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The NerveGuard Nerve Block Injection Pressure Limiter is a disposable manometer for measuring injection pressure during administration of peripheral nerve blocks.

The NerveGuard NRFit and NerveGuard LUER are single use sterile devices.
The NerveGuard NRFit and NerveGuard LUER are packed in a soft blister package.
The procedure requires connection to a needle intended for peripheral neve block and an injection device, typically a 10/20ml syringe (not subject to this 510(k)).
The NerveGuard is attached between the hub of the needle and the syringe via male and female connector.
Upon starting injection the pressure is monitored while the needle is inserted into the patients' skin. When exceeding the maximum pressure the NerveGuard limits the injection pressure. The user can slightly release force and proceed injection beyond the limitation value.
The NerveGuard pressure monitor is a disposable manometer for objective monitoring of injection pressure during administration of peripheral nerve blocks (PNB). Monitoring opening injection pressure with the NerveGuard helps identify unsafe injections before they start. When the NervGuard measures high opening injection pressure and limits this pressure down to a maximum of 18Psi. the needle can be repositioned and the injection resumed.
Usually the operator creates a force on the plunger (Fo) on the filled syringe which leads to normal flow of anesthetic through a valve in the NerveGuard. At this time, the resistance force of the locking mechanism Fs is higher when Fo. The locking mechanism closes the valve as soon as the force Fo overshoots Fs. The flow is stopped immediately. The NerveGuard will prevent a flow of anesthetic and fullfill it's protective function. Upon release of pressure Fo the valve reopens and the procedure can move on.

Here's a breakdown of the acceptance criteria and study information for the NerveGuard device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for each individual test (e.g., number of devices tested for liquid leakage, air leakage, etc.). It generally states that "Sterility tests have been performed using worst case devices," and "Performance... has been tested with real time aged devices (1 year) and devices subject to accelerated aging (1 year, 3 years, 5 years)."

The data provenance is from Germany (PAJUNK GmbH Medizintechnologie is located in Geisingen, Germany, and the contract sterilizer Sterigenics Germany GmbH is in Wiesbaden, Germany). The studies appear to be prospective in nature, as they involve testing the manufactured device against specific standards and internal protocols.

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

This information is not provided in the document. The tests performed are primarily engineering and performance tests against established international standards (ISO) and an internal protocol, rather than clinical studies requiring expert ground truth in the medical sense.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. The tests involve objective measurements against pass/fail criteria defined by standards or internal protocols, not subjective human adjudication of medical findings.

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

No, an MRMC comparative effectiveness study was not done. The device (NerveGuard) is a physical medical device (a disposable manometer/pressure limiter) and not an AI or imaging diagnostic tool that would typically undergo such a study. The comparison is against a predicate device's characteristics and performance, not human reader performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. The NerveGuard is a physical device used with human intervention for nerve blocks. It is not an algorithm or an AI system that operates in a standalone capacity.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests is based on:

• International Standards: e.g., ISO 11135 for sterilization, ISO 10993-7 for residuals, ISO 10993-1 for biocompatibility, ISO 80369-7 and ISO 80369-6 for connector integrity tests.
• Internal Protocols: For "Accuracy of measuring," "Compatibility LUER," and "Compatibility NRFit," as well as the implicit pressure limitation function.
• Predicate Device Equivalence: The primary means of demonstrating substantial equivalence is by comparing the device's characteristics and intended use to a legally marketed predicate device (K031128 B-Smart).

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm, so there is no "training set."

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

Not applicable. As there is no training set, there is no ground truth for a training set.

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