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The IMAGE1 SPIES is a camera control unit (CCU) for use with camera heads or video endoscopes for the visualization. image recording and documentation during general endoscopic and microscopic procedures.

The modified Image1 SPIES (Storz Professional Image Enhancement System) camera control unit includes an additional camera head that can be connected to the X-link module and software updates for improvement of existing features and bug fixes. The SPIES Camera System is intended and designed for use during endoscopic and microscopic procedures.

The document provided is a 510(k) summary for the Karl Storz Endoscopy America, Inc. Image1 SPIES System. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for proving a device meets
clinical acceptance criteria through a specific study in the way a novel AI algorithm might.

Based on the provided text, here's a breakdown of the acceptance criteria and the study that "proves" the device meets them, keeping in mind the context of a 510(k) for an endoscopic camera system:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide specific numerical acceptance criteria (e.g., minimum resolution in lp/mm, acceptable latency in ms) in a table format. Instead, it states that the device "met all its specifications." The performance validation involved a series of bench tests.

The "bench test data for the Image1 SPIES System demonstrates that the design characteristics used as the basis for the comparison have been met. The results show that the subject device has met all its specifications. The performance validation test report can be provided upon request."

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

• Test Set Sample Size: The document does not specify a "sample size" in terms of cases or patients for the bench tests. The testing performed was on the device itself and its components.
• Data Provenance: Not applicable in the context of clinical data. The tests were bench tests conducted on the device.

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

• Number of Experts: Not applicable. The ground truth for bench tests is based on engineering specifications and direct physical measurements, not expert consensus on medical images.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Bench testing relies on objective measurements against predefined technical specifications.

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

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is typically done for diagnostic aids or AI algorithms that assist human readers in interpreting medical images, assessing the impact on diagnostic accuracy, sensitivity, or specificity. The Image1 SPIES System is a camera control unit for visualization, not a diagnostic AI tool.

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

• Standalone Study: Yes, in a sense, the bench testing performed is analogous to a standalone performance evaluation for the device's technical specifications. The performance of the camera control unit itself (resolution, brightness, etc.) was evaluated independently of human interpretation of clinical outcomes. However, this is not an "algorithm only" study as would be described for AI.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the bench tests was based on engineering specifications and objective physical measurements. For example, resolution would be measured against a standard test pattern, and latency would be measured with specialized equipment.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this device.

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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

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