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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 Insulin Syringes without needle is intended for medical purpose in conjunction with sterile needle for the manual aspiration and injection of U100 insulin into subcutaneous tissues.

The Insulin Syringes without needle is a sterile and single use syringe intended for injection of U-100 insulin into the body, in conjunction with a sterile needle. The proposed device is available in 1 ml. The proposed device is sterilized by Ethylene Oxide to achieve a SAL of 10-6 and supplied in immediate package to maintain the sterility of the device during the shelf life of 5 years.

This document is a 510(k) Summary for a medical device called "Insulin Syringes without needle" (K221045) from Berpu Medical Technology Co., Ltd. It compares the proposed device to a predicate device (K162180) to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and supporting studies as presented in the document:

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

The document does not explicitly present acceptance criteria in a table format with corresponding reported device performance for a specific study. Instead, it describes adherence to recognized standards and successful completion of various tests. For the purpose of this request, I will synthesize the information into a table based on the non-clinical testing performed and the standards referenced.

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

The document does not specify sample sizes for "test sets" in the context of clinical studies, as it explicitly states "No clinical study is included in this submission."

For non-clinical tests (e.g., performance, biocompatibility, sterilization validation, shelf-life, packaging), specific sample sizes used for testing are not provided in this summary. The data provenance would be from the manufacturer's internal testing or contracted laboratories performing tests according to the cited ISO and ASTM standards. This testing is typically prospective, performed on manufactured devices.

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

Not applicable. No clinical studies were conducted, and therefore, no expert-established ground truth for a clinical test set is relevant to this submission.

4. Adjudication method for the test set

Not applicable. No clinical studies were conducted, and therefore, no adjudication method for a clinical test set is relevant to this submission.

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 an insulin syringe, not an AI-powered diagnostic or assistive tool. No MRMC study was mentioned or would be relevant.

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

Not applicable. This device is an insulin syringe, not an algorithm or AI system.

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

For the non-clinical tests, the "ground truth" is established by the specified international (ISO) and national (ASTM, USP) standards. The device is tested against these standards, and its performance is compared to the requirements outlined in those standards. For example, for particulate matter, the ground truth is the maximum particle count allowed by USP . For sterility, the ground truth is a SAL of 10^-6^ as per ISO 11135.

8. The sample size for the training set

Not applicable. No AI/machine learning component is involved, so there is no training set in this context.

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

Not applicable. No AI/machine learning component is involved, so there is no training set or corresponding ground truth establishment in this context.

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The Safety Insulin Syringe is a sterile, single use and non-reusable syringe intended for injection of U-100 insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse.

The Safety Insulin Syringe is a sterile, single use and non-reusable syringe with a permanently attached needle, which is intended for injection of U-100 insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse. The proposed device is available in 0.3ml, 0.5ml, 1ml volumes with a 26G-34G gauge needle. The safety feature will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.

The provided text describes a 510(k) premarket notification for a medical device, the "Safety Insulin Syringe," not an AI/ML medical device. Therefore, the information required to populate the fields related to AI/ML acceptance criteria and study design (such as training sets, test sets, expert adjudication, MRMC studies, etc.) is not present in the document.

The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing of the physical, chemical, and performance characteristics of the syringe itself, as well as its safety features.

However, I can extract the acceptance criteria and performance data that are relevant to this type of medical device submission.

Here's a summary based on the provided text, focusing on the available information:

Acceptance Criteria and Device Performance (for a non-AI/ML medical device)

The device, a "Safety Insulin Syringe," is evaluated based on its physical, chemical, and safety performance. The acceptance criteria are typically compliance with recognized international standards and demonstration of specific functional parameters.

