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The sterile Insulin Syringe is for single use, with the calibrated unit of insulin for U-40 & U-100. The Insulin Syringe is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface of the skin. The device is intended to be used for adults only.

The proposed device, Insulin Syringe, is a sterile device consisting of a calibrated hollow barrel, needle, needle cover and end cap. The Insulin syringe is intended for medical purpose for the manual aspiration of insulin and for the injection of insulin into parts of the body below the surface skin. The device is intended to be used for adults only. The needle is fixed on the syringe. The syringes barrel and plunger is made up of Polypropylene, the gasket is of Thermo Plastic Elastomer (TPE) and the needle cover (Top Cap) and end cap (Bottom Cap) is made of polypropylene.

The provided document describes the FDA 510(k) clearance for an Insulin Syringe (K233794). This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that a device meets specific performance criteria for an AI/ML algorithm.

Therefore, the information typically required to answer your request regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" for an AI/ML-powered device is not present in this document.

This document describes a medical device, an insulin syringe, which is a physical product, not an AI/ML software. The performance data presented refers to standard physical and biological tests for such a device (e.g., sterilization, biocompatibility, needle strength, etc.), not the performance metrics of an AI algorithm.

Here's a breakdown of why this document doesn't fit your request and what is actually discussed:

• Type of Device: The device is an "Insulin Syringe," a physical medical instrument for injecting insulin. It does not incorporate AI or machine learning.
• Purpose of the Document: This is an FDA 510(k) clearance letter. Its primary purpose is to establish "substantial equivalence" of a new device to a legally marketed predicate device, allowing it to be marketed. This is a common regulatory pathway for non-novel medical devices.
• "Acceptance Criteria" discussed: The "acceptance criteria" for a physical device like an insulin syringe are generally defined by recognized standards (e.g., ISO standards for sterile hypodermic needles, biocompatibility standards). The document states that performance testing was conducted "to ensure the substantial equivalence...and verify conformity to the applicable parts of ISO standards."
• "Study" discussed: The "study" refers to a series of performance tests (e.g., ISO 7864:2016, ISO 9626:2016, ISO 8537:2016 for physical characteristics; Biocompatibility testing as per ISO 10993-1; Sterilization, shipping, and shelf-life validation). These are laboratory and bench tests, not clinical studies involving AI models.

In summary, as the provided text is for a physical medical device (Insulin Syringe) and not an AI/ML-powered device, it does not contain the information you requested regarding acceptance criteria and study data for AI/ML performance.

To answer your prompt for an AI/ML device, you would need a document detailing the validation of an AI algorithm, which would include information on metrics like sensitivity, specificity, AUC, human-in-the-loop studies (MRMC), ground truth establishment, training data, and more. This document does not pertain to such a device.

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Flush Syringe (Prefilled 0.9% normal saline solution) is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices.

Flush Syringe (Prefilled 0.9% normal saline solution) is a polypropylene plastic syringe filled with 0.9% sodium chloride for injection, USP, and capped with a polypropylene syringe tip cap. The Flush Syringe (Prefilled 0.9% normal saline solution) consists of barrel, plunger, gasket and thread stopper which is used after the intended purpose is achieved to cover the barrel tip of the device. The Flush Syringe (Prefilled 0.9% normal saline solution) is sterile, non-pyrogenic and for single use.

The provided document describes the acceptance criteria and a summary of non-clinical testing for the "Flush Syringe (Prefilled 0.9% normal saline solution)". This is a medical device, and the testing outlined is for its safety and performance, not for an AI model. Therefore, many of the requested fields related to AI/algorithm performance (e.g., effect size of human readers with AI assistance, standalone algorithm performance, training set details) are not applicable.

Here's the information extracted from the provided text, focusing on the device's acceptance criteria and the study proving it:

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

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

The document does not specify the exact sample sizes for each test conducted. It only lists the tests performed, the methods used, and the acceptance criteria. The provenance of the samples (e.g., country of origin, retrospective/prospective) is also not mentioned. These tests are laboratory-based non-clinical tests rather than studies involving patient data.

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 is a medical device, and the performance testing is based on established international and national standards and laboratory methods, not expert interpretation of outputs like in AI/CAD systems.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth in AI model evaluations, not for the direct physical and chemical testing of a sterile medical device.

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 document is for the premarket notification of a physical medical device (flush syringe), not an AI or CAD system. Thus, no MRMC study or AI-related effectiveness is discussed.

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 system.

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

The "ground truth" for this device is established by adherence to recognized consensus standards and validated chemical/physical testing methods (e.g., ISO, ASTM, USP). The acceptance criteria for each test (e.g., pH range, bacterial endotoxin limits, physical strength) serve as the objective ground truth.

8. The sample size for the training set

Not applicable. This device is not an AI model, so there is no training set.

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

Not applicable. There is no training set for a physical medical device.

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