(134 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 unchanneled endoscope that has the capability of varying direction of view from 10° to 90°, 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 55° 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 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 provided 510(k) summary for the Acclarent Cyclops Multi-Angle Endoscope (K110097) details the device's technical specifications and performance testing to demonstrate substantial equivalence to a predicate device (K100577). However, it does not describe an AI/algorithm-driven device or study. Therefore, most of the requested information regarding acceptance criteria and studies for an AI device is not applicable to this document.
The document describes bench testing and a cadaver study for the Acclarent Cyclops Multi-Angle Endoscope. The "acceptance criteria" are implicitly stated as meeting the requirements of specific international and national standards for medical devices and endoscopes.
Here's a breakdown of what can be extracted from the document, and where the requested information is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Attribute | Acceptance Criteria (Implied by Standards) | Reported Device Performance (as stated in the document) |
|---|---|---|
| Distal shaft diameter | Met acceptance criteria (no specific value stated) | Met all acceptance criteria |
| Working length | Met acceptance criteria (no specific value stated) | Met all acceptance criteria |
| Field of view | Met acceptance criteria (no specific value stated, but predicate was 60°, subject device is 55°) | Met all acceptance criteria (subject device's FoV is 55°) |
| Fixed focus | Met acceptance criteria (no specific value stated, but predicate was 5-45mm, subject device is 5-40mm) | Met all acceptance criteria |
| Direction of view | Met acceptance criteria (no specific value stated, but predicate was 10°-100°, subject device is 10°-90°) | Met all acceptance criteria |
| Rotation of view | Met acceptance criteria (no specific value stated) | Met all acceptance criteria |
| Illumination | Met acceptance criteria (no specific value stated) | Met all acceptance criteria |
| Scope resolution | Met acceptance criteria (no specific value stated) | Met all acceptance criteria |
| Dial actuation forces | Met acceptance criteria (no specific value stated) | Met all acceptance criteria |
| Temperature testing | Met acceptance criteria (evaluating temperature at nine locations with 300W Xenon light source at 100% output, time to heat/cool) | Met all acceptance criteria |
| Field strength testing of magnets | Met acceptance criteria (≤10 gauss at 2cm) | Met all acceptance criteria (magnetic strength is ≤10 gauss at 2cm) |
| Electrical safety | Compliance with IEC 60601-2-18 (specific value not stated) | Performance data demonstrates intended function according to IEC 60601-2-18 |
| EMC testing | Compliance with IEC 60601-1-2 (specific value not stated) | Performance data demonstrates intended function according to IEC 60601-1-2 |
| Durability testing | Met acceptance criteria (no specific value stated) | Met all acceptance criteria |
| Environmental conditioning | Met acceptance criteria (no specific value stated) | Met all acceptance criteria |
| Compression testing | Met acceptance criteria (no specific value stated) | Met all acceptance criteria |
| Random vibration testing | Met acceptance criteria (no specific value stated) | Met all acceptance criteria |
| Shock (free fall drop) testing | Met acceptance criteria (no specific value stated) | Met all acceptance criteria |
| Reprocessing Methods Validation | Compliance with AAMI/ANSI ST35, AAMI TIR 12, AAMI TIR 30, ANSI/AAMI ST79 A1/A2, ANSI/AAMI ST8, ANSI/AAMI ST81, ASTM E1766 | Full manual cleaning with extended enzymatic soak plus general instrument automated washer Pre-vacuum steam sterilization (wrapped) were validated. |
| Biocompatibility | Compliance with ISO10993-1 (specific value not stated) | Performance data demonstrates intended function according to ISO10993-1 |
| Endoscope Characteristics/Requirements | Compliance with ISO 8600-3, ISO 8600-5 (specific value not stated) | Performance data demonstrates intended function according to ISO 8600-3, ISO 8600-5 |
Regarding AI-specific questions (2-9), this document does not describe an AI/algorithm device, so these are not applicable.
- Sample size used for the test set and the data provenance: Not applicable, as this is a physical medical device, not an AI/algorithm. Bench testing was performed, and a cadaver study was conducted. No sample sizes for a "test set" in the context of AI are provided. Data provenance would be from laboratory bench testing and a cadaver lab.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for device performance was established through engineering specifications, standard compliance, and physical testing.
- Adjudication method: Not applicable.
- Multi reader multi case (MRMC) comparative effectiveness study: Not applicable. This is not an AI-assisted diagnostic device.
- Standalone (i.e. algorithm only without human-in-the loop performance) study: Not applicable.
- The type of ground truth used: For the physical device, the ground truth is established by engineering specifications, validated test methods (bench and cadaver), and adherence to recognized medical device standards (e.g., ISO, IEC, AAMI). For surgical device performance in a cadaver, this would likely be direct observation and assessment by qualified personnel (e.g., surgeons).
- The sample size for the training set: Not applicable. This is not an AI/algorithm device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
§ 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.