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The SpyGlass DS and DS II Direct Visualization System is indicated for use in diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.

The SpyGlass DS and DS II Direct Visualization System comprises two components: the SpyScope DS Access and Delivery Catheter or SpyScope DS II Access and Delivery Catheter, and the SpyGlass DS Digital Controller.

The SpyScope DS Access and Delivery Catheter and SpyScope DS II Access and Delivery Catheter are intended to provide direct visualization and to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.

The SpyGlass DS Digital Controller is intended to provide illumination and receive, process, and output images from the SpyScope DS Access and Delivery Catheter or SpyScope DS II Access and Delivery Catheter for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts.

The SpyGlass DS and DS II Direct Visualization System comprises two components: (1) a sterile, single-use choledochoscope, either the SpyScope DS Access and Delivery Catheter or the SpyScope DS II Access and Delivery Catheter (the "Scope"); and (2) a non-sterile endoscopic video imaging system, the SpyGlass DS Digital Controller (the "Controller").

The Scope is introduced into the pancreatico-biliary system via a duodenoscope. The Scope comprises a handle, an insertion tube, and a connection cable. The handle includes two articulation control knobs, a lever to lock the control knobs in place, connectors for irrigation and aspiration, a working channel port, and a strap to attach the Scope to the duodenoscope. The insertion tube contains one working channel for accessory devices and aspiration, two channels for irrigation, two optical fibers to transmit illumination from the Controller, and wiring to transmit video signals to the Controller. The bending section at the distal portion of the insertion tube is controlled by the user via the articulation control knobs on the handle. The distal end of the insertion tube contains a camera for capturing video and transmitting it to the Controller, elements for transmitting illumination from the Controller, and the distal openings of the irrigation and working channels. The connection cable connects the Catheter handle to the Controller for transmitting illumination and video signals.

The Controller is an endoscopic video imaging component that combines the functionality of a camera and an LED light source. The Controller receives video signals from the Scope, processes the video signals, and outputs video images to an attached monitor. The Controller also generates and controls the illumination transmitted to the distal end of the Scope. The user interface of the Controller comprises a power button, a receptacle to connect the Scope connection cable, buttons to turn illumination on or off and to control the illumination intensity, and an illumination intensity indicator. The Controller outputs video images to an attached monitor via DVI, VGA, or S-Video ports, and the user may select NTSC or PAL video formats according to the geographic region of use.

The provided document is a 510(k) premarket notification for a medical device. It describes performance data but does not present a detailed study with acceptance criteria and reported device performance in the format requested. It generally states that "non-clinical testing was successfully performed" and "All acceptance criteria were met," but it doesn't provide the specific criteria or the numerical results against those criteria.

Therefore, I cannot fulfill your request for "A table of acceptance criteria and the reported device performance" based on the provided text.

However, I can extract information related to the other points based on what is available:

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

As explained above, this information is not provided in sufficient detail in the document. The document states that performance testing was "successfully completed" and that "All acceptance criteria were met," but it does not specify what those criteria were nor the quantitative results.

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

• Sample Size: Not specified. The document refers to "non-clinical testing" and "performance testing (bench)" which typically involve a number of devices/components rather than patient data.
• Data Provenance: Not specified, but given it's "non-clinical" and "bench" testing, it likely occurred in a lab setting rather than involving human subjects or population data.

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

• Not Applicable: This type of information is relevant for studies involving human interpretation (e.g., diagnostic accuracy studies). The "Performance Data" section describes bench testing (e.g., field of view, resolution, irrigation flow rate), which doesn't typically involve experts establishing "ground truth" in the same way clinical diagnostic studies do.

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

• Not Applicable: Given the nature of the bench testing described, an adjudication method for a test set is not relevant.

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: The document does not mention any MRMC comparative effectiveness study or any studies involving AI. The device is a "Direct Visualization System" (endoscope and related components), not an AI-powered diagnostic tool.

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

• Not Applicable: The device is hardware (endoscope, camera, light source) with associated software for image processing and output. It is not an algorithm designed for standalone diagnostic performance.

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

• Objective Measurements: For the "Performance Data" listed (Field of view, Resolution, Irrigation flow rate, etc.), the "ground truth" would be established through objective measurement standards and specifications, not expert consensus or clinical outcomes data. For biocompatibility and electrical safety, the "ground truth" is adherence to recognized consensus standards.

8. The sample size for the training set:

• Not Applicable: The document does not describe a machine learning model or an algorithm that would require a "training set." The device is a direct visualization system. While it has software for image processing, the context does not suggest a deep learning model requiring a large training dataset for classification or detection.

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

• Not Applicable: See point 8.

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