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The MHC Standard and NRFit™ Tip Syringes are intended to inject fluids into or withdraw fluids from the body.

The MHC Standard and NRFit™ Tip Syringes are provided sterile or in bulk non-sterile for further processing (e.g., sterilization). They are single use devices consisting of rigid polycarbonate barrels and plungers with a synthetic rubber gasket. The syringe barrels with neuraxial tips are ISO 80369 - 6 compliant and allow for connections of neuraxial specific applications while reducing the likelihood of misconnections to non-neuraxial devices. The syringe barrels are printed with graduated markings in cc (millliters) indicating the volume of liquid inside the syringe barrel.

1. Table of Acceptance Criteria and Reported Device Performance:

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

   • The document does not explicitly state the specific sample size used for each non-clinical test. It generally refers to "verification and validation testing" performed with the subject neuraxial (NRFit) Tip Syringes.
   • Data Provenance: The tests are non-clinical, implying they were conducted in a laboratory setting. The country of origin of the data is not specified, but the testing was performed to international standards (ISO 80369-6 and ISO 80369-20) and FDA guidance for biocompatibility. The data is prospective, generated specifically for this submission.

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

   • This information is not applicable. The "ground truth" for the test set is established by the specified acceptance criteria within the ISO standards and FDA guidance rather than expert consensus on medical images or diagnoses. The "experts" would be the personnel conducting the laboratory tests according to the standard operating procedures of the testing facility.

4. Adjudication Method for the Test Set:

   • This information is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to the resolution of discrepancies between multiple human readers in diagnostic studies. For non-clinical device performance testing against defined standards, results are objective measurements compared against predetermined thresholds.

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

   • No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical tests were not required to demonstrate performance of between the subject and predicate devices. Product functionality has been adequately assessed by non-clinical tests."

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

   • This information is not applicable as the device is a medical syringe, not an AI algorithm.

7. The Type of Ground Truth Used:

   • The ground truth used for the acceptance criteria and testing is based on established international standards (ISO 80369-6:2016 and ISO 80369-20:2016) and FDA guidance documents (ISO10993-1 for biocompatibility). These standards define objective performance thresholds and test methods to ensure the safety and efficacy of the device.

8. The Sample Size for the Training Set:

   • This information is not applicable. The device is a physical medical device (syringe) and does not involve AI or machine learning algorithms that would require a "training set."

9. How the Ground Truth for the Training Set was Established:

   • This information is not applicable as there is no training set for this type of device submission.

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