Search Results

The intended use of the N7-S is to provide patients with muscle relaxation therapy by delivering heat and soothing massage. Additionally, it provides topical heating for;
-Temporary relief of minor muscle and joint pain, and stiffness.
-Temporary relief of minor joint pain associated with arthritis.
-The temporary increase in local circulation where applied.
-Relaxation of muscle.
The air massager module of N7-S is indicated for the temporary relief of minor muscle aches and for temporary increase in blood circulation to the treated areas. The air massager module of N7-S stimulates kneading of tissues by using an inflatable garment.

The N7-S is a multi-function physical therapy device offering muscle relaxation through heat therapy and massage.
It has an internal heating unit (smart module), and this module, equipped with four individual heating elements, delivers targeted heat therapy to the cervical, thoracic, and lumbar vertebrae. An auxiliary heating unit is used for the heating units located on both arms to boost the heating effect. For more focused heat therapy and massage, 9-ball projector, Abdominal heating pad are also available. Additionally, it includes an air massager module that features air compression technology to deliver a relaxing and therapeutic massage.

The given document is a 510(k) premarket notification for a medical device (N7-S Multi-Function Physical Therapy Table) and does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

The document primarily focuses on establishing substantial equivalence to predicate devices (CGM MB-1701 & CGM MB-1702, and N5-1) based on indications for use, technological characteristics, and performance testing for safety and basic functionality (e.g., temperature range, pressure performance of air cell massager).

The sections that might contain information about studies are "Performance Test" and "Clinical Test Summary" (page 14). However, these sections state:

• Performance Test: "A comprehensive performance test was conducted on the subject device, including a pressure performance test of the Air Cell Massager, to substantiate its equivalence to the predicate device A(K220572)." It lists items evaluated such as temperature range, extra overheating protection, temperature sensor function, heating part, skin surface temperature, and pressure performance of the Air cell massager. It concludes that "the subject device met all applicable performance requirements and was substantial equivalent with predicate devices."
• Clinical Test Summary: "No clinical studies are considered necessary and performed."

Therefore, the provided document does not describe: AI/ML acceptance criteria, a study proving an AI/ML device meets acceptance criteria, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone AI performance, or how ground truth for training data was established.

The device, N7-S, appears to be a physical therapy table with heat and massage functions, including an air massager. It is not an AI/ML-driven device based on the provided text, and thus, the detailed questions about AI/ML performance metrics are not applicable to this submission.

Without information on AI/ML components or their performance evaluations, I cannot fill out the requested table or provide details on the study's AI/ML specific aspects.

Ask a specific question about this device

The intended use of the N5-1 is to provide patients with muscle relaxation therapy by delivering heat and soothing massage. Additionally, it provides topical heating for;

-Temporary relief of minor muscle and joint pain, and stiffness.

• Temporary relief of minor joint pain associated with arthritis.

• The temporary increase in local circulation where applied.

• Relaxation of muscle.

The N5-1 Personal Heating Therapeutic Device is the electric multi-function physical energy device. Its use is to provide muscle relaxing therapy to patients via a thermal function and massage and this device consist of the following components:

• (1) Main assembly
• (2) 5-Ball Projector
• (3) Remote Control
• (4) Accessories

Inside the main assembly, 7 internal heating roller type ceramics, which can massage from the cervical vertebra to the lumbar, have been installed.

This document is a 510(k) Premarket Notification from Nuga Medical Co., Ltd. for their device, the N5-1. The primary purpose of this document is to demonstrate "substantial equivalence" to a predicate device, not to present a study proving the device meets specific acceptance criteria in terms of clinical performance or accuracy in the way an AI/software device typically would.

Therefore, many of the details requested in your prompt (such as acceptance criteria for performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance) are not applicable or not provided in this regulatory document. This submission focuses on comparing the N5-1's design, technological characteristics, and intended use to a previously cleared predicate device to show that it does not raise new questions of safety or effectiveness.

Here's an breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• This document is for a physical therapy device, not an AI/software device that processes data for diagnosis or treatment decisions. Therefore, there is no "test set" in the context of data for an algorithm.
• The safety and performance are evaluated through engineering tests (electrical safety, EMC) and comparison to a predicate device. Clinical studies were explicitly stated as not being necessary or performed.

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

• Not applicable. There is no "test set" in the context of an algorithm's performance requiring ground truth established by experts.

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:

• No. This is not an AI-assisted diagnostic or therapeutic device that requires human readers.

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

• No. This is a physical therapy device, not an algorithm.

7. The type of ground truth used:

• Not applicable in the context of an AI/software device's performance. The "ground truth" for this device's safety and effectiveness is established through adherence to recognized standards (e.g., AAMI ES60601-1, IEC 60601-1-2) and demonstrating substantial equivalence to a legally marketed predicate device with the same intended use and similar technological characteristics.

8. The sample size for the training set:

• Not applicable. There is no AI training set.

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

• Not applicable. There is no AI training set.

