(261 days)
PENTAX Medical ENT Video Imaging System consists of PENTAX Medical Video Naso-Pharyngo-Laryngoscope, PENTAX Medical Video Processor and other ancillary equipment.
- 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.
- 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:
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- PENTAX Medical Video Naso-Pharyngo-Laryngoscopes (VNL-1570STK)
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- 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.
| Criterion Type | Description / Reported Performance |
|---|---|
| Optical Performance | Bench Testing: |
- 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.
§ 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.