• Force to activate the safety mechanism: less than 5N.
• Force that the safety mechanism is destroyed (resist force): greater than 20N. | The safety feature performance test for the proposed device was evaluated, and the test result conforms to requirements of ISO 23908:2011 standards.
• "The force to activate the safety mechanism is less than 5N" was met.
• "The force that the safety mechanism is destroyed is greater than 20N" was met. |
  | Biocompatibility | Compliance with ISO 10993-1 for Externally Communicating Device, Blood Path Indirect, Prolonged Contact (>24 hours to 30 days). Testing includes: Cytotoxicity, Sensitization, Irritation or intracutaneous reactivity, Acute systemic toxicity, Pyrogenicity, Hemocompatibility, Subacute Systemic Toxicity. | Biocompatibility evaluated and results comply with ISO 10993 requirements. Specific tests conducted were: Cytotoxicity, Sensitization, Irritation or intracutaneous reactivity, Acute systemic toxicity, Pyrogenicity, Hemocompatibility, and Subacute Systemic Toxicity. |
  | Particulate Matter | Compliance with USP . | Testing performed and results not explicitly stated but implied to be compliant through lack of identified issue. |
  | Sterilization & Residues | Validation of sterilization per ISO 11135. Compliance with ISO 10993-7:2008 for EO and ECH (Ethylene Chlorohydrin) residue limits. Compliance with USP for Bacterial Endotoxin Limit. | Sterilization method validated per ISO 11135. Device found to be compliant with ISO 10993-7:2008 for EO and ECH residue and USP for Bacterial Endotoxin Limit. |
  | Shelf Life & Packaging Integrity | Shelf life of 5 years. Evaluation using physical, mechanical, chemical, and package tests on aging samples (validated using ASTM F1980-16 for accelerated aging). Simulated Transportation Test (ASTM D4169-16). Sterile Barrier Packaging Testing: Visual Inspection (ASTM F1886 / F1886M-16), Seal Strength (ASTM F88/F88M-15), Dye Penetration (ASTM F1929-15). | 5-year shelf life determined based on stability studies including accelerated aging. Simulated transportation test conducted according to ASTM D4169-16. Sterile barrier packaging tests performed: Visual Inspection (ASTM F1886 / F1886M-16), Seal Strength (ASTM F88/F88M-15), and Dye Penetration (ASTM F1929-15) – all implied to be compliant. |
  | Simulated Clinical Use (for Sharps Injury Prevention) | Evaluation of the safety mechanism according to FDA Guidance, "Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature" (August 9, 2005) and ISO 23908. Pre-established criteria for safe and effective activation and protection. | A simulated clinical use study was performed on 500 device samples. The results demonstrated that the proposed device met the pre-established criteria. |

Since this is not an AI/ML device, the following points are not applicable and are listed as "N/A":

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

   • Test Set Sample Size: N/A (for AI/ML test sets). For simulated clinical use of the physical device, 500 device samples were used.
   • Data Provenance: N/A (for AI/ML test sets, as no image/data input is being classified). The physical device performance testing was performed by the manufacturer, Berpu Medical Technology Co., Ltd. (China). The tests are non-clinical (laboratory/bench testing) and simulate real-world use.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (no ground truth based on expert review of data is established for this type of device).

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

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: N/A.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A (for AI/ML ground truth). The "ground truth" for this medical device is adherence to physical/performance standards (e.g., ISO, ASTM, USP) and functional testing parameters for its mechanical safety features.

8. The sample size for the training set: N/A.

9. How the ground truth for the training set was established: N/A.

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The Sterile Safety Insulin Syringes For Single Use are a sterile, single-use, disposable and non-reusable, manual retractable safety insulin syringe intended for injection of U40 or U100 insulin into the body, the sliding sleeve helps protect against needle puncture once activated.

KDL Sterile safety insulin syringes have a sliding sleeve which is designed to shield the injection needle to protect the user from needle puncture and the sliding sleeve helps protect against needle puncture once activated. The sliding sleeve can be activated manually.

The provided text is a 510(k) summary for a medical device (Sterile Safety Insulin Syringes for Single Use) and primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study proving the device meets specific acceptance criteria in the format requested.

The document outlines conformity to various ISO standards and other regulatory requirements but does not detail a specific study with an acceptance criteria table, sample sizes for test/training sets, expert qualifications, or MRMC study results as one might expect for a diagnostic AI/imaging device. Instead, it describes a series of non-clinical tests to verify design specifications and compliance with recognized standards.

Therefore, many sections of your request cannot be directly answered from the provided text.

Here's what can be extracted and inferred:

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

The document lists several ISO standards that the device "complies with" or "conforms to." These standards inherently contain acceptance criteria, and the statement of compliance/conformance indicates that the device met these criteria. However, specific numerical acceptance criteria and reported device performance values are not explicitly stated in a consolidated table format in this document. Instead, compliance with the standard is the reported performance.

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

The document states "Non-clinical tests were conducted to verify that the proposed device met all design specifications." However, specific sample sizes for these tests are not provided. The data provenance (e.g., country of origin, retrospective/prospective) is also not specified.

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

This type of information is generally relevant for studies involving human interpretation or subjective assessment, particularly in AI or imaging diagnostics. For a non-clinical device like a syringe, "ground truth" is established through physical and chemical testing against defined standards. Therefore, this information is not applicable and not provided in the document.

