(38 days)
To provide visualization of the nasal cavities, including the nasal mucosa, during a variety of ENT diagnostic and surgical procedures, utilizing both panoramic and tissue contact vision at high magnification.
The KSEA Contact Nasal Micro-Endoscope is a manually operated, reusable surgical device with an assortment of magnifying powers. The KSEA Contact Nasal Micro-Endoscope is long enough to gain access to the surgical site. The body contact materials are surgical grade stainless steel.
The provided text is a 510(k) summary for the Karl Storz Contact Nasal Micro-Endoscopes. It details the device's identification, indication, description, and substantial equivalence to predicate devices, but it does not include information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot provide the requested table or answer most of the questions based on the provided text.
Here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
- Information not provided. The document focuses on substantial equivalence to predicate devices rather than specific performance metrics or acceptance criteria for a new device study.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Information not provided. No study data is presented.
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)
- Information not provided. No study data is presented.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Information not provided. No study data is presented.
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
- Information not provided. This device is a manually operated micro-endoscope, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Information not provided. This device is a manually operated micro-endoscope, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Information not provided. No study data is presented.
8. The sample size for the training set
- Information not provided. This device is a manually operated micro-endoscope, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- Information not provided. This device is a manually operated micro-endoscope, not a machine learning model.
The document primarily states that the device is "substantially equivalent" to predicate devices, meaning it has the same basic features, design, and intended uses, and that minor differences do not affect safety or effectiveness. This type of submission relies on demonstrating similarity to already approved devices rather than presenting new clinical study data with specific performance metrics.
§ 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.