(163 days)
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.
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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. -
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:
| Acceptance Criteria Category | Reported Device Performance/Conclusion |
|---|---|
| System Interoperability | "Interoperability verification and validation testing of the end-to-end system has been informed by the FDA Guidance document 'Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices' and has been verified and validated through Design Verification testing. The acceptance criteria have been satisfied for all tests." |
| Cybersecurity | "Cybersecurity risks have been assessed and mitigated according to the FDA Guidances for Industry and Staff 'Content of Premarket Submissions for Management of Cybersecurity in Medical Devices' issued October 2, 2014, and 'Postmarket Management of Cybersecurity in Medical Devices.' issued December 28, 2016." |
| EMC and Electrical Safety | Confirmed by adherence to IEC 60601-1-2:2007; ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012, and A2:2010/(R)2012. |
| Optical Performance (Signal to Noise, Color (IEE), Limiting Spatial Resolution, Modulation Transfer Function (MTF), Distortion, Light distribution, Spectral distribution, Total luminous flux) | "Based on the tests results, the optical performance of the subject device is substantially equivalent to that of the predicate device." |
| Photobiological Safety of Lamps | Evaluated in accordance with IEC62471. "The measured output of the tested lamps is in the Exempt group that does not pose any photobiological hazard." |
| Clinical Performance (Visualization) | "subject devices were evaluated as having equivalent ability to visualize vascular structure and/or mucosal surface to for both white light images (WLE) and i-Scan images, as compared to the predicate device." |
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.
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.