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A catheter tunneler is indicated whenever a surgeon would like to create a minimally invasive subcutaneous path for an implanted catheter. The implanting surgeon would oftentimes utilize the tunneler when implanting our TrimPort Systems. Our TrimPort Systems are indicated whenever patient therapy requires repeated intravascular injection or continuous infusion of fluids, medications, antibiotics, nutritionals and the withdrawal of venous blood samples.

Gerard Medical plans to manufacture and market a catheter tunneler. This device will be used to create a subcutaneous path for an intraluminal catheter. The design of the device is such that the distal tip can separate subcutaneous tissues when manual force is applied in the direction of the tip along the length of the device proximal to the tip. The device has a means to connect the catheter in order to draw it through the subcutaneous tunnel. The tunneler may be constructed of any material (eg. metal or plastic) which permits separation of, and passage through, subcutaneous layers and is suitable for contact with this tissue. The initial device that we plan to produce and market is made of the plastic Delrin 500. We may, at a later date, provide an additional model that would consist of a medical grade stainless steel.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Catheter Tunneler:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: The document states, "we will mandate that the following tests be performed for the appropriate percentage of our finished devices prior to their being released for usage." It does not specify an exact number or "percentage" of devices that will be tested. This implies an ongoing quality control process rather than a one-time validation study with a fixed set.
• Data Provenance: The tests are described as part of the "Manufacturing Specification" and are performed on "finished devices prior to their being released for usage." This indicates the data is prospective as it's part of the manufacturing and release process. There is no information about the country of origin.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

• Not Applicable. This type of device (a mechanical surgical tool) does not involve expert interpretation or subjective evaluation for its primary acceptance criteria. The criteria are purely mechanical benchmarks (force and tension).

4. Adjudication Method for the Test Set:

• Not Applicable. Adjudication is typically used for subjective assessments (e.g., medical image interpretation). The tests described are objective, pass/fail mechanical tests.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

• No. An MRMC study is not relevant for this type of device. There is no "reader" (human interpreter) or "AI assistance" being evaluated in the context of device performance. The device is a standalone surgical tool.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):

• Yes, implied. The described tests are for the device's standalone mechanical performance, without human "in-the-loop" interaction for meeting the acceptance criteria. The performance is solely based on whether the device itself can withstand the specified forces and maintain catheter connection. While a human applies the force for the test, the test result is about the device's inherent capability, not a human's performance using the device.

7. Type of Ground Truth Used:

• Mechanical Stress/Strength Thresholds. The ground truth is established by predetermined, objective mechanical thresholds (5 pounds of force, 2 pounds of tension) that the device must meet or exceed. These thresholds were determined based on "bench testing" which indicated they are "significantly higher than would be anticipated during the actual surgical procedure."

8. Sample Size for the Training Set:

• Not Applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set" in the context of algorithm development. The "bench testing" mentioned in the document likely referred to early prototype testing and design validation to determine the appropriate stress levels for the acceptance criteria, but not a dataset for training an algorithm.

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable. As there is no training set, this question is not applicable. The "ground truth" for the acceptance criteria (the force and tension values) was established through internal "bench testing" and engineering evaluation to ensure the device could withstand stresses "significantly higher than would be anticipated during the actual surgical procedure."

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