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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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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 Predicate Device, 510(k) Number: K111034, cleared on July14, 2011 consists of a plastic syringe filled with 0.9% Sodium Chloride Solution that is terminally sterilized. The predicate syringe is fluid path sterile with a Sterility Assurance Level (SAL) of 10⁻⁶. This is a single use device packaged in a dust cover.

The Modified Device, the subject of this 510 (k), consists of a plastic syringe filled with 0.9% Sodium Chloride Solution that is terminally sterilized. The modified device has a sterile exterior in addition to the sterility of the fluid, fluid path and the exterior of the device. The package that maintains the sterility of the modified device has a Sterility Assurance Level (SAL) is 10⁻⁶. This is a single use device.

Technical Data: The technical characteristics of the syringe for the modified device do not differ from those of the currently marketed predicate device. These syringes have the same design, the same functional characteristics, and have the same intended use. The proposed modification involves a change in packaging from the dust cover with a sterile barrier package for use in a sterile field. All other aspects of the syringe design remain the same.

This document is a 510(k) summary for a medical device called the "0.9% Sodium Chloride Flush Syringe". It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.

The 510(k) is for a physical medical device (saline flush syringe), not an AI/ML software device. Therefore, the questions related to AI/ML device performance, ground truth, expert adjudication, training/test sets, and MRMC studies are not applicable to the provided text.

The "study" mentioned here is a series of non-clinical verification tests for the physical changes to the syringe (specifically, the sterile packaging).

Here's how I can address the prompts based only on the provided text:

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

The document does not explicitly state "acceptance criteria" in a quantitative format for device performance as one would expect for an AI/ML device. Instead, it refers to:

Explanation: The "acceptance criteria" here are largely implied by the concept of "substantial equivalence" to the predicate device. The goal was to demonstrate that modifications (specifically to the sterile packaging) did not negatively impact the safety or effectiveness of the device, making it perform in an "equivalent manner."

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

• Sample Size: Not specified. The document mentions "non-clinical verification testing" which included "chemical-physical, functional, and package validation studies" but does not detail the sample sizes for these tests.
• Data Provenance: Not specified, but these would be laboratory test results related to the physical syringe and its packaging, likely conducted by the manufacturer (AMUSA) or a contracted lab. The manufacturer's address is Nashville, TN, USA. These tests are prospective in the sense that they were conducted for the purpose of this 510(k) 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. This pertains to a physical medical device. Ground truth as typically understood for AI/ML algorithms (e.g., diagnostic labels) is not relevant here. The "ground truth" for the tests would be the established performance characteristics for medical devices (e.g., SAL for sterility, validated functional tests).

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

• Not applicable. This pertains to a physical medical device. Adjudication methods are typically for resolving discrepancies in expert interpretations, which is not relevant here.

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 physical medical device, not an AI/ML system, so no MRMC study would be performed.

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

• Not applicable. This is a physical medical device; there is no algorithm.

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

• The "ground truth" for this physical device would be derived from standardized testing protocols and specifications for medical devices, specifically related to sterility, material properties, functional performance (e.g., fluid delivery), and package integrity. These are objective measures, not expert consensus or pathology in the AI/ML sense.

8. The sample size for the training set

• Not applicable. This is a physical medical device; there is no training set for an AI/ML algorithm.

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

• Not applicable. There is no training set for an AI/ML algorithm.

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