The DEKA Arm System consists of a prosthetic arm and accessories, which are used by a certified prosthetist to create a full upper extremity prosthesis indicated for individuals, age 18 years and older, who have partial or full upper limb amputations or congenital defects. The device is used to assist in activities of daily living (ADLs).

Device Description

The DEKA Arm System is a lithium-ion battery operated upper limb prosthesis intended to restore limb functions in individuals who lost all (i.e., shoulder disarticulations) or part of either upper limb (e.g., trans-radial amputation). Three configurations may exist, depending on the level of amputation or congenital defect: shoulder configuration (SC), humeral configuration (HC), and radial configuration (RC). It can provide up to 10 active degrees of freedom. Main components consist of Mechanical limb hardware, Arm Control Interfaces (ACI) that record user input signals (myoelectric recording electrodes, discrete bump switches, linear transducers, Inertial Measurement Units (IMUs), and force sensing resistors), Inertial Measurement Units (IMU) that record arm and foot movements, Master Arm Controller (MAC) that is the main processor, Arm Control Modules (ACM)/Hand Control Module (HCM) that control movement and are used for each respective limb component, and One or more battery modules and holsters. These components communicate via the Controller Area Network (CAN). The device is powered through a separate power bus. The system, not including the IMUs, is IP52 rated. The MAC controls wrist movement only, but oversees all actuators. There is afferent and efferent communication between the MAC and ACMs, HCM, IMUs, ACIs and battery module. The ACMs control actuators above the wrist while the HCM controls actuators below the wrist. The battery module may be embedded inside the arm, or worn outside the arm. IMUs do have a Power Control Module for the battery and are IP57 liquid/particle ingress rated. The hand has a grip release button that will release the grip in emergencies. The arm communicates wirelessly via 2 RF channels to a personal computer (PC) for configuration, as well as up to two IMUs. Signal acquisition from the user may be derived from cutaneous myoelectric recording electrodes, discrete bump switches, linear transducers, IMUs, and force sensing resistors, with the ability to accommodate 4 inputs (including up to 2 wireless inputs). Each of the 4 input methods may use up to 4 channels each. Wireless input comes only from the IMUs. Wired input is acquired through the ACIs and transmitted to the MAC. Modes are used to control the 10 degrees of freedom, including Standby, Hand, and Arm modes. Feedback will be provided by a tactor and an LED control display on the arm.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the DEKA Arm System, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the "SPECIAL CONTROLS" section and the "Basic Safety and Essential Performance" section within the Electrical Testing. The reported device performance is gathered from the "SUMMARY OF NONCLINICAL/BENCH STUDIES" and "SUMMARY OF CLINICAL INFORMATION" sections.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Electrical Safety & EMC	- Appropriate analysis/testing must validate electronic compatibility (EMC), electrical safety, thermal safety, mechanical safety, battery performance and safety, and wireless performance. - Leakage current tests within specification. - During operation, a failure in communication between control modules shall result in the prosthesis reverting to a safe state. - During operation, a detectable failure or out of range reading of any sensor or motor shall result in the prosthesis reverting to a safe state. - When power is removed, system shall revert to a safe state. - Means to turn power on/off.	- Leakage current tests (IEC 60601-1: Sec. 8.7) were within specification and acceptable. - EMC testing performed to IEC 60601-1-2 and additional FDA RF Wireless Guidance, all tests passed for various configurations. - Software/firmware review (Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, 2005) determined moderate level of concern. - Wireless communications with PC are checksummed to maintain safety. - Fault Safety: During fault/shutdown, arm slows/stops, hand stops; sensory input ignored (except hand open button). - Sudden power loss testing ensured defined safe state is reached. - Arm is limited in joint speed and further reduced when moving towards face. - Hand has a grip release button (two for redundancy) that releases grip in emergencies. - System provides ON/OFF switches (soft Off 1-2s, hard Off 8s).
Software Performance	- Appropriate software verification, validation, and hazard analysis must be performed.	- All software (Luke Arm Software, Prosthetist Interface (PI) Software) was appropriately validated. - PI Software allows configuration of arm movements in response to EMG/other inputs, with a virtual reality environment for testing.
Non-clinical Performance	- Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. - Mechanical bench data, including durability testing, to demonstrate that the device will withstand forces, conditions, and environments encountered during use. - Simulated use testing to demonstrate performance of arm commands and safeguard(s) under worst-case conditions and after durability testing. - Verification and validation of force sensors and hand release button. - Device functionality in terms of flame retardant materials, liquid/particle ingress prevention, sensor/actuator performance, motor/brake performance. - Accuracy of device features and safeguards.	- Durability testing (2 samples, simulated 3 years of usage by cycling arm 4,000-28,000 times) found some components required maintenance after 18 months, leading to updated labeling. Tests were acceptable, criteria met. - Mechanical strength testing (IEC 60601-1:2005 Sec. 15.3) conducted. - IP52 testing documented (IMU is IP57 rated) in accordance with IEC 60529. - Testing of face approach velocity slowdown done (from various initial positions). - ACI and IMU communication loss testing performed. - Hand open button tested with different grips. - Device reverts to safe state if joint is overloaded (prevents whipping). - Can carry payload of up to 3.9 kg. - Biocompatibility evaluation of patient-contacting materials performed (electrodes cleared in K032833; socket materials tested per ISO 10993). Materials well-characterized. - Abuse testing (shock and impact) done per IEC 60601-1-11 2010 and IEC 60601-1:2005 Sec. 15.3. - Device passed all identified non-clinical tests.
Clinical Performance	- Non-clinical and clinical performance testing must demonstrate the accuracy of device features and safeguards. - Documented clinical experience and human factors testing must demonstrate safe and effective use, capture any adverse events observed during clinical use and demonstrate the accuracy of device features and safeguards.	VA Study (Study 1): - Evaluated usability, dexterity, prosthetic skill, spontaneity, daily activities, and satisfaction. - 29 subjects completed objective testing. - Comparison of DEKA Arm (Gen3) vs. current prosthesis showed DEKA Arm outperformed current prosthesis in most activities (Figure 3), and was preferred by 83% of users (Table 2). - Two of four self-report measures (UEFS Use, Patient Specific Functional Scale) were significantly better with the DEKA Arm. - 77% of participants wanted a DEKA Arm in the future. DEKA Study (Study 2): - 10 arm users. - Participants found Gen2 and Gen3 comfortable, wore them 7 hrs/day and 6 hrs/day respectively. - Reported DEKA Arm was better at performing tasks than existing prosthesis. - Reliability reported as fair, improving to near excellent for later Gen3 subjects. - Feedback from heavy users led to design changes. Overall: Studies "reasonably demonstrate the safety and effectiveness of the DEKA arm system during the completion of predefined tasks and spontaneous activities in both the laboratory and home settings."
Biocompatibility	- Elements of the device that may contact the patient must be demonstrated to be biocompatible.	- Electrodes previously cleared (K032833) and passed biocompatibility testing. - Socket materials (prolonged contact) tested per ISO 10993 for skin irritation, sensitization, and cytotoxicity. - Materials well characterized in prosthetic applications.
Labeling	- Labeling for Prosthetist and User Guide must include: a. appropriate instructions, warnings, cautions, limitations, info on safeguards (e.g., driving). b. specific instructions and clinical training (assembling, fitting, programming, controls, modes, safety features, maintenance). c. information on patient population for which device effective. d. detailed summary of non-clinical and clinical testing.	- Patient labeling written according to "Guidance on Medical Device Patient Labeling" (2001), readable and understandable. - Definitions of symbols described. - Labeling checked according to IEC 60601-1:2005 Clause 7. - Indications for Use in User and Prosthetist guides. - Contraindications in Prosthetists Guide are general and appropriate. - User/Prosthetist Guides provide clear and understandable instructions, warnings, cautions. - Contact info provided for electrode replacement. - Labeling updated for maintenance needs based on durability testing.

