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This device is designed to be used in the treatment of chronic, acute, and post-surgical pain.

EA Stimulator is a battery powered TENS, which is used in the treatment of chronic, acute, and post-surgical pain. The device contains a printed circuit board, independent intensity controlled channels, and Microcurrent-Milliampere Switches. It also has windows, display frequency, pulse width, and time settings. The device has different stimulation frequency modes with different selected waveforms. EA Stimulator uses self adhesive electrodes and has energy saving feature that automatically turns off if the device has no activity for 5 minutes or when a treatment session is completed.

Here's an analysis of the provided text regarding the acceptance criteria and study for the EA Stimulator (K080221):

The provided document (K080221) is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device called the "EA Stimulator." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving de novo effectiveness through extensive clinical trials.

As such, many of the requested criteria for a clinical study proving device performance, particularly those related to AI algorithms, ground truth establishment, and multi-reader studies, are not applicable to this 510(k) submission. This is a common characteristic of TENS device submissions, which typically rely on adherence to established electrical and safety standards and comparison to a legally marketed predicate.

Here's what can be extracted and inferred from the provided text:

Acceptance Criteria and Reported Device Performance

• EN60601-1-2:2001/A1:2006 (Electromagnetic Compatibility - EMC)
• IEC 60601-1-2:2001/A1:2004 (Electromagnetic Compatibility - EMC)
• IEC 60601-1 / EN60601-1 (General Requirements for Basic Safety and Essential Performance)
• IEC 60601-2-10 / EN60601-2-10 (Particular Requirements for the Safety of Nerve and Muscle Stimulators - specific to TENS devices). |
  | Substantial Equivalence to Predicate | The device must demonstrate technological characteristics, intended use, and performance that are substantially equivalent to a legally marketed predicate device. This implies that any differences do not raise new questions of safety or effectiveness. The predicate device here is ES-160 (K051020). | FDA's review determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use. The technological characteristics described (battery-powered, independent intensity channels, microcurrent/milliampere switches, display, frequency modes, waveforms, self-adhesive electrodes, energy-saving feature) are implicitly deemed equivalent to the predicate. |
  | Intended Use | The device's intended use must align with the predicate device and established uses for TENS units. | The device is designed to be used in the treatment of chronic, acute, and post-surgical pain. This matches the common indications for TENS units and is consistent across the 510(k) summary and the "Indications For Use" page. |
  | Device Configuration/Features | The functional description and features of the device (e.g., battery power, number of channels, adjustability, display, auto-off) should be consistent with safe and effective operation for a TENS unit and comparable to the predicate. | The device is battery powered, has independent intensity controlled channels, Microcurrent-Milliampere Switches, windows, display frequency, pulse width, and time settings, different stimulation frequency modes with different selected waveforms, uses self-adhesive electrodes, and has an energy saving feature (auto-off after 5 mins inactivity or treatment completion). These features are presented to demonstrate functional equivalence and safety. |

Regarding the study that proves the device meets the acceptance criteria:

The primary "study" or evidence for this 510(k) clearance is the demonstration of compliance with relevant consensus standards and substantial equivalence to a predicate device. There is no mention of a clinical performance study (e.g., randomized controlled trial on patients using the device to measure pain reduction) in this summary. For TENS devices, generally, if a device is substantially equivalent in technology and intended use to a legally marketed device and meets recognized safety standards, explicit new clinical performance data is often not required for 510(k) clearance.

Let's address the specific points based on the provided text:

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

   • (See table above) The acceptance criteria are largely based on regulatory compliance and technical standards.

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. No clinical performance test set or data provenance is mentioned as this is a safety/technical standards compliance and substantial equivalence demonstration, not a clinical efficacy trial. The "tests" relate to electrical and mechanical performance in a lab setting against standards, not patient outcomes.

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. Ground truth, in the context of clinical or diagnostic performance, is not established or discussed for this type of device submission. The "ground truth" here is compliance with technical standards as assessed by engineers/testing labs.

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

   • Not applicable / Not provided. No adjudication method for a clinical test set is mentioned.

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 device is a physical TENS unit, not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study and AI assistance are entirely irrelevant.

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

   • No. This is not an algorithm-only device. It's a hardware medical device.

