The Dexus Prosthetic System is to be used exclusively for external prosthetic fittings of the upper limbs. This Dexus Prosthetic System is suitable for upper limb disabled groups (wrist disarticulated, forearm amputated, congenital missing hand, etc.), for upper limb amputees to compensate or make up for some of the functions of the amputated limb. It applies the surface electromyography (sEMG) signal to realize the control of the upper limb prosthetic device. The collected EMG signals are processed through specific algorithms to achieve the delicate control of the prosthetic hand. The Dexus Prosthetic System is developed to facilitate daily life and must not be used for unusual activities (e.g. sports that may damage the mechanical wrist, like pushups) and should not be used for the operation of motor vehicles, heavy equipment, industrial machines, or motor-driven equipment.

The Dexus Prosthetic System is not suitable for patients with severe disorders of blood clotting mechanism, patients with mental diseases, patients with unhealed wound on the stump, and other patients who are considered medically unable to fit a prosthetic hand.

The Dexus Prosthetic System is intended exclusively for use on one patient. The Dexus Prosthetics System needs to be installed by trained prosthetists to meet the needs of the end-users.

The Dexus Prosthetic system consists of an electric prosthetic hand and a socket (customized according to the stump of the user and does not come with the subject device), two electrodes, electrode patch cord and electrode screw, charging cord, battery cable and adapter plate, heat-shrinkable sleeve, Power switch assembly, some screws and glove.

The Dexus Prosthetic System has a total of 6 degrees of freedom (DOF), the distribution is as follows:

Thumb (1st finger) DOF: 2 degrees of freedom, which are flexion/extension, adduction/abduction, respectively, a combination of them can make the thumb move freely, and the state can be identified;
Index finger (2nd finger) DOF: 1 degree of freedom, flexion/extension movement;
Middle finger (3rd finger) DOF: 1 degree of freedom, flexion/extension movement;
Ring finger (the 4th finger) DOF: 1 degree of freedom, flexion/extension movement;
Little finger (5th finger) DOF: 1 degree of freedom, flexion/extension movement.

In addition, its gesture functions include Prehensile Grasp, Tipping, Tripod Pinch, Index pointing, Lateral Pinch, and Hook. The functions can be switched through the buttons on the back of the hand.

AI/ML Overview

The provided text is a 510(k) summary for the Dexus Prosthetics System. It does not describe a study that uses AI or machine learning, nor does it conduct a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm-only performance study. The device in question is an electromechanical prosthetic system, and the submission primarily focuses on engineering and component comparability to a predicate device, along with performance against established safety and electrical standards.

Therefore, many of the requested criteria cannot be answered from the provided text, as they pertain to clinical or AI-driven performance testing which was not conducted or reported in this submission.

Here's an analysis based on the information provided, highlighting what is present and what is absent:

Acceptance Criteria and Device Performance:

The document doesn't explicitly define "acceptance criteria" in terms of clinical performance metrics (like accuracy, sensitivity, specificity for an AI model). Instead, acceptance is implied by meeting safety and performance standards for an electromechanical device and demonstrating substantial equivalence to a predicate. The "Reported Device Performance" is primarily from bench testing against these standards rather than clinical outcomes or AI model performance.

Criterion Type	Acceptance Criteria (Implicit from submission)	Reported Device Performance (Summary from section 6.1, and comparison table)
Electrical Safety	Compliance with IEC 60601-1 and IEC 60601-1-11 standards.	Evaluated, stated to meet requirements (implied by "all of them meet the requirements of safety and performance standards IEC 60601-1" - Note 6, and "in compliance with the currently valid standards" - Note 7). Specific quantitative results are not provided, but the successful evaluation is confirmed.
EMC	Compliance with IEC 60601-1-2 standard.	Evaluated, stated to meet requirements (implied by "in compliance with the currently valid standards" - Note 7). Specific quantitative results are not provided.
Lithium Battery	Compliance with IEC 62133-2 standard.	Evaluated, although specific results are not provided.
Biocompatibility	Compliance with ISO 10993-5 and ISO 10993-10 standards (also ISO 10993-1).	Evaluated, stated to meet requirements for materials intended to contact patients (Note 5). Specific results are not provided.
Software V&V	Compliance with FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".	Verification and validation test performed according to FDA guidance. Specific results or a detailed V&V report are not provided in this summary.
Max. Gripping Force	70N (opposition mode), 60N (lateral mode), 15N (neutral mode) - based on predicate.	70N (opposition mode), 60N (lateral mode), 15N (neutral mode) - Same as predicate. This is a direct comparison rather than an individual measured "performance."
Max. Grip Speed	Not explicitly stated as a numerical criterion, but compared to predicate.	150mm/s (Subject Device) vs. 325mm/s (Predicate Device). The document states this difference "will not affect the safety and effectiveness of the subject device" and "meet the requirements of performance requirements" (Note 4), implying the lower speed is acceptable.
Frequency Bandwidth	Not explicitly stated as a numerical criterion, but compared to predicate.	80 - 500 Hz (Subject Device) vs. 90 - 450 Hz (Predicate Device). The document states this difference "will not affect the safety and effectiveness of the subject device" and "meet the requirements of performance requirements" (Note 4), implying the slightly different range is acceptable.

