(311 days)
The Acclarent Cyclops Multi-Angle Endoscope is intended to provide an endoscopic means to view the nasal cavity and nasopharynx in an operating room environment.
The Acclarent Cyclops Multi-Angle Endoscope is a 4mm rigid endoscope that has the capability of varying direction of view from 10° to 100°, which is altered by the direction of view dial. The direction of view is indicated by visible markings on the scope body Cyclops provides a 60° field of view and a depth of focus from 5 mm to 40mm. The device shaft can also rotate 320° to allow for visualization of structures without rotating the device; this is controlled by the shaft rotation dial. Small rare-earth permanent magnets are incorporated into the proximal scope control body (≤10 gauss at 2cm) and drive the change in the direction of view. A standard eyepiece located on the proximal end of the device is compatible with a standard camera coupler. The light post on the subject device is compatible with an ACMI light source. There are two stainless steel adapters that accompany the Acclarent Cyclops Multi-Angle Endoscope to facilitate connection with Wolf or Storz/Olympus medical light sources. The adapters connect to the light post. The Acclarent Cyclops Multi-Angle Endoscope is a reusable device and must be cleaned and sterilized according to the user manual prior to every use.
The Acclarent Cyclops Multi-Angle Endoscope is intended to provide an endoscopic means to view the nasal cavity and nasopharynx in an operating room environment. The device's performance was evaluated through bench testing and a cadaver study, which are summarized below:
1. Table of Acceptance Criteria and Reported Device Performance
| Attribute | Acceptance Criteria (Implied by Predicate Devices / Stated Performance) | Reported Device Performance (Acclarent Cyclops Multi-Angle Endoscope) |
|---|---|---|
| Distal Shaft Diameter | Not explicitly stated as acceptance criteria, but predicate devices are 2.7mm or 4mm | 4mm (Same as predicate) |
| Working Length | Not explicitly stated as acceptance criteria, but predicate devices vary from 6.89 to 11.8 inches | 6.89 inches (175mm) (Same as a predicate) |
| Field of View | Not explicitly stated as acceptance criteria, but predicate devices are 70°, 95°, 71°-83° | 60° |
| Fixed Focus (Depth of View) | Not explicitly stated as acceptance criteria, but predicate devices are 5-50mm or 5mm-45mm | 5mm to 40mm (Matches a predicate device depth of view of 5-45mm) |
| Direction of View | Not explicitly stated as acceptance criteria, but predicate devices are 0°-135°, 0°, 30°, 45°, 70° | 10° to 100° |
| Rotation of View | Capable of shaft rotation for visualization | 320° shaft rotation |
| Illumination | Effective illumination for endoscopic viewing (implied) | Utilizes Glass Fibers and compatible with Medical light source (Same as predicates) |
| Scope Resolution | Adequate resolution for visualization (implied) | Bench testing met acceptance criteria for scope resolution |
| Dial Actuation Forces | Within acceptable ergonomic limits (implied) | Bench testing met acceptance criteria for dial actuation forces |
| Temperature Testing | Withstands operational temperature ranges (implied) | Bench testing met acceptance criteria for temperature testing |
| Field Strength Testing of Magnets | ≤10 gauss at 2cm | Small rare-earth permanent magnets incorporated (≤10 gauss at 2cm) |
| Electrical Safety | Compliant with electrical safety standards (implied) | Bench testing met acceptance criteria for electrical safety |
| EMC Testing | Compliant with electromagnetic compatibility (EMC) standards (implied) | Bench testing met acceptance criteria for EMC testing |
| Durability Testing | Withstands repeated use and sterilization procedures (implied) | Bench testing met acceptance criteria for durability testing |
| Environmental Conditioning | Withstands specified environmental conditions (implied) | Bench testing met acceptance criteria for environmental conditioning |
| Compression Testing | Withstands compressive forces (implied) | Bench testing met acceptance criteria for compression testing |
| Random Vibration Testing | Withstands vibrational forces (implied) | Bench testing met acceptance criteria for random vibration testing |
| Shock (Free Fall Drop) Testing | Withstands impact forces (implied) | Bench testing met acceptance criteria for shock (free fall drop) testing |
| Reprocessing Methods | Validated for cleaning and sterilization (implied) | Full manual cleaning with extended enzymatic soak plus general instrument automated washer; Pre-vacuum steam sterilization (wrapped) |
| Substantial Equivalence | Demonstrated through relevant performance tests and attributes compared to predicate devices. | The Acclarent Cyclops Multi-Angle Endoscope is substantially equivalent to the predicate devices as confirmed through relevant performance tests and attributes. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document explicitly mentions "bench testing and a cadaver study". However, it does not specify the sample size for either of these studies.
- Data Provenance: The document does not provide details regarding the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
The document does not mention the use of experts to establish ground truth for the bench testing or cadaver study. The performance data is presented as objective measurements against acceptance criteria.
4. Adjudication Method for the Test Set
As no experts were explicitly mentioned for ground truth establishment, there is no adjudication method specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document states, "Clinical data was not necessary for the subject device." This indicates that the evaluation focused on technical performance and equivalence to predicate devices rather than direct clinical comparison or human reader performance.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
This device is a physical endoscope and not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable. The performance evaluation is for the device itself.
7. Type of Ground Truth Used
For the bench testing, the ground truth was based on objective measurements against pre-defined acceptance criteria for various physical and functional attributes of the device (e.g., diameter, length, field of view, resolution, temperature tolerance, etc.).
For the cadaver study, the ground truth would inherently be the anatomical structures and visualization capabilities within a cadaveric model, assessed against the intended use of viewing the nasal cavity and nasopharynx.
8. Sample Size for the Training Set
This device is not an AI/ML algorithm that requires a "training set." Therefore, the concept of a training set sample size is not applicable.
9. How the Ground Truth for the Training Set was Established
As this is not an AI/ML device, there is no training set and thus no ground truth established for a 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.