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

   • For the technical standards compliance, the "ground truth" is adherence to the specifications outlined in standards like IEC 60601-1 andIEC 60601-2-10, verified through engineering tests. For substantial equivalence, the "ground truth" is established by comparing the device's technological characteristics and intended use to the predicate device (ES-160, K051020) and finding no new questions of safety or effectiveness. No clinical "outcomes data" or "pathology" is mentioned.

8. The sample size for the training set:

   • Not applicable / Not provided. There is no "training set" in the context of an AI algorithm described here. The device itself is designed and manufactured according to specifications.

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

   • Not applicable / Not provided. As there's no training set for an AI algorithm, this question doesn't apply.

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

Not Found

The provided text is a 510(k) clearance letter from the FDA for a device called "Lyra Acupuncture Needles." It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert evaluations.

The document primarily focuses on:

• Confirming that the device is substantially equivalent to legally marketed predicate devices.
• Outlining the regulatory requirements the manufacturer must adhere to (e.g., registration, labeling, good manufacturing practice).
• Stating the intended "Indications For Use" for the device, which is "To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States."

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

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

Not Found

This document is a 510(k) premarket notification letter from the FDA regarding a medical device called "Seven Star Needle." It establishes substantial equivalence for the device for the stated indications for use.

Based on the provided text, the document does not contain the detailed acceptance criteria or a study that proves the device meets specific performance criteria in the way typically expected for AI/ML-based medical devices. This is a notification for an acupuncture needle, which is a traditional medical device, not a software-based or AI-driven diagnostic/prognostic tool. Therefore, many of the questions asked in the prompt, such as those related to AI performance, sample sizes for test/training sets, expert adjudication, or MRMC studies, are not applicable to the content of this document.

The document primarily focuses on:

• Confirming the device's substantial equivalence to a legally marketed predicate device.
• Stating the intended use of the device (to pierce the skin in the practice of acupuncture by qualified practitioners).
• Regulatory classification (Class II, Product Code MQX).
• General regulatory requirements for the manufacturer.

Since the prompt asks for information that is not present in the document for a device of this nature, I will explicitly state where the information is not provided.

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

• Acceptance Criteria: Not provided in this document. For a traditional medical device like an acupuncture needle, acceptance criteria would typically relate to manufacturing specifications, material biocompatibility, sterility, needle sharpness, and structural integrity, rather than performance metrics like sensitivity or specificity. These details would be in the full 510(k) submission, not the FDA's final decision letter.
• Reported Device Performance: Not provided in this document.

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. This document pertains to a traditional medical device, not one that undergoes performance evaluation with a "test set" in the context of AI/ML.

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.

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

• Not applicable/Not provided.

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-assisted diagnostic tool.

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

• Not applicable/Not provided.

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

• Not applicable/Not provided. Ground truth is not relevant for this type of device in the context of this document. The "ground truth" for an acupuncture needle would be its physical properties and functionality.

8. The sample size for the training set

• Not applicable/Not provided.

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

• Not applicable/Not provided.

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

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to Helio Medical Supplies, Incorporated regarding their Press Tack/Intradermal Acupuncture Needles. This document is a regulatory approval letter and does not contain information about acceptance criteria or a study proving device performance as typically understood for medical device AI/algorithm submissions.

Therefore, I cannot extract the requested information from the provided text. The document primarily focuses on:

• Device Name: Press Tack/Intradermal Acupuncture Needles
• Regulatory Classification: Class II
• Product Code: MQX
• Submission Date and Receipt Date: February 3, 2005 / February 7, 2005
• FDA Determination: Substantially equivalent to a legally marketed predicate device.
• Indications for Use: To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.
• Prescription Use status: Prescription Use.

To address your request, I would need a document that presents a clinical or performance study for a medical device, ideally one involving an AI or algorithmic component, which would then detail its acceptance criteria and the results of the study.

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

Not Found

The provided text is a U.S. FDA 510(k) clearance letter for a medical device: "C&G Acupuncture Needle." This type of document does not contain the information requested regarding acceptance criteria studies, performance data, sample sizes, expert qualifications, or ground truth establishment.

