The intended use of the ES-130 is an ELECTRO-ACUPUNCTURE DEVICE for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

Device Description

ES-130 is a palm-size ELECTRO-ACUPUNCTURE DEVICE equipped with three independent output channels. This unit has incorporated similar features as the predicate devices such as: Variable Frequency Settings & Similar Frequency Range, Variable Intensity Settings & Similar Output Range, Biphasic Pulse Waveform, Similar Pulse Shape & Pulse Charge, Battery Power & Portability.

AI/ML Overview

The provided text discusses the ES-130 Electro-Acupuncture Device and its submission for FDA 510(k) clearance. The crucial point for your request is that no clinical testing or performance study with acceptance criteria was conducted for this device beyond non-clinical verification and validation testing, as explicitly stated in the document.

Therefore, I cannot populate a table of acceptance criteria and reported device performance based on a human-in-the-loop or standalone AI study from this document, nor can I provide information about sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, or training sets.

Here's a breakdown of what the document does state in relation to your questions:

1. Table of acceptance criteria and the reported device performance

No acceptance criteria for clinical performance are reported, as no clinical studies were performed. The "performance" described focuses on demonstrating equivalence to predicate devices based on technical specifications.

Acceptance Criteria	Reported Device Performance
N/A (No clinical or human performance acceptance criteria were established or studied)	The ES-130 device's features and characteristics, including frequency settings, output intensity, number of channels, supply voltage, pulse width, pulse charge, delivered current density, and delivered power density, fall within the range of those of the predicate devices.

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. No clinical test set was used. "Non-clinical verification and validation testing was conducted on ES-130 device" but details on sample size or data provenance for these engineering tests are not provided.

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. No clinical test set requiring expert ground truth was used.

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

Not applicable. No clinical test set requiring adjudication was used.

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. No MRMC study was done, as this is an electro-acupuncture device and not an AI-assisted diagnostic tool.

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

Not applicable. This device is not an algorithm or AI system. Its performance was assessed through non-clinical verification and validation to demonstrate technical equivalence to predicate devices, not as a standalone AI.

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

Not applicable. No clinical ground truth was established because no clinical studies were conducted. The "ground truth" for the submission was established by comparing the device's technical specifications and electrical outputs to those of three predicate devices.

8. The sample size for the training set

Not applicable. This device is not an AI/algorithm-based system requiring a training set.

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

Not applicable. This device is not an AI/algorithm-based system requiring a training set.

Summary of the Study Discussed in the Document:

The study referenced in the document is a non-clinical verification and validation testing of the ES-130 device. Its purpose was to demonstrate substantial equivalence to three legally marketed predicate devices (K051197: ACULIFE/Model SMW-01, K840983: Pulselife Model PL2, and Pre-Amendment: Model WQ-10B).

The submission states: "Using three similar predicate devices, detailed comparisons of specific ES-130 features and characteristics are contained in Section 8 of this submission... This side-by-side comparison demonstrates that the performance characteristics of the predicate devices encompass the entire range of performance characteristics of the proposed ES-130 device including frequency values, output intensity values, number of channels, supply voltage value, pulse width value, pulse charge value, delivered current density, and delivered power density."

Crucially, the document explicitly states: "Clinical testing was neither required nor conducted regarding the ES-130 submission." Therefore, there are no acceptance criteria or performance metrics related to human or clinical outcomes in this document. The device gained market clearance based on its technical specifications falling within the range of existing, legally marketed devices.

Summary

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伊藤超短波株式会社 CO,. LTD.

