The Keeogo is robotic exoskeleton that fits orthotically on the user's waist, thigh, and shin, outside of clothing. The device is intended to help assist ambulatory function in rehabilitation settings under the supervision of a trained healthcare professional for the following population:

Individuals with stroke who have gait deficient hip (MMT Hip >= 3) and knee strength (MMT Knee >= 2) and who are capable of standing and initiating gait movement without assistance.

The trained healthcare professional must successfully complete a training program prior to fitting and tuning the device. The device is not intended for sports.

Device Description

KeeogoTM Dermoskeleton System is an ambulatory assistive device that is fitted to the lower body, and is powered at the knee. This computer-controlled orthosis provides complementary force to the knee joint to assist with: (1) knee flexion and extension in the swing phase of gait, and (2) eccentric knee control and extension in the weight bearing phase.

KeeogoTM Dermoskeleton System does not move through a pre-determined pattern of movement, but rather integrates seamlessly with movements initiated by the user themselves, and provides assistance based on the detected activity.

AI/ML Overview

Here's an analysis of the acceptance criteria and study detailed in the provided document, addressing each of your requested points:

The provided text describes the B-Temia Inc. Keeogo Dermoskeleton System, a robotic exoskeleton intended to assist ambulatory function in rehabilitation settings for individuals with stroke. The submission focuses on demonstrating substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in the traditional sense of pre-defined quantitative thresholds for clinical performance that the device must meet to be approved. Instead, it presents the results of a clinical trial designed to show improvement with the device, which implicitly served as evidence for effectiveness.

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance
Safety	No Serious Adverse Events	No Serious Adverse Events reported for participant or physical therapist/clinician.
Effectiveness (Gait)	Statistically significant improvement in Wisconsin Gait Scale (WGS)	Participant group showed a statistically significant improvement in WGS (p < 0.001) with the use of Keeogo. Improvement: 2.60 (1.71) (95% CI: 2.60 ± 0.55). Minimum Clinically Important Difference (MCID) for WGS is 2.25. The observed improvement of 2.60 exceeds the MCID.
Overall Effectiveness	Improvement in at least one effectiveness assessment for all participants, and improvement in >50% of effectiveness assessments for 75% of participants.	All participants showed improvement with one effectiveness assessment (WGS, 30SCT, TST-up, TST-down, ClinRO, PRO). Seventy-five percent showed an improvement with more than 50% of the effectiveness assessments.

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

Sample Size for Effectiveness Population: 48 subjects
Sample Size for Safety Population: 55 subjects
Data Provenance: Prospective. The study mentions "Trial Sites" which are:
- The Shirley Ryan AbilityLab (Chicago, Illinois, USA)
- Human Performance and Engineering Research (HPER) (West Orange, New Jersey, USA)
- James J Peters VA Medical Center - Center for the Medical Consequences of Spinal Cord Injury (Bronx, New York, USA)
- Assistive Technology Clinic (ATC) (Toronto, Ontario, Canada)
  Therefore, the data provenance includes both USA and Canada.

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

The document does not specify the number of experts used or their qualifications for establishing the ground truth measurements (e.g., Wisconsin Gait Scale scores, MMT scores). These are typically assessed by trained clinicians or researchers as part of standard clinical practice or research protocols. While "trained healthcare professional" is mentioned for device supervision, it doesn't detail the assessors of the outcome measures.

4. Adjudication Method for the Test Set:

The document does not specify any adjudication method for the test set. Clinical outcome assessments like the Wisconsin Gait Scale are typically performed by a single trained assessor at each site.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study design is typically used for diagnostic devices where multiple readers interpret images or data. The Keeogo is a therapeutic/assistive device, and the study was focused on its direct impact on patient gait, not on reader interpretation. Therefore, there's no mention of effect size of human readers improving with/without AI assistance.

6. Standalone Performance:

Yes, a standalone performance was done, in the sense that the clinical trial evaluated the performance of the device when used by participants (i.e., with human-in-the-loop) but the "performance" here refers to the patient's functional improvement. The device itself (the "algorithm only") operates in real-time to assist the user's movements based on detected activity, but its "performance" is inherently linked to the human using it. The study assesses the combined human-device system's effectiveness.

