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The DiLumen Endolumenal Interventional Knife ("DiLumen |ç") is a disposable monopolar electrosurgical device intended to be used for marking, cutting, and cauterizing tissue within the digestive tract during endoscopic procedures. This device is also indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions under direct endoscopic visualization.

The DiLumen Ix is a sterile, single patient use, disposable electrosurgical instrument. The DiLumen ly utilizes a pistol style handle, flexible shaft with an articulating section at its distal end, and a stainless-steel knife tip that can be extended and retracted. The handle incorporates controls that allow the clinician to rotate the shaft, extend or retract the knife tip, articulate the distal end of the shaft in a specific plane, and lock the articulation in a fixed position. The DiLumen Ik has a plug at the bottom of the handle that is used to connect the device to an electrosurgical unit. When connected to the generator, and used in combination with grounding pads, high-frequency current can be applied through the knife tip to mark, cut or cauterize tissue at the lesion site. There is also a female luer lock connector on the handle that can be used with a standard luer lock syringe to introduce sterile saline at the distal end for flushing the knife tip or to inject saline into the submucosa to lift lesions.

This document is a 510(k) summary for the DiLumen Endolumenal Interventional Knife (DiLumen IK™), a medical device. It does not describe a study involving algorithms, AI assistance, or human readers. Therefore, I cannot provide information on acceptance criteria or studies related to AI performance metrics (like sensitivity, specificity, or MRMC studies) for this particular device based on the provided text.

The document focuses on demonstrating the substantial equivalence of the DiLumen IK to a predicate device (DiLumen Endolumenal Interventional Scissors) and a reference device (Olympus Single Use Electrosurgical Knife) through non-clinical performance testing.

Here's what can be extracted about the device's validation:

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

The document lists performance tests but does not provide specific quantitative acceptance criteria or the numerical results of these tests. It generally states, "In all instances, the device functioned as intended and the results observed were as expected."

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

The document does not specify sample sizes for any of the performance tests nor the data provenance (e.g., country of origin, retrospective/prospective). These details would typically be found in the full 510(k) submission, not the summary.

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

Not applicable, as this is for a physical medical device, not an AI, so "ground truth" in the context of expert review of images is not relevant here. The "ground truth" for this device would be established by physical testing and adherence to engineering specifications and safety standards.

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

Not applicable for a physical device's performance testing.

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 device is a manual surgical tool, not an AI or imaging diagnostic aid.

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

Not applicable. This is a physical device used by a clinician.

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

The "ground truth" for this device's performance is based on direct physical and electrical testing against pre-defined specifications and industry standards for electrosurgical devices and biocompatibility. For example, electrical safety is tested against relevant standards, and biocompatibility is tested according to ISO standards.

8. The sample size for the training set:

Not applicable. This device does not involve a training set as it is not an AI/ML algorithm.

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

Not applicable.

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