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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 comes into limited (

The provided text describes a medical device called the DiLumen C2 and its accessory, the Tool Mount, and generally states their performance and equivalence to a predicate device. However, it does not contain the detailed acceptance criteria and the results of a specific clinical study in the format requested.

The document is a 510(k) Premarket Notification summary from the FDA, aiming to demonstrate substantial equivalence to a legally marketed predicate device (DiLumen Endolumenal Interventional Platform, K162428). This typically relies on comparing technological characteristics and demonstrating that any differences do not raise new questions of safety or effectiveness, often through bench testing rather than extensive clinical trials with specific performance metrics against pre-defined acceptance criteria.

The "Performance Data" section lists various tests performed (e.g., Biocompatibility, Balloon Diameter, Inflation/Deflation and Leakage Test, User Validation), but it does not provide quantitative acceptance criteria or the specific performance results from these tests. It merely states, "In all instances, the device functioned as intended and the results observed were as expected." It also explicitly states, "No animal or clinical testing was required to demonstrate substantial equivalence to the predicate."

Therefore, I cannot fill in the requested table and answer many of the specific questions about clinical study details (sample size, data provenance, expert ground truth, MRMC study, standalone performance, training set) because this information is not present in the provided document.

Here's what I can extract and state based on the provided text, and where I must indicate information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The document indicates "No animal or clinical testing was required," implying that the performance data primarily comes from bench testing, for which sample sizes are not detailed in this summary.
• Data Provenance: Not applicable for a clinical study, as the document states no clinical testing was required. For bench testing, provenance details like country of origin or whether data was retrospective/prospective are not provided.

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

• This information is not applicable as no clinical study or expert-adjudicated ground truth for a test set is described.

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

• This information is not applicable as no clinical study with a test set requiring adjudication is described.

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 comparative effectiveness study was done. The device (DiLumen C2 and Tool Mount) is an endoscope accessory, not an AI diagnostic or assistive imaging tool that involves "human readers" in the context of an MRMC study.

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• Ground truth in the traditional sense of clinical studies (e.g., pathology, outcomes) is not mentioned as "No animal or clinical testing was required." For the enumerated performance tests, the "ground truth" would be the engineering specifications and functional requirements of the device.

8. The sample size for the training set

• Not applicable as this is a physical medical device, not an AI algorithm requiring a training set.

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

• Not applicable.

Summary of what the document does provide regarding performance:
The document states that "Performance testing has demonstrated that the DiLumen C2 meets specifications and is as safe and effective as the predicate." The listed tests (Biocompatibility, Balloon Diameter, etc.) are bench tests. The conclusion is that the device is "substantially equivalent" to its predicate based on these tests and similar technological characteristics, not based on a clinical trial with acceptance criteria for specific performance metrics against clinical outcomes.

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