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The Retractable Safety Insulin Syringe is a sterile, single use, disposable and non-reusable, automatically retractable safety insulin 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 Retractable Safety Insulin Syringe has the same technological characteristics as the Retractable Safety Syringe(manufacture by Jiangsu Caina Medical Co., Ltd.) as cleared in K191490 at date 2019/10/03. The difference between the Retractable Safety Insulin Syringe and the 1ml Retractable Safety Syringe is only the scale.

The Retractable Safety Insulin Syringe works like a conventional insulin syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. Because the contaminated needle is automatically withdrawn into the syringe plunge, the syringe user is protected from accidental needle sticks. These accidental needle sticks would occur between removing the needle from the patient and disposing of the syringe in a sharps disposable container.

The Retractable Safety Insulin Syringe is available in various specifications. The proposed device consists of eleven components: (1) plunger. (2) piston. (3) barrel. (4) needle cap. (5) sealing plug. (6) slide bushing, (7) needle tube, (8) spring, (9) plunger lid, (10) barrel barb, (11) hub.

The proposed device is provided sterile. The product is sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years.

The provided text is a 510(k) Summary for a Retractable Safety Insulin Syringe (proposed device) and focuses on demonstrating its substantial equivalence to a predicate device (U&U Insulin Syringe with/without Safety Retractable Device). The acceptance criteria and supporting study details provided are primarily non-clinical, comparing the proposed device against established standards and to the predicate.

Here's the information extracted and organized as requested, with "N/A" where the document does not provide the specific detail, indicating it was likely not part of this specific submission or the type of device.

Table of Acceptance Criteria and Reported Device Performance

Study Details

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

   • Test Set Sample Size: Not explicitly stated for each test, but standard test methods (e.g., ISO, ASTM) typically specify lot sizes or sample numbers for compliance testing. The provided values for force measurements (e.g., 10.48-20.91 N) are ranges, suggesting multiple units were tested.
   • Data Provenance: The tests were non-clinical, conducted by the manufacturer (Jiangsu Caina Medical Co., Ltd., China) as part of their substantial equivalence submission. The studies are by nature prospective tests performed on the manufactured device.

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

   • Number of Experts: N/A. This was a non-clinical device performance and materials testing study, not a study involving expert human interpretation or ground truth establishment in a clinical sense (e.g., image-based diagnosis). The "ground truth" here is compliance with established international and national standards for medical devices and their components.
   • Qualifications of Experts: N/A. The compliance is assessed by technical testing, not expert consensus on interpretations.

3. Adjudication Method for the Test Set:

   • Adjudication Method: N/A. As a non-clinical, standards-based compliance study, there was no "adjudication" in the sense of reconciling differing expert opinions. Test results are objective measurements against predefined criteria.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

   • MRMC Study: No. The document explicitly states: "Simulated clinical study was not conducted on proposed device," and "No clinical study is included in this submission." This type of study is common for diagnostic AI, not for a mechanical medical device like a syringe.
   • Effect Size of Human Readers Improvement: N/A, as no MRMC study was performed.

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

   • Standalone Performance: N/A. This device is a mechanical syringe, not an algorithm. The "performance" discussed is the mechanical, biological, and material compliance of the device itself.

6. The Type of Ground Truth Used:

   • Ground Truth: The ground truth for this device's acceptance is adherence to established international and national standards (e.g., ISO, ASTM, USP) for the performance, safety, and biocompatibility of syringes and their components, as well as comparison to a legally marketed predicate device. For example, the "ground truth" for "Force to activation" is that it must be

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The Retractable Safety Syringe works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection is activated by the syringe user. Because the contaminated needle is automatically withdrawn into the syringe user is protected from accidental needle sticks. These accidental needle sticks would occur between removing the needle from the patient and disposing of the syringe in a sharps disposable container.

For general injection use: The function of Retractable Safety Syringe is to provide a safe and reliable method of injecting fluids into or withdrawing fluids from the body. The Retractable Safety Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential or syringe contains various capacity, such as 1ml, 2.5ml, 3ml, 5ml and 10ml.

