(183 days)
The AED Sinuscope is intended for use in otolaryngology and Head and Neck procedures, including rhinology, and endoscopic plastic and reconstructive surgery.
The AED Sinuscope is a reusable rod lens sinuscope consisting of an eyepiece lens and a light post connection for fiber optic light cables. A shaft composed of surgical grade stainless steel encloses the glass rod-lens system and a built-in fiber optic light carrier made of glass/acrylic. The light post body is also comprised of surgical stainless steel. The eyepiece is made from Ultem.
AED Sinuscopes are manufactured in multiple configurations that differ in insertion tube outer diameter and working length and with respect to optical parameters (direction of view, field of view).
The AED Sinuscope is reusable and provided non-sterile. It must be cleaned and sterilized prior to use.
The provided document describes the AED Sinuscope, a reusable rigid rod lens sinuscope, and its substantial equivalence to a predicate device (Schoelly Sinuscope) for 510(k) clearance.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Temperature Testing | Meet requirements specified in IEC 60601-2-18: Medical Electrical Equipment - Part 2: Particular Requirements For The Basic Safety And Essential Performance Of Endoscopic Equipment. Edition 3.0 2009-08 (Surface temperatures at various locations over time). | "The device was measured for surface temperatures at various locations over time and found to meet the requirements specified in IEC 60601-2-18." |
| Optical Parameter Testing | Meet minimum requirements defined in internal specifications and as specified in ISO 8600-3:1997 and ISO 8600-3: Amendment 1: 2003 standards (specifically for field of view and direction of view). | "The device was tested for all relevant optical parameters and found to meet the minimum requirements defined in internal specifications and as specified in the ISO 8600-3:1997 and ISO 8600-3: Amendment 1: 2003 standards (field of view, direction of view)." |
| Reprocessing: Cleaning | Validated in accordance with AAMI TIR12:2010 (Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers), AAMI TIR30:2011 (A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable devices) and FDA Guideline on General Principles of Process Validation, January 2011, Rev 1. | "The cleaning study has been performed in accordance with AAMI TIR12:2010... AAMI TIR30:2011... and FDA Guideline on General Principles of Process Validation..." |
| Reprocessing: Sterilization | Validated in accordance with ISO 14937:2009 (Sterilization of health care products - General requirements for characterization of sterilizing agent and the development, validation and routine control of a sterilization process for medical devices), ANSI/AAMI/ISO 17665-1:2006 (Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of sterilization process for medical devices), AAMI TIR 12:2010 (Designing, testing and labeling reusable medical devices for reprocessing in health care facilities) and ISO 17665-2:2009 (Sterilization of health care products - Moist heat - Part 2: Guidance of the application of ISO 17665-1). | "The sterilization study has been performed in accordance with ISO 14937:2009... ANSI/AAMI/ISO 17665-1:2006... AAMI TIR 12:2010... and ISO 17665-2:2009." |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical performance testing for the device itself (temperature, optical parameters, reprocessing). It does not mention a "test set" in the context of patient data, imaging data, or human interpretation. Therefore, phrases like "sample size used for the test set" and "data provenance (e.g. country of origin of the data, retrospective or prospective)" are not applicable to the type of device and testing described. The tests were performed on the device prototypes/production samples in a lab environment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the document describes physical and reprocessing performance testing of a medical device, not a diagnostic algorithm that requires expert-established ground truth from medical images or patient data.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as points 2 and 3. The testing involves objective measurements against established technical standards, not subjective assessments requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document describes the testing of a physical medical device (sinuscope), not an AI algorithm intended to assist human readers. Therefore, there is no mention of "human readers" or "AI assistance" in this context.
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 done. This device is a physical medical instrument, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the tests described are the specified technical standards and internal specifications. For example:
- Temperature Testing: Ground truth is defined by the limits and requirements of IEC 60601-2-18.
- Optical Parameter Testing: Ground truth is defined by the minimum requirements in ISO 8600-3:1997 and Amendment 1:2003, and internal specifications.
- Reprocessing: Ground truth for cleaning efficacy and sterilization assurance is defined by the requirements and methodologies outlined in the various AAMI and ISO standards (e.g., AAMI TIR12, AAMI TIR30, ISO 14937, ANSI/AAMI/ISO 17665-1).
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical instrument, not an AI or machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
§ 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.