Study Details:

2. Sample Size Used for the Test Set and Data Provenance

Study 1 (VA Study):
- Test Set Sample Size: 36 arm users enrolled, 29 completed all objective testing.
- Data Provenance: Retrospective and prospective. The study was described as an "iterative usability and optimization study with repeated measures collected prior to and after users received the DEKA Arm." It was conducted in the US (Veterans Affairs).
Study 2 (DEKA Study):
- Test Set Sample Size: 10 arm users.
- Data Provenance: Retrospective and prospective. The study involved daily interviews during a home use portion (two-week interval), suggesting a prospective data collection approach. Conducted by the sponsor, likely in the US.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The studies primarily used a mixed-methodology approach involving performance-based tests (objective measures) and self-report measures (subjective from users). There isn't an explicit mention of a panel of independent experts establishing a "ground truth" in the sense of diagnostic imaging (e.g., radiologists interpreting images). Instead, the "ground truth" for performance was based on:

Clinical Assessments: Administered by study personnel/therapists using standardized tests (e.g., Modified Box and Blocks Test, Jebsen-Taylor Hand Function Test). These individuals would be qualified in rehabilitation and prosthetics.
Prosthetist Ratings: Evaluations of ease of fitting and setup.
Therapist Ratings: Evaluations of ease of training and aspects of the arm's function.
User Reports: Self-reported ease of use, satisfaction, and ability to perform tasks.

The number and specific qualifications (e.g., years of experience) of the prosthetists, therapists, or other clinical personnel involved in administering these tests or providing ratings are not specified in the provided text.

4. Adjudication Method for the Test Set

The text does not explicitly describe an adjudication method (like 2+1 or 3+1 consensus) for the test set. For performance-based tests, scores are derived from direct observation or timed tasks. For self-report measures, user responses are directly collected. The study design does not suggest a need for "adjudication" in the typical sense of resolving conflicting expert opinions on a specific diagnosis or finding.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

Yes, a comparative effectiveness study was done, comparing the DEKA Arm to the subjects' existing prostheses. However, it was not an MRMC study in the traditional sense of multiple "readers" (e.g., radiologists) evaluating cases.
Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: This specific metric (human reader improvement with/without AI assistance) is not applicable here as the DEKA Arm is a prosthetic device for physical function, not an AI diagnostic tool primarily assisting human interpretation.
- Instead, the studies compared the human user's performance with the DEKA Arm to their performance with their existing prosthesis.
- Study 1 (VA Study) results:
  - The DEKA Arm (Gen3) outperformed current prostheses in most activities (Figure 3, where DEKA Arm, black bars, are generally longer).
  - 83% of users preferred the DEKA Arm for specific activities (Table 2).
  - Two of four self-report measures were significantly better with the DEKA Arm.
  - Performance was significantly slower on 2 measures (Box and Block and Jebsen feeding tests) with the DEKA Arm.
- Study 2 (DEKA Study) results: Participants reported the arm system was better at performing tasks than their existing prosthesis.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable to the DEKA Arm System. The DEKA Arm is a prosthetic device designed for human use and controlled directly by the user. It does not operate as a standalone algorithm or AI model in a diagnostic or interpretive capacity. Its "performance" is inherently human-in-the-loop. The non-clinical bench testing does evaluate the device's technical functions independently, but this is not a standalone "algorithm" performance test.

7. The Type of Ground Truth Used

The "ground truth" was established through a combination of:

Performance-based tests: Objective measures of dexterity and functional activities (e.g., number of blocks moved, tasks completed in time, observation of successful completion).
Self-report measures: Subjective assessment of satisfaction, ease of use, and perceived difficulty from the users themselves.
Professional ratings: Evaluations by prosthetists and therapists.

This is a clinical "ground truth" based on observed functional performance and user experience, rather than a pathological or outcomes-based "ground truth" derived from a definitive diagnostic test.

8. The Sample Size for the Training Set

The provided document describes clinical studies and non-clinical/bench studies. There is no explicit mention of a "training set" in the context of machine learning model development for the DEKA Arm System's operation or evaluation. The studies focus on testing the finished device.

The development process for the DEKA Arm involved iterative design based on feedback, especially from the Gen2 to Gen3 versions ("changes listed above are improvements made based on feedback received during device testing"). This feedback loop could be considered a form of "training" or refinement for the device design, but not a "training set" for a separate AI model within the device in the sense of deep learning.

9. How the Ground Truth for the Training Set Was Established

As there is no distinct "training set" for a machine learning model identified in the document, this question is not applicable. The "ground truth" for the device's development was likely established through engineering specifications, user requirements, and iterative testing and feedback during the design phases.

Summary

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DE NOVO CLASSIFICATION REQUEST FOR DEKA ARM SYSTEM

REGULATORY INFORMATION

FDA identifies this generic type of device as:

Upper Extremity Prosthesis Including a Simultaneously Powered Elbow and/or Shoulder with Greater than Two Simultaneous Powered Degrees of Freedom and Controlled by Non-Implanted Electrical Components. An Upper Extremity Prosthesis including a simultaneously powered elbow and/or shoulder with greater than two simultaneous powered degrees of freedom and controlled by non-implanted electrical components, is a prescription device intended for medical purposes, and is intended to replace a partially or fully amputated or congenitally absent upper extremity. It uses electronic inputs (other than simple, manually controlled electrical components such as switches) to provide greater than two independent and simultaneously powered degrees of freedom and includes a simultaneously powered elbow and/or shoulder. Prosthetic arm components that are intended to be used as a system with other arm components must include all degrees of freedom of the total upper extremity prosthesis system.

