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PENTAX Medical EPK-3000 Video Imaging System consists of PENTAX Medical VIDEO PROCESSOR EPK-3000, PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-J10 Series, PENTAX Medical Digital Video Capture Modules, PENTAX Medical Laryngeal Strobe, and other ancillary equipment.

1. PENTAX Medical Video Processor EPK-3000

The PENTAX Medical EPK-3000 Video Processor is intended to be used with the PENTAX VNL8-J10, VNL11-J10, and VNL15-J10 endoscopes, PENTAX Medical Laryngeal Strobe, video monitors and other ancillary equipment for ENT endoscopic observation and nasopharyngoscopic (ENT) diagnosis, treatment and video observation with or without stroboscopy.

The PENTAX Medical EPK-3000 Video Processor 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.

2. PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-J10 Series

The PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-J10 Series (VNL8-J10, VNL11-J10 and VNL15-J10) are intended to be used with a PENTAX EPK-3000 Video Processor, PENTAX Medical Laryngeal Strobe, documentation equipment, video monitor, endoscopic device and other ancillary equipment for optical visualization (via a video monitor) of, and, for VNL15-J10 only, therapeutic access to, nasal, pharyngeal, laryngeal and the upper airway anatomy.

PENTAX Medical EPK-3000 Video Imaging System is used for ENT endoscopic observation and nasopharyngo-laryngoscopic (ENT) diagnosis, treatment, and video observation.

The System functions by receiving image signals from the image sensor in an endoscope, which are processed within a video processor and then output to a monitor. Brightness, color balance, and other properties of the displayed images can be adjusted using the system's control panel. The light from a xenon lamp at the distal end of the endoscope illuminates the body cavities of the patient through the endoscope connected to the video processor.

The primary components of the system include the following:

• PENTAX Medical Video Processor EPK-3000
• PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-J10 Series (VNL-J10 Series)
• PENTAX Medical Laryngeal Strobe 9400
• PENTAX Medical Digital Video Capture Modules (two models are available: 9310HD/9372HD)

The PENTAX Medical EPK-3000 Video Imaging System is provided with the following accessories:

• 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 high-frequency electro cautery device use with Pentax endoscopes
• Inlet Seal - prevents suctioned fluid from coming out of the instrument Channel Inlet during the use of suction function. During the reprocessing, it seals the instrument Channel Inlet in order to full 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
  Additional accessories for reprocessing are provided with the device. These include Cleaning Adapter, Soaking Cap, Ventilation Cap, Cleaning Brush Kits, Endoscope Cleaning Brush Kits, and replacement O- Rings.

The PENTAX Medical Video Processor EPK-3000 is intended to be used with the PENTAX compatible endoscopes, light sources (including strobe), vide monitors and other ancillary equipment for ENT endoscopic observation and nasopharyngo-laryngoscopic (ENT) diagnosis, treatment, and video observation with or without stroboscopy.

PENTAX Medical Video Processor EPK-3000 functions with the PENTAX i-Scan technology, 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.

White light is captured from a 150-Watt xenon lamp housed in the EPK-3000 Video Processor. All visualization is done with the white light mode first. White light 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 red, green, blue (RGB) components for each pixel occurs when the i-Scan function is turned on in the EPK-3000 Video Processor. The resulting i- Scan image is then displayed on the observation monitor. The PENTAX Medical Video Processor EPK-3000 is compatible with PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-J10 Series. The PENTAX Medical Video Naso-Pharyngoscope VNL-J10 Series are intended to be used with a PENTAX Video Processor (including Light source), documentation equipment, video monitor, and other ancillary equipment for optical visualization (via a video monitor) of, and/or therapeutic access to, nasal, pharyngeal, laryngeal and the upper airway anatomy. Three scopes are included in the VNL-J10 Series of scopes that is the subject of this submission: VNL8-J10, VNL11-J10, and VNL15-J10.

The VNL-J10 Series endoscopes are inserted transorally to visualize subjects under illumination transmitted from a video processor with a solid-state image sensor located at the distal end of the endoscope, and provide images of the target anatomy on the video monitor. The endoscopes are flexible which allows the insertion portion to shape according to the body cavity. They are also composed of an Insertion Portion, Control Body, PVE Connector, and Light Guide Plug. The VNL15-J10 can be used with endoscopic devices, each of which is introduced from the instrument channel inlet of the control body. Additionally, suctioning from the instrument channel at the distal end of the endoscope by pressing the suction control valve is available with this model. The VNL8-10 and the VNL11-J10 do not have an instrument channel.

The provided document is a 510(k) premarket notification for the PENTAX Medical EPK-3000 Video Imaging System. This submission focuses on adding two new components (Laryngeal Stroboscope 9400 and High-Definition Digital Video Capture Module) to an existing cleared system (K172156).

