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The Epimed Feth-R-Kath epidural catheter is intended for administration of local anesthetics into the epidural space to provide continuous epidural or caudal anesthesia for up to 72 hours.

The Epimed Feth-R-Kath epidural catheter is a Class II device that is substantially equivalent to the Arrow International Flex Tip Plus® epidural catheter in design, composition, performance characteristics and intended use. Both devices incorporate a Fluoropolymer tube encompassing a stainless steel spring. The Arrow Flex Tip Plus® is a 19G catheter 36 inches in length. The Feth-R-Kath will be offered in both a 19G and 20G size each with a length of 36 inches. The Flex Tip Plus® has a .019 inch inner diameter while the Feth-R-Kath has a .021 inch inner diameter. Both catheters are sold as sterile, single-use devices. Both catheters are radiopaque and designed to administer continuous epidural and/or caudal anesthesia.

The provided text describes a 510(k) premarket notification for the Feth-R-Kath Epidural Catheter, focusing on its substantial equivalence to a predicate device. The information primarily comes from regulatory approval documents and thus lacks details on a traditional clinical study with specific acceptance criteria and detailed performance reporting.

However, based on the provided text, I can infer and summarize the information related to the device's acceptance criteria and the "study" (bench testing in this case) that supports it.

Here's a breakdown of the requested information:

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

The acceptance criteria are implicitly defined as meeting or exceeding the performance characteristics of the predicate device, the Arrow International Flex Tip Plus® epidural catheter, and other epidural catheters currently on the market.

2. Sample sizes used for the test set and the data provenance

The document refers to "bench testing" but does not specify the exact sample size for the test set for each performance characteristic (tensile strength, percent elongation, flow rate, kink resistance). It mentions that "the catheters were tested," implying a sufficient number for comparison, but no specific N is given.

• Sample size for test set: Not explicitly stated (implied to be sufficient for bench testing comparisons).
• Data provenance: Bench testing results, likely conducted internally by Epimed International, Inc. The document does not specify the country of origin of the data beyond the company's location (Gloversville, NY, USA). It is retrospective in the sense that the testing was completed prior to the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable to this type of device and study. Bench testing for physical performance characteristics of a medical device does not typically involve human experts establishing "ground truth" in the way it would for diagnostic imaging or clinical outcomes. The "ground truth" for these tests would be derived from calibrated measurement equipment and established engineering standards.

4. Adjudication method for the test set

This is not applicable as the "test set" involves physical measurements and comparisons, not subjective interpretations requiring adjudication.

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

This is not applicable. The device is an epidural catheter, not an AI-powered diagnostic tool. No MRMC study was performed.

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

This is not applicable. The device is a physical medical instrument, not an algorithm.

7. The type of ground truth used

For the performance characteristics (tensile strength, percent elongation, flow rate, kink resistance), the "ground truth" was established by objective measurements using engineering principles and industry standards, compared against the performance of a predicate device and other market-available catheters. For biocompatibility, standard biocompatibility testing protocols were used.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of this device's bench testing and 510(k) submission. This concept applies to machine learning algorithms.

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

This is not applicable for the reasons stated in point 8.

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