NEW REGULATION NUMBER: 21 CFR 890.3450

CLASSIFICATION: II

PRODUCT CODE: PAE

BACKGROUND

DEVICE NAME: DEKA ARM SYSTEM

SUBMISSION NUMBER: DEN120016

DATE OF DE NOVO: JUNE 14, 2012

REQUESTOR CONTACT:	ROGER LEROUX
	340 COMMERCIAL STREET
	MANCHESTER, NH 03101

REQUESTOR'S RECOMMENDED CLASSIFICATION: II

INDICATIONS FOR USE

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The DEKA Arm System is indicated for Prescription Use.

LIMITATIONS

The DEKA arm has the following key Cautions and Warnings:

Warnings

The safety and effectiveness of the DEKA Arm System has not been established for . bilateral amputees that include a unilateral or bilateral transhumeral or scapulothoracic level of amputation.
. Do not use the arm if it or any of the arm's parts have been damaged. This can lead to harm. Contact your prosthetist and have the damaged part(s) serviced.
Use care when handling hot liquids with the arm.
. Do not touch live electric wires with the arm.
Use extreme care when using the arm near any type of heavy machines. Getting the arm trapped in a machine can pull you in.
. Do not use the arm to drive a car or truck or other motor vehicle. Moving the arm in the wrong way can lead to loss of control.
. Use extreme care when picking up or holding sharp or heavy objects with the arm. Moving the arm in the wrong way can lead to dropping these items or hitting someone nearby with these items.
Do not take apart or change the arm or connected parts. This could lead to harm.
. The arm should be kept away from anesthetics, oxygen rich areas, and flammable liquids.
. If you are unable to reliably press the hand open button, take extra care when grasping items. Failure to release the item using the hand open button could lead to injury.
. Use care when using the arm near sources of heat or open flame such as heaters, fireplaces and stove burners. Getting too close to these items could cause the arm to catch fire and lead to injury.
. When getting medical care, remove the arm. Contact with or being close to medical hardware can cause the arm to move or lead to electric shocks.
. MRI Safety Information: The arm is MR Unsafe. Remove the arm before entering an MRI scan room. Contact with or being in proximity to an MRI scanner can cause the arm to move or lead to electric shocks and may result in severe injury.

Cautions

The arm system has been designed for activities of daily living. This includes such . tasks as moving a gallon of milk around and carrying heavy loads (a 20-lb bag of groceries, for instance). The amount of weight that can be carried or moved using the arm system also depends on the fit of your socket, your body's ability to support the load, and your arm position. Use caution when lifting or carrying a heavy load with the arm which you haven't carried before.
PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.

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DEVICE DESCRIPTION

Hardware and Motor output:

Image /page/2/Picture/3 description: The image shows a robotic arm against a black background. The arm is silver and white, and it has a clear plastic hand attached to the end. The arm is bent at the elbow, and the hand is open and facing forward. The arm appears to be very advanced and is likely used in a variety of applications, such as manufacturing, healthcare, or research.

Figure 1 - DEKA Arm System

Three configurations may exist, depending on the level of amputation or congenital defect. These are:

shoulder configuration (SC) for shoulder disarticulations,
humeral configuration (HC) for humeral disarticulations, and
radial configuration (RC) for radial disarticulations.

The external battery (RC configuration only, and SC/HC configuration with only external battery), and SC/HC configuration (with an internal battery) have ON/OFF switches: soft Off when held down for 1-2 seconds, hard Off at 8 seconds. The arm is applied using standard fitting and fabrication techniques. It can provide up to 10 active degrees of freedom, including:

shoulder abduction ●
shoulder flexion/extension ●
humeral rotation
elbow flexion/extension
wrist pronation/supination
wrist flexion/extension
index finger flexion/extension
flexion/extension of other fingers
thumb flexion/extension, and
thumb abduction/adduction.

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Main components consist of (see Figure 2 below):

Mechanical limb hardware,
. Arm Control Interfaces (ACI) that record user input signals (myoelectric recording electrodes, discrete bump switches, linear transducers, Inertial Measurement Units (IMUs), and force sensing resistors ),
Inertial Measurement Units (IMU) that record arm and foot movements,
Master Arm Controller (MAC) that is the main processor,
Arm Control Modules (ACM)/Hand Control Module (HCM) that control movement and ● are used for each respective limb component, and
One or more battery modules and holsters. ●

The IMUs and force sensing resistors are preferably placed in the shoes or on the feet.

Image /page/3/Figure/8 description: This image shows the components of the DEKA Arm System. The components include the Elbow Arm Control Module (ACM), Wrist Pronation/Supination Joint, Master Arm Controller (MAC), Hand Control Module (HCM), Wrist Flexion/Extension Ulnar/Radial Joint, Optional Internal Battery, and Hand. The image shows how the components fit together.

Figure 2 - DEKA Arm System components

These components communicate via the Controller Area Network (CAN). The device is powered through a separate power bus. The system, not including the IMUs, is IP52 rated (small dust and light rain impermeable). The MAC controls wrist movement only, but oversees all actuators. There is afferent and efferent communication between the MAC and ACMs, HCM, IMUs, ACIs and battery module. The ACMs control actuators above the wrist while the HCM controls actuators below the wrist. The battery module may be embedded inside the arm, or worn outside the arm. IMUs do have a Power Control Module for the battery and are IP57 liquid/particle ingress rated.

The hand has a grip release button that will release the grip in emergencies. Because of the importance of this safety feature, there are two buttons present to add redundancy. When either

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button is pressed for 5 seconds, it releases the brakes in the shoulder, humeral rotator and elbow (if present), and allows the arm to be manually repositioned.

Wireless and "Sensory" input:

The arm communicates wirelessly via 2 RF channels to a personal computer (PC) for configuration, as well as up to two IMUs. The 2 antennas for the PC link are located in the MAC, while the IMU antenna is located in the wrist.

Signal acquisition from the user may be derived from cutaneous myoelectric recording electrodes, discrete bump switches, linear transducers, IMUs, and force sensing resistors, with the ability to accommodate 4 inputs (including up to 2 wireless inputs). Each of the 4 input methods may use up to 4 channels each.

Wireless input comes only from the IMUs. These are positioned to sense gait position and to have the arm respond accordingly by disabling the present mode and IMU motion control and thereby moving with gait. The IMUs are ignored during walking, and users are instructed to put the arm into standby mode while walking. IMUs are activated by shaking, and will consider a standing position to be whatever the orientation of the foot is when the device is brought out of standby. Wired input is acquired through the ACIs and transmitted to the MAC. In order for these 4 inputs to control the 10 degrees of freedom, modes are used. The user may choose between 3 modes, which are initiated by a predefined input from one of the 4 inputs (e.g., muscle twitch, but not the IMUs) and include:

. Standby: the arm is on, and ready to be put into a mode; no movement is possible.
. Hand: the inputs will control hand and wrist movements.
Arm: the inputs will control arm movements (proximal and including the elbow).

