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SonoPlex STIM and SonoPlex II Needles equipped with Cornerstone reflectors are used to puncture the tissue in order to gain entry and inject local anesthetics to induce regional anesthesia. An electrical stimulus may be applied to the needle via a cable and connector to assist the physician pinpoint the area of application.

The subject device, the SonoPlex STIM and SonoPlex II nerve block needle is a single-use anesthesia conducting needle intended to gain entry or puncture the tissue and inject anesthetics to induce regional anesthesia. The SonoPlex STIM and SonoPlex II needle is intended for use under ultrasound guidance. Visibility under ultrasound is enhanced by CornerStone reflectors as cleared by FDA in several Premarket Notification Submissions. The SonoPlex STIM and SonoPlex II needle is equipped with an connecting cable, injection tube and NanoLine® coating (Parylene, no nanomaterials incorporated). The distal connection of the tube is either equipped with a LUER Connector according to ISO 80369-7 or a NRFit-Connector according to ISO 80369-6. The device in focus is a single use device and has an intended time of use up to 24 hours acc. EO-residuals acc. DIN EN ISO 10993-7. The standard time of use is less than 60 minutes. The SonoPlex STIM and SonoPlex II cannulas are not for intrathecal use. The SonoPlex STIM and SonoPlex II cannulas are produced at PAJUNK® GmbH Medizintechnologie in Geisingen, Germany.

The provided FDA 510(k) clearance letter and associated summary pertain to the SonoPlex STIM and SonoPlex II anesthesia conduction needles. This document focuses on demonstrating substantial equivalence to a predicate device (SonoBlock/SonoBlock II) and primarily addresses changes related to sterilization and packaging, rather than the performance of an AI/ML-driven device.

Therefore, the requested information regarding AI/ML device performance (e.g., acceptance criteria for AI, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone algorithm performance, ground truth definitions for AI models) cannot be extracted from this document, as it describes a traditional medical device and not an AI-powered one.

The "study" described in the document is a series of performance tests and validations for the physical properties, sterilization, and biocompatibility of the needles, and not a study validating an AI/ML diagnostic or assistive tool.

However, I can provide a summary of the acceptance criteria and the studies that prove the device (SonoPlex STIM and SonoPlex II needles) meets its acceptance criteria based on the information provided:

Acceptance Criteria and Device Performance (SonoPlex STIM and SonoPlex II Needles)

The acceptance criteria for the SonoPlex STIM and SonoPlex II needles are primarily based on established international standards for medical devices, specifically for anesthesia conduction needles. The studies performed were performance testing, sterilization validation, and shelf-life testing, demonstrating that the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criteria are compliance with various ISO standards, ensuring the physical and biological safety and efficacy of the needles.

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

• Sample Size: The document repeatedly mentions that tests were conducted, but does not specify the exact sample sizes for each of the performance tests (e.g., how many needles were tested for patency, stiffness, etc.). It mentions "process most challenging worst case devices" were used for shelf life and sterility tests.
• Data Provenance: The devices are manufactured by PAJUNK GmbH Medizintechnologie in Geisingen, Germany. The contract sterilizers are Sterigenics Germany GmbH (Wiesbaden, Germany) and HA2 Medizintechnik GmbH (Halberstadt, Germany). The tests appear to be prospective (conducted specifically for this submission) in a laboratory/manufacturing setting.

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

This section is not applicable as the device is a physical medical needle, not an AI/ML diagnostic or assistive device that would require expert-established ground truth from medical images or clinical data. The acceptance criteria are based on engineering specifications and international standards.

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as above. The tests performed are objective, quantitative measurements against defined standard specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This section is not applicable. This is a physical medical device, not an imaging or diagnostic AI/ML tool that would be subject to MRMC studies. The document specifies that the new devices are "substantially equivalent" to predicate devices, and the dual guidance (ultrasound + electrical stimulus) for localization is considered "state of the art" and "safe and effective."

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

This section is not applicable. The device is a needle used by a human physician, possibly with assistance from an ultrasound machine and/or an electrical stimulator. There is no AI algorithm component.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is defined by the specifications within the cited ISO standards (e.g., acceptable limits for fluid leakage, minimum breaking strength, chemical residue limits) and validated manufacturing processes (e.g., sterilization parameters, biocompatibility testing). It is not derived from patient outcomes, expert consensus on clinical findings, or pathology reports in the context of an AI/ML algorithm.

8. The Sample Size for the Training Set

This section is not applicable. There is no AI/ML component; therefore, no training set is relevant to this device submission.

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

This section is not applicable for the same reason as above.

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