7. Type of Ground Truth Used:

The ground truth for effectiveness was established using clinical outcome assessments administered by trained personnel. Specifically, the primary outcome mentioned is the Wisconsin Gait Scale (WGS), which is a scalar measure of gait quality. Other assessments included "30SCT, TST-up, TST-down, ClinRO, PRO." The MMT (Manual Muscle Test) scores for hip and knee strength were used as inclusion criteria. Safety ground truth was based on the reporting of adverse events.

8. Sample Size for the Training Set:

The document does not mention a separate training set or its sample size for the device's algorithm. The "Training Program" described refers to the training for clinicians on how to use the device, not a data set used to train an AI model within the device. For powered exoskeletons, the "training" of the device typically happens through development and testing of its control algorithms rather than a distinct "training set" of patient data in the way a diagnostic AI would have. The mechanism described for the device is that it "does not move through a pre-determined pattern of movement, but rather integrates seamlessly with movements initiated by the user themselves, and provides assistance based on the detected activity." This implies a reactive control system, not a predictive AI model trained on a large dataset of patient movements.

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

As there is no explicit "training set" for the device's algorithm mentioned (it appears to be a reactive control system assisting human-initiated movements, rather than a predictive AI), the concept of "ground truth for the training set" as it applies to AI/ML models is not directly applicable here. The device's "training" would be through engineering design and validation of its control logic.

Summary

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September 09, 2020

B-Temia Inc. % Kristin Davenport Of Counsel Covington & Burling LLP 850 10th St NW Washington, DC 20001

Re: K201539

Trade/Device Name: Keeogo Dermoskeleton System Regulation Number: 21 CFR 890.3480 Regulation Name: Powered Lower Extremity Exoskeleton Regulatory Class: Class II Product Code: PHL Dated: May 31, 2020 Received: June 9, 2020

Dear Kristin Davenport:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-

542 of the Act); 21 CFR 1000-1050.

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

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

Sincerely.

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

Enclosure

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Indications for Use

510(k) Number (if known) K201539

Device Name Keeogo Dermoskeleton System

Indications for Use (Describe)

Individuals with stroke who have gait deficient hip (MMT Hip ≥ 3) and knee strength (MMT Knee ≥ 2) and who are capable of standing and initiating gait movement without assistance.

The trained healthcare professional must successfully complete a training program prior to fitting and tuning the device. The device is not intended for sports.

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

GeneralInformation:	Sponsor's Name:	B-Temia, Inc.
	Address:	4780, rue St-Félix - unité 105St-Augustin-de-Desmaures (QC) G3A 2J9Canada
	Contact Person:	Alexandre JokicVP Regulatory, Clinical Affairs and QualityAssurance, B-Temia Inc.
	Address:	4780, rue St-Félix - unité 105St-Augustin-de-Desmaures (QC) G3A 2J9Canada
	Telephone:	418-653-1010 ext. 248
	Fax Number:	418 653-0155
	Date Prepared:	May 31, 2020
Subject Device:	Trade Name:	Keeogo™ Dermoskeleton System
	Common Name:	Powered Exoskeleton
	Product Code:	PHL
	FDA Regulation:	21 CFR 890.3480 Powered lower extremityexoskeletons
	Device Classification:	Class II
Predicate Device:	Trade Name:	Honda Walking Assist Device
	Common Name:	Powered Exoskeleton
	Product Code:	PHL
	FDA Regulation:	21 CFR 890.3480 Powered lower extremityexoskeletons
	Device Classification:	Class II
	Premarket Notification:	K181294
Indications forUse:	The Keeogo™ Dermoskeleton System is robotic exoskeleton that fitsorthotically on the user's waist, thigh, and shin, outside of clothing. Thedevice is intended to help assist ambulatory function in rehabilitationsettings under the supervision of a trained healthcare professional for thefollowing population:Individuals with stroke who have gait deficits and sufficient hip(MMT Hip $≥$ 3) and knee strength (MMT Knee $≥$ 2) and who are capableof standing and initiating gait movement without assistance.
Description ofdevice:	KeeogoTM Dermoskeleton System is an ambulatory assistive device that isfitted to the lower body, and is powered at the knee. This computer-controlled orthosis provides complementary force to the knee joint toassist with: (1) knee flexion and extension in the swing phase of gait, and(2) eccentric knee control and extension in the weight bearing phase.
	KeeogoTM Dermoskeleton System does not move through a pre-determined pattern of movement, but rather integrates seamlessly withmovements initiated by the user themselves, and provides assistance basedon the detected activity.

