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The Sterile Safety Syringes for Single Use are intended for use in the aspiration of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to mimize risk of accidental needle sticks. The Sterile Safety Syringes for Single Use are single use, disposable devices, provided sterile.

The proposed device consists of a safety hypodermic needle and a luer slip or luer lock syringe. Models of Sterile Safety Syringes for Single Use shown in Table 11.1 and 11.2 are available in various models according to different syringe volume and needle specifications.

The provided text describes the 510(k) premarket notification for "Sterile Safety Syringes for Single Use." This document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone study of the device's performance against specific acceptance criteria in the manner one would see for an AI/ML medical device or a novel product requiring a clinical trial.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" (especially those related to clinical studies, human expert involvement, ground truth, and training data for AI/ML) are not applicable to this type of submission.

However, I can extract information related to the technical performance tests conducted to show equivalence.

Here's a breakdown based on the provided document:

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

The document doesn't explicitly state "acceptance criteria" as pass/fail thresholds for clinical outcomes, but rather lists the standards to which the device conforms and the results of the tests confirming that conformity. The "acceptance" is that the device's performance meets the requirements of these recognized standards.

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

• Sample Size: The document does not specify the exact number of units tested for each standard. This level of detail is typically found in the full test reports, which are summarized in the 510(k) submission.
• Data Provenance: The tests were non-clinical performance tests conducted for the purpose of demonstrating substantial equivalence. The document doesn't explicitly state the country of origin for the testing data, but the manufacturer is based in Shanghai, China. The tests are "retrospective" in the sense that they were completed prior to this submission for regulatory review.

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 submission refers to a traditional medical device (syringes), not an AI/ML device or one requiring human expert interpretation of complex data for "ground truth" establishment. The "ground truth" for these tests is defined by the objective measurements and pass/fail criteria specified within the referenced ISO and ASTM standards.

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

• Not applicable. See point 3.

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 type of study is relevant for diagnostic devices interpreting complex data (e.g., radiology images) and involving human readers. It is not applicable to a safety syringe.

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

• Not applicable. This isn't an algorithm. The "performance" is mechanical and material integrity.

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

• For this device, the "ground truth" is established by the objective, quantitative requirements and methods defined in the listed international and national standards (ISO, ASTM, USP) for sterility, biocompatibility, and physical performance of hypodermic needles and syringes. For instance, a test for "Force to activate safety mode" would have a defined NMT (Not More Than) value (e.g., 10N), and passing means the device operates within that mechanical specification.

8. The sample size for the training set:

• Not applicable. This refers to machine learning. No training set was used for a physical syringe.

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

• Not applicable. See point 8.

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The Sterile Safety Syringe for Single Use (Retractable) is intended to provide a safe and reliable method of injecting fluids into or withdrawing fluids from the body. The Sterile Safety Syringe for Single Use (Retractable) is designed to aid in the prevention of needle stick injuries and reduce the potential for syringe reuse. The Sterile Safety Syringe for Single Use (Retractable) is a single use, disposable device, provided sterile.

The proposed device, Sterile Safety Syringe for Single Use (Retractable), is available in 1ml. The proposed device consists of seven components:(1) protective cap, (2) needle tube, (3) connecting seat, (4) plunger stopper, (5) sliding sleeve, (6) barrel, (7) plunger. The proposed devices are sterilized by ethylene oxide to achieve a SAL 10-6 and supplied in sterility maintenance small package which could maintain the sterility of the device during the shelf life of 5 years.

The provided document is a 510(k) premarket notification for a medical device: "Sterile Safety Syringe for Single Use (Retractable)". It declares the device's substantial equivalence to a predicate device.

However, the document does not contain the acceptance criteria and performance data for a study proving the device meets those criteria in the format requested (i.e., a table of "acceptance criteria vs. reported device performance").

