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PENTAX Medical ENT Video Imaging System consists of PENTAX Medical Video Naso-Pharyngo-Laryngoscopes, PENTAX Medical Video Processor, PENTAX Medical Digital Video Capture Module, PENTAX Medical Laryngeal Strobe and other ancillary equipment.

1. PENTAX Medical Video Naso-Pharyngo-Laryngoscope
   The PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-J10 Series (VNL8-J10, VNL11-J10 and VNL15-J10) is intended to be used with a PENTAX Medical 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.

2. PENTAX Medical Video Processor
   The PENTAX Medical Video Processor (EPK-i5010) is intended to be used with the PENTAX Medical camera heads, PENTAX Medical VNL-1570STK, VNL8-10, VNL11-J10, and VNL15-J10 endoscopes, PENTAX Medical Laryngeal Strobe, video monitors and other ancillary equipment for ENT endoscopic observation and naso-pharyngo-laryngoscopic (ENT) diagnosis, treatment and video observation with or without stroboscopy.

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

PENTAX Medical ENT Video Imaging System is used for ENT endoscopic observation and nasopharyngolaryngoscopic (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 buttons on the system's control panel. The light 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-i5010
• PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-1570STK
• 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/937HD)

The provided document describes the PENTAX Medical ENT Video Imaging System and its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of specific quantitative acceptance criteria alongside performance data for individual parameters (e.g., specific signal-to-noise ratio values). Instead, it states that "The acceptance criteria have been satisfied for all tests" for system interoperability and that "Based on the tests results, the optical performance of the subject device is substantially equivalent to that of the predicate device."

Here's a summary of the evaluated parameters and the general conclusion:

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

• Sample Size: The document refers to a "library of images" being captured for evaluation. However, it does not specify the exact number of images or cases used in this "library."
• Data Provenance: The document does not explicitly state the country of origin. It indicates that it was a "non-significant risk clinical study with IRB approval," which suggests a prospective clinical study, though the specifics of the patient population are not provided beyond the scope of image evaluation.

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

• Number of Experts: The document states that the images were "evaluated by experienced ENT physicians." The exact number of experts is not specified.
• Qualifications of Experts: They are described as "experienced ENT physicians." Specific details such as years of experience or board certification are not provided.

4. Adjudication Method for the Test Set

The document states that the images were "evaluated by experienced ENT physicians" and that the "subject devices were evaluated as having equivalent ability to visualize vascular structure and/or mucosal surface." This implies a subjective assessment, but it does not detail any specific adjudication method (e.g., 2+1, 3+1 consensus).

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

The study described is a comparative visualization study between two imaging systems (subject vs. predicate). It is not an MRMC comparative effectiveness study involving AI assistance. The PENTAX i-Scan™ is a digital, post-processing imaging enhancement technology included in the video processor, but the study focuses on the overall performance of the imaging system and does not specifically measure human reader improvement with or without AI (i-Scan) assistance in the context of an MRMC study.

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

No, a standalone algorithm-only performance study was not explicitly described. The clinical performance data presented involves human interpretation ("evaluated by experienced ENT physicians"). The i-Scan technology is an integrated enhancement, not a separate AI algorithm being evaluated for standalone performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the clinical performance evaluation was based on the subjective assessment/evaluation of "experienced ENT physicians" regarding the visualization ability of vascular structure and/or mucosal surfaces. It is not explicitly stated to be an expert consensus of a specific number of experts, nor is it based on pathology or outcomes data from the patients.

8. The Sample Size for the Training Set

This document describes a premarket notification for a medical imaging system, not an AI/ML device that requires a distinct training set for an algorithm. Therefore, no training set sample size is mentioned or applicable in the context of an algorithm. The "library of images" mentioned pertains to the evaluation (test) set for demonstrating equivalence.

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

As this is not an AI/ML device with a distinct training set for an algorithm, this question is not applicable. The "ground truth" discussed in the performance study relates to the evaluators' assessment of image quality from the captured library of images.

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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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The iMESH Tacker is indicated for fixation of prosthetic material to soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair.

The iMESH Tacker is a sterile, single use device for the fixation of prosthetic material, such as a hernia mesh, onto soft tissue. The applicator features an articulating tip. The absorbable tack is made of synthetic polyester derived from a lactic acid and glycolic acid copolymer. The Applicator is pre-loaded with 30 tacks.

The iMESH Tacker is a device for fixing prosthetic material to soft tissue, primarily in hernia repair. The acceptance criteria and the study proving it meets these criteria are based on its substantial equivalence to predicate devices, namely the Covidien Protack (K090470) and Absorbatack (K071061).

1. Table of Acceptance Criteria and Reported Device Performance

Note on Differences: The only stated differences are the iMESH Tacker's helical, bio-absorbable tack (Protack also has a helical tack, Absorbatack has screw) and its articulating tip to facilitate tack placement (the predicates have non-articulating tips). These differences were not considered to preclude substantial equivalence as the performance data demonstrated similarity or improvement where applicable.

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

The provided document does not specify a separate "test set" in the context of an AI/ML device. The performance data is presented as a comparison of the iMESH Tacker's fixation force with that of a predicate device (Absorbatack, K071061).

• Sample Size: The exact sample size (number of tacks, trials, etc.) for the fixation force testing is not explicitly stated. The data provided (e.g., "On implantation 17.07 N") represents the results of the tests, not the number of samples used to achieve those results.
• Data Provenance: The document implies the testing was conducted by EasyLap Ltd., the manufacturer based in Kfar Truman, Israel. The data would be considered prospective in the sense that it was generated for the purpose of this 510(k) submission to demonstrate the device's performance.

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

This information is not applicable to this 510(k) submission. The device is a mechanical surgical instrument, not an AI/ML diagnostic or prognostic tool that requires expert human interpretation to establish ground truth for a test set. The "ground truth" for this device's performance is derived from physical and mechanical testing (e.g., fixation force measurements) against a specified standard or comparison to a predicate device's established performance.

4. Adjudication Method for the Test Set

This information is not applicable. Since the "ground truth" is based on physical performance measurements, there is no need for human adjudication of results in the way there would be for an image-based diagnostic AI.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The iMESH Tacker is a surgical device, not an AI-assisted diagnostic tool. Therefore, MRMC studies and human reader improvement are not relevant to its evaluation.

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

This information is not applicable. The iMESH Tacker is a mechanical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the iMESH Tacker's performance validation is based on objective physical and mechanical performance data, specifically:

• Fixation Force measurements: Quantifying the force required for a tack to remain in place on implantation and after a set period (14 days).
• Comparison to Predicate Device Performance: The primary "ground truth" or benchmark is the established mechanical performance of a legally marketed predicate device (Covidien Absorbatack). The claim of substantial equivalence hinges on demonstrating that the iMESH Tacker's performance characteristics align with or are superior to the predicate, within acceptable limits.

8. The Sample Size for the Training Set

This information is not applicable. The iMESH Tacker is a physical device, not an AI/ML algorithm that requires a training set.

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

This information is not applicable. As there is no training set for an AI/ML algorithm, no ground truth needed to be established in this context.

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