4. Adjudication method for the test set

Similarly, adjudication methods (e.g., 2+1, 3+1) are common in studies where multiple human readers interpret data that is then arbitrated. This is not applicable to the non-clinical testing of a syringe and therefore not provided.

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

An MRMC study is relevant for evaluating the impact of AI assistance on human performance, typically in diagnostic tasks. This document describes a physical medical device (syringe) and its non-clinical testing. Therefore, an MRMC comparative effectiveness study is not applicable and not performed/reported.

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

This question is also related to AI algorithm performance. As this document concerns a physical syringe, a standalone algorithm performance study is not applicable and not performed/reported. The non-clinical tests served as the "standalone" evaluation of the device's physical properties.

7. The type of ground truth used

For this device, the "ground truth" used for testing would be the specifications and requirements defined by the various ISO standards and USP . This includes physical dimensions, material properties, sterility, particulate matter limits, and biocompatibility criteria.

8. The sample size for the training set

This question is relevant for AI/machine learning models. For the non-clinical testing of a physical medical device, there is no "training set" in the AI sense. This information is not applicable and not provided.

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

Again, this is relevant for AI/machine learning. For this device's non-clinical testing, there is no training set. The "ground truth" for evaluating the device's conformance to standards is established by the scientific and regulatory consensus embodied in the ISO standards and USP monographs themselves. This information is not applicable and not provided.

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Sure-fine Insulin Syringes are hypodermic insulin syringes for subcutaneous injection of U100 insulin.

Sure-fine Insulin syringes are designed for the subcutaneous injection of a desired dose of insulin. The syringe has a graduated barrel(U-100), a plunger rod, needle cap, protective end cap and needle permanently affixed to the tip of the syringe with expoxy.

The provided document describes a 510(k) premarket notification for "Sure-Fine Insulin Syringes." The submission is based on demonstrating substantial equivalence to a legally marketed predicate device, rather than a clinical effectiveness study. Therefore, some of the requested information (such as effect size of human readers with/without AI assistance, standalone algorithm performance, number of experts for ground truth, and training set details) is not applicable to this type of medical device submission.

Here's the information that can be extracted from the document:

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

The acceptance criteria are implicitly tied to various testing standards to demonstrate biocompatibility and performance. The reported performance is that the device complies with these standards, supporting its substantial equivalence.

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

The document does not explicitly state the sample sizes for each specific test. These are typically determined by the requirements of the individual ISO and ASTM standards cited for each test. Data provenance is not specified, but these are laboratory tests performed on the device components or final product itself, not clinical data from countries of origin. The study described is a series of laboratory and biocompatibility tests, not a clinical study involving patients or data sets.

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

Not applicable. This is not a study requiring expert readers to establish ground truth. The "ground truth" for these tests comes from established scientific and engineering principles within each standard.

4. Adjudication method for the test set:

Not applicable. This is not a study requiring adjudication of expert interpretations. The results are typically quantitative measurements or qualitative assessments (e.g., presence/absence of cytotoxicity) as defined by the standard.

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-assisted diagnostic tool, but a medical syringe.

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

Not applicable. This device is not an algorithm.

7. The type of ground truth used:

The ground truth is based on recognized industry standards and scientific testing procedures (ISO 10993 series, ASTM F756-17, ASTM F1980, ISO 8537, ISO 7864, USP ) for biocompatibility and performance of syringes.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI-driven device requiring a training set.

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

Not applicable. This is not a machine learning or AI-driven device.

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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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Sure-Fine Insulin Syringes are hypodermic insulin syringes for subcutaneous injection of U100 insulin.

Sure-fine Insulin syringes are designed for the subcutaneous injection of a desired dose of insulin. The syringe has a graduated barrel, a plunger rod, needle cap, protective end cap and needle permanently affixed to the tip of the syringe with epoxy. The syringes are available in the following sizes and cap color. The modified Sure-Fine Insulin syringe is substantially equivalent to the predicate device (Sure-Fine Insulin Syringes, K152879). The biggest difference between the modified device and predicate device is the addition of needle gauge (27G) and the addition of needle length (1/4"). The devices operate in the principles of a piston syringe fluid path is sterile (EO gas sterilization), Non-toxic, Non-pyrogenic and single use disposable.

This document is a 510(k) Pre-market Notification for "Sure-Fine Insulin Syringes." It focuses on demonstrating substantial equivalence to a previously cleared predicate device (K152879) rather than presenting a standalone study with acceptance criteria and device performance metrics in the typical sense of AI/software device evaluation.

