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The Lumendi DiLumen is an accessory to an endoscope. The DiLumen dual balloon accessory is intended for use with any standard endoscope that has a distal tip outer diameter of 12.5 – 14.3 mm and a working length of 1680 mm or greater. The device is indicated to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and endoscopic treatment.

The DiLumen Endolumenal Interventional Platform is a non-sterile, single-use, close-fitting sleeve that fits securely over a standard endoscope. The DiLumen utilizes two balloons to position and stabilize the endoscope within a patient's large intestine. After the DiLumen is installed over the endoscope, the endoscope and DiLumen are navigated to the target zone with the balloons deflated. Once the clinician is at the area of interest, the Aft Balloon, which is attached to the DiLumen sleeve, will be inflated until it contacts the intestinal wall near the proximal end of the articulating section of an endoscope. The second balloon, the Fore Balloon, is also attached to the sleeve via two flexible extension push rods and is deployed at the distal end of the endoscope at a variable distance. Once extended and inflated, the Fore Balloon contacts the patient's intestinal wall, and in combination with the Aft Balloon, creates an isolated diagnostic or therapeutic zone. Both balloons are controlled using an Inflation Handle with a squeeze bulb to manually inflate and deflate the two balloons with ambient air. The balloons assist in stabilizing the endoscope and the therapeutic area and are inflated or deflated independently. The balloons and sleeve are designed to permit the usage of any standard endoscopic tool (such as biopsy forceps, snare, needle, etc.) through the endoscope working channel. The endoscope flexibility, maneuverability and functionalities (such as visualization, insufflations, etc.) are unaffected by the presence of the DiLumen.

The provided text describes the 510(k) summary for the DiLumen Endolumenal Interventional Platform, a medical device. However, it does not contain the specific details about the acceptance criteria or a dedicated study that rigorously proves the device meets specific performance criteria with quantitative metrics like sensitivity, specificity, or reader improvement. The document focuses on demonstrating substantial equivalence to predicate devices through various performance tests, but these tests are not presented as a formal study with detailed acceptance criteria and reported numerical performance.

Therefore, I cannot generate the exact table or detailed information requested without that specific data.

However, I can extract the types of performance tests conducted, which imply underlying acceptance criteria, and some general statements about the studies.

General Information Extracted:

• Device Name: DiLumen Endolumenal Interventional Platform
• Intended Use: Accessory to an endoscope, intended for use with standard endoscopes with specific distal tip outer diameter and working length. Indicated to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and endoscopic treatment.
• Predicate Devices: Fujinon EC-450B15 Double Balloon Enteroscopy System (K090116), Smart Medical Systems NaviAID™ BGE (K060923), and Smart Medical Systems NaviAID™ BGC (K102616).
• Performance Data Provided: The document lists 18 performance tests conducted to support the premarket notification.

Here's how I can answer the prompt based on the available information, noting the absence of specific quantitative acceptance criteria and results:

1. A table of acceptance criteria and the reported device performance

Based on the provided text, specific numerical acceptance criteria (e.g., "burst pressure must be > X psi") and reported quantitative performance values are not detailed. The document lists the types of performance tests conducted and generally states that the device "meets specifications" and "has substantially equivalent performance to the predicates."

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

The document does not specify the sample sizes used for any of the listed "Performance Data" tests. It also does not mention an explicit "test set" in the context of clinical data or patient images for algorithm evaluation. The tests listed are primarily bench tests and engineering validations. Data provenance (country of origin, retrospective/prospective) is not applicable or provided for these types of tests.

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

Not applicable. The listed performance data are mainly physical/mechanical bench tests. "User Validation" implies involvement of users, likely medical professionals, but their number and specific qualifications for establishing a "ground truth" (in the diagnostic sense) are not provided.

4. Adjudication method for the test set

Not applicable. The listed performance data are mainly physical/mechanical bench tests.

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 such study is mentioned or provided in the document. The device itself is an accessory for an endoscope, not an AI diagnostic tool.

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

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used

For the bench tests, the "ground truth" is typically established by engineering specifications, physical measurements, and functional requirements of the device. For example, a burst pressure test would compare actual burst pressure to a pre-defined minimum specification. For "User Validation," the ground truth would be user feedback and ability to complete tasks effectively with the device.

8. The sample size for the training set

Not applicable. This is not an algorithm-based device requiring a training set.

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

Not applicable. This is not an algorithm-based device.

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