(66 days)
The EksoNR™ is intended to perform ambulatory functions in rehabilitations under the supervision of a trained physical therapist for the following populations:
· Individuals with multiple sclerosis (upper extremity motor function of at least one arm).
• Individuals with acquired brain injury, including traumatic brain injury and 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 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 provided text, extracting information related to acceptance criteria and the study proving the device meets them. Please note that the document is a 510(k) summary for a medical device (exoskeleton), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a formal "acceptance criteria" table as might be seen for an AI/ML diagnostic tool. Therefore, some requested information may not be directly available or applicable in the provided context.
Overview:
The document clears the EksoNR powered lower extremity exoskeleton. The primary purpose of this 510(k) submission (K220988) is to expand the indications for use of the already cleared EksoNR (predicate device K200574) to include individuals with multiple sclerosis (MS). The device itself is essentially unchanged from the predicate.
Acceptance Criteria and Device Performance
Given this is a 510(k) for an updated indication for an existing medical device (exoskeleton) rather than an AI/ML diagnostic, the concept of "acceptance criteria" isn't framed as statistical thresholds for sensitivity/specificity. Instead, the acceptance criteria are implicitly that the device is safe and effective for the expanded population, demonstrating gait ambulation effectiveness and no new safety concerns in the specified population, thus maintaining substantial equivalence to the predicate.
Table of Acceptance Criteria (Implicit) and Reported Device Performance:
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Safety: Device is safe for the expanded MS population (no new adverse events). | ADEMBI MS Study: "There were no falls or other adverse events reported."Kessler MS Study: "There were no falls or other adverse events reported."Overall Conclusion: "The clinical data reported no adverse events demonstrating the device is safe on this patient population when used in accordance with existing labeling." |
| Effectiveness: Device effectively facilitates gait ambulation in the expanded MS population. | ADEMBI MS Study (n=17-18):- TUG scores improved significantly: from 24s at baseline to 20.61s at completion of all Ekso sessions.- Average walking speed maintained: from 0.69m/s at baseline to 0.66m/s at completion of all Ekso sessions.- Average cognitive MOCA scores improved slightly.Kessler MS Study (n=8):- TUG scores improved significantly: from 16.99s at baseline to 14.15s at completion of all Ekso sessions.- Average walking speed maintained: from 10.37s at baseline to 10.63s at completion of all Ekso sessions (note: units here are stated as 's' which is unusual for speed, likely a typo and referring to time for a specific distance or a different test. See 6MWT below).- Symbol digit modalities test (cognition) improved.- 6 minute walk test (6MWT) distance increased: from 279.65m to 294.69m.- Average functional reach test distance increased.Overall Conclusion: "The supporting clinical data demonstrating the use of the product with patients with multiple sclerosis (MS), show that the device effectively facilitates gait ambulation in the expanded patient population." |
| Substantial Equivalence: Device remains substantially equivalent to the predicate (K200574). | "This device and the previously cleared (predicate) device (K200574) are essentially the same products.""The device is essentially unchanged from the current (predicate) device.""The indications for use are identical to that of the predicate device, with the addition of the following: Individuals with multiple sclerosis...""When used as instructed, the device is as safe to use with a broader population of patients with neurological conditions to include the already cleared ABI and SCI population and this new MS population." |
Study Details
-
Sample sizes used for the test set and the data provenance:
- Test Sets:
- ADEMBI MS Study: 18 subjects total used the Ekso. (n=17 for TUG post-testing, n=18 for others).
- Kessler MS Study: 9 subjects total used the Ekso. (n=8 for pre/post testing).
- Data Provenance: Not explicitly stated regarding country of origin, but described as "Single center, prospective parallel-assignment, single-blinded, randomized controlled study" for ADEMBI MS and "Single center, randomized study" for Kessler MS. This implies prospective data collection for these specific studies. No specific mention of retrospective vs. prospective is made for the original 7 studies that supported the predicate.
