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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 manufacture for the appropriate device.

The Predicate Device, 510(k) Number: K111034, AMUSA consists of a plastic syringe filled with 0.9% Sodium Chloride Flush Solution that is terminally sterilized. The predicate device filud path of 10 Section Onlonde Hush Oolution that is terminally sterlized. This is a single use device.

The Modified Device, the subject of this 510 (k), consists of a plastic syringe filled with 0.9% Sodium Chlerida Fluch Calification that the United on the Sodium Chloride Flush Solution that is terminally sterilized. The modified device fluid path sterile has a Sterility Assurance Level (SAL) of 108. This is a single use device.

The provided text describes a 510(k) submission for a medical device, the "0.9% Sodium Chloride Flush Syringe". However, it is not a study report for an AI/ML powered device, but rather a submission for a standard medical device that has undergone a change in component supplier.

Therefore, the information requested regarding acceptance criteria and studies for an AI/ML device (e.g., performance metrics like sensitivity/specificity, sample sizes for test/training sets, expert qualifications, MRMC studies, ground truth establishment) is not applicable to this document. The document focuses on demonstrating substantial equivalence to a predicate device for a physical product by verifying technical characteristics and conducting non-clinical testing.

Here's what can be extracted from the provided text, adapted to the context of a traditional medical device submission:

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

Since this is a Class II medical device being evaluated for substantial equivalence after a component supplier change, the acceptance criteria are not in terms of AI performance metrics, but rather in terms of demonstrating that the modified device is as safe and effective as the predicate device.

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

• Sample Size: The document does not specify exact sample sizes for the "chemical-physical, functional, and product stability testing." It only mentions that these tests were conducted.
• Data Provenance: Not explicitly stated, however, the testing would have been conducted by the manufacturer, AMUSA, or a qualified contract lab under their direction, as part of the regulatory submission process in the United States. It is "prospective" to the decision of equivalence, meaning it was performed specifically for this submission.

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

This concept is not applicable here. Ground truth in the context of this device relates to established engineering and quality standards for medical devices (e.g., sterility, material compatibility, functional performance). The "experts" would be the engineers, scientists, and quality assurance personnel performing and interpreting the non-clinical tests, and the FDA reviewers evaluating the submission. Their qualifications are assumed to be appropriate for their roles.

4. Adjudication method for the test set:

Not applicable in the context of ground truth for an AI/ML device. The "adjudication" for this type of device is the FDA's regulatory review process, where they evaluate the submitted data against regulatory requirements and accepted 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:

Not applicable. This device is not an AI/ML product and does not involve human readers interpreting data with or without AI assistance.

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

Not applicable. This device is not an AI/ML algorithm.

7. The type of ground truth used:

The "ground truth" for this device is based on established engineering principles, material science, microbiology (for sterility), and functional performance standards relevant to sterile, single-use medical devices. It would involve objective measurements from the chemical-physical, functional, and product stability tests.

8. The sample size for the training set:

Not applicable. This device does not involve a training set as it's not an AI/ML model.

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 manufacture for the appropriate device.

The Predicate Device, 510(k) Number: K984590 (Baxter Healthcare), consists of a sterile plastic syringe aseptically filled with 0.9% Sodium Chloride Flush Solution. The predicate device is fluid path sterile with a Sterility Assurance Level (SAL) of 10 . This is a single use device. AMUSA is the legal owner of the Baxter 510(k) K984590.

The Modified Device, the subject of this 510 (k), consists of a non-sterile plastic syringe filled with 0.9% Sodium Chloride Flush Solution that is sterilized by the addition of terminal sterilization (Radiation). The modified device is fluid path sterility Assurance Level (SAL) of 10 This is a single use device.

The provided text describes a 510(k) summary for a medical device called "0.9% Sodium Chloride Flush Syringe". This document is a premarket notification to the FDA to demonstrate that the modified device is substantially equivalent to a legally marketed predicate device.

