The subject of this 510(k) Notification - the KHT Soft Needle - is a sterile, silicon coated, single use only acupuncture needle. The design, material used, sterlity and biocompatibility of this acupuncture needle meet the general specifications and criteria for an single use acupuncture needle and is effective for the practice of acupuncture.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "KHT Soft Needle" acupuncture needle, seeking clearance by demonstrating substantial equivalence to a legally marketed predicate device. This is primarily a regulatory submission, not a study reporting on the performance of a device against pre-defined acceptance criteria in the way a clinical or technical performance study would.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not present in this type of document for this particular product.

Here's an attempt to answer the questions based solely on the provided text, indicating where information is not available or not applicable for this kind of submission:

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

For a 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device. The performance is assessed against the design, materials, sterilization, and biocompatibility of the predicate. Formal numerical acceptance criteria (e.g., minimum sensitivity/specificity) for a diagnostic device or specific measured performance for a therapeutic device are typically not explicitly stated and measured in this type of document for a Class II acupuncture needle.

Acceptance Criteria (Implicit for 510(k) Substantial Equivalence)	Reported Device Performance (as claimed by applicant)
Intended Use: "To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States."	Same as predicate (implied, as it's an acupuncture needle)
Sterile: Single-use	"sterile, silicon coated, single use only acupuncture needle"
Material/Design: Meets general specifications and criteria for an acupuncture needle	"The design, material used, sterility and biocompatibility of this acupuncture needle meet the general specifications and criteria for an single use acupuncture needle"
Biocompatibility: Safe for use in humans with skin penetration	"biocompatibility... meet the general specifications and criteria"
Safety Record: No serious or life-threatening accidents when used appropriately	Predicate devices have a history of safe use ("not aware of any serious or life threatening accidents involving acupuncture needles" for 30+ years)

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

Sample Size for Test Set: Not applicable. This document does not describe a clinical study with a test set where device performance metrics are calculated based on patient data. Substantial equivalence is primarily demonstrated through comparison of technical characteristics, intended use, and materials to a predicate device.
Data Provenance: Not applicable for a typical performance study. The 510(k) relies on the established safety and effectiveness of a predicate device already marketed in the US.

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)

Number of Experts: Not applicable. No "ground truth" was established in a clinical sense for a test set, as this is a regulatory submission for a simple medical device, not a diagnostic or complex therapeutic device requiring such evaluation.
Qualifications of Experts: Not applicable. No such expert panel was used to establish ground truth.

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

Adjudication Method: Not applicable. There was no test set requiring adjudication in the context of this 510(k) submission.

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

MRMC Comparative Effectiveness Study: No. This is an acupuncture needle, not an AI-powered diagnostic or therapeutic device that would involve human readers or AI assistance.

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

Standalone Performance Study: No. This product is an acupuncture needle, not an algorithm.

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

Type of Ground Truth: Not applicable in the context of a performance study. The "ground truth" for a 510(k) of this nature is essentially the established safety and effectiveness of the legally marketed predicate device (the Seirin Brand Acupuncture Needle, 510(k) Document Number: K963769, and pre-amendments devices) through their history of use and regulatory clearance.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This is not an AI/machine learning device that requires a training set.

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

Ground Truth Establishment for Training Set: Not applicable. No training set was used.

Summary

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Kg80472

APR - 9 1998

SOFT NEEDLES K980472

American Institute of Koryo Hand Therapy, Inc.

3435 Wilshire Blvd., Suite 690, Los Angeles, CA 90010 Tel: (213) 380-5878 Fax: (213) 380-5876

Premarket Notification (510(k) Number):

510(k) SUMMARY As Required by 21 CFR 807.92(c)

Trade Name:	KHT Soft Needle
Common Name:	Acupuncture Needles
Classification Name:	Class II, Single use acupuncture needles

Legally Marketed Device to Which We Are Claiming Equivalence: Seirin Brand Acupuncture Needle 510(k) Document Number: K963769

Acupuncture needles are defined as prescription devices intended to pierce the skin In the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.

Acupuncture needles have been used for the general practice of acupuncture in the United States for over 30 years. Since that time, we are not aware of any serious or life threatening accidents involving acupuncture needles.

Acupuncture needles which were sold through commercial interstate distribution prior to May 28, 1976 were non-sterile, rousable acupuncture needles. Acupuncture needles which are currently being marketed through interstate distribution (i.e., 1997) offer greater safety since they are sterilized, single use only acupuncture needles.

In conclusion, based on the information provided with this 510(k) Notification, the KHT Soft Needle meets the criteria for 510(k) acceptance. The KHT Soft Needle is equivalent to acupuncture needles which were in commercial distribution prior to May 28, 1976. Also, the KHT Soft Needle is equivalent to other single use acupuncture needles which are currently being sold through interstate commerce.

Jin Hae Lew, Director

1-22-98 Date

Page 3 of 19

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Image /page/1/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is black and the background is white.

APR - 9 1998

American Institute of Koryo Hand Therapy, Incorporated ·C/O Mr. George Su Regulatory Consultant Crosslinks International 17870 Castleton Street, Suite 265 Industry, California 91748

Re : K980472 KHT Guam Needle, Acupuncture Needles Trade Name: Requlatory Class: II Product Code: MQX January 22, 1998 Dated: Received: February 6, 1998

Dear Mr. Su:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਚੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Su

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041, or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

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K980472

Indications For Use

510(k) Number ( if known ) _

Device Name: KHT Soft Needle, Acupuncture Needle

Indications For Use:

To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

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

Concurrence of CDRH, Office of Device Evaluation ( ODE )

Petucio Cuevaste
Division Sign Off

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices

510(k) Number K980422

Prescription Use

Over-The-Counter Use __

( Optional Format 1-2-96 )

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.