- Test Sets:
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not an AI/ML diagnostic device where ground truth is established by expert readers interpreting images or data. For an exoskeleton, the "ground truth" for effectiveness is whether the patient can ambulate and improve functional scores, as measured by standardized clinical tests (TUG, 6MWT), and the "ground truth" for safety is the absence of adverse events/falls during supervised use.
- The device is used under the supervision of a "trained physical therapist." While not "experts establishing ground truth" in the diagnostic sense, their training and supervision are crucial for the device's safe and effective use and thus for the clinical outcomes.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is a functional device study, not an imaging diagnostic study requiring adjudication of image interpretations for ground truth. Clinical outcomes were measured directly using standardized tests and adverse events were reported.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI-assisted diagnostic tool. No MRMC study was performed or needed. The device (
EksoNR) is the primary intervention.
- Not applicable. This is not an AI-assisted diagnostic tool. No MRMC study was performed or needed. The device (
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a physical exoskeleton designed for human-in-the-loop use under therapist supervision. It does not operate as a standalone algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Outcomes Data: The primary ground truth is established through measured clinical outcomes using validated functional assessment tools (e.g., Timed Up and Go (TUG) test, 6-minute walk test (6MWT), cognitive assessments like MOCA/Symbol Digit Modalities Test) and direct observation/reporting of adverse events (falls). This is outcomes-based evidence of safety and functional improvement.
-
The sample size for the training set:
- Not applicable in the context of device approval for an exoskeleton. This is not an AI/ML algorithm that requires a "training set" in the computational sense. The device itself is "trained" during the manufacturing and design process, and the physical therapists are trained for its use.
-
How the ground truth for the training set was established:
- Not applicable. As above, there is no AI/ML "training set" for this device. The physical therapists are trained users, and their "ground truth" would be established through their professional education, experience, and the specific training program provided for the EksoNR device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 9, 2022
Ekso Bionics, Inc. Michael Glover Global Director of Clinical Experience 1414 Harbour Way South, Suite 1201 Richmond, California 94804
Re: K220988
Trade/Device Name: EksoNR Regulation Number: 21 CFR 890.3480 Regulation Name: Powered Lower Extremity Exoskeleton Regulatory Class: Class II Product Code: PHL Dated: March 31, 2022 Received: April 4, 2022
Dear Michael Glover:
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.
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
{1}------------------------------------------------
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 (OS) 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 mediation-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 Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K220988
Device Name EksoNR
Indications for Use (Describe)
The EksoNR™ is intended to perform ambulatory functions in rehabilitations under the supervision of a trained physical therapist for the following populations:
· Individuals with multiple sclerosis (upper extremity motor function of at least one arm).
• Individuals with acquired brain injury, including traumatic brain injury and 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 devices are not intended for sports or stair 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
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:Scott DavisPresident and COOTel: +1 603-831-2980Email: sdavis@eksobionics.com | |
| Ekso Bionics Tel: +1 (510) 984-1761Ekso Bionics Fax: +1 (510) 927-2647 | |
| Preparation Date | March 29, 2022 |
| Device Name &Classification | Trade Name: EksoNR™Common Name: ExoskeletonClassification Name: Powered ExoskeletonDevice Classification: Class II, 21 CFR 890.3480Product Code: PHL |
| Legally MarketedPredicate Device | K200574, EksoNR, Ekso Bionics, Inc. |
