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The Gas/Water Feeding Valve OE-B14 is intended to be attached in place of Air/Water Feeding Valve (OE-B12) to PENTAX Medical GI endoscopes and used to feed the gas/water to the body (via the air/water channel).

The Gas/Water Feeding Valve OE-B14 is intended to be attached in place of Air/Water Feeding Valve (OE-B12) to PENTAX Medical GI endoscopes and used to feed the gas/water to the body (via the air/water channel).

The OE-B14 is attached onto the air/water feeding cylinder of the control body of PENTAX Medical endoscope. The endoscope is linked to non-flammable gas cylinder and the water bottle assembly via air/water feeding circuit.

The device descriptions for the PENTAX Medical EPK-i8020c Video Imaging System remain unchanged from K231249. They include the PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, and PENTAX Medical Video Colonoscope EC38-i20cL.

The provided text describes the regulatory clearance of the PENTAX Medical Gas/Water Feeding Valve OE-B14, an accessory for GI endoscopes. The device's clearance is based on its substantial equivalence to a predicate device. The information provided focuses on non-clinical performance data rather than a clinical study evaluating diagnostic or therapeutic efficacy with human subjects.

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

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is an accessory device and the review focuses on substantial equivalence based on non-clinical performance, the "acceptance criteria" here refer to meeting standards for reprocessing, sterilization, biocompatibility, and system/mechanical performance. There are no specific quantifiable clinical performance metrics like sensitivity/specificity for a diagnostic device.

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

The document describes non-clinical bench testing and validation studies, not a clinical trial with human subjects. Therefore, the concept of a "test set" in the context of clinical data or patient samples, sample size, or data provenance (country of origin, retrospective/prospective) is not applicable here as it would be for a diagnostic or therapeutic device. The "test set" would refer to the physical devices subjected to the various non-clinical tests (reprocessing, mechanical, etc.), for which specific numerical sample sizes are not provided in this summary.

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

This information is not applicable. The device underwent non-clinical performance testing and validation against recognized standards and internal criteria. There was no "ground truth" derived from expert clinical opinion on patient data as would be for an AI/diagnostic device.

4. Adjudication Method for the Test Set

This information is not applicable. There was no clinical test set requiring expert adjudication for ground truth.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The device is an accessory that feeds gas/water, not a diagnostic or AI-assisted tool that would involve human readers interpreting cases.

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

No, a standalone performance study in the context of an algorithm or AI was not done. The device is a physical accessory.

7. The Type of Ground Truth Used

For this device, the "ground truth" for proving its safety and effectiveness was established through:

• Compliance with recognized consensus standards: (e.g., AAMI TIR 30: 2011/(R)2016 for reprocessing, ISO 10993-1: 2018 for biocompatibility).
• Achievement of pre-defined acceptance criteria for bench testing of functions, performance, and safety (e.g., residual soil levels, successful steam sterilization, acceptable toxicity levels, sufficient gas/water feeding performance, verified mechanical performance).
• Comparison to a legally marketed predicate device (PENTAX Gas/Water Feeding Valve OF-B194) to demonstrate substantial equivalence, particularly regarding intended use and technological characteristics.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical accessory, not an AI or machine learning algorithm that requires a training set.

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

This information is not applicable as there was no training set for an AI/ML algorithm.

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PENTAX Medical Single Use Video Bronchoscope EB-S01 is sterile single use flexible endoscopes intended for use with PENTAX Medical mobile processor, therapeutic accessories, and other ancillary equipment for endoscopy and endo-therapeutic procedures within the airways and tracheobronchial tree.

PENTAX Medical Mobile Processor ONE-M is intended to be used with PENTAX Medical endoscopes and other peripheral devices for endoscopic diagnosis, treatment and video observation.

PENTAX Medical Mobile Processor Plug-in ONE-Dock is intended to be attached to the PENTAX Medical Mobile Processor to provide additional ports for hardware interface.

PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System is intended to provide the optical visualization of the airways and tracheobronchial tree for diagnostics and therapeutic applications. The PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System consist of the following three component devices:

• . PENTAX Medical Single Use Video Bronchoscope EB11-S01 / EB15-S01
• . PENTAX Medical Mobile Processor ONE-M
• . PENTAX Medical Mobile Processor Plug-in ONE-Dock

The EB11-S01 / EB15-S01 endoscopes are connected to the ONE-M and video images captured with the bronchoscope are displayed on the touch screen of the ONE-M. The ONE-M is also connected to the Plug-in ONE-Dock, which has several interfaces, such as an external monitor to display captured images by the bronchoscope and a connection with an external network.

