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The Modular Endoscope is intended for use for visualization and to magnify and illuminate body cavities, hollow organs and canals in ENT procedures. The Modular Endoscope is intended for use for visualization and to magnify and illuminate dental surfaces. The Modular Endoscope is intended for using additional accessories to perform various diagnostic and therapeutic procedures in ENT surgery, including but not limited to, salivary gland diseases.

The Modular Endoscope utilizes a fiberoptic technology to allow visualization of body cavities. The 6000/10,000 pixel optic system is semi rigid and is contained within a very small diameter of less than 1mm. The endoscope contains a working channel to allow access of various accessories for different therapeutic applications.

The Modular Endoscope is used with single use, multi port (2 or 3 port), sterile cannulas with diameters ranging from 0.9-2.3 mm, which provide the surgeon good flexibility in choosing the right equipment for the clinical procedure.

The single lumen cannula is inserted into the salivary gland or other body cavities or canals and serves as a working and irrigation channel, as well as containing the fiberoptic system. The fiberoptic system is protected from surgical tools and instruments by a nitinol coating.

An ocular is connected at the proximal end and light is transmitted via a light source cable from various commercially available Xenon lamp light sources to the optic system. The image can be visualized by connecting the endoscope to a camera and a monitor screen. The light source, camera and monitor are user-supplied.

The provided text describes the Sialo Technologies Ltd. Modular Endoscope and its 510(k) submission (K093785). The document primarily focuses on demonstrating substantial equivalence to predicate devices and lists various performance standards the device complies with. However, it does not contain explicit acceptance criteria or a detailed study description of how the device meets specific performance metrics beyond compliance with general standards.

Therefore, I cannot fully complete the requested table and answer all questions based solely on the provided text. I will, however, extract all relevant information to the best of my ability and indicate where information is missing.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

• Specific numerical acceptance criteria for "Resolution and Distortion testing" are not provided.
• The actual results of the "Resolution and Distortion testing" are not detailed beyond the statement that it was performed.

2. Sample Size Used for the Test Set and Data Provenance

The document states: "The Modular Endoscope has been tested for performance as follows: - Resolution and Distortion testing" and "Although clinical data is not required to support the substantial equivalence of the Sialo Modular Endoscope, information regarding the use of the device for dental surfaces is presented in Section 20."

• Sample Size for Test Set: Not specified for non-clinical testing. Clinical data was deemed not required, and no specific test set sample size for "Resolution and Distortion" is provided.
• Data Provenance: Not specified. It's non-clinical performance data, so country of origin isn't directly applicable in the same way as clinical data. The testing would have been conducted by the manufacturer, Sialo Technologies Ltd. (Israel).
• Retrospective/Prospective: Not applicable, as no clinical data is primarily presented for substantial equivalence.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: Not applicable, as detailed clinical data requiring expert ground truth is not the primary basis for the 510(k) clearance in this document. The "Resolution and Distortion" testing likely involved objective measurements rather than expert consensus on images.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable, as there is no mention of a human-reviewed test set or a need for adjudication for the performance testing described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• MRMC Study: No, the document explicitly states: "Although clinical data is not required to support the substantial equivalence of the Sialo Modular Endoscope..." Therefore, an MRMC comparative effectiveness study was not conducted or presented for the 510(k) submission.
• Effect Size: Not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: Not applicable. This device is an endoscope, a hardware device for visualization, not an algorithm. Its performance is inherent in its optical and mechanical characteristics, not an AI algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the "Resolution and Distortion testing," the ground truth would typically be established based on standardized test patterns and objective measurements, not pathology, outcomes data, or expert consensus in the clinical sense. For compliance with standards, the ground truth is the adherence to the requirements outlined in those specific standards.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. The device is a hardware endoscope, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth Was Established: Not applicable, as there is no training set for an AI model.

Summary of what's missing and why:

The provided document is a 510(k) summary for a physical medical device (an endoscope). While it details compliance with various engineering and safety standards, it does not involve artificial intelligence, machine learning, or extensive clinical trials with human readers. Therefore, many of the questions related to AI performance, expert ground truth, sample sizes for test/training sets, MRMC studies, and adjudication methods are not applicable to this specific device as described in this regulatory submission. The primary "proof" that this device meets acceptance criteria is its stated compliance with established voluntary standards and the performance testing of resolution and distortion.

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The PolyScope Flexible Endoscope is indicated in flexible endoscopic procedures for diagnostic and therapeutic applications where flexible endoscopes are standard of care including:

• Gastroenterology, including procedure of the Biliary system involving the hepatic and pancreatic ducts.
• Urology, including procedures involving the bladder, ureter, renal pelvis and kidney.

The PolyScope Xenon-Endoscopic light source LS 200 provides white examination light (sunlight spectrum) for all endoscopic applications including:

• During video endoscopy.
• During fiber endoscopy.
• During micro-endoscopy.
• During endoscopy using rigid optics.
• During usage of forehead illumination.

The PolyScope Flexible Endoscope is comprised from two main components: a disposable, flexible, steerable mini-endoscope and a flexible, modular, reusable optical disposable, Holters, etc. to the catheter to allow the visualization of the desired area.

The PolyScope LS 200 XENON-Endoscopic light source provides white examination light (sunlight spectrum) for all endoscopic applications including:

• During video endoscopy.
• During fiber endoscopy.
• During micro-endoscopy.
• During endoscopy using rigid optics.
• During usage of forehead illumination.

The provided text is a 510(k) summary for the PolyScope Flexible Endoscope and PolyScope Xenon Light Source. It focuses on establishing substantial equivalence to predicate devices based on intended use, general design, and fundamental scientific technology. There is no information provided regarding specific acceptance criteria or a study proving the device meets performance metrics in the way a clinical study would for an AI-powered device.

Therefore, I cannot provide a detailed answer to your request regarding acceptance criteria and a study proving the device meets those criteria, as the document doesn't contain that type of information.

The document discusses:

• Device Description and Intended Use: Clearly outlines what the devices are and what they are used for.
• Predicate Devices: Identifies the legally marketed devices to which the PolyScope devices are compared for substantial equivalence.
• Technological Characteristics Summary & Substantial Equivalence Statement: Asserts that the subject devices share the same intended use, general design, and fundamental scientific technology as their predicates.
• Performance Data Summary: States that "appropriate testing including safety, performance and functional testing" was conducted, but does not provide any specific criteria, results, or study details. This typically refers to bench testing, electrical safety, biocompatibility, and sterilization validations, which are not outlined in the provided text.

Specifically, the following information you requested is not available in the provided text:

1. A table of acceptance criteria and the reported device performance: No specific performance metrics or acceptance criteria are listed.
2. Sample size used for the test set and the data provenance: No test set details are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical study or test set with ground truth is described.
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: This device is an endoscope and light source, not an AI-powered diagnostic device, so an MRMC study is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device