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P-Scope is intended to be used in diagnostic and therapeutic procedures for endoscopy within the peritoneal cavities including the female reproductive organs.

The device contains two separate functioning components. First is the single-use, sterile P-scope device, which includes camera mounted on a 3 or 5 mm rigid shaft and reusable high-definition video display includes ports such as USB and HDMI, which allow for connections to external high-definition video screens. This feature enables the surger and more detailed view of the surgical field during the procedure.

In summary, the P-scope combines the single-use laparoscope device with a high-definition video camera for imaging, and a reusable video display with an image processor for displaying the video feed, along with connectivity options to external video screens.

The provided text is a 510(k) summary for the medical device P-Scope. This document focuses on demonstrating that the P-Scope is "substantially equivalent" to legally marketed predicate devices, primarily through non-clinical testing. It explicitly states that "The subject devices do not require clinical studies to support the determination of substantial equivalence."

Therefore, based solely on the provided text, there is no information available regarding acceptance criteria related to AI performance, sample sizes for test sets (as no clinical test sets were used for AI evaluation), expert ground truth establishment, adjudication methods, MRMC studies, standalone AI performance, or training set details. The 510(k) summary concerns the physical endoscope device and its safety/performance, not an AI component.

To fulfill your request, I must state what can be extracted from the document concerning the device's validation against its intended use, even if it doesn't involve AI.

Here's an interpretation based on the provided text, highlighting the absence of information related to AI-specific criteria, as the document doesn't pertain to an AI device:

Device: P-Scope (Endoscope)
Regulatory Submission: K241502

Based on the provided K241502 510(k) summary, the P-Scope device's acceptance criteria and proven performance relate to its physical and functional attributes as an endoscope, not to an AI component or its performance. The document explicitly states that "The subject devices do not require clinical studies to support the determination of substantial equivalence." Therefore, no information regarding AI-specific acceptance criteria or human-AI interaction studies is present.

The study that proves the device meets the acceptance criteria is detailed as non-clinical bench testing, EMC, and electrical safety testing.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance (Non-AI Related):

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

• Test Set: No patient or image data test sets were used, as the validation was based on non-clinical bench testing of the physical device.
• Data Provenance: Not applicable for a non-clinical, non-AI device validation. The testing was conducted in accordance with international and FDA-recognized standards.

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

• Not applicable. Ground truth in the context of AI/diagnostic accuracy was not established, as no clinical test set was used and there is no AI component. The validation focused on engineering specifications and safety standards met through bench testing.

4. Adjudication Method for the Test Set:

• Not applicable. No human-interpreted test sets requiring adjudication were involved.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. An MRMC study was not conducted because:
  • The device is an endoscope, not an AI image analysis system.
  • The submission explicitly states, "The subject devices do not require clinical studies to support the determination of substantial equivalence."

6. Standalone Performance (Algorithm Only without Human-in-the-Loop):

• Not applicable. There is no algorithm or AI component to report standalone performance for.

7. Type of Ground Truth Used:

• Not applicable. For this submission, "ground truth" refers to the engineering specifications and performance benchmarks outlined in the referenced international standards (e.g., ISO 8600-1, IEC 60601 series). The device's performance was measured against these predefined physical and electrical safety parameters.

8. Sample Size for the Training Set:

• Not applicable. There is no AI component, and thus no training set was used.

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

• Not applicable. There is no AI component or training set.

In summary, the provided FDA 510(k) summary for the P-Scope pertains to a conventional medical device (an endoscope) and not an AI-powered device. Therefore, the questions related to AI-specific acceptance criteria, test sets, ground truth establishment, and human-AI studies are not addressed by this document. The device's acceptance criteria are met through adherence to established engineering, safety, and performance standards via non-clinical bench testing.

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