(15 days)
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, therapy accessories, and other ancillary equipment for observation, diagnosis, and treatment within the nasal and nasopharyngeal lumens.
The VISERA Rhino-Laryngovideoscope Olympus ENF type VT, hereafter referred to as ENF-VT, is a flexible endoscope intended for observation, diagnosis, and treatment within the nasal and nasopharyngeal lumens. The modifications from the predicate device are: Field of view is wider, Instrument channel inner diameter is smaller, Instrument changed to a CCD based system, allowing endoscopic image display on a video monitor, Improved resolution. The subject device is not compatible with a miniature light source, whereas the predicate device is.
The provided 510(k) summary for the VISERA Rhino-Laryngovideoscope Olympus ENF type VT (K052452) does not contain specific acceptance criteria or details of a study that objectively proves the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity.
This 510(k) submission primarily focuses on establishing substantial equivalence to a predicate device (Rhino-Laryngofiberscope Olympus XENF-TP, K013591). The assessment of substantial equivalence relies on demonstrating that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to the predicate.
The "modifications" listed (wider field of view, smaller instrument channel, CCD-based system, improved resolution) are qualitative descriptions of changes, not quantifiable performance metrics with associated acceptance criteria. The claim of "improved resolution" is stated but without a specific benchmark or a study proving that improvement.
Therefore, I cannot populate most of the requested fields because the information is not present in the provided text.
Here's a breakdown of what can be inferred or is explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not explicitly defined in the document) | - Wider field of view |
- Smaller instrument channel inner diameter
- Changed to a CCD based system
- Improved resolution |
Note: The "reported device performance" here refers to the qualitative description of the device's characteristics or changes from the predicate, not performance against specific acceptance metrics.
2. Sample size used for the test set and the data provenance
Not applicable/Not provided. This type of information is typically associated with clinical performance studies or specific technical validation tests involving patient data or objective measurements. The 510(k) emphasizes substantial equivalence based on design and intended use, not new clinical performance data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. This information would be relevant if a clinical study involving human assessment and ground truth establishment was conducted.
4. Adjudication method for the test set
Not applicable/Not provided. Similar to the above, adjudication methods are used in cases where multiple experts assess an outcome and consensus is needed for ground truth.
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 a medical endoscope, not an AI-powered diagnostic tool. MRMC studies are not relevant to its type of submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/No. This device is a visual instrument for human operators, not an standalone algorithm.
7. The type of ground truth used
Not applicable. No specific "ground truth" (e.g., pathology, outcomes data) was used in a performance study for this 510(k) submission, as it relies on substantial equivalence.
8. The sample size for the training set
Not applicable/Not provided. The concept of a "training set" applies to machine learning models, which are not involved in this device's submission.
9. How the ground truth for the training set was established
Not applicable/Not provided. (See point 8).
In summary, this 510(k) focuses on demonstrating that the new endoscope, despite its technological updates (CCD, wider field of view, improved resolution), is substantially equivalent to a previously cleared device. The submission does not detail specific performance acceptance criteria or report on studies that would objectively quantify and prove performance against such criteria. For devices like this, the FDA typically reviews engineering specifications, bench testing results (which are not detailed here), and comparison to the predicate to ensure that the changes do not negatively impact safety or effectiveness.
§ 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.