Information Not Present in the Document (Related to AI/Clinical Trial Requirements):

The following points cannot be answered from the provided text because it's a 510(k) summary for a physical medical device, not an AI/ML-based diagnostic or therapeutic software, and no clinical studies were performed.

Sample size used for the test set and the data provenance: Not applicable. No clinical test set data is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable. No clinical test set or ground truth establishment process is described.
Adjudication method for the test set: Not applicable.
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, it was explicitly stated: "No clinical study is included in this submission." This means no human reader study, with or without AI assistance, was performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is an electromechanical prosthetic arm, not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No clinical ground truth or AI model performance is evaluated. The "ground truth" for this submission revolved around engineering specifications and compliance with recognized standards.
The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no training set in the AI sense.
How the ground truth for the training set was established: Not applicable.

Summary of what the document IS:

The document is a US FDA 510(k) premarket notification summary. It aims to demonstrate "substantial equivalence" of the Dexus Prosthetics System to a legally marketed predicate device (Otto Bock Healthcare Products GmbH's Axon-Bus Prosthetic System). The safety and effectiveness are established primarily through bench testing against recognized international standards (IEC, ISO) and by comparing the technical characteristics and intended use to the predicate device, highlighting that any differences do not raise new questions of safety or effectiveness. No clinical studies were conducted, nor does the device appear to incorporate AI/ML as its primary function for which performance would be evaluated as such.

Summary

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September 9, 2022

Zhejiang Qiangnao Technology Co.,Ltd % Cassie Lee Official Correspondent Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road Huangpu District Guangzhou, Guangdong 510000 China

Re: K220002

Trade/Device Name: Dexus Prosthetics System (Model: MSL1, MSR1) Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY, IQZ Dated: June 8, 2022 Received: June 13, 2022

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,

Tushar Bansal, PhD Acting Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220002

Device Name

Dexus Prosthetics System (Model: MSL1, MSR1)

Indications for Use (Describe)

The Dexus Prosthetic System is to be used exclusively for external prosthetic fittings of the upper limbs.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary for K220002

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 801.92.

1. Submitter's Information

510(k) Owner's Name: Zhejiang Qiangnao Technology Co.,Ltd Establishment Registration Number: Applying Address: Room 201-5, Building 1, No.1818-2, Wenyi West Road, Yuhang Street, Yuhang District, Hangzhou, Zhejiang, China Tel: +(86)15814407855 Contact Person: Boyuan Meng E-mail: boyuan.meng@brainco.cn

Application Correspondent:

Contact Person: Cassie Lee Company: Share Info (Guangzhou) Medical Consultant Ltd. Address: No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District, Guangzhou, China Tel: +86 20 8266 2446 E-mail: regulatory@share-info.com

Date of the summary prepared: 8/19/2022

2. Subject Device Information

Type of 510(k): Traditional Common Name: Powered, External Upper Limb Prosthetic System Classification Name: Cutaneous electrode Trade Name: Dexus Prosthetics System Model Name: MSL1, MSR1 Review Panel: Neurology Product Code: GXY, IQZ Regulation Number: 21 CFR 882.1320 Regulatory Class: II

3. Predicate Device Information

Sponsor: Otto Bock Healthcare Products GmbH Trade Name: Axon-Bus Prosthetic System Common Name: Powered, External Upper Limb Prosthetic System

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Classification Name: Cutaneous Electrode 510(K) Number: K123795 Review Panel: Neurology Product Code: GXY, IQZ Regulation Number: 21 CFR 882.1320 Regulation Class: II

4. Device Description

The Dexus Prosthetic System is intended exclusively for use on one patient. The Dexus Prosthetics System needs to be installed by trained prosthetists to meet the needs of the end-users.