Crucially, this document is for a medical device (syringe) and not an AI/ML software device. Therefore, the concepts of "acceptance criteria for an AI device", "study that proves the device meets the acceptance criteria", "sample size for test set", "ground truth", "number of experts", "adjudication method", "MRMC study", "standalone performance", and "training set" are not applicable in the context of this 510(k) submission.

The document focuses on demonstrating substantial equivalence through non-clinical verification testing due to a change in the sterilization process, not on the performance of a diagnostic or predictive algorithm.

However, based on the provided text, I can extract information related to the device and its assessment:

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

Since this is a non-AI/ML device, the concept of "acceptance criteria" is related to its physical, chemical, and functional properties, as well as its sterility and stability, rather than diagnostic performance metrics.

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "non-clinical verification testing" which would involve a set of syringes, but the specific number tested is not provided in this summary.
• Data Provenance: Not applicable in the context of data for an AI/ML model. The testing was performed on the modified syringe product itself. Location of testing and specific methodology are not detailed in this summary.

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" in the AI/ML sense is not relevant here. The assessment is based on physical, chemical, and biological testing, not expert interpretation of outputs.

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

Not applicable. This is not a study requiring expert adjudication of outputs.

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 (syringe), not an AI/ML diagnostic tool involving human readers.

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

Not applicable. This is not an algorithm.

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

Not applicable. The "truth" for this device relates to meeting established engineering and sterility standards through laboratory testing (e.g., measuring chemical composition, mechanical strength, sterility testing results, stability over time).

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML model.

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

Not applicable.

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Kendall Monoject PreFill™ ADVANCED™ 0.9%Sodium Chloride Flush Syringes for Sterile Delivery is indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.

The proposed device is an extension to the Kendall Monoject PreFill™ ADVANCED™ Flush Syringe line is to include one or more PreFill syringe configurations equivalent to those already marketed by Tyco Healthcare with the syringe delivered to the customer in a package that will maintain the sterility of the syringe exterior surface.

The provided text is a 510(k) summary for a medical device: "Kendall Monoject PreFill™ ADVANCED™ 0.9%Sodium Chloride Flush Syringes for Sterile Delivery." This document describes the device, its intended use, and its substantial equivalence to a legally marketed predicate device.

However, the provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria in the context of an algorithm or AI performance. The document is for a physical medical device (pre-filled syringes) and a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device, primarily through nonclinical testing (like biocompatibility) and comparison of technological characteristics.

Therefore, I cannot provide the requested information, such as:

• A table of acceptance criteria and reported device performance (for an algorithm).
• Sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, type of ground truth used, or training set details.

The nonclinical testing mentioned in the document is:

Nonclinical Testing:

• Biocompatibility testing against ISO Standard 10993, Part 1 and FDA modified matrix (G95-1).

This testing is relevant to the safety and compatibility of the physical syringe and its contents with the human body, not to the performance of any AI or algorithmic component.

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The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
The 0.9% Sodium Chloride Flush Syringe is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
The Heparin Lock Flush Syringe, 10 and 100 units/ml is intended for use in flushing compatible intravenous administration sets and industrials and individually

The proposed device is a sterile, single use, standard piston syringe of various sizes and fill volumes containing either 10 or 100 USP Heparin units/ml, or, 0.9% Sodium Chloride USP.

This document describes the Kendall Monoject® Prefill Flush Syringes, which contain either heparin or 0.9% sodium chloride, and are intended for flushing intravenous tubing and access devices. The submission focuses on substantial equivalence to predicate devices, particularly regarding a change in the manufacturing process rather than an AI/ML device. Therefore, many of the requested criteria for AI/ML devices, such as those related to AI-specific performance metrics, reader studies, and ground truth establishment, are not applicable or not provided in this regulatory document.

