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The Pre-Filled Normal Saline Flush Syringe is intended to be used only for the flushing vascular access devices.

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I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for a medical device called "TK Pre-Filled Normal Saline Flush Syringe."

The letter acknowledges the submission of a premarket notification and states that the device is substantially equivalent to legally marketed predicate devices. It also outlines regulatory requirements but does not include details about performance testing, study designs, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot generate the requested table and information based on the given input.

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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.

Pre-Filled Normal Saline Flush Syringe is a polypropylene syringe filled with 0.9% sodium chloride for injection. It contains 3ml, 5ml and 10ml and consists of tip cap, barrel, piston, and plunger. This is a single use, disposable device(s), provided sterile.

The provided document is a 510(k) summary for a medical device called "Pre-Filled Normal Saline Flush Syringe." This document focuses on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical testing. It does not describe a study involving an AI/CADe device or human readers. Therefore, I cannot provide information regarding acceptance criteria and studies typical for AI/CADe devices, such as those related to multi-reader multi-case studies, effect size of AI assistance, expert qualifications, or ground truth establishment for training and test sets in an AI context.

However, I can extract the acceptance criteria and performance data for the non-clinical (bench) tests conducted on the Pre-Filled Normal Saline Flush Syringe to demonstrate its safety and effectiveness.

Here's the information based on the provided text, specifically from Section VII "Summary of Non-clinical Testing (Bench)":

1. Table of Acceptance Criteria and the Reported Device Performance

Note on ISO standards in the table: There appears to be a typo for test IDs 4.2 and 4.3 in the provided document (ISO 10995 instead of ISO 10993 for biocompatibility tests). I have kept the text as written but noted the likely correct standard.

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

• Sample Size: "Real time aged samples from three non-consecutive lots were tested for all performance criteria."
• Data Provenance: The document does not specify the country of origin for the test samples or explicitly state if the study was retrospective or prospective. It implies prospective testing of manufactured lots.

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

Not applicable. This is a non-clinical, bench testing study for a physical medical device, not an AI/CADe device requiring expert-established ground truth from medical images or patient data.

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

Not applicable, as this is bench testing. The results are based on objective measurements against established standard 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 not an AI/CADe device, and the study did not involve human readers or AI assistance.

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

Yes, in a sense. The "device" in this context is the physical syringe. The performance tests conducted are standalone tests of the device itself (its materials, chemical contents, physical properties, and biocompatibility), without specific human-in-the-loop performance measurement beyond standard laboratory procedures.

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

The "ground truth" for this device's performance is established by internationally recognized consensus standards (e.g., ISO, USP, AAMI TIR) which define the acceptable limits and test methodologies for the physical, chemical, and biological properties of the device.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set or ground truth establishment for it.

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The AMSafe® 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 syringe tip cap.

This document describes the premarket notification (510(k)) for the AMSafe® Pre-Filled Normal Saline Flush Syringe. The information provided outlines the device's technical characteristics, intended use, and comparison to a legally marketed predicate device (K183473). The study performed is a non-clinical bench testing study, not an AI/ML-based clinical study, therefore, many of the requested elements for an AI/ML study (e.g., sample size for test set, number of experts, MRMC study, training set details) are not applicable.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and reported device performance are detailed in "Table 5-2" on page 6 of the document.

Additionally, shelf life was evaluated:

• Test: Shelf life
• Method: ASTM F1980-16
• Acceptance Criteria/Conclusion: Verify that the device will remain within specification during the prescribed shelf life when stored under labeled conditions. (Implied Pass, as per overall conclusion).

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

The document describes non-clinical bench testing of manufacturing characteristics and chemical composition, not an AI/ML-based study with a "test set" composed of patient data. Therefore, the concept of sample size for a test set (e.g., number of images, patient records) and data provenance (country of origin, retrospective/prospective) as typically understood for AI/ML studies are not applicable. The tests were performed on samples of the device itself. The specific number of units tested for each criterion is not provided, but it would typically be a predetermined number based on the statistical requirements of the specific test methods (e.g., ISO, ASTM, USP standards).

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable. This was a bench study, not an AI/ML study requiring expert labeling of data. The "ground truth" for these tests are the established physical, chemical, and biological standards and methodologies outlined in the referenced ISO, ASTM, and USP documents.

4. Adjudication Method for the Test Set

Not Applicable. This was a bench study; there was no human-in-the-loop expert adjudication process as would be typical for AI/ML algorithm evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC study was not done. This is a review of a physical medical device (pre-filled syringe), not an AI/ML diagnostic or assistive tool where human reader performance would be a relevant metric.

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

Not Applicable. This document describes the performance of a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on established industry standards and pharmacopeial specifications. This includes:

• Physical Properties: Standards like ISO7886-1, ISO80369-7, ASTM F2338-09.
• Chemical Composition: United States Pharmacopeia (USP) monographs such as USP, USP, USP6-466, USP6-471, USP, USP, USP, USP.
• Biocompatibility: ISO10993 series (ISO10993-11, ISO10993-10, ISO10993-5) and ASTM F756-17.
• Sterility Assurance: The mention of 10-6 SAL (Sterility Assurance Level) indicates adherence to established sterilization standards.

8. The Sample Size for the Training Set

Not Applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

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

Not Applicable. As there is no training set for a physical device, there is no ground truth establishment process in that context.

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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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