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The MedSource IV Safety Catheter is indicated to sample blood or administer fluids intravenously. The MedSource IV Safety Catheter may be used for any patient population with consideration given to adequacy for the vascular anatomy appropriateness for the solution being administered and duration of the therapy.

The MedSource IV Safety Catheter is a safety medical device used for inserting a catheter into a patient's body for purpose of delivery of fluids or drainage of fluids from the patient's body. This device is engineered to protect healthcare workers using it against accidental needle stick injury and exposure to parts of the device that have come in contact with patient's blood or other body fluids, and have hence been potentially contaminated with infectious agents. In addition this device also secures the needle (used to insert the catheter) in an enclosed chamber, thus protecting healthcare and other personnel from exposure to patient body fluids after the device has been discarded postuse.

The device comprises a sharp needle attached to a hub which projects into a chamber. In the 'unactivated' state prior to insertion, the needle and hub are 'locked' in position. There exists a retraction mechanism for 'unlocking' the needle such that on activation of this mechanism it is withdrawn and completely enclosed within the chamber. This mechanism for retracting the needle preferably includes a coiled spring or other elastic components. The retraction mechanism is activated by the user using only one hand by means of a lever or 'switch'.

The provided text is a 510(k) Summary for the MedSource IV Safety Catheter, which is a medical device and not an AI/ML product. Therefore, many of the requested elements pertaining to AI/ML device studies (such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this document.

However, I can extract the acceptance criteria and performance data as presented for this traditional medical device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document performs a comparison to a predicate device (Becton Dickinson Angiocath Autogaurd, K984059) to demonstrate substantial equivalence. The "acceptance criteria" for the MedSource IV Safety Catheter are implied by its performance being equivalent to or better than the predicate device's established performance, as well as compliance with specific ISO and ASTM standards.

2. Sample size used for the test set and the data provenance: Not applicable. This summary presents comparative performance data against a predicate device rather than a study on a specific test set for an AI/ML algorithm. The data reflects device specifications and compliance with standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document pertains to the physical and chemical properties and performance of a medical device, not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth.

4. Adjudication method for the test set: Not applicable (see point 3).

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 traditional medical device, not an AI/ML product involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document describes a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device's performance is established by compliance with international standards (ISO, USP, ASTM) and direct comparison to the specifications of a legally marketed predicate device. For example, "Sterile ETO" is a factual characteristic, and "Complies to USP-34" refers to a specific standard.

8. The sample size for the training set: Not applicable. This is a traditional medical device, not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable (see point 8).

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is detailed within the "Summary of Performance Testing Characteristics" section. This study involved direct comparison testing of the MedSource IV Safety Catheter against the established specifications and performance of its predicate device, the Becton Dickinson Angiocath Autogaurd (K984059).

The testing covered:

• Chemical Tests: Volatile Residue, Heavy Metals, Residue on Ignition, and Buffering Capacity. The results showed identical performance to the predicate device, meeting the specified limits (e.g., <15.0mg for volatile residue, <1ppm for heavy metals, complies to USP-34).
• Biological Tests: Sterility. Both the submission device and predicate demonstrated "Sterile ETO."
• Physical Tests: Integrity (compliance to ISO 10555-1 and ISO10555-5), Flow-rate for various gauges, and Tensile strength for various gauges. For all these physical tests, the MedSource IV Safety Catheter exhibited performance metrics identical to those reported for the predicate device.

The study concludes that "there are no significant performance specification differences between the MedSource IV Safety Catheter and the substantially equivalent device," leading to the determination that it is as safe, as effective, and performs as well as or better than the predicate device. The reference documents listed (ISO, ASTM, USP standards) indicate the methods and criteria against which these tests were conducted to demonstrate compliance and equivalence.

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