The changes in the current device (K191531) compared to the predicate device (K152879) are primarily the addition of a new needle gauge (27G) and a new needle length (1/4").

Therefore, the "acceptance criteria" and "study" described in the document are about demonstrating that these new configurations and the overall modified device continue to meet established standards for insulin syringes.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a typical "acceptance criteria" table with specific quantitative thresholds. Instead, it refers to compliance with recognized international standards for medical devices, which inherently contain the acceptance criteria for various tests. The "reported device performance" is essentially the finding that the device complies with these standards.

Note: The document states "appropriate testing was completed to demonstrate that the syringes comply with the following FDA recognized standards". It does not provide the raw data or specific test results for each of these standards in this summary. The "reported performance" is the claim of compliance.

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

• Sample Size: The document does not specify the sample sizes used for the testing conducted against the ISO standards. This information would typically be found in the full test reports, not in the 510(k) summary.
• Data Provenance: The document doesn't explicitly state the country of origin for the testing data itself, but the manufacturer is SHINA MED CORPORATION in South Korea (Rep. of Korea). The testing would presumably be conducted by or for the manufacturer, either in Korea or by a certified testing lab. The study is prospective in the sense that the testing was performed to support this specific submission for the modified device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This question is not applicable to this type of device submission. Insulin syringes are physical medical devices, and their performance is evaluated through engineering and biological testing against established international standards (like ISO standards), not by human expert interpretation or ground truth labeling in the way an AI/software device would be.

4. Adjudication Method for the Test Set

• This question is not applicable. There is no "test set" that requires adjudication by human experts. Device performance is determined by objective measurements against specified physical and chemical properties and functional requirements outlined in the ISO 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

• This question is not applicable. This submission is for an insulin syringe, which is a physical medical device, not an AI/software device that involves human readers or AI assistance.

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

• This question is not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is defined by the requirements and test methods specified in the referenced international standards (ISO 7864, ISO 9626, ISO 8537, ISO 10993-1). Compliance with these standards serves as the "ground truth" that the device is safe and effective for its intended use. For example, a needle's sharpness or a syringe's dose accuracy would be measured against specific, quantifiable criteria in these standards.

8. The Sample Size for the Training Set

• This question is not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.

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

• This question is not applicable. As there is no training set for a physical device.

In summary: The acceptance criteria and "study" for this device are based on demonstrating compliance with recognized international standards for medical devices, particularly those related to sterile hypodermic needles and insulin syringes. The document asserts that "appropriate testing was completed" to show this compliance, thereby proving the device meets the acceptance criteria for substantial equivalence to its predicate for its intended use, including the newly added specifications.

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Becton Dickinson insulin syringes are intended for subcutaneous injection of U-100 insulin.

The subject BD Insulin Syringes (BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine™ needle and BD Insulin Syringes with Micro-Fine™ IV Needle) are a 1.0mL self-contained plastic syringe designed for subcutaneous injection of a desired dose of insulin. The BD Insulin Syringe consists of a graduated barrel, plunger rod and needle/hub assembly. It is available in various needle gauge sizes (27G, 28G, 29G, 30G and 31G) and various needle lengths (6mm, 8mm, 12.7mm and 16mm). The BD Insulin Syringes are sterile, single use, and non-toxic. The fluid path of the syringe is sterile and non-pyrogenic. These devices operate on the principles of a piston syringe.

The document describes the acceptance criteria and the study that proves the device meets those criteria for the BD Ultra-Fine™ Insulin Syringe and related insulin syringes.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it describes general categories of testing and confirms that the results were "acceptable" and met "requirements for its intended use." Based on the provided text, the acceptance criteria are implicitly defined by compliance with ISO standards and the demonstrated equivalence to predicate devices.

• Hemolysis: Acceptable
• Acute Systemic Toxicity: Acceptable
• Intracutaneous Reactivity: Acceptable
• Pyrogenicity: Acceptable
• Sensitization: Acceptable
• Comparative Extractables/Leachables: Acceptable
• Primary Dermal Irritation: Acceptable |
  | Device Functional Performance | - Cannula-Syringe Bond: Acceptable (met requirements)
• Scale Mark Permanency: Acceptable (met requirements)
• Scale Mark Legibility: Acceptable (met requirements)
• Drug Compatibility/Stability: Acceptable (met requirements) |
  | Sterility | Yes (Gamma Irradiation), SAL 10^-6 |
  | Single Use Only | Yes |
  | Non-pyrogenic | Yes |
  | Substantial Equivalence to Predicate Devices | Demonstrated through analysis and testing of modifications. |

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

The document does not specify the sample sizes used for any of the described tests (biocompatibility or functional performance tests).

