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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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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 gastrointestinal endoscopic diagnosis, treatment and video observation.

The PENTAX Medical EPK-i7010 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 Medical video gastrointestinal endoscopes.

The PENTAX EPK-i5010 Video Processor is intended to be used with the PENTAX camera heads, endoscopes, light sources, monitors and other ancillary equipment for gastrointestinal endoscopic diagnosis, treatment and video observation.

The PENTAX EPK-i5010 includes PENTAX i-Scan™, a digital post-processing imaging enhancement technology. i-Scan is intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan is compatible with PENTAX k-series and i-series gastrointestinal videoscopes and colonovideoscopes.

The PENTAX Medical EPK-i7010 Video Processor and PENTAX EPK-i5010 Video Processor each consist of a video system, integrated light source, monitor, and ancillary equipment. These processors are intended for gastrointestinal endoscopic diagnostic, treatment and video observation.

The PENTAX Medical EPK-i7010 Video Processor contains two types of contrast enhancement techniques: PENTAX i-Scan technology, and optical enhancement (OE) technology. The PENTAX EPK-i5010 Video Processor contains only PENTAX i-Scan. The PENTAX i-Scan technology is a digital post-processing image enhancement technique with three modes, i-Scan 1, 2 and 3.

The provided text is a 510(k) summary for the PENTAX Medical EPK-i7010 and EPK-i5010 Video Processors, with a focus on a minor design change related to the Water Bottle Assembly OS-H5. It is NOT a study proving the device meets acceptance criteria for an AI/imaging diagnostic device.

The document discusses performance testing in a general sense, but this testing relates to the physical and functional characteristics of the water bottle accessory and its reprocessing, not to the diagnostic accuracy or clinical performance of the imaging enhancement technologies (i-Scan and OE) with human readers.

Therefore, many of the requested criteria for describing an AI/imaging diagnostic study (e.g., sample size for test set, number of experts for ground truth, MRMC study, effect size) cannot be found in this document because the document does not describe such a study.

The closest relevant information relates to the performance of the Water Bottle Assembly OS-H5.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent:

Acceptance Criteria and Study for PENTAX Medical EPK-i7010/EPK-i5010 (Water Bottle Assembly OS-H5)

The provided document (510(k) summary) does not describe a study related to the diagnostic performance of the PENTAX i-Scan or Optical Enhancement (OE) technologies, especially in conjunction with human readers or AI algorithms. Instead, it focuses on demonstrating the substantial equivalence of the PENTAX Medical EPK-i7010 and EPK-i5010 Video Processors, specifically addressing a minor design change: the replacement of a disposable water bottle system with the reusable PENTAX Water Bottle Assembly OS-H5.

The "acceptance criteria" and "study" described pertain to the safety and functional performance of the reusable water bottle accessory and its reprocessing methods, not the diagnostic utility of the imaging processors themselves or any associated AI.

1. Table of Acceptance Criteria and Reported Device Performance (Specific to Water Bottle Assembly OS-H5)

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The PENTAX Medical Endoscopic Ultrasound System is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to the organs, tissues, and subsystems: Esophagus, Stomach, Duodenum, Small Bowel, 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 EG-3270UK, Ultrasound Upper GI Video Scope, is an endoscope used to provide visualization of, and therapeutic access to, the upper gastrointestinal tract. It is used with cleared Pentax Video processors (a software controlled device) and cleared Hitachi Ultrasound Scanner (a software controlled device). The endoscope has 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 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 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 video processor contains a lamp that provides white light and is focused at the PVE connector light guide prong. The endoscope light carrying bundles present the light to the body cavity and the CCD collects endoscopic image data. Image data and other screen display information are formatted and presented to the video outputs of the video processor for display. The ultrasound transducer delivers ultrasonic pulses, reflections of the pulses are received and the signals are passed to the ultrasound scanner for processing and display. The instrument is immersable (with the use of supplied cleaning accessories) except for the ultrasound scanner connector (as described in the endoscope operator manual cleaning instructions)

The provided text is a 510(k) summary for the PENTAX Medical Endoscopic Ultrasound System. It describes the device, its intended use, and a comparison to a predicate device, along with performance data to support substantial equivalence.

