(55 days)
The Ekso™ (version 1.1) and Ekso GT™ (version 1.2) are intended to perform ambulatory functions in rehabilitation institutions under the supervision of a trained physical therapist for the following population:
• Individuals with hemiplegia due to stroke (upper extremity motor function of at least 4/5 in at least one arm)
• Individuals with spinal cord injuries at levels T4 to L5 (upper extremity motor function of at least 4/5 in both arms)
• Individuals with spinal cord injuries at levels of C7 to T3 (ASIA D with upper extremity motor function of at least 4/5 in both arms).
The therapist must complete a training program prior to use of the device. The devices are not intended for sports or stair climbing.
The Ekso is a powered motorized orthosis. It consists of a fitted metal brace that supports the legs, feet, and torso. It is worn via straps on the body, legs, and feet. Battery powered motors drive knee and hip joints. It has an integrated solid torso containing the computer and power supply. It has a hand-held user interface to specify settings and initiate steps. The Ekso is used with a cane, crutch, or walker.
Here's an analysis of the acceptance criteria and supporting study for the Ekso™ (version 1.1) and Ekso GT™ (version 1.2) based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of numerical acceptance criteria with corresponding device performance metrics in the way one might see for diagnostic accuracy. Instead, the acceptance criteria are implicitly defined by the safety and effectiveness demonstrated in the clinical studies, particularly for the expanded Indications for Use. The core acceptance criterion appears to be: safe and effective ambulation for the specified patient populations, demonstrated by a lack of adverse events.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Safety: Device operation without falls, adverse events, or significant harm during ambulation. | Study 1: 50 out of 54 patients (93%) safely performed ambulatory functions with only one arm to maintain stability. No falls or other adverse events reported. |
| Study 2: 7 out of 8 patients (88%) safely performed ambulatory functions with only one arm to maintain stability. No falls or other adverse events reported. | |
| Overall: "The lack of adverse events over 216 walking sessions in 57 patients demonstrates the safety and effectiveness of the Ekso device..." | |
| Effectiveness (Ambulatory Function): Patients with conditions covered by the expanded indication can ambulate. | Study 1: Focused on patients with hemiplegia due to stroke, specifically those with "upper extremity motor function of less than 4/5 in one arm" (34 patients) and others not recorded (19 patients). The study demonstrated that these patients could "safely performed ambulatory functions with only one arm to maintain stability." |
| Study 2: Focused on patients with hemiplegia due to stroke, "All limited household ambulators at recruitment." Demonstrated that patients could "safely performed ambulatory functions with only one arm to maintain stability." | |
| Indirect Evidence: "The indirect evidence documents that regardless of upper extremity motor function, 23 patients were able to safely perform ambulatory functions in the Ekso device using only one arm to control the assistive device. The ability of such patients to support themselves and recover from a stumble is equivalent to that of a patient who has upper extremity strength of at least 4/5 in only one arm." | |
| Training Effectiveness: Certified therapists can safely and independently operate the device. | The document describes a two-phase training and certification program for therapists, ensuring competence in screening, setup, fitting, operation, safety, and emergency management. The implication is that this training enables safe operation. |
2. Sample Sizes and Data Provenance
-
Test Set (Clinical Studies):
- Study 1: 54 subjects total.
- 34 subjects with affected upper extremity (UE) motor function of less than 4/5 in one arm.
- 1 patient with affected UE motor function of 4/5.
- 19 patients with UE motor function not recorded.
- 216 walking sessions across both studies.
- Study 2: 8 subjects total.
- All 8 subjects were limited household ambulators at recruitment.
- Data Provenance: Both studies are described as "Single center, prospective studies." The country of origin is not explicitly stated, but given the FDA submission, it is likely the United States.
- Study 1: 54 subjects total.
-
Training Set: Not applicable for this device as it is a physical exoskeleton, not an AI/software device that requires a "training set" in the machine learning sense. The "training" described in the document refers to human therapist training.
