The Slendertone System Ultra is indicated for the improvement of abdominal muscle tone, for the strengthening of the abdominal muscles and for the development of a firmer abdomen.

Device Description

System Ultra, Type 390, Model E70/X70 is a two-channel, battery powered, muscle stimulation system. It is supplied with a three-electrode abdominal belt garment, a hand-held rechargeable control unit, a pack of 3 adhesive backed gel based electrodes, instructions for use and a carry pouch. The control unit is interchangeable between all the cleared System models from the Slendertone® range of garments. There are ten programs available to users of the System Ultra, Type 390, E70/X70. Power is derived from a 3.6V NiMH rechargeable battery pack pre-installed in the unit. All the internal connections are over-molded to prevent moisture ingress. The user has no access to the wiring or connectors within the garment and is unable to alter the current path.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way typically found for AI/ML devices, such as performance metrics (e.g., accuracy, sensitivity, specificity) against a ground truth.

This document is a 510(k) summary for a muscle stimulator (System Ultra, Type 390, Model E70/X70) by Bio-Medical Research Ltd. It primarily focuses on demonstrating substantial equivalence to a predicate device (Slendertone System-Abs, Type 390, E10/X10) based on technological characteristics and compliance with international safety standards, rather than clinical performance metrics of an AI/ML algorithm.

Therefore, most of the requested information regarding acceptance criteria, reported device performance, sample sizes, expert involvement, ground truth, and specific study types (MRMC, standalone) for an AI/ML device is not applicable or not provided in this document.

Here's a breakdown of what can be extracted and what is missing based on the prompt:

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

Acceptance Criteria (Implicit): Substantial equivalence to the predicate device in terms of intended use, technological characteristics, and compliance with safety standards. The FDA's approval indicates these implicit criteria were met.
Reported Device Performance: Not presented as specific performance metrics (e.g., accuracy, precision) as would be for an AI/ML device. The "performance" is implicitly tied to its ability to meet the intended use safely, similar to the predicate. The document states: "System Ultra, Type 390, E70/X70 device complies with the following international safety standards:" followed by a list of IEC standards.

Acceptance Criterion (Implicit/Stated)	Reported Device Performance
Intended Use: Improvement of abdominal muscle tone, strengthening, firmness	Similar to predicate device; FDA found substantially equivalent.
Technological Characteristics	Incorporates control unit and garment technology of existing predicate.
Safety Standards Compliance	Complies with IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2.
Battery Charger Safety	Complies with IEC 60950 and UL 1950.

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 / Not provided: This document does not describe a clinical study with a test set in the context of AI/ML performance evaluation. It states, "No new clinical studies have been submitted as part of this premarket notification." The evaluation was based on demonstrating equivalence and compliance to standards.

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

Not applicable / Not provided: No ground truth establishment by experts for a test set is described.

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

Not applicable / Not provided: No adjudication method is described as there is no test set in the context of an AI/ML performance study.

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: No MRMC study was done, as this is not an AI-assisted device.

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

No: This is not an AI/ML algorithm, so no standalone algorithm performance study was relevant or performed.

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

Not applicable / Not provided: The concept of "ground truth" as used in AI/ML performance evaluation is not relevant to this submission, which relies on equivalence and compliance with engineering standards.

8. The sample size for the training set

Not applicable / Not provided: There is no AI/ML algorithm, so no training set is mentioned.

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

Not applicable / Not provided: Not an AI/ML algorithm.

Summary

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search Ltd.

0191 774300

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This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.

1. Contact Details

MAY - 5 2010

Name:	Deirdre Barrow
Address:	Bio-Medical Research Ltd.,Parkmore Business Park, WestGalway, Ireland
Telephone:	+353 91 774300
Fax:	+353 91 774302
E-Mail:	dbarrow@bmr.ie
Prepared:	25th January 2010

Alternative Contact Person	Michael O'Sullivan
Title:	Quality Systems Manager
Telephone	+353 91 774395
Fax:	+353 91 774301
E-Mail:	mosullivan@bmr.ie

2. Device Name

Trade Name of Device:	System Ultra, Type 390, Model E70/X70
Common Name:	Muscle Stimulator
Classification Name:	Stimulator, muscle, powered, for muscle conditioning
Product Code:	NGX

3. Identification of Equivalent Legally Marketed Device

Device Trade Name:	Slendertone System-Abs, Type 390 E10/X10 device
Manufacturer:	Bio-Medical Research Ltd
510(k) Nos:	K070142

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4. Description of Device

-- - ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ System Ultra, Type 390, Model E70/X70 is a two-channel, battery powered, muscle stimulation system. It is supplied with a three-electrode abdominal belt garment, a hand-held rechargeable control unit, a pack of 3 adhesive backed gel based electrodes, instructions for use and a carry pouch.

The control unit is interchangeable between all the cleared System models from the Slendertone® range of garments reference Table 10.1

Device	Type, Model No.	510k No.
System-Abs (Female Version)	Type 390, E10	K070142
System-Abs (Male Version)	Type 390, X10	K070142
System-Shorts	Type 390, E20	K070142
System-Mini	Type 390, E30	K072294
System-Arms	Type 390, E60	K072553
System-Arms	Type 390, X60	K083164

Table 10.1 System from Slendertone Range of devices

There are ten programs available to users of the System Ultra, Type 390, E70/X70. Power is derived from a 3.6V NiMH rechargeable battery pack pre-installed in the unit.

All the internal connections are over-molded to prevent moisture ingress. The user has no access to the wiring or connectors within the garment and is unable to alter the current path.

For purposes of hygiene, the garment may be cleaned and instructions for belt care are included in the user manual.

5. Statement of Intended Use/Indications for Use

The proposed device, System Ultra, Type 390, E70/X70 is a powered muscle stimulator intended for over-the-counter use; there is no change to the indications for use from the predicate product Slendertone System-Abs, Type 390, E10/X10.

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Proposed Device: "System Ultra, Type 390, Model E70/X70" is intended for the improvement of abdominal muscle tone, for the strengthening of the abdominal muscles and for the development of a firmer abdomen.

6. Technological Characteristics

The System Ultra, Type 390, E70/X70 incorporates the control unit and garment technology of the existing predicate Slendertone System-Abs, Type 390, E10/X10 (K070142).

7. Clinical and Non-Clinical Tests

No new clinical studies have been submitted as part of this premarket notification.

System Ultra, Type 390, E70/X70 device complies with the following international safety standards:

. IEC 60601-1:1988 & A1:1991, A2:1995 Medical electrical equipment - Part 1: General requirements for safety
. IEC 60601-2-10:1987 & Al 2001 Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators
. IEC 60601-1-2:2001 (EN 60601-1-2:2001) Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility -Requirements and tests

The battery charger complies to safety standards IEC 60950 and UL 1950

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Bio-Medical Research Ltd. % Ms. Deidre Barrow Quality/Regulatory Engineer Parkmore Business Park, West Galway, Ireland

Re: K100320

Trade/Device Name: Slendertone System Ultra, Type 390, Model E70/X70 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: NGX Dated: January 26, 2010 Received: February 4, 2010

MAY - 6 2010

Dear Ms. Barrow:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Deidre Barrow

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark A. Milliken

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Device Name:

s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Slendertone System Ultra, Type 390, Model E70/X70

Indications for Use:

The Slendertone System Ultra is indicated for the improvement of abdominal muscle tone, for the strengthening of the abdominal muscles and for the development of a firmer abdomen.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

(Division Sign-Off) (Division Sign-on), Orthopedic, and Restorative Devices

K100320

510(k) Number __

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).