However, the provided document does not contain information about:

• A table of acceptance criteria and reported device performance for a specific clinical study.
• Sample sizes used for test sets or their data provenance (country, retrospective/prospective).
• Number of experts used or their qualifications for establishing ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes for AI assistance.
• Standalone algorithm performance studies.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a specific clinical evaluation.
• Sample size for a training set or how its ground truth was established.

The document primarily focuses on engineering and regulatory performance data, such as biocompatibility, reprocessing validation, electrical safety, software verification, and acoustic output measurements, to demonstrate that the device is as safe and effective as a legally marketed predicate device. These are not clinical performance parameters that would typically be described with the detailed acceptance criteria and study design requested in the prompt.

Therefore, I cannot fulfill the request for a table of acceptance criteria, device performance, and details about a clinical study based on the provided text. The document refers to various standards and guidance documents (e.g., ISO 10993, IEC 60601, FDA Guidance for Software and Diagnostic Ultrasound Systems) which set out general performance requirements and testing methodologies, but these are not presented as specific acceptance criteria tied to a clinical performance study as typically understood in the context of an AI/algorithm-based device.

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The PENTAX Medical EPK-i5010 Video Processor is intended to be used with the PENTAX camera heads, endoscopes, light sources, monitors and other ancillary equipments for bronchoscopic diagnosis, treatment and video observation.
The PENTAX Medical EPK-i5010 includes PENTAX i-Scan™, a digital, post-processing imaging enhancement technology. i-Scan is intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan is compatible with PENTAX k-series and i-series video bronchoscopes.

The PENTAX EPK-i5010 video processor consists of a video system, integrated light source, monitor, and ancillary equipment. This processor when connected to a compatible EB family bronchoscope is intended for endoscopic diagnostic, treatment and video observation.
The PENTAX i-Scan technology is a digital filter-based image enhancement technique with three modes, i-Scan 1, 2 and 3. i-Scan 1 enhances image topography and edges and i-Scan 2 and 3 enhances the color tone of the image by dissecting and recombining the individual red, green and blue (RGB) components of a white light image.
PENTAX i-Scan™ modes 1, 2, and 3, are intended to give the user an enhanced view of the texture of the mucosal surface and blood vessels. i-Scan 1 provides the user with a view that sharpens surface vessels and enhances surface texture of the mucosa. i-Scan 2 provides the user with increased visibility of blood vessels while also providing the same enhancements to the mucosa achieved in i-Scan 3 provides the user with increased visibility of blood vessels including dimly illuminated far-field regions while also providing the same enhancement to the mucosa achieved in i-Scan 1. The user can select either white light image or i-Scan modes by pressing a pre-programmed button on the scope, by using a pre-programmed foot pedal or by pressing a keyboard button. i-Scan is intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling.
White light is captured from a 300 Watt xenon lamp housed in the EPK-i5010 video processor. All visualization is done with the white light mode first. White light (BGR) illuminates the tissue and transfers the captured light through the video scope or a charged coupled device (CCD). Note that the white light visualization mode is always used first by the physician. The modification of the combination of RGB components for each pixel occurs when the i-Scan function is turned on in the EPK-i5010 video processor. The resulting i-Scan image is then displayed on the observation monitor.

Here's a breakdown of the acceptance criteria and the study details based on the provided document. It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical trial for a novel AI device. Therefore, some information typically found for AI device studies (like a deep dive into AI model training, specific performance metrics for disease detection, or expert consensus on ground truth for a diagnostic task) is not explicitly detailed.

The device in question is the PENTAX Medical EPK-i5010 Video Processor with EB Family, which includes PENTAX i-Scan™, a digital, post-processing imaging enhancement technology. The primary function described is image enhancement for bronchoscopic diagnosis, treatment, and video observation, as an "optional adjunct following traditional white light endoscopy" and "not intended to replace histopathological sampling."

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of explicit acceptance criteria with numerical targets for clinical performance (e.g., sensitivity, specificity for a diagnostic task). Instead, the studies aim to demonstrate safety, effectiveness, and substantial equivalence to a predicate device. The performance is assessed through various engineering and non-clinical tests.