Based on the provided text, the document is a 510(k) Premarket Notification for the PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System. This type of submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, rather than proving clinical effectiveness through extensive clinical trials for new indications or technologies. Therefore, the information provided focuses on demonstrating equivalence through non-clinical performance data and technological comparisons, rather than a clinical study with detailed acceptance criteria and a human-in-the-loop performance study as might typically be found for AI/ML device submissions.

The document does not describe a study that proves the device meets specific acceptance criteria related to an AI/ML algorithm's diagnostic performance, as it is a bronchoscope system, not an AI/ML diagnostic aid. It lists various non-clinical performance tests to demonstrate substantial equivalence to a predicate device.

Therefore, many of the requested fields regarding acceptance criteria, study design for AI/ML, human expert involvement, and ground truth establishment are not applicable or not detailed in this submission because it is not an AI/ML device submission for diagnostic accuracy.

However, I can extract the relevant information that is present and explain why other requested information is not available:

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

The document describes general performance equivalency rather than specific quantitative acceptance criteria for image analysis or diagnostic performance of an AI system. The key "acceptance criteria" here relate to demonstrating equivalence to a predicate device and meeting recognized standards for safety and performance (e.g., electrical safety, biocompatibility).

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

• Test Set: Not applicable in the context of an AI/ML "test set" for diagnostic performance. Performance testing involved various engineering and animal studies. For the "Animal Image Capture Study," an animal model was used, but the specific number of animals is not provided. The data provenance is implied to be from internal testing by PENTAX Medical.
• Data Provenance: Implied to be from internal testing and validation studies conducted by PENTAX Medical (e.g., "PENTAX Medical coordinated with HA2 Medizintechnik GmbH (German company) to validate the use of EO sterilization"). The animal study location and specifics are not provided.

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

This information is not applicable and not provided. The ground truth for this device's performance does not involve human expert adjudication of images for diagnostic purposes in the way it would for an AI/ML algorithm. The performance evaluation focused on physical, electrical, and optical properties as well as safety and biocompatibility.

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

Not applicable, as this is not an AI/ML diagnostic device requiring expert adjudication of 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 device is a bronchoscope system, not an AI-assisted diagnostic tool for image interpretation. No MRMC study was conducted or required for this type of submission.

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

Not applicable, as this is a medical device for direct visualization and not an AI algorithm.

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

Not applicable in the AI/ML sense. The "ground truth" for this submission are the established performance specifications for medical devices, relevant ISO standards, and the performance of the predicate device, against which the subject device's non-clinical performance was compared (e.g., electrical safety standards, biocompatibility testing results, optical measurements, and visualization capabilities in an animal model).

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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The PENTAX Medical Video Duodenoscope ED32-i10 is intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Common Bile, Hepatic and Cystic Ducts.

This endoscope is introduced via the mouth when indications consistent with the need for the procedure are observed in adult and pediatric patient populations.

The PENTAX Medical Video Duodenoscope ED32-i10 is intended to be used with a PENTAX Video Processor, documentation equipment, video monitor, endoscopic device and other ancillary equipment for optical visualization (via a video monitor) of, and/or therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Common Bile, Hepatic and Cystic Ducts.

The PENTAX Medical Video Duodenoscope ED32-i10 has a smaller insertion portion width (32 French size) compared to the predicate device, ED34-i10T2, (34 French size) and is expected to provide better access to patients for whom that the ED34-i10T2 may have had difficulties accessing, for example in patients with narrowed lumens and in pediatric patients.

The ED32-i10 is composed of the following main parts: 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 objective lens, light guide, instrument channel, elevator link, and air/water 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, cannula/forceps elevator control lever, air/water cylinder, suction cylinder, remote button, and instrument channel inlet. The air/water feeding valve is attached to the air/water cylinder, and the suction control valve is attached to the suction cylinder. The inlet seal is attached to the instrument channel inlet. The PVE connector is connected to the video processor via electrical contacts.

