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Seirin JR acupuncture needles are (defined as) devices intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.

The subject of this 510(k) application - the Seirin JR Acupuncture Needle - is a sterile, single use only acupuncture needle. The Seirin JR Acupuncture Needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture.

I am sorry, but the provided text is a 510(k) summary for an acupuncture needle. It describes the intended use, safety, and equivalence of the Seirin JR Acupuncture Needle to existing devices. However, it does not contain information about a study with acceptance criteria and device performance in the context of an AI/ML powered medical device.

Therefore, I cannot extract the requested information regarding:

• A table of acceptance criteria and reported device performance
• Sample size used for the test set and data provenance
• Number of experts used to establish ground truth and their qualifications
• Adjudication method for the test set
• Multi-reader multi-case (MRMC) comparative effectiveness study results
• Standalone algorithm performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

This document is for a traditional medical device (acupuncture needle) and not an AI/ML powered device.

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Pyonex acupuncture needles are (defined as) devices intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.

The Seirin PYONEX Acupuncture Needle is a sterile, single use only acupuncture needle. The Seirin PYONEX Acupuncture Needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture.

This document is a 510(k) summary for an acupuncture needle, not a study describing the performance of a novel AI device. Therefore, most of the requested information regarding AI device acceptance criteria, performance studies, sample sizes, expert ground truth, and MRMC studies is not applicable to this submission.

However, I can extract the relevant information from the provided text based on the nature of this medical device submission.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable. This submission relies on historical data, market comparisons, and the absence of adverse event reports, rather than a specific "test set" in the context of an AI device performance study. The statement "no accidents or device failure claims have been reported as a result of using the Seirin PYONEX brand acupuncture needle since its import into the USA in 1983" serves as post-market safety data.

• Data Provenance: The device was manufactured in Japan in 1978 and imported/sold in the USA since 1983. The data regarding lack of adverse events is retrospective, based on "no accidents or device failure claims" reported during its marketing in the USA.

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

• Not applicable. There was no "test set" and thus no ground truth established by experts in a formal study setting for this needle. The safety and effectiveness are established through predicate device comparison and a lack of reported adverse events over a long period of marketing.

4. Adjudication method for the test set:

• Not applicable, as no formal test set with ground truth adjudication was conducted.

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. This is not an AI device.

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

• Not applicable. This is not an AI device.

7. The type of ground truth used:

• The "ground truth" here is implied by historical safety data and market acceptance of similar devices. For the PYONEX needle specifically, the "ground truth" for its safety and effectiveness is primarily established by:
  • Predicate device equivalence: Comparison to acupuncture needles in commercial distribution prior to May 28, 1976.
  • Absence of reported adverse events: "no accidents or device failure claims have been reported as a result of using the Seirin PYONEX brand acupuncture needle" since 1983.

8. The sample size for the training set:

• Not applicable. This is not an AI device.

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

• Not applicable. This is not an AI device.

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

The subject of this 510(k) application - the Seirin Spinex acupuncture needle - is a sterile, single use only acupuncture needle. The Seirin Spinex acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture.

Here's an analysis of the provided text regarding the Seirin Spinex acupuncture needle, structured to address your questions about acceptance criteria and supporting studies.

Based on the provided 510(k) summary, the device is an acupuncture needle, and the regulatory pathway is demonstrating substantial equivalence to predicate devices already on the market. Therefore, the "acceptance criteria" are primarily related to general performance, safety, and equivalence to existing devices, rather than specific performance metrics like sensitivity or specificity for a diagnostic algorithm.

Here's a breakdown of the requested information:

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

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

The provided text does not describe a formal "test set" with a defined sample size in the context of evaluating a diagnostic or AI device. The evidence for the Seirin Spinex acupuncture needle primarily relies on:

• Historical safety data: No reported accidents since 1983 for the Seirin Spinex. This is a retrospective observation based on commercial use.
• General understanding of acupuncture needles: The statement about effectiveness is more of a declaration based on the established practice of acupuncture rather than a specific clinical study for this particular needle.
• Comparison to predicate devices: The equivalence argument is based on the characteristics of the device itself (sterile, single-use, general specifications) aligning with devices already on the market or those historically used.

There is no mention of a specific country of origin for any "data" other than the manufacturing origin in Japan for the Seirin Spineus.

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

This information is not applicable to the provided 510(k) summary. The context is a medical device (acupuncture needle) demonstrating substantial equivalence, not a diagnostic algorithm requiring ground truth established by experts.

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

This information is not applicable for the same reasons as above. There was no formal test set requiring adjudication.

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. An MRMC study is relevant for evaluating the impact of an AI-assisted diagnostic tool on human performance. The Seirin Spinex is an acupuncture needle, not a diagnostic AI system.

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

This information is not applicable. The device is a physical medical instrument, not a standalone algorithm.

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

The concept of "ground truth" as typically defined for diagnostic device validation is not directly applicable here. The "truth" for this device lies in its physical characteristics (sterility, single-use, dimensions) and its historical safety record, as well as the generally accepted effectiveness of acupuncture itself. There's no diagnostic output for which an external "ground truth" would be compared.

8. The sample size for the training set

This information is not applicable. There is no machine learning model or algorithm discussed in this 510(k) summary, therefore no "training set" exists.

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

This information is not applicable for the same reasons as above.

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

The subject of this 510(k) application - the Seirin acupuncture needle - is a sterile, single use only acupuncture needle. The Seirin 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 acupuncture needles and does not contain the kind of information requested regarding acceptance criteria, study details, and performance metrics typically associated with modern AI/ML medical devices.

Therefore, I cannot answer your request based on the input document. The document describes a traditional medical device (acupuncture needles) and focuses on demonstrating substantial equivalence to previously marketed devices, rather than providing performance data for a new AI-powered diagnostic or therapeutic tool.

Ask a specific question about this device