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The AMSafe® 0.9% Sodium Chloride Pre-Filled Normal Saline Flush Syringe, is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacturer for the appropriate device.

AMSafe® Pre-Filled Normal Saline Flush Syringe is a polypropylene plastic syringe filled with 0.9% sodium chloride for injection, USP, and capped with a polypropylene cap. The device will be terminally sterilized by gamma radiation sterilization. The device will be marketed as a 12mL syringe with a 3mL, 5mL, or 10mL fill volume, and a 20mL syringe with 20mL fill volume. The products are in two different packages, one is poly blister package and the entire packaged device are gamma radiation sterilized for sterile delivery to a sterile field; another is PP wrapper as a dust cover for non-sterile field. The solution is sterile normal saline for injection and meets the requirements of USP.

This document is a 510(k) Premarket Notification from the FDA regarding a medical device, the AMSafe® Pre-Filled Normal Saline Flush Syringe. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study of an AI-powered diagnostic device. Therefore, much of the requested information regarding acceptance criteria and study design for an AI device is not applicable to this document.

However, I can extract information related to the device's acceptance criteria for performance (bench testing) and the testing done to prove it meets those criteria.

Here's an attempt to answer your questions based only on the provided text, recognizing its limitations for an "AI-powered diagnostic device":

Device: AMSafe® Pre-Filled Normal Saline Flush Syringe

Type of Device: Prefilled plastic piston syringe with 0.9% sodium chloride for injection, USP, intended for flushing intravenous administration sets and indwelling intravenous access devices. This is a medical device, not an AI-powered diagnostic device.

Study Type: Non-clinical (bench) testing to demonstrate substantial equivalence to a predicate device. No clinical study with human subjects, AI assistance, or MRMC design was conducted.

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

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

• Sample Size for Test Set: The document describes "non-clinical testing" and lists various tests, each presumably with its own sample size of syringes or solution, but these specific sample sizes are not detailed in the provided text.
• Data Provenance: The tests are standard industry bench tests (e.g., ISO, USP, ASTM standards). The country of origin for the data is not explicitly stated within the context of the testing, but the company is Amsino International Inc., based in Pomona, CA, USA, suggesting testing likely occurred in or for a US regulatory submission. The data is from prospective bench testing, not retrospective or prospective clinical data.

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

• This device is not an AI diagnostic, so there is no concept of "ground truth" derived from expert consensus of images/data in the way it applies to AI devices. The "ground truth" for the performance tests (e.g., pH, chemical content, sterility) is established by the specified reference standards (USP, ISO, ASTM) and the inherent measurable properties of the device and its contents. The results are objective, quantitative measurements following validated methods, not subjective interpretations by experts.

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

• Not applicable as this is not an AI diagnostic device requiring human expert adjudication of diagnostic outcomes. The results are objective measurements against pre-defined criteria.

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, an MRMC comparative effectiveness study was not done. This device is a pre-filled saline syringe, not an AI-powered diagnostic. This type of study is irrelevant to its purpose and regulatory pathway.

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

• Not applicable. This device is not an algorithm or AI. The tests performed are standalone bench tests of the physical and chemical properties of the syringe and its contents.

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

• The "ground truth" for these tests is based on established scientific and engineering standards and methods (e.g., USP monographs for chemical purity and content, ISO standards for device properties, ASTM for packaging). It is a direct measurement against defined physical, chemical, and biological specifications, not a diagnostic ground truth derived from expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device; therefore, there is no concept of a "training set."

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

• Not applicable. As there is no training set for this type of device, no ground truth needed to be established for it.

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0.9% Sodium Chloride Flush Syringes are intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacturer for the appropriate device.

The new device, the subject of this 510(k), consists of a 20 mL, non-sterile plastic syringe filled with 20 mL of 0.9% Sodium Chloride Flush Solution USP that is terminally sterilized. The new devine is starle on the outside and has a sterile fluid path. The Sterility Assurance Level (SAL) is 10°. The syringe may be used on a sterile field if packaging is not damaged and aseptic technique is used. This is a ningle use device. The solution contains no preservatives, or antimicrobial agents. No plasticizers, additives, crosslink agents, reagents, colorants, inks, adhesives, surfactants, detergents, used during the manufacture of the syringes. The 20mL filled with 0.9% Sodium Chloride Flush Solution in a 20mL syringe is the only model which is subject to this 510(k). Other models previously cleared under 510K (K120836) consists of a non-sterile plastic 12 cc syringe filled with 3 mL, 5 mL, or 10 mL of 0.9% Sodium Chloride Flush Solution that is terminal sterilized.

This document is a 510(k) premarket notification for a medical device called the "0.9% Sodium Chloride Flush Syringe". It's a submission to the FDA to demonstrate that the new device is substantially equivalent to a previously cleared predicate device.

Here's an analysis of the provided text in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" with corresponding "reported device performance" in the way one might expect for a diagnostic or AI-driven device. Instead, it focuses on demonstrating substantial equivalence to a predicate device by comparing various technical characteristics and outlining the types of tests performed.

However, based on the "Technological/Substantial Equivalence Comparison Table" (Page 5) and the accompanying text, we can infer some "acceptance criteria" through the lens of equivalence and the types of tests performed to ensure that equivalence is met.

Key Differences and Specific Performance:

• Size and Fill Volumes:
  • Predicate: 3 mL/12 mL; 5 mL/12 mL, 10 mL/12 mL
  • New Device: 20 mL/20 mL (This is the primary change in the new device, and verification testing was done to ensure equivalence despite this change).

2. Sample Size Used for the Test Set and Data Provenance

This document is for a medical device (flush syringe), not a diagnostic algorithm or AI product. Therefore, the concepts of "test set," "training set," "data provenance," "country of origin," and "retrospective/prospective" studies as they apply to AI/software performance evaluation do not apply to this submission.

Instead,

• The "test set" would be akin to the samples of the device itself that underwent various physical, chemical, and biological tests. The document doesn't specify the exact number of syringes tested for each benchmark, which is typical for a 510(k) summary (detailed test reports would be in the full submission, not the summary).
• The "data provenance" is derived from the testing of the manufactured devices, following established quality control and testing protocols for medical devices.

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

Not applicable. This is not an AI/diagnostic device that relies on expert interpretation of data to establish ground truth. Device performance is measured against established scientific and engineering standards (e.g., sterility, pH, particulate matter).

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable. This is not an AI/diagnostic device that relies on human adjudication of results.

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 medical device (flush syringe), not an AI-assisted diagnostic tool.

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

Not applicable. This is a medical device (flush syringe), not an algorithm.

7. The Type of Ground Truth Used

For this medical device, the "ground truth" for its performance is established by:

• Physical/Chemical Standards: Adherence to USP (United States Pharmacopeia) standards for sodium chloride solution, and specifications for materials (polypropylene, rubber, etc.).
• Biological Standards: Sterility Assurance Level (SAL) of 10⁻⁶, non-pyrogenicity (LAL analysis).
• Functional Standards: Performance during bench testing for water loss, particulate matter, etc., ensuring the syringe functions as intended.
• Stability data: To confirm the product maintains its characteristics over its shelf life (2 years).

These are objective, measurable outcomes, not expert consensus or pathology reports.

8. The Sample Size for the Training Set

Not applicable as this is a medical device, not an AI/ML algorithm requiring a "training set."

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

Not applicable.

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