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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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