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The Lumendi DiLumen C² is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and endoscopic treatment.

The DiLumen C2 consists of a sleeve including two inflatable balloons that fits over a standard endoscope to facilitate positioning and stabilization of the endoscope during surgical procedures. The C2 is provided non-sterile and does not require disinfection or sterilization prior to use. The device is intended only for single patient use.

To stabilize the system during clinical use, the C2 is provided with its own designated accessory, known as the Tool Mount, a metal holding system that fastens the tool channels to a surqical table rail. The Tool Mount is re-usable and is provided non-sterile; it must be cleaned, disinfected and sterilized prior to each use following the instructions in the device labeling.

The provided text is a 510(k) summary for a medical device (DiLumen C2 and Tool Mount) and thus focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study description of how acceptance criteria were met for a novel AI/software device. Consequently, many of the requested details about acceptance criteria, study design for AI models, ground truth, and expert involvement are not applicable or available in this document.

However, I can extract the general "performance data" that was provided to support the device's substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists performance tests but does not explicitly state quantitative acceptance criteria for each. Instead, it generally states that the device "meets specifications" and "functioned as intended."

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

• Sample Size: Not specified.
• Data Provenance: Not applicable as this is a physical medical device, not an AI/software device generating data. The testing would have been conducted on physical units of the device.

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

• Not applicable. This is a physical device submission; ground truth in the context of expert consensus for AI models is not relevant here. "User Verification Testing" implies evaluation by users/clinicians, but specific numbers or qualifications are not provided.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. This is a physical device.

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:

• Not applicable. This is a physical device, not an AI or software product that assists human readers.

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

• Not applicable. This is a physical device.

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

• Not applicable in the context of AI/software ground truth. For a physical device, "ground truth" would refer to established engineering and performance specifications and industry standards for safety and effectiveness.

8. The sample size for the training set:

• Not applicable. This is a physical device, not an AI/software product requiring a training set.

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

• Not applicable. This is a physical device.

Study that proves the device meets the acceptance criteria:

The document states: "Performance testing has demonstrated that the DiLumen C2 meets specifications and is as safe and effective as the predicate device. As the DiLumen C2 shares many of the same components as the predicate and reference devices, bench testing primarily targeted verification of the balloon integrity and operation of the DiLumen C2 with an endoscope."

The specific studies performed were:

1. Biocompatibility (cytotoxicity, sensitization, systemic toxicity, material mediated pyrogenicity)
2. Fore and Aft Balloon Diameter
3. Therapeutic Zone Creation
4. Balloon/Endoscope Centering
5. Endoscope Insertion Force
6. Instrument Insertion and Removal Force
7. Tool Channel Deflection
8. User Verification Testing

The conclusion is that "In all instances, the device functioned as intended and the results observed were as expected," supporting its substantial equivalence to the predicate device. The details of these "bench tests" are not provided in this summary.

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