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

• Test Set Description: The "test set" primarily comprises images obtained during a non-clinical animal study and optical bench testing. It's not a clinical diagnostic test set for evaluating specific disease detection performance.
• Sample Size:
  • Animal Study: A "library of images" was obtained. The exact number of individual images or animal subjects is not specified.
  • Bench Testing: Images were generated from the porcine pulmonary location using two PENTAX bronchoscopes (one HD, one standard def) and one Olympus bronchoscope. The number of images is not specified.
• Data Provenance:
  • Country of Origin: Not specified, but given Pentax's global presence, it could be from various locations.
  • Retrospective/Prospective: The animal study and bench testing were likely prospectively generated for the purpose of this submission. The historical data for the reference predicate (PENTAX EPK-i5010 Video Processor K122470) would be retrospective for comparison, but the new data generated for the current submission is prospective.

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

• Number of Experts: The document does not specify the number of human experts used for formal "ground truth" establishment in the context of disease diagnosis.
• Qualifications of Experts: Not specified. Given the nature of an image enhancement device, the evaluation of image quality (e.g., "enhanced view of the texture of the mucosal surface and blood vessels") would likely involve experienced endoscopists, but their roles and specific qualifications are not detailed. The primary goal was to show technical performance and equivalence, not a direct clinical diagnostic improvement verified by experts.

4. Adjudication Method for the Test Set

The document does not describe any formal adjudication method (e.g., 2+1, 3+1 consensus) for establishing ground truth or evaluating the test set images. The evaluation appears to be technical in nature (e.g., optical performance metrics) and qualitative assessment of image enhancement.

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

Data for an MRMC comparative effectiveness study, which would quantify how much human readers improve with AI vs. without AI assistance, is not provided or mentioned. The i-Scan technology is a "digital, post-processing imaging enhancement technology," which means it's an imaging aid. The study presented here focuses on technical performance and equivalence, not on a direct comparison of diagnostic accuracy with and without the i-Scan function by multiple human readers across many cases.

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

The device is an "imaging enhancement technology" intended to be an "optional adjunct following traditional white light endoscopy" and specifically "not intended to replace histopathological sampling." Therefore, a "standalone" performance evaluation in the context of diagnostic accuracy was not conducted nor would it be appropriate since the device is designed as a human-in-the-loop aid, not a standalone diagnostic algorithm. The reported optical performance and image enhancement capabilities are effectively the "standalone" performance of the image processing aspect.

7. The Type of Ground Truth Used

Given that the device is an image enhancement tool and not a diagnostic AI that provides a specific disease classification, the "ground truth" in this context refers more to:

• Reference Optical Measurements: For bench testing, established physical and optical performance parameters (distortion, resolution, color accuracy) serve as ground truth for technical equivalence.
• Real-world Image Characteristics: The animal study images provide a real-world, yet controlled, "ground truth" for evaluating how the i-Scan technology enhances relevant anatomical features (mucosal surface, blood vessels) compared to white light and other technologies (Olympus NBI). This is a qualitative assessment of the image output itself.
• Compliance with Standards: For electrical, EMC, and software, the ground truth is adherence to the specified international standards.

There is no mention of pathology confirmation or outcomes data being used as ground truth for evaluating the diagnostic performance of the i-Scan feature for specific lesions or conditions.

8. The Sample Size for the Training Set

The document does not specify a training set size. The i-Scan technology is described as a "digital, post-processing imaging enhancement technology" with "three modes, i-Scan 1, 2, and 3." This description suggests it might be based on fixed digital filters or algorithms rather than a machine learning model that requires a "training set" in the conventional sense (i.e., for learning from data to make predictions). If any machine learning elements are present, they are not detailed as such, and no training data is specified.

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

As no "training set" (in the machine learning sense) is specified, there is no information on how ground truth for a training set was established. The i-Scan modes are described as enhancing "image topography and edges" and "color tone" by dissecting and recombining RGB components, implying a rule-based or filter-based approach rather than a data-trained predictive model.

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