The Device is defined as prescription device intended to to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states. The Device consists of a solid stainless steel needle with handle attached to facilitate the delivery of acupunture treatment. The material for the Device is stainless steel wire 0Cr19Ni9, which complies with the Chinese National Standard GB2024-94 for acupuncture needles. The handles of the Device are in flat, ring, flower or tube shape and are made of different materials including copper, stainless steel, aluminum, and plastic. The length of the Device conforms to GB2024-94, which meets the needs for depth of insertion and manipulation. The diameters of the needle come in 0.16mm, 0.18mm, 0.25mm, 0.30mm, 0.35mm, 0.40mm, and 0.45mm, depending on the needs. The point of the needle is round, straight, and smooth and complies with GB2024-94. Each acupuncture needle is individually packaged, with or without a guide (insertion) tube. The Device is sterilized with Ethylene Oxide, whose residue on the surface of needle body meets clinical health requirements. The Device package is confirmed to remain stainless and aseptic in two years of shelf life at room temperature, normal pressure, and ≤80%RH. The Device is sterile, disposable, and for single use only. The material, sterility, and biocompatibility of the Device meet the general specifications and the criteria for single use acupuncture needle. In addition, the Device is designed such that it is compatible with the current acupuncture needles produced by other major acupuncture needle manufacturers.

AI/ML Overview

The provided text is a 510(k) summary for acupuncture needles. It describes the device, its intended use, and argues for substantial equivalence to predicate devices. However, it does not include information about specific acceptance criteria or a study that rigorously proves the device meets those criteria in the way a clinical trial or performance study would for an AI/ML device.

Acupuncture needles, as described here, are physical medical devices, and their evaluation for market clearance (via 510(k)) focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through material composition, manufacturing processes, sterility, and biocompatibility, rather than performance metrics derived from complex data analysis.

Therefore, many of the requested categories (like effect size of human readers with AI, standalone algorithm performance, training set details, etc.) are not applicable to this type of device and submission.

Here's the information that can be extracted or derived from the provided document, framed as close as possible to your request for acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance/Characteristics
Material Composition	Stainless steel wire 0Cr19Ni9, complying with Chinese National Standard GB2024-94. Handles made of copper, stainless steel, aluminum, and plastic.
Dimensions (Length)	Conforms to GB2024-94, meeting needs for depth of insertion and manipulation.
Dimensions (Diameter)	0.16mm, 0.18mm, 0.25mm, 0.30mm, 0.35mm, 0.40mm, and 0.45mm.
Needle Point Quality	Round, straight, and smooth; complies with GB2024-94.
Sterilization Method	Sterilized with Ethylene Oxide.
Ethylene Oxide Residue	Residue on the surface of the needle body meets clinical health requirements.
Packaging Integrity/Shelf Life	Package confirmed to remain stainless and aseptic in two years of shelf life at room temperature, normal pressure, and ≤80%RH.
Single Use & Disposable	Sterile, disposable, and for single use only.
Biocompatibility	Meets general specifications and criteria for single-use acupuncture needles (implied by statement: "material, sterility, and biocompatibility of the Device meet the general specifications and the criteria for single use acupuncture needle.").
Compatibility with Existing Devices	Designed to be compatible with current acupuncture needles produced by other major manufacturers.
Intended Use Equivalence	Intended to pierce the skin in the practice of acupuncture by qualified practitioners, identical to predicate devices.
Safety and Effectiveness Equivalence to Predicate Devices	"Where there is a difference in the subject device, the difference does not raise any question in terms of the subject device's safety and effectiveness." (Conclusion of substantial equivalence).

Study Details (Based on 510(k) Substantial Equivalence Determination)

For this type of device (acupuncture needle), the "study" is primarily a comparison to predicate devices and adherence to recognized standards, rather than a prospective clinical trial with human subjects testing performance criteria directly.

Sample Size used for the test set and the data provenance: Not directly applicable in the conventional sense of a "test set" for algorithm performance. The evaluation is based on comparing the device's design, materials, manufacturing processes, and sterilization to those of legally marketed predicate devices and relevant industry standards (e.g., Chinese National Standard GB2024-94). The "data" provenance would be the technical specifications, material certifications, and manufacturing process documentation provided by the manufacturer.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device like this is established by adherence to engineering specifications, material standards, biocompatibility testing (often outsourced to labs), and sterilization validation rather than expert consensus on interpretive data. The FDA reviewers are the "experts" who evaluate the submission against regulatory requirements and established-predicate device characteristics.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This concept is relevant to interpreting ambiguous clinical data, not the characterization of a physical product.
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 relates to AI/ML devices influencing human interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
The type of ground truth used:
- Engineering specifications and standards: GB2024-94 for material, dimensions, and needle point.
- Material certifications: For 0Cr19Ni9 stainless steel.
- Sterilization validation data: To demonstrate efficacy of Ethylene Oxide sterilization and confirm residue levels.
- Biocompatibility testing reports: To ensure the materials are safe for patient contact.
- Shelf-life stability data: To support the 2-year claim.
- Comparison to predicate devices: The "ground truth" for substantial equivalence is the known safety and effectiveness of the existing predicate devices.
The sample size for the training set: Not applicable. This device does not use machine learning with a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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K052731

