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This instrument has been designed to be used with a Suction Pump and other ancillary equipment for airway management, which includes diagnosis and observation to access airway anatomy, endotracheal/endobronchial intubation and management.

This instrument has been designed to be used with a Suction Pump and EndoTherapy accessories and other ancillary equipment for airway management, which includes endoscopic treatment, diagnosis, and observation to access airway anatomy, endotracheal/endobronchial intubation and management.

The AIRWAY MOBILESCOPE OLYMPUS MAF-DM2/GM2/TM2 are all in one mobile endoscopes that enables efficient airway management. These endoscopes comprises a 3.5" monitor, LED light source, battery and recording features in a handy single unit, which enable observation without peripherals or cables, allowing them to be used in Intensive Care Unit (ICU), Operating Room (OR) and emergency procedures and so on.

This document is a 510(k) Summary for the Olympus AIRWAY MOBILESCOPE MAF-DM2, MAF-GM2, and MAF-TM2. It details a premarket notification for these devices, asserting their substantial equivalence to previously marketed predicate devices.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of acceptance criteria and the reported device performance:

   The document does not explicitly list a table of quantifiable acceptance criteria with corresponding performance results. Instead, it states that "design verification tests and their acceptance criteria were identified and performed as a result of this risk management" (Section 7.8). The performance data section describes various types of tests conducted, implying that the devices met the acceptance criteria for each test type.

   Here's a summary of the types of performance tests conducted:

   Test Type	Objective/Purpose	Reported Performance (Implicit)
   Reprocessing Validation Testing	Validate reprocessing instructions and methods.	Conducted as per FDA guidance, implies successful validation.
   Biocompatibility Testing	Assess biological compatibility with human tissue.	Conducted as per ISO 10993-1, included cytotoxicity, intracutaneous, and sensitization tests, implies satisfactory results.
   Software Verification and Validation Testing	Ensure software performs as intended and meets specifications.	Conducted as per FDA guidance for software and cybersecurity, implies successful verification and validation.
   Electrical Safety and Electromagnetic Compatibility (EMC) Testing	Ensure compliance with electrical safety and EMC standards.	Complies with ANSVAAMI ES 60601-1:2005/(R)2012, A1:2012, IEC 60601-2-18:2009, and IEC 60601-1-2:2014.
   Bench Performance Testing	Ensure the device performs as intended and meets design specifications.	Conducted for: Mechanical durability, Thermal safety, Depth of field, Direction of view, Image performance resolution, Signal to noise ratio, Dynamic range, Photobiological safety, Color performance, Image intensity uniformity. Implies all tests met design specifications.
   Risk Management	Identify and mitigate risks, inform design verification tests and acceptance criteria.	Performed in accordance with ISO 14971:2007.
   Human Factors Validation	Assess usability and human-device interaction.	Conducted in accordance with FDA Guidance, implies satisfactory results.

2. Sample size used for the test set and the data provenance:

   The document does not specify sample sizes for any of the test sets (e.g., number of devices tested for mechanical durability or image performance). All tests appear to be in-vitro bench tests performed on the physical devices or their components. No information is provided regarding the country of origin of the data, but given a major manufacturing site is in Japan (Aizu Olympus Co., Ltd., Fukushima, Japan), some testing may have occurred there. The data is prospective in the sense that it was generated for this specific submission to demonstrate equivalence of the new devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   This information is not provided. The performance data consists of engineering and safety tests rather than clinical evaluations requiring expert interpretation of ground truth (e.g., medical image diagnosis).

4. Adjudication method for the test set:

   This information is not provided. As the tests are largely objective engineering and safety assessments, a formal adjudication method for ground truth establishment as seen in clinical studies is 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:

   No MRMC comparative effectiveness study was conducted. The device is a bronchoscope, a direct observation tool, and not an AI-powered diagnostic system that would typically undergo such a study.

