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510(k) Data Aggregation
(245 days)
KM Needles (Acupuncture Needle)
This KM Needles (Acupuncture Needle) is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the state regulations.
The KM Needles (Acupuncture Needle) are simple stainless steel pins that are used by an acupuncture practioner in the treatment of various conditions. Acupuncture is the timulation of specific acupuncture points along the skin of the body involving various methods such as penetration by thin needles or the application of heat, pressure, or laser light. Clinical practice varies depending on the country. Traditional acupuncture involves needle insertion, moxibustion, and cupping therapy. It is a form of alternative medicine and a key component of traditional Chinese medicine (TCM).
The KM Needles (Acupuncture Needle) are constructed of stainless steel, with pin body diameters ranging from 0.16 to 0.70 mm and vary in length from 15 to 135 mm. Each acupuncture needle has a handle for the practioner to manipulate the needle. The handle is also made from stainless steel and range in length from 20-30 mm.
The manufacturer, K.M.S. Inc., states that the KM Needles (Acupuncture Needle) are substantially equivalent to the Dong Bang Acupuncture Needles (K972659). The performance data section describes bench testing for tensile strength and sterility testing.
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria / Test | Reported Device Performance |
|---|---|
| Tensile Strength of the Acupuncture Needle | Met criteria. |
| * Diameter 0.20 mm | 723.3gf |
| * Diameter 0.25 mm | 726.6gf |
| * Diameter 0.35 mm | 733.3gf |
| Biocompatibility (e.g., cytotoxicity, irritation, sensitization) | Conform to ISO10993-1 (Biological evaluation of medical devices). Specifically: ISO 10993-5 (In Vitro cytotoxicity), ISO 10993-10 (irritation and skin sensitization). All test results were satisfactory. |
| Sterilization Dose (Gamma radiation) | Met criteria, established per ISO 1137-2. All test results were satisfactory. |
| Microbiological Methods (Bioburden) | Met criteria, performed per AAMI/ISO/ANSI 11737-1. All test results were satisfactory. |
| Packaging for Terminally Sterilized Medical Devices | Met criteria, performed per AAMI ANSI ISO 11607-1 (materials, sterile barrier systems, packaging systems) and AAMI ANSI ISO 11607-2 (validation requirements for forming, sealing and assembly processes). All test results were satisfactory. |
| Accelerated Aging of Sterile Barrier Systems | Met criteria, performed per ASTM F1980-07. All test results were satisfactory. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not explicitly state the sample sizes used for each of the bench tests (tensile strength, biocompatibility, sterilization, packaging, accelerated aging). It only mentions that "Bench testing was performed" and "Sterility testing was performed."
The data provenance is not specified beyond being generated by K.M.S. Inc. for the K.M.S Inc. device. There is no information regarding country of origin of data, or if it was retrospective or prospective.
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):
This information is not applicable. The device is an acupuncture needle, and the testing involves physical and biological properties rather than diagnostic accuracy requiring expert interpretation of results. The "ground truth" for these tests would be established by validated scientific methods and international standards (e.g., ISO, AAMI, ASTM), rather than expert consensus on diagnostic imaging.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable as the study involves bench testing of physical and biological properties, not a clinical study requiring adjudication of expert interpretations.
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. The device is a medical instrument (acupuncture needle), not an AI-powered diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance would not be conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable as the device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the performance claims of the KM Needles is based on established international standards and validated scientific testing methodologies. For example:
- Tensile Strength: Objective measurement against specified physical limits.
- Biocompatibility: Evaluation against the requirements of ISO 10993 series standards, which define acceptable biological responses.
- Sterilization: Demonstration of a sterility assurance level (SAL) of $10^{-6}$ using validated methods like ISO 1137-2 concerning radiation sterilization.
- Packaging: Compliance with AAMI ANSI ISO 11607 series standards for maintaining sterility.
- Accelerated Aging: Compliance with ASTM F1980-07 for determining package integrity over time.
8. The sample size for the training set:
This information is not applicable. This is not a study involving machine learning or AI where a "training set" would be used. The testing described is verification and validation of a physical medical device.
9. How the ground truth for the training set was established:
This information is not applicable, as there is no training set for this device.
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