The document details non-clinical performance data to demonstrate substantial equivalence, rather than a clinical study evaluating diagnostic performance or comparative effectiveness with human readers using AI. Therefore, most of the requested information regarding acceptance criteria for diagnostic performance, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable to this specific submission.

The acceptance criteria and reported device performance discussed relate to the interoperability, safety, and functionality of the expanded system, not its diagnostic accuracy.

Here's a breakdown of the applicable information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This submission details non-clinical performance testing for system interoperability and safety, not a clinical test set for diagnostic performance. The testing involved verification and validation activities of the hardware and software components.

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

• Not Applicable. Ground truth, in the context of diagnostic accuracy, is not relevant to the non-clinical performance and safety testing described. Test results were based on engineering verification and validation against specified standards and functionality.

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

• Not Applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations in clinical studies. This submission focuses on non-clinical engineering and safety 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

• No, an MRMC comparative effectiveness study was not done. The PENTAX i-Scan™ technology is mentioned as a digital, post-processing imaging enhancement, but the submission does not present a study on its comparative effectiveness with or without AI assistance for human readers. The new components added (Laryngeal Strobe and Digital Video Capture Modules) are for observation and recording, not for AI-driven diagnostic assistance.

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

• Not Applicable / Not Described. The i-Scan technology is described as an "optional adjunct following traditional white light endoscopy" and "not intended to replace histopathological sampling," clearly indicating it's not a standalone diagnostic algorithm. No standalone performance evaluation for i-Scan is presented in this document. The other components are hardware for visualization and recording, not algorithms.

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

• Not Applicable. For the non-clinical tests described, "ground truth" was internal design specifications, regulatory standards (e.g., IEC standards for electrical safety), and established functional requirements for interoperability.

8. The sample size for the training set

• Not Applicable. This document describes a 510(k) submission for device modifications and interoperability, not the development or evaluation of a machine learning algorithm.

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

• Not Applicable. Since there is no machine learning model training described, this information is not relevant to the content provided.

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1. PENTAX Medical VIDEO PROCESSOR EPK-3000

The PENTAX Medical VIDEO PROCESSOR EPK-3000 is intended to be used with the PENTAX VNL8-J10, VNL11-J10, and VNL15-J10 endoscopes, light sources (including strobe), video monitors and other ancillary equipment for ENT endoscopic observation and nasopharyngo-laryngoscopic (ENT) diagnosis, treatment and video observation.

The PENTAX Medical VIDEO PROCESSOR EPK-3000 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.

2. PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-J10 Series

The PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-J10 Series (VNL8-J10, VNL11-J10, and VNL15-J10) are intended to be used with a PENTAX EPK-3000 Video Processor (including Light source), documentation equipment, video monitor, endoscopic device and other ancillary equipment for optical visualization (via a video monitor) of, and, for VNL15-J10 only, therapeutic access to, nasal, pharyngeal and the upper airway anatomy.

PENTAX Medical EPK-3000 Video Imaging System is used for ENT endoscopic observation and nasopharyngo-laryngoscopic (ENT) diagnosis, treatment, and video observation.

The System functions by receiving image signals from the image sensor in an endoscope, which are processed within a processor and then output to a monitor. Brightness, color balance, and other properties of the displayed images can be adjusted using the buttons on the system's control panel. The light from a xenon lamp at the distal end of the endoscope illuminates the body cavities of the patient through the endoscope connected to the video processor.

The primary components of the system include the following:

• PENTAX Medical Video Processor EPK-3000
• PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-J10 Series (VNL-J10 Series)

The PENTAX Medical EPK-3000 Video Imaging System is provided with the following accessories:

• . 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 high-frequency electro cautery device use with Pentax endoscopes.
• . Inlet Seal - prevents suctioned fluid from coming out of the instrument Channel Inlet during the use of suction function. During the reprocessing, it seals the instrument Channel Inlet in order to full 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.

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

The PENTAX Medical Video Processor EPK-3000 is intended to be used with the PENTAX compatible endoscopes, light sources (including strobe), vide monitors and other ancillary equipment for ENT endoscopic observation and nasopharyngo-laryngoscopic (ENT) diagnosis, treatment, and video observation.

PENTAX Medical Video Processor EPK-3000 functions with the PENTAX i-Scan technology, 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.

White light is captured from a 150-Watt xenon lamp housed in the EPK-3000 Video Processor. All visualization is done with the white light mode first. White light 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 red, green, blue (RGB) components for each pixel occurs when the i-Scan function is turned on in the EPK-3000 Video Processor. The resulting i- Scan image is then displayed on the observation monitor.

The PENTAX Medical Video Processor EPK-3000 is compatible with PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-J10 Series. The PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-J10 Series are intended to be used with a PENTAX Video Processor (including Light source), documentation equipment, video monitor, endoscopic device and other ancillary equipment for optical visualization (via a video monitor) of, and/or therapeutic access to, nasal, pharyngeal, laryngeal and the upper airway anatomy. Three scopes are included in the VNL-J10 Series of scopes that is the subject of this submission: VNL8-J10, VNL11-J10, and VNL15-J10.

