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The Insulin Syringes are intended for subcutaneous injection of U100 insulin or U40 insulin.

The Insulin Syringes are 0.3 mL, 0.5 mL, or 1.0 mL synnges designed for subcutaneous injection of a desired dose of insulin. The Insulin Syringes consist of a graduated barrel, plunger rod and needle/hub assembly. It is available in various needle gauge sizes (25G, 26G, 27G, 28G, 29G, 30G and 31G) and various needle lengths (6mm). The Insulin Syringes are sterile, single use, and non-toxic. These devices operate on the principles of a piston syringe.

The provided document is an FDA 510(k) premarket notification for "Insulin Syringes," which are medical devices, not AI/ML-driven software with specific acceptance criteria related to a test set, expert ground truth, or MRMC studies. The document describes a traditional medical device (insulin syringes) and its substantial equivalence to previously cleared predicate devices.

Therefore, the requested information regarding acceptance criteria, study design (test set, ground truth, expert adjudication, MRMC, standalone performance, training set details) for an AI/ML device is not available in this document. The document primarily focuses on:

• Device Description: Physical characteristics (volume, needle gauge/length, materials), intended use (subcutaneous injection of U100/U40 insulin).
• Modifications: Updates to packaging options and syringe sizes compared to the predicate.
• Substantial Equivalence Justification: Comparison of indications for use, technological characteristics (design, materials, sterilization) with predicate devices.
• Performance Testing: References to ISO standards for sterile single-use syringes, hypodermic syringes, stainless steel needle tubing, hypodermic needles, and sterilization validation (e.g., ISO 8537, ISO 7886-1, ISO 9626, ISO 7864, ISO 11135, ASTM F1980-16). These are standard tests for physical and functional properties of syringes, not AI/ML performance metrics.

The "Performance Testing" section refers to engineering and manufacturing standards for physical device performance, not for the performance of an algorithm or software. There are no mentions of AI/ML, image data, diagnostic accuracy, or human reader studies.

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The CHIRANA® Insulin Syringes are intended for subcutaneous injection of U100 insulin or U40 insulin.

The CHIRANA® Insulin Syringes are a 0.3mL, 0.5mL, or 1.0mL syringes designed for subcutaneous injection of a desired dose of insulin. The CHIRANA® Insulin Syringes consist of a graduated barrel, plunger rod and needle/hub assembly. It is available in various needle gauge sizes (27G, 29G, 30G and 31G) and various needle lengths (6mm, 8mm, and 12.7mm). The CHIRANA® Insulin Syringes are sterile, single use, and non-toxic. These devices operate on the principles of a piston syringe.

The provided document is a 510(k) summary for the CHIRANA Insulin Syringes. It details the device's characteristics, indications for use, and performance testing to demonstrate substantial equivalence to a predicate device. However, this document does not contain the specific acceptance criteria and detailed study results for an AI/ML-based device in the format requested.

The document discusses the physical characteristics, materials, and mechanical performance testing of an insulin syringe, which is a traditional medical device, not a software-driven or AI/ML-enabled diagnostic or therapeutic device. The performance testing section refers to standards for sterile single-use syringes, hypodermic syringes, and needles, as well as biocompatibility and sterilization validations. These are typical assessments for a Class II physical medical device.

Therefore, I cannot fully complete the requested table and answer all questions related to AI/ML device performance validation, as the information is not present in the provided text.

However, I can extract information relevant to a physical medical device's performance assessment where applicable, and highlight what is missing based on the prompt's requirements for an AI/ML device.

Information that is applicable to a traditional medical device performance:

1. Table of Acceptance Criteria and Reported Device Performance:

For a physical device like an insulin syringe, acceptance criteria relate to physical and functional properties, manufacturing standards, and safety. The document states compliance with recognized ISO standards. While specific numerical acceptance criteria (e.g., maximum force to inject, specific flow rates) are not explicitly listed in a table, the document implies that the device met the requirements of these standards.

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

• Sample Size: Not explicitly stated in terms of number of units tested. For mechanical testing, this would typically be a specific number of syringes/needles per test type.
• Data Provenance: Not applicable in the context of "data provenance" for patient data in an AI/ML model. The testing is for manufactured physical goods. The testing was performed by "Empirical Testing Corp." (a consultant listed for the submitter).

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

• Not applicable (N/A). This is a physical device, not one requiring expert interpretation of complex data for ground truth establishment. Validation relied on adherence to engineering and material standards.

4. Adjudication Method for the Test Set:

• Not applicable (N/A). Adjudication (e.g., 2+1, 3+1) is a common practice for complex medical image interpretation or clinical outcome assessment in AI/ML studies to establish a consensus ground truth. For a physical device, compliance with established test methods and specifications is directly assessed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, not performed. This type of study is specific to AI/ML imaging or diagnostic devices where human readers' performance with and without AI assistance is evaluated. This device is a physical syringe.

