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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) Notification - the KHT Soft Needle - is a sterile, silicon coated, single use only acupuncture needle. The design, material used, sterlity 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 text describes a 510(k) premarket notification for the "KHT Soft Needle" acupuncture needle, seeking clearance by demonstrating substantial equivalence to a legally marketed predicate device. This is primarily a regulatory submission, not a study reporting on the performance of a device against pre-defined acceptance criteria in the way a clinical or technical performance study would.

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 document for this particular product.

Here's an attempt to answer the questions based solely on the provided text, indicating where information is not available or not applicable for this kind of submission:

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

For a 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device. The performance is assessed against the design, materials, sterilization, and biocompatibility of the predicate. Formal numerical acceptance criteria (e.g., minimum sensitivity/specificity) for a diagnostic device or specific measured performance for a therapeutic device are typically not explicitly stated and measured in this type of document for a Class II acupuncture needle.

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

• Sample Size for Test Set: Not applicable. This document does not describe a clinical study with a test set where device performance metrics are calculated based on patient data. Substantial equivalence is primarily demonstrated through comparison of technical characteristics, intended use, and materials to a predicate device.
• Data Provenance: Not applicable for a typical performance study. The 510(k) relies on the established safety and effectiveness of a predicate device already marketed in the US.

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)

• Number of Experts: Not applicable. No "ground truth" was established in a clinical sense for a test set, as this is a regulatory submission for a simple medical device, not a diagnostic or complex therapeutic device requiring such evaluation.
• Qualifications of Experts: Not applicable. No such expert panel was used to establish ground truth.

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

• Adjudication Method: Not applicable. There was no test set requiring adjudication in the context of this 510(k) submission.

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

• MRMC Comparative Effectiveness Study: No. This is an acupuncture needle, not an AI-powered diagnostic or therapeutic device that would involve human readers or AI assistance.

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

• Standalone Performance Study: No. This product is an acupuncture needle, not an algorithm.

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

• Type of Ground Truth: Not applicable in the context of a performance study. The "ground truth" for a 510(k) of this nature is essentially the established safety and effectiveness of the legally marketed predicate device (the Seirin Brand Acupuncture Needle, 510(k) Document Number: K963769, and pre-amendments devices) through their history of use and regulatory clearance.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Ground Truth Establishment for Training Set: Not applicable. No training set was used.

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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) Notification - the KHT Guam Needle - is a sterile, single use only acupuncture needle. 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 for K980471 pertains to the clearance of an acupuncture needle (KHT Guam Needle). The submission is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical performance studies with acceptance criteria in the way a novel medical device or AI-driven diagnostic would require.

Therefore, many of the requested elements regarding acceptance criteria, study design, expert involvement, and ground truth are not applicable in this context. The 510(k) process for this type of device relies on established safety and efficacy profiles of similar legally marketed devices.

Here's a breakdown based on the available 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)

• Not applicable for this 510(k) submission. There was no "test set" in the sense of a clinical performance study with a specific sample size. The substantial equivalence argument relies on comparison to existing devices and general knowledge of acupuncture needle safety.

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. No ground truth was established by experts for a specific test set. The regulatory determination of "substantial equivalence" is made by the FDA based on the provided documentation and comparison to predicate devices, not on expert consensus on a new test set's ground truth.

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

• Not applicable. There was no test set or adjudication method as typically understood in performance studies.

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 applicable. The device is an acupuncture needle, not an AI-driven diagnostic or image analysis tool. Therefore, MRMC studies and AI assistance are irrelevant.

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

• No, this is not applicable. The device is an acupuncture needle, not an algorithm.

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

• Not applicable in the conventional sense of a clinical study. The "ground truth" for this 510(k) process is the established safety and effectiveness of the predicate devices and the general understanding of acupuncture needles as a class of device that has been in safe use for an extended period. The FDA's determination of substantial equivalence serves as the regulatory "truth."

8. The sample size for the training set

• Not applicable. There was no "training set" for an algorithm.

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

• Not applicable. There was no "training set" or algorithm.

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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 KHT Soft Sooji Needle - is a sterilized, silicon coated, single use only hand acupuncture needle. 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 text from K980470 is a 510(k) summary and FDA clearance letter for the KHT Soft Sooji Needle, which is a hand acupuncture needle. This document does not describe a study involving performance metrics, acceptance criteria, or ground truth as would be associated with a device using AI or advanced diagnostic capabilities.

The clearance is based on substantial equivalence to previously marketed devices, not on a performance study against specific acceptance criteria. The criteria for acceptance in this context refer to meeting the requirements for 510(k) clearance, primarily by demonstrating equivalence to a predicate device.

Therefore, I cannot populate the requested table and answer the specific questions about device performance studies. The provided text does not contain that information.

Explanation based on the provided document:

This 510(k) notification is for a Class II medical device, a KHT Soft Sooji Needle (Hand Acupuncture Needles). The clearance is based on the device being "substantially equivalent" to legally marketed predicate devices, both those marketed prior to May 28, 1976, and other currently marketed single-use acupuncture needles (specifically referencing CW-Disposable Acupuncture Needle, K962419).

