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Peripherally inserted central venous (PICC) and midline catheters placed for venous access or prolonged intravenous therapy.

Peripherally inserted central venous (PICC) and midline catheters placed for venous access or prolonged intravenous therapy. Method of insertion is through an introducer sheath. The optimal catheter tip location for the PICC catheter is in the superior vena cava of the heart. The recommended tip location for the midline catheter is below the shoulder, at the level of the axilla. The products will be available in single and dual lumen confiqurations; with and without a flushable guidewire; and as sterile individual units or in insertion kits containing the components used for insertion of the device.

This is a medical device application for a Peripherally Inserted Central Venous Catheter (PICC) and Midline Catheter, not an AI/ML powered device. Therefore, many of the requested fields are not applicable.

Here's the information that can be extracted from the provided text:

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

The document states "The JJMI Polyurethane PICC and midline catheters have passed all tests for safety and effectiveness (i.e., biocompatibility, sterility and device performance)." and then lists specific tests with a "Passed" conclusion. While the document doesn't explicitly state the acceptance criteria values for each test (e.g., minimum flow rate, specific tensile strength), it implies that these criteria were met, leading to a "Passed" conclusion.

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

This information is not provided in the given text. For a medical device like this, the sample size would typically refer to the number of catheters tested for each performance characteristic. The provenance of the data is also not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as this is a physical medical device, not an AI/ML system that relies on expert interpretation for ground truth. The "ground truth" for these tests would be objective measurements and adherence to engineering and biological standards.

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

This is not applicable as this is not an AI/ML system that requires adjudication of interpretations. The tests performed are objective, laboratory-based physical and biological assessments.

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

This is not applicable. This is a physical medical device, not an AI assistance tool for human readers.

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

This is not applicable as there is no algorithm or AI component to this device.

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

The "ground truth" for the device's performance is based on objective measurements against established engineering, material, and biocompatibility standards. For example:

• Flow rate: Measurement against a specified flow rate standard.
• Tensile strength: Measurement of force at failure against a minimum requirement.
• Biocompatibility: Results of standardized in vitro and in vivo tests as per ISO 10993.
• Sterilization: Verification of sterility (absence of viable microorganisms) and pyrogenicity (absence of pyrogens) through standard laboratory protocols.

8. The sample size for the training set

This is not applicable as this is not an AI/ML powered device that requires a training set.

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

This is not applicable as this is not an AI/ML powered device.

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