonstrating reduction of microbial burden to acceptable levels, often involving inoculation of devices with specific microorganisms and subsequent recovery and enumeration after cleaning and disinfection.
• Visual inspection: Ensuring macroscopic cleanliness.

8. The sample size for the training set:

Not applicable. This section pertains to AI/ML models that require training data. For a hardware device with revised reprocessing instructions, there is no "training set" in this sense. The initial design and testing of the endoscope itself formed the basis for its predicate clearance. The current submission focuses on validating the reprocessing instructions.

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

Not applicable, as there is no training set for an AI/ML algorithm. The "data" used for this submission is the reprocessing validation study data, as described in point 7.

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