Here's the information that can be extracted or inferred from the provided text, primarily focusing on the non-AI aspects of the device and its testing:

Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) summary for a medical device (pre-filled syringes) and not an AI/ML device, the "acceptance criteria" and "reported device performance" are based on traditional non-clinical testing for safety, function, and stability, rather than diagnostic accuracy metrics. The document states:

Note: The document only states that "Verification testing for the proposed change involved microbiological, physical, functional and product stability testing." It does not provide specific acceptance thresholds or detailed numerical results for these tests. The outcome of these tests was a determination of substantial equivalence (K032438).

Study Details

• 1. Sample sized used for the test set and the data provenance: Not applicable or not specified for an AI/ML device context. The verification testing mentioned (microbiological, physical, functional, product stability) would have involved sample sizes appropriate for those specific types of engineering tests. No details on these sample sizes are provided.
• 2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI/ML device requiring expert ground truth for classification or diagnosis.
• 3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is not an AI/ML diagnostic or classification device.
• 4. 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 not an AI/ML device and no MRMC study was conducted or is relevant.
• 5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
• 6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI/ML ground truth. For the non-clinical testing, the "ground truth" would be established by validated test methods and specifications for sterility, physical properties (e.g., flow rate, burst strength), functional performance (e.g., proper flush), and stability (e.g., shelf-life studies).
• 7. The sample size for the training set: Not applicable. This is not an AI/ML device.
• 8. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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The device is intended for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.

The proposed device consists of various sizes and fill volumes of plastic syringes aseptically filled with sterile 0.9% sodium chloride solution.

The provided document is a 510(k) Premarket Notification for a 0.9% Sodium Chloride Flush Syringe. This type of regulatory submission is for medical devices and does not typically include information about studies related to AI/ML device performance or clinical outcomes.

The document discusses nonclinical tests to ensure the device meets safety and performance requirements for a sterile saline flush syringe. These tests focus on aspects like stability, container/closure suitability, and functional requirements.

Therefore, I cannot provide the requested information about acceptance criteria and studies as it pertains to AI/ML device performance (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance), because this type of information is not relevant or present in this specific regulatory document for a non-AI/ML device.

Here's a breakdown of what can be inferred from the document regarding the device's validation, but without the AI/ML specific details:

• Acceptance Criteria and Reported Device Performance: This would relate to the nonclinical tests.

  • Acceptance Criteria (Inferred): The device is expected to meet or exceed "all functional requirements," and demonstrate "stability" and "container/closure suitability." These criteria would be defined internally by Baxter Healthcare Corporation based on relevant standards for medical devices of this type.
  • Reported Device Performance: "Performance testing indicates that the proposed device meets or exceeds all functional requirements and supports its suitability for use." Specific quantitative results or detailed criteria are not provided in this summary.

• Study That Proves the Device Meets Acceptance Criteria:

  • Type of Study: Nonclinical tests (stability testing, container/closure suitability testing, performance testing).
  • Description: "Test data have been generated for stability and container/closure suitability. Performance testing indicates that the proposed device meets or exceeds all functional requirements and supports its suitability for use."

Regarding the specific questions asked that are relevant to AI/ML devices, the information is not applicable or present in this document:

1. A table of acceptance criteria and the reported device performance: As explained above, the acceptance criteria are general ("all functional requirements," "stability," "container/closure suitability") and specific performance metrics are not detailed.
2. Sample sized used for the test set and the data provenance: Not relevant for this type of device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not relevant for this type of device.
4. Adjudication method: Not relevant for this type of device.
5. Multi reader multi case (MRMC) comparative effectiveness study: Not relevant for this type of device.
6. Standalone (i.e. algorithm only without human-in-the loop performance) was done: Not relevant for this type of device.
7. The type of ground truth used: Not relevant for this type of device. The "ground truth" for this device would be established by physical, chemical, and biological testing against product specifications.
8. The sample size for the training set: Not relevant for this type of device.
9. How the ground truth for the training set was established: Not relevant for this type of device.

This document clearly describes a conventional medical device (a pre-filled syringe) and its regulatory pathway based on substantial equivalence to a predicate device, not an AI/ML powered diagnostic or therapeutic device.

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