| Device Description | The Ekso is a powered motorized orthosis. It consists of a fitted metalbrace that supports the legs, feet, and torso. It is worn via straps on thebody, legs, and feet. Battery powered motors drive knee and hip joints. Ithas an integrated solid torso containing the computer and power supply. Ithas a hand-held user interface to specify settings and initiate steps. TheEkso is used with a cane, crutch, or walker. |
| Indication for UseStatement | The EksoNR™ is intended to perform ambulatory functions in rehabilitationinstitutions under the supervision of a trained physical therapist for thefollowing populations:• Individuals with multiple sclerosis (upper extremity motor functionof at least 4/5 in at least one arm)• Individuals with acquired brain injury, including traumatic braininjury and stroke (upper extremity motor function of at least 4/5 inat least one arm).• Individuals with spinal cord injuries at levels T4 to L5 (upperextremity motor function of at least 4/5 in both arms).• Individuals with spinal cord injuries at levels of C7 to T3 (ASIA Dwith 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. |
| SubstantialEquivalenceDiscussion | This device and the previously cleared (predicate) device (K200574) areessentially the same products. |
| Differences in Indications for UseThe purpose of this 510(k) is to update the indications for use. Theindications for use are identical to that of the predicate device, with theaddition of the following: | |
| ● Individuals with multiple sclerosis (upper extremity motor functionof at least 4/5 in at least one arm) | |
| The change noted above expands the existing indications to includeindividuals with multiple sclerosis (MS). The intended use of the device isunchanged. For the purposes of this intended use (ambulatoryrehabilitation), patients with MS present similarly, are screened for devicesafety requirements, and are treated in the same way as patients with ABIor SCI. As such, gait ambulation effectiveness of the device is no differentwhen used on patients with MS. When used as instructed, the device is assafe to use with a broader population of patients with neurologicalconditions to include the already cleared ABI and SCI population and thisnew MS population. |
{4}------------------------------------------------
Technical Characteristics
The device is essentially unchanged from the current (predicate) device. All changes since the previous submission fall below the threshold requiring a 510(k) per the FDA's October 25, 2017, " Guidance for Industry and FDA Staff: Deciding When to Submit a 510(k) for a Change to an Existing Device". Even though there is no change, for completeness, the technical characteristics of the device are compared with the current device below.
| Current Device | Current Device | ||
|---|---|---|---|
| Manufacturer | Ekso Bionics®, Inc. | Ekso Bionics®, Inc. | |
| Trade Name | EksoNR™ | EksoNR™ | Differences |
| 510(k) Number | K220988 | K200574 | N/A |
| Product Code | PHL | PHL | Same |
| Regulation Number | 890.3480 | 890.3480 | Same |
| Regulation Name | Powered Exoskeleton | Powered Exoskeleton | Same |
| Body Coverage | Worn over legs and upperbody with rigid torso | Worn over legs and upperbody with rigid torso | Same |
| Size of Components | Adjustable upper leg, lowerleg, and hip width; controlunit integrated into thetorso | Adjustable upper leg, lowerleg, and hip width; controlunit integrated into thetorso | Same |
| Comparison of Technical Characteristics | |||
| Current Device | Current Device | ||
| Manufacturer | Ekso Bionics®, Inc. | Ekso Bionics®, Inc. | |
| Trade Name | EksoNR™ | EksoNR™ | Differences |
| Mobility Aid | Walker, Crutches, Cane | Walker, Crutches, Cane | Same |
| Ability of User Mobility | 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 |
| Height of Patient | ~62″ to 74″ (1.58 m to 1.88m) | ~62″ to 74″ (1.58 m to 1.88m) | Same |
| Weight of Patient | Up to 220 lbs (100kg) | Up to 220 lbs (100kg) | Same |
| Control Method | Handheld interface for PT;weight shift to initiate steps | Handheld interface for PT;weight shift to initiatesteps | Same |
| Range of Motion | Hips: 135° flexion to 20°extensionKnees: 130° flexion to 0°extensionAnkles: 10° flexion to 10°extension | Hips: 135° flexion to 20°extensionKnees: 130° flexion to 0°extensionAnkles: 10° flexion to 10°extension | Same |
| Device Weight | 50 lbs (23 kg) | 50 lbs (23 kg) | Same |
| Rechargeable Battery | Rechargeable lithium ionbatteries 48.1V, 30A peakcurrent, 1 hour ofcontinuous usage percharge | Rechargeable lithium ionbatteries 48.1V, 30A peakcurrent, 1 hour ofcontinuous usage percharge | 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 |