The trained healthcare professional must successfully complete a training program prior to fitting and tuning the device. The device is not intended for sports.

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Several performance tests were conducted with the Keeogo™ Non-Clinical Performance Data Dermoskeleton System to demonstrate safety, effectiveness, and usability: Add here

Durability
Vibration IEC 60601-1-11
Electrical Safety IEC . 60601-1
. Electromagnetic Compatibility (EMC) IEC 60601-1-2
. Usability IEC 62366
. Battery Safety IEC 62133:2012
. Sensor accuracy
. Biocompatibility testing in accordance with ISO 10993-1:2009, ISO 10993-5 & ISO 10993-10)

TrialRegistration	URL: http://www.clinicaltrials.govIdentifier: NCT03986320
Trial Design	Interventional, comparative, single-arm trial
Trial Sites	• The Shirley Ryan AbilityLab (Chicago, Illinois, USA)
	• Human Performance and Engineering Research(HPER) (West Orange, New Jersey, USA)
	• James J Peters VA Medical Center - Center for theMedical Consequences of Spinal Cord Injury (Bronx,New York, USA)
	• Assistive Technology Clinic (ATC) (Toronto, Ontario,Canada)

Condition	Stroke
Test Groups	Keeogo – Intervention
Intervention	• Week 1: 3 baseline sessions• Week 2: 3 device familiarization sessions• Week 3: 3 Keeogo testing sessions
Total Subjects	Population	Safety PopulationVisit 1	EffectivenessPopulation
	N	55	48
	Age	$58 \pm 11$	$58 \pm 11$

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	Gender	26 female, 29male	23 female, 25male
	Hemiparesis	25 left-side, 30right-side	23 left-side, 25right-side
	StrokeLegacy	$70 \pm 81$ months	$74 \pm 84$ months
		Hip: MMT ≥ 3+(flexors &extensors),	Hip: MMT ≥ 3+(flexors &extensors),
	MMT	Knee: MMT ≥ 2(flexors &extensors)	Knee: MMT ≥ 2(flexors &extensors)
ClinicalOutcomeAssessments		● Baseline (each of three baseline test visits)
		● Intervention (each of three device test visits)
		● Post (after 9 visits)
Results		Gait Quality Assessment, Wisconsin Gait Scale
		Units: scalar
		Scale Range: [13.35, 42] = [healthy gait, max gaitdisability]
		Mean (SD)
		Baseline: 20.36 (3.22)
		Gait with Device: 17.76 (2.54)
	Change from Baseline (Paired test)
	Minimum Clinically Important Difference: 2.25
	Improvement: 2.60 (1.71)
	95% Confidence interval for Improvement: $2.60 \pm$ 0.55
	Significance: P-Value = p < 0.001
	Safety results:
	No Serious Adverse Event was reported either for the
	participant (primary outcome) or physical therapist /
	clinician (secondary outcome).
	Effectiveness results:
	Participant group showed a statistically significant
	improvement in the WGS (secondary outcome) with the
	use of the Keeogo™ (p < 0.001)
	All the participants showed an improvement with one
	effectiveness assessment (WGS, 30SCT, TST-up, TST-
	down, ClinRO, PRO; assessments described under
	secondary and tertiary outcomes). Seventy-five percent
	showed an improvement with more than 50% of the
	effectiveness assessments.

