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The Schoelly Video Bronchoscope System is intended for use by physicians for diagnostic and therapeutic procedures in nasopharyngeal endoscopy, bronchoscopy, tracheoscopy, and laryngoscopy. The Schoelly Video Bronchoscope is intended to provide visualization via a video monitor.

The Schoelly Video Bronchoscope System consists of a flexible and steerable endoscope with an integral working/suction channel and a camera control unit (CCU) for regulation of light intensity and connection to a commercially available monitor, PC, and medical video and image capture unit for image display or image documentation.

The endoscope has outer surfaces mainly made from plastic. The endoscope handle incorporates a control lever to bend the distal tip and a working channel port enabling the insertion of instruments for access to the endoscope tip through the working channel.

For sampling of tracheobronchial secretion or irrigation, the endoscope further incorporates a suction channel with the suction valve port located at the endoscope handle and is accompanied by a suction valve/seal accessory . Suction and working channel converge within the endoscope handle, thus within the endoscope shaft there is only one lumen towards the endoscope tip. The suction power can be adjusted at the suction valve which is rotatable by 360°.

The endoscope further comprises a ventilation system to protect the endoscope shaft during sterilization. The exhaust valve at the endoscope handle can also be used for leakage testing. For this purpose the system is accompanied by a leakage tester and accessories.

LED light sources are integrated in the endoscope handle to illuminate the anatomy under investigation. Light is transmitted through fiberoptic bundles to provide standard dual wide angle illumination as well as a narrower light beam which acts as a focused spot light thereby allowing for an improved visualization of more distal anatomical structures (DeepVu illumination). The DeepVu function can be activated by pressing a button at the endoscope handle.

The video signal is captured by a CMOS imaging sensor located at the tip of the endoscope and transferred to the CCU. Images can be frozen and stored on a PC or medical video and image capture unit by pressing a button at the endoscope handle.

The Schoelly Video Bronchoscope System is delivered in a non-sterile condition and is already CE marked.

The provided document is a 510(k) summary for the Schoelly Video Bronchoscope System. It describes the device, its intended use, and its comparison to predicate devices, but it does not contain the specific details about acceptance criteria, device performance, and the study methodology asked for in the prompt.

The document states:
"Performance data demonstrated that the Schoelly Video Bronchoscope System has met pre-determined acceptance criteria and is substantially equivalent to the predicate device."
"Testing has been conducted in accordance with recognized consensus standards to demonstrate electrical safety. EMC, biocompatibility, and optical performance characteristics and to validate the software encompassed in the device."
"The Schoelly Video Bronchoscope System meets all the pre-determined testing and acceptance criteria to effectively demonstrate substantial equivalence to the predicate device"

However, it does not provide the acceptance criteria themselves, nor the reported device performance values, nor details about the study design (sample size, ground truth, experts, etc.). The document focuses on demonstrating substantial equivalence primarily through technological characteristics and adherence to recognized standards, rather than presenting a detailed clinical performance study with specific metrics.

Therefore, I cannot provide the requested information. The document indicates that such data exists and was used but does not disclose it.

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The SciCan Classic and accessories is to provide video images of the mouth and oral structures, dental cavities, dental pulps, dental canal morphology. It is used to perform various diagnostic procedures, to provide educational information to patients as well as to other clinical personnel and to provide documentation for patient records and for insurance companies.

SciCan Classic also is used for inspection of reliable diagonsis of border gaps when dealing with inlays. Additionally it acts as an effective caries detector during the examination of areas of the mouth which are normally difficult to approach. Further indications for use are extra-oral imaging of the whole face and of the mouth, outline imaging of the quadrants and macroscopic images of the dental enamel.

The SciCan Classic and accessories are indicated for use when video images are desired to provide visual information during dental examinations and procedures.

The SciCan Classic is a video camera system with a modular design due to a handpiece system with interchangeable optics. It uses a CCD ½" camera chip and provides fiber optic illumination by an integrated light source with automatic exposure control. It has removable and interchangeable probe options (90° probes, 0° probe). It supports NTSC / PAL video systems and has a power consumption of 150 Watt.

The provided 510(k) summary for the Ka84556 SciCan Classic device does not contain a study that proves the device meets specific acceptance criteria in the way a clinical performance study for an AI/ML device would be analyzed.

Instead, this submission is for a video camera system, and its "effectiveness" is established based on its intended use for providing video images and adherence to general safety and quality standards, and comparison to a predicate device.

Here's an breakdown of the information as requested, highlighting what is present and what is absent given the nature of this submission:

1. A table of acceptance criteria and the reported device performance

Based on the provided document, specific quantitative "acceptance criteria" related to a performance study for image quality or diagnostic accuracy are not defined. The effectiveness is broadly stated:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not applicable. This submission does not describe a clinical performance study with a test set of data (e.g., images for diagnostic evaluation). Its effectiveness is based on technological characteristics and comparison to a predicate device, rather than a statistical analysis of a sample of cases.

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)

• Not applicable. No such test set or ground truth establishment by experts is described for this device.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable. No test set requiring expert adjudication is described.

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

• Not applicable. This device is a video camera system, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance was not conducted or reported.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not applicable. The SciCan Classic is a hardware device (a camera system), not an algorithm. Standalone performance as typically described for AI/ML devices is not relevant here.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable. No explicit "ground truth" as would be used in a diagnostic performance study is mentioned. The device's "effectiveness" is tied to its ability to capture and display images, fulfilling its intended diagnostic and educational purposes, and its technical specifications compared to a predicate.

8. The sample size for the training set

• Not applicable. This is a hardware device (video camera system), not a machine learning algorithm. Therefore, there is no "training set."

9. How the ground truth for the training set was established

• Not applicable. As there is no training set, this question is not relevant.

Summary Explanation:

The K984556 submission for the SciCan Classic is for a general-purpose video camera system intended for dental use. Its clearance is primarily based on:

• Substantial Equivalence: Demonstrated by comparing its design, power consumption, camera type, video system, illumination, light control, handpiece, probes, and standards met to the legally marketed predicate device, the Welch Allyn Reveal Intraoral Camera System (K981937).
• Compliance with Standards: Adherence to safety standards like IEC 601-1-2 and IEC 601-2-18.
• Stated Effectiveness: The device's ability to provide "video images of the mouth and oral structures, dental cavities, dental pulps, dental canal morphology" for diagnostic, educational, and documentation purposes.

The rigor of clinical performance studies with acceptance criteria, test sets, expert ground truth, and statistical analyses (like those for AI/ML or complex diagnostic devices) is not typically required for this type of device, especially given its 1998 submission date. The FDA determined it substantially equivalent to a predicate, allowing it to proceed to market under general controls.

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