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LifeShield® Latex-Free Primary IV Pump Set Distal Microbore Patient Line, Convertible Pin, 72 Inch, with 2 Pressure-Activated Anti-Siphon Valves, Inline Cassette, Collection Bag, CLAVE® and OPTION-LOK® is a single use device for the delivery of fluids from a container to a patient's vascular system.

The intended use and indications for use are the same as other commercially available IV administration sets designated for use with the Omni-Flow® Medication Management Systems™. This set is not intended for gravity use.

The device is used with the Omni-Flow® Medication Management System™ for intravenous infusion by or under the order of a licensed medical practitioner. The device can be used to simultaneously infuse up to four solutions/medications from both syringes and IV fluid containers.

The LifeShield® Latex-Free Primary IV Pump Set Distal Microbore Patient Line, Convertible Pin, 72 Inch, with 2 Pressure-Activated Anti-Siphon Valves, Inline Cassette, Collection Bag, CLAVE® and OPTION-LOK® is designed to be used exclusively with Omni-Flow® Medication Management Systems™. The set is equipped with two pressure-activated anti-siphon valves. The two valves limit gravity flow (free flow) to 1ml per hour when the set is primed and attached to a solution bag hanging vertically at full set extension (72 inches).

The provided text is a 510(k) summary for a medical device (LifeShield® Latex-Free Primary IV Pump Set), focusing on its substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a specific study proving the device meets acceptance criteria in the manner requested (e.g., performance metrics, sample sizes, expert involvement, or comparative effectiveness studies for AI/algorithm-based devices).

The document is a regulatory submission for a physical medical device, not a software or AI-driven device. Therefore, many of the requested points, such as "effect size of how much human readers improve with AI vs without AI assistance" or "standalone (i.e. algorithm only) performance," are not applicable to this type of submission.

The "study" referenced in this type of submission is typically a comparison of the new device to a legally marketed predicate device to demonstrate substantial equivalence, rather than a clinical trial with acceptance criteria for performance metrics as might be found for a novel AI diagnostic tool.

However, based on the information provided, here's an attempt to answer the relevant sections:

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

The document does not explicitly state "acceptance criteria" in a quantitative manner with reported performance values for the new device against those criteria. Instead, it demonstrates substantial equivalence by comparing characteristics to a predicate device.

The closest equivalent to a performance claim and its fulfillment is regarding gravity flow protection:

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

Not applicable. This is a 510(k) for a physical IV administration set, not a data-driven device that would involve a test set of data. The submission relies on comparative analysis of specifications and design to a predicate device.

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)

Not applicable. There is no mention of experts or ground truth establishment for a test set in this context.

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

Not applicable. There is no test set or adjudication process described.

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

Not applicable. This is not an AI or imaging device.

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

Not applicable. This is not an algorithm-based device.

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

Not applicable. There is no concept of "ground truth" as relevant to data-driven performance in this submission. The "truth" is established through engineering specifications, material compatibility, and demonstrated functional equivalence to a legally marketed predicate device.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that would have a training set.

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

Not applicable. There is no training set for this device.

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To administer IV fluids/medication to the patient's vascular system through a needle-free system that aids in the elimination of needle-stick injury.

The Victus I.V. Administration Sets are single use, sterile, non-pyrogenic devices used to administer I.V. fluids/medication to a patient's vascular system via gravity control.

The provided text describes a 510(k) premarket notification for the Victus IV Administration Sets. However, it does not contain the detailed acceptance criteria, study design, or performance data that you've requested regarding device performance. The document explicitly states:

"The Victus I.V. Administration Sets have undergone performance and safety testing to verify mechanical properties and biocompatibility using FDA recognised standards."

This indicates that testing was performed, but the results of that testing (i.e., acceptance criteria and reported performance) are not included in this document. Instead, this document is a summary for a 510(k) submission, confirming that the device is substantially equivalent to predicate devices. Substantial equivalence means it has the same intended use and similar technological characteristics, and any differences don't raise new questions of safety or effectiveness.

Therefore, I cannot populate the table or answer the specific questions about "the study that proves the device meets the acceptance criteria" using the provided text. The document focuses on regulatory approval based on substantial equivalence, not on a detailed clinical or performance study report.

Here's what I can extract based on the limited information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not provided. The document states "performance and safety testing" was done, but gives no details about the sample size, type of test set, or data provenance.

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):

• Not applicable/Not provided. This type of information is relevant for studies involving human interpretation (e.g., medical imaging AI). For an IV administration set, "ground truth" would typically be established through engineering specifications, material science testing, and biological assays, not expert consensus on interpretations. No details on specific experts or their qualifications are mentioned.