| User Feedback | Provides visual feedback onthe handheld controller andauditory feedback | Provides visual feedback onthe handheld controllerand auditory feedback | Same |
| Fall Detection andMitigation | None | None | Same |
| Failsafe Feature | In event of power failure-knees become locked andhips free (similar to typicalpassive leg braces) | In event of power failure-knees become locked andhips free (similar to typicalpassive leg braces) | Same |
| Current Device | Current Device | ||
| Manufacturer | Ekso Bionics®, Inc. | Ekso Bionics®, Inc. | |
| Trade Name | EksoNR™ | EksoNR™ | Differences |
| Operating Temperature | 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 Safety Testing | IEC 60601-1:2005 with US deviations | IEC 60601-1:2005 with US deviations | Same |
| Electromagnetic Compatibility Testing | Passed IEC 60601-1-2: 2014 | Passed IEC 60601-1-2: 2014 | Same |
Comparison of Technical Characteristics
{5}------------------------------------------------
{6}------------------------------------------------
Clinical Performance Summary
The current device utilized 7 different studies to demonstrate safety and efficacy of the current indications for use (K200574). This submission builds from those 7 studies with 2 additional clinical studies (summarized below) focusing on the specific population added by the expanded indication for use in this submission. These studies demonstrate the device effectively enables gait ambulation, and there were no reported adverse events indicating the device is safe to use with this expanded population.
{7}------------------------------------------------
| Study | Description |
|---|---|
| ADEMBI MS | Single center, prospective parallel-assignment, single-blinded, randomized controlledstudy of patients with multiple sclerosis. Only patients who were randomized toutilize Ekso were included in this submission. |
| Duration of Intervention• Ambulation during a mean of 18.4 sessions per patient (range 13 to 20) | |
| 18 subjects total used the Ekso• Mean time since MS diagnosis: $12.94\pm8.11$ years• 3 were diagnosed with primary progressive MS• 8 were diagnosed with secondary progressive MS• 7 were diagnosed with relapsing remitting MS | |
| Results:For those participants who completed pre and post testing (n=17 for TUG, n=18 forothers) | |
| • TUG scores improved significantly from 24s at baseline to 20.61s atcompletion of all Ekso sessions• Average walking speed was maintained throughout the intervention from0.69m/s at baseline to 0.66m/s at completion of all Ekso sessions• Average cognitive MOCA scores improved slightly from 25.39 at baseline to26.06 at completion of all Ekso sessions• There were no falls or other adverse events reported |
{8}------------------------------------------------
Single center, randomized study of patients with multiple sclerosis. Only patients who Kessler MS were randomized to utilize Ekso were included in this submission.
Duration of Intervention
-
Ambulation during a mean of 7.78 sessions per patient (range 6 to 8) ●
9 subjects total used the Ekso -
1 was diagnosed with secondary progressive MS
-
. 8 were diagnosed with relapsing remitting MS
Results:
For those participants who completed pre and post testing (n=8)
- . TUG scores improved significantly from 16.99s at baseline to 14.15s at completion of all Ekso sessions
- Average walking speed was maintained throughout the intervention from 10.37s at baseline to 10.63s at completion of all Ekso sessions
- Symbol digit modalities test measuring cognition improved from baseline scores of 39.38 to post scores of 45.63
- 6 minute walk test (6MWT) distance increased from 279.65m to 294.69m
- Average functional reach test distance increased from baseline of 9.61cm to 10.46cm at completion of all Ekso sessions
- There were no falls or other adverse events reported
Substantial Equivalence Conclusion
This device is substantially equivalent to the current device has technical characteristics and intended uses listed above to facilitate gait ambulation. The supporting clinical data demonstrating the use of the product with patients with multiple sclerosis (MS), show that the device effectively facilitates gait ambulation in the expanded patient population. The clinical data reported no adverse events demonstrating the device is safe on this patient population when used in accordance with existing labeling.
§ 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).