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The B. Braun Regional Anesthesia Catheter is a device intended to provide, via percutaneous administration, continuous and/or intermittent infusion of local anesthetics and analgesics in the epidural space or near a nerve for regional anesthesia and pain management during the pre- operative, perioperative and postoperative periods associated with general and orthopedic surgery as well as labor and delivery. Routes of administration include epidural and perineural (peripheral nerve block).

The B. Braun Regional Anesthesia Catheter is a co- extruded anesthesia conduction catheter consisting of an inner layer of polyamide and an outer layer of polyurethane. The catheter will range in length from 400 – 1010 millimeters and will be available in both 19 and 20 Ga. diameters. The catheter will be available in an open tip configuration as well as a closed tip configuration. The closed tip catheters will have a rounded closed tip with six side ports for distribution of anesthetics and analgesics. The catheter will also have depth markings beginning within 50.5 millimeters from the tip of the catheter and ending at approximately 250 millimeters from the tip.

The provided text is a 510(k) summary for a medical device, the B. Braun Regional Anesthesia Catheter. It describes the device, its intended use, and its substantial equivalence to predicate devices based on performance and functionality testing. However, it does not detail specific acceptance criteria or the study data in the format requested.

The document states that "The effect of these material and side port differences was evaluated by performance and functionality testing. The result of this testing does not raise any new issues of safety and effectiveness." This indicates that tests were performed to demonstrate that the new catheter performs comparably or acceptably, but the specifics of these tests (e.g., precise acceptance criteria, study sizes, ground truth, etc.) are not publicly available in this summary.

Therefore, many of the requested details cannot be extracted directly from this document.

Here's what can be gathered and what cannot:

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

The document broadly states that "performance and functionality testing" was conducted and "The result of this testing does not raise any new issues of safety and effectiveness." This implies that the device met the acceptance criteria established for safety and effectiveness, likely by demonstrating equivalence to the predicate devices in various performance aspects. However, the specific quantitative acceptance criteria (e.g., tensile strength minimum, flow rate range, radiopacity level) and measured performance values are not provided in this summary.

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

This information is not available in the provided text.

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 information is not available in the provided text. The testing appears to be primarily engineering/functionality testing rather than clinical studies requiring expert ground truth in the typical sense of diagnostic accuracy.

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

This information is not available in the provided text.

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

An MRMC study is not applicable here. This is a medical device (catheter) clearance based on substantial equivalence, not an AI diagnostic algorithm.

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

This is not applicable as it's not an AI algorithm.

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

Given the nature of the device (catheter), the "ground truth" for performance testing would likely involve engineering specifications, material properties, and functional benchmarks (e.g., flow rates, burst pressure, radiopacity, lubricity, mechanical strength), rather than clinical outcomes or expert consensus on diagnostic images. However, the specifics are not detailed. It's established by demonstrating "substantial equivalence" to predicate devices, implying these predicate devices are already considered safe and effective.

8. The sample size for the training set

This is not applicable as this is not an AI algorithm.

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

This is not applicable as this is not an AI algorithm.

Summary of available information related to the "study" for acceptance:

• Study Type: Performance and functionality testing to demonstrate substantial equivalence.
• Purpose: To evaluate the effect of material and side port differences compared to predicate devices and confirm that these differences do not raise new issues of safety and effectiveness.
• Predicate Devices:
  • Csen Ltd, Combined End-Multiple Lateral Hole Epidural Catheter, K951927
  • B. Braun Medical Inc., B. Braun Nerve Block Catheter, K030380
• Key Differences Evaluated:
  • Co-extruded material (polyamide and polyurethane)
  • Radiopaque stripes (three barium sulfate vs. one tungsten)
  • Number of side ports (six vs. seven or three on predicate devices)
• Outcome: "The result of this testing does not raise any new issues of safety and effectiveness." This implies the device met the unstated acceptance criteria for performance and safety.

In essence, the document serves as a regulatory summary indicating that testing was performed and the results were satisfactory for clearance, but it does not provide the granular details of those tests requested in the prompt.

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