(582 days)
The KARL STORZ CMOS Flexible Video Rhino-Laryngoscope System may only be used by persons with an appropriate medical qualification and who are acquainted with the rhino/laryngoscopic technique. The endoscope is used for endoscopic diagnosis within the nasal lumens and airway anatomy, and is intended to provide visualization via a video monitor.
The Karl Storz CMOS Video Rhino-Laryngoscope System includes a flexible endoscope and a monitor. The rhino-laryngoscope consists of an integrated light located in the handle. The light is transmitted thought the fiber optic bundles and illuminates the anatomy under visualization. A new Storz specific CMOS imaging sensor located at the distal tip of the endoscope shaft which is inserted into the body cavities. The captured video signal is then transferred to the C-MAC monitor for display purposes. The Karl Storz CMOS Video Rhino-laryngoscope is a Class II device under 21 CFR874.4760, Rhino-Laryngoscope and accessories.
The provided 510(k) summary (K103467) describes a medical device, the Karl Storz CMOS Video Rhino-Laryngoscope System, and its substantial equivalence to a predicate device. However, it does not contain the level of detail requested regarding specific acceptance criteria, a dedicated clinical study proving performance against those criteria, or information related to AI integration.
This submission is for a traditional medical device (an endoscope system), not an AI/ML-powered device. Therefore, many of the questions regarding AI-specific evaluation metrics (e.g., effect size of human readers with AI assistance, standalone algorithm performance, training set details) are not applicable to this 510(k) document.
Here's a breakdown of the information that is available and what is absent from the provided text according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than defining specific quantitative acceptance criteria for this device's performance against predefined metrics.
| Criteria Category / Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Intended Use | Must be equivalent to predicate: Endoscopic diagnosis within nasal lumens and airway anatomy, providing visualization via a video monitor. | "The KARL STORZ CMOS Flexible Video Rhino-Laryngoscope System ... is used for endoscopic diagnosis within the nasal lumens and airway anatomy, and is intended to provide visualization via a video monitor." (Matches predicate's indicated use). |
| Technological Characteristics | Must be substantially equivalent for safety and effectiveness, despite minor differences. | Comparison table provided, highlighting differences (CMOS vs. CCD imaging, LED vs. Xenon illumination) but asserting these "raise no issue of safety and effectiveness, as these differences have no effect on the performance, function or general intended use of these devices." |
| Safety Testing | Compliance with relevant FDA recognized standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, ISO 10993). | "The Karl Storz Flexible Video Rhino-Laryngoscope system has been successfully tested for its functions, performance and safety as per FDA recognized standards." (No specific results or acceptance criteria for each standard are detailed). |
| Performance Testing | Compliance with ISO 8600. | "The performance of the device is tested by complying with ISO 8600." (No specific results or acceptance criteria for ISO 8600 are detailed). |
| Biocompatibility | Compliance with relevant ISO 10993 standards. | "Testing has been conducted as per ... ISO 10993 to address the safety aspect of the device." (No specific results or acceptance criteria for each standard are detailed). |
| Reprocessing | Successful cleaning and high-level disinfection validated according to AAMI TIR 12:2010, AAMI TIR 30:2003, AAMI 7:1999, AAMI E 1837, and FDA draft guidance. | "The cleaning and high-level disinfection studies were perform in accordance with AAMI TIR 12:2010...", etc. (Implies successful validation, but no specific acceptance criteria or results are provided). |
2. Sample size used for the test set and the data provenance
- Not Applicable / Not Provided. This 510(k) submission describes non-clinical performance data (testing to standards) and reprocessing validation, not a clinical study involving a "test set" of patient data in the typical sense for AI/ML devices. Therefore, there's no mention of a test set sample size or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Provided. As there's no clinical "test set" and ground truth establishment in the context of device performance, this information is not present. The device is for visualization, and its performance is assessed against engineering and cleaning standards.
4. Adjudication method for the test set
- Not Applicable / Not Provided. No clinical test set.
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 is a traditional medical device (endoscope), not an AI-assisted device. Therefore, no MRMC study with AI assistance was performed or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a traditional medical device, not an AI algorithm.
7. The type of ground truth used
- The "ground truth" for this device's performance evaluation is based on compliance with established engineering and biocompatibility standards (e.g., IEC 60601 series, ISO 10993, ISO 8600) and reprocessing validation protocols (AAMI TIRs, FDA draft guidance). It's not clinical "ground truth" derived from expert consensus, pathology, or outcomes data.
8. The sample size for the training set
- Not Applicable / Not Provided. This is not an AI/ML device, so there is no concept of a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. As there is no training set for an AI/ML algorithm, this question is not relevant.
In summary: K103467 is a 510(k) submission for a conventional video rhinolaryngoscope system. The approval is based on demonstrating substantial equivalence to a predicate device and compliance with applicable safety, performance, and reprocessing standards, rather than a clinical study evaluating diagnostic accuracy or AI performance. The detailed questions about AI performance metrics, clinical test sets, ground truth establishment, and training data are not addressed in this type of submission.
§ 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.