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The Medline Epidural Catheter is indicated for the injection of local anesthetics into the epidural space for patients over 22 lbs. (10kgs.), for a duration of use of up to 72 hours.

The Medline Epidural Catheter is a single use device made of flexible, nylon tubing which is sold as sterile individually packaged and sterile packaged inside a kit/procedure tray. The epidural catheter is designed as a closed tip device with 3 eyes for distribution of anesthetic agents. The catheters have a black radiopaque stripe. The catheter is available in 19G and is 800 millimeters long. The catheter has a marked tip, with 1cm increments up to 25cm. The 10cm mark is indicated by two marks, 15cm by three marks, 20cm by four marks and 25cm by five marks. As an added safety feature, the solid wide warning mark indicates exit of catheter from needle when using a Medline Epidural Needle. This device is intended to be used in conjunction with an epidural catheter connector cleared under K051171.

The provided text describes the 510(k) premarket notification for the Medline Epidural Catheter, seeking to demonstrate its substantial equivalence to a predicate device. This document does not pertain to an AI/ML device, and therefore, many of the requested criteria related to AI/ML device evaluation are not applicable.

Here's an analysis based on the provided text, focusing on the available information:

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

The document does not explicitly present "acceptance criteria" in the typical sense for an AI/ML device where specific metrics like sensitivity, specificity, or AUC are outlined. Instead, it relies on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. The "acceptance criteria" here are implicitly that the device performs comparably to the predicate or within established safety and performance standards for its type, as indicated by the "Pass" results for each test.

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

The document provides a summary of non-clinical testing. It does not specify sample sizes for each test listed. The tests are laboratory-based and material-based, not involving patient data or clinical samples in the way an AI/ML device would. Data provenance is not applicable in the context of clinical populations for these types of tests.

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

Not applicable. This is a non-clinical evaluation of a physical medical device. Ground truth is established by standardized laboratory methods and measurements, not by expert interpretation of data.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in interpreting images or clinical cases, which is not relevant to the non-clinical testing of this device.

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

Not applicable. This device is not an AI-assisted diagnostic or therapeutic tool. No human reader studies (MRMC) were performed.

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

Not applicable. This is not an algorithm.

7. The type of ground truth used

The ground truth for the non-clinical tests is based on established scientific and engineering standards and measurements (e.g., ISO, ASTM, USP standards) for material properties (cytotoxicity, dermal irritation, etc.), physical performance (flow rate, tensile strength), and safety (pyrogenicity, extractables).

8. The sample size for the training set

Not applicable. This device does not involve training data as it is not an AI/ML model.

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

Not applicable. This device does not involve training data.

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The Spirol® Block Continuous Peripheral Nerve Block Catheter permits placement of catheters next to nerve plexuses for continuous nerve block anesthesia or analgesia techniques including upper extremity, lower extremity, abdominal and paravertebral locations for periods not exceeding 72 hours.

Epimed's Spirol® Block Continuous Peripheral Nerve Block Catheter has the following characteristics:

• · 19 Ga. & 20 Ga., 14" to 24" in length.
• · Offered in open and closed end distal tip configurations.
• · Offered in styletted and non-styletted versions.
• · Internal radiopaque, echogenic coiled reinforced wire to allow visibility under fluoroscopy and/or ultrasound.
• · Catheters to be provided in sterile kit/set style configurations or as a standalone replacement catheter.

The catheter is a single-use, disposable device consisting of a polymer coated stainless steel spring. The catheter is available in various lengths, as well as open-ended or closed-ended configurations; the closed-ended models having three eyes (injection ports) at the distal end. The Spirol® Block is also available in styletted or non-styletted versions, as well as 19 Ga. or 20 Ga. models.

The provided document is a 510(k) summary for a medical device called the "Spirol® Block Continuous Peripheral Nerve Block Catheter." This type of document focuses on demonstrating substantial equivalence to existing predicate devices rather than proving a device meets specific acceptance criteria through a comparative effectiveness study or standalone performance.

As such, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not directly applicable to this document because it describes a different type of device approval process.

Here's why and what information can be extracted:

• No Acceptance Criteria or Performance Metrics: The 510(k) process for this type of device does not typically involve defining specific numerical "acceptance criteria" and then demonstrating the device "meets" them in the way clinical trials for new drugs or AI algorithms might. Instead, the focus is on showing the new device functions similarly and is as safe and effective as a legally marketed predicate device.
• No "Study" as such for comparative efficacy: There isn't a "study that proves the device meets acceptance criteria" in the sense of a clinical trial or a performance study with human readers improvement. The "study" here refers to non-clinical testing to confirm technological characteristics and biocompatibility.
• No AI Component: This device is a physical catheter, not an AI or algorithm-based device. Therefore, questions related to AI-specific metrics (standalone performance, MRMC studies, human reader improvement with AI) are not relevant.

However, I can extract information about the non-clinical testing performed and the basis for substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified for any of the non-clinical tests. Medical device bench testing often uses small, representative samples, but specific numbers are not provided in this summary.
• Data Provenance: The tests were performed internally by Epimed International, Inc. or by external labs for specific ISO 10993 testing. No country of origin for data is specified beyond the company's location in the USA. All testing described is pre-clinical/bench testing, not human clinical data.

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

• This is not applicable. "Ground truth" in the context of expert consensus is typically for diagnostic interpretation tasks (e.g., radiology). For a physical medical device, "ground truth" refers to established engineering specifications, material standards (e.g., ISO 10993), and regulatory requirements. These were assessed through the non-clinical testing listed. While engineers and quality assurance personnel ("experts") would design and oversee these tests, their number and specific qualifications for "establishing ground truth" are not detailed.

4. Adjudication method for the test set:

• Not applicable. This concept applies to expert review of clinical cases. The tests described are objective, physical, and chemical tests against defined standards.

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:

• Not applicable. This device is a physical catheter, not an AI or imaging interpretation device, and no human reader studies were performed.

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

• Not applicable. This device is a physical catheter, not an algorithm.

7. The type of ground truth used:

• For technological characteristics and functional performance: Engineering specifications, design inputs, and established performance of the predicate devices.
• For biocompatibility: ISO 10993 series of standards.
• For non-clinical testing (dimensional, strength, flow, etc.): Industry standards, internal specifications, and performance data from predicate devices.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI/machine learning device. The design validation and non-clinical testing confirm the device meets its intended specifications.

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

• Not applicable for the same reason as above.

In summary, the document demonstrates substantial equivalence through:

• Comparing the Intended Use and Indications For Use to Predicate Device #2 (K122027).
• Comparing the design, manufacture, and material composition to Predicate Device #1 (K981329).
• Presenting results from a series of non-clinical bench and laboratory performance tests (dimensional, substance compatibility, kink testing, stiffness, tensile strength, connector attachment, flow test, resistance to leakage, corrosion resistance, and skive testing) to show comparable performance to the predicate devices.
• Confirming biocompatibility according to ISO 10993 standards.

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