page 1 of 2

-ER I 2006

510(k) Summary

1 Submitter's Identification:

Lee & Xiao 2600 Mission Street, Suite 100 San Marino, CA 91108 Tel: (626)799-0998 Fax: (626)799-1588

Contact Person: Yingchao Xiao, Esq.

Date: September 27, 2005

2. Device Name:

Trade Name:	Kangsheng Brand/Kangnian Brand/Unilink Brand/Huazhong Brand Acupuncture Needles
Common Name:	Acupuncture Needle
Classification Name:	Needle, Acupuncture, Single Use

3. Predicate Device Information:

Vinco Brand Acupuncture Needle (K024207) Acumaster Band Acupuncture Needle (K991508) Carbo Brand/Viva Brand Acupuncture Needles (K961339)

4. Device Description:

、 The Device is defined as prescription device intended to to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states. The Device consists of a solid stainless steel needle with handle attached to facilitate the delivery of acupunture treatment. The material for the Device is stainless steel wire 0Cr19Ni9, which complies with the Chinese National Standard GB2024-94 for acupuncture needles.

The handles of the Device are in flat, ring, flower or tube shape and are made of different materials including copper, stainless steel, aluminum, and plastic. The length of the Device conforms to GB2024-94, which meets the needs for depth of insertion and manipulation. The diameters of the needle come in 0.16mm, 0.18mm, 0.25mm, 0.30mm, 0.35mm, 0.40mm, and 0.45mm, depending on the needs. The point of the needle is round, straight, and smooth and complies with GB2024-94.

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K0527731 page 2 of 2

Each acupuncture needle is individually packaged, with or without a guide (insertion) tube. The Device is sterilized with Ethylene Oxide, whose residue on the surface of needle body meets clinical health requirements. The Device package is confirmed to remain stainless and aseptic in two years of shelf life at room temperature, normal pressure, and ≤80%RH

The Device is sterile, disposable, and for single use only. The material, sterility, and biocompatibility of the Device meet the general specifications and the criteria for single use acupuncture needle. In addition, the Device is designed such that it is compatible with the current acupuncture needles produced by other major acupuncture needle manufacturers.

5. Intended Use:

The device is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states

6. Conclusion:

Kangsheng Brand, Kangnian Brand, Unilink Brand, and Huazhong Brand Acupuncture Needles are very similar to the Predicate Device in all areas of comparison. Where there is a difference in the subject device, the difference does not raise any question in terms of the subject device's safety and effectiveness. Therefore, Kangsheng Brand, Kangnian Brand, Unilink Brand, Huazhong Brand Acupuncture Needles are substantially equivalent to Vinco Brand, Acumaster Brand, Carbo Brand/Viva Brand acupuncture needles.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features three abstract human figures in profile. The figures are arranged in a row, with each figure slightly overlapping the previous one. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA".

2006 FEB 1

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Daxin Li C/O Mr. Yingchao Xiao Lee & Xiao Attorneys 2600 Mission Street, Suite 100 San Marino, California 91108

Re: K052731

Trade/Device Name: Kangsheng Brand/Kangnian Brand/Unilink Brand/Huazhong Brand Acupuncture Needles Regulation Number: 21 CFR 880.5580 Regulation Name: Acupuncture Needle Regulatory Class: II Product Code: MQX Dated: January 9. 2006 Received: January 13, 2006

Dear Mr. Xiao:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.

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Page 2 - Mr. Xiao

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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K0527731

INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Kangsheng Brand/Kangnian Brand/Unilink Brand/Huazhong Brand Acupuncture Needles

Indications for Use:

The device is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

()ver-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chr. Vintges

and they Caneral Hospital, n Chayel, Danial Davices

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Pagel of l

Regulation Number and Section

§ 880.5580 Acupuncture needle.

(a)
Identification. An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.(b)
Classification. Class II (special controls). The device, when it is an acupuncture point locator or a single use acupuncture needle, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9. Acupuncture needles must comply with the following special controls:(1) Labeling for single use only and conformance to the requirements for prescription devices set out in 21 CFR 801.109,
(2) Device material biocompatibility, and
(3) Device sterility.