The Dexus Prosthetic System has a total of 6 degrees of freedom (DOF), the distribution is as follows:

Thumb (1st finger) DOF: 2 degrees of freedom, which are flexion/extension, ● adduction/abduction, respectively, a combination of them can make the thumb move freely, and the state can be identified;
Index finger (2nd finger) DOF: 1 degree of freedom, flexion/extension movement;
Middle finger (3rd finger) DOF: 1 degree of freedom, flexion/extension movement;
Ring finger (the 4th finger) DOF: 1 degree of freedom, flexion/extension movement;
Little finger (5th finger) DOF: 1 degree of freedom, flexion/extension movement.

In addition, its gesture functions include Prehensile Grasp, Tipping, Tripod Pinch, Index pointing, Lateral Pinch, and Hook. The functions can be switched through the buttons on the back of the

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hand.

5. Intended Use / Indications for Use

The Dexus Prosthetic System is to be used exclusively for external prosthetic fittings of the upper limbs.

6. Test Summary

6.1 Summary of Non-Clinical Tests

Dexus Prosthetics System has been evaluated the safety and performance by lab bench testing as following:

≫ Electrical safety test according to IEC 60601-1 and IEC 60601-1-11 standards
Electromagnetic compatibility test according to IEC 60601-1-2 standard
Safety test of lithium battery according to IEC 62133-2 standard
Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
A 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"

6.2 Summary of Clinical Performance Test

No clinical study is included in this submission.

7. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, mode of operation, and intended use of Dexus Prosthetics System 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 of Comparison	Subject Device	Predicate Device	Verdict
Manufacturer	Zhejiang QiangnaoTechnology Co.,Ltd	Otto Bock HealthcareProducts GmbH	--
Trade Name	Dexus Prosthetic System	Axon-Bus ProstheticSystem	--
Models	MSL1, MSR1	--	--
510(k) Number	K220002	K123795	--
Classification Name	Cutaneous electrode	Cutaneous electrode	Same
Classification ProductCode	GXY	GXY	Same
Subsequent ProductCode	IQZ	IQZ	Same
Intended Use / Indicationsfor Use	The Dexus ProstheticSystem is to be used	The Axon-Bus ProstheticSystem is to be used	Same
Elements of Comparison	Subject Device	Predicate Device	Verdict
	exclusively for externalprosthetic fittings of the upperlimbs.	exclusively forexoprostheticfittings of the upper limbs.
Principle of operation	Detect, process, and transmitphysiological signals for usewith a prosthesis and controlsthe terminal device.	Detect, process, andtransmit physiologicalsignals for use with aprosthesis and controls theterminal device.	Same
System Components	Dexus Hand (terminaldevice)Dexus Wrist (passiverotation)Dexus Power (battery)Dexus Charge (charger)Dexus Center (control unit)Dexus Electrode (detectEMG signals)Dexus Skin (prosthetic glove)	Michelangelo Hand(terminal device)AxonFlexion Adapter(passive flexion)AxonRotation Adapter(passive rotation)AxonArm (passive elbowjoint with mechanicaland/or electrical lock)AxonEnergy Integral(battery)AxonCharge (charger)AxonMaster (control unit)Electrode (detecting EMGInput signals)AxonSoft (adjustmentsoftware)AxonSkin (prostheticglove)	SimilarNote 1
Environment of Use	Professional healthcarefacility and home use	Professional healthcarefacility and home use	Same
Assembling procedure	Components are assembledby a prosthetist	Components areassembled by a prosthetist	Same
Technological Characteristics - System
Signal acquisition	EMG electrode	EMG electrode	Same
Power Source	Rechargeable battery	Rechargeable battery	Same
Adjustment software	No	YesAxonSoft	DifferentNote 2
Software/Firmware/Micropr	Yes	Yes	Same
Elements of Comparison	Subject Device	Predicate Device	Verdict
ocessor Control?
Terminal device (e.g., Hand, wrist or elbow) included?	Yes	Yes	Same
Wireless Communication	No	YesBluetooth	DifferentNote 2
Technological Characteristics - Hand
Operating temperature	+5°C to +40°C	-10°C to +60°C	DifferentNote 3
Weight	530g	600g (incl. Passive flexion and rotation)	DifferentNote 3
Max. Gripping force	70N (opposition mode)60N (lateral mode)15N (neutral mode)	70N (opposition mode)60N (lateral mode)15N (neutral mode)	Same
Max. Grip Speed	150mm/s	325mm/s	DifferentNote 4
Max. Opening Width	106mm	120mm	DifferentNote 3
Technological Characteristics - Electrode
Dimensions	34.5mm x 16mm x 11.5mm	27mm x 18mm x 9.5mm	DifferentNote 3
Operating temperature	0°C - 40°C	-15°C to +60°C	SimilarNote 3
Material	Polycarbonate: PC2858,Thermoplastic Elastomer:TM5ADT and Metal Pieces(Copper gold plated):C1SQIN	Piastics (ASA)SiliconeCyanacrylate	DifferentNote 5
Contact area	Copper gold plated	Titanium (grade 1)	DifferentNote 5
Frequency bandwidth	80 - 500 Hz	90 - 450 Hz	SimilarNote 4
Adjustment	None	Potentiometer 1-7	DifferentNote 3
Installation	Suction socket	Suspension arms/suction socket	Same
Technological Characteristics - Battery
Chemistry	Li Ion	Li Ion	Same
Elements of Comparison	Subject Device	Predicate Device	Verdict
Number of cells	2	3	DifferentNote 6
Nominal voltage	7.4V	11.1V	DifferentNote 6
Battery capacity	2200mAh	Various(1150mAh/1500mAh)	DifferentNote 6
Charging time	Max.3.0h	Max.3.5h	DifferentNote 6
Battery weight	110g	140g	DifferentNote 3
Battery dimensions (LWH) (mm)	68x38x20	various (75x60x21 / 55x35x23)	DifferentNote 3
Installation	Integrated	Integrated	Same
Safety and Performance Testing
Electrical Safety	IEC 60601-1:2005/A1:2012IEC 60601-1-11:2015	IEC 60601-1:2005	SimilarNote 7
Electromagnetic Compatibility	IEC 60601-1-2:2014	IEC 60601-1-2:2007	SimilarNote 7
Biocompatibility	ISO 10993-1:2018ISO 10993-5:2009ISO 10993-10:2010	ISO 10993-1:2009ISO 10993-5:2009ISO 10993:2009	Same

