(185 days)
TIPCAM 1S 3D: The Rigid Videoendoscope is intended to be used together with the camera control unit for use to visualize the nasal cavity and nasal pharynx during diagnostic and therapeutic procedures.
IMAGE1 S is a camera control unit (CCU) for use with camera heads or videoendoscopes for the visualization and documentation of endoscopic and microscopic procedures.
The TIPCAM®1S 3D System is intended for use during diagnostic and/or surgical procedures when endoscopic video assistance is required within nasal cavity and nasal pharynx. The TIPCAM®1S 3D System is a medical device system which consists of a 4mm Tipcam®1S and a previously 510k cleared camera control unit (CCU), K150525.
The TIPCAM®1S 3D System includes the following components: 4mm 3D TIPCAM®1S Videoendoscope, 0° or 30° Image1S CCU (Image1S Connect + D3-Link) The 4mm TIPCAM®1S 3D Videoendoscope is intended to be connected to a compatible light source via a light cable as the source of illumination to allow visualization of inside the patient's anatomy and the Image1S CCU for image processing. The live image will be captured by the videoendoscope, processed by the CCU and finally projected to any connected medical grade monitors.
The provided document is a 510(k) Summary for the TIPCAM 1S 3D System. This document outlines the device's technical characteristics, intended use, and substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria related to AI or diagnostic accuracy.
The "Non-Clinical Performance Data" section lists several types of tests, primarily related to:
- Software Verification and Validation Testing: Adherence to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Device" and states the software is a "moderate level of concern." This is about software quality, not diagnostic performance.
- Performance Testing: White Balance, Brightness, Image Enhancement, Video Output Format, Zoom, Image Quality, Image Capture, Latency, Interface Control, 3D-2D mode. These are functional performance aspects of an endoscopic camera system.
- Reprocessing (Cleaning and Steam Sterilization): Adherence to AAMI and ISO standards for sterilization. This is about device safety and reusability.
The document explicitly states: "No clinical information is required for this submission." This means a study on diagnostic performance or clinical outcomes was not conducted or provided as part of this 510(k) submission.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them in the context of diagnostic accuracy or AI performance, as this information is not present in the provided text.
Based on the available text, here's what can be inferred:
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A table of acceptance criteria and the reported device performance:
- No specific quantitative acceptance criteria or reported performance (e.g., sensitivity, specificity, AUC) for diagnostic accuracy or AI performance are provided.
- The document lists areas of "Performance Testing" which include qualitative aspects like White Balance, Brightness, Image Enhancement, Image Quality, Image Capture, Latency, Interface Control, 3D-2D mode, Video Output Format, and Zoom. The "acceptance criteria" for these would likely be that the system functions as intended and meets engineering specifications, but specific metrics are not detailed.
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Sample size used for the test set and the data provenance: Not applicable, as no diagnostic or AI performance study is described.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
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Adjudication method for the test set: Not applicable.
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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, and there is no mention of AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone algorithm performance was studied, as there is no mention of an algorithm or AI.
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The type of ground truth used: Not applicable.
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The sample size for the training set: Not applicable, as there is no mention of an AI model requiring a training set.
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How the ground truth for the training set was established: Not applicable.
§ 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.