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DBC Dongbang Acupuncture Needles have been used for "the general practice of acupuncture without any other specific use or treatment" in the United States. These single-use-only acupuncture needles are "intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States."

The acupuncture needles manufactured by Dong Bang Medical Co., LTD in Korea have been imported and sold through interstate commerce in the USA since 1988 under the FDA labeling restrictions of "Caution: Federal law restricts this device to sale by or on the order of qualified practitioners as determined by the State." The subject of this 510(k) application, "DBC, Dong Bang Acupuncture Needles," is a y-ray or EOG sterile, non-pyrogen, stainless, and single use only acupuncture needle and is identical to the DBC brand needles, 510(k) K963300. The DBC, Dong Bang acupuncture needles have various type (pipe or spring) needle handles, and are packaged by bulk or single sealed blister.

The provided text is a 510(k) summary for a medical device (DBC, Dong Bang Acupuncture Needles) seeking substantial equivalence to a predicate device. It is not a study report demonstrating the device meets specific acceptance criteria based on performance data.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not present in this type of pre-market notification. The 510(k) process focuses on demonstrating equivalence to a previously cleared device, not necessarily on new studies proving specific performance metrics beyond what's implied by the predicate.

Here's an analysis based on the information available within the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not present in the 510(k) summary. A 510(k) summary for substantial equivalence primarily focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than presenting a table of acceptance criteria with measured performance against those criteria. The "acceptance criteria" here are inherent to the substantial equivalence determination process itself.

The key "performance" reported is:

• "Since 1988, no accidents or device failure claims have been reported as a result of using the acupuncture needles supplied by Dong Bang Medical Co., LTD in the U.S.A."
• "Sterile, stainless, single use only acupuncture needles offer greater safety."
• "The proposed DBC, Dong Bang acupuncture needles meet the general specifications and criterion for acupuncture needles and are effective for the practice of acupuncture."
• The device is "identical to the DBC brand needles, 510(k) K963300."

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

Not applicable/Not provided. This is not a performance study as typically understood for new algorithms or diagnostic devices. The submission relies on the established safety and effectiveness of the predicate device and the assertion that the new device is identical.

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

Not applicable/Not provided. No "test set" or ground truth establishment by experts for specific performance metrics (e.g., accuracy, sensitivity) is described. The "ground truth" for substantial equivalence is the predicate device and its established market history.

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

Not applicable/Not provided. No expert adjudication process for a test set is described.

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

No. This is not an AI/diagnostic device, and no MRMC study was conducted or required. The device is a physical acupuncture needle.

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

No. This is not an algorithmic device.

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

The "ground truth" in this 510(k) application is the predicate device (DBC Acupuncture Needles, 510(k) K963300) and its established history of safe and effective use in the market. The applicant's primary argument is that the proposed device is "identical" to this legally marketed predicate. The lack of reported accidents or device failures for the manufacturer's products since 1988 also serves as supportive "outcomes data" for the predicate device.

8. The sample size for the training set

Not applicable/Not provided. There is no "training set" as this is not a learning algorithm.

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

Not applicable/Not provided. There is no "training set."

Summary of Device Acceptance:

The device's acceptance is based on the criteria for substantial equivalence under the 510(k) pathway, not on an independent study demonstrating novel performance metrics.

The "Study" (or rather, the basis for clearance):

The "study" that proves the device meets acceptance criteria is essentially the comparison to a legally marketed predicate device (K963300). The applicant asserts that the new device is "identical" to this predicate.

Key arguments for substantial equivalence presented by the applicant:

• Identicality: The proposed "DBC, Dong Bang Acupuncture Needles" are stated to be "identical to the DBC brand needles, 510(k) K963300." Both are manufactured by the same company (Dong Bang Medical Co., LTD).
• Intended Use: The proposed device has the "same intended use" as the predicate – "to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture."
• Technological Characteristics: The devices share fundamental scientific technology (sterile, non-pyrogen, stainless, single-use only acupuncture needles).
• Safety Record: No accidents or device failure claims reported related to the manufacturer's acupuncture needles in the U.S. since 1988.
• Predicate Acceptance: The predicate device (K963300) was already cleared by the FDA.

The FDA reviewed these claims and determined that the device is "substantially equivalent" to the predicate, allowing it to be marketed. This regulatory determination serves as the "proof" the device meets the acceptance criteria for a 510(k) marketing clearance.

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To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

The Dong Bang acupuncture needle is a sterile surgical stainless steel, single use only acupuncture needle. The Dong Bang acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture.

The provided document is a 510(k) summary for the Dong Bang Acupuncture Needle and a subsequent FDA clearance letter. It does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The document primarily focuses on establishing substantial equivalence to existing legally marketed devices, which is the basis for 510(k) clearance. The crucial aspects for your request are missing.

Therefore, I cannot provide the requested information, including the table of acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, details of comparative effectiveness studies (MRMC), standalone performance, types of ground truth, or training set information.

The only relevant statements from the document are:

• "The Dong Bang acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture." (This is a general claim, not supported by data in this document).
• "Since 1992, no accident or device failure claims have been reported as a result of using the Dong Bang acupuncture needle." (This is a safety claim based on past performance, not a study against specific acceptance criteria).

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