3. Number of Experts and Qualifications for Ground Truth
-
Ground Truth for Test Set: The "ground truth" here is the clinical assessment of safety and ability to ambulate. This would have been established by the trained physical therapists supervising the sessions and likely by the principal investigator(s) of the studies. The document states the device is used "under the supervision of a trained physical therapist," and the therapists themselves undergo certification. While no specific number of "experts" are listed for establishing ground truth post-hoc, the safety and effectiveness were directly observed and recorded during the prospective studies by qualified clinical personnel. Their qualifications are implied by their role as physical therapists and study investigators.
-
Training Set Ground Truth: Not applicable.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for the outcome of the clinical studies. The results are presented as direct observations and reports from the prospective studies ("No falls or other adverse events reported"). This implies the safety and functional performance were observed and recorded directly by the study investigators/therapists.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance) is relevant for diagnostic imaging AI. The Ekso device is a physical exoskeleton for rehabilitation, not a diagnostic AI.
6. Standalone (Algorithm Only) Performance
- Not applicable. The Ekso is an exoskeleton requiring human interaction (the patient wearing it, the therapist supervising it). It does not have a "standalone" algorithm performance in the way an AI diagnostic tool would. Its performance is intrinsically linked to the human operator and patient.
7. Type of Ground Truth Used
- Clinical Observation and Outcomes Data:
- The primary ground truth for the clinical studies was the direct clinical observation of patient safety (absence of falls, adverse events) and their ability to perform ambulatory functions while using the device, as assessed by trained physical therapists and study investigators.
- The "results" section directly references "safely performed ambulatory functions" and "no falls or other adverse events reported," which are observed clinical outcomes.
8. Sample Size for the Training Set
- Not applicable. As noted above, this is a physical medical device, not an AI/machine learning algorithm requiring a "training set" of data. The "training" refers to physical therapist training.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8. The training for therapists involves demonstrating competence in operating the device and supervising patients safely, as evaluated by the "Ekso Bionics Clinical Training Team."
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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of three stylized human profiles facing to the right, with a design element below them that resembles flowing water or fabric.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 19, 2016
Ekso Bionics, Inc. % John J. Smith, MD, JD Regulatory Counsel Hogan Lovells U.S. L.L.P. 555 Thirteenth Street NW Washington, DC 20004
Re: K161443
Trade/Device Name: Ekso™ (version 1.1) and Ekso GTTM (version 1.2) Regulation Number: 21 CFR 890.3480 Regulation Name: Powered Lower Extremity Exoskeleton Regulatory Class: Class II Product Code: PHL Dated: Mav 25, 2016 Received: May 25, 2016
Dear Dr. Smith:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J. Hoffmann -A
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161443
Device Name
EksoTM (version 1.1) and Ekso GTTM (version 1.2)
Indications for Use (Describe)
The Ekso™ (version 1.1) and Ekso GT™ (version 1.2) are intended to perform ambulatory functions in rehabilitation institutions under the supervision of a trained physical therapist for the following population:
· Individuals with hemiplegia due to stroke (upper extremity motor function of at least one arm)
- · Individuals with spinal cord injuries at levels T4 to L5 (upper extremity motor function of at least 4/5 in both arms)
· Individuals with spinal cord injuries at levels of C7 to T3 (ASIA D with upper extremity motor function of at least 4/5 in both arms).
