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The Encore™ Neutral is intended for single patient use in intravenous and blood administrations and aspiration without the need for needles, thus eliminating the potential for needle-stick injuries during use.

The Encore™ Neutral may be used with low pressure power injectors having a maximum pressure of 325 psi and a maximum flow rate of 10 mL/sec. The subject device does not have to be changed subsequent to use with a low pressure power injector.

The Encore™ Neutral is a luer activated needleless IV Connector that is disposable and for single patient use. It includes the following features:

• . smooth swabbable surface
• . tight seal integrity with no gaps or openings
• straight-through fluid pathway resulting in zero dead space ●
• 100% effective blood clearing
• neutral fluid displacement ●
• . low priming volume
• saline-only flush option
• . no clamping sequence or positive pressure syringe technique required

The Encore™ Neutral is a sterile single-use device which is provided individually packaged. The Encore™ Neutral is also provided bulk non-sterile, to be further processed (packaged and sterilized) by another manufacturer.

The Encore™ Neutral is available with an optional protective end cap attached to the male luer of the device.

The Encore™ Neutral is compatible with ISO 594 compliant male luer slip devices and male luer lock devices.

The Encore™ Neutral is composed of medical grade materials that are not made with Bisphenol A (BPA), di-2-ethylhexyl phthalate, diethylhexyl phthalate (DEHP) or natural rubber latex. The materials used have been subjected to and have passed biocompatibility testing per the latest ISO 10993 standards.

The Encore™ Neutral is MR Safe as it does not contain metallic, magnetic or metal components.

The Encore™ Neutral may be used with low pressure power injectors having a maximum pressure of 325 psi and a maximum flow rate of 10 mL/sec. The device does not have to be changed subsequent to use with a low pressure power injector. When used with a low pressure power injector, the Encore™ Neutral must be secured with other devices rated for pressures up to 325 psi with a luer lock connection.

This document describes the Encore™ Neutral device, an intravenous (IV) connector, and its substantial equivalence to a predicate device. However, it does not contain a study that proves the device meets specific performance acceptance criteria in the manner you've requested (e.g., using a test set, ground truth, expert adjudication, etc.). The document focuses on regulatory approval (510(k)) based on substantial equivalence to an existing marketed device.

Here's an analysis based on the information provided, highlighting what is and is not present:

Summary of Acceptance Criteria and Device Performance (Limited Information)

The document states that "All testing met the predetermined acceptance criteria." However, the specific quantitative acceptance criteria and the corresponding reported device performance values are generally not provided in a detailed table format within this regulatory submission. For most items, it only lists the "performance test conducted" without numerical criteria or results.

Detailed Information as Requested:

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

   • As shown in the table above, the document lists performance tests and states that "All testing met the predetermined acceptance criteria." However, it does not provide the specific numerical acceptance criteria for each test (e.g., "activation force must be >X and <Y N") nor the specific numerical results of those tests (e.g., "activation force was Z N").

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 performance test. It mentions "All testing was conducted on the final finished sterile device."
   • The data provenance (country of origin, retrospective/prospective) is not stated.

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 question is not applicable to this type of device and study. The testing described involves physical, chemical, and microbiological performance evaluations, not diagnostic interpretation requiring expert medical review.

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

   • This question is not applicable for the reasons stated above.

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 question is not applicable. This is a medical device for intravenous access, not an AI-assisted diagnostic tool or an imaging device.

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

   • This question is not applicable. There is no algorithm involved.

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

   • The "ground truth" for the performance tests would be the established physical, chemical, and engineering standards defined by the cited ISO and ASTM standards, as well as internal procedures. For example, for sterility, the ground truth is a Sterility Assurance Level (SAL) of 10-6. For biocompatibility, it's compliance with ISO 10993 standards.

8. The sample size for the training set

   • This question is not applicable. There is no "training set" as this is not an AI/machine learning device. The device itself is the product being tested.

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

   • This question is not applicable for the reasons stated above.

In conclusion: The provided document is a 510(k) summary for a medical device (IV connector) seeking market clearance based on substantial equivalence. It describes a series of non-clinical performance and biocompatibility tests conducted to demonstrate that the device meets safety and effectiveness requirements relative to a predicate device and relevant standards. While it states that all predetermined acceptance criteria were met, it does not provide the specific numerical details of those criteria or the test results, nor does it involve the type of clinical or AI-related study design (experts, ground truth adjudication, MRMC, training/test sets for algorithms) that your questions typically address.

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