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The device is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

The Device is defined as prescription device intended to to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states. The Device consists of a solid stainless steel needle with handle attached to facilitate the delivery of acupunture treatment. The material for the Device is stainless steel wire 0Cr19Ni9, which complies with the Chinese National Standard GB2024-94 for acupuncture needles. The handles of the Device are in flat, ring, flower or tube shape and are made of different materials including copper, stainless steel, aluminum, and plastic. The length of the Device conforms to GB2024-94, which meets the needs for depth of insertion and manipulation. The diameters of the needle come in 0.16mm, 0.18mm, 0.25mm, 0.30mm, 0.35mm, 0.40mm, and 0.45mm, depending on the needs. The point of the needle is round, straight, and smooth and complies with GB2024-94. Each acupuncture needle is individually packaged, with or without a guide (insertion) tube. The Device is sterilized with Ethylene Oxide, whose residue on the surface of needle body meets clinical health requirements. The Device package is confirmed to remain stainless and aseptic in two years of shelf life at room temperature, normal pressure, and ≤80%RH. The Device is sterile, disposable, and for single use only. The material, sterility, and biocompatibility of the Device meet the general specifications and the criteria for single use acupuncture needle. In addition, the Device is designed such that it is compatible with the current acupuncture needles produced by other major acupuncture needle manufacturers.

The provided text is a 510(k) summary for acupuncture needles. It describes the device, its intended use, and argues for substantial equivalence to predicate devices. However, it does not include information about specific acceptance criteria or a study that rigorously proves the device meets those criteria in the way a clinical trial or performance study would for an AI/ML device.

Acupuncture needles, as described here, are physical medical devices, and their evaluation for market clearance (via 510(k)) focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through material composition, manufacturing processes, sterility, and biocompatibility, rather than performance metrics derived from complex data analysis.

Therefore, many of the requested categories (like effect size of human readers with AI, standalone algorithm performance, training set details, etc.) are not applicable to this type of device and submission.

Here's the information that can be extracted or derived from the provided document, framed as close as possible to your request for acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

Study Details (Based on 510(k) Substantial Equivalence Determination)

For this type of device (acupuncture needle), the "study" is primarily a comparison to predicate devices and adherence to recognized standards, rather than a prospective clinical trial with human subjects testing performance criteria directly.

1. Sample Size used for the test set and the data provenance: Not directly applicable in the conventional sense of a "test set" for algorithm performance. The evaluation is based on comparing the device's design, materials, manufacturing processes, and sterilization to those of legally marketed predicate devices and relevant industry standards (e.g., Chinese National Standard GB2024-94). The "data" provenance would be the technical specifications, material certifications, and manufacturing process documentation provided by the manufacturer.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device like this is established by adherence to engineering specifications, material standards, biocompatibility testing (often outsourced to labs), and sterilization validation rather than expert consensus on interpretive data. The FDA reviewers are the "experts" who evaluate the submission against regulatory requirements and established-predicate device characteristics.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This concept is relevant to interpreting ambiguous clinical data, not the characterization of a physical product.

4. 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: Not applicable. This relates to AI/ML devices influencing human interpretation.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.

6. The type of ground truth used:

   • Engineering specifications and standards: GB2024-94 for material, dimensions, and needle point.
   • Material certifications: For 0Cr19Ni9 stainless steel.
   • Sterilization validation data: To demonstrate efficacy of Ethylene Oxide sterilization and confirm residue levels.
   • Biocompatibility testing reports: To ensure the materials are safe for patient contact.
   • Shelf-life stability data: To support the 2-year claim.
   • Comparison to predicate devices: The "ground truth" for substantial equivalence is the known safety and effectiveness of the existing predicate devices.

7. The sample size for the training set: Not applicable. This device does not use machine learning with a training set.

8. How the ground truth for the training set was established: Not applicable.

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