Search Results

Needle Stimulator is an electro-acupuncture stimulator device, which is indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

Needle Stimulator is an electro-acupuncture device for acupuncture therapy, powered by 6 pieces of 1.5V batteries or AC 100-240V. It is composed of a console and 6 channels of electrode cables with alligator type connectors. The console has the operating controls including function knobs or buttons. Needle Stimulator does not equip with acupuncture needles. The practitioners should select legally marketed needles.

The provided text is an FDA 510(k) summary for a medical device called "Needle Stimulator." It details the device, its intended use, and a comparison to a predicate device to establish substantial equivalence.

However, the provided text does not contain any information about a study that proves the device meets specific performance acceptance criteria for an AI/ML-based device. The information is primarily focused on electrical safety, essential performance, and electromagnetic compatibility tests as per general medical device standards, and not on the performance metrics of an AI system detecting or classifying something.

The recurring phrases like "Similar Note 1," "Similar Note 2," etc., refer to explanations for minor differences between the subject device and the predicate device in terms of hardware specifications and compliance with voluntary standards. They are not related to an AI/ML performance study.

Specifically, the section "6. Clinical Test" states, "Clinical data were not included in this submission." This strongly indicates that no clinical study was performed for this 510(k) submission, and therefore, no AI/ML performance data against ground truth or human readers would be available within this document.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML-based device based on the information provided. The document describes a standard medical device (an electro-acupuncture stimulator), not an AI/ML product requiring the detailed performance study you've outlined.

If this was a misunderstanding and you expected a generic answer for an AI/ML device based on typical FDA requirements, please clarify. But based solely on the provided text, the requested information is absent.

Ask a specific question about this device

Needle Stimulator (Model: RJNS6-1) is an electro-acupuncture stimulator device, which is indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

Needle Stimulator (Model: RJNS6-1) is an electro-acupuncture device for acupuncture therapy, powered by 6 pieces of 1.5V batteries or AC 100-240V. It is composed of a LCD, a console and 6 channels of electrode cables with alligator type connectors. Only 3 channels at most could work together on single patient. The console has the operating elements of Channel selecting button, Setting button, Operation suspending switch button, Wave-selecting button, On/off switch, Mute button, Therapy time adjusting button, Output frequency adjusting button, Intensity adjust knobs, and Output indicator light. Needle Stimulator (Model: RJNS6-1) does not equip with acupuncture needles. The practitioners should select 510(k) cleared needles (with minimum diameter of 0.40mm and insertion depth of 16mm) for use.

The provided text describes the 510(k) submission for the "Needle Stimulator (Model: RJNS6-1)" and its substantial equivalence to a predicate device. However, the document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/human-in-the-loop diagnostic system.

The device in question is an electro-acupuncture stimulator, and the FDA's review focuses on its electrical safety, performance parameters, and substantial equivalence to a legally marketed predicate device (K202861). The testing mentioned is related to electrical safety and electromagnetic compatibility (e.g., IEC 60601 standards), not diagnostic performance or AI assistance.

Therefore, I cannot provide a table of acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC study details, standalone performance, or ground truth establishment as these concepts are not applicable or mentioned in the context of this specific device's 510(k) submission as provided.

The document confirms the following:

• Device Name: Needle Stimulator (Model: RJNS6-1)
• Intended Use: An electro-acupuncture stimulator indicated for use in the practice of acupuncture by qualified practitioners.
• Regulatory Pathway: 510(k) Premarket Notification.
• Predicate Device: Needle Stimulator (Model: CMNS6-2), K202861.
• Performance Evaluation: Substantial equivalence based on non-clinical tests (electrical safety, EMC, etc.) according to recognized standards (ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-10).

In summary, the provided text does not contain the specific information requested about acceptance criteria and a study proving an AI-powered device meets them. The evaluation described is for a non-AI medical device and focuses on electrical and functional equivalence.

Ask a specific question about this device

Needle Stimulator is an electro-acupuncture stimulator device, which is indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

Needle Stimulator is an electro-acupuncture device for acupuncture therapy powered by 6 pieces of 1.5V batteries or AC 100-240V. It is composed of a console and 6 channels of electrode cables with alligator type connectors. The console has the operating controls including function knobs or buttons. Needle Stimulator does not equip with acupuncture needles. The practitioners should select legally marketed needles.

Based on the provided text, the device in question is a "Needle Stimulator," an electro-acupuncture stimulator. The document is a 510(k) Summary, which aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This type of submission relies on comparisons to demonstrate safety and effectiveness rather than conducting extensive clinical studies typically associated with novel devices.

Therefore, the acceptance criteria and the "study" proving the device meets them are primarily based on equivalence to a predicate device through engineering and performance testing, rather than a clinical efficacy study with human subjects.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the parameters of the predicate device (K130768) and compliance with relevant safety standards. The reported device performance is presented as a comparison to these predicate specifications.

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

The document does not describe a "test set" in the context of clinical data for performance evaluation. Instead, the "testing" refers to engineering and compliance testing of the device prototypes themselves. Therefore, the "sample size" is the manufactured device unit or units tested for compliance.

• Sample Size: Not applicable in the context of a clinical test set. The testing was performed on the device models themselves (CMNS6-1 and CMNS6-2).
• Data Provenance: Not specified as clinical data. The tests were likely conducted by the manufacturer in China, given their location. The studies are retrospective in the sense that they are proving equivalency to a device already on the market, but the testing on the new device would have been done prospectively for this submission.

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 as the ground truth for this type of submission is established through:

• Engineering specifications and design requirements.
• Compliance with recognized national and international safety standards (ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-10).
• Demonstration of substantial equivalence to a legally marketed predicate device.

No human expert interpretation of clinical data (like radiology reads) is involved in establishing "ground truth" for this device's safety and performance claim.

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

This is not applicable as there is no clinical test set requiring human adjudication. The "adjudication" is done through engineering measurements and conformity assessments to established standards and predicate specifications.

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 is not applicable. The device is an electro-acupuncture stimulator, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or required for this type of device.

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

This is not applicable. The device is a physical medical instrument, not a software algorithm. Its performance is inherent in its electrical and mechanical properties, not an algorithm's output.

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

The "ground truth" for this submission is:

• Engineering specifications and performance characteristics of the predicate device (K130768).
• International and national safety standards (ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-10), which define acceptable limits for various electrical and physical parameters, ensuring patient and user safety.
• The premise that if the new device operates within the same safety and performance parameters as a previously cleared predicate and complies with relevant standards, it is "safe and effective."

8. The sample size for the training set

This is not applicable. This is not an AI/ML device that requires a "training set."

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

This is not applicable. As it is not an AI/ML device, there is no training set or associated ground truth establishment process.

Ask a specific question about this device