The WL-2206B and WL-2106E are the device which generates the small true-sine pulses of electrical current. The generated current may be delivered to the patient skin and/or underlying nerves through the cable and electrode placed on skin.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the IF series True sine interferential stimulator:

First, it is important to note that the provided document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study demonstrating new efficacy or specific performance metrics with acceptance criteria, as one might find for a novel or higher-risk device.

Based on the information provided, here's a breakdown:

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

The document does not provide a specific table of acceptance criteria with detailed performance metrics for the device's clinical efficacy (e.g., pain reduction scores, percentage of patients achieving a certain relief level). Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to an existing predicate device and compliance with relevant standards.

Therefore, the table would look like this, highlighting the lack of specific quantitative clinical performance criteria in this type of submission:

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance (from document)
Intended Use	The device's intended use must be the same as the predicate device.	"The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain," which is explicitly stated as the intended use, implying it matches the predicate.
Technological Characteristics	The device's fundamental technological characteristics must be substantially equivalent to the predicate device.	"The WL-2206B and WL-2106E have output characteristics and controls that are identical to those of the predicate device." (WL-2206B is functionally identical; WL-2106E has different control interface but same output characteristics). "Verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device."
Safety and Effectiveness	The device must demonstrate the same safety and effectiveness as the predicate device.	"Verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device." "In the other words, those engineering difference do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device."
Compliance with Standards	Compliance with applicable voluntary standards.	"Compliance to applicable voluntary standards includes ANSI/AAMI, NS4-1985, as well as EN 60601-1, and EN 60601-1-2 requirement."
Software Verification	Software verification according to FDA software guidance.	"In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA software guidance."

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

Sample Size for Test Set: The document does not describe a clinical test set with human subjects as part of its substantial equivalence argument. The "verification and validation tests" mentioned are likely engineering and performance bench tests rather than clinical trials.
Data Provenance: Not applicable, as there's no mention of a clinical test set with human data.

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

Not applicable. There's no mention of a test set requiring expert ground truth establishment for clinical outcomes. The "ground truth" for the engineering tests would be derived from physical measurements and specifications compared against the standards.

4. Adjudication method for the test set:

Not applicable, as there's no mention of a human-reviewed 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:

No. This device is an interferential stimulator, which is a physical therapy device. It does not involve "readers" or "AI assistance" in the context of diagnostic imaging analysis. Therefore, an MRMC study is not relevant to this device.

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

Not applicable. This is not an AI-driven or algorithmic diagnostic device. The device's "performance" is its ability to generate electrical current as specified and safely, not an interpretation of data by an algorithm.

7. The type of ground truth used:

The de facto "ground truth" for this submission is the predicate device (WL-2206A2 K060975). The new devices are considered substantially equivalent if they meet the same specifications and perform safely and effectively as the predicate device, and comply with relevant voluntary standards (ANSI/AAMI, EN 60601-1, EN 60601-1-2) for electrical safety and performance.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable, as there is no training set for this device.

In summary:

This 510(k) submission relies on demonstrating substantial equivalence to a predicate device and compliance with established performance and safety standards, rather than presenting a novel clinical study with quantitative performance metrics and acceptance criteria for a new clinical claim. The "study" mentioned refers to "verification and validation tests" which are typically engineering and bench tests to confirm the new device's technical specifications and safety are comparable to the predicate and comply with recognized standards.

Summary

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510(K) Summary

This 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K090023

JAN 3 0 2009

1. Submitter's Identifications:

Company Name:	Well Life Healthcare Limited
Contact person:	Jenny Hsieh
Address:	1FL., No.16, Lane 454, Jungjeng Rd., Yunghe City, Taipei County,Taiwan, R.O.C.
TEL No.:	886-2-2928-2112
Fax No.:	886-2-2928-1880
E-mail address:	jenny@welllifehealthcare.com.tw

2. Name of the Device:

IF series True sine interferential stimulator / Model: WL-2206B & WL-2106E.

3. Information of the 510(k) Cleared Device (Predicate Device):

WL-2206A2 (K060975).

4. Device Description:

5. Intended Use:

The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.

In addition, the standard format for the statement of indications and contraindication for use are provided hereafter.

6. Substantial Equivalence Comparison

The WL-2206B and WL-2106E have output characteristics and controls that are identical to those of the predicate device. The new devices are different in that WL-2106E is controlled using knobs and multi-position switches versus input buttons in conjunction with an LCD display. WL-2206B is functionally identical to WL-2206A2.

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7 . Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows:

Compliance to applicable voluntary standards includes ANSI/AAMI, NS4-1985, as well as EN 60601-1, and EN 60601-1-2 requirement.

In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA software guidance.

8. Conclusions

The true sine interferential stimulator, model WL-2206B & WL-2106E, has the same intended use and technological characteristics as the cleared device of WL-2206A2 (K060975). Moreover, verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device.

In the other words, those engineering difference do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is depicted in a simple, abstract style, with bold lines forming its shape. The text is in uppercase letters and is evenly spaced around the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3.0 2009

Well Life Healthcare Limited % Ms. Jenny Hsieh 1Fl., No. 16, Lane 454 Jungjeng Road Yunghe City, Taipei County Taiwan, R.O.C.

Re: K090023

Trade/Device Name: IF series True sine interferential stimulator/Model: WL-2206B & WL-2106E

Regulatory Class: Unclassified Product Code: LIH Dated: January 5, 2009 Received: January 5, 2009

Dear Ms. Hsieh:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Jenny Hsieh

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N Milkersan

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: IF series True sine interferential stimulator / Model: WL-2206B & WL-2106E.

Indications For Use:

The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.

(Division Sigi Division of Ge

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Division of General, Restorative, and Neurological and Neurological Devices

510(k) Number

51%(%) Numbe

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V OR

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).