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The Signal Gear Urethral Catheter Electrode is intended for mucosal surface stimulation/recording from the external urinary sphincter for use in conjunction with urodynamic evaluation of the patient.

The Signal Gear Urethral Catheter Electrode is a single patient use, disposable sterile device. It consists of an adhesive, highly flexible, polyurethane film substrate that wraps around the urethral (Foley) catheter. The conductive portion of the electrode is printed onto the polyurethane film substrate in a pattern that, when the electrode is wrapped around the catheter, leaves two conductive contact surfaces forming the two electrical contacts of the electrode. The remainder of the conductive pattern is overwrapped by an additional layer of polyurethane film during manufacture in order to insulate the traces. The conductive ink used is silver, with the exception of the two electrical contacts of the electrode, which have an additional printed layer of gold ink.

Lead wires are attached that terminate in a safety connector that cannot be connected to an AC power outlet. The Electrode connects to the user's electrodiagnostic equipment. The electrode is to be used under the supervision of a physician. When the urethral catheter with the applied electrode is inserted in the human urethra, the exposed two electrical contacts of the electrode contact the mucosal lining of the urethra in the location of the external urinary sphincter muscle, and the end of the electrode with leadwire attachments are outside of the urethral meatus.

The provided 510(k) summary for the Neurovision Medical Products Inc. Signal Gear Urethral Catheter Electrode (K113771) describes a non-clinical study to support substantial equivalence. It does not present acceptance criteria or detailed performance data for clinical use, nor does it describe a study involving human subjects or AI.

Here's an analysis based on your request, highlighting what information is not present in the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not present in the provided document. The 510(k) summary focuses on non-clinical testing to demonstrate substantial equivalence to a predicate device, rather than defining specific performance metrics or acceptance criteria related to its intended physiological function (mucosal surface stimulation/recording) in a clinical setting.

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

• Sample Size for Test Set: Not applicable, as this was a non-clinical study.
• Data Provenance: Not applicable, as this was a non-clinical study.

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

Not applicable, as this was a non-clinical study. The "ground truth" in this context would be engineering specifications and standards for electrical, biocompatibility, and sterilization testing.

4. Adjudication Method for the Test Set

Not applicable, as this was a non-clinical study.

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

No, an MRMC comparative effectiveness study was not done and is not mentioned. This type of study is relevant for diagnostic devices where human readers interpret images or data, often with AI assistance. The Signal Gear Urethral Catheter Electrode is a medical instrument for stimulation/recording, not a diagnostic imaging device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone (algorithm only) study was not done and is not mentioned. The device is an electrode for use in conjunction with urodynamic evaluation, implying human operation and interpretation of data. There is no mention of an "algorithm" as a component of this device's performance.

7. Type of Ground Truth Used

For the non-clinical testing, the "ground truth" was based on:

• Engineering specifications and quality standards for manufacturing.
• Established international and industry standards for biocompatibility (ISO 10993-5:2009, ISO 10993-10:2010).
• Standards for accelerated aging (ASTM F1980-07).
• Standards for packaging validation (UNI EN ISO 868-5, 11607-1, DIN 58953-6).
• Standards for bioburden and sterility (UNI EN ISO 11737-1, 11737-2).

8. Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. As there is no training set mentioned, the ground truth for it was not established.

Summary of the Study that Proves the Device Meets Acceptance Criteria (Non-Clinical):

The Neurovision Medical Products Inc. Signal Gear Urethral Catheter Electrode underwent several non-clinical tests to demonstrate its safety and performance, and thus its substantial equivalence to the predicate device (Dantec 13L40 St Mark's Pudendal Electrode).

The study involved:

• Inspection for defects: Manufacturing, workmanship, and packaging.
• Electrical continuity testing: To ensure proper electrical function.
• Lead wire pull testing: To assess the mechanical strength of the lead wire attachment.
• Biocompatibility testing:
  • In vitro cytotoxicity: According to ISO 10993-5:2009.
  • Irritation and delayed-type hypersensitivity: According to ISO 10993-10:2010.
• Accelerated aging: Conducted according to ASTM F1980-07 to predict shelf life.
• Packaging validation tests: Conducted according to UNI EN ISO 868-5, 11607-1, and DIN 58953-6 to ensure package integrity and maintain sterility.
• Bioburden and sterility tests: Conducted according to UNI EN ISO 11737-1 and 11737-2 to confirm the device is sterile when packaged.

The document indicates that these non-clinical tests were sufficient to demonstrate that "No new questions of safety or effectiveness are raised," supporting its substantial equivalence to the predicate device. However, specific acceptance criteria for each test (e.g., minimum pull strength, maximum cytotoxicity score) and the quantitative results are not provided in this summary. The FDA's 510(k) clearance implies that the agency found these non-clinical tests adequate for demonstrating substantial equivalence based on the provided data.

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