The RC configuration can use Hand and Standby modes, while the other configurations can use Hand, Arm or Standby modes. These modes include only certain degrees of freedom, as listed above. The Hand mode is also called simultaneous mode. The Standby mode is set by holding the mode select input to threshold for 1-3 (configurable) seconds. Furthermore, for bidirectional movements. 2 electrodes must be used. while only 1 IMU or switch is necessary. Note - IMUs may put the device in standby during walking or make bidirectional arm movements.

Feedback will be provided by a tactor, which will be used to provide vibration feedback (for grip strength and/or mode changes) to the user, and LED control display on the arm (which displays battery status, grip status, mode selected, and alerts). If both internal and external batteries are used, then the battery charge shown is the combined charge. The LED display contains redundant icons on both sides of the arm, so that it may be seen easier depending on how the arm is positioned.

EMG Electrode Information:

The cutaneous EMG electrodes were cleared in K032833. Based on the information in K032833. these electrodes are intended for EMG applications and contain 3 terminals and a differential pre-amp. The contacts are gold-plated. Electrodes may only be placed in the socket or harness.

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Lithium Ion Polymer Batteries:

There are three batteries that may be used with this device: an internal battery, an external battery, and an IMU battery. Each is a lithium ion battery. The internal battery and the IMU battery are technician replaceable only, the external is user replaceable. One battery may exist in the forearm for either the SC or HC configuration. The external battery is used in any configuration including the third RC.

Fault Safety

During a fault or shutdown, the arm slows or stops depending on the present action, while the hand will only stop. All sensory input is ignored, except for the emergency hand open button. To mitigate aberrant action, the arm is limited in joint speed is further reduced when movement is bringing the hand towards the face as detected by the angles of the joints. The IMUs are designed to detect a fall, and command the MAC to ignore all inputs. Grip may only be changed when the hand is within 10% of fully open. If there is an interruption of less than 0.5 seconds with the IMUs, the motions of the arm will be stopped. If this continues to 2 seconds, the arm resets to Standby mode. If a joint is commanded to move, but fails due to being overloaded, the arm is designed to prevent whipping when the load is removed. If the device encounters a failure, it reverts to a safe state; this is possible while carrying a payload of less than 3.9 kg. A load of 3.9 ± 0.1 kg is used in testing to ensure all joints are able to move their full range with this load.

SUMMARY OF NONCLINICAL/BENCH STUDIES

A. MECHANICAL/DURABILITY TESTING

The sponsor provided durability testing as a mitigation for some risks listed in their risk analysis. Durability testing was completed on 2 samples, although some samples received maintenance service after 18 months of accelerated life-time testing use, since certain components were not able to withstand a 3 year test. To simulate usage over three vears, the durability testing in question involves cycling the arm several times (4,000 and 28,000 times, depending on the test) through different types of movement (e.g., turning door knobs, moving objects from tables to shelves). Mechanical strength testing from IEC 60601-1:2005 Sec. 15.3 was conducted. Many of the risks mitigated with durability testing are mitigated through other means as well (e.g., IEC 60601-1, 60529 testing). Testing was acceptable since all criteria of the standards were met, and durability testing demonstrated when maintenance will be necessary. Labeling was updated accordingly.

B. BIOCOMPATIBILITY/MATERIALS

The sponsor performed an evaluation of the patient contacting materials. The electrodes were previously cleared (K032833) and were previously evaluated for and found to successfully pass biocompatibility testing. Most other DEKA arm parts are incidentally contacting, and not intended to have prolonged contact with the skin. Only the socket has prolonged contact, and is a standard fitting using standard fitting materials and standard prosthetic procedures. The materials used in the socket have had skin irritation,

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sensitization and cytotoxicity testing performed per ISO 10993. The materials in the arm and the socket are well characterized in prosthetic applications, and do not require additional biocompatibility testing as part of this submission.

C. SHELF LIFE/STERILITY

Neither the device nor the components are provided sterile nor is this necessary for this device.

The sponsor states in the labeling the device shall have a service life of 3 years, with a servicing at 18 months. The sponsor notes that the user should: "Periodically clean the arm with a wash cloth wetted with water and a mild soap such as hand soap." These cleaning instructions are similar to other prosthetic devices, and are also appropriate for this device, particularly because it has an IP52 rating.

D. ELECTRICAL TESTING

1. LEAKAGE CURRENTS

Leakage current tests from IEC 60601-1: Sec. 8.7 are within specification and acceptable (this includes when using mains power).

2. ELECTROMAGNETIC COMPATIBILITY (EMC) AND ELECTRICAL SAFETY

Testing was performed to address EMC concerns for this device which is intended to be used in a wide variety of environments. Each test was performed for multiple arm configurations on the production-ready version. The sponsor determined the basic safety and essential performance of their device per IEC 60601-1: to determine the compliance criteria which were applied for all tests in the EMC Test Summary table (see Table 1). All tests were performed and passed to the most recent recognized version of IEC 60601-1-2: with test levels appropriate for the home use environment. Additional tests were carried out to account for specific

EMC Test Summary
Test Method	Frequency	Level	Fi

Table 1 - EMC Test Summary

Test Method	Frequency	Level	Finding
Emissions
BS EN 55011:2009	150-30000 kHz	Group 1Class B	Pass
BS EN 55011:2009	30-1000 MHz	Group 1Class B	Pass
47 CFR 15.249	1-40 GHz	N/A	Pass
Immunity
IEC 61000-4-2(contact)	N/A	±2, ±4,& ±6 kV	Pass
IEC 61000-4-2(air)	N/A	±2, ±4,& ±8 kV	Pass
IEC 61000-4-3	80 - 2500 MHz	3V/m	Pass
IEC 61000-4-4	N/A	±2 kV	Pass
IEC 61000-4-5	N/A	±1 &±2 kV	Pass
IEC 61000-4-6	150 - 80000 kHz	3VRMS	Pass
IEC 61000-4-8	50 & 60 Hz	3A/m	Pass
IEC 61000-4-11	N/A	N/A	Pass
FDA RF WirelessGuidance⁸	100 - 3500 Hz¹	300A/m	Pass
FDA RF WirelessGuidance⁸	10 - 60 kHz²	50A/m	Pass
FDA RF WirelessGuidance⁸	50 - 150 kHz²	30A/m	Pass
FDA RF WirelessGuidance⁸	26 - 80 MHz³	10V/m	Pass
FDA RF WirelessGuidance⁸	460 - 470 MHz⁴	10V/m	Pass
FDA RF WirelessGuidance⁸	690 - 965 MHz⁵	20V/m	Pass
FDA RF WirelessGuidance⁸	1390 - 6000 MHz⁶	20V/m	Pass
FDA RF WirelessGuidance⁸	2400 - 2500 MHz⁷	10V/m	Pass

emitters not fully covered by IEC 60601-1-2: (labeled as FDA RF Wireless Guidance in Table 1).

