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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 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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