(130 days)
The 3NT endoscopy system is intended to visualize the internal cavities of the ear, airways, nose and sinus cavites during diagnostic and therapeutic endoscope procedures.
3NT endoscopy system is a single-use flexible ENT (ear, nose & throat) endoscope (provided sterile) which allows the user to steer through the anatomy and visualize it.
3NT endoscopy system includes:
- A Single-use flexible endoscope (provided sterile) includes a distal tip CMOS imager and an integrated working channel which allows irrigation through a single channel. It is the only part that comes in contact with the patient and is disposed of at the end of the procedure.
- A Multi-use handle accessory (re-processible and auto-clavable) engages the single-use endoscope component and allows the user to mechanically control its articulation through dedicated levers.
- A Camera control unit (CCU) includes a video processor and a white LED light source. The CCU includes an attachment cable which connects to the single-use endoscope, receives video images from the endoscope, and delivers LED light to the endoscope.
The provided text is a Premarket Notification (510(k)) summary for the 3NT Endoscopy System. The information focuses on demonstrating substantial equivalence to predicate devices, primarily through bench testing, biocompatibility, sterilization validation, software validation, electrical safety, and a cadaver study.
However, the document does not contain the detailed information required to answer the specific questions about acceptance criteria for an AI/ML-based device and the study that proves it meets those criteria.
Here's why and what information is missing:
- This is not an AI/ML device: The document describes a "3NT Endoscopy System" which is a flexible ENT endoscope system. It consists of a single-use flexible endoscope (CMOS imager), a multi-use handle, and a Camera Control Unit (CCU) with a video processor and LED light source. There is no mention of any artificial intelligence, machine learning, or algorithmic analysis of the images for diagnostic purposes. The device is a direct visualization tool.
- No acceptance criteria for AI performance: Since it's not an AI device, there are no acceptance criteria related to AI performance metrics (e.g., sensitivity, specificity, AUC). The acceptance criteria mentioned refer to the successful completion of engineering bench tests, biocompatibility tests, sterilization, and a cadaver study for visualization.
- No "ground truth" establishment for AI: The "ground truth" described is based on the ability to visualize anatomical landmarks in a cadaver study, not on expert consensus or pathology for an AI's output.
- No "test set" and "training set" for AI: The data provenance, sample sizes for test/training sets, number of experts for ground truth, and adjudication methods are details specific to the validation of AI models, which are not applicable here.
- No MRMC study: A Multi-Reader Multi-Case (MRMC) study is relevant for evaluating the impact of AI on human reader performance, which isn't applicable to a direct visualization endoscope.
- No standalone AI performance: Standalone performance refers to the AI algorithm's performance without human intervention, which is not relevant for this device.
In summary, the provided document describes a medical device clearance for an endoscope based on traditional engineering and medical device testing, not an AI/ML product. Therefore, it does not contain the information requested in the prompt regarding AI acceptance criteria and study details.
§ 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.