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The Praxiject™ 0.9% NaCl prefilled syringe with 0.9% Sodium Chloride Injection, USP, is intended only for flushing vascular access devices. May be placed on a sterile field.

The Praxiject™ family of 0.9% NaCl prefilled syringes marketed in the U.S.A. includes the following models: 37043US (3 mL/5 cc), 3704US (5 mL/5 cc), 37053US (3 mL/10 cc), 37055 US (5 mL/10 cc), 3705CUS (10 mL/10 cc), 3705-1US (10 mL/10 cc) and 3706US (20 mL/20 cc). These devices are single use plastic piston syringes with a Luer lock connection fitting, prefilled to labeled volume with 0.9% Sodium Chloride Injection USP, with no preservatives (normal saline), and capped with a plastic tip cap. Model 3705-1US (10 mL/10 cc) is individually packaged in a heat-sealed foil pouch, all other models are individually packaged in a heat-sealed peel pouch. All Praxiject™ 0.9% NaCl prefilled syringes are terminally sterilized by gamma irradiation.

The provided document is a 510(k) Pre-Market Notification for a medical device called Praxiject™ 0.9% NaCl, which is a prefilled saline flush syringe. The purpose of this notification is to demonstrate that the modified device is substantially equivalent to legally marketed predicate devices.

The document does not describe a study involving an AI/ML device, a "test set" of data, or "ground truth" as typically understood in the context of evaluating AI/ML performance. Instead, it details the analytical and performance testing conducted for a physical medical device to ensure its safety and effectiveness.

Therefore, many of the requested categories (2, 3, 4, 5, 6, 7, 8, 9) are not applicable to this document as they are specific to AI/ML device evaluation.

However, I can extract information related to acceptance criteria and device performance based on the non-clinical testing summary.

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

The document provides a comprehensive table of "Device Specification," "Standard," and "Acceptance Criteria" under the "Summary of Non-Clinical Testing" section. The "reported device performance" is implicitly stated as meeting these acceptance criteria, as the conclusion states, "The conclusions drawn from the non-clinical testing demonstrate that the modified Praxiject™ 0.9% NaCl prefilled syringe, is as safe, as effective, and performs as well as or better than the legally marketed primary predicate device." This implies all listed acceptance criteria were met.

Here is a summary of the acceptance criteria:

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 a way that is applicable to an AI/ML "test set." The document describes non-clinical testing of a physical device. While specific sample sizes and testing methodologies are implied by the listed standards (e.g., ISO, ASTM, USP), the exact sample sizes for each test are not explicitly enumerated in this summary. Data provenance, in terms of country of origin or retrospective/prospective collection, is not relevant for this type of device submission.

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)

Not applicable. "Ground truth" and "experts" are terms used in the context of evaluating diagnostic AI/ML models. This document describes the physical and chemical testing of a medical device.

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

Not applicable. This refers to methods for resolving discrepancies in expert interpretations, which is not relevant for physical device testing.

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 type of study specifically for evaluating AI/ML diagnostic tools.

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

Not applicable. This refers to the standalone performance of an AI/ML algorithm.

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

Not applicable. The "ground truth" for this device's performance is objective measurements against established international and USP standards for product quality, safety, and performance (e.g., pH, sterility, particle count, leakage, biocompatibility).

8. The sample size for the training set

Not applicable. This concept pertains to AI/ML model development.

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

Not applicable. This concept pertains to AI/ML model development.

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