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The KSEA Sialoendoscopes and Accessories are used by qualified surgeons in the diagnosis and treatment of salivary gland diseases. The Sialoendoscope is used to visualize the target anatomy. The telescope is used in salivary gland diagnostic and therapeutic procedures. The obturator allows the surgeon to gain access to the surgical site without damaging other tissue layers. The grasping forceps are used to grasp and remove foreign bodies. The stone basket is used to entrap and remove stones during salivary gland endoscopic therapeutic procedures.

The KSEA Sialoendoscope is a fiber optic micro-endoscope. The body contact portions of the KSEA Sialoendoscopes and Accessories are composed of chromium plated Monel 400 and surgical grade stainless steel, which are commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.

This document is a 510(k) summary for the KSEA Sialoendoscopes and Accessories. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria or standalone algorithm performance. Therefore, most of the requested information regarding specific acceptance criteria, study data, sample sizes, expert qualifications, and ground truth establishment is not present in this submission.

Here's a breakdown of what can be derived from the provided text, and what cannot:

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

This information is not provided in the document. The 510(k) summary focuses on demonstrating substantial equivalence based on design, materials, and intended use being identical or similar to predicate devices, rather than presenting specific quantitative performance data against predefined acceptance criteria.

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

This information is not provided in the document. No specific clinical study or test set evaluation is described.

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):

This information is not provided in the document. No expert review or ground truth establishment for a test set is mentioned.

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

This information is not provided in the document. No test set or adjudication process 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:

This information is not provided in the document. This device is a physical medical instrument (sialoendoscope), not an AI-powered diagnostic system. Therefore, an MRMC study with AI assistance is not applicable.

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

This information is not provided in the document. This device is a physical medical instrument, not an algorithm.

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

This information is not provided in the document. There is no mention of ground truth as no performance study is described. The submission relies on substantial equivalence to predicate devices.

8. The sample size for the training set:

This information is not provided in the document. As this is not an AI/algorithm device, a training set is not applicable.

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

This information is not provided in the document. As this is not an AI/algorithm device, a training set is not applicable.

Summary of available information:

• Device Identification: KSEA Sialoendoscopes and Accessories (Miniature Telescope and Accessories).
• Indication for Use: "The KSEA Sialoendoscopes and Accessories are used by qualified surgeons in the diagnosis and treatment of salivary gland diseases. The Sialoendoscope is used to visualize the salivary gland during diagnostic and therapeutic procedures. The obturator allows the surgeon to gain access to the surgical site without damaging other tissue layers. The grasping forceps are used to grasp and remove stones. The stone basket is used to entrap and remove a foreign body, grasp and retrieve stones during salivary gland endoscopic therapeutic procedures."
• Device Description: Fiber optic micro-endoscope with body contact portions made of chromium plated Monel 400® and surgical grade stainless steel.
• Substantial Equivalence Claim: The device is claimed to be "substantially equivalent to the predicate devices since the design, materials and intended uses are identical or similar. The minor differences between the subject and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices." This is the primary "proof" offered in a 510(k) for devices of this nature.

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