(141 days)
The KARL STORZ CMOS HD Video Rhino-Laryngoscope System is indicated to provide visualization of the nasal lumens and airway anatomy (including nasopharyngeal and trachea) during diagnostic procedures.
The components subject of this submission are: the Flexible HD Video-Rhino-Laryngoscope (Part Number: 11101 HD), and the IMAGE1 S CCU. The CCU consists of the IMAGE1 S Connect Module (Model Number: TC200US) and IMAGE1 S X-Link (Model Number: TC301US).
The provided text describes a 510(k) premarket notification for a medical device called the "Flexible HD Video Rhino-Laryngoscope System." This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing rather than clinical trials or AI performance evaluations. Therefore, many of the requested details about acceptance criteria for AI performance, clinical study design, and ground truth establishment for AI models are not applicable to this submission.
However, I can extract information related to the device's technical specifications and the non-clinical tests performed to demonstrate its performance and safety.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria in a pass/fail table for all parameters, but it lists various tests performed and that the device is "in compliance" with recognized standards. This implies that the device met the requirements outlined in those standards for each tested characteristic.
| Feature | Acceptance Criteria (Implied by Compliance with Standards) | Reported Device Performance |
|---|---|---|
| Physical Characteristics | Not explicitly stated as acceptance criteria, but compared to predicate devices. | Flexible, Insertion Shaft Diameter: 3.7 mm, Length: 300 mm, Deflection: 140° Up/Down |
| Optical Characteristics | Not explicitly stated as acceptance criteria, but compared to predicate devices. | CMOS Imager, Direction of View: 0°, Internal LED Light Source, Field of View: 100° |
| On-axis Resolution (minimal) | Must meet performance of predicate devices and/or relevant standards for visualization. | 40 lp/mm@3 mm, 2.5 lp/mm@50 mm (Subject Device) |
| Image Illumination Uniformity | In compliance with IEC 60601-2-18 and general image quality expectations. | Bench tested, "in compliance." |
| Latency | In compliance with IEC 60601-2-18 and general image quality expectations for real-time use. | Bench tested, "in compliance." |
| Dynamic Range and Linearity | In compliance with relevant image quality standards. | Bench tested, "in compliance." |
| Signal to Noise Ratio & Sensitivity | In compliance with relevant image quality standards. | Bench tested, "in compliance." |
| Color Performance and Color Contrast Enhancement | In compliance with relevant image quality standards. | Bench tested, "in compliance." |
| System Resolution | In compliance with relevant image quality standards. | Bench tested, "in compliance." |
| Field of View Distortion | In compliance with relevant image quality standards. | Bench tested, "in compliance." |
| Safety | ||
| Electrical Safety | In compliance with ANSI/AAMI ES:60601-1:2005/(R) 2012 and A1:2012, IEC 60601-1-2:2014, IEC 60601-2-18: 2009. | Bench tested, "in compliance." |
| Electromagnetic Compatibility | In compliance with ANSI/AAMI ES:60601-1:2005/(R) 2012 and A1:2012, IEC 60601-1-2:2014, IEC 60601-2-18: 2009. | Bench tested, "in compliance." |
| Biocompatibility | In compliance with ISO 10993-1, ISO 10993-5:2009/(R) 2014, ISO 10993-10:2010, ISO 10993-11:2006/(R) 2010. | Biocompatibility evaluation performed, "in compliance." |
| Reprocessing Validation | In compliance with AAMI TIR 12:2010, ISO 15883-5:2005, AAMI TIR 30:2011, AAMI/ANSI/ISO 11737-1:2006/(R)2011, ASTM E1837-96:2014. | Reprocessing validation performed, "in compliance." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The document states "Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications." This indicates that the testing was performed on the device itself and its components, not on a patient test set, and therefore there's no "sample size" in the context of clinical data.
- Data Provenance: Not applicable in the context of patient data. The tests are bench tests performed on the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. As no clinical test set was used, there was no need for expert ground truth establishment in this context. The "ground truth" for the non-clinical tests would be the established performance metrics defined by the relevant engineering and medical device standards.
4. Adjudication Method for the Test Set
- Not applicable. There was no clinical test set requiring adjudication.
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
- Not applicable. This device is an imaging system (rhino-laryngoscope) and the submission details focus on its technical functionality, safety, and equivalence to predicate devices, not on AI-assisted diagnostic capabilities or human reader performance improvement.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device does not incorporate an AI algorithm for standalone performance evaluation.
7. The Type of Ground Truth Used
- For the Device's Functionality and Safety: The ground truth for the non-clinical performance and safety tests (e.g., electrical safety, EMC, biocompatibility, reprocessing validation, optical parameters) is established by adherence to recognized international and national standards (e.g., IEC, ANSI/AAMI, ISO, ASTM). These standards define acceptable limits and methodologies for testing.
8. The Sample Size for the Training Set
- Not applicable. This submission does not involve an AI model, and therefore, no training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no AI model or training set, this information is not relevant to the provided document.
§ 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.