Improvement of abdominal tone, strengthening of the abdominal muscles development of firmer abdomen. Strengthening, Toning and Firming of buttocks and thighs.

Device Description

Intelligent Wireless Fitness Apparatus is indicated to be used for: Improvement of abdominal tone, strengthening of the abdominal muscles development of firmer abdomen. By muscle stimulation, the device helps to strengthen and firm the abdomen, arms and thighs. The device is including a main unit and 3 kinds of electrode pads. The therapeutic parameters are easily set using the buttons on the device. There are three buttons on the main unit, On/off button for on/off and mode selection, "+" button and "-" button for level adjustment. The accessories is electrode pads. The electrode pads connect to the main unit by buttons (which is permanent secured on the main unit and the electrode pad). All the accessories can only be changed by local distributor.

AI/ML Overview

This document is a 510(k) summary for the Intelligent Wireless Fitness Apparatus (Models: AST-301, AST-302, AST-303). It is a submission to the FDA demonstrating substantial equivalence to previously cleared predicate devices.

Based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific performance criteria in terms of accuracy, sensitivity, specificity, or human perception improvement (e.g., MRMC studies). This document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with general safety and performance standards, rather than a clinical performance study with specific acceptance criteria as you've described.

The "Test Summary" section (page 4, Section 6) outlines bench testing to ensure safety and functionality, but these are not performance studies in the context of diagnostic accuracy or human performance with AI assistance.

Therefore, I cannot provide the information requested in your bullet points regarding acceptance criteria, performance data, sample sizes, expert involvement, or MRMC studies, as this type of information is not present in the provided 510(k) summary for this particular device.

Here's an explanation for each of your points based on the absence of this information in the provided document:

A table of acceptance criteria and the reported device performance:
- Not provided. This document details technical characteristics and compliance with safety standards (e.g., electrical safety, EMC, usability), not performance against clinical acceptance criteria (e.g., accuracy for a diagnostic task).
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable for performance test sets as described. The "tests" here are bench tests for electrical safety, electromagnetic compatibility, usability, and software verification/validation, not clinical performance studies involving patient data. Therefore, there's no "test set" in the sense of patient data for clinical evaluation.
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 ground truth establishment for a clinical test set is mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set requiring adjudication is described.
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, an MRMC comparative effectiveness study was not done or reported. This device is a muscle stimulator, not an AI-assisted diagnostic device, so such a study would not be relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm. Its performance is evaluated through physical and electrical bench testing, not algorithmic accuracy.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not applicable. No clinical ground truth is established or used for performance evaluation in this 510(k) summary. The "truth" here relates to compliance with engineering and safety standards.
The sample size for the training set:
- Not applicable. This device does not use a training set as it's not a machine learning/AI device.
How the ground truth for the training set was established:
- Not applicable. No training set ground truth to establish.

In summary, the provided document is a 510(k) Premarket Notification for a Powered Muscle Stimulator. The focus is on demonstrating substantial equivalence to existing predicate devices based on technological characteristics, intended use, and compliance with recognized safety and performance standards through bench testing. It explicitly states, "The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness." This type of submission does not typically include the kind of clinical performance study details (like sensitivity, specificity, or MRMC studies) that would be found for a diagnostic device or an AI-powered medical device.

Summary

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October 10, 2019

Shenzhen OSTO Technology Co., Ltd. % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park Guangzhou. 510663 CN

Re: K182136

Trade/Device Name: Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-303) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: September 10, 2019 Received: September 13, 2019

Dear Cassie Lee:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For Vivek Pinto. PhD Director (Acting) DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182136

Device Name Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)

Indications for Use (Describe)

Intelligent Wireless Fitness Apparatus is indicated to be used for:

Improvement of abdominal tone, strengthening of the abdominal muscles development of firmer abdomen. Strengthening, Toning and Firming of buttocks and thighs.