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Basic Safety and Essential Performance included:

. During operation of the prosthesis by the wearer, a failure in communication between control modules shall result in the prosthesis reverting to a safe state.
During operation of the prosthesis by the wearer, a detectable failure or out of . range reading of any sensor or motor shall result in the prosthesis reverting to a safe state.
. When power is removed from the prosthesis system, the prosthesis system shall revert to a safe state.
The prosthesis system shall provide a means to the user to turn the prosthesis power on and off.
The prosthesis system shall slow gross movements of the terminal device to 130 mm/second or less, averaged over a time interval of 1.00 s ± 0.25 s, when moving toward the wearer's face at distances of 65 mm or less.
The terminal device shall have a manual release feature that allows the terminal device to release its grasp without the use of a tool in less than 10 seconds while power is applied to the prosthesis.
Upon power up, the system shall default to Standby mode.
. IMUs shall not command motion if rotated more than 50° in either the pitch or roll axes relative to the orientation at which the system was last brought out of standbv.
The HC configurations of the prosthesis system shall limit elbow flex speed to less than 10°/s when within 5° of the limit of elbow flexion.
. During normal operation, the system shall leave the white and blue LEDs on the wrist-mounted display off when the system is in Standby mode of operation and not displaying state of battery charge.
. During normal operation, the system shall illuminate the white LED at the user selected illumination level on the wrist-mounted display when the system is the Arm mode of operation and not displaying state of battery charge.

3. BATTERY TESTING

Three batteries may be used with the device: external battery, the internal battery and the IMU battery.

The internal battery uses a b(4) electrolyte, which holds b(4) ● mAh, which may deliver up to 12A and has a nominal voltage of 14.8 V (there are four 3.7 V cells). A 3-state charger is used, which is built into the arm takes 2 hours to charge to 80%. The external battery or an AC transformer may be used in supplying current at 24 VDC. The arm may be activated and used while mains charge the internal battery. The external and IMU battery are separated from the device during charging.
. The external battery uses 8 cells (4 rows of 2 parallel cells). The external battery uses ab(4) , holds D(4) mAh, which may deliver up to 12 A, and has a nominal voltage of 14.8 V. It takes 2 hours to charge to 80%. The specifications for the batteries and chargers were provided. The usual

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safety mechanisms a 15A fast acting fuse are used with this battery. The cells were evaluated to UL 1642 (a test report for IEC 62133:2002 was also provided with only passing results) and the battery was evaluated to IEC 60601-1:2005.

. The IMU battery is a lithium polymer (Li-Po) battery, has aO(4) electrolyte, holds 190 mAh, may deliver up to 0.38 A, and has a nominal voltage of 3.7 V. The IMU battery is charged via an inductive Qi version 1.1 charging pad, and takes 2 hrs to charge to 80%. It uses the same standards for Verification & Validation as the other batteries above.
Battery testing was conducted to demonstrate the device is sufficiently able to detect when the battery is low on capacity (the level of detection is determined by the configuration of the arm). Low battery testing demonstrated adequate detection of a low battery. The battery is in a low battery state when it has ~15 minutes of life left. The arm has an alarm, and notable slowing of the arm will occur to advise the user the arm is low on power.

E. MAGNETIC RESONANCE (MR) COMPATIBILITY

The DEKA arm device system is labeled as MR Unsafe. Testing for determining the MR compatibility was not conducted for the device.

F. SOFTWARE

The software/firmware was reviewed according to the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005.

The software is determined to be a moderate level of concern. It is divided into internal (Luke Software) and external (Prosthetist Interface (PI)) applications; the external software is run on a PC computer. The software applications adapt the device to the specific configuration needed by the patient for optimum performance. Since the wireless communications with the PC are checksummed, safety and essential performance should be maintained in the event of a fault.

1. PI SOFTWARE

The arm may be configured to perform a sequence of movements in response to a single type of EMG (electrode) input. EMG (and other input) data are interpreted as either analog (low to high value) or digital (on and off). Whether analog or digital is chosen for a movement is based on the user's unique circumstances. Configuration is done in 5 steps by the PI software, and can save and setup more than one arm. The software includes a virtual reality environment for testing the input commands of the arm. A 3D representation of the patient and arm demonstrates how the arm will move when certain inputs are activated (e.g., EMG detection of muscle contraction).

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2. LUKE ARM SOFTWARE

The Gen 3 MAC software interprets the signal inputs, and in turn controls the HCM or ACM. HCM or ACM software interprets data from the MAC and feeds it data from sensors. The ACM controls arm movement, while the ACI pre-processes data from the sensors.

All software was appropriately validated.

G. OTHER NONCLINICAL PERFORMANCE TESTS

Concerns about electrode placement, retention, and fluid tolerance were adequately addressed by usability testing (see the Summary of Clinical Information section) of the SC configuration during times of physical exertion and sweating, which was determined to be the worst case scenario for this testing.

The following identify other notable nonclinical performance tests that were conducted by the sponsor:

. The sponsor used IEC 60601-2-40 for EMG related tests, although the sponsor did not assess for evoked response related clauses, which was deemed appropriate.
Abuse testing (consolidation of shock and impact testing) was included (and done . according to several sections of IEC 60601-1-11 2010 and IEC 60601-1:2005 Sec. 15.3).
. IP52 testing was documented (the IMU is IP57 rated) and done in accordance with IEC 60529.
Testing of the face approach velocity slowdown was done. The sponsor tested the . arm from various initial positions (from the front, side and above the head) to accurately test the ability of the arm to detect the position.
ACI and IMU communication loss testing was done.
Sudden power loss testing, ensuring the defined safe state is reached, was ● performed.
The hand open button (previously manual release) was tested with different grips. ● The sponsor recommends it be tested monthly.
. The sponsor provided an analysis of the doffing time, which found an average doffing time of 14.4 and 17.6 seconds for the SC and HC configurations, respectively.

The device passed all of these tests, and the results were found to be acceptable.

