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JMS Safe Wing Cath (SWC) is intended for short-term (less than 30 days) access to patient's vascular system for intravascular fluid administration and to sample blood, and to monitor blood pressure. The device is intended for single use only and has an anti-stick feature integrated which aids in prevention of needle-stick injuries.

JMS Safe Wing Cath (SWC) is a single lumen intravenous catheter device for vascular access incorporating an anti-needle stick safety feature. The anti-needle stick feature is integrated in the Safe Wing Cath (SWC) body and functions during retraction of the needle, after vascular access is accomplished (there is a stopper to prevent unwanted retraction of needle during insertion). During retraction, the needle will slide into the body and will lock at the final locking position. An audible clicking sound is heard or locking force is felt when the needle is fully retracted into the final locking position. The entire needle is encapsulated within the body and prevents needle-stick injuries, while the catheter still has vascular access for intravenous fluid administration.

The JMS Safe Wing Cath (SWC) device is an intravascular catheter with an anti-needle stick safety feature. The study conducted to demonstrate its performance and substantial equivalence to predicate devices involved multiple types of tests.

1. Table of Acceptance Criteria and Reported Device Performance

• Catheter (Elastic Modulus in Tension, Tensile Strength, Tensile Elongation)
• Catheter Flexural Modulus
• Force Break of Tubing and Female Connector
• Force Break of tubing to needle hub
• Force Break needle and needle hub
• Catheter collapse Pressure test |
  | | Determination of: | Pressure determined for maximum positive pressure
  Volumes determined for priming volume |

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

• Simulated Clinical Use Test: "over 500 samples" of the device were tested.
• Predicate Comparison Bench Testing: The specific sample sizes for each mechanical and flow test are not explicitly stated, but the results indicate that a sufficient number were tested to determine statistical significance or lack thereof.
• Data Provenance: The simulated clinical use test involved "43 healthcare workers from the Washington/Baltimore area," suggesting a prospective clinical simulation within the USA. The bench testing data would be internal laboratory data.

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

• Simulated Clinical Use Test: "43 healthcare workers" were involved. Their specific qualifications (e.g., years of experience, specialty) are not detailed in the provided summary, but they are described as "healthcare workers," implying relevant professional experience in using such devices.
• Bench Testing: For the in-house bench testing comparing to the predicate, the "ground truth" is established through standardized laboratory test methods (e.g., ISO 10555-1, JIS T3223:2011). No "experts" in the human assessment sense are required to establish this type of ground truth; rather, the tests are performed by qualified laboratory personnel following validated protocols.

4. Adjudication Method for the Test Set

• Simulated Clinical Use Test: The text states "100% success with no device failures and all devices performing as intended." This implies a binary assessment of success or failure for each device, likely without complex adjudication, as any failure would presumably disqualify it from the "100% success" claim.
• Bench Testing: For the laboratory tests, the "adjudication" is based on meeting the defined parameters of the standard test methods or demonstrating statistical equivalence to the predicate device. This is an objective measurement rather than a consensus-based adjudication.

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

• No MRMC comparative effectiveness study was done. This type of study is typically associated with diagnostic imaging devices where multiple human readers assess cases with and without AI assistance. The JMS Safe Wing Cath is a medical device for vascular access, and its evaluation focuses on physical performance, safety features, and clinical usability rather than diagnostic accuracy.

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

• This device does not involve an algorithm or AI. Its performance is entirely device-centric (e.g., mechanical properties, flow rates, safety mechanism function), and its evaluation is based on bench testing and simulated clinical use involving human interaction with the physical device. Therefore, a standalone algorithm-only study is not applicable.

7. Type of Ground Truth Used

• Biocompatibility: Ground truth is established by adherence to ISO 10993 standards and passing specified biological tests.
• Sterilization: Ground truth is established by achieving a validated Sterility Assurance Level (SAL) and meeting residual chemical limits.
• ISO 10555-1 Compliance: Ground truth is defined by the passing criteria of the specific ISO 10555-1 test methods.
• Simulated Use: Ground truth is based on functional performance during simulated clinical scenarios, assessed by healthcare workers, with the criterion being "performing as intended" and "no device failures."
• Predicate Comparison Bench Testing: Ground truth is the measured performance of both the JMS Safe Wing Cath and the predicate device, with the acceptance criterion being "no significant difference" between the two.

8. Sample Size for the Training Set

• Not applicable. This device is not an AI/ML algorithm that requires a training set. Its development and testing are based on engineering principles, materials science, and medical device standards.

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

• Not applicable, as there is no training set for this device.

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