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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 Bronchoscopes EB-J10 Series have been designed to be used with a PENTAX Video Processor (including Light source), documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopic surgery within the airways and tracheobronchial tree.

The EB-J10 series endoscopes are used to provide visualization of, and therapeutic access to, the airways and tracheobronchial tree. There are two models of EB-J10 series: EB15-J10 and EB19-J10. These models are identical in all parameters and only differ in French size: 15 and 19.

The bronchoscopes are used with cleared PENTAX Video Processors (a softwarecontrolled device). The endoscopes have a flexible insertion tube, a control body, and PVE connector. The PVE connector will be attached to the Video Processor and has connections for illumination, video signals, air/ water and suction.

The control body includes controls for up/ down angulation, air/ water delivery, and an accessory inlet port. The endoscope contains light carrying bundles (LCB) to illuminate the body cavity, and a charge coupled device (CCD) to collect endoscopic 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 instrument is immersible (with the use of supplied cleaning accessories) as described in the endoscope reprocessing instructions.

Here's a summary of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size for the clinical image capture study (test set) or its specific provenance (e.g., country of origin, retrospective/prospective). It only mentions that "A clinical image capture study was performed."

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

This information is not provided in the document. The document only mentions "visualization of vascularity and mucosal surface for each anatomical area" as the outcome of the clinical image capture study, implying expert assessment, but no details about the experts are given.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. The clinical image capture study primarily aimed to compare the visualization capabilities of the subject device against the predicate, not to assess human reader performance with or without AI assistance.

6. Standalone Performance Study

A standalone performance study (algorithm only without human-in-the-loop) was not performed as the device is a bronchoscope, which is a physical instrument used by a clinician, not an AI algorithm. The performance tests focused on the physical and optical characteristics of the device itself.

7. Type of Ground Truth Used

For the clinical image capture study, the "ground truth" was likely based on expert assessment of the bronchoscope's ability to clearly visualize vascularity and mucosal surface. However, the document does not explicitly state the methodology for establishing this ground truth (e.g., expert consensus, pathology, etc.). The other tests (reprocessing, software, EMC, optical) used established engineering standards and measurements as their "ground truth".

8. Sample Size for the Training Set

This information is not applicable and not provided. The PENTAX Medical Video Bronchoscope EB-J10 Series is a medical device, specifically a bronchoscope, and not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of AI.

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

This information is not applicable as there is no "training set" for this device.

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The PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Track including but not restricted to organs, tissues, and subsystem: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), 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.

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows.
Clinical Application: Endoscopy
Mode of Operation: B, M, PWD, Color Doppler, Amplitude Doppler

The PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U connects with a video processor and an ultrasound scanner, both of which are software controlled devices.

The endoscope has a flexible insertion tube, a control body, PVE connector, and scanning unit connector. The PVE connector attaches to the video processor and has connections for illumination and video signals. The ultrasound umbilical connector attaches to the ultrasound scanner unit.

The control body includes remote buttons for functions assigned from the video processor. It also includes controls for up/down angulation or neutral position, suction control, and ports for manual balloon insufflation/evacuation and accessory inlet.

The endoscope contains light carrying bundles to illuminate the body cavity, a change couple device to collect endoscopic image data, and a convex 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 focused at the endoscope 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 immersible (with the use of supplied cleaning accessories). EB19-J10U is connected to the ultrasound scanners Arietta 70 and Noblus via the scanning unit connector of the endoscope directly to the probe connector of the scanning unit. In order to connect to the Preirus scanning unit, junction box PUN-JBP1 is required to connect the scanning unit connector to the probe connector.

The instrument is immersible (with the use of supplied cleaning accessories).

The provided text is a 510(k) Summary for the PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U. It details the device's technical specifications, intended use, and a summary of testing conducted to demonstrate substantial equivalence to predicate devices. However, it does not contain any information about a study proving that the device meets specific acceptance criteria based on performance metrics like sensitivity, specificity, accuracy, or reader performance with or without AI assistance.

The document focuses on non-clinical testing to demonstrate that the device is equivalent to a legally marketed predicate device, especially regarding safety and effectiveness from a design and manufacturing perspective. It mentions "Performance Testing - Bench" for "System compatibility" and "Optical characteristics," but does not provide specific acceptance criteria or quantitative results for these tests.

Therefore, I cannot fully answer your request for acceptance criteria and a study that proves the device meets them, as the provided text does not include the necessary information regarding a clinical performance study involving AI, human readers, or specific diagnostic performance metrics.

