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The KARL STORZ ShuntScope is indicated to provide visualization and access during cranial diagnostic and therapeutic procedures such as shunt placement, tumor biopsy and resection, hydrocephalus treatment, endoscopic third ventriculostomy with choroid plexus cauterization (ETV/CPC), endoscopic third ventriculostomy, cyst fenestration, and aqueduct exploration in pediatrics and adult population.

The components subject of this submission are: (1) the KARL STORZ ShuntScope (Model Number: 28164SSA), (2) the examination sheath (Model Number: 11577KA) and (3) operating sheath (Model Number: 11577KE)

The KARL STORZ ShuntScope is indicated to provide visualization and access during cranial diagnostic and therapeutic procedures. This response pertains to the non-clinical performance data for the device. Clinical studies were not required or performed to demonstrate substantial equivalence to predicate devices, as non-clinical bench testing was deemed sufficient.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample size (number of ShuntScope units) used for each bench test. The term "bench testing" refers to in-vitro testing, suggesting the tests were performed on manufactured devices. The provenance of the data is from KARL STORZ Endoscopy-America, Inc., and these tests are inherently prospective as they are performed to verify the design of the new device.

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

Not applicable. This is a non-clinical bench testing study assessing physical and optical characteristics of a device, not a diagnostic or clinical performance study requiring expert interpretation or ground truth establishment in a clinical context. The "ground truth" here is adherence to manufacturing specifications and design requirements.

4. Adjudication Method for the Test Set:

Not applicable. As this is non-clinical bench testing, there is no adjudication method in the context of clinical interpretation or diagnosis. The "Pass" results indicate that the device met its pre-defined engineering and performance specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. An MRMC comparative effectiveness study was not done. This study focuses on the technical performance of the device itself (e.g., its physical dimensions, optical properties) rather than its effectiveness in a clinical setting with human readers.

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

Not applicable. This device is a neurological endoscope, which is a physical instrument for visualization and access, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used:

The ground truth used for these bench tests consisted of pre-defined technical specifications and engineering requirements. For instance, the "Maximum insertion portion width" has a ground truth of "not larger than 1 mm," and the "Direction of view" has a ground truth of "0° ± 10°." These are objective, measurable criteria established during the device's design and manufacturing process.

8. The Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI-based device, so there is no concept of a "training set" in the context of this performance evaluation.

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

Not applicable, as there is no training set for this type of device.

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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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