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Pressure Rated: The MaxZero nulti fuse extension set with needleless connector(s) is for single use only. The extension set may be used for direct injection, intermittent infusion or aspiration. This set may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10mL per second.

Non Pressure Rated: The MaxZero multi fise extension set with needleless connector(s) is for single use only. The extension set may be used for direct injection, intermittent infusion, continuous infusion or aspiration.

The CareFusion MaxZero Extension Sets with Needleless Connector are intravascular extension sets intended for single patient use, including pediatrics and immunocompromised patients, for direct injection, intermittent infusion continuous infusion or aspiration of drugs, blood and fluids. All MaxZero Extension Sets with Needleless Connector include the previously cleared zero reflux MZ1000 Needleless Connector (K132413) bonded to the extension set tubing. The MZ1000 needleless connector allows thorough and easy disinfection due to a solid, flat smooth surface and eliminates the risk of needlestick injuries. The MaxZero Extension Sets with Needleless Connectors are sterile single patient devices that can be used for seven (7) days and 200 activations. All extension sets included in this submission are not made from natural rubber latex or DEHP.

This is a 510(k) premarket notification for a medical device, not a study evaluating an AI algorithm. Therefore, the questions related to AI/algorithm performance, ground truth, expert adjudication, and sample sizes for training/test sets are not applicable.

The document describes the CareFusion MaxZero Extension Sets with Needleless Connector and aims to demonstrate its substantial equivalence to previously marketed predicate devices. The "acceptance criteria" here refer to the performance standards and tests that the new device must meet to prove its safety and effectiveness, similar to the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "All test results met their acceptance criteria and support that the MaxZero Extension Sets with Needleless Connector are appropriately designed for their intended use." However, specific quantitative acceptance criteria or detailed reported performance values for each test are not provided in this summary. The summary only lists the types of tests performed.

The document states that a "complete list of functional/performance testing protocols and reports are included in Section 18 of this submission," which is not provided here.

2. Sample size used for the test set and the data provenance:
Not applicable for this type of device submission. This is a medical device, not an AI or data-driven software. The "test set" here refers to physical devices undergoing various laboratory and performance tests. The sample sizes for these physical product tests are not specified in this summary. Data provenance is also not relevant in the context of device testing as described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is not an AI algorithm study or a study requiring expert consensus for ground truth. The "ground truth" for this device would be established by objective physical and chemical testing against predetermined performance standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. There is no human interpretation or adjudication described for the device performance tests.

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 a medical device, not an AI system being evaluated with human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance is established by standardized laboratory testing protocols, national/international standards (e.g., ISO), and engineering specifications designed to ensure the device's safety and effectiveness (e.g., microbial barrier effectiveness, material biocompatibility, pressure ratings).

8. The sample size for the training set:
Not applicable. This is a medical device, not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established:
Not applicable. This is a medical device, not an AI algorithm requiring a training set with ground truth.

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The Drug Access Spike is a device used to aspirate solutions/medications from a drug container (drug vial/bag). The Drug Access Spike may incorporate componentry that aid in the prevention of accidental needle sticks.

The Drug Access Spike is a plastic conduit that is a means to access drug containers. The device is center on top of the stopper of a drug container. The Drug Access Spike is pushed through the rubber stopper and locks into position. A syringe is attached to the Drug Access Spike in order to draw from the drug container. After detaching the syringe, solution/medications are dispensed into a needleless injection site. The use of a Drug Access Spike eliminates the need for a conventional needle.

On multi-dose containers, a needleless injection site is bonded to the Drug Access Spike. This allows the drug container to be accessed multiple times while maintaining a physical barrier to prevent microbial ingress.

The needleless injection port incorporated into some of the configurations of the Drug Access Spike is the NAC " Needleless Access Connector. The NAC " Needleless Access Connector was previously cleared under SE-K011193 and SE-K992268.

Here's a breakdown of the acceptance criteria and study information for the Medegen Medical Manufacturing Services Drug Access Spike, based on the provided 510(k) summary:

This device (Drug Access Spike) is a relatively simple medical accessory, and as such, the "acceptance criteria" and "study" are not presented in the same highly quantitative, performance-metric-driven way you might see for a diagnostic AI device. Instead, the submission focuses on substantial equivalence to legally marketed predicate devices, and the "proof" is demonstrating that the new device shares the same intended use and technological characteristics, and raises no new questions of safety or effectiveness.

Therefore, for aspects related to "device performance" in the context of an AI-driven system, the information is largely absent or inferred, as it's not a diagnostic or decision-support tool.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this device (a drug access spike), the acceptance criteria are not in the form of specific performance metrics like sensitivity, specificity, or AUC, as would be common for AI-based diagnostic devices. Instead, they revolve around safety, functionality, and equivalence to existing devices.

