(262 days)
The Acclarent Cyclops Multi-Angle Endoscope is intended to provide an endoscopic means to view the nasal cavity and nasopharynx.
The Acclarent Cyclops Multi-Angle Endoscope is a 4.3 mm 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 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 or subjected to High Level Disinfection according to the user manual prior to every use.
The provided text describes a 510(k) premarket notification for the "Acclarent Cyclops Multi-Angle Endoscope." This is a medical device and not an AI/ML algorithmic device. Therefore, many of the requested fields regarding AI/ML models (e.g., training set, test set, ground truth establishment, MRMC studies) are not applicable.
The submission focuses on establishing substantial equivalence to predicate devices based on technological characteristics and performance data related to device reprocessing and sterilization, rather than algorithmic performance.
Here's an analysis of the provided text in the context of the user's request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" in a quantitative performance metric sense for viewing capabilities, but it does for reprocessing and sterilization. The table below compiles the technological characteristics and reported performance from the document.
| Attribute/Criteria | Predicate Device (Acclarent Cyclops Multi-Angle Endoscope) | Subject Device (Acclarent Cyclops Multi-Angle Endoscope) | Reported Performance / Meets Criteria |
|---|---|---|---|
| Technological Characteristics (for Equivalence) | |||
| 510(k) number | K110097 | TBD (K132433 was assigned later) | N/A (for identification) |
| Model Number | CYE002 | Same | Meets "Same" |
| Rigidity | Rigid | Same | Meets "Same" |
| Viewing Optics | Lens (Sapphire cover) | Same | Meets "Same" |
| Depth of View | 5-45 mm | Same | Meets "Same" |
| Field of View | 55° | Same | Meets "Same" |
| Direction of View | 10° to 90°C | Same | Meets "Same" |
| Shaft Body Diameter | 4.3 mm | Same | Meets "Same" |
| Working Length | 6.89 inches (175mm) | Same | Meets "Same" |
| Magnetic Strength | ≤10 gauss at 2cm | Same | Meets "Same" |
| Performance Data (for Safety & Effectiveness) | |||
| Reprocessing & Sterilization | |||
| Overall Reprocessing | Met all acceptance criteria | Met all acceptance criteria | Met all acceptance criteria |
| Sterilization (Steam/STERRAD) | N/A | Sterility Assurance Level of 10⁻⁶ | Achieved SAL of 10⁻⁶ |
| Validation Method | N/A | Overkill (half-cycle approach) in a fixed chamber | Validated via specified method |
| High-Level Disinfection (OPA) | N/A | Validated using 0.55% ortho-Phthalaldehyde (Cidex OPA®) | Validated |
| High-Level Disinfection (Glutaraldehyde) | N/A | Validated using 2.4% glutaraldehyde (Cidex®) solutions | Validated |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of an AI/ML algorithm. The performance data presented relates to engineering and microbiological testing for reprocessing and sterilization, not a clinical "test set" of patient data for diagnostic accuracy.
- Data Provenance: The data provenance for the reprocessing and sterilization testing is not specified in terms of country of origin or whether it was retrospective/prospective. This testing would typically be performed in a controlled laboratory environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. As this is not an AI/ML device making diagnostic assessments, there's no "ground truth" to be established by experts in the sense of image interpretation. The "ground truth" for sterilization is a sterility assurance level (SAL), and for reprocessing, it's the successful removal of biological debris and chemical residues, determined by laboratory-based assays and methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There's no human interpretation or adjudication involved in the performance validation described.
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. This device is an endoscope, not an AI-assisted diagnostic tool. An MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. There is no algorithm to perform a standalone test.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance validation relates to engineering and microbiological standards for device reprocessing and sterilization.
- For sterilization, the ground truth is a demonstrated Sterility Assurance Level (SAL) of 10⁻⁶, which is a microbiological standard indicating the probability of a single viable microorganism remaining on an item after sterilization. This is established through validated sterilization cycles (e.g., half-cycle overkill approach) and biological indicators.
- For reprocessing, the ground truth involves demonstrating effective cleaning (removal of organic and inorganic residues) and high-level disinfection, validated through standardized test methods (e.g., testing for residual protein, hemoglobin, carbohydrates, and successful inactivation of challenge microorganisms).
8. The sample size for the training set:
- Not applicable. There is no AI/ML training set.
9. How the ground truth for the training set was established:
- Not applicable. There is no AI/ML training set.
Conclusion on Study Proving Acceptance Criteria:
The study proving the device meets its acceptance criteria (primarily related to safety and effectiveness through reprocessing and sterilization) involved rigorous engineering and microbiological validation. The document states:
- "Reprocessing and sterilization testing met all acceptance criteria."
- The sterilization process achieved a "sterility assurance level of 10⁻⁶ when the device is sterilized via either steam or STERRAD methods."
- The sterilization validation used an "overkill (half-cycle approach) in a fixed chamber."
- The device was "validated to be high level disinfected using either 0.55% ortho-Phthalaldehyde (Cidex OPA®) or 2.4% glutaraldehyde (Cidex®) solutions."
The specific raw data, detailed methodologies, and precise number of cycles/samples for these tests are not provided in this summary but would have been part of the full 510(k) submission. The FDA's clearance (K132433) indicates that they found these data sufficient to demonstrate substantial equivalence and safety/effectiveness for the stated indications for use.
§ 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.