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The VACUTAINER® Brand ECLIPSE™ Blood Collection Needle is a sterile, multiple sample, single-use device for blood collection. The needle is designed with an attached safety shield, which can be activated to cover the needle immediately after venipuncture salery only accidental needle sticks needle sticks.

The VACUTAINER® Brand ECLIPSE™ Blood Collection Needle is a sterile, multiple sample, single-use device for blood collection. The needle is designed with an attached safety shield, which can be activated to cover the needle immediately after venipuncture to provide protection from accidental needle sticks.

The provided text describes the Becton Dickinson VACUTAINER® Brand ECLIPSE™ Blood Collection Needle, a sterile, multiple sample, single-use device for blood collection with an attached safety shield.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample size for the test set: A panel of twenty healthcare professionals was used for Simulated Use Testing. The specific number of individual tests or cases performed by these professionals is not detailed.
• Data provenance: Prospective, as it involved "Simulated Use Testing by a panel of twenty healthcare professionals." The country of origin of the data is not explicitly stated, but given the submission is to the FDA, it is likely US-based or for the US market.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of experts: Twenty healthcare professionals.
• Qualifications of those experts: Not explicitly detailed beyond "healthcare professionals." Their specific roles (e.g., phlebotomists, nurses) or years of experience are not mentioned.

4. Adjudication method for the test set

• The text does not specify a formal adjudication method (like 2+1 or 3+1). The "Simulated Use Testing" implies a direct observation and evaluation by the healthcare professionals themselves, who served as the de facto evaluators of reliable activation and ease of use.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted in the context of comparing human readers' performance with and without AI assistance. This device is a physical medical device, not an AI diagnostic tool.

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

• This question is not applicable as the device is a physical blood collection needle with a safety mechanism, not an algorithm. The "standalone" performance refers to the mechanical function of the safety shield and its activation, which was evaluated through "Mechanical Testing" and "Simulated Use Testing."

7. The type of ground truth used

• The ground truth for the mechanical aspects (forces, lock engagement, defeat conditions) was established through objective mechanical measurements and evaluations.
• For the simulated use aspects (reliable activation, blood splatter observation, ease of activation, technique, handedness, single-handed operation), the ground truth was based on the direct observation and feedback/assessment of the twenty healthcare professionals during the simulated use scenarios. This falls under expert judgment/assessment in a practical use setting.

8. The sample size for the training set

• The concept of a "training set" is not applicable here as the device is a physical medical device, not an AI model requiring a dataset for training. The device's design is stated to use "components that are identical to the conventional VACUTAINER® Brand Blood Collection Needle," implying its functional basis is derived from an established design.

9. How the ground truth for the training set was established

• Not applicable, as there is no "training set" in the context of an AI algorithm. The device's performance is based on its mechanical design and human-factors testing for safety and ease of use.

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