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Jeesung safety syringe and single use needles is a sterile, single-use, disposable and non-reusable, manual retractable safety syringe intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.

Jeesung Safety Syringe and Single Use Needles is an integrated needle and piston syringe with an anti-needle-stick mechanism. There is a swell on the top of inside barrel, which can be used to fix the top of inside barrel. Four legs on the bottom of hub are caught on the top of inside barrel when the hub is pulled. After using this syringe (such as injecting medicine into body etc.), the hub of needle is pulled back to the inside of the barrel. Because the four legs of hub is bound to the top of the plunger which has a smaller swell part than the top of inside barrel for being caught. Therefore, by pushing plunger until it makes a binding sound, the hub can follow with the plunger. Then the plunger is broken off and the needle cannot be come out of the barrel. This renders the needle unusable and safe from accidental needle sticks.

The provided text details a 510(k) submission for the Jeesung Safety Syringe and Single Use Needles, a Class II medical device. However, the document does not contain the specific acceptance criteria and detailed device performance results that you requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9.

This document is a regulatory submission summary that outlines the device, its intended use, comparison to a predicate device, and a list of the types of performance testing conducted. It states that "Test results were acceptable" but does not provide the quantitative acceptance criteria or the reported performance values.

Therefore, I cannot fulfill your request for:

• 1. A table of acceptance criteria and the reported device performance: The document lists the types of tests performed (e.g., limits for acidity, force to operate piston, cytotoxicity) but does not provide the specific "acceptance criteria" (e.g., "pH between X and Y," "force less than Z N") or the actual "reported device performance" (e.g., "pH was P," "force was Q N").
• 2. Sample size used for the test set and the data provenance: Not specified.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is a physical device and not an AI/imaging diagnostic device requiring expert interpretation for ground truth.
• 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, as this is a physical medical device, not an AI diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For physical device performance, ground truth typically refers to established standards and physical measurements, and the document states conformance to ISO standards (e.g., ISO7864, ISO7886, ISO10993).
• 8. The sample size for the training set: Not applicable, as this is a physical device, not a machine learning model.
• 9. How the ground truth for the training set was established: Not applicable.

What the document does provide regarding the study:

• Study Type: Performance testing (mechanical, chemical, biological) as required for a physical medical device under the MEG product code. This includes:
  • Needle Performance Testing (e.g., Appearance, Limits for acidity/alkalinity, Extractable metals, Lubricant, Graduated scale, Barrel, Plunger stopper/plunger assembly, Nozzle, Dead space, Freedom from liquid/air leakage, Force to operate the piston, Fit of plunger stopper/plunger in barrel).
  • Biocompatibility Testing (Cytotoxicity test, Intracutaneous Reactivity Test, Acute Systemic Toxicity Test, Pyrogen Test, Hemolysis Test, Skin Sensitization study, Particulate matters).
  • Sterilization Validation (EO Sterilization Validation in accordance with ISO 11135).
  • Shelf Life Study (Accelerated Aging, Packaging Integrity test).
  • Packaging Process Validation Study (Sealing condition).
  • Shipping Validation Study (ISTA 2018 Integrity Test Procedure 2A, ASTM D4169-16).
• Ground Truth for Physical Device Testing: Conformance to established international standards (ISO7864, ISO7886, ISO10993, ISO 11135, ISTA 2018, ASTM D4169-16) and relevant regulations (21 CFR Part 801).
• Clinical Testing: "Clinical testing was not required to support substantial equivalence." This means no human subject studies were conducted for this 510(k) submission.
• Conclusion: The manufacturer concluded that "The proposed device... have similar technological characteristics... Appropriate performance testing was conducted... results of this testing demonstrates that the subject device is substantially equivalent in safety and performance to the predicate device."

To obtain the specific quantitative acceptance criteria and detailed performance data, one would typically need to refer to the full 510(k) submission document, which is generally not publicly available in its entirety beyond the summary provided.

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