This device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic acute pain.

Device Description

The IF-4000 generates small pulses of electrical current. Delivered along lead cables to electrodes placed on your skin, these pulses pass through the skin and activate underlying nerves. The relief from chronic and acute pain that the IF-4000 can provide results from this electrical stimulation.

AI/ML Overview

This submission describes a medical device, the IF-4000 Portable Interferential Stimulation Device, and compares it to a predicate device, the IF-4150. The core of this 510(k) summary is to demonstrate substantial equivalence, not to prove the device meets specific acceptance criteria through a clinical study with performance metrics in the way a novel AI algorithm might.

Therefore, the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is not applicable to this type of regulatory submission for a medical device that relies on substantial equivalence to a predicate device.

Here's how we can address the specific points based on the provided text, primarily noting what is not present in this type of submission:

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

Acceptance Criteria (Not Explicitly Stated as such for performance)	Reported Device "Performance" (Comparison to predicate)
Safe as predicate device	Met UL-544, AAMI/ANSI NS-4 (TENS), EMC Testing, allowable variations in supply voltage, patient applied risk current.
Effective as predicate device	Functionally similar to IF-4150 for pain relief via electrical stimulation.
Key Technical Specifications:
Carrier Frequency	4000 Hz, fixed
Difference Frequency	1-150 beats per second, adjustable
Output Current	0-29 milliamps, adjustable
Output Voltage	0-14.5 volts (29 volts peak to peak)
Waveform	Symmetric bi-phasic square
Pulse Width	125 microseconds for each phase
Max. Charge Per Cycle	7.25 microcoulombs
Power Source	9V alkaline battery or adapter
Size	2.4" x 3.5" x 1.1"
Frequency Shift Option	Continuous, 1/1 abrupt, 8/8 abrupt, 10/10 ramped

Note: The "acceptance criteria" for this type of submission are primarily that the device is "as safe and as effective" as the predicate device, demonstrated through meeting recognized safety standards and showing comparable technical specifications and intended use. There are no performance metrics like sensitivity, specificity, or accuracy stated for a diagnostic AI, as this is a therapeutic electrical stimulation device.

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

Not applicable. This submission discusses non-clinical tests (electrical safety, EMC, etc.) comparing the device specifications to industry standards and a predicate device. It does not involve a "test set" of patient data for performance evaluation in the way an AI/diagnostic device would.

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 is no "ground truth" to establish for a test set in this context. The "truth" for safety and effectiveness is established by adherence to standards and comparison to a legally marketed predicate device.

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

Not applicable. No adjudication method for a test set is relevant 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 is a therapeutic electrical stimulation device, not a diagnostic device involving "human readers" or AI assistance.

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

Not applicable. This is not an algorithmic or AI-based device.

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

Not applicable. No "ground truth" in this sense is used. The basis for safety and effectiveness is adherence to recognized standards (e.g., UL-544, AAMI/ANSINS-4) and direct comparison to a predicate device's established safety and efficacy profile.

8. The sample size for the training set

Not applicable. This device does not involve a "training set."

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

Not applicable. This device does not involve a "training set" or "ground truth" establishment in this context.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets the "acceptance criteria" (i.e., is substantially equivalent to a predicate device and safe/effective for its intended use) is documented through non-clinical tests and a comparison to a predicate device (IF-4150).

Non-Clinical Tests: The manufacturer performed the following tests and confirmed they met required standards specifications:
- UL-544 (Safety Standard for Medical and Dental Equipment)
- AAMI/ANSI NS-4 Specifications for TENS Devices (American Association for Medical Instrumentation/American National Standards Institute standard for Transcutaneous Electrical Nerve Stimulators)
- EMC Testing (Electromagnetic Compatibility)
- Allowable variations in supply voltage
- Patient Applied Risk Current
Comparison to Predicate Device (IF-4150): A detailed comparison chart was provided, demonstrating that the IF-4000 has similar technological characteristics and intended use to the predicate device. Key differences noted (e.g., the IF-4000 not having a timer or high voltage protection, and having a lower maximum output current/voltage) were implicitly deemed not to raise new questions of safety or effectiveness.
Conclusion: Based on these non-clinical tests and the comparison, the manufacturer concluded that the IF-4000 is "as safe as effective as the predicate - which is the INF-4150." No clinical trials were deemed necessary ("Non applicable" for clinical tests).

Summary

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K95X683

APR - 1 199

EXHIBIT #11 Page 1 of 3

510(K) SUMMARY APEX MEDICAL CORP.,

PORTABLE INTERFERENTIAL STIMULATION DEVICE

IF-4000

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is: K952683

1. Submitter's Identification:

Daniel Lee Apex Medical Corp. P.O. Box, 18-17 Taipei, Taiwan

Date Summary Prepared: December 30, 1996

2. Name of the Device:

IF-4000

3. Predicate Device Information:

IF-4150

4. Device Description:

5. Intended Use:

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EXHIBIT #11 Page 2 of 3

6. Comparison to Predicate Devices:

IF-4150 is with the timer and protection with high voltage. IF-4000 is without the timer and stable voltage. Please refer to chart below:

BRAND NAME	IF-4000	INF 4150/A
MAKER	APEX MEDICAL CORP.	BIOMEDICAL LIFESYSTEMS, INC.
510(K) NUMBER	K952683	K921441
CARRIER FREQUENCY	4000 Hz, fixed	4000 Hz, fixed
DIFFERENCEFREQUENCY	1-150 beats per second,adjustable	1-150 beats per second,adjustable
OUTPUT CURRENT	0-29 milliamps,adjustable	0-50 milliamps,adjustable
OUTPUT VOLTAGE	0-14.5 volts(29 volts peak to peak)	0-25 volts(50 volts peak to peak)
WAVEFORM	symmetric bi-phasicsquare	symmetric bi-phasicsquare
PULSE WIDTH	125 microseconds foreach phase	125 microseconds foreach phase
MAX. CHARGE PERCYCLE	7.25 microcoulombs	12.5 microcoulombs
POWER SOURCE	9V alkaline battery oradapter	Four 1.5V alkalinebatteries or optional walladapter
SIZE	2.4" x 3.5" x 1.1"	2.75" x 4.5" x 1.5"
FREQUENCY SHIFTOPTION	Continuous, 1/1 abrupt,8/8 abrupt, 10/10ramped	Continuous, 1/1 abrupt,8/8 abrupt, 10/10ramped

COMPARISON BETWEEN IF-4000 AND INF 4150/A

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EXHIBIT #11 Page 3 of 3

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

The following non-clinical tests were performed and met required standards specifications:

UL-544 a)
AAMI/ANSI NS-4 Specifications for TENS Devices b)
EMC Testing C)
Allowable variations in supply voltage d)
Patient Applied Risk Current e)

Discussion of Clinical Tests Performed: 8.

Non applicable.

9. Conclusions:

The IF-4000 is as safe as effective as the predicate - which is the INF-4150.

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).