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

• Not applicable/Not provided. Adjudication methods are typically used when multiple human experts provide opinions that need to be reconciled, such as in clinical studies evaluating diagnostic accuracy. This is not mentioned or relevant for the type of device and testing described.

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. This is not an AI device. It is a traditional medical device (IV administration set).

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

• Not applicable. This is not an algorithm or AI device.

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

• Inferred: For this type of device, ground truth would be established by engineering specifications, material properties, biocompatibility standards, and functional performance benchmarks (e.g., flow rates, leak integrity, particulate matter, pyrogenicity). The document mentions "FDA recognised standards" were used, implying these types of criteria formed the "ground truth." Specific details are not provided.

8. The sample size for the training set:

• Not applicable/Not provided. This is not an AI device that requires a training set.

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

• Not applicable. This is not an AI device.

In summary: The provided 510(k) summary is a regulatory document focused on demonstrating substantial equivalence to pre-existing devices, rather than a detailed scientific study report outlining specific performance criteria and test results. It confirms that "performance and safety testing" was conducted using "FDA recognized standards," but the specifics of those tests and their outcomes are not included in this document.

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The proposed luer access injection site and sets incorporating it will be used with a vascular access device for fluid administration and blood sampling. The luer access injection site can be connected to male luer adapters, (e.g., syringes or sets) to allow needleless access to the vascular path. This device is for use as part of a program to reduce needle-stick injuries and the associated transmission of blood borne pathogens.

The subject of this submission is a luer access injection site which will be marketed as a stand-alone device for use as a heparin lock and will also be incorporated into currently marketed solution sets. The proposed injection site consists of a pre-slit synthetic polyisoprene septum and a polyester housing.

This submission describes a medical device, a Luer Access Injection Site, and its equivalence to a predicate device. It is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence, not necessarily on detailing rigorous clinical studies with acceptance criteria in the same way a PMA (Premarket Approval) might.

Based on the provided text, here's a breakdown of the requested information, noting what is available and what is not available in this specific document:

Description of the Acceptance Criteria and Study to Prove Device Meets Criteria

The document reports that "Performance testing of the proposed luer access injection site has been conducted including microbiological evaluations. A description of the testing along with test results has been provided. All data indicate that the proposed device meets or exceeds all functional and microbiological requirements and thus support its suitability for use." However, the specific acceptance criteria and detailed study results are not provided in this summary. The submission focuses on substantial equivalence to a predicate device, the ICU Medical Inc. Clave™ Needleless Connector.

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The document states that testing was conducted and met requirements, but does not enumerate the specific criteria or the quantitative results against those criteria.

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

Not available in the provided text. The document mentions "performance testing" and "microbiological evaluations" were conducted, but does not specify sample sizes or the origin of the data. Given the nature of a 510(k) for a device like this, it's highly likely the testing was conducted in a laboratory setting, not with human subjects.

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

Not applicable/Not available for this type of device and submission. The testing described (functional and microbiological) would involve laboratory measurements and standards, not human expert interpretation of data or images.

4. Adjudication Method for the Test Set

Not applicable/Not available. As mentioned above, the testing for this type of device does not involve human expert adjudication in the context of clinical interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, not done or not reported. This type of study is relevant for diagnostic devices where human readers interpret data (e.g., medical images). The Luer Access Injection Site is a physical medical device for fluid administration and blood sampling, and its evaluation focuses on functional performance and microbiological integrity, not human interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance assessment was done. The document describes "performance testing" and "microbiological evaluations" conducted on the device itself. This refers to the device's inherent function, independent of a human operator's interpretative skills.

7. The Type of Ground Truth Used

For the performance testing, the "ground truth" would be established by validated laboratory methodologies and industry standards for functional performance (e.g., fluid flow, resealing efficacy, luer compatibility) and microbiological integrity (e.g., sterility, microbial ingress prevention). The document mentions "functional and microbiological requirements," implying a comparison against established benchmarks for these types of devices.

8. The Sample Size for the Training Set

Not applicable/Not available. This device is a physical medical component, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The design and manufacturing process would involve engineering specifications and quality control, but not a data-driven training set.

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

Not applicable/Not available. As there is no AI/ML training set, the concept of establishing ground truth for it does not apply.

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The Capless Luer Activated Valve, incorporating a luer activated valve, is intended for use in facilitating needleless fluid delivery and may be swabbed with antiseptic just prior to use, thereby eliminating the need for capping between uses.

The Capless Luer Activated Valve is a two-part device consisting of a Gland Housing Assembly and a Gland/Center Post Assembly, as described below:

The Gland is a valve/gasket which provides a seal against the syringe/luer connector when the device is being utilized. The Gland incorporates a slit to accept the syringe/luer connector. The Gland is also the swabbable surface of the Capless Luer Activated Valve. The valve can be easily swabbed per hospital protocol before each connection.