A 510(k) clearance letter primarily focuses on:

• Confirming that a new device is substantially equivalent to a legally marketed predicate device.
• Outlining the regulatory classification and general controls applicable to the device.
• Stating the intended use of the device.

To obtain the information requested, one would typically need to review the 510(k) summary document submitted by the manufacturer to the FDA, or potentially a clinical study report if such studies were conducted and summarized for the 510(k) application. These documents would detail the testing performed to demonstrate substantial equivalence, including performance data and the methods used to obtain it.

Therefore, I cannot provide the requested information based on the given text.

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

Vinco Brand Acupuncture Needle

Here's an analysis of the provided text regarding the Vinco Brand Acupuncture Needle, focusing on the requested information:

The provided document is a 510(k) clearance letter from the FDA for a medical device: the Vinco Brand Acupuncture Needle. This type of document primarily confirms that a new device is "substantially equivalent" to a legally marketed predicate device, rather than detailing a comprehensive scientific study evaluating its performance against specific acceptance criteria.

Therefore, many of the requested points regarding acceptance criteria and a study proving device performance cannot be found within this document. The FDA clearance is based on a demonstration of equivalence in design, materials, and intended use to a pre-existing device, not necessarily extensive new clinical trial data.

Based on the provided text, here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance

• Not explicitly available. The document does not list specific performance criteria (e.g., tensile strength, sharpness, sterility levels) or corresponding test results for the Vinco Brand Acupuncture Needle. The clearance is based on substantial equivalence to a predicate device.

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

• Not available. The document does not describe any specific "test set" or studies of this nature. Given it's a 510(k) for an acupuncture needle, any testing would likely be bench testing related to safety and manufacturing, not clinical trials with human subjects in the typical sense.

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/available. This refers to clinical studies where expert consensus defines ground truth, which is not described here.

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

• Not applicable/available. This refers to clinical studies where expert consensus defines ground truth, which is not described here.

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 type of study is relevant for AI-powered diagnostic tools, not for an acupuncture needle.

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

• Not applicable. This is for AI algorithms, not for a physical medical device like an acupuncture needle.

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

• Not applicable/available. Ground truth is a concept for diagnostic or predictive models; for a physical device like this, compliance with manufacturing standards and safety profiles are key.

8. The sample size for the training set

• Not applicable. This refers to AI algorithms, not a physical medical device.

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

• Not applicable. This refers to AI algorithms, not a physical medical device.

Summary from the document:

• Device Name: Vinco Brand Acupuncture Needle
• Regulation Number: 880.5580
• Regulation Name: Acupuncture Needle
• Regulatory Class: II
• Product Code: MQX
• Indication for Use: To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.
• Basis for Clearance: Substantial equivalence to legally marketed predicate devices, meaning it has essentially the same intended use, technological characteristics, and safety/effectiveness profile as a device already on the market. The document implies that the device meets the general controls provisions of the Act (e.g., annual registration, listing, good manufacturing practice, labeling, prohibitions against misbranding and adulteration) and any additional Class II special controls, though these specific controls are not detailed in this letter.

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

Not Found

I am sorry, but based on the provided text, I cannot provide the requested information. The text is a letter from the FDA regarding the 510(k) premarket notification for "AcuGlide brand Acupuncture Needles." It indicates that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

However, the document does NOT contain:

• A table of acceptance criteria or reported device performance.
• Details of any study that proves the device meets acceptance criteria, including sample sizes, data provenance, expert information, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance.
• Information on training sets or how ground truth was established for any studies.

The letter is a regulatory approval document and does not delve into the technical details of performance studies.

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

Kangnian Brand Acupuncture Needle

This document is a FDA 510(k) clearance letter for a Kangnian Brand Acupuncture Needle. It does not contain information about the acceptance criteria or a study proving the device meets those criteria, as it is a regulatory approval document rather than a performance study report.

Therefore, I cannot extract the requested information from the provided text.

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

Not Found

The provided text is a 510(k) clearance letter from the FDA for an acupuncture needle. It does not contain information about the acceptance criteria or a study that proves the device meets those criteria, as typically found in a clinical or performance study summary.

Therefore, I cannot extract the requested information to fill the table and answer the questions. The document's purpose is to grant market clearance based on substantial equivalence to a predicate device, not to detail device performance studies against specific acceptance criteria.

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