Here's an breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided. The document lists various types of non-clinical testing (Sterilization, Reprocessing, Biocompatibility, Software, EMC + Electrical Safety, System Compatibility, Optical Characteristics), and states that "Testing results confirm the subject device is safe and effective as the predicate device, and performs as intended." However, it does not provide specific quantitative acceptance criteria or detailed numerical results for these tests. For example, it says "The subject device demonstrates equivalent or better optical characteristics than the predicate device," but gives no numerical value for either.

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

• Cannot be provided definitively for a performance study. The document outlines non-clinical bench testing. These tests typically don't involve "samples" in the same way clinical studies do (e.g., patient data). The data provenance (country of origin, retrospective/prospective) is not applicable or mentioned for the types of tests described.

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

• Not applicable. This information is relevant for studies establishing diagnostic ground truth, often used for AI/clinical performance evaluations. The document describes engineering and safety testing, not clinical diagnostic performance.

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

• Not applicable. Adjudication methods are used in clinical studies to resolve discrepancies in expert interpretations for ground truth establishment. This document doesn't describe such a 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, such a study was not done according to this document. This device is a bronchoscope, which is a physical instrument for visualization and access, not an AI software intended to assist human readers in image interpretation. The document does not mention any AI component or any MRMC studies.

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

• No, this is not an AI algorithm. This is a hardware device (bronchoscope) with associated software for its operation. Therefore, a standalone algorithm performance study is not applicable.

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

• Not applicable in the context of diagnostic performance. The "ground truth" for the tests described relates to engineering specifications and safety standards (e.g., whether the device sterilizes correctly, whether electrical current is within safe limits, whether optical clarity meets design specs).

8. The sample size for the training set:

• Not applicable. There is no mention of a "training set" as this is not an AI device being trained.

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

• Not applicable. (See point 8).

In summary, the provided FDA 510(k) summary focuses on demonstrating the substantial equivalence of a medical device (a bronchoscope) through non-clinical testing of its physical, electrical, and reprocessing characteristics. It does not involve AI or diagnostic performance studies that would require the types of acceptance criteria and study details you requested for AI-driven devices.

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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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PENTAX Medical ENT Video Imaging System consists of PENTAX Medical Video Naso-Pharyngo-Laryngoscope, PENTAX Medical Video Processor and other ancillary equipment.

1. PENTAX Medical Video Naso-Pharyngo-Laryngoscope

The PENTAX Medical Video Naso-Pharyngo-Laryngoscopes (VNL-1570STK) is designed to be used with a PENTAX Medical video processor, light source, document, display monitor, endoscopic accessories, and other ancillary equipment and intended to provide optical visualization (via a video monitor) of, and therapeutic access to, nasal, pharyngeal, laryngeal and the upper airway anatomy.

2. PENTAX Medical Video Processor

The PENTAX Medical Video Processor (EPK-i5010) is intended to be used with the PENTAX Medical camera heads. compatible endoscopes, light sources, monitors and other ancillary equipment for ENT endoscopic observation and diagnosis, and naso-pharyngo- laryngoscopic diagnosis, and treatment.

The PENTAX Medical EPK-i5010 includes PENTAX i-Scan™, a digital, post-processing imaging enhancement technology.

PENTAX Medical ENT Video Imaging System consists of a PENTAX Medical Video Naso-Pharyngo-Laryngoscope (VNL-1570STK), PENTAX Medical Video Processor (EPK-15010) and other ancillary equipment, which is intended for ENT endoscopic observation and diagnosis and naso-pharyngo-laryngoscope diagnosis and treatment.

The following two major sub-systems/devices with their required accessories and other ancillary equipment are part of this submission:

• 1. PENTAX Medical Video Naso-Pharyngo-Laryngoscopes (VNL-1570STK)
• 2. PENTAX Medical Video Processor (EPK-i5010)

Based on the provided text, the device in question is the PENTAX Medical ENT Video Imaging System. This document is specifically a 510(k) summary for a premarket notification to the FDA, which aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical performance study.

Therefore, much of the requested information regarding acceptance criteria, performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment cannot be directly extracted from this document, as it focuses on non-clinical performance data and a comparison to a predicate device.

The document primarily discusses technical performance characteristics and safety validations (biocompatibility, reprocessing, electrical safety, software verification) rather than clinical performance metrics in the context of specific disease detection or diagnostic accuracy.