The therapist must complete a training program prior to use of the devices are not intended for sports or star climbing.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary as required by 21 CFR 807.92(c)
| Device name | Ekso |
|---|---|
| Submitters name &contact info | Ekso Bionics® Inc.1414 Harbour Way SouthSuite 1201Richmond, CA 94804 |
| Contact Details:Thomas LoobyCEOTel: +1 937-838-0842Email: tom@eksobionics.comTel: +1 (510) 984-1761Fax: +1 (510) 927-2647 | |
| Preparation Date | June 27, 2016 |
| Device Name &Classification | Trade Name: Ekso™ (version 1.1) and Ekso GT™ (version 1.2)Common Name: ExoskeletonClassification Name: Powered ExoskeletonDevice Classification: Class II, 21 CFR 890.3480Product Code: PHL |
| Indications for Use | The Ekso™ (version 1.1) and Ekso GT™ (version 1.2) are intended to perform ambulatory functions in rehabilitation institutions under the supervision of a trained physical therapist for the following population:• Individuals with hemiplegia due to stroke (upper extremity motor function of at least 4/5 in at least one arm)• Individuals with spinal cord injuries at levels T4 to L5 (upper extremity motor function of at least 4/5 in both arms)• Individuals with spinal cord injuries at levels of C7 to T3 (ASIA D with upper extremity motor function of at least 4/5 in both arms).The therapist must complete a training program prior to use of the device. The devices are not intended for sports or stair climbing. |
| Device Description | The Ekso is a powered motorized orthosis. It consists of a fitted metal brace that supports the legs, feet, and torso. It is worn via straps on the body, legs, and feet. Battery powered motors drive knee and hip joints. It has an integrated solid torso containing the computer and power supply. It has a hand-held user interface to specify settings and initiate steps. The Ekso is used with a cane, crutch, or walker. |
| Predicate Device | Manufacturer: Ekso Bionics510(k): K143690Date of Clearance: 4/1/2016 |
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| Manufacturer | Ekso Bionics®, Inc. | Predicate EksoBionics®, Inc. | Differences |
|---|---|---|---|
| Trade Name | Ekso™ (version 1.1)and Ekso GT™ (version1.2) | Ekso™ (version 1.1)and Ekso GT™ (version1.2) | |
| 510(k) Number | TBD | K143690 | N/A |
| Product Code | PHL | PHL | Same |
| Regulation Number | 890.3480 | 890.3480 | Same |
| Regulation Name | Powered Exoskeleton | Powered Exoskeleton | Same |
| Indications for Use | The Ekso™ is intendedto perform ambulatoryfunctions inrehabilitationinstitutions under thesupervision of a trainedphysical therapist forthe followingpopulation:Individuals withhemiplegia due tostroke (upperextremity motorfunction of at least 4/5in at least one arm),Individuals with spinalcord injuries at levelsT4 to L5 (upperextremity motorfunction of at least 4/5in both arms),Individuals with spinalcord injuries at levelsof C7 to T3 (ASIA Dwith upper extremitymotor function of atleast 4/5 in both arms).The therapist mustcomplete a trainingprogram prior to use ofthe device. Thedevices are notintended for sports orstair climbing. | The Ekso™ is intendedto perform ambulatoryfunctions inrehabilitationinstitutions under thesupervision of a trainedphysical therapist forthe followingpopulation with upperextremity motorfunction of at least 4/5in both arms:Individuals withhemiplegia due tostroke, Individuals withspinal cord injuries atlevels T4 to L5, andIndividuals with spinalcord injuries at levelsof C7 to T3 (ASIA D).The therapist mustcomplete a trainingprogram prior to use ofthe device. The Ekso1.1 and 1.2 are notintended for sports orstair climbing. | Similar; the newindication is clarifiedto explicitly includeindividuals withhemiplegia due tostroke, who haveupper extremity motorfunction of at least 4/5in only one arm.Individuals with spinalcord injury still requireupper extremity motorfunction of at least 4/5in both arms. |
| Body Coverage | Worn over legs andupper body with rigidtorso | Worn over legs andupper body with rigidtorso | Same |
| Manufacturer | Ekso Bionics®, Inc. | Predicate EksoBionics®, Inc. | Differences |