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Comparison in Detail(s):

Note 1:

Although the "System Components" of the subject device is different from the predicate device, the difference is that the subject device does not have related components and adjustment software for the elbow joint part. Because the subject device is only suitable for users with residual limbs of the elbow and forearm, not for users with deformed elbow joints, so the subject device is no related components for the elbow joint part. And the adjustment software is for the subsequent adjustment of the assembly posture, but the theme device will adjust the preset posture for the user before assembly. So, the difference will not affect the safety and effectiveness of the subject device.

Note 2:

The "Adjustment software" and "Wireless Communication" of the subject device are different from the predicate device, although there is no adjustment software, wireless function or control method, it is already adjusted in the product when the subject device preset, which will not affect any daily

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usage. So, the slight difference will not affect the safety and effectiveness of the subject device.

Note 3:

Although the "Operating temperature", "Dimensions", "Max. Opening Width", and "Adjustment" of the subject device are different from the predicate device, all of them meet the requirements of safety and performance standards IEC 60601-1. So, the differences between the predicate device and the subject device will not affect the safety and effectiveness of the subject device.

Note 4:

Although the "Max. Grip Speed" and "Frequency bandwidth" of the subject device are different from the predicate device, all of them meet the requirements of performance requirements. The differences between the predicate device and the subject device will not affect the safety and effectiveness of the subject device.

Note 5:

Although the "Material" and "Contact area" of the subject device are different from the predicate device, all the materials intended to be contacted by the patients of them meet the requirements of ISO 10993 series standards. So, the differences between the predicate device and the subject device will not affect the safety and effectiveness of the subject device.

Note 6:

Note 7:

Although the subject device and the predicate device use slightly different versions of the test standards, the subject device is in compliance with the currently valid standards. So, the differences between the predicate device and the subject device will not affect the safety and effectiveness of the subject device.

8. Final Conclusion:

The subject device Dexus Prosthetics System has all features of the predicate device. The few differences do not affect the safety and effectiveness of the subject device. Thus, the subject device is substantially equivalent to the predicate device K123795.

Regulation Number and Section

§ 882.1320 Cutaneous electrode.

(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).