Type of Use (Select one or both, as applicable)

|--|--|

| | Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

1. Submitter's Information

510(k) Owner's Name: Shenzhen OSTO Technology Co., Ltd. Establishment Registration Number: Applying Address: No.43 Longfeng Road, Xinsheng Community, Longgang Street Longgang District, Shenzhen City Guangdong Province, CHINA Tel: +86-755-29769546 Fax: +86-755-29769540 Contact Person: Li Yang (General Manager) Email: annaosto@163.com

Application Correspondent:

Contact Person: Ms. Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Tel: +86-20-61099984 Email: regulatory@glomed-info.com

2. Subject Device Information

Company Name: Shenzhen OSTO Technology Co., Ltd. Trade/Device Name: Intelligent Wireless Fitness Apparatus Model Name: AST-301, AST-302, AST-303 Common Name: Powered Muscle Stimulator Product Code: NGX Regulation Number: 21 CFR 890.5850 Regulatory Class: 2

3. Predicate Device Information

Predicate Device 1:

510(K) Number: K131291 Company Name: Johari Digital HealthCare Ltd. Trade/Device Name: Torc Body Common Name: Powered Muscle Stimulator Product Code: NGX Regulation Number: 21 CFR 890.5850 Regulatory Class: 2

Predicate Device 2:

510(K) Number: K133929 Company Name: Shenzhen OSTO Technology Co., Ltd. Trade Device Name: Health Expert Electronic Stimulator Common Name: Electronic Stimulator Product Code: NUH, NGX Regulation Number: 882.5890, 890.5850 Regulatory Class: 2

4. Device Description

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The device is including a main unit and 3 kinds of electrode pads. The therapeutic parameters are easily set using the buttons on the device.

There are three buttons on the main unit, On/off button for on/off and mode selection, "+" button and "-" button for level adjustment.

The accessories is electrode pads. The electrode pads connect to the main unit by buttons (which is permanent secured on the main unit and the electrode pad). All the accessories can only be changed by local distributor.

5. Intended Use / Indications for Use

Intelligent Wireless Fitness Apparatus is indicated to be used for:

lmprovement of abdominal tone, strengthening of the abdominal muscles development of firmer abdomen. Strengthening, toning and firming of buttocks and thighs.

6. Test Summary

Intelligent Wireless Fitness Apparatus, Model: AST-301, AST-302, AST-303 had been evaluated the safety and performance by lab bench testing as following:

Electrical safety test according to IEC 60601-1, IEC 60601-1-11 and IEC 60601-2-10 standards �
� Electromagnetic compatibility test according to IEC 60601-1-2 standard
� Usability test according to IEC 62366 standard
� Software verification and validation test according to the requirements of the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
� IEC 62133 Edition 2.0 2012-12 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications [Including: Corrigendum 1 (2013)]

Note:

The materials and manufacturing used for the Intelligent Wireless Fitness Apparatus are identical to those of the predicate device K133929, and the Electrode Pads have been demonstrated to conform with the following biocompatibility standards:

• ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity

• ISO 10993-10: 2009, Biological evaluation of medical devices - Part 10: Tests for irritation and delayedtype hypersensitivity

7. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, mode of operation, and intended use of Intelligent Wireless Fitness Apparatus is substantially equivalent to the predicate devices quoted above. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

Elements ofComparison	Subject Device	Predicate Device	Predicate Device	Remark
510(k) number	Applying	K131291	K133929	--
Device name	Intelligent WirelessFitness Apparatus	Torc Body	Health ExpertElectronic Stimulator	--
Model Name:	AST-301, AST-302,	--	AST-300C and AST-	--