The data provenance is from non-clinical testing performed by Becton, Dickinson and Company. The document does not provide information regarding the country of origin of the data or whether it was retrospective or prospective, as these are non-clinical (laboratory) tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable as the study described is non-clinical performance and biocompatibility testing of medical devices, not a study involving human subjects or expert assessment of clinical data to establish ground truth. The "ground truth" here is determined by objective laboratory measurements against established standards (ISO 10993-1, ISO 8537) and internal company specifications.

4. Adjudication Method for the Test Set

This information is not applicable to non-clinical laboratory testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for independent review of patient cases.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study involves human readers interpreting cases, often with and without AI assistance, to measure diagnostic performance. The described study focuses on the physical and chemical properties and performance of an insulin syringe.

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

This concept is not applicable to this device. A standalone algorithm performance study relates to AI/machine learning algorithms. The device in question is a physical insulin syringe, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this non-clinical testing is established by:

• Compliance with International Standards: Specifically ISO 10993-1 (Biological evaluation of medical devices) and ISO 8537 (Sterile single-use syringes, with or without needle, for insulin).
• Established Test Methodologies: Standardized laboratory tests for properties like cytotoxicity, bond strength, scale readability, and material compatibility.
• Substantial Equivalence: Comparison against the performance characteristics of predicate devices already cleared by the FDA.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is not a machine learning or AI-based device. The testing focuses on manufacturing processes, materials, and mechanical/chemical performance.

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

This information is not applicable for the same reason as above.

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Sure-Fine Insulin Syringes are hypodermic insulin syringes for subcutaneous injection of U100 insulin.

Sure-Fine Insulin Syringes are designed for the subcutaneous injection of a dose of U-100 insulin. The syringe has a graduated barrel, a plunger rod, needle cap, protective end cap and needle permanently affixed to the tip of the syringe with epoxy. The syringes are available in the following sizes and cap color.
Category: U-100
Insulin syringe: 1/2cc and 1cc, 3/10cc, 1/2cc and 1cc
Needle Gauge: 28Gauge, 29Gauge, 30Gauge, 31Gauge
Needle Length: 1/2", 5/16"
Cap color: Needle cap: Orange, Plunger Cap: Orange or white
This device operates in the principles of a piston syringe fluid path is sterile (EO gas sterilization), single use disposable.

This document is a 510(k) Summary for the Sure-Fine Insulin Syringes, which is a regulatory submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. As such, it does not describe an acceptance criteria or a study designed to establish clinical performance of a novel device in the same way one might describe for a diagnostic AI algorithm.

Instead, the document details non-clinical testing to demonstrate that the Sure-Fine Insulin Syringes meet established performance and safety standards, proving substantial equivalence to a predicate device.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a typical "acceptance criteria" table with specific numerical thresholds for accuracy, sensitivity, or specificity as one would expect for an AI/diagnostic device. Instead, it lists the voluntary standards and clauses from those standards that the device was designed and tested to meet. The "reported device performance" is the conclusion that the device successfully met these requirements, thus demonstrating substantial equivalence.

| Standard/Test | Acceptance Criteria (implied by standard) | Reported Device Performance |
| :----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------- |
| Performance Testing (per ISO 8537:2007) | Compliance with physical and functional requirements for sterile single-use hypodermic syringes for insulin. (e.g., freedom from extraneous matter, extraction, lubrication, range of sizes, graduated scale, barrel, piston/plunger, nozzle, needles, assembled syringe performance). | Successfully met the applicable requirements. |
| Biocompatibility Testing (per ISO 10993 Series) | Compliance with biological safety requirements for devices in contact with patients (e.g., in vitro cytotoxicity, irritation, sensitization, acute systemic toxicity, interaction with blood, pyrogenicity). | Successfully passed testing as outlined. |
| Sterilization & Shelf-life Testing (per ISO 11135, ISO 10993-7) | Sterility Assurance Level (SAL) of 10-6; maximum levels of ethylene oxide and ethylene chlorohydrins within limits; a 5-year shelf-life. | Validated sterilization with SAL = 10-6; EO/ECH levels did not exceed limits; 5-year shelf-life supported. |

Important Note: This is a traditional medical device (insulin syringe), not an AI/software device. Therefore, the questions related to AI-specific metrics, ground truth, expert consensus, and MRMC studies are not applicable. The device's performance is assessed through engineering and biological safety tests against established standards for its mechanical function and material safety.

