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SMC ACUPUNCTURE NEEDLE is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

The Acupuncture Needles are sterile, hair thin needles which are inserted into specific points on the skin, called "acupuncture points". The Acupuncture Needles are manufactured from stainless steel and sterilized with gamma irradiation and/or ethylene oxide.

The Acupuncture Needles are available in nine needle diameters (0.16 to 0.70 mm), ten needle lengths (15-135 mm), and ten tube lengths (30-160 mm).

This document is a 510(k) Premarket Notification for the SMC Acupuncture Needle, comparing it to a predicate device, the WOOJEON ACUPUNCTURE NEEDLE (K111392). The information provided focuses on demonstrating substantial equivalence rather than a detailed study proving the device meets strict acceptance criteria in the way a clinical trial for a novel, complex diagnostic or therapeutic AI device would.

Therefore, many of the requested categories (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable or not provided in this type of regulatory submission, as it's for a relatively simple medical device (acupuncture needle) and relies on demonstrating equivalence to an already marketed device.

However, I can extract the relevant information regarding performance and "acceptance criteria" as implied by the comparison to the predicate device and the non-clinical testing.

Here's the breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are implicitly defined by the characteristics of the predicate device and relevant international standards (like ISO 10993 for biocompatibility) as well as general performance expectations for acupuncture needles. The comparison table below highlights how the new device's attributes align with or expand upon the predicate.

Study Details:

The primary "study" described is a non-clinical performance and comparison study to demonstrate substantial equivalence to a predicate device, not a human clinical trial against specific acceptance criteria for diagnostic accuracy or treatment efficacy.

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

• Sample Size for Test Set: Not specified in terms of a "test set" for performance metrics like sensitivity/specificity. The testing involved dimensional conformance, visual inspections, design verification, and biocompatibility on representative samples of the device. The exact number of units or samples for each test is not provided.
• Data Provenance: Not applicable in the context of clinical data provenance (country, retrospective/prospective) for this type of device and submission. The non-clinical tests were likely conducted by the manufacturer, SMC, or their designated testing laboratories.

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

• This is not applicable. The "ground truth" for this device relates to its physical and biological safety characteristics, which are assessed through engineering tests and biocompatibility standards, not expert consensus on medical images or patient outcomes.

4. Adjudication method for the test set

• This is not applicable. Adjudication methods (like 2+1, 3+1) are common in studies involving human interpretation or subjective assessments, which are not relevant for the non-clinical testing of an 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

• This is not applicable. An acupuncture needle is a physical tool, not an AI-powered diagnostic or assistive device. Therefore, MRMC studies and AI assistance metrics are irrelevant.

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

• This is not applicable. This device is not an algorithm.

7. The type of ground truth used

• The "ground truth" for this submission is based on:
  • Predicate Device Characteristics: The established safety and effectiveness profile of the legally marketed WOOJEON ACUPUNCTURE NEEDLE (K111392).
  • International Standards: Compliance with relevant standards like ISO 10993 series for biocompatibility.
  • Engineering Specifications: Conformance to pre-defined dimensional, material, and manufacturing specifications for acupuncture needles.

8. The sample size for the training set

• This is not applicable. There is no "training set" in the context of an AI/machine learning device. For manufacturing, routine quality control involves statistical process control, but this is not what is typically meant by a "training set" in medical device studies that involve algorithms.

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

• This is not applicable as there is no training set.

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