The bending section is bent by the angulation control knob to operate the endoscope angulation. The angulation lock knob/lever is used to adjust the rotation torque of the angulation control knob. The cannula/forceps elevator mechanism is used to control the position of the cannula which is inserted through the Instrument Channel.

The cannula/forceps elevator control lever is used to operate the cannula/forceps elevator of the Distal End Cap with Elevator (OE-A65). The air/water feeding system is used to deliver the air and water to the objective lens from the air/water 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 remote button is used to operate the functions of the video processor and any external device from the control body, as necessary.

The single use, Distal End Cap with elevator (OE-A65) is provided as a sterile product. OE-A65 is attached to the elevator link of the distal end of ED32-i10. It is discarded after use.

Endoscopic devices such as biopsy forceps are inserted from the instrument channel Inlet into the body cavity through the instrument channel.

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.

The PENTAX Medical Video Processors EPK-i5010 and EPK-i7010 are compatible with PENTAX Medical Video Duodenoscope ED32-i10.

The PENTAX Medical ED32-i10 Video Imaging System is provided with the following accessories:

• Inlet Seal - prevents suctioned fluid from coming out of the instrument Channel Inlet during the use of suction function. During reprocessing, it seals the instrument Channel Inlet in order to fill the chemical solution inside the channel.
• Bite Block - prevents patients from biting the endoscope insertion tube during an endoscopic examination.
• Suction Control Valve - intended to control suction.
• Air/Water Valve - intended to control air and water feeding.
• Distal End Cap with Elevator - intended to guide the endoscopic device.

Additional accessories for reprocessing are provided with the device. These include a Cleaning Adapter, Soaking Cap, Ventilation Cap, Endoscope Cleaning Brush Kits, and replacement O-Rings.

The provided text describes a 510(k) premarket notification for the PENTAX Medical Video Duodenoscope ED32-i10, asserting its substantial equivalence to a predicate device, the PENTAX Medical Video Duodenoscope ED34-i10T2 (K192245). This is a medical device clearance, not an AI/ML device, so many of the requested sections related to AI/ML studies are not applicable.

Here's an analysis based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a single table directly comparing acceptance criteria with reported performance in a quantitative manner for most tests. Instead, it states that "All acceptance criteria were satisfied" for most tests.

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

The document does not specify exact sample sizes for each individual test in the non-clinical performance data section. It generally refers to "validation studies," "verification studies," and "test results" without numerical detail for the number of devices or data points used.

• Provenance: The studies were conducted by PENTAX Medical and STERIS Corporation. The document doesn't explicitly state the country of origin for the data, but it's part of a submission to the U.S. FDA by PENTAX Medical HOYA Corporation located in Montvale, New Jersey, USA. All studies mentioned appear to be prospective testing for device verification and validation.

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

This information is not provided in the document. Given this is a non-AI/ML device, the concept of "ground truth" established by experts as typically understood in AI/ML performance evaluation doesn't directly apply in the same way. The performance is assessed against engineering specifications, recognized standards, and equivalence to a predicate device.

4. Adjudication Method for the Test Set

This information is not applicable to this type of device clearance. Adjudication methods are typically used in clinical studies or AI/ML studies where multiple human readers' interpretations of data need to be resolved to establish ground truth or evaluate diagnostic performance. This document focuses on engineering and performance testing.

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. This document describes a medical device (endoscope) and not an AI/ML software device. No MRMC study or AI assistance evaluation is mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. This is a hardware medical device; it does not have a standalone algorithm for performance evaluation in the context of AI/ML. Its performance is assessed as an integrated system with compatible video processors.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to established engineering specifications, performance standards (e.g., AAMI TIR 30:2011, IEC 60601 series), and the performance of the legally marketed predicate device (PENTAX Medical Video Duodenoscope ED34-i10T2). For reprocessing, laboratory tests were used to measure residual soil and extraction efficiency against pre-defined limits.

8. The Sample Size for the Training Set

This is not applicable. This is a hardware medical device, not an AI/ML device that requires a "training set."

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

This is not applicable. As it's not an AI/ML device, there is no "training set" or ground truth established for one.

