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Flexible Fiberscope: For examination, diagnosis, and/or therapy in connection with Flexible Fiberscope. Tor exammation, chughts used through the working channel of the instrument for use in lumbar spine applications.

Flexible Biopsy Forcep: Used to obtain small biopsies from tissue

Electrodes: Used for unipolar coagulation.

Flexible fiberscopes are used for examination, diagnosis, and/or therapy in connection with endoscopic accessories and auxiliary instruments used through the working channel of the instrument for use in lumbar spine applications.

The flexible endoscope consists of an eyepiece, with a focusing ring for direct view or connection to a video camera, a lever to control the flexible tip of the scope, and the flexible insertion portion.

The tip of the sheath has an active deflection up to 360°, depending on the fiberscope. The deflecting position can be locked with a brake on some fiberscopes. The image is transmitted via objective, fiber bundle and eyepiece for direct view or connection to a video camera. The total number of pixels and the fibers per mm² are increased to get an image with higher resolution. Biopsy material can be taken by the wide working channel, which is simultaneously used for irrigation. Auxiliarv instruments such as forceps are inserted via a proximal mounted insertion cock with supply and discharge.

The provided text is a 510(k) summary for the Richard Wolf Medical Instruments Corporation's Flexible Fiberscopes and Accessories. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices, not a study proving the device meets specific acceptance criteria in the manner of a clinical trial or performance study comparing a new device against a defined standard.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, or MRMC studies for demonstrating device performance against specific metrics is not available in the provided document. The document focuses on demonstrating substantial equivalence based on technological characteristics and intended use compared to predicate devices.

However, I can extract information related to the device and its claimed equivalence:

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

This information is not provided in the document. The filing is a 510(k) premarket notification claiming substantial equivalence, not a report on meeting specific performance acceptance criteria from a pre-defined study.

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

This information is not provided. No specific test set or data provenance is mentioned as this is a premarket notification based on substantial equivalence to existing 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. Ground truth establishment, in the context of performance testing with a test set, is not described.

4. Adjudication method for the test set:

This information is not provided. An adjudication method for a test set is not 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:

This information is not applicable and not provided. The device is a "Flexible Fiberscope and Accessories," which are physical medical instruments, not an AI-based system. Therefore, MRMC studies with AI assistance are irrelevant to this filing.

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

This information is not applicable and not provided. The device is a physical medical instrument, not an algorithm.

7. The type of ground truth used:

This information is not provided. Ground truth, in the context of performance testing, is not described.

8. The sample size for the training set:

This information is not provided. A training set, in the context of algorithm development, is not applicable to this physical medical device.

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

This information is not provided. Ground truth establishment for a training set is not applicable.

Information that is available from the document related to the device and its claims:

• Device Name: Flexible Fiberscopes and Accessories
• Intended Use: For examination, diagnosis, and/or therapy in connection with flexible fiberscope. Accessories and auxiliary instruments used through the working channel of the instrument for use in lumbar spine applications. Flexible Biopsy Forcep: Used to obtain small biopsies from tissue. Electrodes: Used for unipolar coagulation.
• Field of Application: Spine, urology, surgery, gynecology, and ENT, by adequately trained and qualified medical personnel.
• Technological Characteristics (claimed relevance for equivalence):
  • Tip of the sheath has active deflection up to 360°, depending on the fiberscope (some can be locked).
  • Image transmitted via objective, fiber bundle, and eyepiece for direct view or connection to a video camera.
  • Increased total number of pixels and fibers per mm² for higher resolution image.
  • Wide working channel for biopsy material and irrigation.
  • Auxiliary instruments (e.g., forceps) inserted via a proximal mounted insertion cock with supply and discharge.
• Substantial Equivalence Claim: The submitted devices are claimed to be substantially equivalent to existing pre-enactment and 510(k) devices sold by Richard Wolf in the urology branch, and to devices sold by Clarus and Sofamor Danek.
• Predicate Devices (for claiming substantial equivalence):
  1. K962172 - Flexible Mini-Fiberscopes (Richard Wolf)
  2. LASE Flexible Endoscope (Clarus)
  3. K971455 - SITEprobe diagnostic spinal endoscope (Clarus)
  4. K946087 - The Inclusive ™ Endoscope System (Sofamor Danek)
• Performance Data & Clinical Tests:
  • No known FDA performance standard exists.
  • Clinical tests were not performed.
• Conclusions Drawn (by applicant): Devices are designed and tested to assure safety and effectiveness when used according to instructions manual.

In summary, the provided document is a regulatory filing for market clearance based on substantial equivalence, and therefore does not contain the detailed performance study information requested.

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For examination, diagnosis and/or therapy in connection with endoscopic accessories and auxiliary instruments used through the working channel of the instrument for use in urology, surgery, and GYN.

The flexible fiberscopes consist of a flexible insertion part, a control part and an eyepiece for direct view or connection to a video camera.

This document, K980401, describes the premarket notification for "Flexible Fiberscopes and Accessories" by Richard Wolf Medical Instruments Corporation. It primarily focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a study proving a device meets specific performance acceptance criteria.

Therefore, many of the requested details about acceptance criteria and a study to prove performance cannot be extracted from this document, as such a study was explicitly stated as not performed.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

The document does not specify quantitative acceptance criteria or report performance against such criteria. It states, "No known FDA performance standard exists."

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. The document explicitly states: "Clinical tests performed were not performed."

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 clinical tests were performed, so no ground truth was established through expert review for a test set.

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

Not applicable. No clinical tests were performed, hence no test set or adjudication method.

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 medical device for direct visualization, not an AI-assisted diagnostic tool. No MRMC study was performed.

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

Not applicable. This is a medical device (fiberscope), not an algorithm.

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

Not applicable. No clinical tests were performed, and thus no ground truth was established in this context. The document relies on design and testing to assure safety and effectiveness rather than clinical ground truth derived from patient data.

8. The sample size for the training set

Not applicable. This document is for a physical medical device, not a machine learning algorithm that requires a training set.

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

Not applicable. As above, this is a physical medical device.

Summary of Device Safety and Effectiveness Demonstration:

Instead of a study with acceptance criteria, the document demonstrates substantial equivalence by:

• Technological Characteristics: Stating "There are no significant technological changes or characteristics to the new devices compared to the existing devices" and detailing minor improvements like increased pixels/fibers for higher resolution.
• Intended Use: Consistent with predicate devices.
• Substantial Equivalence Claim: Comparing the device to several pre-enactment and 510(k) cleared flexible fiberscopes from Richard Wolf, Circon, Karl Storz, and Olympus.
• Performance Data: Reporting that the electrodes in combination with the fiberscopes were tested to meet appropriate sections of ANSI/AAMI standard HF18 (on high frequency devices) and IEC601-1/IEC601-2-2. These are engineering performance standards for electrical safety and electromagnetic compatibility, not clinical performance criteria.
• Conclusion: The devices are "designed and tested to assure their safety and effectiveness when used according to the instructions manual," relying on engineering standards and design verification rather than clinical outcomes.

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