MANUFACTURERS & EXPORTERS established in 1916

NOV 2 4 2008

3-3-3 TOYOTAMA-MINAMI, NERIMA-KU, TOKYO,176-0014 JAPAN

K081943

510(k) Summary: Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination Regarding the ES-130 Electro-Acupuncture Device

Submitter Name:	ITO CO., LTD.
	3-3-3 TOYOTAMA-MINAMI, NERIMA-KU
	TOKYO, 176-0014 JAPAN
	TEL: (+81) 3-3994-4619
	FAX: (+81) 3-3994-8384

KENNETH L. BLOCK, RAC Contact Name:
Date Prepared: September 30, 2008

Proprietary Name:	ES-130
Primary Product Code:	BWK
Common Name:	Stimulator, Electro-Acupuncture
Class:	Unclassified

Predicate Devices:	K051197: ACULIFE/Model SMW-01 (Inno-Health Technology, Inc.)
	K840983: Pulselife Model PL2 (Pulse Life)
	Pre-Amendment: Model WQ-10B (Danghua Electronic Instrument Factory)

Device Description:

ES-130 is a palm-size ELECTRO-ACUPUNCTURE DEVICE equipped with three independent output channels. This unit has incorporated similar features as the predicate devices such as:

Variable Frequency Settings & Similar Frequency Range ●
Variable Intensity Settings & Similar Output Range .
. Biphasic Pulse Waveform
. Similar Pulse Shape & Pulse Charge
. Battery Power & Portability

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Using three similar predicate devices, detailed comparisons of specific ES-130 features and characteristics are contained in Section 8 of this submission, in accordance with the FDA publication Guidance Document for Powered Muscle Stimulator 510(k)s. This side-by-side comparison demonstrates that the performance characteristics of the predicate devices encompass the entire range of performance characteristics of the proposed ES-130 device including frequency values, output intensity values, number of channels, supply voltage value, pulse width value, pulse charge value, delivered current density, and delivered power density.

Indication for Use:

The indication for use of ES-130 is an ELECTRO-ACUPUNCTURE DEVICE for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

Cited Standards to Determine Substantial Equivalence:

ES-130 complies with FDA recognized standards IEC 60601-1-1, and IEC 60601-1-1, and IEC 60601-2-10. In addition, ES-130 complies with technical requirements outlined in 21 CFR 898.

Non-clinical Testing:

Non-clinical verification and validation resting was conducted on ES-130 device, and the results of such testing appear in Section 18 of this submission. Clinical testing was neither required nor conducted regarding the ES-130 submission. Form FDA-3674 is contained in Section 20 of this submission, which certifies compliance to FDA requirements regarding clinical data.

Truthful and Accuracy Statement:

Signed by a corporate management representative of the submitter, the required statement attesting to the truthfulness and accuracy of the information contained in Section 6 of this submission.

Further Information:

Please contact the following individual to request any further information regarding this submission:

Kenneth L. Block, RAC Official Correspondent (ITO CO., LTD.) Ken Block Consulting 1201 Richardson Dr. Suite 140 Richardson, TX 75080 TEL: 972-480-9554 FAX: 972-767-4325 EMAIL: ken@kenblockconsulting.com

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Public Health Service

Image /page/2/Picture/12 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ito Co., Ltd. % Ken Block Consulting Mr. Kenneth L. Block, RAC Certified Regulatory Consultant 1201 Richardson Dr., Suite 140 Richardson, Texas 75080

NOV 2 4 2008

Re: K081943

Trade/Device Name: Model ES-130 Electro-Acupuncture Device Regulation Name: Electro-Acupuncture Stimulator Regulatory Class: Unclassified Product Code: BWK Dated: November 14, 2008 Received: November 17, 2008

Dear Mr. Block:

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. Ilsting 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 - Mr. Kenneth L. Block, RAC

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 Biometrics' (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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark M. Mulhern

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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Indication for Use

510(k) number (if known): K

Device name: ES-130

Indication for Use:

The intended use of the ES-130 is an ELECTRO-ACUPUNCTURE DEVICE for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

Over-The-Counter Use_

(Part 21 CFR 801 Subpart D)

Prescription Use______________________________________________________________________________________________________________________________________________________________

(21 CFR 801 Subpart C)

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

AND/OR

Concurrence of CDHR, Office of Device Evaluation (ODE)

FOR M. MELKERSON

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K081943

Regulation Number and Section

N/A