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The PENTAX Medical EG-J10U Endoscopic Ultrasound System is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Tract including but not restricted to the organs, tissues, and subsystems: Esophagus, Stomach, Duodenum and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

The EG34-J10U, EG36-J10UR and EG38-J10UT Ultrasound Upper GI Video Scopes, are endoscopes used to provide visualization of, and therapeutic access to, the upper gastrointestinal tract. They are used with cleared Pentax Video Processors (a softwarecontrolled device) and cleared Hitachi Ultrasound Scanners (a software-controlled device). The endoscopes have a flexible insertion tube, a control body, PVE umbilical connector, and ultrasound scanner umbilical connector. The PVE umbilical connector will be attached to the Video Processor and has connections for illumination, video signals, air/ water/ and suction. The ultrasound scanner umbilical connector will be attached to the ultrasound scanner unit. A sterile, single use disposable natural rubber latex balloon is fitted over the convex array ultrasound transducer prior to the procedure. During an ultrasound endoscopy procedure, the latex balloon is inflated with water. The water that is contained within the balloon creates a water field that covers the transducer. The water field enables more effectively transport of ultrasonic pulses from the ultrasound transducer to the target anatomical site and back to the ultrasound transducer. The control body includes controls for up/ down/ left/ right angulation, air/ water delivery, and an accessory inlet port. The endoscope contains light carrying bundles to illuminate the body cavity, a charge couple device (CCD) to collect endoscopic image data, and a linear or radial array ultrasound transducer to collect ultrasonic image data. The instrument contains a working channel through which biopsy devices, or other devices, may be introduced.

The provided text is a 510(k) premarket notification for the PENTAX Medical EG-J10U Endoscopic Ultrasound System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the context of an AI/ML medical device.

Therefore, many of the requested details, such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set information (which are typical for AI/ML device submissions), are not present in this document.

The document primarily addresses hardware, software, and reprocessing aspects of the endoscopic ultrasound system. The "performance data" mentioned refers to non-clinical testing for functionality, safety, human factors, reprocessing validation, sterilization, shelf life, software verification/validation, EMC, electrical safety, and optical testing, rather than clinical performance metrics for a diagnostic or AI/ML algorithm.

Here's an attempt to answer the questions based on the available information, noting significant gaps:

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

The document describes performance testing in general terms rather than specific quantifiable acceptance criteria with corresponding results in a table format. It states that the system "has been successfully tested for its functions, performance and safety as per FDA recognized consensus standards." For optical testing, it notes "All results show that there are no differences between the subject device, and the predicate device."

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

• Sample Size: Not specified in the document for any of the non-clinical tests.
• Data Provenance: Not specified. The tests are described as being conducted "as a part of Design Verification and Validation" and for "support of the substantial equivalence determination," implying internal company testing rather than clinical trials.

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

• Not applicable / Not specified. This document describes a medical device, not an AI/ML algorithm that requires expert ground truth for diagnostic accuracy. The "human factors" study involved reprocessing staff, not clinical experts establishing ground truth for diagnostic images.

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

• Not applicable / Not specified. No adjudication method is mentioned as it's not a diagnostic AI/ML study.

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. This is not an AI-assisted device. The document does not describe any MRMC studies or human reader improvement with AI assistance.

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

• Not applicable. This is not an AI/ML algorithm. The device is a physical endoscope with associated control software.

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

• Not applicable. The "ground truth" for this device's performance testing would be engineering specifications, industry standards (e.g., IEC standards for electrical safety), and validated reprocessing protocols, rather than clinical ground truth for disease states.

8. The sample size for the training set:

• Not applicable. This document describes a medical device, not an AI/ML algorithm requiring a training set.

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

• Not applicable. As above, no training set for an AI/ML algorithm is described.

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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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The PENTAX Medical EPK-i7010 Video Processor is intended to be used with the PENTAX camera heads, endoscopes, light sources, monitors and other ancillary equipment for bronchoscopic diagnosis, treatment and video observation.

The PENTAX Medical EPK -7010 includes a digital post-processing imaging enhancement technology (PENTAX i-Scan™) and an optical imaging enhancement technology (OE). These imaging enhancement technologies are intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan and OE are compatible with PENTAX video bronchoscopes.

The PENTAX Medical EPK-i7010 Video Processor is intended to be used with the PENTAX camera heads, endoscopes, light sources, monitors and other ancillary equipment for bronchoscopic diagnosis, treatment and video observation.

The PENTAX Medical EPK-i7010 Video Processor contains PENTAX i-Scan and Optical Enhancement (OE) technologies.

