(87 days)
The HENKE- SASS, WOLF Sinuscope is intended to provide the physician with a means of endoscopic diagnostic and therapeutic sinus surgical procedures. The HENKE-SASS WOLF of America Inc. Sinuscope Accessories include Sheaths - to establish surgical access and the removal of debris and body fluids from the surgical site and to provide irrigation of the site with a sterile solution such as saline water. The Sinuscope and accessories are indicated for use in, but not limited to such procedures as examination of sinus passages and cavities, removal of abnormal growths such as polyps and facio-plastic surgery.
The HENKE-SASS, WOLF Sinuscopes are reusable hand-held instruments designed for a means of performing diagnostic and therapeutic sinus procedures. The HENKE-SASS, WOLF Sinuscopes and accessories have the same operating principals and intended uses as many of the competitive sinuscopes and accessories already in commercial distribution
The provided text does not contain information about acceptance criteria or a study proving device performance using quantitative metrics. The document is a 510(k) summary for a Nasopharyngoscope and Accessories (Sinuscope) from HENKE-SASS, WOLF of America, Inc. It primarily focuses on demonstrating substantial equivalence to predicate devices, material composition, and intended use, rather than detailed performance study results with acceptance criteria.
Therefore, most of the requested information cannot be extracted from this document.
Here's what can be inferred or explicitly stated from the provided text:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as quantitative performance metrics. The implicit acceptance criterion is "substantial equivalence" to predicate devices, meaning the device performs as safely and effectively for its intended use.
- Reported Device Performance: Not presented with quantitative metrics. The document states:
- "The sinuscope itself is well recognized as being safe and effective for diagnostic and therapeutic sinus procedures."
- "The HENKE SASS WOLF Sinuscopes and accessories have the same operating principals and intended uses as many of the competitive sinuscopes and accessories already in commercial distribution."
- "The sinuscope material and design is identical to the predicate devices... In function, the sinuscopes and accessories are the same as the predicate devices."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- No specific test set or study data is mentioned that would allow reporting of sample size or data provenance. The submission relies on equivalence to existing devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable as no specific test set or ground truth establishment process is described beyond the general understanding that sinuscopes are "well recognized as being safe and effective."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no specific test set or adjudication process is 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 MRMC study was done, as this is a medical device (endoscope), not an AI-assisted diagnostic tool for "human readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is an endoscope, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- No explicit ground truth is mentioned in the context of a performance study. The "ground truth" for the device's safety and effectiveness appears to be established by the general clinical acceptance and regulatory history of similar predicate devices.
8. The sample size for the training set:
- Not applicable, as this is a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable, for the same reason as above.
§ 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.