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The NP Medical Extension Set with stabilizing base is a sterile single patient use device.

The NP Medical Extension Set is intended for direction, intermittent infusion, continuous infusion or aspiration for all patients for which IV therapy is prescribed.

The NP Medical Extension Set incorporates a normally closed bidirectional pressure-activated valve that prevents low pressure retrograde flow and is intended for power injector procedures to a maximum pressure of 325 psi at a flow rate of 10ml per second.

The NP Medical Extension Set with Stabilizing Base is a sterile, single use, nonpyrogenic intravenous administration extension set comprised of a side repositionable tube bonded to a connector hub on one end and a female luer on the other end with a clamp in between. The connector hub has a locking male luer and a rotating tube connection joint. The hub houses a bidirectional Pressure-Activated Valve (PAV) and an integral stabilizer under the connector hub. The stabilizing base component (along with IV tape / adhesive) is intended to help anchor the extension set to the patient. This device is not made with plasticizers Diethylhexylphthalate (DEHP). The NP Medical Extension Set with Stabilizing Base may be used with compatible Vascular Access Devices (VAD), Needle Free Connectors, and other commercially available devices.

Based on the provided text, the device in question is the "NP Medical nCompass Extension Set with Stabilizing Base," which is an intravascular administration set. The document is a 510(k) summary for premarket notification to the FDA, demonstrating substantial equivalence to a predicate device.

The acceptance criteria and study proving the device meets these criteria are primarily based on bench performance testing and biocompatibility testing, as no clinical data was required or provided.

Here's a breakdown of the requested information:

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

The document doesn't provide specific numerical acceptance criteria for each test with their corresponding reported performance values. Instead, it states that the device "met all requirements" and "satisfy the acceptance criteria specified by the above applicable standards."

However, we can infer some criteria and the general reported performance:

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

• Sample Size for Test Set: The document does not specify the sample size for any of the performance tests. It states that tests were conducted using "appropriate methodology" and "NP Medical established test protocols."
• Data Provenance: The data is generated from bench testing conducted by NP Medical. The country of origin for the testing itself is not explicitly stated, but NP Medical is based in Clinton, Massachusetts, USA. The studies appear to be prospective in nature, as they were conducted specifically for the purpose of demonstrating substantial equivalence for this 510(k) submission.

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

• This device, being a physical medical device (extension set), does not involve diagnostic interpretations or algorithms that would require expert human review for ground truth establishment in the traditional sense of AI/imaging studies.
• The "ground truth" for its performance is established through adherence to recognized consensus standards (e.g., ISO, USP) and validated bench testing protocols. The experts involved would be technical professionals (engineers, quality assurance personnel, lab technicians) performing the tests and interpreting results against the objective criteria of these standards, rather than clinical experts establishing a "truth" from patient data. Their qualifications would be in metrology, engineering, and quality systems for medical devices. The document does not specify the number or specific qualifications of these individuals.

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

• Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or AI performance evaluations where multiple human readers interpret data, and a consensus or tie-breaking mechanism is needed for ground truth. For bench testing of physical device performance against objective criteria, such methods are not used. The results are quantitative measurements against predefined specifications.

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. An MRMC comparative effectiveness study is not applicable as this is a physical medical device (extension set), not an AI algorithm for diagnosis or interpretation. The document explicitly states: "VIII. CLINICAL DATA: Not applicable."

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

• Not applicable. This relates to AI/software as a medical device. This product is a physical medical device.

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

• The ground truth for the performance of this device is established by:
  • Objective measurements against physical and chemical standards (e.g., flow rate, burst pressure, particulate count, material composition).
  • Adherence to recognized consensus standards (e.g., ISO 10993 for biocompatibility, ISO 11135 for sterilization, ISO 11607-1 for packaging) and FDA guidance documents.
  • Comparison to the performance characteristics of the legally marketed predicate device.

8. The sample size for the training set:

• Not applicable. This device is a physical product and does not involve machine learning or AI, and therefore no "training set" in the context of data for algorithm development.

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

• Not applicable. See point 8.

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