(238 days)
The flexible ENT-5000 Video ENT Scope with EndoSheath® Technology is intended for use in flexible endoscopic examination of the upper airway, vocal cords and/or nasal passages; and for use in diagnostic arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening.
The digital video processor is intended for use with the VSI flexible video scope.
The VSI endoscopes are flexible endoscopes with connections to a video processor and display monitor. The EndoSheath® Techology for the ENT-5000 are optional, sterile, single-use protective sheath systems, with or without a working channel, that are intended to cover the entire insertion tube of the videoscope. The digital video processors are used with the flexible videoscopes for image visualization and capture.
The provided text is a 510(k) Premarket Notification for a medical device (Flexible ENT Scopes with Digital Video Processor and Disposable EndoSheath® Technology). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical studies with specific acceptance criteria in the way a pharmaceutical trial or a software AI device might.
Therefore, the document does not contain the information requested regarding acceptance criteria, a specific study proving the device meets those criteria, sample sizes, data provenance, expert adjudication, MRMC studies, standalone performance, or detailed ground truth establishment as it would for a performance-based assessment (e.g., for an AI/ML algorithm).
Here's why and what the document does state:
- Type of Device: The device is a flexible endoscope system. These are physical instruments used for visualization. Substantial equivalence for such devices is typically demonstrated through engineering tests (electrical safety, thermal, EMC), material compatibility, and a comparison of technological characteristics and intended use to existing devices, showing they are as safe and effective as the predicate.
- Regulatory Pathway: 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device). It's not a de novo pathway or a PMA, which might require extensive clinical trials with specific statistical endpoints.
- Focus of the Document: The document focuses on:
- Identifying the device and its intended use.
- Identifying predicate devices.
- Comparing the technological characteristics of the subject device to predicate devices.
- Stating that the device has undergone and passed "electrical safety, thermal, and EMC testing requirements."
- Stating that "patient contact materials in the endoscope are identical to the materials used in predicate device Vision Sciences' ENT-5000 (K072073)."
- Concluding that, based on this comparison, the device is "safe and effective for their intended use."
To reiterate, the document does not include:
- A table of acceptance criteria and reported device performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy) are defined or reported.
- Sample size used for the test set and data provenance: No "test set" in the context of an algorithm's performance is present.
- Number of experts used to establish ground truth & qualifications: No ground truth establishment process is described as there's no diagnostic algorithm being validated.
- Adjudication method: Not applicable.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable, as this is for evaluating reader performance, typically with diagnostic outputs.
- Standalone (algorithm only) performance: Not applicable, as there's no algorithm.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The "Performance Testing" section states: "The subject device has been subjected to and passed electrical safety, thermal, and EMC testing requirements." These are engineering and safety standards, not a clinical performance study with "acceptance criteria" as you might expect for an AI device.
In summary, the provided text describes a regulatory filing for an endoscopy system, not a study validating an AI/ML algorithm or a diagnostic test with performance-based acceptance criteria.
§ 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.