Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device