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

• Sample Size for Test Set: Not applicable. This device is a physical medical accessory, not an AI model that processes data or images. Performance is demonstrated through compliance with standards (biocompatibility) and functional description/comparison to predicates, rather than a data-driven "test set."
• Data Provenance: Not applicable for an AI test set. The "provenance" here relates to the predicate devices themselves, which are legally marketed in the US.

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

• Number of Experts & Qualifications: Not applicable. The "ground truth" for this device's safety and effectiveness is established by its compliance with recognized standards (ISO 10993), functional design, and comparison to existing, cleared devices. It does not involve expert review of data/images to establish a diagnostic ground truth.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no diagnostic test set requiring adjudication in this context.

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

• MRMC Study: No. This is not an imaging or diagnostic device that involves human readers interpreting cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: Not applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this device's approval is based on:
  • Regulatory Standards Compliance: Demonstrated adherence to ISO 10993 for biocompatibility.
  • Functional Equivalence: The described mechanism of action and intended use are directly comparable to those of the predicate devices.
  • Predicate Device History: The predicate devices themselves have an established history of safety and effectiveness on the market.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not an AI model with a training set.

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

• Ground Truth for Training Set: Not applicable. This is not an AI model.

Summary of the "Study" (Rationale for Acceptance):

The "study" or basis for acceptance described in this 510(k) is a substantial equivalence demonstration. This process involves:

• Identification of Predicate Devices: Three equivalent devices (from ICU Medical and Baxter Healthcare Corp) with established 510(k) clearances were identified.
• Comparison of Intended Use: The applicant demonstrated that the Drug Access Spike shares the same intended use as the predicate devices.
• Comparison of Technological Characteristics: The applicant detailed the physical design and function of the device, showing it operates similarly to the predicates. Specific mention of the previously cleared NAC component further supports this.
• Biocompatibility Testing: The device's materials were tested to meet the ISO 10993 standard for biocompatibility, addressing a key safety aspect.
• Conclusion of No New Questions of Safety or Effectiveness: By successfully demonstrating the above, the FDA concluded that the device is substantially equivalent to the predicates and raises no new questions of safety or effectiveness.

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IV/Catheter Extension Set with NAC Plus Needleless Access Connector is intended to administer drugs and solutions into a patient's vascular system. The NAC Plus (integral or stand-alone) allows the user to administer or withdraw solutions. The NAC Plus Needleless Access Connector, available as a stand-alone accessory or as part of the IV/Catheter Extension set, may aid in the prevention of needlestick injury.

The IV/Catheter Extension Set with NAC Plus Luer Access Connector constitutes a set for continuous and intermittent fluid delivery into the vascular system. The extension set has luer locks, tubing, slide clamps, tip protectors, and NAC Plus Luer Access Connectors.

The NAC Plus Needleless Access Connector is a Luer activated device cleared under K011193 (Medegen) April 10, 2001. This component is purchased bulk, non-sterile and is packaged by Baxter as both a stand-alone accessory device and as a component integral to IV/Catheter sets. The devices are subsequently packaged, gamma irradiated and distributed to the end user in a cardboard carton.

The provided text is a 510(k) summary for a medical device (IV/Catheter Extension Set with NAC Plus Needleless Access Connector and NAC Plus Needleless Access Connector). It outlines the device description, intended use, and comparison to predicate devices, along with some nonclinical testing information.

However, the document does not contain the specific information required to answer your detailed questions about acceptance criteria and a study proving those criteria are met. The 510(k) summary is a regulatory document focused on demonstrating substantial equivalence to a predicate device, not typically a detailed report of individual performance studies and their specific acceptance criteria.

Here's a breakdown of why I cannot provide the requested information from the given text:

1. A table of acceptance criteria and the reported device performance: The document states, "The results indicate that the proposed device meets or exceeds all functional requirements," but it does not list the specific functional requirements (acceptance criteria) or quantify the reported device performance against those criteria in a table or any other format.
2. Sample size used for the test set and the data provenance: This information is not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
4. Adjudication method: This information is not present.
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 device is a physical medical device (IV/catheter extension set), not an AI-powered diagnostic or interpretive system. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: As a physical device, this concept does not apply.
7. The type of ground truth used: This information is not present.
8. The sample size for the training set: As a physical device, this concept does not apply.
9. How the ground truth for the training set was established: As a physical device, this concept does not apply.

What the document does state regarding testing:

• Nonclinical Tests:
  • Biological and chemical reactivity of materials assessed using ISO Standard 10993-1 and USP physicochemical tests. "The material was found to be acceptable for its intended use."
  • "Results regarding the functional performance of the proposed NAC Plus have been submitted."
  • "The results indicate that the proposed device meets or exceeds all functional requirements."

In summary: The provided 510(k) summary affirms that nonclinical tests were conducted and that the device met functional requirements and material biocompatibility standards. However, it does not detail the specific acceptance criteria, test methodologies, sample sizes, or the quantitative results of those tests. These granular details would typically be found in the full test reports submitted to the FDA, not necessarily in the publicly available 510(k) summary.

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