(272 days)
PENTAX Medical EPK-3000 Video Processor is intended to be used with the PENTAX Medical camera heads with PENTAX sinuscopes (8890, 8891, 8892, 8893), PENTAX Medical VNL8-J10, VNL11-J10, and VNL15-J10 endoscopes, PENTAX Medical Laryngeal Strobe, video monitors and other ancillary equipment for ENT endoscopic observation and 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.
The PENTAX Medical Video Processor (EPK-i5010) is intended to be used with the PENTAX Medical camera heads with PENTAX sinuscopes (8890, 8891, 8892, 8893), PENTAX Medical VNL-1570STK, VNL8-J10, VNL11-J10, and VNL15-J10 endoscopes, PENTAX Medical Laryngeal Strobe, video monitors and other ancillary equipment for ENT endoscopic observation and 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 EPK-3000 and ENT Video Imaging Systems are 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 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 new component to be added to the subject system is the PENTAX Medical Camera Head, model PVK-J10. The PVK-J10 is used in conjunction with a non-video endoscope, video processor, and light guide. The non-video endoscope is connected to the video processor via the camera head and the light guide. The light supplied from the video processor is transmitted to the distal end of the endoscope via the light guide and connector in order to illuminate the patient's body cavity. Light captured by the endoscope are converted into the video signals by the camera head, and the signals are transferred to the video processor to display the video images on the monitor.
The PVK-J10 camera head connects to rigid, non-video sinuscopes (K142249). It takes images formed on the ocular lens by CCD sensor inside the control head, and transmits the image signal to the video processor. Image signal from CCD sensor is adjusted in terms of color, contrast, etc., inside the video processor, and displayed on video equipment such as a monitor.
The camera head has a zoom function with focal lengths of 6.5 mm for the wide end and 13mm for the telephoto end.
The video processors to be connected to the PVK-J10 camera head and light guides are PENTAX Medical Video Processors EPK-i5010 and EPK-3000, both of which have been cleared.
PENTAX Medical sinuscopes 8890, 8891,8892, 8893, manufactured by Schoelly Fiberoptic GmbH and cleared under K142249. The light guides 8899HT used to connect PVK-J10 with these endoscopes are also manufactured by Schoelly Fiberoptic GmbH.
The provided text describes the acceptance criteria and study for the PENTAX Medical EPK-3000 Video Imaging System and PENTAX Medical ENT Video Imaging System, specifically regarding the addition of the PENTAX Medical Camera Head PVK-J10. However, the document does not focus on providing specific quantitative acceptance criteria or detailed results of a comparative effectiveness study with human readers (MRMC). Instead, it focuses on demonstrating substantial equivalence to predicate devices through various non-clinical performance data and a qualitative clinical image capture study.
Here's an attempt to extract and infer the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria with reported performance values for image quality metrics. Instead, it states that "All results show that the optical characteristics of the subject device is equivalent to those of the predicate device" and that the clinical study indicates that "the subject device is able to visualize structure, vascularity and mucosal surface as well or better than the predicate device."
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from text) | Reported Device Performance |
|---|---|---|
| Reprocessing Validation | Effectiveness of reprocessing in accordance with FDA's 2015 Final Guidance and AAMI TIR 30:2011 for residual soil accumulation and extraction efficiency. | All acceptance criteria were satisfied. |
| Sterilization & Shelf Life | Compatibility with System 1E liquid chemical sterilization. Not provided sterile, so shelf-life not applicable. | Validation coordinated with STERIS Corporation; successful. |
| Biocompatibility | Not applicable, as the device is non-contact with patients. | Not applicable. |
| Software & Cybersecurity | Compliance with IEC 62304: 2006 and relevant FDA Guidances. | Verification and validation including cybersecurity assessments were conducted and met requirements. |
| Electrical Safety (ES) & Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2:2014; IEC 60601-1:2005+CORR 1:2006+CORR 2:2007+A1:2012; and IEC 60601-2-18:2009. | Acceptable levels confirmed. |
| System Performance | Equivalence to predicate devices; Service life of six years for PVK-J10 and AP-RV3. | Demonstrated equivalence to predicate devices; demonstrated six years of service life. |
| Optical Performance | Equivalence of imaging and illumination performances to predicate device. Ability to visualize structure, vascularity, and mucosal surface. | All results show that the optical characteristics of the subject device are equivalent to those of the predicate device. Able to visualize structure, vascularity and mucosal surface as well or better than the predicate device. |
| Photobiological Safety | Acceptable hazards related to photobiological safety. | All hazards related to the photobiological safety are acceptable. |
2. Sample Size for the Test Set and Data Provenance
The document mentions a "Clinical Image Capture Study" for optical and color performance testing.
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number or qualifications of experts used for establishing ground truth in the clinical image capture study. The assessment appears to be qualitative, stating the subject device can visualize "as well or better than the predicate device."
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method for the clinical image capture study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? No, a formal MRMC comparative effectiveness study demonstrating how much human readers improve with AI vs. without AI assistance was not conducted or reported in this document. The focus was on the camera head's imaging performance and its substantial equivalence to predicate devices. The i-Scan™ technology is mentioned as "an optional adjunct" but no comparative effectiveness study for its impact on human readers is provided here.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was it done? Not explicitly stated as a separate standalone study for an algorithm. The clinical image capture study assessed the device's ability to visualize, which is related to the imaging performance itself, but not specifically an "algorithm only" performance separate from human interpretation of the images. The i-Scan™ is a "digital, post-processing imaging enhancement technology," which would imply an algorithm, but no standalone performance metrics are provided for it here.
7. Type of Ground Truth Used
For the "Clinical Image Capture Study," the ground truth seems to be a qualitative assessment of the ability to visualize structure, vascularity, and mucosal surface in comparison to the predicate device. This implies expert observation and comparison, but not necessarily a quantifiable gold standard like pathology or outcome data.
8. Sample Size for the Training Set
The document describes the addition of a camera head to existing video imaging systems and refers to a "Clinical Image Capture Study" for performance testing. It does not mention a "training set" as would be relevant for an AI/algorithm where machine learning is involved. If the i-Scan™ technology involves machine learning, the training set information is not provided in this document.
9. How the Ground Truth for the Training Set Was Established
As no training set is explicitly mentioned or detailed (see point 8), the method for establishing its ground truth is also not provided.
§ 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.