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The Pump Alignment Syringe is intended for use by healthcare professionals for injection of fluids for medical purposes into patients of all ages, including neonates in a controlled manner with compatible infusion pumps. The Pump Alignment Syringe can also be used for manual injection of fluids for medical purposes.

The Pump Alignment Syringe is available in various specifications, including 3ml, 5ml, 10ml, 30ml and 60ml. The proposed device consists of three components: (1) plunger, (2) piston, (3) barrel. The connector of barrel have two types of luer-lock and luer-slip. The proposed device is provided sterile. The product is sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years.

The provided text describes the submission of a 510(k) premarket notification for a Pump Alignment Syringe (K220184) and its comparison to a predicate device (K980987). However, it does not contain information regarding traditional acceptance criteria, performance metrics, or study details (like sample size, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies) typically associated with AI/ML-based medical device studies.

The document focuses on demonstrating substantial equivalence based on non-clinical tests and a comparison of technical characteristics. The "performance testing" mentioned refers to compliance with ISO standards for syringes, not a study evaluating specific performance metrics against acceptance criteria in the context of AI/ML.

Here's an analysis based on the information provided in the document:

1. A table of acceptance criteria and the reported device performance:

The document does not explicitly state "acceptance criteria" and "reported device performance" in the context of AI/ML. Instead, it lists standards that the device conforms to. For the purpose of this request, I will interpret "reported device performance" as the device's conformity to these standards.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria consists of non-clinical tests conducted to verify that the proposed device met all design specifications and was substantially equivalent to the predicate device. These tests assessed biocompatibility, packaging integrity, sterility, and physical/functional performance according to the listed standards.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided in the document. The document primarily reports adherence to engineering and biological safety standards, not a clinical or AI/ML performance study involving test sets of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable/not provided. The device is a physical medical device (syringe), and its performance evaluation involves compliance with established engineering and biological standards, not interpretation by experts to establish a "ground truth" on a test set (as would be typical for an AI/ML diagnostic or prognostic device).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable/not provided. Adjudication methods are relevant for studies where expert disagreement needs a resolution mechanism, which is not the case for the type of testing described (compliance with physical and biological standards).

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:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/ML devices that assist human interpretation, which is not the function of this Pump Alignment Syringe.

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

No, a standalone algorithm-only performance assessment was not done. The device is a physical syringe and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this device is its adherence to established international and national standards (e.g., ISO, ASTM, USP) for materials, sterility, package integrity, and functional performance. It is not based on expert consensus, pathology, or outcomes data in the traditional sense of a clinical diagnostic study.

8. The sample size for the training set:

This information is not applicable/not provided. The device is not an AI/ML product developed using training data. Its development involves engineering design and manufacturing processes, followed by testing against standards.

9. How the ground truth for the training set was established:
This information is not applicable/not provided as there is no training set for this type of device.

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