SUMMARY OF CLINICAL INFORMATION

Over the course of clinical studies, the Arm was modified from Generation 2 (Gen2) to Generation 3 (Gen3), the version to be marketed. The testing below includes subjects who used the Gen2 arm and Gen3 arm. The Gen3 arm was changed to include:

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a wrist with the combined movements of flexion/extension with ulnar/radial deviation ●
smaller IMUs
updated pressure transducer ●
increased shoulder abductor speed
increased battery capacity
control module integrated into forearm
reduced size of arm control interface
decreased size of hand palm ●
shoulder mount changed from horizontal to vertical ●

FDA believes the data collected on the Gen2 system can be used to support the safety and effectiveness of the Gen3 arm because the changes listed above are improvements made based on feedback received during device testing and do not adversely affect the safety or effectiveness of the device.

A. Study 1: Veterans Affairs (VA) Study to Optimize the DEKA Arm: Research Design And Analytical Methods

1. Objectives

Although the VA reported multiple aims in the study, the aims most relevant to determining reasonable assurance of safety and effectiveness of the device are as follows:

1. Evaluate the usability of the Gen2 DEKA Arm and Gen3 DEKA Arm prototypes
1. Quantify the dexterity, prosthetic skill, spontaneity of prosthetic use, performance of daily activities and device satisfaction of amputee users of the DEKA Arm
1. Compare scores of dexterity, prosthetic skill, spontaneity of prosthetic use, performance of daily activities and device satisfaction tests when using the DEK A Arm to scores using the existing prosthesis

2. Methods

The VA described their study as an iterative usability and optimization study with repeated measures collected prior to and after users received the DEKA Arm. It employed a multiple case study design using a mixed-methodology (quantitative and qualitative) approach. Multiple endpoints included 5 performance-based and 6 self-report measures obtained at 5 time points: baseline (twice), at finalization of arm set up, and after the 5th, 10th and 15th (for shoulder configuration (SC) arm only) training sessions depending on the arm configuration. There were approximately 21 visits for each user. Some subjects with SC configuration had an additional 6 visits: training sessions 11-15 plus one testing visit.

3. Participants

Thirty-six (36) arm users were purposively sampled in the VA Study to represent amputation levels appropriate for device. Enrollment began using the Gen2 version of the DEKA Arm System. During the course of the study a modified version of the arm (Gen3) was implemented. A representative number of subjects using each configuration were also studied. The breakdown of the number of subjects and versions of the arm by configuration tested are given below:

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Gen 2 (26 subjects)

RC: 8 ●
HC: 8 .
SC: 10 .

Gen 3 (10 subjects)

RC: 3 .
. HC: 4
SC: 3 .

Repeat participation was allowed for bilateral users (each side contributed data), unilateral users that could be fit with two different configurations, or users of earlier versions that may have yielded different results (e.g., five Gen2 users participated in Gen3 study).

4. Outcome Measures

Dexterity,Performance, andSatisfaction Test/Measures	Type of Test	Brief Description and Scoring
Modified Box andBlocks Test ofManual Dexterity	Performance- dexterity	Generic test that measures the number of blocksmoved in 60 seconds. Reported inblocks/60secs
Jebsen-Taylor HandFunction Test	Performance- dexterity	Seven part dexterity test that evaluates howmany events of each sub-task are completed in2 minutes. Reported in tasks completed in 2 minand tasks/sec.
UNB - University ofNew Brunswick Testof Prosthetic Function(not presented)	Performance-functionalactivities	Performance of ten adult tasks withperformance score based on spontaneity andskill of prosthetic function.
AM-ULA - ActivitiesMeasure for UpperLimb Amputees(VA developed midstudy, 2 measuresbelow related)	Performance-functionalactivities	Performance of 18 items of daily activity.Rating based on ability to complete task, speed,movement quality, skillfulness, andindependence. Scale: 0=unable, 1=poorperformance, 2=fair performance, 3=goodperformance-similar to natural extremity
ActivitiesPerformance Measure(VA developed forGen3)	Performance-functionalactivities	Observation of successful (1) or unsuccessful(0) completion of 24 item task list.
Extended ActivitiesMeasure(VA developed for	Performance-functionalactivities	Observation of successful (1) or unsuccessful(0) completion of 11 item task list ofchallenging activities
Gen3)
UEFS - UpperExtremity FunctionalScale	Self-report	Subject rates the ease of performing 23activities using a 5 point scale (1-very easy, 5-can't perform)
UEFS Use Scale	Self-report	Similar to UEFS but ask if the subject woulduse their prosthesis or DEKA arm to performthe activity. Score is proportion of activities thatsubject indicated they would perform with theprosthesis.
PSFS - PatientSpecific FunctionalScale	Self-report	Outcome measure to assess functional statusbased on subject identifying five activities thatare difficult to perform and how this situationimproves with the prosthesis (0-unable toperform, 10-perform with no problem)
TAPES - TrinityAmputations andProstheticsExperience Scale	Self-report	Primarily assesses psychosocial adjustment,activity restriction, and satisfaction with theprosthesis. 10 items assessed with 5 point scalewith (1-very dissatisfied, and 5-very satisfied)
DEKA ArmSatisfaction Scale	Self-report	Twenty four item survey to measure satisfactionwith features of the DEKA arm on a six pointscale (1-very unhappy, 7-very happy)
DEKA Arm UsabilityScale	Self-report	Twenty item survey to rate ease of use of theDEKA arm controls, sensors, harnesses andgrip. (1-unable to do, 6-very easy)
Prosthetist RatingScale(not presented)	Prosthetistreport	Prosthetist evaluation of ease of fitting andsetup of the DEKA arm system (0-unable, 5-very easy)
Therapist RatingScale(not presented)	Therapistreport	Therapist evaluation of ease of training andaspects of the DEKA arm's function (0-unable,5-very easy)
Open Ended SurveyQuestions	Interview	Experience participating in study, process offitting, overall impression, and ease of use ofthe DEKA arm

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5. Results

Of the 36 subjects enrolled, 29 subjects completed all objective testing. Seven subjects terminated early due to poor attendance (2), scheduling/repair issues (4), and no explanation (1). Some of these subjects completed a subset of the tests.

DEKA Arm Overall

Combined performance and satisfaction with all configurations and versions of the DEKA Arm were compared to the current prosthesis in 26 subjects with a paired t-test. Subjects compared the DEKA Arm (Gen3) performance versus their current prosthesis performance for specific activities; please see Figure 3 for the results on the percentage of

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subjects able to complete the tasks with their current prosthesis vs. the DEKA Arm (Gen3). Subjects also rated their preference for using the DEKA Arm (combined and each version: Gen2 and Gen3) versus their current prosthesis for specific activities; please see Table 2 for the results. A rationale was provided for excluding 3 subjects with end of study data for reasons other than performance with the DEKA Arm. For the 8 performance measures reported, function was significantly slower with the DEKA Arm on 2 measures (Box and Block and the Jebsen feeding tests). Two of 4 self-report measures were significantly better with the DEKA Arm (UEFS Use and the Patient Specific Functional Scale).

