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The intended use of the VanishPoint® I.V. Cathcter is to provide safe and reliable access to the vascular system for short term use (less than 30 days). t The VanishPoint® I.V. Catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure. The VanishPoint I.V. Catheter aids in the prevention of needlestick injuries.

The VanishPoint® I.V. Catheter is a safety device. The retracting introducer places the catheter portion in a vascular vessel in the same way as a conventional catheter, but upon removal of the placement needle, the caregiver activates a safety mechanism which retracts the needle completely into the handle/introducer assembly. In this way, if properly performed, it does not expose the caregiver to an accidental stick from a contaminated needle. The energy to retract the needle and chamber is provided by a spring interacting between the housing and the needle chamber assembly. Once the needle/chamber is retracted, the retracting introducer assembly is no longer required and taken away from the patient.

The provided text describes a 510(k) submission for a medical device (VanishPoint® I.V. Catheter), which focuses on demonstrating substantial equivalence to a predicate device rather than conducting a new study to prove device performance against specific acceptance criteria. Therefore, several of the requested sections below cannot be fully populated as they pertain to such a study.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the 510(k) summary. The submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (VanishPoint® I.V. Catheter, K051355) rather than presenting new performance data against specific acceptance criteria for a novel device. The text states:

• "The subject VanishPoint I.V. Catheter and the VanishPoint I.V. Catheter predicate device are very similar in design and technological characteristics."
• "The different materials are equivalent and the intended use is identical."
• "There is no substantive differences between the predicate device and subject device that would raise new issues of safety and effectiveness."

Therefore, the "acceptance criteria" here are implicitly tied to the safety and effectiveness profile of the predicate device, which the new device is claimed to match. No specific performance metrics or their corresponding acceptance thresholds are listed.

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

No specific test set or study with a defined sample size is described. The submission relies on the established safety and effectiveness of the existing predicate device.

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

Not applicable. No new clinical or performance study requiring expert adjudication for ground truth establishment is described.

4. Adjudication Method for the Test Set

Not applicable.

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

Not applicable. No MRMC study is mentioned. The device is a physical medical device (catheter), not one that typically involves human readers interpreting data.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

Not applicable. The "ground truth" for this submission is effectively the established safety and effectiveness of the legally marketed predicate device.

8. The Sample Size for the Training Set

Not applicable. This is a 510(k) submission for a physical device demonstrating substantial equivalence, not a machine learning model requiring a training set.

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

Not applicable.

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The intended use of the VanishPoint® I.V. Catheter is to provide safe and reliable access to the vascular system for short term use (less than 30 days). The VanishPoint® I.V. Catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure. The VanishPoint® I.V. Catheter aids in the prevention of needlestick injuries.

Not Found

The provided text is a 510(k) clearance letter for the VanishPoint I.V. Catheter, which is a medical device. It does not contain any information about acceptance criteria or a study proving device performance as typically understood for AI/ML or diagnostic devices.

The letter states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. This determination implies that the device meets the safety and effectiveness requirements for its intended use, but it doesn't detail performance metrics in the way you've requested.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study with specific acceptance criteria, sample sizes, ground truth establishment, or expert involvement.

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