| Trade Name | Ekso™ (version 1.1)and Ekso GT™ (version1.2) | Ekso™ (version 1.1)and Ekso GT™ (version1.2) | |
| Size of Components | Adjustable upper leg,lower leg, and hipwidth; control unitintegrated into thetorso | Adjustable upper leg,lower leg, and hipwidth; control unitintegrated into thetorso | Same |
| Mobility Aid | Walker, Crutches, Cane | Walker, Crutches, Cane | Same |
| Ability of UserMobility | Sit, stand, walk, andturn | Sit, stand, walk, andturn | Same |
| Walking Speed | ~2 km/hr | ~2 km/hr | Same |
| Grade of Inclination | 1.15 deg | 1.15 deg | Same |
| Type of Surface | Smooth, cement,carpet | Smooth, cement,carpet | Same |
| Patient Population | Adults over age of 18with hemiplegia due tostroke, Spinal CordInjury (SCI) from T4 toL5, and SCI from C7 toL5 ASIA D | Adults over age of 18with hemiplegia due tostroke, Spinal CordInjury (SCI) from T4 toL5, and SCI from C7 toL5 ASIA D | Same |
| Height of Patient | ~62″ to 74″ (1.58 m to1.88 m) | ~62″ to 74″ (1.58 m to1.88 m) | Same |
| Weight of Patient | Up to 220 lbs (100kg) | Up to 220 lbs (100kg) | Same |
| Control Method | Handheld interface forPT; weight shift toinitiate steps | Handheld interface forPT; weight shift toinitiate steps | Same |
| Range of Motion | Hips: 135° flexion to20° extensionKnees: 130° flexion to0° extensionAnkles: 10° flexion to10° extension | Hips: 135° flexion to20° extensionKnees: 130° flexion to0° extensionAnkles: 10° flexion to10° extension | Same |
| Weight | 50 lbs (23 kg) | 50 lbs (23 kg) | Same |
| Rechargeable Battery | Rechargeable lithiumion batteries 48.1V,30A peak current, 1hour of continuoususage per charge | Rechargeable lithiumion batteries 48.1V,30A peak current, 1hour of continuoususage per charge | Same |
| Battery Charge Time | 1 hour | 1 hour | Same |
| Expected Useable Life | 4 years | 4 years | Same |
| Training Program | Yes | Yes | Same |
| Certification Program | Yes | Yes | Same |
| Manufacturer | Ekso Bionics®, Inc. | Predicate EksoBionics®, Inc. | Differences |
| Trade Name | Ekso™ (version 1.1)and Ekso GT™ (version1.2) | Ekso™ (version 1.1)and Ekso GT™ (version1.2) | |
| User Feedback | Provides visualfeedback on thehandheld controllerand auditory feedback | Provides visualfeedback on thehandheld controllerand auditory feedback | Same |
| Fall Detection andMitigation | None | None | Same |
| Failsafe Feature | In event of powerfailure- knees becomelocked and hips free(similar to typicalpassive leg braces) | In event of powerfailure- knees becomelocked and hips free(similar to typicalpassive leg braces) | Same |
| OperatingTemperature | 10° to 95°F (-12° to -35°C) | 10° to 95°F (-12° to -35°C) | Same |
| Operating Humidity | Not available | Not available | Same |
| Electrical SafetyTesting | IEC 60601-1:2005 withUS deviations | IEC 60601-1:2005 withUS deviations | Same |
| ElectromagneticCompatibility Testing | Passed IEC 60601-1-2:2007 | Passed IEC 60601-1-2:2007 | Same |
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Table 2 - Clinical Information
| Study | Description |
|---|---|
| Study 1 | Single center, open-label, non-comparative, non-randomized, prospectivestudy of patients with hemiplegia due to strokeDuration of Intervention• Mean of 3 sessions (range 1 to 9)54 subjects total• Mean time since injury 25.1 days (range of 5 to 146 days)• 41 ischemic, 13 hemorrhagic• 4 moderate, 50 severe• 34 had affected upper extremity (UE) motor function of less than 4/5 in one arm (95 walking sessions)• 19 (56%) of these had UE motor function of 0 (59 walking sessions)• 2 (6%) of these had UE motor function 0/2 (3 walking sessions)• 2 (6%) of these had UE motor function 0/3 (5 walking sessions)• 2 (6%) of these had UE motor function 2/2+ (4 walking sessions)• 1 (3%) of these had UE motor function 2/3 (3 walking sessions)• 8 (24%) of these had UE motor function 3-/3+ (21 walking |
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| sessions) | |
|---|---|
| 38% (13/34) of these were female 74% (25/34) of these suffered an ischemic stroke 97% (33/34) of these had a severe stroke | |
| 1 patient had affected upper extremity motor function of 4/5 (3 walking sessions) | |
