(27 days)
Acupuncture needles are defined as devices intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.
The subject of this 510(k) application - the Seirin Spinex acupuncture needle - is a sterile, single use only acupuncture needle. The Seirin Spinex acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture.
Here's an analysis of the provided text regarding the Seirin Spinex acupuncture needle, structured to address your questions about acceptance criteria and supporting studies.
Based on the provided 510(k) summary, the device is an acupuncture needle, and the regulatory pathway is demonstrating substantial equivalence to predicate devices already on the market. Therefore, the "acceptance criteria" are primarily related to general performance, safety, and equivalence to existing devices, rather than specific performance metrics like sensitivity or specificity for a diagnostic algorithm.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Safety: No serious or life-threatening accidents. | "not aware of any serious or life threatening accidents involving acupuncture needles" (general statement about acupuncture needles). "Since 1983, no accidents or device failure claims have been reported as a result of using the Seirin Spinex brand acupuncture needle." |
| Effectiveness: Effective for the practice of acupuncture. | "is effective for the practice of acupuncture." |
| Sterile: Supplied as sterile. | "is a sterile, single use only acupuncture needle." |
| Single Use: Intended for single use only. | "is a sterile, single use only acupuncture needle." |
| Meets General Specifications: Conforms to general requirements for acupuncture needles. | "meets the general specifications and criteria for an acupuncture needle." |
| Substantial Equivalence to Pre-Amendment Devices (e.g., pre-May 28, 1976): | "equivalent to acupuncture needles which were in commercial distribution prior to May 28, 1976." |
| Substantial Equivalence to Currently Marketed Devices (e.g., 1996): | "equivalent to other acupuncture needles which are currently being sold through interstate commerce." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided text does not describe a formal "test set" with a defined sample size in the context of evaluating a diagnostic or AI device. The evidence for the Seirin Spinex acupuncture needle primarily relies on:
- Historical safety data: No reported accidents since 1983 for the Seirin Spinex. This is a retrospective observation based on commercial use.
- General understanding of acupuncture needles: The statement about effectiveness is more of a declaration based on the established practice of acupuncture rather than a specific clinical study for this particular needle.
- Comparison to predicate devices: The equivalence argument is based on the characteristics of the device itself (sterile, single-use, general specifications) aligning with devices already on the market or those historically used.
There is no mention of a specific country of origin for any "data" other than the manufacturing origin in Japan for the Seirin Spineus.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to the provided 510(k) summary. The context is a medical device (acupuncture needle) demonstrating substantial equivalence, not a diagnostic algorithm requiring ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the same reasons as above. There was no formal test set requiring adjudication.
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
This information is not applicable. An MRMC study is relevant for evaluating the impact of an AI-assisted diagnostic tool on human performance. The Seirin Spinex is an acupuncture needle, not a diagnostic AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical instrument, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically defined for diagnostic device validation is not directly applicable here. The "truth" for this device lies in its physical characteristics (sterility, single-use, dimensions) and its historical safety record, as well as the generally accepted effectiveness of acupuncture itself. There's no diagnostic output for which an external "ground truth" would be compared.
8. The sample size for the training set
This information is not applicable. There is no machine learning model or algorithm discussed in this 510(k) summary, therefore no "training set" exists.
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as above.
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K 96-3769
OCT 16 1996
September 18, 1996
SEIRIN-America, Inc. 230 Libbey Parkway
fax: 617-335-5779 phone: (617) 340-1827
Weymouth, MA 02189
PRE-MARKET NOTIFICATION 510(k) SUMMARY (As Required by 21 CFR 807.93)
Acupuncture needles are defined as 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 this 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, reusable acupuncture needles. Acupuncture needles which are currently being marketed through interstate distribution (ie, 1996) offer greater safety since they are sterile, single use only acupuncture needles.
The subject of this 510(k) application - the Seirin Spinex acupuncture needle - is a sterile, single use only acupuncture needle. The Seirin Spinex acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture.
The Seirin Spinex brand acupuncture needle was first manufactured in Japan in 1978 and has been imported and sold through interstate commerce in the USA since 1983 under the FDA labeling restrictions of: "Caution: Investigational device limited by U.S. law to investigational use". Since 1983, no accidents or device failure claims have been reported as a result of using the Seirin Spinex brand acupuncture needle.
In conclusion, based on the information provided with this 510(k) application, the Seirin Spinex acupuncture needle meets the criteria for 510(k) acceptance. The Seirin Spinex needle is equivalent to acupuncture needles which were in commercial distribution prior to May 28, 1976. Also, the Seirin Spinex needle is equivalent to other acupuncture needles which are currently being sold through interstate
commerce.
Thoma A. Riihimaki
Thomas A. Riihimaki, President
9-18-96 page 7
Date
§ 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.