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Jiajian Acupuncture Needle is intended to piece the skin in the practice of acupuncture therapy by qualified practitioners or acupuncture doctors as determined by the states.

Jiajian brand Acupuncture Needle consists of a stainless steel wire (ASTM 304) as the needle body, with a stainless steel wire handle, a copper wire handle or polystyrol handle. The handles make the needles easier to manipulate and place. The acupuncture needle is sterilized and disposable. The diameter of the needle is 0.140.80mm; the length of the needle is 7100mm; the invasive length is 2~47mm.

The provided text is a 510(k) Premarket Notification Summary for the Jiajian Acupuncture Needle. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than robust clinical studies with acceptance criteria and statistical analysis typical of software or AI/ML medical devices. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics is not present.

Here's an analysis based on the available information:

1. Table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or detailed performance metrics. The primary "performance" demonstrated is the substantial equivalence to predicate devices. This means the device is considered as safe and effective as the predicate devices.

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

No test set for performance evaluation in the typical sense (e.g., a dataset of images for an AI model) is described. The device is a physical acupuncture needle.

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

Not applicable, as no such test set or ground truth determination process is described for this physical medical device.

4. Adjudication method 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. This is not an AI/ML device, and no MRMC study was conducted.

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

Not applicable. The "ground truth" for this submission is establishing that the device's design, materials, and intended use are similar enough to existing legally marketed devices.

8. The sample size for the training set

Not applicable, as this is a physical device and not an AI/ML model requiring a training set.

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

Not applicable.

Summary of Device and Substantial Equivalence Information (from the provided text):

The Jiajian Acupuncture Needle is a single-use acupuncture needle made of stainless steel wire with various handle options. It is sterilized by Co-60 irradiation and intended for use by qualified practitioners for acupuncture therapy.

The manufacturer claims substantial equivalence to two predicate devices:

• DN Acupuncture Needles (K983800)
• Singer Acupuncture Needles (K974616)

Similarities claimed between the Jiajian Acupuncture Needle and predicate devices:

1. Similar materials composition and structure.
2. Same intended use.
3. All are sterile.
4. All are used as prescription.

Differences:

1. Different sizes scale (This difference was not deemed significant enough to preclude substantial equivalence).

The FDA concurred with the substantial equivalence determination.

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