| 19 patients were not recorded in upper extremity motor function 16 of these used a cane or an arm sling (62 walking sessions) 19% (3/16) of these were female 63% (10/16) of these suffered an ischemic stroke 88% (14/16) of these had a severe stroke | |
| Results | |
| 50 patients (93%) safely performed ambulatory functions with only one arm to maintain stability There were no falls or other adverse events reported | |
| Study 2 | Single center, prospective, two-arm study of patients with hemiplegia due to stroke |
| Duration of Intervention | |
| 6 subjects had between 25 and 27 sessions (Arm 1) 2 subjects had 18 sessions (Arm 2) | |
| 8 subjects total | |
| Mean time since injury 601 days (range of 333 to 1550 days) 7 ischemic, 1 hemorrhagic All limited household ambulators at recruitment 7 used a cane or an arm sling (121 walking sessions) 7 used a cane (120 walking sessions) 3 used an arm sling with a cane (45 walking sessions) 1 used an arm sling with a walker (1 walking session) |
- 100% (7/7) of these suffered an ischemic stroke
Results
- . 7 patients (88%) safely performed ambulatory functions with only one arm to maintain stability
- There were no falls or other adverse events reported
The data summarized above includes a total of 216 walking sessions in which 57 patients with hemiplegia due to stroke performed ambulatory functions in the Ekso device using only one arm to control the assistive device. The direct evidence demonstrates that 34 patients safely performed ambulatory functions with UE motor function of at least 4/5 in only one arm. The indirect evidence documents that regardless of upper extremity motor function, 23 patients were able to safely perform ambulatory functions in the Ekso device using only one arm to control the assistive device. The ability of such patients to support themselves and recover from a stumble is equivalent to that of a patient who has upper extremity strength of at least 4/5 in only one arm.
In sum, the data submitted for this population is representative of the ability of stroke patients with upper extremity strength of at least 4/5 in only one arm to maintain stability using an assistive device. The lack of adverse events over 216 walking sessions in 57 patients demonstrates the safety and
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effectiveness of the Ekso device in individuals with hemiplegia due to stroke with upper extremity motor function of at least 4/5 in at least one arm.
Training
The Ekso provides various dynamic programming options that enable the physical therapist to customize sessions for patients based on a wide array of clinical presentations. To ensure safe operation, certification training is required before a therapist may use the Ekso.
To optimize the integration of the technology, certification training takes place in two phases. The training program is offered for up to 4 therapists from each facility with each Ekso purchased.
Phase 1 – Initial Training Week
The first phase is a full week of training for each therapist on the basic feature set of the Ekso. During training a therapist will become competent to:
- Screen, evaluate, and measure Patients
- Setup the Ekso
- Fit the Ekso to the Patient ●
- Use the Safety Checklist
- Select and use the operating mode appropriate for the patient
- Safely guard and cue patient during operation of the Ekso
- Use the LCD Controller
- . Perform after secession physical checks
When a therapist is determined to be at Level 1 by the Ekso Bionics Clinical Training Team, it means the therapist has demonstrated the competence to safely operate the Ekso when working with another therapist at Level 1 (or higher).
At Level 1, a therapist does not direct any other staff or team member to aid in operation of the Ekso. Two therapists are required to do the following.
- . screening appropriate patients for using the Ekso
- administering a walking session
- selecting appropriate programming
- managing emergency situations.
lt is important for therapists at Level 1 to continue using the Ekso after the initial training week to build their skills and be prepared for the second phase of training. It is recommended that they achieve the following prior to beginning phase 2.
