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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.

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.

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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

Regarding AI-specific questions (2-9), this document does not describe an AI/algorithm device, so these are not applicable.

2. 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.
3. 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.
4. Adjudication method: Not applicable.
5. Multi reader multi case (MRMC) comparative effectiveness study: Not applicable. This is not an AI-assisted diagnostic device.
6. Standalone (i.e. algorithm only without human-in-the loop performance) study: Not applicable.
7. 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).
8. The sample size for the training set: Not applicable. This is not an AI/algorithm device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

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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

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.

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