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Disposable Sterile Syringe is intended to inject fluids into or withdraw fluids from the body.

Disposable Sterile Syringe, is a plastic syringe designed for intended to inject fluids into or withdraw fluids from the body. The product is a single use, sterile, non-toxic, non-pyrogenic, disposable syringe that consists of a barrel, plunger, Piston, Needle tube, Needle hub and Needle cap.

All specifications of product subject to the same design and the difference between each specification is syringe volume and needle size. The product is available in a variety combination of needle size and syringe volume.

The provided text describes the 510(k) summary for a Disposable Sterile Syringe (K221777) and its substantial equivalence to a predicate device. This document is a regulatory submission for a medical device that does not involve AI or complex software, and therefore, many of the requested details regarding acceptance criteria, study methodologies for AI/software performance (e.g., sample size for test sets, expert adjudication, MRMC studies, standalone performance, ground truth for AI), and training set information are not applicable.

The device is a simple, physical product (a syringe) and its "performance" is assessed through adherence to established international and ASTM standards for physical, chemical, and biological properties, as well as sterility and packaging integrity. The acceptance criteria for such a device are primarily defined by these international standards.

Here's an attempt to address the points based on the provided document, highlighting what is applicable and what isn't:

Device: Disposable Sterile Syringe (K221777)
Purpose: Intended to inject fluids into or withdraw fluids from the body.

This device is a traditional medical device, not an AI/Software as a Medical Device (SaMD). Therefore, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" refers to compliance with recognized standards and biocompatibility testing, rather than performance metrics like sensitivity, specificity, or AUC for an AI algorithm.

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

The acceptance criteria for this device are its compliance with various ISO and ASTM standards. The "reported device performance" is essentially that the device "meets the requirements of related standards" and that "there are no negative impacts from the materials that are used in the proposed device."

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

• Sample Size: The document does not specify exact sample sizes for each test. For medical device testing, samples are typically chosen according to relevant standard methods (e.g., lot-based sampling conforming to AQL – Acceptable Quality Level).
• Data Provenance: Not explicitly stated regarding country of origin for the non-clinical test data. The tests were performed by "Weihai Shengjie Medical Technology Co., Ltd." in China, where the manufacturing entity is located. The tests are "nonclinical" (laboratory-based) and are implicitly prospective for the purpose of demonstrating compliance.

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 is a physical device, not an AI algorithm requiring expert ground truth for image interpretation or diagnosis. The "ground truth" is provided by the universally recognized and standardized test methods and their defined acceptance limits (e.g., ISO, ASTM standards).

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

• Not Applicable. No human interpretation or adjudication of case data is involved for this type of device submission. Compliance is determined by objective physical, chemical, and biological test results against predefined standard thresholds.

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 not an AI-assisted device.

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

• Not Applicable. This is not an AI algorithm.

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

• The "ground truth" for this medical device's performance is compliance with established international and national standards (ISO, ASTM). These standards define the acceptable physical, mechanical, chemical, and biological properties for the device. For example, for biocompatibility, the ground truth is "no cytotoxicity" as per ISO 10993-5, determined by validated laboratory methods.

8. The sample size for the training set

• Not Applicable. This device uses traditional manufacturing and testing, not machine learning, so there is no "training set."

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

• Not Applicable. As there is no training set for an AI/ML model, this question is irrelevant.

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