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The Image1 SPIES is a camera control unit (CCU) for use with camera heads or video endoscopes for visualization, image recording and documentation during general endoscopic and microscopic procedures.

The Image1 SPIES (Storz Professional Image Enhancement System) camera control unit is a medical device which consists of an Image1 Connect display module (TC200), and a combination of a minimum of one to a maximum of three camera head input modules that is intended and designed for use during endoscopic procedures. Image1 H3-Link (TC300) and Image1 X-Link (TC301) are available as head input modules. The device's modularity enables customers to customize their Image1 SPIES system to their specific current and future video needs. Descriptions of these three modular devices are provided below.

Image1 Connect (TC200):
The Image1 Connect displav module is connected to the head module(s) via an inter-module link cable. The Image1 Connect accepts video from the head module(s) and offers additional functionality such as image capture, image printing, picture-in-picture representation and generation of a digital video output for monitor viewing purposes.

Image1 H3-Link (TC300):
The Image1 H3-Link head module processes raw video signals from the H3 family of camera heads.

Image1 X-Link (TC301)
The Image1 X-Link head module also processes raw video signal from a certain set of imagers housed in a camera head. Visually, the card edge connector receptacle of the X-Link is wider than the receptacle of the H3-Link.

The provided text describes a 510(k) summary for the KARL STORZ Image1 SPIES, an endoscopic video imaging system. It details the device, its intended use, and substantial equivalence to predicate devices, but does not contain explicit acceptance criteria or a detailed study proving the device meets specific performance criteria through a clinical trial or a statistically designed non-clinical study that would typically generate the requested performance metrics.

The document focuses on demonstrating substantial equivalence to previously cleared devices (Image1 Video Imaging System K070716 and Fujinon EPX-4440HD Video Processor and Light Source K102466) through non-clinical bench testing.

Here's an analysis based on the provided text, addressing each point as much as possible:

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

   The document mentions the types of non-clinical tests performed but does not provide specific numerical acceptance criteria or the reported performance values. It states:

   Test Category	Acceptance Criteria (Not explicitly stated with values)	Reported Device Performance (Not explicitly stated with values)
   Electrical Safety	Compliance with IEC 60601-1 and IEC 60601-1-2 standards.	"demonstrates the continued electrical safety of the device"
   Optical Performance	"includes white balance, brightness, image enhancement, video output format, zoom, image quality, image capture, latency and interface control"	Implied to meet or exceed predicate devices' performance.
   Software Reliability	(Not explicitly stated)	"reliability of the software" is tested.
   Overall Performance	As safe, as effective, and performs as well as or better than legally marketed predicate devices.	"demonstrates that the device is as safe, as effective and performs as well as or better than the legally marketed devices."

   Note: The document only lists the categories of tests and a general conclusion of meeting requirements, rather than providing specific quantifiable acceptance criteria (e.g., "latency must be <X ms") and the measured results.

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

   • Sample Size: Not specified. The studies mentioned are described as "non-clinical bench testing," which implies physical device testing rather than testing on a dataset of images or clinical cases.
   • Data Provenance: Not applicable in the context of clinical/image data. The testing involves the device itself.

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

   • Not applicable. The tests are non-clinical bench tests focusing on technical specifications and safety, not on human interpretation or diagnosis.

4. Adjudication method for the test set:

   • Not applicable as no human interpretation or ground truth establishment by multiple experts is described for this type of non-clinical bench testing.

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 explicitly states "non-clinical performance tests." There is no mention of an MRMC study, human readers, or AI assistance. The device is a camera control unit, not an AI-driven diagnostic tool.

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

   • Not explicitly applicable in the context of an "algorithm only" performance because the device is hardware (a camera control unit) with integrated software for image processing and control. The performance tests are for the device's functional capabilities, such as image quality and safety, rather than a standalone algorithm's diagnostic accuracy. The non-clinical tests assess the device's technical performance.

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

   • Not applicable. For non-clinical bench testing, "ground truth" would relate to engineering specifications and objective measurements (e.g., a calibrated light source for brightness, a specific pattern for image resolution, electrical safety standards compliance). No clinical ground truth (like pathology) is used as it's not a diagnostic device with outputs requiring such validation.

8. The sample size for the training set:

   • Not applicable. The device is not described as using machine learning or AI that would require a "training set."

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

   • Not applicable, as there is no training set described.

In summary:

The provided document describes the KARL STORZ Image1 SPIES as a camera control unit that underwent non-clinical bench testing to demonstrate electrical safety, optical performance (white balance, brightness, image enhancement, video output, zoom, image quality, image capture, latency, interface control), and software reliability. The conclusion is that these tests demonstrate the device is as safe and effective as, and performs as well as or better than, its predicate devices. However, the document lacks specific, quantifiable acceptance criteria and detailed numerical results for any of these tests, and it does not involve clinical studies with human readers or AI components that would typically require the detailed information requested in points 2-9.

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