6. Standalone (Algorithm Only) Performance:

• Not applicable (N/A). This refers to the performance of a software algorithm without human interaction. The CHIRANA Insulin Syringe is a physical device.

7. Type of Ground Truth Used:

• Not applicable in the AI/ML sense. For this physical device, "ground truth" would be defined by the specifications in the relevant ISO and ASTM standards (e.g., dimensional tolerances, material properties, injection force, leak rates, sterility assurance level). The device's performance was measured against these engineering standards. The phrase "expert consensus, pathology, outcomes data" is generally used for clinical ground truth in AI/ML or diagnostic studies.

8. The Sample Size for the Training Set:

• Not applicable (N/A). This concept pertains to machine learning models. For a physical device, there isn't a "training set" in the AI/ML sense. Training involves manufacturing processes and quality control.

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

• Not applicable (N/A). As above, this is an AI/ML concept.

In summary: The provided document describes the substantial equivalence review for a traditional medical device (insulin syringe) and details its compliance with relevant engineering and quality standards. It does not provide the information typically requested for demonstrating the performance of an AI/ML-driven medical device.

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The CHIRAVAC™ Blood Collection Needles are single use and are intended for venous blood collection in connection with blood collection tubes.

The CHIRAVAC™ Blood Collection Needles consists of a double-ended hollow stainless steel thin-walled cannula, a threaded polypropylene hub, a sleeve that interrupts blood flow between filling multiple tubes, and polypropylene caps. The device is single use and supplied sterile (ethylene oxide sterilized). The stainless steel cannula and silicone cannula lubricants are classified as externally communicating with limited (≤24 hours) duration contact; all other device components have no contact with patient blood, tissue, or skin. Once the vein has been accessed by puncturing with the intravenous end of the cannula, the healthcare professional will begin the blood collection process by placing evacuated blood collection tubes on the cannula's non-patient end, where the sleeve acts as a non-return valve and allows for more than one tube to be used to collect blood from the vein puncture.

This document describes a 510(k) premarket notification for the CHIRAVAC™ Blood Collection Needles. It does not present a clinical study involving human readers or AI algorithms. Instead, it focuses on demonstrating substantial equivalence to a legally marketed predicate device through performance testing (bench testing, biocompatibility, sterilization, shipping, and shelf-life).

Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria, specifically concerning human reader performance, AI assistance, standalone algorithm performance, and sample sizes for training/test sets, cannot be fully provided as it is not present in the document.

However, I can extract information related to the acceptance criteria for the device's physical and functional characteristics and the bench testing conducted to meet these criteria.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance (Summary of Bench Testing)

The document lists several international standards (ISO) and internal procedures to which the CHIRAVAC™ Blood Collection Needles were tested. The "reported device performance" is generally implied as "passed" or "met requirements" for each test, as the overall conclusion is that the device is substantially equivalent to the predicate. The document does not provide specific quantitative results for each test (e.g., "Fragmented less than X%").

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

This document describes bench testing of a physical medical device (blood collection needles), not a diagnostic algorithm that relies on a "test set" of data in the common sense (e.g., medical images).

• Sample Size: The document does not explicitly state the number of samples (e.g., individual needles or batches) used for each specific test. This level of detail is typically found in the full test reports, not the 510(k) summary.
• Data Provenance: The tests are conducted according to international standards (ISO, ASTM, European Pharmacopoeia) and internal Standard Operating Procedures (SOPs). The testing was performed by CHIRANA T. Injecta or third-party labs on their behalf, based in the Slovak Republic (Submitter's address). This is a prospective evaluation of manufactured 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 a study requiring expert interpretation of data to establish a "ground truth" for a diagnostic task. The ground truth for device performance is established by objective measurements against predefined acceptance criteria from the relevant standards (e.g., physical dimensions, strength, sterility).

4. Adjudication Method for the Test Set

Not applicable. No "adjudication" is described as this is not a diagnostic performance study involving multiple human readers or AI.

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. This is not an MRMC comparative effectiveness study, nor does it involve AI. It's a submission for a physical medical device.

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

No. This device does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on:

• International Standards: e.g., ISO 7864, ISO 6009, ISO 9626, ISO 10993 series, ASTM F756, ASTM F1980, European Pharmacopoeia. These standards define the acceptable physical, chemical, and biological properties.
• Predicate Device Characteristics: The device is compared to a legally marketed predicate (Sol-M Blood Collection Needles, K182146) to demonstrate substantial equivalence, implying the predicate's performance against relevant standards serves as a benchmark for safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device, so there is no training set.

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

Not applicable. There is no training set or associated ground truth as this is not an AI/ML device.

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