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EG Family: 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.

EC Family: 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 Upper G.I. scopes (EG Family) and Colonoscopes (EC 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 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. 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 Magnification Control Lever is used to magnify the image on the video monitor, as necessary. As this magnification function 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 and Colonoscopes 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 high-level disinfection or sterilization processes.

This document describes a 510(k) premarket notification for PENTAX Medical Video Upper GI Scopes (EG Family) and PENTAX Medical Video Colonoscopes (EC Family). The submission focuses on changes to reprocessing instructions, not the devices themselves.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

   The document does not explicitly present a table of acceptance criteria or performance metrics for the device itself in terms of diagnostic accuracy, sensitivity, specificity, or similar clinical performance measures. This 510(k) submission is for a modification to the reprocessing instructions for existing, already cleared devices (K131902 and K131855). Therefore, the "acceptance criteria" here relate to the reprocessing instructions being safe and effective.

   The primary "performance" reported is related to human factors and the safety/effectiveness of the reprocessing process as modified.

   Acceptance Criterion (Implicit for Reprocessing)	Reported Performance (from Human Factors Study)
   Reprocessing instructions are effective	A Summative Human Factors Study was conducted to validate the effectiveness and risk management measures for reprocessing.
   Reprocessing instructions are safe	The study aimed to ensure reprocessing can be performed in a safe manner. Although use errors, close calls, and difficulties were observed, "it is estimated that the risks identified, and the root causes assigned to those risks can be reduced and/or mitigated via additional modifications of the rIFU design and the further refinement of the training materials."

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

   The document mentions a "Summative Human Factors Study." While the number of participants (test set size) is not explicitly stated, it refers to "the same group of stakeholders." The provenance of this data (e.g., country of origin) is not provided, but such studies are typically conducted with users representative of the intended clinical environment. The study is implicitly prospective, as human factor studies involve observing users interacting with the device/instructions.

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

   This information is not applicable in the context of this 510(k) submission. The ground truth for a human factors study on reprocessing focuses on whether users can correctly and safely follow the instructions. This isn't a diagnostic accuracy study requiring expert adjudication of clinical findings. The "experts" involved would likely be human factors professionals and potentially subject matter experts in endoscope reprocessing, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set:

   This is not a clinical study involving diagnostic outputs requiring adjudication. In a human factors study, observations of user performance (following instructions, committing errors) are typically recorded and analyzed by human factors specialists. There is no mention of a traditional adjudication method (like 2+1, 3+1 consensus) for this type of test.

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

   No, an MRMC comparative effectiveness study was not done. This submission is about reprocessing instructions, not a diagnostic AI device to be used by human readers for clinical diagnosis.

6. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study:

   No, a standalone algorithm study was not done. This submission is for endoscopes and their reprocessing instructions, not an AI algorithm.

7. Type of Ground Truth Used:

   For the human factors study, the "ground truth" would be the correct and safe steps for reprocessing the endoscopes, as defined by the manufacturer's validated procedures. The performance of the participants is compared against these predetermined correct steps. It is not clinical ground truth derived from pathology or patient outcomes.

8. Sample Size for the Training Set:

   This information is not applicable. This is not an AI/machine learning submission with training data.

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

   This information is not applicable, as there is no training set for an AI algorithm.

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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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