(14 days)
The MicroEndoscope is intended to provide an endoscopic means to view a body cavity for ear, nose or throat procedures.
The MicroEndoscope is a semi-rigid fiberscope that allows for visualization of the ear, nose, and throat. The device is labeled non-sterile and must be sterilized prior to use. The MicroEndoscope is accompanied by a camera coupler, which allows the MicroEndoscope to connect to a standard endoscopic camera.
The provided document for the Acclarent MicroEndoscope is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against specific acceptance criteria.
Therefore, the document explicitly states: "The MicroEndoscope met all performance testing acceptance criteria." However, it does not provide the specific acceptance criteria, the detailed results, or the methodology of the study.
Based on the provided information, I cannot complete the requested tables and sections with the specific details about acceptance criteria, detailed device performance, sample sizes, ground truth establishment, or multi-reader studies. The document only offers a general statement of compliance.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Met all performance testing acceptance criteria. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified. The document does not detail any human expert review or ground truth establishment relevant to a clinical performance study. The performance testing is likely related to engineering and functional specifications of the endoscope itself (e.g., image quality, illumination, durability, sterilization effectiveness).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. Given the nature of a medical device submission focused on physical and functional performance rather than diagnostic accuracy, adjudication methods as typically understood in AI/imaging studies are not relevant here.
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
- Not applicable. This is a physical medical device (MicroEndoscope) for visualization, not an AI or diagnostic software. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a direct visualization tool; there is no "algorithm only" performance. Its primary function is to provide an image for a human user.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not specified. For this type of device, "ground truth" would likely relate to objective measurements of image quality, illumination, structural integrity, and successful sterilization, rather than clinical diagnostic outcomes or pathology.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not an AI or machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. (See #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.