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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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