Summary of the Study:

The document describes a non-clinical study primarily focused on demonstrating substantial equivalence to a predicate device (K111329, NM-7000) for regulatory clearance. This is done by comparing:

• Intended Use: The N5-1's intended use is identical to the predicate device.
• Technological Characteristics: The N5-1 is shown to have similar design, function, and technical characteristics (e.g., emission source, temperature range, safe working load) to the predicate device. Minor differences are identified and argued not to raise new safety or effectiveness concerns.
• Performance via Standards Compliance: Electrical safety and electromagnetic compatibility (EMC) were tested against recognized standards (AAMI ES60601-1 and IEC 60601-1-2, respectively). The device "complies" with these standards.
• Software Validation: The device's software (classified as "MODERATE level of concern") was designed, developed, verified, and validated according to a software development process and FDA guidance.
• Biocompatibility: No biocompatibility testing was performed as the device does not have direct patient contact.

Conclusion: Based on this comparison and compliance with engineering standards, NUGA MEDICAL Co., Ltd. concludes that the N5-1 is substantially equivalent to the predicate device. No clinical studies were deemed necessary or performed for this submission.

Ask a specific question about this device

The intended use of the NM-7000 is to provide patients with muscle relaxation therapy by delivering heat and soothing massage. Additionally, the infrared lamps provide topical heating for;

• Temporary relief of minor muscle and joint pain, and stiffness -
• The temporary relief of minor joint pain associated with arthritis -
• The temporary increase in local circulation where applied -
• Relaxation of muscles -

The NM-7000 Personal Heating Therapeutic Device is an electric multifunctional physical energy device. Its use is to provide muscle relaxing therapy to patients via a thermal function and massage. It includes ceramics which emit far infrared radiation and is for temporary easing of muscle pains, joint aches, and stiffening.

This device is made up of the main mat, auxiliary mat, frame, 5ball, 9ball external light projector, Leg holding heater as well as a regulator that can regulate and control the function of the device. Inside the main mat, 7 internal heating roller type ceramics, which can massage from the cervical vertebra to the lumbar, have been installed. A motor that can operate the heating ceramics top down, the main pcb, and a temperature sensor that can control the temperature are attached to the internal heating ceramics.

When massaging the cervical vertebra to lumbar, place the upper body over the main mat, and place the leg on the auxiliary mat which has the heating function. Also, when massaging the leg, it can be used the other way. The internal light projector moves and massages the area where the muscle has cramped and is aching and at the same time, provides thermotherapy that can relax the muscle.

The 5ball or 9ball Tourmanium projector was designed in a way it can manually provide thermotherapy and stimulation for the aching area and can easily be selected according to the aching area.

The leg holding heater can additionally provide thermotherapy for the knee or calf and was designed in a way it can be attached and fixed after wrapping the frame with a integrated Velcro band.

The main mat and auxiliary mat are both separate module types and are installed above the frame. They should be connected with the Velcro of each mat area, attached, and fixed.

The connection cable that can link the main mat with the auxiliary mat provides power for the heater from the main mat to the auxiliary mat.

The electronic components of each module such as the traction motor are loaded above the lower plywood of each module.

This document is a 510(k) summary for the NUGA MEDICAL Co., Ltd. NM-7000 Personal Heating Therapeutic Device. The document focuses on establishing substantial equivalence to a predicate device (MIGUN MEDICAL INSTRUMENT Co., Ltd. HY-7000) rather than providing detailed acceptance criteria and study results for de novo approval.

Therefore, many of the requested sections regarding acceptance criteria and detailed study information for device performance (especially those related to AI or clinical effectiveness studies) are not applicable or not available in this type of submission.

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

1. Table of acceptance criteria and reported device performance:

The submission explicitly states: "Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1, EN/IEC 60601-2-38 was performed, and EMC testing conducted in accordance with standard EN/IEC 60601-1-2(2001). was Temperature testing was conducted. All test results were satisfactory."

However, specific numerical acceptance criteria (e.g., maximum temperature deviation, specific EMC limits) and the detailed numerical results for each test are not provided in this 510(k) summary. The summary only gives a conclusive statement that "All test results were satisfactory."

Acceptance Criteria (General): Conformity to EN/IEC 60601-1 (general medical electrical equipment safety), EN/IEC 60601-2-38 (particular requirements for electric beds), and EN/IEC 60601-1-2 (EMC). Temperature testing also performed.
Reported Device Performance: "All test results were satisfactory."

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

This information is not provided in the 510(k) summary. The testing mentioned (electrical, mechanical, environmental, EMC, temperature) refers to engineering and bench testing, not clinical studies with human subjects or a "test set" in the context of AI/diagnostic device performance.

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 this device is a physical therapeutic device, not an AI or diagnostic device that requires expert-established ground truth for performance evaluation in the context of the 510(k) summary.

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.

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. This device is a standalone physical therapeutic device, not an AI-assisted diagnostic tool.

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

This information is not applicable. There is no algorithm in the sense of AI or diagnostic interpretation being evaluated. The device's function is mechanical and thermal, primarily for massage and heat therapy.

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

This information is not applicable. The "ground truth" for this device's regulatory review is its conformity to safety and performance standards (IEC/EN 60601 series) and its substantial equivalence to a predicate device for its stated indications for use (muscle relaxation, temporary pain relief, increased local circulation).

8. The sample size for the training set:

This information is not applicable. There is no "training set" in the context of AI or machine learning for this device.

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

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

Ask a specific question about this device