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The epidural catheter is intended for administration of local anesthetics into epidural space. Busse recommends the removal and/or replacement of the catheter every 72 hours.

The Epidural Catheter kit consists of clear tubing with a black radiopaque stripe, a Thread assist guide, a Connector Gasket, and a Tuohy Borst adapter catheter connection. All inserted in a Polvethylene bag. The catheter is marked at 5 cm from the tip with 1 cm increments up to 20 cm. The 10 cm mark is indicated by two marks, the 15 cm by three marks, and the 20 cm by four marks. The Catheter will be available 20 Gauge, with a nominal length of 36 inches. It will be available in open tip or closed tip with 3 eyes. As an extra safety feature, the tip of the catheter is incorporated with a marking to assure the completed catheter has been removed.

The provided text describes a 510(k) premarket notification for a medical device, the Busse Epidural Catheter Kit. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a clinical trial or a deep learning algorithm's performance study.

Therefore, the information typically requested in your prompt (e.g., acceptance criteria tables, sample sizes for test sets, expert-driven ground truth, MRMC studies, standalone algorithm performance) is not applicable or present in this 510(k) summary.

Here's why and what information is available:

• 510(k) Submissions are about Substantial Equivalence: The primary goal of a 510(k) is to show that a new device is as safe and effective as a legally marketed predicate device, not necessarily to prove it meets a set of predefined performance "acceptance criteria" in the way a novel AI algorithm might.
• Focus on Bench Testing and Biocompatibility: The "study" here consists of bench tests and biocompatibility evaluations, demonstrating that the device materials and physical performance are acceptable and comparable to the predicate.

Information provided in the text that is relevant to your request (though not directly "acceptance criteria" for an AI or clinical study):

1. A table of acceptance criteria and the 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)

• Sample Size: Not specified for the bench tests or biocompatibility tests. These are typically laboratory tests on manufactured units or material samples, not patient data.
• Data Provenance: Not applicable in the sense of patient data. The "data" comes from laboratory testing of the device materials and components.

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: "Ground truth" in the context of expert consensus on medical images or clinical outcomes is not relevant for this type of device submission. The "truth" is established by adherence to recognized testing standards for material biocompatibility and physical performance characteristics.

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

• Not Applicable: Adjudication methods are for resolving discrepancies in expert interpretations, which is not part of this submission. The tests performed have clear pass/fail criteria based on established laboratory protocols.

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, not done: This is a submission for a physical medical device (an epidural catheter kit), not an AI-powered diagnostic tool. MRMC studies are not relevant here.

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

• No, not done: This is a physical device, not an algorithm.

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

• Laboratory Standard Compliance: The "ground truth" or "reference standard" for this submission is compliance with established biocompatibility testing standards (e.g., ISO 10993 series, though not explicitly stated that exact standard, it's implied for such tests) and engineering performance specifications for devices of this type.

8. The sample size for the training set

• Not Applicable: There is no "training set" as this is not an AI/machine learning device.

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

• Not Applicable: There is no "training set."

Summary of the "Study" mentioned:

The "study" referenced in the 510(k) summary is a series of laboratory-based biocompatibility tests and performance tests conducted on the Busse Epidural Catheter and its materials. The purpose of these tests was to demonstrate that the device materials are safe for patient contact and that the device performs functionally as expected, showing substantial equivalence to the predicate device. The document explicitly states: "All materials used in the fabrication of the epidural catheter were evaluated through biological qualification safety tests" and "These materials have met the testing requirements and were found to be acceptable for the intended use."

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