Search Results

Hummingbird brand acupuncture needles are defined as prescription devices intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.

Hummingbird brand acupuncture needles are sterile, single use only. The design, material used, sterility and biocompatibility of this acupuncture needle meet the general specifications and criteria for an single use acupuncture needle and is effective for the practice of acupuncture.

The provided document is a 510(k) Summary for the Hummingbird Medical Technology H.M.T. Acupuncture Needle. This document focuses on demonstrating substantial equivalence to previously approved devices, rather than outlining a study with specific performance acceptance criteria and a detailed study design to prove those criteria.

Therefore, many of the requested sections (e.g., specific performance metrics, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not present in this type of regulatory submission.

Here's an breakdown of what can be extracted and what cannot:

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

• Acceptance Criteria (as implied by Substantial Equivalence): The device (Hummingbird brand acupuncture needles) must meet general specifications and criteria for a single-use acupuncture needle and be effective for the practice of acupuncture, consistent with predicate devices. This includes aspects like sterility, material used, and biocompatibility. The primary acceptance criterion for 510(k) is "substantial equivalence" to a predicate device.
• Reported Device Performance: The document states that the design, material used, sterility, and biocompatibility of the Hummingbird acupuncture needle meet the general specifications and criteria for a single-use acupuncture needle and is "effective for the practice of acupuncture." It also notes that a search of federal consumer information centers found "no serious or life-threatening accidents involving acupuncture needles," implying a safety profile consistent with predicate devices. Specific quantitative performance metrics (e.g., force to penetrate, breakage rates) are not reported.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable / Not Provided: A dedicated "test set" with a specific sample size for performance evaluation in the way a diagnostic or AI device would have is not described. The submission relies on demonstrating equivalence through design, materials, and existing safety data for acupuncture needles in general.

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)

• Not Applicable / Not Provided: As there is no "test set" with ground truth requiring expert adjudication described for this type of device, this information is not relevant or present.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable / Not Provided: See point 3.

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

• Not Applicable / Not Provided: This device is an acupuncture needle, not an AI or imaging diagnostic tool. Therefore, MRMC studies are not relevant.

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

• Not Applicable / Not Provided: This device is an acupuncture needle, not an algorithm. Standalone performance as typically described for AI/software devices is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Implicit "Ground Truth": For an acupuncture needle, "ground truth" relates to its physical properties, sterility, biocompatibility, and intended function (piercing the skin effectively and safely). This is established through engineering specifications, material standards (e.g., ISO for sterility, biocompatibility testing), and clinical experience with equivalent devices. The submission heavily relies on the fact that these types of devices have been "used for general practice... since 1996" without serious incidents.

8. The sample size for the training set

• Not Applicable / Not Provided: This is not an AI/machine learning device that would have a "training set."

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

• Not Applicable / Not Provided: See point 8.

In summary: The provided document is a 510(k) summary for an acupuncture needle, demonstrating substantial equivalence to predicate devices rather than proving specific performance criteria through a detailed clinical or technical study as would be seen for a novel diagnostic or AI-powered device. The "study" referenced is the 510(k) submission process itself, where the manufacturer provides information to the FDA to demonstrate equivalence based on design, materials, manufacturing controls, and the established safety profile of similar devices already on the market.

Ask a specific question about this device