- Perform 3-5 new patient evaluations and screenings for use of the Ekso
- Adjust the Ekso hardware and software for 15 to 20 Ekso walking sessions
- Manage 15 to 20 walking sessions in the Ekso with both new and recurring patients,
- Don and Doff the Ekso for 10 to 15 patient sessions
- Manage Ekso safety features (requires a variable number of sessions)
Phase 2 – Advanced Features
The Ekso Bionics Training Team returns to complete the second phase of training after a period of continued use of the Ekso by therapists at Level 1. Phase two training lasts 2-3 days and incorporates the remaining features of Ekso, and expands the possibilities for clinical use.
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To progress from Level 1 to Level 2, a therapist must demonstrate the following mastery safely and independently.
- evaluating and screening appropriate persons for use of the Ekso
- directing all aspects of Ekso operation to support personnel
- device operation and selection of appropriate programming for an Ekso walking session
- . managing emergency situations
At Level 2, a therapist independently operates the Ekso with support personnel of his or her choice, and is fully responsible for directing and running all aspects of the Ekso walking session. Level 2 Ekso therapists are also able to delegate appropriate (high level) patients to support personnel that they supervise and train on proper Ekso operation/spotting.
Statement of Substantial Equivalence
Based on the clinical data and training described above, the Ekso has been demonstrated to be appropriate for its intended use and is considered to be substantially equivalent to the predicate device.
§ 890.3480 Powered lower extremity exoskeleton.
(a)
Identification. A powered lower extremity exoskeleton is a prescription device that is composed of an external, powered, motorized orthosis that is placed over a person's paralyzed or weakened limbs for medical purposes.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Elements of the device materials that may contact the patient must be demonstrated to be biocompatible.
(2) Appropriate analysis/testing must validate electromagnetic compatibility/interference (EMC/EMI), electrical safety, thermal safety, mechanical safety, battery performance and safety, and wireless performance, if applicable.
(3) Appropriate software verification, validation, and hazard analysis must be performed.
(4) Design characteristics must ensure geometry and materials composition are consistent with intended use.
(5) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Performance testing must include:
(i) Mechanical bench testing (including durability testing) to demonstrate that the device will withstand forces, conditions, and environments encountered during use;
(ii) Simulated use testing (
i.e., cyclic loading testing) to demonstrate performance of device commands and safeguard under worst case conditions and after durability testing;(iii) Verification and validation of manual override controls are necessary, if present;
(iv) The accuracy of device features and safeguards; and
(v) Device functionality in terms of flame retardant materials, liquid/particle ingress prevention, sensor and actuator performance, and motor performance.
(6) Clinical testing must demonstrate a reasonable assurance of safe and effective use and capture any adverse events observed during clinical use when used under the proposed conditions of use, which must include considerations for:
(i) Level of supervision necessary, and
(ii) Environment of use (
e.g., indoors and/or outdoors) including obstacles and terrain representative of the intended use environment.(7) A training program must be included with sufficient educational elements so that upon completion of training program, the clinician, user, and companion can:
(i) Identify the safe environments for device use,
(ii) Use all safety features of device, and
(iii) Operate the device in simulated or actual use environments representative of indicated environments and use.
(8) Labeling for the Physician and User must include the following:
(i) Appropriate instructions, warning, cautions, limitations, and information related to the necessary safeguards of the device, including warning against activities and environments that may put the user at greater risk.
(ii) Specific instructions and the clinical training needed for the safe use of the device, which includes:
(A) Instructions on assembling the device in all available configurations;
(B) Instructions on fitting the patient;
(C) Instructions and explanations of all available programs and how to program the device;
(D) Instructions and explanation of all controls, input, and outputs;
(E) Instructions on all available modes or states of the device;
(F) Instructions on all safety features of the device; and
(G) Instructions for properly maintaining the device.
(iii) Information on the patient population for which the device has been demonstrated to have a reasonable assurance of safety and effectiveness.
(iv) Pertinent non-clinical testing information (
e.g., EMC, battery longevity).(v) A detailed summary of the clinical testing including:
(A) Adverse events encountered under use conditions,
(B) Summary of study outcomes and endpoints, and
(C) Information pertinent to use of the device including the conditions under which the device was studied (
e.g., level of supervision or assistance, and environment of use (e.g., indoors and/or outdoors) including obstacles and terrain).