Instead, it lists various standard tests and their respective ISO/ASTM/USP standards that were applied to the device to demonstrate its safety and effectiveness and its substantial equivalence to the predicate device. These tests primarily focus on:

• Biocompatibility: Adhering to ISO 10993 standards for biological evaluation.
• Sterility, Shipping and Shelf-Life: Meeting ISO 10993-7, USP, and ASTM standards for sterilization residuals, bacterial endotoxins, packaging integrity (seal strength, leak detection), and accelerated aging for a 5-year shelf life.
• Performance Testing: Conforming to ISO 7864 (hypodermic needles), ISO 7886-1 (hypodermic syringes for manual use), ISO 9626 (stainless steel needle tubing), and ISO 23908 (sharps injury protection features).
• Simulated Clinical Use Study: Conducted to evaluate the effect of the safety feature per FDA Guidance "Medical Devices with Sharps Injury Prevention Features" and stated that "The test results demonstrated that the subject device complies with the requirements."

Therefore, I cannot extract the requested table of acceptance criteria and reported device performance from this document as it is not presented in that specific comparative format. The document primarily asserts compliance with established regulatory standards and guidelines through various tests, rather than detailing specific quantitative acceptance criteria and their corresponding empirical results in a side-by-side comparison for each performance aspect.

Moreover, the document explicitly states: "No clinical study is included in this submission." This means that information regarding human-in-the-loop performance, multi-reader multi-case studies, sample sizes for test sets involving human readers, expert consensus for ground truth, or adjudication methods are not applicable and thus not provided in this document. The device's safety feature validation was done through a simulated clinical use study, not a true clinical study with human subjects.

Given the limitations of the provided document, I can only state what is addressed and what is not:

Based on the provided document, here's what can be inferred and what information is absent:

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

• Not explicitly provided in the requested comparative "acceptance criteria vs. reported performance" table format. The document lists the standards and guidances that the device was tested against (e.g., ISO 7864, ISO 7886-1, ISO 9626, ISO 23908, ISO 10993 series, USP standards, ASTM standards). It generally states that the device "met" acceptance criteria or "complies with the requirements" of these standards.
• Example from text: "Particulate matter testing was conducted in accordance with USP Particulate Matter in Injection and met the USP acceptance criteria." This implies the acceptance criteria are those defined by USP , and the reported performance was "met" these criteria, but specific quantitative values are not given.
• Example from text: "The safety feature of the proposed device has been validated to verify the prevention function." and "a simulated clinical use study was conducted on the subject device... to evaluate the effect of safety feature per FDA Guidance... The test results demonstrated that the subject device complies with the requirements." This indicates compliance with FDA guidance on sharps injury prevention.

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

• Test Set Sample Size: Not specified for any of the performance tests (e.g., ISO 7864, ISO 7886-1 tests, biocompatibility tests). Standard industrial testing often relies on predefined sample sizes per standard, but these are not enumerated here.
• Data Provenance: The manufacturing entity, Shanghai Kindly Enterprise Development Group Co., Ltd., is based in China. The location where the testing was performed (country of origin of the data) is not explicitly stated, but it's implied to be associated with the manufacturer or their chosen testing labs. The studies are pre-market notification tests to demonstrate substantial equivalence, implying they are conducted for regulatory submission. Whether specific tests were retrospective or prospective is not detailed, but routine device testing for regulatory submission is typically prospective for the purpose of the submission.

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

• Not applicable. The document states "No clinical study is included in this submission." Ground truth, in the context of expert consensus, is typically established for diagnostic or screening devices evaluated in clinical settings, often for image interpretation or diagnosis. This document pertains to a medical device (syringe) where performance is assessed against engineering standards and simulated use.

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

• Not applicable. As there's no clinical study involving human interpretation or subjective assessment, adjudication methods are 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 device is a syringe, not an AI-assisted diagnostic tool. No MRMC study was performed.

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

• Not applicable. This is a mechanical device, not an algorithm. Performance tests are inherently "device only" without human-in-the-loop performance in terms of interpretation, but involve human operation for mechanical tasks.

7. The type of ground truth used:

• Engineering Standards and Specifications: The "ground truth" for the device's performance is established by the specified international (ISO), national (USP, ASTM), and FDA standards/guidances (e.g., ISO 7864 for needle requirements, ISO 7886-1 for syringe performance, ISO 23908 for sharps injury protection, FDA guidance on sharps injury prevention). The device's physical and functional properties are tested against the objective, measurable criteria defined within these standards.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device, so there is no "training set."

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

• Not applicable. No training set exists for this device.

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