For allergy use: The 1ml Retractable Safety Allergy Syringe is intended for the preparation/mixing of allergenic extracts/ prescribed substances, the manual aspiration of fluids, and for the injection of fluids into parts of the body below the surface of the skin. The Retractable Safety Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential or syringe reuse.

For Tuberculin use: The 1ml Retractable Safety Tuberculin Syringe is intended for the delivery of Tuberculin. The Retractable Safety Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential or syringe reuse.

The proposed devices are available in various specifications, including 1ml, 2.5ml, 3ml, 5ml and 10ml. The applications of Retractable Safety Syringe include general injection, allergy and Tuberculin. General injection use is for 1ml, 2.5ml, 3ml, 5ml and 10ml, while allergy and Tuberculin uses are only for 1ml. The combinations of syringe and needle are listed in the below table.

The proposed device consists of eleven components: (1) piston, (3) barrel, (4) needle cap, (5) sealing plug, (6) slide bushing, (7) needle tube, (8) spring, (9) plunger lid, (10) barrel barb, (11) hub.

The proposed devices are provided sterile. The product is sterilized by Ethylene Oxide Gas to achieve a SAL of 10 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years.

The provided text describes the 510(k) premarket notification for a Retractable Safety Syringe. It does not contain information about a study proving the device meets specific acceptance criteria in the context of AI/ML performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing against established international standards for medical devices.

Therefore, many of the requested elements for an AI/ML-focused study acceptance criteria cannot be extracted from this document, such as sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, or ground truth types.

However, I can extract information related to the device's functional and safety performance, which are its acceptance criteria in this context, and the studies performed to demonstrate these.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices like syringes, "acceptance criteria" are typically defined by regulatory standards (e.g., ISO, ASTM, USP) that specify performance requirements. The "reported device performance" is then the demonstration that the device meets these standards.

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 mentions "non-clinical tests" and a "simulated clinical use study." However, it does not specify the exact sample sizes for these tests. The data provenance (country of origin, retrospective/prospective) is also not stated. These are typically detailed in the full test reports, which are not included in this summary.

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 device is a physical medical device (syringe) and its performance is evaluated against engineering and biological standards, not through expert-labeled ground truth for AI/ML performance.

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

Not applicable. As above, this pertains to expert review for AI/ML ground truth, which is not relevant here.

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 for AI/ML-assisted diagnostic or interpretative devices.

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

Not applicable. This device is a manual physical device, not an algorithm.

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

The "ground truth" for this device's performance is established by international and national standards (e.g., ISO, ASTM, USP) for physical and biological characteristics of syringes and needles. For the safety feature, it involves demonstration of compliance during a simulated clinical use study as per FDA guidance.

8. The sample size for the training set

Not applicable. This is for AI/ML models.

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

Not applicable. This is for AI/ML models.

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets its acceptance criteria is a comprehensive set of non-clinical performance tests conducted in accordance with recognized international and national standards. These include:

• Biocompatibility tests (ISO 10993 series, ASTM F756-17) to ensure the materials are safe for human contact.
• Sterilization and packaging integrity tests (ISO 10993-7, USP , ASTM F1929-15, ASTM F88/F88M-15, ASTM F1886/F1886M-16, USP 39-NF34 ) to confirm sterility and maintain it until use.
• Physical and functional performance tests for needles and syringes (ISO 7864:2016, ISO 9626:2016, ISO 7886-1:2017) to ensure they meet specifications for injection.
• Sharps injury prevention tests (ISO 23908:2011) to verify the effectiveness of the retractable safety feature.
• Particulate matter tests (USP 39-NF34 ) to ensure fluid cleanliness for injection.
• A simulated clinical use study to specifically evaluate the effect and effectiveness of the safety feature as per FDA guidance.

The document states that "The test results demonstrated that the proposed device complies with the following standards" for each category, indicating that the device met the acceptance criteria defined by these standards.

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