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

   No standalone algorithm performance study was done. The device is a medical imaging instrument (bronchoscope), not an algorithm or AI. All performance is inherently "human-in-the-loop" as it is operated by a healthcare professional.

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

   For the engineering and safety tests performed (e.g., depth of field, resolution, electrical safety), the "ground truth" would be the design specifications established by the manufacturer and relevant international and national standards (e.g., IEC, ISO, AAMI). For example, a depth of field test would compare the measured depth of field to the specified acceptable range.

8. The sample size for the training set:

   Not applicable. The devices are physical medical instruments (bronchoscopes), not AI/ML models that require a training set.

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

   Not applicable. As above, the devices are hardware instruments and do not involve AI/ML training sets.

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The bronchoscope and EndoSheath® Technology are designed to be used for upper airway management: including endoscopic treatment, diagnosis, and intubation of the airways.

The digital video processor is intended for use with the VSI flexible video scope.

The VSI flexible endoscopes are flexible endoscopes with connections to a video processor and display monitor. The EndoSheath® Systems are sterile, single-use protective sheath systems, with or without a working channel, that are intended to avver the entire insertion tube of the videoscope. The digital video processors are used with the flexible videoscopes for image visualization and capture.

This 510(k) premarket notification (K091768) describes a device modification to a video bronchoscope system. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving new safety and effectiveness through extensive clinical performance studies. Therefore, much of the requested information regarding acceptance criteria, sample sizes for training/test sets, expert ground truth, and comparative effectiveness studies is not present in the provided document.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Not Applicable / Not Provided. The submission does not detail a test set in the context of clinical performance data. Performance testing mentioned (electrical safety, thermal, EMC) likely involved engineering tests on the device itself, not a patient-based test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable / Not Provided. No ground truth for a test set is mentioned.

4. Adjudication method for the test set

• Not Applicable / Not Provided. No test set or adjudication method 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

• No. An MRMC comparative effectiveness study was not performed. This device is a bronchoscope, not an AI-powered diagnostic tool.

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

• No. This device is hardware (bronchoscope and video processor), not an algorithm.

7. The type of ground truth used

• Not Applicable / Not Provided. No ground truth in a clinical or diagnostic sense is mentioned. The "performance testing" refers to engineering and safety standards.

8. The sample size for the training set

• Not Applicable / Not Provided. No training set is mentioned as this is a hardware device modification, not an AI model.

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

• Not Applicable / Not Provided. No training set or ground truth for it is mentioned.

Summary of the Study Proving Device Meets Acceptance Criteria (Based on Provided Text):

The acceptance criteria for this device modification are primarily technical and material-based, focused on ensuring the modified device maintains the safety and performance characteristics of its predicate devices.

Study Description:

The study proving the device meets the acceptance criteria consisted of the following:

• Performance Testing: The subject device underwent and successfully passed electrical safety, thermal, and Electromagnetic Compatibility (EMC) testing requirements. These tests are standard engineering evaluations to ensure the device operates safely and as intended within its environment.
• Material Comparison: A comparison of patient contact materials in the endoscope confirmed they are identical to the materials used in the predicate device (Vision Sciences' TNE-5000, K072088). This demonstrates that the biological safety characteristics remain unchanged from an already cleared device.
• Technological Characteristics Comparison: The submission asserted substantial equivalence based on the subject device having "very similar material composition and working dimensions" and "identical viewing direction, image size, bending, reprocessing/sterilization method and working dimensions" to the predicate. It also uses the "same video processor" as other Vision Sciences' videoscopes.

Conclusion stated in the 510(k) Summary:

"Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the VSI flexible video endoscopes with digital video processors and disposable EndoSheath® Systems have been shown to be safe and effective for their intended use."

In essence, this 510(k) relies on demonstrating that the modified device is substantially equivalent to legally marketed predicate devices, with performance testing confirming adherence to relevant safety and performance standards for new hardware. It does not involve clinical studies with human readers or AI-driven diagnostic performance.

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