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The VACUETTE EVOPROTECT Safety Blood Collection/Infusion Set is indicated for venous blood collection and/or the short-term infusion of intravenous fluids. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.

The VACUETTE® EVOPROTECT SAFETY Blood Collection/Infusion Set is a singleuse, sterile, winged needle bonded to flexible tubing with a Luer connector and a semiautomatic release of the safety mechanism. The winged needle is designed with a safety mechanism, which allows for activation ensuring the needle is covered immediately following venipuncture to aid in the protection against accidental needlestick injury. The EVOPROTECT Safety Blood Collection/Infusion Set is individually wrapped, sterile with a luer port. The luer port can be used to connect FDA cleared accessories like luer adapter, holder, etc.

Here's an analysis of the provided text regarding the acceptance criteria and study for the VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set:

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical trial report for novel technologies. Therefore, some of the requested information (like MRMC studies, specific sample sizes for all tests, or detailed expert qualifications) is not typically found in this type of submission.

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 sample sizes for each specific test or the "test set" in the context often used for AI/algorithm performance. The studies performed are primarily bench and biocompatibility tests for medical devices.

• Sample Size: Not explicitly detailed for each test. The document mentions adherence to specific ISO and ASTM standards, which would dictate appropriate sample sizes for those tests. For example, biocompatibility studies would involve a certain number of samples for each test (e.g., cytotoxicity, sensitization, etc.).
• Data Provenance: The studies are laboratory and bench tests conducted to international (ISO, ASTM) and national (USP, ANSI/AAMI, FDA guidance) standards. It does not involve patient data or human clinical trials in the way an AI algorithm might be evaluated. Therefore, there's no country of origin of data in the typical sense, nor is it a retrospective or prospective clinical study. These are product performance verification and validation tests.

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

This information is not applicable and not provided in the document. The "ground truth" for these types of mechanical, chemical, and biological performance tests is established by adherence to recognized international and national standards (e.g., ISO 7864 for cannula cleanliness, ISO 10993 for biocompatibility). There isn't an "expert consensus" in the sense of clinicians reviewing images or patient outcomes. The "experts" would be the metrology and biological testing technicians and scientists performing the tests according to the specified standard operating procedures and trained in those specific methods.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or expert reviews where there might be disagreement or a need for a definitive "ground truth" established by multiple human evaluators (e.g., in radiology image reading). For the enumerated engineering and material science tests, the results are typically quantitative measurements or qualitative observations that either meet or do not meet predefined criteria according to the standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic AI algorithms where human interpretation is involved. The VACUETTE EVOPROTECT is a physical medical device (blood collection/infusion set), not an AI-powered diagnostic or assistive tool for human readers.

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

No, a standalone AI algorithm performance study was not done. This device is not an AI algorithm. Its performance is evaluated through physical, mechanical, and biological testing as listed in the table.

7. The Type of Ground Truth Used

The "ground truth" used for this device's performance evaluation is based on:

• Adherence to Recognized Consensus Standards: Many tests refer to specific ISO or ASTM standards (e.g., ISO 7864:2014 for cannula cleanliness, ISO 23908:2011 for breaking compressive force, ISO 10993-1 for biocompatibility). These standards define the test methods and often the criteria for acceptable performance.
• Equivalence to Predicate Device: For several parameters (e.g., penetration resistance, cannula radial orientation, flow rate, detaching torque/force, leakage, spring characteristic), the acceptance criterion is "Equivalent to predicate device." This means the new device performed comparably to a previously cleared, legally marketed device that has demonstrated safety and effectiveness.
• Internal Specification: For some flow rate tests, "internal Specification" is cited, meaning the manufacturer has defined its own performance targets based on the intended use and established engineering principles.

8. The Sample Size for the Training Set

This information is not applicable. The concept of a "training set" refers to data used to train machine learning models. This document describes the testing of a physical medical device, not an AI algorithm.

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

This information is not applicable, as there is no "training set" in the context of an AI algorithm for this device.

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