However, I can provide what information is available:

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

The document does not provide a table of acceptance criteria in the sense of specific quantitative performance thresholds (e.g., sensitivity, specificity, AUC) for clinical performance. Instead, it describes general claims of equivalence and outlines the types of non-clinical tests performed.

• Accepted Performance: "It was concluded that the performance of the subject and predicate devices are equivalent."
• Measured Parameters: Signal to Noise, Color (IEE), Resolution, Distortion, Light distribution, Spectral distribution, and Total luminous flux.
  Animal Study:
• Accepted Performance: "The images captured during the study demonstrate no difference between systems in all of their enhancement settings."
• Observation: Similarity of visual experience between the PENTAX Medical ENT Video Imaging System and the predicate system. |
  | Biocompatibility | Accepted Performance: "Biocompatibility of direct and indirect contact materials were confirmed by testing the Cytotoxicity, Sensitization and Intracutaneous Reactivity of the materials of the VNL-1570STK with limited (less than 24 hours) contact with mucosal membrane in accordance with the ISO 10993-1, 5, and 10 Biological Evaluation of Medical Devices." |
  | Reprocessing Validation | Accepted Performance: "Simulated use testing, soil accumulation analysis, cleaning, and high level disinfection validation studies of the VNL-1570STK and its accessories were conducted and confirmed the effectiveness of reprocessing procedures." |
  | Electrical Safety (ES) & Electromagnetic Compatibility (EMC) | Accepted Performance: "The acceptable level of Electromagnetic Compatibility (EMC) and Electrical Safety (ES) for the PENTAX Medical ENT Video Imaging System has been confirmed by testing the VNL-1570STK and EPK-i5010 in accordance with the following standards: IEC 60601-1:2005+A1:2012, IEC 60601-1-2:Edition 3:2007, IEC 60601-1-6 Edition 3.0:2010, IEC 60601-2-18 Edition 3.0:2009." |
  | Software Verification & Validation | Accepted Performance: "Software verification and validation testing were conducted... and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.'"
• Classification: CLASS B under IEC 62304:2006, "Moderate" level of concern.
• Compliance: ISO 14971:2007, IEC 62304:2006, IEC 62471:2006. |

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

• Optical Performance - Animal Study: "a live porcine study was conducted". The exact number of animals is not specified.
• Other performance data (Biocompatibility, Reprocessing, ES/EMC, Software): These are engineering and compliance tests, not typically described with "sample sizes" in the context of clinical data. They involve testing materials, devices, or software components according to established standards.
• Data Provenance: The animal study was "live porcine". The document does not specify the country of origin for the non-clinical test data. It is a premarket submission to the US FDA. The studies appear to be prospective in the sense that they were conducted for this submission.

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

• This information is not provided. As this is a 510(k) summary relying on non-clinical data for substantial equivalence, clinical ground truth establishment by experts in the typical diagnostic AI sense is not detailed. The "ground truth" for the animal study was visual comparison by unspecified observers.

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

• Adjudication methods are not mentioned as this was not a clinical reader study requiring such.

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 MRMC comparative effectiveness study was reported. The document focuses on the device's technical performance and visual equivalence to a predicate system, not the improvement of human reader performance with the device. The i-Scan™ feature is noted as a "digital, post-processing imaging enhancement technology" intended to give the user an enhanced view, but no study is presented to quantify human reader improvement.

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

• This device is an imaging system (endoscope and processor), not an AI algorithm intended for standalone diagnostic performance. Therefore, a "standalone algorithm only" performance study is not applicable in the sense of an AI diagnostic device. The optical bench tests and animal study demonstrate the imaging system's independent (standalone) performance in image quality, equivalent to the predicate.

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

• For the non-clinical studies:
  • Optical Bench Testing: Ground truth is against engineering specifications and direct comparison with the predicate device's measured optical properties.
  • Animal Study: "Ground truth" was visual observation and comparison by unspecified individuals (presumably the study team) of the images produced by the subject device versus the predicate device, confirming "no difference". This is, therefore, a comparative visual assessment.
  • Biocompatibility, Reprocessing, Electrical Safety, Software: Ground truth is compliance with relevant international and national standards (ISO, IEC, FDA guidance) and successful completion of specified tests.

8. The sample size for the training set:

• This document describes non-clinical studies for a medical device (endoscopy system) and does not mention a "training set" in the context of machine learning or AI models. Therefore, this information is not applicable or not provided.

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

• As related to point 8, this information is not applicable or not provided as there is no mention of a machine learning training set.

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