HAKOMED ELECDT / PRO ELEDT SERIES by ALIVE, INC.

For adjunctive use in post-traumatic pain syndromes; for management and symptomatic relief of chronic (long term) pain; as an adjunctive treatment in the management of post surgical pain an adjust relaxation of muscle spasms; prevention or retardation of tissue atrophy; increasing blood circulation; muscle re-education; immediate post-surgical stimulation of calf muscles to prevent phlebothrombosis; and maintaining or increasing range of provide philosouncemes , al nerves for the purpose of providing pain relief and to stimulate motor nerves for the purpose of muscle rehabilitation.

Device Description

Not Found

AI/ML Overview

This is a challenging request as the provided text is a 510(k) clearance letter from the FDA, not a study report or clinical trial summary. Therefore, the document does not contain the detailed information required to describe acceptance criteria and a study proving device performance in the way a modern medical device submission would.

The letter simply states that the FDA has reviewed the submission and found the device to be "substantially equivalent" to legally marketed predicate devices from before May 28, 1976. This means the device met the regulatory requirements for safety and effectiveness based on comparison to an existing device, rather than on specific, prospectively defined performance metrics from a dedicated clinical study.

Therefore, for each point requested, I will explain why the information is not present in the provided text.

Here's an analysis of why the requested information is absent:

A table of acceptance criteria and the reported device performance:
- Reason for Absence: The FDA 510(k) clearance letter (K980892) is a regulatory document affirming substantial equivalence to a predicate device, not a clinical study report. It does not contain specific performance metrics, acceptance criteria, or a table of reported device performance. For general control devices cleared in 1998, the focus was on demonstrating equivalent intended use and technological characteristics to a predicate device already on the market prior to 1976, rather than hitting specific performance targets in a new study.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Reason for Absence: Since no new clinical study data with a "test set" is described or referenced in the clearance letter, this information is not available. The substantial equivalence pathway for this type of device in 1998 typically relied on established safety and effectiveness of the predicate device, not new clinical data demonstrating specific performance on a test set.
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):
- Reason for Absence: As no specific "test set" or new clinical study is detailed, the concept of establishing ground truth by experts for a test set is not applicable to the information provided in this regulatory letter.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Reason for Absence: Without a described test set or clinical study, there is no adjudication method to report.
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:
- Reason for Absence: The device is described as an "ELECDT/PROELECDT SERIES" for pain syndromes and muscle rehabilitation, which suggests an electrical stimulation device, not an AI-based diagnostic or assistive technology for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device and is not mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Reason for Absence: This device is an electrical stimulation device, not an algorithm. Therefore, "standalone" algorithm performance is not applicable or discussed.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Reason for Absence: As no new clinical study or specific performance data is provided, the concept of ground truth for a new study is not present in the clearance letter. The "ground truth" for a 510(k) submission of this era and device type would effectively be the established safety and effectiveness of the existing predicate device.
The sample size for the training set:
- Reason for Absence: The device is a physical electromedical device, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML.
How the ground truth for the training set was established:
- Reason for Absence: As there is no training set for this type of device, the concept of establishing ground truth for it is irrelevant and not discussed.

In summary, the provided FDA 510(k) clearance letter dated 1998 pertains to a device cleared through the substantial equivalence pathway, which does not typically include the detailed performance metrics, acceptance criteria, or study designs (especially for AI/ML) that are standard for modern device submissions and clinical study reports. The letter confirms the device's clearance based on its equivalence to a predicate device, not on meeting specific, prospectively defined performance criteria from a new clinical study.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY || | 10988

Mr. Kai Hansjurgens Alive Inc. 537 Cummins Street Honolulu, Hawaii 96814

Re : K980892 Hakomed Elecdt/Pro Eledt Series Trade Name: Requlatory Class: II Product Codes: IPF and LIH Dated: March 5, 1998 Received: March 9, 1998

Dear Mr. Hansjurgens:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਰੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Kai Hansjurgens

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of vicio diagnobero actions, productionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) NUMBER (IF KNOWN) : K980892

DEVICE NAME: HAKOMED ELECDT/PROELECDT SERIES

INDICATIONS FOR USE:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter-Use
(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K980892

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).