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The Camera Enabled Probe is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening.

The Camera Enabled Probe is a battery operated, portable, visualization device that uses a probe with integrated camera and separate LCD monitor attached via cable. The sterile, single-use probe includes the camera and image capture features with LED light source. The LCD Monitor displays real-time video from the probe and is attached via cable to provide power to the probe. The probe scope extends from the handle as a rigid shaft with retractable needle and flushing port for cleaning the field of view. The distal tip of the probe contains the illumination and imaging optics. The Camera Enabled Probes are identical in design and function and available in three lengths: 50mm, 95mm, and 160mm. The monitor is 220mm X 135mm X 39mm. The entire unit weight is less than 300 grams.

The provided text describes a 510(k) premarket notification for a medical device called the "Camera Enabled Probe." The regulatory submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and testing against those criteria in a way that would be typical for an AI/ML device.

Therefore, the requested information elements related to AI/ML device performance (like specific performance metrics, sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not present in the provided document. The document describes functional and safety testing to ensure the device meets predefined technical standards, which are different from a clinical performance study with statistical results against acceptance criteria for a diagnostic aid.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists industry standards that the device underwent testing against for functional and safety aspects. These are not performance metrics in the sense of accuracy, sensitivity, or specificity for a diagnostic output, but rather specifications for the device's physical and operational attributes.

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

• Sample Size: Not specified for any specific clinical performance test. The testing mentioned refers to "representative samples" for functional and safety testing.
• Data Provenance: Not applicable as no clinical performance study data is presented.

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

• Not applicable as no clinical performance test with expert-established ground truth is described.

4. Adjudication method for the test set:

• Not applicable.

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 MRMC study was done. This is not an AI-assisted device.

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

• No standalone algorithm performance study was done. This is not an AI device.

7. The type of ground truth used:

• Not applicable, as no clinical ground truth for diagnostic accuracy is presented. The "ground truth" for the functional and safety tests would be the specifications outlined in the respective standards.

8. The sample size for the training set:

• Not applicable as this is not an AI/ML device and no training set is mentioned.

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

• Not applicable.

Overall Study Description:

The provided document describes a technical performance and safety assessment rather than a clinical performance study. The study presented focuses on ensuring the device (Camera Enabled Probe) meets established industry standards for:

• Biocompatibility (ISO 10993-1)
• Electrical safety and essential performance (IEC-60601-1)
• Electromagnetic compatibility (EN-60601-1-2)
• Sterilization validation (ISO-11135-1)
• Material specifications (ISO-9626, ISO-7864)

The conclusion states that Trice Medical, Inc. considers the Camera Enabled Probe to be equivalent to the predicate device (K093717 - C-MOR Visualization System) based on:

• Similarities in indications for use.
• Principles of operation.
• Technology.
• Materials.

This type of submission (510(k)) primarily demonstrates substantial equivalence to a legally marketed predicate device, often relying on non-clinical performance data and comparison to the predicate's technical specifications and safety profile, rather than a de novo clinical performance study against specific diagnostic acceptance criteria.

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