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

The Busse Epidural Catheter is a single use device, which is sold as sterile individually packaged and sterile packaged inside a kit/procedure tray. The Catheter will also be sold as a non-sterile product to kit packers, who then may sterilize the catheter as part of a kit.

The provided document is a 510(k) summary for the Busse Epidural Catheter, which primarily focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about a study with acceptance criteria for device performance in the way a clinical trial or algorithm performance study would. Instead, it details biocompatibility testing for the materials used in the catheter.

Here's an breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "These materials have met the testing requirements and were found to be acceptable for the intended use" for all listed tests, implying that meeting the standard for each test constitutes the acceptance criteria.

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

This document describes biocompatibility testing of materials, not a test set of data for an AI/algorithm. Therefore, concepts like sample size for a test set, and data provenance (country of origin, retrospective/prospective) are not applicable in this context. The tests listed are laboratory-based assessments of material interaction with biological systems.

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

Not Applicable. Ground truth, in the context of expert review, is not relevant for the biocompatibility tests described. These tests have established scientific methods and pass/fail criteria.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods are typically used when there's subjective interpretation, like in a clinical image review. Biocompatibility tests have objective results.

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

No, an MRMC study was not done. This document is for a physical medical device (epidural catheter), not an AI/algorithm where human reader performance would be evaluated.

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

No, this is not an AI/algorithm device, so standalone performance is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for the biocompatibility tests is the established scientific methodology and criteria for each specific test (e.g., cell viability in L929, skin reaction scores in Kligman, hemolytic index in rabbit blood). Pathology would be relevant if the study involved tissue analysis from implantation, which is part of the Intramuscular Implantation Test. Outcomes data is not mentioned in these specific tests.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/algorithm, so there is no training set.

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

Not Applicable. As there's no training set, this question is not relevant.

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