Search Results

The CAD 12 is indicated for use with a flexible endoscope to aid endoscopic insertion and advancement during diagnostic and therapeutic lower gastrointestinal endoscopy.

The CAD 12 is an endoscopic accessory device configured as an overtube to aid insertion and advancement of an endoscope. The CAD 12 utilizes a rotating membrane tube to advance the endoscope in the lower GI tract. The rotating membrane tube is driven by two mechanical rotating drive wires.

The provided document does not contain details about specific acceptance criteria, study design, or performance metrics in a structured way that would allow for the filling of the requested table and detailed description. The document states:

"An extensive collection of tests has been conducted and successfully completed, including functional performance, safety, biocompatibility and sterility testing. All testing indicates that CAD 12 meets its specification requirements."

However, it does not elaborate on what those "specification requirements" or "acceptance criteria" are, nor does it provide performance data, sample sizes, ground truth establishment methods, or details about expert involvement in a study. The focus of this 510(k) summary is on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study report against pre-defined acceptance criteria.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be answered from the provided text:

1. Table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not specified in the document.
• Reported Device Performance: Not specified in terms of quantitative metrics or individual test results. The document only states "All testing indicates that CAD 12 meets its specification requirements."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
• The document only mentions "extensive collection of tests" including "functional performance, safety, biocompatibility and sterility testing," but no details on study participants, data sources, or cohorts.

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

• Not specified. The document does not describe any study involving experts to establish a "ground truth" for colonoscopy assistance device performance.

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

• Not specified. Without a study involving ground truth establishment by multiple experts, an adjudication method is not applicable or mentioned.

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 or comparative effectiveness study involving human readers with/without AI assistance is mentioned. The device is a mechanical "Colonoscopy Assist Device" (overtube with rotating membrane), not an AI diagnostic tool.

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

• The device is a physical, mechanical endoscopic accessory, not an algorithm. Therefore, a "standalone algorithm performance" study is not applicable.

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

• Not applicable as no specific "ground truth" for a performance study is described. The "testing" mentioned refers to functional, safety, biocompatibility, and sterility tests against internal specifications, not clinical outcomes or expert consensus for diagnostic accuracy.

8. The sample size for the training set:

• Not applicable. The device is a mechanical overtube, not an AI/machine learning algorithm that requires a "training set."

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

• Not applicable. (See #8)

Ask a specific question about this device