Substantial Equivalence

CATEGORY	KEEOGO™	HONDA WALKINGASSIST DEVICE (HWA)	Substantial EquivalenceComments
510(k) Number	TBA	K181294	N/A
Product Code	PHL	PHL	[SAME]
CATEGORY	KEEOGOTM	HONDA WALKINGASSIST DEVICE (HWA)	Substantial EquivalenceComments
Sub-Product Code	N/A	N/A	[SAME]
Regulation Name	Powered LowerExtremity Exoskeleton	Powered LowerExtremity Exoskeleton	[SAME]
Device Class	Class II	Class II	[SAME]
Regulation	21 CFR 890.3480	21 CFR 890.3480	[SAME]
Indications for Use	The KeeogoDermoskeleton Systemis a robotic exoskeletonthat fits orthotically onthe user's waist, thigh,and shin, outside ofclothing. The device isintended to help assistambulatory function inrehabilitation settingsunder the supervision ofa trained healthcareprofessional for thefollowing population:Individuals with strokewho have gait deficitsand sufficient hip (MMTHip $\geq$ 3) and kneestrength (MMT Knee $\geq$2) and who are capableof standing and initiatinggait movement withoutassistance.The trained healthcareprofessional mustsuccessfully complete atraining program prior tofitting and tuning thedevice. The device is notintended for sports	The Honda WalkingAssist Device is arobotic exoskeleton thatfits orthotically on theuser's waist and thigh,outside of clothing. Thedevice is intended tohelp assist ambulatoryfunction in rehabilitationinstitutes under thesupervision of a trainedhealthcare professionalfor the followingpopulation:Individuals with strokewho have gait deficitsand exhibit gait speedsof at least 0.4m/s and areable to walk at least 10meters with assistancefrom a maximum of oneperson.The trained healthcareprofessional mustsuccessfully complete atraining program prior touse of the device. Thedevices are not intendedfor sports.	[SIMILAR]- The patient populationis the same- The Keeogo indicationdefines the necessaryphysical characteristicsof the patient populationin terms of minimumhip and knee strength,while the predicatedescribes the patientcharacteristics in termsof minimum gait speed- Hip and knee strengthcorrelate to gait speed,as supported by datareported in literature- The difference in howminimum physicalcharacteristics aredescribed anddetermined does notraise different questionsof safety oreffectiveness
CATEGORY	KEEOGO™	HONDA WALKINGASSIST DEVICE (HWA)	Substantial EquivalenceComments
Device Weight	15 lbs (6.8 kg)	5.95 lbs (2.7 kg)	[SIMILAR]- Difference in weight isdue to the Keeogo'sdesign (covers areabetween hip and shin)compared to thepredicate that covers thearea between the hipand above the knee.This difference inweight does not raisedifferent questions ofsafety or effectiveness
Body Coverage andArea of Assistance	Worn around the waist& legs; assistanceprovided to knee joint	Worn around the waist& thighs; assistanceprovided at hip	[SIMILAR]- As described above, theKeeogo covers the areabetween the hip andshin and providesassistance at the knee.The Honda devicecovers the area betweenhip and above the kneeand provides assistanceat the hip.- The differences in bodycoverage and area towhich assistance isapplied do not raisedifferent questions ofsafety or effectiveness
Mobility Aid	Optional (e.g., walker,cane)	Optional (e.g., walker,cane)	[SAME]
Patient Population	• Individuals withstroke who have gaitdeficits and sufficienthip (MMT Hip $\geq$ 3) andknee strength (MMTKnee $\geq$ 2) and who arecapable of standing andinitiating gait movementwithout assistance.	• Individuals withstroke who have gaitdeficits and exhibit gaitspeeds of at least 0.4m/sand are able to walk atleast 10 meters withassistance from amaximum of one person.	[SAME]- The patient populationis the same, i.e.,individuals with strokewho have gait deficits- The difference in howminimum physical usercharacteristics aredescribed and measureddoes not raise differentquestions of safety oreffectiveness
Device limit onuser's gait speed	None	None	[SAME]
Type of Surface forTraining	Smooth, cement, carpet	Smooth, cement, carpet	[SAME]
CATEGORY	KEEOGO™	HONDA WALKINGASSIST DEVICE (HWA)	Substantial EquivalenceComments
