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SonoMSK anesthesia conduction needles enhanced for ultrasound visibility are intended for the transient delivery of anesthetics to provide regional anesthesia and analgesia.

The subject device, the SonoMSK needle is a single-use anesthesia conducting needle intended for for the transient delivery of anesthetics to provide regional anesthesia and analgesia.

The SonoMSK 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 SonoMSK needle is equipped with an injection tube. The distal connection of the tube is equipped with a LUER Connector according to ISO 80369-7.

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 SonoMSK cannulas are not for intrathecal use.

The SonoMSK cannulas are produced at PAJUNK® GmbH Medizintechnologie in Geisingen, Germany.

Based on the provided FDA 510(k) Clearance Letter for SonoMSK, here's a detailed description of the acceptance criteria and the study proving the device meets them:

Disclaimer: This document is a 510(k) Summary, not the full submission. Therefore, it focuses on demonstrating "substantial equivalence" to a predicate device, rather than proving novel performance claims directly against established acceptance criteria for a new type of device. The acceptance criteria described below are primarily related to meeting established international standards for similar devices and ensuring equivalence to the predicate. The "study" largely consists of performance testing against these standards and validation of manufacturing processes (sterilization, packaging, shelf life).

Acceptance Criteria and Device Performance for SonoMSK

The SonoMSK device, as per this 510(k) submission, demonstrates substantial equivalence to its predicate device (SonoTAP) by meeting a series of performance and safety standards, particularly concerning its materials, manufacturing processes (sterilization, packaging), and device characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by compliance with specific sections of recognized international standards for hypodermic needles and connectors. The reported device performance is a "Passed" status for each tested section, indicating compliance with the respective standard's requirements.

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

The document does not explicitly state the numerical sample sizes for each specific test (e.g., "n=X needles for cleanliness testing"). However, it indicates that testing was performed "on a regular basis as well as type tests performed after design transfer" and "using process most challenging worst case devices."

• Test Set Sample Size: Not explicitly stated for each test, but implied to be sufficient for compliance with the referenced ISO standards. For shelf-life testing, "process most challenging worst case devices" were used.
• Data Provenance: The device is manufactured in Geisingen, Germany by PAJUNK GmbH Medizintechnologie. Sterilization is performed at Sterigenics Germany GmbH (Wiesbaden, Germany) and HA2 Medizintechnik GmbH (Halberstadt, Germany). The testing itself would have been conducted by the manufacturer or accredited labs in support of the submission, likely within Germany. The data is retrospective, as it covers tests completed before the 510(k) submission.

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

This submission does not involve clinical data or "ground truth" established by expert review in the sense of image interpretation or diagnostic accuracy. The "ground truth" here is adherence to engineering and safety standards (e.g., ISO, component specifications). Compliance is determined by objective measurements against these standards, not subjective expert consensus.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the basis for "ground truth" is objective measurement against specified international standards, not subjective assessment requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. The device is an anesthesia conduction needle, not an AI-powered diagnostic imaging tool. The submission focuses on demonstrating substantial equivalence in physical characteristics, biocompatibility, sterilization, and basic performance parameters to a predicate device.

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

Not applicable. SonoMSK is a physical medical device (anesthesia needle), not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" used is defined by the objective requirements and test methods outlined in the cited international standards:

• ISO 7864 (Sterile hypodermic needles for single use)
• ISO 9626 (Stainless steel needle tubing)
• ISO 80369-7 (Small-bore connectors for intravascular or hypodermic applications)
• ISO 10993-series (Biological evaluation of medical devices)
• ISO 11135-1 (Sterilization of health care products - Ethylene oxide)

These standards specify measurable parameters (e.g., dimensions, force, pH limits, sterility levels, residual limits) that the device must meet.

8. The Sample Size for the Training Set

Not applicable. SonoMSK is a physical medical device, not an AI algorithm requiring a training set.

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

Not applicable, as there is no training set for a physical device.

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The SonoTAP and SonoTAP II anaesthesia conduction needles enhanced for ultrasound visibility are intended for the transient delivery of anesthetics to provide regional anesthesia and analgesia.

The subject device, the SonoTAP II needles are single-use anaesthesia conducting needles intended for the transient delivery of anesthetics to provide regional anesthesia and analgesia. The SonoTAP and SonoTAP II needles are intended for use under ultrasound guidance. Visibility under ultrasound is enhanced by CornerStone reflectors as cleared by FDA in several Premarket Notification Submissions. The SonoTAP and SonoTAP II needles is equipped with an injection tube. 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 SonoTAP and SonoTAP II cannulas are not for intrathecal use.

The provided text is a 510(k) Summary for the SonoTAP and SonoTAP II anesthesia conduction needles. It focuses on demonstrating substantial equivalence to a predicate device (SonoTAP, K113207) primarily by addressing changes related to sterilization facilities and packaging materials.

The document does not describe a study involving an AI/human reader comparative effectiveness study, nor does it provide a standalone algorithm performance study data, nor does it typically include details on ground truth establishment for a diagnostic AI study. This submission is for a medical device (anesthesia conduction needles), not an AI-powered diagnostic device. Therefore, the questions related to AI performance, ground truth, expert adjudication, and training/test set sample sizes in the context of AI are not applicable to the scope of this regulatory submission.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and biocompatibility tests for the needle itself, validating manufacturing processes and material changes, rather than a clinical performance study involving human interpretation of diagnostic images or AI output.

Here's an analysis based on the provided text, addressing the applicable points:

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

The document lists various sections of ISO standards as "sections tested" and reports "Pass / Fail" for them. This indicates that the tests successfully met the acceptance criteria defined by those standards. However, specific numerical performance results against acceptance thresholds are only given for one specific test:

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

• Sample Size: The document does not specify the exact sample sizes for each mechanical and sterility test, only that "worst case needles" were subjected to testing for hub-to-needle bonding strength and that "sample size" for ISO 9626 was "Passed," implying it met the standard's requirements. For sterility validation, ISO 11135 dictates specific sample sizes based on the method (e.g., overkill, half-cycle approach), which would have been followed but are not explicitly reported in quantitative terms in this summary.
• Data Provenance: The tests were conducted internally by PAJUNK GmbH Medizintechnologie (Germany) or by their contract sterilizers (Sterigenics Germany GmbH and HA2 MEDIZINTECHNIK GMBH, Germany). The data is generated from prospective testing of manufactured devices and packaging.

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

Not applicable. This is not a diagnostic AI device requiring expert ground truth for image interpretation. The "ground truth" here is the physical measurement results from standardized tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This is not a study assessing subjective interpretation (e.g., radiological reads). Quality control and engineering tests have defined pass/fail criteria.

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-powered diagnostic tool.

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

Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The ground truth used for these tests are objective, measurable physical and chemical properties and performance characteristics defined by international standards (e.g., force in Newtons for bonding strength, presence/absence of leakage, sterility assurance level).

8. The sample size for the training set:

Not applicable. As this is not an AI/ML device, there are no training sets.

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

Not applicable.

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