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		AST-303		300D
Company name		Shenzhen OSTOTechnology Co., Ltd.	Johari DigitalHealthCare Ltd	Shenzhen OSTOTechnology Co., Ltd.
Product Code		NGX	NGX	NUH, NGX	SE
Regulation Number		21 CFR 890.5850	21 CFR 890.5850	882.5890, 890.5850	SE
Indications forUse		Intelligent WirelessFitness Apparatus isindicated to be usedfor:Improvement ofabdominal tone,strengthening of theabdominal musclesdevelopment offirmer abdomen.Strengthening, toningand firming ofbuttocks and thighs.	Torc Body isindicated to be usedfor:Improvement ofabdominal tone, forstrengthening of theabdominal muscles,for development offirmer abdomen.Strengthening,Toning and Firmingof buttocks & thighs.	PMS (Mode 1~~8) It isintended to stimulatehealthy muscles inorder to improve andfacilitate muscleperformance. TENS(Mode 9~~25) To beused for temporaryrelief of painassociated with soreand aching muscles inthe shoulder, waist,back, back of theneck, arm, leg, andfoot due to strain fromexercise or normalhousehold workactivities by applyingcurrent to stimulatenerve.	SE
Primary Function		Muscle stimulation	Muscle stimulation	Muscle stimulation	SE
Principle ofAction		Initiating actionpotential of nervesresults in musclecontraction	Initiating actionpotential of nervesresults in musclecontraction	Initiating actionpotential of nervesresults in musclecontraction	SE
Clinical Use		OTC	OTC	OTC	SE
Target area		abdominal muscles,buttocks and thighs	abdominal muscles,buttocks and thighs	abdominal muscles,buttocks thighs andfoot	SE
Shape of electrode		Butterfly-shaped,irregular	Butterfly-shaped,irregular	Rectangle, irregular	SE
Method of electrodeapplication		Self-adhesive withbelt versus adhesivesilicone	Self-adhesive withbelt versus adhesivesilicone	Self-adhesive withbelt versus adhesivesilicone, non-adhesive	SE
Power Source(s)		Adapter (ModelHDMU05E-050100,HDMU05B-050100,HDMU05U-050100 )Input:100-240 Vac;50/60 Hz; 0,3A;Output: 5 V ; 1ARechargeableLithium-ion Battery:3.7Vdc	24 V DC Batterypack	100 - 240 V AC, 50-60 Hz	SENote 2
Electrical Protection		Class II, BF	Class II, BF	Class II, BF	SE
-Method of LineCurrent Isolation		Type BF Applied Part	Type BF Applied Part	Type BF Applied Part	SE
PatientLeakage	NC	$\leq$ 0.1 $\mu$ A	--	--	SE
Current
Number of OutputModes		8	2	25	SENote 1
Number of OutputChannels:		2	--	2	SE
Synchronous orAlternating		Alternating	--	Alternating	SE
Method of ChannelIsolation		Voltage TransformIsolation	--	Voltage TransformIsolation	SE
Regulated Current orRegulated Voltage		Voltage Control	Voltage Control	Voltage Control	SE
Software/Firmware/MicroprocessorControl		Yes	Yes	Yes	SE
Automatic OverloadTrip		No	No	No	SE
Automatic No-LoadTrip		No	No	No	SE
Automatic Shut Off		Yes	--	Yes	SE
Patient OverrideControl		Yes	Yes	Yes	SE
	On/OffStatus	Yes	--	Yes	SE
IndicatorDisplay	LowBattery	Yes	--	No	SE
	Voltage/CurrentLevel	Yes		Yes	SE
Timer Range(minutes) (clarify foreach mode ifdifferent)		15min	1- 60 min	25min	SENote1
Compliance withVoluntary Standards		Complied withISO 10993-5,ISO 10993-10,IEC 60601-1,IEC 60601-1-2,IEC 60601-2-10	Complied withISO 10993-5,ISO 10993-10,IEC 60601-1,IEC 60601-1-2,IEC 60601-2-10	Complied withISO 10993-5,ISO 10993-10,IEC 60601-1,IEC 60601-1-2,IEC 60601-2-10	SE
	Weight		80g (Withoutaccessories)	--	2Kg (Withoutaccessories)	SENote1
	Housing Materialsand Construction		Main unit: ABSplastic	--	Main unit: ABS plastic	SE
	Waveform (e.g.,pulsed monophasic,biphasic)		Pulsed, symmetric,biphasic	--	Pulsed, symmetric,biphasic	SE