The VNL-J10 Series endoscopes are inserted transorally or transnasally to visualize subjects under illumination transmitted from a video processor with a solid-state image sensor located at the distal end of the endoscope, and provide images of the target anatomy on the video monitor. The endoscopes are flexible which allows the insertion portion to shape according to the body cavity. They are also composed of an Insertion Portion, Control Body, PVE Connector, and Light Guide Plug.

The VNL15-J10 can be used with endoscopic devices, each of which is introduced from the instrument channel inlet of the control body. Additionally, suctioning from the instrument channel at the distal end of the endoscope by pressing the suction control valve is available with this model. The VNL8-110 and the VNL11-J10 do not have an instrument channel.

The provided text describes the PENTAX Medical EPK-3000 Video Imaging System, a medical device for ENT endoscopic observation. The document is a 510(k) summary, which aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness on its own. Therefore, much of the information requested, particularly regarding acceptance criteria and detailed study results that prove the device meets specific performance criteria for new features, is not explicitly present in the provided text in the way one might expect for a de novo submission.

However, I can extract information related to the device's technical specifications and the comparison with a predicate device, which forms the basis for its clearance. The "acceptance criteria" here are largely implied by the successful comparison to the predicate device and compliance with various recognized standards.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) summary focused on substantial equivalence to a predicate device (PENTAX Medical ENT Video Imaging System (K162151)), the "acceptance criteria" are implicitly met by demonstrating that the new device is either identical or equivalent in performance to the predicate and complies with relevant standards. Specific quantitative acceptance criteria for novel image enhancement features like i-Scan are not detailed with numerical thresholds but are instead assessed against the predicate's overall visualization capabilities.

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

• Test Set Sample Size: Not explicitly stated. The text mentions "A library of images was captured" for the clinical usability test and "side-by-side bench and clinical usability tests." The number of images or cases in the "library" is not quantified.
• Data Provenance: The clinical usability study was performed by PENTAX Medical, implying the data was generated specifically for this submission. The country of origin is not specified, but the submission is to the U.S. FDA by PENTAX of America, Inc. It was a "non-significant risk clinical study with IRB approval," which indicates it was a prospective study.

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

• Number of Experts: Not explicitly stated, but referred to as "experienced ENT physicians."
• Qualifications of Experts: "Experienced ENT physicians." Specific details like years of experience or board certification are not provided in this summary.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not specified. The text merely states that "These images were evaluated by experienced ENT physicians." It doesn't describe how consensus or a definitive ground truth was reached from multiple readers' evaluations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

• MRMC Comparative Effectiveness Study: A clinical usability test was performed which compares the subject device's performance to a predicate device, and physicians evaluated images from both. This technically involves multiple readers (experienced ENT physicians) evaluating multiple cases (images from the subject and predicate devices). However, it's not described as a formal "MRMC comparative effectiveness study" in the sense of a rigorous statistical design to quantify human reader improvement with AI vs. without AI assistance.
• Effect Size: No specific effect size is reported for how much human readers improve with AI (i-Scan) vs. without AI assistance (white light). The study concluded that the subject device's ability to visualize vascular structure and/or mucosal surface (both with white light and i-Scan) was equivalent to the predicate device. The i-Scan feature itself is positioned as an "optional adjunct" for enhanced viewing, not as a tool to improve human diagnosis over white light in quantified terms within this submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• The i-Scan technology is a "digital, post-processing imaging enhancement technology." While it operates as an algorithm, its performance is described in the context of human evaluation of the resulting images ("i-Scan is intended to give the user an enhanced view..."). The clinical usability study involved human readers evaluating the images enhanced by i-Scan, demonstrating its utility as an adjunct. There is no mention of a standalone diagnostic accuracy study of the i-Scan algorithm without a human reader interpreting the enhanced image against a diagnostic ground truth.

7. The Type of Ground Truth Used:

• For the clinical usability test, there isn't an explicit "ground truth" (e.g., pathology report) against which the device's diagnostic accuracy is measured. Instead, the "ground truth" for the comparison was the expert evaluation/consensus of "experienced ENT physicians" who assessed the ability to visualize vascular structure and/or mucosal surface in images from both the subject and predicate devices. The study aimed to show equivalence in visualization capabilities, not diagnostic accuracy against a definitive disease state.

8. The Sample Size for the Training Set:

• Training Set Sample Size: The document does not mention a training set for the i-Scan algorithm or any other machine learning component in the traditional sense, as it focuses on demonstrating substantial equivalence of a video imaging system. The i-Scan is described as a "digital filter-based image enhancement technique," implying it might use pre-defined filters and algorithms rather than requiring ongoing machine learning with a specific training set.

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

• As no training set is mentioned for an AI/ML algorithm requiring ground truth, this information is not applicable and therefore not provided in the document.

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