The Center Post mechanically supports the Gland and serves as the primary high pressure seal to keep the fluid path closed during the resting state.

The Gland and the Center Post are mechanically press-fit together to form the Gland/Center Post Assembly.

In the resting state, the Center Post is flush with the walls of the Gland Housing, ensuring that there is no fluid path. As the device is activated by a syringe/male luer connector, the flexible Gland is forced open and the Center Post is pushed down. As the Center Post is forced further down into the Gland Housing, the fluid path is established.

The provided text describes a 510(k) submission for a medical device, the "NP Medical Capless Luer Activated Valve." However, it does not contain the detailed information necessary to fully answer all aspects of your request, particularly regarding specific numerical acceptance criteria and the results of a study that quantifies device performance against those criteria. The submission states that performance requirements were met but does not provide the specific metrics or values.

Here's a breakdown of the available information based on your requested points:

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

The document mentions that mechanical, biocompatibility, and microbial challenge testing were performed and that the device "meets their performance requirements" or "passed all" tests. However, it does not specify the exact acceptance criteria or the quantitative results achieved. Without specific numerical values for acceptance criteria and device performance from the document, a table cannot be constructed with the requested level of detail.

Illustrative Table (Based on available qualitative information):

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 sample sizes used for any of the tests (Mechanical, Biocompatibility, Microbial Challenge). It also does not explicitly state the provenance of the data (country of origin, retrospective or prospective). Given that NP Medical, Inc. is located in Clinton, MA, and the submission is to the FDA, it is highly probable the testing was conducted in the USA by or for the manufacturer. The testing described (mechanical, biocompatibility, microbial challenge) is typically prospective and laboratory-based.

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

This information is not applicable and therefore not available in the provided document. The device is a physical medical device (a luer activated valve), not an AI or diagnostic imaging device that requires expert review for ground truth establishment. The performance is assessed through laboratory testing (mechanical, chemical, microbial) rather than interpretation by human experts.

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

This information is not applicable and therefore not available in the provided document. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human expert assessment where there might be disagreement in interpretations (e.g., in radiology studies). This submission describes laboratory-based engineering and biological tests for a physical device, not an interpretive process.

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 and therefore not available in the provided document. An MRMC study is relevant for evaluating diagnostic tools, often AI-powered, where human readers interpret patient cases. The Capless Luer Activated Valve is a physical device for fluid delivery, not a diagnostic tool, and involves no "human readers" in its intended function or performance testing described.

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

This information is not applicable and therefore not available in the provided document. "Standalone performance" in this context usually refers to the performance of an AI algorithm alone. The NP Medical Capless Luer Activated Valve is a physical medical device, not an algorithm. Its performance is inherent in its physical and material properties.

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

For the mechanical testing, the "ground truth" would be defined by engineering specifications and established test methods (e.g., pressure resistance, flow rates, number of activation cycles without failure). For biocompatibility, the "ground truth" is determined by standardized biological assays according to ISO 10993. For microbial challenge testing, the "ground truth" is the absence of microbial growth in the fluid pathway after being subjected to a known microbial load, following established microbiological testing protocols.

8. The sample size for the training set

This information is not applicable and therefore not available in the provided document. "Training set" refers to data used to train machine learning models. As this is a physical medical device, there is no "training set" in the context of AI. The device's design and manufacturing rely on engineering principles and material science, not machine learning.

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

This information is not applicable and therefore not available in the provided document. As there is no AI training set for this physical device, there is no ground truth to be established for it.

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The Douglas Medical Products Maxcess Needlefree Connector is intended to be used as a needleless injection port that can be attached to a Luer Lock connector. It is intended for single patient use and can be swabbed and then accessed multiple times within the limits of CDC guidelines and or institutional guidelines. The closure system has been found to maintain line patency throughout the labeled duration of use.

The Douglas Medical Products Maxcess Needlefree Connector is a one piece design, Luer interfacing injection port. It is sterile, non-pyrogenic and packaged in a tyvek\polyethylene form, fill, and seal package. The materials used to manufacture the Douglas Medical Products Maxcess Needlefree Connector have been tested per tripartite guidelines and are safe for their intended use. The Douglas Medical Products Maxcess Connector utilizes similar and equivalent designs, and materials, as currently legally marketed products.

This document is a 510(k) summary for a medical device (Maxcess Needlefree Connector). It is a pre-market notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of regulatory submission does not typically include a study with acceptance criteria and device performance as would be expected for an AI/ML medical device.

Therefore, I cannot extract the requested information from the provided text because it describes a traditional hardware medical device and not a software/AI medical device. The information requested (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is specific to the development and validation of AI/ML algorithms, which are not relevant to this type of device submission.

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