Image /page/13/Figure/1 description: The image is a bar graph comparing the performance of the DEKA Arm to a current prosthesis across various activities. The activities are listed on the y-axis, and the performance score (presumably a percentage) is on the x-axis, ranging from 0 to 100. For each activity, there are two bars: one representing the DEKA Arm's performance and the other representing the current prosthesis's performance. In most activities, the DEKA Arm outperforms the current prosthesis, as indicated by the longer black bars compared to the gray bars.

Figure 3 - Comparison of Activities Performance of DEKA Arm (Gen3) compared to Current Prosthesis

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Table 2 - Prosthetic Preference for Specific Activities

Preference	Gen2 (N=21)	Gen3 (N=9)	All (N=30)	Examples
DEKA Arm System	81%	89%	83%	Everything, housework, cooking, any activity involving wrist rotation and flexion, picking up granddaughter, holding a trumpet, feeding myself, getting items out of refrigerator, playing cards, reaching overhead, anything with fine pinch grip, drinking liquids, pushing a mower, using scissors
Current Prosthesis	24%	67%	37%	Any small task due to finger size, running, things that require a light touch, rock climbing, carrying heavy objects, activities that require waterproofing, activities that might cut or damage the hand covering

Arm Version

All of the 9 Gen3 users who were tested at the end of the study were able to perform 18 of 35 every day activities from the Activities Performance Measure and the Extended Activities Measure with the DEKA Arm. The most difficult activity was removing or replacing a wallet from a back pocket. Data were not provided for the Gen2 version of the device for these measures because the assessment tool was implemented for the Gen3 portion of the study. Differences between arm versions were plotted graphically for the other performance and self-report measures, but not compared statistically. Patient reported measures tended to favor Gen3 across all configurations. Performance measures showed more mixed trends across configurations and versions, but for the RC configuration, performance tended to be better for the Gen3 users than the Gen2 users.

Arm Configuration

The results of Wilcoxon signed-ranks tests show that performance with the DEKA Arm compared to the subject's current prosthesis varied by arm configuration for some tests with no clear trends emerging. Self-report measures revealed that users of all configurations performed significantly more activities and reported less difficulty with activities that were important to them when using the DEKA Arm as compared to their current prosthesis. Comparison of within DEKA Arm scores with Kruskal-Wallis tests showed that dexterity and activity performance was consistently better for RC users as compared to HC and SC users. No differences were observed for the self-report measures.

6. Effectiveness/Self-Report Measures

The VA study asked users several questions about their impressions of the DEKA Arm. Results highlighted the following:

77% of participants said "yes" they wanted to receive a DEKA Arm in the future. ●

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o All Gen 3 users indicated that either they wanted to receive or might want to receive a DEKA Arm in the future.
Participants that were unequivocally favorable of the device or favorable with critical ● suggestions varied by configuration: SC 92% or 12/13; HC 73% or 8/11; and RC 82% or 9/11.
- O HC users expressed the highest percentage of responses that were unfavorable (27%, 3/11). HC configuration users also accounted for nearly all of those who failed to complete the study.
Participants who were generally favorable but had critical feedback commented on issues such as: weight, reliability (breakage and need for repair). range of motion (ROM) of the wrist, and the need to put the arm in standby while walking.
Four Gen2 participants (16%). including at least one user of each configuration, and ● two Gen3 participants (20%) had unfavorable impressions of the DEKA Arm at the end of the study.
Although all Gen3 users expressed an interest in using the prosthesis in the future, they also expressed concerns about taking the arm home.
At the end of the study, the majority of participants expressed some type of concern ● about using a DEKA Arm at home. All Gen 3 RC users expressed concern about breakage and need for repair.

Concern	Gen2	Gen3
No concern	16%	0%
Some concern	84%	100%
Concerns:
-Breakage/repair/reliability	44%	60%
-Unintended stoppages/safety	20%	40%
-Getting it wet	24%	20%
-Independent donning/doffing	24%	20%
-Too many wires/cables	16%	10%
-Controls	12%	10%
-Weight	24%	0%
-Too big/bulky	12%	0%
-Other	28%	10%

Table 3 - Concerns Expressed by Subjects

B. Study 2: DEKA Study: Evaluation of a Multi-Articulated Upper Limb Prosthesis Using Advanced Control Systems

The DEKA study focused on unstructured prosthesis use across a broad range of userdefined activities and was documented through interviews with open-ended and Likert scale questions. Ten (10) arm users were studied in the DEKA Study. DEKA reports that their studies include 3.000 hours of total use time by their participants, including a home use portion that allowed each participant to use the device at home for a two-week interval.

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1. Arm Versions Tested

5 subjects used both the Gen2 and the Gen3,
1 subject used Gen2 only, and .
4 subjects used Gen 3 only. .

All 9 Gen3 subjects used prostheses with IMUs; 3 of 6 Gen2 subjects used prostheses with IMUs, while the other 3 used prostheses with foot pads.

2. Participants

10 individuals. .
7 unilateral and 3 bilateral amputees. One of the ten amputees also participated in the ● VA study and had received more extensive training in use of the arm than the other DEKA study participants.
. 1 RC user only contributed data from a Gen2 arm version with foot pads not IMUs. Two other users that contributed data from a Gen2 arm with foot pads also contributed data from another arm with IMUs.

3. Arm Configurations Tested

2 SC. 5 HC. 2 RC .
SC -

4 users*; 1 bilateral, 2 unilateral; 2 right, 3 left 3 tests; 3 Gen3 with IMUs; 2 Gen2 with foot pads

HC -●
5 users*; 1 bilateral, 4 unilateral; 1 right, 4 left side 7 tests; 4 Gen3 with IMUs; 3 Gen2, 1 with foot pads, 2 with IMUs
RC -.
2 users*; 2 bilateral, 0 unilateral;

3 tests; 1 Gen3 with IMUs; 1 Gen2 with foot pads and 1 Gen2 with IMU

Bilateral amputees of different amputation levels used arms of different configurations on each side, so numbers of users exceed number of individual participants.

4. Outcome Data

Given the small sample size and usability study aims, the study methods utilized daily interviews of participants during the home use portion of the study. Another set of questions was asked at the end of the two week home use study. The questionnaire and scales were developed by the sponsor and has not undergone external validation.

5. Effectiveness/Home Use Study

Participants using the Gen2 arm version found the device to be comfortable and wore it on average of 7 hours per day (range 2-16 hrs). Participants reported that the arm system

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was better at performing tasks than their existing prosthesis. Reliability was reported as being fair to good.

