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The A6 Luer Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector. The A6 Luer Access Device may be used with power injectors at a maximum pressure of 300 psi and a maximum flow rate of 10 mL/sec.

B. Braun's A6 Luer Access Device is a positive displacement valve intended to provide needle-free access to IV gravity sets, pump sets and extension sets for the administration of IV fluids and blood. The piston/valve assembly of the A6 is a 3-piece assembly containing an elastomeric piston with a pre-slit septum, which is housed within a clear, rigid body. The A6 requires swabbing to disinfect prior to insertion of a male Luer connector. The A6 Luer Access Device may be used with power injectors at a maximum pressure of 300 psi and a maximum flow rate of 10 mL/sec. The A6 is individually packaged and is supplied as a sterile, non-pyrogenie, single use, disposable device.

The provided document, K083723, is a 510(k) Pre-Market Notification for the B. Braun Medical Inc. A6 Luer Access Device. It describes the device, its intended use, and claims substantial equivalence to a predicate device. This document is a regulatory submission for a medical device and does not contain a study that proves the device meets specific acceptance criteria in the way that an AI algorithm's performance would be evaluated.

Instead, the submission demonstrates substantial equivalence through a variety of tests. For a device like the A6 Luer Access Device (a physical medical device, not an AI algorithm), "acceptance criteria" are typically defined by recognized standards and internal company specifications for product performance, safety, and effectiveness. The "study" refers to the battery of tests conducted to ensure these criteria are met and to prove substantial equivalence to a predicate device.

Given this context, I will interpret your request to describe the tests conducted and their outcomes as they relate to the "acceptance criteria" for this physical device. Many of your specific points (e.g., sample sizes for test sets in AI, ground truth establishment, expert qualifications, MRMC studies) are not applicable to the type of device and regulatory submission presented in the text.

Here's an interpretation based on the provided text for the A6 Luer Access Device:

Description of Acceptance Criteria and Substantiating "Study" for the A6 Luer Access Device

Since the A6 Luer Access Device is a physical medical device and not an AI algorithm, the concept of "acceptance criteria" and "study" differs from an AI performance evaluation. The submission demonstrates substantial equivalence to a predicate device by meeting various performance, safety, and effectiveness standards through a series of tests.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table with specific numerical acceptance criteria. Instead, it states that the device was subjected to various tests to demonstrate substantial equivalence and verify safe and effective use. The "reported device performance" generally means that the device successfully passed these tests, indicating it met the implicit or explicit performance criteria for each test according to relevant standards or internal specifications.

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

The document does not specify the exact sample sizes (e.g., number of units tested) for each individual test. For a physical device, testing typically involves a statistically relevant number of units to ensure reliability. The data provenance is internal to B. Braun Medical Inc. and is generated through prospective testing conducted by the company or its contractors. No information on country of origin for data is provided, but it's implied to be U.S. based on the applicant's location.

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

This concept is not applicable here. "Ground truth" for physical device testing is established through standardized test methods, calibrated equipment, and objective measurements (e.g., pressure gauges, flow meters, bacterial culture results). Expert opinion might be involved in designing the test protocols or interpreting complex results, but it's not "ground truth" in the AI sense.

4. Adjudication Method for the Test Set

This concept is not applicable here. Performance is determined by objective measurements against predefined pass/fail criteria for each test, not by human adjudication of qualitative results.

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

No, an MRMC study was not done. This type of study is relevant to imaging diagnostics or AI algorithms where human readers interpret cases. For a luer access device, comparative effectiveness is shown by demonstrating equivalent functional performance and safety as a predicate device through engineering and biological testing.

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

This concept is not applicable as the A6 Luer Access Device is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests conducted on the A6 Luer Access Device is established through:

• Standardized Test Methods: Adherence to recognized industry standards (e.g., ISO, ASTM) for medical device performance and safety testing.
• Objective Measurements: Using calibrated instruments to measure parameters like pressure, flow rate, and sterility.
• Biological Endpoints: For biocompatibility and microbial ingress, "ground truth" is determined by established biological safety criteria and microbiological methods.

8. The Sample Size for the Training Set

This concept is not applicable. There is no "training set" for a physical medical device in the context of an AI algorithm. The device is designed, manufactured, and then tested to ensure it meets specifications.

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

This concept is not applicable as there is no training set. The design specifications and performance requirements for the device are driven by medical necessity, regulatory standards, and the performance characteristics of predicate devices.

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