The document states: "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." This indicates that the device meets general standards for its type, rather than specific performance metrics from a controlled study comparing its output to a defined ground truth.

Therefore, the following information is not present in the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable, as no performance study with specific metrics is described for the KHT Soft Sooji Needle against an "acceptance criteria" for diagnostic accuracy or similar.
2. Sample size used for the test set and the data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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-enabled device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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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 KHT Sooji Needle - is a sterilized, single use only hand acupuncture needle. 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 KHT Sooji Needle, a hand acupuncture needle. It focuses on demonstrating substantial equivalence to pre-amendment devices and currently marketed single-use acupuncture needles rather than reporting performance against specific acceptance criteria from a comprehensive study to prove detailed device performance.

Therefore, the requested information elements (1-9) about acceptance criteria, study details, and ground truth establishment are largely not applicable or extractable from this type of regulatory submission. This document highlights that the device "meets the general specifications and criteria for a single use acupuncture needle and is effective for the practice of acupuncture," but it does not present a formal study with detailed acceptance criteria and performance metrics in the format requested.

However, I can extract the following information that is available:

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

Comment: The document doesn't define quantitative 'acceptance criteria' in the sense of specific thresholds for a study (e.g., minimum sensitivity, specificity, accuracy). Instead, it asserts that its design, material, sterility, and biocompatibility "meet the general specifications and criteria" for the device type and that it is "effective for the practice of acupuncture." The primary 'acceptance criterion' for a 510(k) is demonstrating substantial equivalence to a legally marketed predicate device.

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

• Not Applicable. The 510(k) summary provided does not describe a performance study with a distinct test set, sample size, or data provenance. The assessment is based on design, materials, and comparison to predicate devices, not on a clinical or performance trial with a test set of data.

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

• Not Applicable. No test set or ground truth establishment by experts is described in this regulatory submission.

4. Adjudication method for the test set

• Not Applicable. No test set or adjudication method 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

• Not Applicable. This device is a physical medical device (acupuncture needle), not an AI-assisted diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is irrelevant.

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• Not Applicable. No formal ground truth for performance evaluation is described. The "ground truth" for the 510(k) process is the established safety and effectiveness of the predicate devices to which substantial equivalence is claimed.

8. The sample size for the training set

• Not Applicable. The 510(k) summary does not describe a machine learning model or a training set.

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

• Not Applicable. The 510(k) summary does not describe a machine learning model or a training set with established ground truth.

In summary, this 510(k) document is a regulatory submission demonstrating substantial equivalence rather than a clinical or performance study that would typically include the detailed information requested for device performance assessment.

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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) Notification - the KHT Seoam Needle - is a sterile, single use only hand acupuncture needle. 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 510(k) summary for the KHT Seoam Needle does not contain the detailed study information typically associated with acceptance criteria tables, sample sizes, expert involvement, or multi-reader multi-case studies as requested in the prompt. This submission relies on substantial equivalence to a predicate device rather than presenting a performance study with specific quantitative acceptance criteria.

Therefore, many of the requested fields cannot be filled based on the provided text.

Here's a breakdown of what can be answered and what cannot:

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

The submission states that the device "meet the general specifications and criteria for a single-use acupuncture needle and is effective for the practice of acupuncture." However, it does not provide specific, quantitative acceptance criteria (e.g., tensile strength, penetration force, sterility pass rates) or detailed performance data against such criteria. The primary "performance" stated is that it is "effective for the practice of acupuncture," which is a general claim rather than a measured performance metric.

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

Not provided. The submission focuses on design, material, sterility, and biocompatibility, but no specific test set sample sizes or data provenance for performance testing are mentioned.

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. There's no indication of a test set requiring expert ground truth establishment in the context of this device.

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

Not applicable.

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 a medical device (acupuncture needle), not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical medical device, not an algorithm.

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

Not applicable in the typical sense of diagnostic ground truth. The "ground truth" for an acupuncture needle would pertain to its physical and functional properties (e.g., sterility, biocompatibility, sharpness, break resistance for effective and safe use).

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

Not applicable.

Summary based on the provided text:

The submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, particularly in terms of design, materials, sterility, and biocompatibility, rather than presenting a detailed performance study against specific, quantitative acceptance criteria.

KHT Seoam Needle Substantial Equivalence Claim:

• Legally Marketed Predicate Device: CW-Disposable Acupuncture Needle (510(k) Document Number: K962419) and acupuncture needles in commercial distribution prior to May 28, 1976.
• Key Equivalence Claims:
  • Sterile
  • Single-use only
  • Hand acupuncture needle
  • Design, material used, sterility, and biocompatibility meet general specifications and criteria for a single-use acupuncture needle.
  • Effective for the practice of acupuncture.

The FDA's letter confirms that the device is "substantially equivalent" to predicate devices for the stated indications for use, without requiring explicit, quantitative performance data beyond the general claims of compliance with specifications and effectiveness for its intended purpose.

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