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This document is a Summary Statement of Safety and Effectiveness for a medical device (acupuncture needles) seeking 510k clearance from the FDA. It is not a study report that describes acceptance criteria and device performance based on a study.
Therefore, I cannot provide the requested information because the provided text does not contain:
- A table of acceptance criteria and reported device performance: The document states the device "meets the general specifications and parameters for an acupuncture needle," but it doesn't define what those specifications or parameters are, nor does it provide a table with quantitative performance metrics.
- Sample size used for the test set and data provenance: There is no mention of a specific test set, its size, or the origin of any data (e.g., country, retrospective/prospective).
- Number of experts and their qualifications for ground truth: No experts or ground truth establishment methods are discussed.
- Adjudication method: Not applicable as no ground truth establishment is described.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: No such study is mentioned or implied.
- Standalone (algorithm only) performance: This is a physical medical device, not an algorithm.
- Type of ground truth used: Not applicable as no specific study data or ground truth is presented.
- Sample size for the training set: Not applicable as this is not a machine learning study.
- How ground truth for the training set was established: Not applicable.
The document primarily makes a declarative statement that the Hua-Xia acupuncture needle "meets the criteria for 510k acceptance" and is "equivalent to acupuncture needles which were in commercial distribution prior to May 28, 1976" and to "other acupuncture needles which are now being sold through interstate commerce." This equivalence claim is based on the general understanding and history of acupuncture needle use, and its sterile, single-use nature, rather than a specific performance study detailed within this summary.
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LHASA MEDICAL, INC.
Image /page/0/Picture/2 description: The image shows a handwritten string of characters. The characters are 'K962916'. The characters are written in black ink on a white background. There is a line drawn underneath the string of characters.
234 Libbey Parkway, Weymouth, MA 02189 (617) 335-6484 (Fax: 617-335-62
July 24, 1996
SUMMARY STATEMENT OF SAFETY AND EFFECTIVENESS
In general, acupuncture needles have been used in the practice of acupuncture in the United States for now over 30+ years. Since this time, we are not aware of any serious or life threatening accidents involving acupuncture needles.
The acupuncture needles which were in commercial interstate distribution prior to May 28, 1976 were sold as a non-sterile, reusable acupuncture needle. However, the acupuncture needles which are now sold in 1996 offer greater safety since they are a sterile, single use only acupuncture needle.
The subject of this 510k application - the Hua-Xia acupuncture needle - is a sterile, single use only acupuncture needle. The Hua-Xia acupuncture needle meets the general specifications and parameters for an acupuncture needle and is effective for the practice of acupuncture.
Lhasa Medical has been selling the Hua-Xia brand acupuncture needle since 1990 as an "Investigational device, limited by U.S. law to investigational use". Since 1990, Lhasa Medical has not received any serious claims of injuries caused by the Hua-Xia acupuncture needle.
Additional information on the safety and effectiveness of the Hua-Xia acupuncture needle will be made available if it is requested.
In conclusion, based on the information provided with this 510k application, the Hua-Xia acupuncture needle meets the criteria for 510k acceptance. The Hua-Xia needle is equivalent to acupuncture needles which were in commercial distribution prior to May 28, 1976. Also, the Hua-Xia needle is equivalent to other acupuncture needles which are now being sold through interstate commerce.
Not Acceptal
§ 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.