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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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For use with the System 100. The System 100 is indicated for temporary (up to eight hours) ultrafiltration treatment of patients with fluid overload.

The UF500 blood circuit with needleless access port allows for aspiration, injection, or gravity flow of fluids using a male luer fitting.

The modified/alternate UF500 circuit incorporates an in-line needleless valve on the circuit withdrawal, infusion or both tubing lines. The in-line needless valve is independently commercially available medical device cleared for commercial distribution since May 15, 1996 (K955585) known as the ULTRASITE® valve. This is a luer activated valve manufactured and distributed by B. Braun Medical. CHF Solutions, Inc. is placing this valve at the end of a short piece of tubing (extension arm) that is permanently joined to the A1500 circuit of the System 100 (K013733) with a tee connector. A sliding clamp is also included on the extension arm and is blue on the withdrawal side and white on the infusion side. The in-line needleless access port allows the health care provided access to the circuit/vasculature without disconnecting the catheter connections or catheter extension (when used) for aspiration, injection, or gravity flow of fluids.

The provided text describes a 510(k) summary for a medical device called "System 100 Modified/Alternate UF500 With In-line Needleless Access Port." However, the document does not contain specific acceptance criteria or a study that rigorously proves the device meets such criteria in a quantitative sense as typically seen in AI/software medical device submissions.

This submission is for a modification of an existing device (UF500 circuit) by adding a commercially available, already cleared, in-line needleless access port. The "study" here is primarily a demonstration of substantial equivalence through bench testing, rather than a clinical trial or performance study with defined statistically-derived acceptance criteria.

Therefore, many of the requested fields cannot be directly extracted from the provided text because they are not applicable to the type of submission described.

Here's an analysis of what information is available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: The document implies that the acceptance criteria are met if the modified device remains compatible with the System 100, is sterile, nonpyrogenic, and satisfies the intended use without introducing new safety concerns compared to the predicate devices. The phrase "Bench tests demonstrate the modified/alternative UF500 is remains compatible with the System 100" serves as the primary "acceptance."

Reported Device Performance:

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

• Sample Size: Not specified. The study involved "bench tests," which are typically laboratory tests of the device itself rather than tests on human subjects or clinical data. The quantity of devices tested is not mentioned.
• Data Provenance: The "bench tests" are presumably conducted by the manufacturer, CHF Solutions, Inc., in the United States. They are retrospective in the sense that they were conducted on the modified device before submission.

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

• Not applicable. This is a hardware modification submission, not an AI/software device requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

• Not applicable. This type of submission does not involve adjudication of clinical data or expert opinions. The evaluation is based on engineering and performance specifications.

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

• No. This is not an AI or software device, and no MRMC study was performed.

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

• Not applicable. This is a physical medical device (circuit with a port), not an algorithm.

7. The Type of Ground Truth Used

• Not applicable in the typical sense for AI/software devices. The "ground truth" here is adherence to engineering specifications for compatibility, sterility, non-pyrogenicity, and mechanical integrity, as demonstrated through bench testing and comparison to predicate device characteristics.

8. The Sample Size for the Training Set

• Not applicable. No training set is mentioned or relevant for this type of device modification.

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

• Not applicable. No training set is mentioned or relevant for this type of device modification.

Summary of the Study (as described in the document):

The study was a series of bench tests conducted by CHF Solutions, Inc. to demonstrate the safety and effectiveness of the modified UF500 circuit. The core of the study aimed to show that integrating an existing, cleared needleless access port into the UF500 circuit did not negatively impact the performance, safety, and compatibility with the System 100. Key aspects verified were:

• Materials, Packaging, and Sterilization: These were confirmed to be identical to the predicate System 100 circuit, leveraging the existing clearance for these aspects.
• Sterility and Nonpyrogenicity: The final modified product was confirmed to be sterile and nonpyrogenic.
• Compatibility: Bench tests specifically demonstrated that the modified/alternative UF500 circuit remains compatible with the System 100, which is crucial as the needleless port is an add-on.

The overall conclusion was that, based on these bench tests and the technological characteristics, the modified device is "safe and effective for its intended use" and "substantially equivalent" to the predicate devices.

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