The PENTAX i-Scan technology is a digital filter-based image enhancement technique with three modes, i-Scan 1, 2, and 3. PENTAX i-Scan™ is intended to give the user an enhanced view of the texture of the mucosal surface and blood vessels.

In addition to i-Scan, OE is intended to provide alternative methods to improve blood vessel visibility by using band limited light illumination source. The OE technology emphasizes mucosal microvasculature and fine mucosal structures on the bronchial surface.

The following accessories are provided for use with the PENTAX Medical EPK-i7010 Video Processor and EB Family of Scopes:

• . Keyboard - input device for the video processor.
• . Foot Switch - used to remotely control processor functions.
• . White Balance Adjuster - used as the object of white balance feature.
• Condenser Earth Cable - used to reduce high-frequency noise generated during highfrequency electro cautery device use with Pentax endoscopes.

The provided text describes the 510(k) premarket notification for the PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes. However, it does not contain a table of acceptance criteria or a detailed study that proves the device meets specific performance acceptance criteria in terms of clinical efficacy or diagnostic accuracy.

The document focuses on demonstrating substantial equivalence to a predicate device (PENTAX Medical EPK-i5010 Video Processor with EB Family) and a reference device (PENTAX Medical EPK-i7010 Video Processor with GI Family), primarily through bench testing comparing optical parameters and a qualitative animal study to show similar visual experience.

Here's a breakdown of the requested information based on the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is NOT explicitly provided in a table format within the document. The document describes various tests performed but does not list specific numerical acceptance criteria for each test or a direct comparison demonstrating the device "meets" those criteria in a quantitative sense. Instead, it states that the performance of the subject and predicate devices are "equivalent" or show "similarity of visual experience."

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

• Test Set Sample Size:
  • Bench Testing (Optical): Not specified (e.g., number of scopes, measurements taken).
  • Animal Testing: "A library of images was captured." The exact number of images or individual animal cases is not specified.
• Data Provenance:
  • Bench Testing: In-house testing, likely derived from laboratory measurements.
  • Animal Testing: Porcine animal study (not human data). No specific country of origin is mentioned, but "PENTAX Medical performed a porcine animal study" implies it was conducted by the manufacturer or a contracted lab. The study type is prospective for the animal model.

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

This information is NOT provided. The studies described (bench testing and animal testing) do not mention the use of experts to establish a "ground truth" in a clinical diagnostic sense. The animal study focused on showing "similar visual experience" which would likely involve subjective assessment, but expert involvement and their qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is NOT provided. Given the nature of the tests described (bench and animal studies focusing on optical/visual similarity rather than diagnostic accuracy), a formal adjudication method like "2+1" or "3+1" for clinical ground truth establishment is not mentioned or applicable.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

No, an MRMC comparative effectiveness study was NOT done. This device is an endoscope video processor with image enhancement technologies (i-Scan and OE), not an AI-assisted diagnostic tool for which human reader improvement would typically be measured. The study focused on demonstrating optical equivalence and similar visual experience compared to a predicate device.

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

Not directly applicable in the typical sense of a diagnostic algorithm. The i-Scan and OE technologies are "imaging enhancement technologies" intended to be an "optional adjunct following traditional white light endoscopy." They are not standalone diagnostic algorithms that provide a diagnosis without human interpretation. The "performance testing" described (bench and animal) assesses the technical performance of the imaging system itself, not the diagnostic performance of the enhancement algorithms in a standalone mode.

7. The Type of Ground Truth Used

• Bench Testing: Physical properties and measurements (e.g., signal-to-noise ratio, resolution, color accuracy, light distribution). The "ground truth" would be the standard physical measurements or specifications for these parameters.
• Animal Testing: Visual observation of pig laryngeal anatomy. The "ground truth" here is the visual appearance of the anatomy as rendered by different processors, to assess "similarity of visual experience." It is not a pathological or outcomes-based ground truth for disease detection.

8. The Sample Size for the Training Set

This information is NOT provided and is not applicable. The document describes a video processor with image enhancement technologies, not a machine learning or AI-based system that would typically require a "training set" in the context of diagnostic algorithm development. The "software verification and validation" (IEC 62304:2006) refers to standard software engineering practices for medical devices, not machine learning model training.

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

This information is NOT provided and is not applicable. As noted above, this device does not appear to be an AI/ML system that requires a "training set" with established ground truth.

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