	Maximum OutputVoltage		44V±10% @ 500Ω80V±10% @ 2ΚΩ112V±10% @ 10ΚΩ	--	44V±10% @ 500Ω80V±10% @ 2ΚΩ112V±10% @ 10ΚΩ	SE
Maximum OutputCurrent		88mA±10% @ 500Ω40mA±10% @ 2ΚΩ11.2mA±10%@10ΚΩ	--	88mA±10% @ 500Ω40mA±10% @ 2ΚΩ11.2mA±10% @10ΚΩ	SE
	For multiphasicwaveforms only: -		Symmetrical phases	--	Symmetrical phases	SE
Symmetrical phases
Phase Duration		$120 \mu s$	$290 \mu s$	$120 \mu s$	SE
Net Charge (mC per pulse)		$10.56 \mu C @ 500\Omega$	--	$10.56 \mu C @ 500\Omega$	SE
Maximum Phase Charge, (mC)		$12.78 \mu C @ 500\Omega$	$35.7 \mu C @ 500\Omega$	$12.78 \mu C @ 500\Omega$	SE
Maximum Average Current		$1.69mA @ 500\Omega$	--	$1.69mA @ 500\Omega$	SE
Maximum Current Density, (mA/cm²)		$0.026mA/cm^2 @ 500\Omega$	$0.176mA/cm^2$	$0.026mA/cm^2 @ 500\Omega$	SE
Maximum Power Density		$16.37 \mu W/cm^2 @ 500\Omega$	$0.0089 W/cm^2$	$16.37 \mu W/cm^2 @ 500\Omega$	SE
Burst Mode (i.e., pulse trains)	Pulses per burst	1	--	1	SE
	Bursts per second	77	--	77	SE
	Burst duration (seconds)	12.94ms	--	12.94ms	SE
	Duty Cycle [Line (b) x Line (c)	$240 \mu s/12.94ms$	--	$240 \mu s/12.94ms$	SE
ON Time (seconds)		3s	--	3s	SE
OFF Time (seconds)		3s	--	3s	SE
Type of Energy		Electrical	Electrical	Electrical	SE
Type of Operation		Continuous	Continuous	Continuous	SE
Pulse Repetition Rate		8.33 Hz	1 – 200 Hz	8.33 Hz	SE
Pulse Amplitude		0 – 100%	0 – 100%	0 – 100%	SE
Induced Current in the Tissue		11.2-80 mA	28 mA	11.2-80 mA	SE
Selection of parameters (Intensity)		Yes	Yes	Yes	SE
Shape of Stimulation Pulse		Rectangular, with interphase interval	Symmetrical Biphasic Square Wave	Rectangular, with interphase interval	SE
Energy Source		Adapter (Model HDMU05E-050100, HDMU05B-050100, HDMU05U-050100 ) Input: 100-240 Vac; 50/60 Hz; 0,3A; Output: 5 V ; 1A Rechargeable Lithium-ion Battery: 3.7Vdc	24 V DC Battery pack and Adaptor: 100 – 240 V AC, 50–60 Hz	Adaptor Input: 100-240Vac, 50-60Hz, 0.1A Output: 5Vdc, 1A Unit Input: 5Vdc, 1A	SE Note 2
System Dimensions		Main Unit: 50X37mm	Main Unit: 152x102x203 mm	428 x428.8 x 185mm	SE Note1
	model AST-301:198mm x 164mm x2mmElectrode pad formodel AST-302:192mm x 164mm x2mmElectrode pad formodel AST-303: 125mm x 80mm x 2mmEach gel sheet90mm x 60mm x2mm	Electrodes:Large (50mm)Small(40mmx80mm)	Electrodes:Foot ConductiveRubber: 254mm x98mm x 13mm,99.27 cm2Small: 88mm x 58mmx 3.2mm,50.04 cm2
Electrode materials	Transparent PETsilicone (Gel sheet)	--	Small Electrode Pads:white silica gel, blackconductive silicone,transparentconductive adhesivesilicone, transparentPET silicone	SE
AmbientTemperature		0°C to +44°C	5°C to +45°C	SENote 1
EnvironmentalSpecifications	For indoor use only	For indoor use only	For indoor use only	SE

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Note 1:

Although the "Number of Output Modes", "Time Range", "Indicator Display", "Ambient Temperature", "Dimensions" and ""weight" are a little difference from the predicate devices, but these are not key parameters which affect safety or effectiveness, so the differences will not raise any safety or effectiveness issue.

Note 2:

Although the "Power Source" and "Energy Source" of subject device are different from predicate devices, but it all comply with IEC 60601-1 and IEC 60601-2-10 requirements, so the differences will not raise any safety or effectiveness issue.

Finial Conclusion:

The subject device "Intelligent Wireless Fitness Apparatus model AST-301, AST-302, AST-303" is Substantial Equivalent to the predicate devices K131291 and K133929.

8. Date of the summary prepared: October 9, 2019

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).