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The Percutaneous Introducer is intended to allow for the percutaneous placement of devices, needles or probes, in close proximity to nerves and around or into surgical wound or non-surgical wound sites. It may be used to inject or aspirate the introduction area via the luer hub of the needle/introducer.

The Percutaneous Introducer is a single-use, disposable device consisting of a flexible polymer sheath with a molded plastic hub. The device incorporates a stainless steel needle inside the flexible cannula and is removed after the introducer is placed. The inserted stainless steel introducer needle has a sharp distal point. The flexible cannula acts as a conduit for percutaneous introduction of medical devices, such as catheters, needles, or probes. A stylet or porous plug (to prevent aspiration during insertion) comes seated in the standard 6 degree luer fitting of the proximal end of the needle hub. The Percutaneous Introducers are used for a short period of time and are supplied sterile and non-pyrogenic. The Percutaneous Introducer is available in four lengths and a 14 gauge.

This document is a 510(k) summary for a "Percutaneous Introducer" device. It outlines the device description, intended use, technological characteristics, and non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with quantitative targets and corresponding "reported device performance" in the way a clinical study might. Instead, it describes various tests performed and states that the device "meets the requirements" or "performs comparably" or has "successful results."

The tests and their reported outcomes are:

The study concludes that based on these results, the Percutaneous Introducer "performs comparably to, and is substantially equivalent to predicate device (K102460)."

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

The document does not specify the sample sizes used for any of the non-clinical tests (e.g., number of introducers tested for tensile strength, burst testing, etc.).
The data provenance is from non-clinical bench and laboratory testing, not human or animal studies. The data would originate from the manufacturing and testing facilities of Epimed International, Inc. or their contracted labs. It is inherently prospective in the sense that the tests were conducted specifically for this submission.

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

This section is not applicable in the traditional sense of clinical or diagnostic device ground truth. The "ground truth" for non-clinical performance and biocompatibility tests is established by adherence to recognized international standards (e.g., ISO, ASTM) and FDA guidance documents. The "experts" would be the qualified personnel within the testing laboratories who perform the tests according to these standards, generate the data, and interpret the results to ensure compliance. Their specific number or qualifications are not detailed here, as the focus is on adherence to standardized testing protocols.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving multiple human readers for diagnostic image interpretation or similar subjective assessments. The tests described are objective, standardized laboratory and bench tests where results are determined by measurement against specified criteria in the standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, and the AI's impact on their performance is being evaluated. This submission is for an interventional medical device (introducer) and focuses on its physical performance, material safety, and substantial equivalence, not diagnostic accuracy or human reader performance.

6. Standalone (Algorithm Only) Performance

No, a standalone (algorithm only) performance assessment was not done because the device is a physical medical instrument (a Percutaneous Introducer), not a software algorithm or AI-driven diagnostic tool. The concept of "algorithm only performance" does not apply to this type of device.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on established international standards and regulatory guidelines. For example:

• Mechanical properties: Defined by performance criteria within ASTM and ISO standards (e.g., specific force values, absence of collapse/peelback).
• Biocompatibility: Defined by the requirements and endpoints outlined in ISO 10993 series of standards (e.g., non-cytotoxic, non-sensitizing, non-irritating).
• Sterility and Packaging: Defined by standards like ASTM F1140, ASTM F1929, and general sterility assurance principles.
• Functional standards: Defined by the specific requirements of ISO 594-1, ISO 594-2, and ISO 10555-5.

Essentially, the "ground truth" is compliance with these widely accepted benchmarks for medical device safety and performance.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not an AI or machine learning model. Therefore, there is no "training set" in the context of an algorithm. The development and testing process involves engineering design, material selection, and verification/validation testing, not data-driven machine learning training.

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

Not applicable, as there is no training set for this type of device.

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The RuloTM Radiofrequency Lesion Probe is an injection probe which may be used either for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. A nerve is localized either by electrostimulation through the needle or by injecting contrast medium through the needle and using radiography concomitantly. The nerve may then be blocked by injecting local anesthetic solution or a radiofrequency lesion may be made.

The Rulo™ Radiofrequency Lesion Probe (Rulo Probe) creates radiofrequency (RF) lesions on nerves and can also create percutaneous nerve blocks by delivering anesthetic to the site. It is a single-use, surgically invasive device. It is inserted with the use of a flexible introducer accessory to contact a nerve in an area of the spine for less than 15 minutes to treat pain. The RF energy creates a lesion on nerve tissue that conducts pain signals. The tissue's ability to conduct electrical signals is disrupted by the lesion. The targeted nerve can be localized either by using RF electrostimulation through the cannula or by injecting contrast medium through the cannula with the use of the fluid injection port and using radiography concomitantly. The nerve may be blocked by injecting local anesthetic solution or making an RF lesion. The device is used by a trained physician in a clinical setting. The device is constructed with a steel cannula and uses a variety of polymers for the insulation, hub, cable, connector, cap and fluid injection port.

This document is a 510(k) premarket notification for the Epimed Rulo™ Radiofrequency Lesion Probe. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed clinical study for novel performance claims. As such, many of the requested data points (e.g., sample size for test/training sets, number of experts for ground truth, MRMC studies, standalone algorithm performance) are not applicable or available in this type of submission.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and device performance are primarily focused on engineering performance and biocompatibility, demonstrating that the device functions as intended and is safe for use, and is comparable to the predicate device. Specific quantitative performance targets typically seen in AI/diagnostic device studies are not present here because this is a physical medical device.

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

• Sample Size: Not specified for individual tests. The nonclinical testing involves laboratory and bench testing of device components and the complete device. This is not a study that uses patient data.
• Data Provenance: Not applicable in the context of patient data. The nonclinical test data is generated in a laboratory setting or through engineering assessments.

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

• This is not applicable as the submission reports on physical and chemical performance tests, not a diagnostic or AI algorithm that requires expert-established ground truth from images or patient data.

4. Adjudication Method for the Test Set

• Not applicable for the types of nonclinical performance and biocompatibility tests performed. These tests have defined pass/fail criteria based on 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 is a physical medical device, not an AI or diagnostic imaging device that involves human readers or an AI algorithm.

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

• Not applicable. This is a physical medical device and does not involve an algorithm.

7. The Type of Ground Truth Used

• For performance tests: The ground truth is defined by the specifications in the referenced international and national standards (e.g., ISO, BS, ANSI/AAMI/EN).
• For biocompatibility: The ground truth is established by the specified tests and evaluation criteria outlined in ISO 10993 series.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable. As above, there is no training set for this device.

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