The following questions are not applicable to this specific submission as it pertains to a physical medical device (insulin syringe) and not an AI or diagnostic software. Therefore, there are no details on test sets, ground truth establishment by experts, or MRMC studies.

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

• Not Applicable. This is a physical medical device. Testing involved physical samples of the syringe, not a "data test set." The document does not specify the number of samples tested for each engineering or biological test.

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. There is no "ground truth" to be established by experts in the context of an insulin syringe's physical and functional properties.

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

• Not Applicable.

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 or diagnostic software. No human readers or AI assistance are involved in its primary function or evaluation for substantial equivalence.

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

• Not Applicable. This is a physical medical device; no algorithm is present.

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

• Not Applicable.

8. The sample size for the training set

• Not Applicable. This is a physical medical device; there is no "training set" in the context of an AI or machine learning model.

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

• Not Applicable.

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This device is a hypodermic insulin syringe for subcutaneous injection of insulin.

Shina Insulin Syringes are designed for the subcutaneous injection of a desired dose of insulin. The syringe has a graduated barrel, a plunger rod and needle/hub assembly. The needle shield is colored orange. The Syringes are available in the following sizes:

1/2cc and 1cc 28 gauge x 1/2"
3/10cc, 1/2cc, and 1cc 29 gauge x ½"
3/10cc, 1/2cc, and 1cc 30 gauge x 1/2"
3/10cc, 1/2cc, and 1cc 30 gauge x 5/16"
3/10cc, 1/2cc, and 1cc 31 gauge x 5/16"

These devices operate on the principles of a piston syringe. The syringe fluid path is sterile (EO Gas sterilization), non-toxic, non-pyrogenic, and single use disposable.

The provided text describes a 510(k) summary for Shina Insulin Syringes, which is a submission to the FDA to demonstrate substantial equivalence to a predicate device. This document does not contain an "acceptance criteria and study" in the typical sense of a clinical or analytical performance study with specific metrics like sensitivity, specificity, or accuracy compared to a ground truth established by experts.

Instead, the "performance" section refers to bench tests conducted to demonstrate equivalence to a predicate device for the purpose of regulatory clearance.

Here's the information extracted from the document, organized to address your questions as much as possible within the given context:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "The results demonstrate that Shina Insulin Syringes perform equivalent to the predicate devices and are safe and effective when used as intended." This implies that the acceptance criteria for each test were met if the performance was equivalent to the predicate devices (BD Insulin Syringe: K941657, K955235, K024112).

2. Sample Size and Data Provenance

• Sample Size for Test Set: The document does not specify the sample size used for the bench tests.
• Data Provenance: The tests were conducted internally by Shina Corporation, whose factory is located in Kongju-City, Choong Nam, Korea. The study is retrospective in the sense that it's a submission for regulatory clearance based on testing of the manufactured product, not a prospective clinical trial.

3. Number of Experts and Qualifications for Ground Truth

• This question is not applicable to this type of regulatory submission. Bench tests for medical devices like syringes do not typically involve human experts establishing a "ground truth" for diagnostic or predictive purposes. The "ground truth" for these tests is based on objective, measurable physical properties and engineering standards (e.g., force measurements, dimensional accuracy).

4. Adjudication Method for Test Set

• Not applicable. Bench tests measure physical properties against defined engineering specifications or in comparison to a predicate device, which does not require adjudication by human experts.

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

• No. This is a physical medical device (syringe), not an AI or diagnostic imaging device that would typically involve an MRMC study.

6. Standalone Performance Study

• Yes, in the context of bench testing. The "Performance" section describes bench tests (needle pull-out, hub pull-off, needle angularity, needle break-off testing, and dose accuracy) that evaluate the device itself. These are considered standalone performance tests for the physical properties of the syringe.

7. Type of Ground Truth Used

• For this type of device, the "ground truth" refers to established engineering specifications, physical measurement standards, and performance characteristics of legally marketed predicate devices. The aim is to demonstrate that the Shina Insulin Syringes meet these specifications and perform equivalently to the predicate.

8. Sample Size for Training Set

• Not applicable. This document is about a physical medical device and its bench testing, not an algorithm or AI model that requires a "training set."

9. How Ground Truth for Training Set Was Established

• Not applicable. As above, no training set is relevant in this context.

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