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.

Device Description

Hansol Acupuncture Needle consists of components commonly found on Single use, Acupuncture Needle. The Hansol acupuncture needle is a sterile surgical stainless steel, single use only acupuncture needle. The Hansol acupuncture needle meets the general specification and criteria for an acupuncture needle and is effective for the practice of acupuncture.

AI/ML Overview

The provided text describes the 510(k) summary for the Hansol Acupuncture Needle, which is a Class II medical device. The summary focuses on establishing substantial equivalence to a predicate device (ASIA-MED Single use, Acupuncture Needle, K052085) rather than presenting a performance study with detailed acceptance criteria and reported device performance metrics like sensitivity, specificity, or accuracy for an AI/algorithm-based device.

Therefore, many of the requested sections related to AI/algorithm performance and ground truth establishment cannot be extracted from this document, as it pertains to a physical medical device (an acupuncture needle) and its safety and effectiveness through bench testing, not an AI or software-as-a-medical-device (SaMD).

Here's an attempt to answer the questions based only on the provided text, highlighting where information is not available or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Biocompatibility: Device must be biocompatible.	Bench tests performed demonstrating biocompatibility.
Sterility: Device must be sterile.	Sterility testing performed.
Substantial Equivalence: Device must be as safe, as effective, and perform in a substantially equivalent manner to the predicate device (ASIA-MED Single use, Acupuncture Needle, K052085).	The tests demonstrated that the device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device.
General Specification & Criteria: Meets general specifications and criteria for an acupuncture needle.	Device meets the general specification and criteria for an acupuncture needle and is effective for the practice of acupuncture.

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

Not Applicable: This document describes a physical medical device (acupuncture needle) and its bench testing to establish substantial equivalence. It does not involve a "test set" of data in the context of an AI/algorithm study. The testing performed involved biocompatibility and sterility. The sample sizes for these bench tests are not provided in this 510(k) summary.

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

Not Applicable: Ground truth establishment by experts is not relevant for the type of device and testing described (physical acupuncture needle, bench testing for biocompatibility and sterility).

4. Adjudication method for the test set

Not Applicable: Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical evaluations involving human interpretation, especially for AI/algorithm-based devices. This is not relevant for the bench testing of a physical acupuncture needle.

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: No MRMC study was done. This type of study is relevant for AI/algorithm-assisted diagnostic or interpretive devices, not for a physical acupuncture needle.

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

No: This is a physical device, not an algorithm. Therefore, "standalone algorithm performance" is not applicable.

7. The type of ground truth used

Not Applicable/Indirect: For a physical device like an acupuncture needle, "ground truth" is typically defined by established engineering standards, material specifications, and biological testing protocols for biocompatibility and sterility. The "ground truth" for the performance claims would be the results of the bench tests against these defined standards and the performance of the predicate device. The document states "Bench tests were performed. Bench testing included biocompatibility, sterility testing." The results of these tests (e.g., passing sterility tests, meeting biocompatibility standards) form the basis of the performance claims.

8. The sample size for the training set

Not Applicable: There is no "training set" as this is not an AI/algorithm-based device.

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

Not Applicable: There is no "training set" or corresponding ground truth establishment described for this device.

Summary

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510(k) Summary ನ.

See 510(k) Summary, below.

1. Trade Name: . Hansol Acupuncture Needle Common Name: Single use, Acupuncture Needle. Classification Name: Single use, Acupuncture Needle. Product Code: MQX Regulation: 880.5580 Class of device : ClassII.
  JUN 300 2009

1. The legally marketed device to which we are claiming equivalence: ASIA-MED Single use, Acupuncture Needle. K052085
1. Description of device: Hansol Acupuncture Needle consists of components commonly found on Single use, Acupuncture Needle.

The Hansol acupuncture needle is a sterile surgical stainless steel, single use only acupuncture needle. The Hansol acupuncture needle meets the general specification and criteria for an acupuncture needle and is effective for the practice of acupuncture.

1. Intended Use: 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.
Technological Characteristics: Hansol Acupuncture Needle and the predicate device have identical technological characteristics and perform the same way as common acupuncture Needle They are sterilized
1. Performance: Bench tests were performed.

Bench testing included biocompatibility, sterility testing.

The tests demonstrated that the device is as safe , as effective and performs in a substantially equivalent manner to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

JUN 30 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Hansol Medical Company C/O Mr. Peter Chun 300 Atwood Street Pittsburgh, Pennsylvania 15213

Re: K090910

Trade/Device Name: Hansol Acupuncture Needle Regulation Number: 21 CFR 880.5580 Regulation Name: Acupuncture Needle Regulatory Class: II Product Code: MOX Dated: June 9, 2009 Received: June 22, 2009

Dear Mr. Chun:

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 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 Federal Register.

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Page 2- Mr. Chun

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Anthony Q. anton for
Susan Runner, D.D.S., M.A.

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

Enclosure.

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510(k) Number (if known): _K0909 1 0 _________________________________________________________________________________________________________________________________________

Device Name: Single use, Acupuncture Needle

Indications For Use:

Prescription Use X (Pr 21 CFR 801 Subpart D)

AND/OR .

Over-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)

(Division Sign=Off) Division of Sign-Olly
Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K090910

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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.