Participants using the Gen3 arm version found the device to be comfortable, and often slightly more comfortable than their existing prosthesis. They wore the prosthesis on average of 6 hours per day (range 3.5-12 hrs) during the take-home study. As with the Gen2 participants, Gen3 participants reported that the arm system was better at performing tasks than their existing prosthesis. Reliability was reported as fair, but there was a significant improvement for the last 4 subjects with reliability average slightly less than excellent.

Activities selected by the participants during take-home studies included activities such as carrying large bales of hay, large pails of water, and cleaning and repair work around horse stalls. Feedback on the needs of these heavy users was used to make design changes to better accommodate these more aggressive user tasks.

The VA and DEKA studies reasonably demonstrate the safety and effectiveness of the DEKA arm system during the completion of predefined tasks and spontaneous activities in both the laboratory and home settings.

However, from the studies provided, only 1 subject was a bilateral amputee with a transhumeral and a scapulothoracic level of amputation. There is concern that this group may not be able to fully utilize all safety features provided and may, therefore, be at a higher potential risk in the absence of further testing. Therefore, the safety and effectiveness of the device has not been demonstrated in bilateral amputees with a unilateral transhumeral or scapulothoracic level of amputation.

LABELING

Patient labeling was written in accordance to the "Guidance on Medical Device Patient Labeling" (issued on April 19, 2001) and is readable and understandable. The definitions of the symbols used are described in the beginning of the User Guide. In addition, labeling was checked according to IEC 60601-1:2005 Clause 7.

The Indications for Use are located in the User and Prosthetist guides. The contraindications in the Prosthetists Guide are general to the device and appropriate.

The User/Prosthetist Guides give clear and understandable instructions to the user and prosthetist with appropriate warnings.

Contact information was also provided for replacing electrodes.

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RISKS TO HEALTH

Table 4 below identifies the risks to health that may be associated with use of the DEKA Arm and the measures recommended to mitigate these risks.

Identified Risk	Mitigation Measures
Unintended Motion	Electronic Input TestingSoftware Verification, Validation andHazards AnalysisWireless TestingElectromagnetic Compatibility (EMC)TestingNon-clinical Performance TestingWater/Particle Ingress TestingDurability TestingBattery TestingLabeling
Adverse Tissue Reaction	Biocompatibility Assessment
Battery Failure	Battery TestingWater/Particle Ingress TestingLabeling
Electromagnetic Incompatibility	EMC testingLabeling
Electrical Safety Issues	Electrical Safety TestingLabeling
Gripping Malfunction	Non-clinical Performance TestingSoftware Verification, Validation andHazards AnalysisLabeling
High Risk Activities (e.g., driving)	Labeling
Malfunction Due to EnvironmentalConditions	Non-clinical Performance TestingBattery TestingWater/Particle Ingress TestingWireless TestingEMC TestingFlammability TestingLabeling
Use Error	Clinical StudiesHuman Factors StudiesLabeling

Table 4 – Identified Risks to Health and Mitigation Measures

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SPECIAL CONTROLS:

In combination with the general controls of the FD&C Act, the Upper Extremity Prosthesis Including a Simultaneously Powered Elbow and/or Shoulder with Greater than Two Simultaneous Powered Degrees of Freedom and Controlled by Non-Implanted Electrical Components is subject to the following special controls:

1. Appropriate analysis/testing must validate electronic compatibility (EMC), electrical safety, thermal safety, mechanical safety, battery performance and safety, and wireless performance, if applicable.
1. Appropriate software verification, validation, and hazard analysis must be performed.
1. Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. Performance testing must include:
- a. Mechanical bench data, including durability testing, to demonstrate that the device will withstand forces, conditions and environments encountered during use.
- b. Simulated use testing to demonstrate performance of arm commands and available safeguard(s) under worst case conditions and after durability testing.
- Verification and validation of force sensors and hand release button, if applicable, C. are necessary.
- d. Device functionality in terms of flame retardant materials, liquid/particle ingress prevention, sensor and actuator performance, and motor and brake performance.
- e. The accuracy of the device features and safeguards.
1. Non-clinical and clinical performance testing must demonstrate the accuracy of device features and safeguards.
1. Elements of the device that may contact the patient must be demonstrated to be biocompatible.
1. Documented clinical experience and human factors testing must demonstrate safe and effective use, capture any adverse events observed during clinical use and demonstrate the accuracy of device features and safeguards.
1. Labeling for the Prosthetist and User Guide must include:
- a. appropriate instructions, warning, cautions, limitations, and information related to the necessary safeguards of the device, including warning against activities that may put the user at greater risk (e.g., driving).
- b. specific instructions and the clinical training needed for the safe use of the device, which includes:
  - instructions on assembling the device in all available configurations, i.
  - ii. instructions on fitting the patient,

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iii. instructions and explanations of all available programs and how to program the device,
iv. instructions and explanation of all controls, input, and outputs,
v. instructions on all available modes or states of the device,
vi. instructions on all safety features of the device, and
instructions for maintaining the device. vii.
c. information on the patient population for which the device has been demonstrated to be effective.
d. a detailed summary of the non-clinical and clinical testing pertinent to use of the device.

BENEFIT/RISK DETERMINATION

The risks of the device are based on non-clinical data as well as data collected from clinical studies described above. The probable risks of abrasions, heat rash, bruising, and blisters with use of the DEKA Arm are the same as other upper extremity prostheses. Additionally, the user may injure themselves or a bystander due to a device malfunction during normal use or while performing higher risk activities (e.g., holding sharp or heavy objects).

The probable benefits of the DEKA Arm System are also based on non-clinical data as well as data collected from clinical studies described above. The probable benefit of the ability to complete some Activities of Daily Living (ADLs) that cannot be completed with currently available prostheses such as hammering, manipulating a door knob, using utensils, don/doff a shirt, and brushing hair and teeth.

While benefit of the device was demonstrated, there were concerns identified in the studies about the reliability of the device. Additionally, the results were primarily on unilateral amputees, and the generalization of the results to all bilateral amputees was inadequate due to concerns with their ability to use the safety features.

In conclusion, given the available information above, the data support that the use of the DEKA Arm to assist with ADLs, and the probable benefits outweigh the probable risks. The device provides benefits, and the risks may be mitigated by the use of general and special controls.

CONCLUSION

The de novo request for the DEKA Arm is granted and the device is classified under the following:

Product Code: PAE Device Type: Upper Extremity Prosthesis Including a Simultaneously Powered Elbow and/or Shoulder with Greater than Two Simultaneous Powered Degrees of Freedom and Controlled by Non-Implanted Electrical Components Class: II Regulation: 21 CFR 890.3450

Regulation Number and Section

N/A