Device Range ofMotion (ROM)	Hips: 150° flexion to 40° extension Knee: 166° flexion to 4° extension	- Hips: 113° flexion to47° extension	[SIMILAR]- Keeogo hip joint ROMis comparable topredicate- Keeogo also has a kneeROM because itprovides assistance atthe knee- Minor differences in hipROM, and additionalknee ROM, do not raisedifferent questions ofsafety or effectiveness
	User HeightRequirement	1.52 m to 1.88 m (~60in to ~74 in)	1.4 m to 2.0 m (~55 into ~79 in)	[SIMILAR]- This minor differencedoes not raise differentquestions of safety oreffectiveness
	User WeightRequirement	≤285 lbs (130 kg)	≤220 lbs (100 kg)	[SIMILAR]- Keeogo is designed toaccommodate up to the95th percentile of adultmen- This minor difference inuser weight does notraise different questionsof safety oreffectiveness
Battery Specifications	- Rechargeable Li-Ion- 39.6 V, 1 A-h- 1 hr continuousoperation- 1 hr charge time	- Rechargeable Li-Ion- 22.2 V, 1 A-h- 1 hr continuousoperation- 2 hr charge time	[SIMILAR]- The minor differencesin battery specifications(voltage and chargetime) do not raisedifferent questions ofsafety or effectiveness
CATEGORY	KEEOGO™	HONDA WALKINGASSIST DEVICE (HWA)	Substantial EquivalenceComments
ActuatorSpecifications	- 2 motors (2 at knee)- Up to 40 Nm maxtorque	- 2 motors (2 at hip)- 4 Nm max torque	[SIMILAR]- Keeogo motors arelocated at the knees,whereas the predicatemotors are located at thehip- Higher torque isrequired at the knee to
			support knees fromcollapsing- This difference does notraise different questionsof safety oreffectiveness
Control Method	- Handheld controllerattached to device- Keeogo does notinitiate steps	- Handheld interface forphysical therapist- HWA does not initiatesteps	[SAME]
Life Cycle	3 years	3 years	[SAME]
Training Program	Yes	Yes	[SAME]
CertificationProgram	Yes	Yes	[SAME]
Device Feedback tothe User	Auditory feedback onthe handheld controllerthat is attached todevice. Visual feedbackis provided on thebattery to indicate thebattery status andcharge level.	Visual & auditoryfeedback on both thehandheld controller &device.	[SAME]
Fall Detection &Mitigation	None	None	[SAME]
Failsafe Features	Motor torque disables;device becomes passive	Motor torque disables;device becomes passive	[SAME]
OperatingTemperature	32 °F to 86 °F(0 °C to 30 °C)	32 °F to 86 °F(0 °C to 30 °C)	[SAME]
Operating Humidity	15% to 90%	30% to 85%	[SIMILAR]- Keeogo has a slightlylarger humidity range,per 60601-1-11- This does not raisedifferent questions ofsafety or effectiveness

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Trainingcertification	Keeogo is an adjustable exoskeleton that allows fitting of the device tothe user's body dimensions and adjustment of the software settings tomeet the user's needs. A mobile application, which runs on a touchscreentablet, allows the clinician to adjust the software settings during deviceinstallation to customize the level of assistance to the individual patient'sneed.
	To ensure safe and effective use, clinicians are required to complete atraining program and obtain a certification prior to using the device withpatients. The 15-18 hours training course is divided into 4 blocks,resulting in a certification test. The training activities allow clinicians tobecome familiar with the device and provide training on the following:
••••••	Screen and evaluate patients for use of KeeogoConfigure the device hardware and software settings use withpatientsPractice training sessions with KeeogoDemonstrate understanding of safety features, device controls,intended use, and patient training proceduresUnderstand Keeogo maintenanceBecome familiar with resources for technical support
Statement onSubstantialEquivalence:	The Keeogo System has the same intended use as the predicate HondaWalking Assist Device. The differences in technological characteristicsbetween the Keeogo and the predicate do not raise new questions ofsafety or effectiveness. The data submitted in the 510(k) show that theKeeogo is at least as safe and effective as the Honda Walking Assist

Regulation Number and Section

§ 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).