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The nPulse™ neutral displacement connector is a single patient use, sterile, nonpyrogenic device for needleless access to the IV line and/or IV catheter during IV therapy. The nPulse™ connector can be used for direct injection, intermittent infusion, continuous infusion, or aspiration.

The nPulse K150 Neutral Displacement Needle Free Connector is a single patient use, sterile, non-pyrogenic device for needleless access to the IV line and/or IV catheter during IV therapy. The nPulse K150 Neutral Displacement Needle Free Connector can be used for direct injection, intermittent infusion, continuous infusion, or aspiration. The nPulse K150 valve is a normally closed, luer-activated, valved connector which has an open mode that permits bi-directional fluid flow and a closed mode that prevents fluid flow.

The provided text describes a medical device, the NP Medical nPulse™ K150 Neutral Displacement Needle Free Connector, and its substantial equivalence to a predicate device (NP Medical K100 Neutral Displacement Needle Free Connector) for FDA 510(k) clearance.

The document highlights performance testing conducted to support this equivalence. Here's extraction of relevant information regarding acceptance criteria and study details:

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

The document does not explicitly present a table of acceptance criteria alongside performance data in a direct row-by-row comparison. Instead, it lists the performance tests conducted and generally states that the device "has been evaluated using the appropriate methodology as specified in the FDA recognized consensus standards and in conjunction with NP Medical established test protocols" and that differences from the predicate "demonstrated applicable performance" or "aligns with current best practices."

However, specific performance claims and how they relate to the predicate and established standards are mentioned for certain differences:

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

The document does not specify the exact sample sizes used for each of the performance tests (e.g., number of devices tested for Air Bolus, Repeat Insertion, etc.). It mentions "all test device replicates" for microbial ingress testing but doesn't quantify this.

The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated in the provided text. It implies internal testing by NP Medical, Inc., located in Clinton, MA, USA.

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 information is not applicable to this type of device and study. The testing for the NP Medical nPulse™ K150 connector involves technical performance benchmarks (e.g., flow rates, pressure resistance, sterility) rather than clinical evaluations requiring expert interpretation of diagnostic images or patient outcomes.

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

This information is not applicable. Adjudication methods are typically used in clinical studies, particularly when interpreting subjective data or reaching consensus on diagnoses, which is not the nature of the bench testing described here.

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 information is not applicable. MRMC studies and AI assistance are relevant to diagnostic tools or image analysis, not to a needle-free connector's performance.

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

This information is not applicable. This device is a physical medical device, not an algorithm or AI system.

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

The "ground truth" for the performance tests conducted on the NP Medical nPulse™ K150 connector and its predicate device is established by specified functional requirements and consensus standards. For example:

• Microbial ingress testing: The ground truth is the absence of microbial growth (0 CFU recovered), demonstrating sterility barrier integrity.
• Pressure ratings, flow rates, etc.: The ground truth is compliance with pre-defined engineering specifications and relevant FDA recognized consensus standards (e.g., ISO standards) for intravascular administration sets.

8. The sample size for the training set

This information is not applicable. This is not a machine learning or AI device that requires a training set.

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

This information is not applicable. As in point 8, this device does not utilize machine learning or AI requiring a training set with established ground truth.

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The nPro surgical masks are intended for operating room personnel health care workers to protect both patients and healthcare workers from the transfer of microorganisms, blood and particulate materials. nPro Surgical Masks are single use, disposable devices provided non-sterile.

The nPro surgical mask meets ASTM F2100-19 Level 1 performance requirements for bacterial filtration efficiency, differential pressure, sub-micron particulate filtration efficiency, resistance to penetration by synthetic blood and flame spread.

The three-ply pleated mask fabric can be vertically adjusted to cover the user's mouth and nose. The inner and outer layers are constructed of non-woven fabric. The middle layer is constructed of melt-blown negative charge non-woven fabric and includes a flexible nose wire to the user's nose and reduce air gaps. The three layers of the mask body are collated and ultrasonically welded around the edges to enclose the filter media and nose wire. The polyester-spandex ear loops are ultrasonically welded to the mask body. All materials are not made with natural rubber latex. The nPro Surgical Masks are single use, disposable devices that are provided non-sterile in a dispensing carton.

This document is a 510(k) premarket notification for a surgical mask, not an AI-powered medical device. Therefore, the information typically requested regarding AI/ML device performance (like MRMC studies, training set details, or multiple expert ground truth establishment) is not applicable here.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical performance testing conducted on the surgical mask to demonstrate its substantial equivalence to a predicate device.

Here's the breakdown of the relevant information provided:

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

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

• Sample Size:
  • Bacterial filtration efficiency, Differential pressure, Sub-Micron particulate filtration efficiency, Resistance to penetration by synthetic blood, Flammability Class: 32 each from 3 lots
  • Structural Integrity Failure: 23 each from 3 lots
• Data Provenance: Not specified in terms of country of origin or retrospective/prospective. The testing appears to be standard laboratory/engineering testing for product performance.

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 pertains to a surgical mask and its physical performance characteristics, not an AI/ML device requiring expert interpretation of medical images or data. The "ground truth" here is established by the standardized test methods (e.g., ASTM F2101-19, EN 14683:2019, ASTM F2299-03, ASTM F1862-17, 16 CFR Part 1610, NP-TM-2019-0188-1) and their associated measurement protocols.

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

This is not applicable. Adjudication methods are relevant for human interpretation of data, typically in clinical studies or AI ground truth establishment. For physical product testing, results are typically objective measurements against defined acceptance criteria.

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. MRMC studies are for evaluating AI-assisted medical imaging devices impacting human reader performance. This document is about a surgical mask's physical performance.

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

This is not applicable. This refers to AI algorithm performance. The "standalone" performance here is the mask's ability to perform against physical and biological challenges.

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

The "ground truth" for the surgical mask's performance is established by standardized laboratory test methods defined by organizations like ASTM, EN, and CFR. These methods provide quantifiable metrics for properties like filtration efficiency, differential pressure, and resistance to synthetic blood penetration. For example, a 99.1% bacterial filtration efficiency is a direct measurement result from the ASTM F2101-19 test method, serving as its own "ground truth" against the acceptance criterion.

8. The sample size for the training set

This is not applicable. This device is a physical product (surgical mask), not an AI/ML algorithm that requires a training set.

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

This is not applicable as there is no training set for this device.

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