Search Results
Found 1 results
510(k) Data Aggregation
(221 days)
The CMOS Video-Rhino-Laryngoscope System is indicated to provide visualization of the nasal lumens and airway anatomy (including nasopharyngeal and trachea) during diagnostic procedures.
The CMOS Video-Rhino-Laryngoscope System includes two main components: (1) the CMOS Video-Rhino-Laryngoscope (11102CM) and (2) the CCU. The CMOS Video-Rhino-Laryngoscope is compatible with two KARL STORZ CCUs: C-HUB and C-MAC.
The document provided is a 510(k) Summary for the KARL STORZ CMOS Video-Rhino-Laryngoscope System (K182186). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving specific clinical performance or to meet acceptance criteria through a clinical study in the way an AI/ML device would.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and multi-reader multi-case studies is not applicable in this context.
This document focuses on comparing the new device's technical specifications and non-clinical performance data (electrical safety, EMC, bench testing, biocompatibility, reprocessing validation) against recognized standards and its predicate device to show that it is substantially equivalent and does not raise new questions of safety or effectiveness.
Here's a summary of the provided information, addressing the spirit of your request where possible, but highlighting the absence of specific clinical performance acceptance criteria:
1. Table of Acceptance Criteria and Reported Device Performance
This type of request for an AI/ML device would typically involve metrics like sensitivity, specificity, AUC, F1-score, etc., with predefined thresholds. For this traditional medical device, the "acceptance criteria" are compliance with established medical device standards and demonstrating substantial equivalence to a predicate device.
| Category | Acceptance Criteria (Compliance with Standards/Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Electrical Safety & EM Compatibility | Compliance with ANSI/AAMI ES:60601-1:2005 and IEC 60601-1-2:2007. | Data included in submission in compliance with these standards. |
| Bench Testing (Performance Standards) | Compliance with ISO 8600-1:2015, ISO 8600-3:1997, ISO 8600-4:2014, ISO 8600-5:2005, IEC 62471:2006, IEC 60601-2-18:2009. | Data included in submission in compliance with these standards. |
| Biocompatibility | Evaluation performed according to ISO 10993-1 and FDA Guidance, including specific tests (ISO 10993-5, ISO 10993-10, ISO 10993-11) based on contact type and duration. | Tests conducted: ISO 10993-5:2009/(R) 2014, ISO 10993-10:2010, ISO 10993-11:2006/(R) 2010. |
| Reprocessing Validation | Compliance with FDA Guidance and standards for cleaning, sterilization, and high-level disinfection (AAMI TIR 12:2010, ISO 15883-5:2005, AAMI TIR 30:2011, AAMI/ANSI/ISO 11737-1:2006/(R)2011, ASTM E1837-96:2014). For semi-critical device status. | Reprocessing data submitted in compliance with cited standards, validated for cleaning, sterilization, and HLD. |
| Technological Characteristics (Comparison to Predicate K103467) | Demonstrate substantial equivalence without raising new questions of safety/effectiveness. Key characteristics compared: Type of Scope, Insertion Shaft Diameter, Length, Deflection, Type of Imager, Direction of View, Light Source, Field of View, Depth of Field, On-axis Resolution. | Subject Device K182186 vs. Predicate K103467: |
- Insertion Shaft Diameter: 2.9 mm (vs. 3.7 mm for predicate)
- Field of View: 100° (vs. 85° for predicate)
- Depth of Field: 5-50mm (vs. 8-50mm for predicate)
- On-axis Resolution: 16 Lp/mm at 5mm, 1.8Lp/mm at 50mm (vs. 8.0 Lp/mm at 8mm, 1.4 Lp/mm at 50 mm for predicate)
- Other characteristics (Scope Type, Shaft Length, Deflection, Imager Type, Direction of View, Light Source, Reprocessing Methods) are "Same as the subject device" or "Same as the predicate device" (implied same). |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This document does not describe a clinical study with a "test set" in the context of an AI/ML algorithm evaluation. The assessments are based on engineering bench tests, biocompatibility tests, and reprocessing validations rather than clinical data sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth, in the AI/ML sense, is not established for this type of device submission.
4. Adjudication method for the test set:
- Not Applicable.
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 visualization tool, not an AI-assisted diagnostic or interpretive system. Clinical studies comparing human reader performance are not described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a physical endoscope system, not an algorithm.
7. The type of ground truth used:
- Not Applicable. The "truth" in this context is defined by adherence to engineering specifications, safety standards, and performance characteristics as verified through non-clinical testing.
8. The sample size for the training set:
- Not Applicable. This device does not involve a "training set" as it is not an AI/ML system.
9. How the ground truth for the training set was established:
- Not Applicable.
Ask a specific question about this device
Page 1 of 1