(114 days)
HAL for Medical Use (Lower Limb Type) orthotically fits to the lower limbs and trunk;
HAL is a gait training device intended to temporarily help improve ambulation upon completion of the HAL gait training intervention. HAL must be used with a Body Weight Support system. HAL is not intended for sports or stair climbing. HAL gait training is intended to be used in conjunction with regular physiotherapy.
The device is intended for individuals with:
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spinal cord injury at levels C4 to L5 (ASIA C, ASIA D) and T11 to L5 (ASIA A with Zones of Partial Preservation, ASIA B);
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post stroke paresis
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paraplegia due to progressive neuromuscular diseases (spinal muscular atrophy, spinal and bulbar muscular atrophy, amyotrophic lateral sclerosis, Charcot-Marie-Tooth disease, distal muscular dystrophy, inclusion body myositis, congenital myopathy, muscular dystrophy) who exhibit sufficient residual motor and movement-related functions of the hip and knee to trigger and control HAL
In preparation for HAL gait training, the controller can be used while the exoskeleton is not donned to provide biofeedback training through the visualization of surface electromyography bioelectrical signals recorded.
HAL is intended to be used inside medical facilities while under trained medical supervision in accordance with the user assessment and training certification program
HAL for Medical Use (Lower Limb Type) is a battery powered lower extremity exoskeleton that provides assistive torque at the knee and hip joints for gait training. HAL is comprised of a controller, a main unit, and sensor shoes. The device comes in 8 size variations (4 different leg lengths and 2 different hip widths) for each of the 3 configuration types (doubleleg, right-leg, and left-leg) and weighs ~14 kg (30 lbs). The device uses legally marketed cutaneous electrodes (up to 18 electrodes) to record surface electromyography bioelectrical signals of the hip and knee extensor and flexor muscles when the device is used in Cybernic Voluntary Control (CVC) mode. This mode provides assistive torque at the corresponding ioint (e.g., hip or knee) using surface electromyography bioelectrical signals that are processed using a propriety signal processing algorithm. The propriety processing algorithm allows the device to detect surface electromyography bioelectrical signals to control the HAL device in CVC mode and provide visualization of the surface electromyography bioelectrical signals during biofeedback training. The assistive torque can be adjusted using three parameters: sensitivity level, torque turner, and balance turner. The device can also provide two additional modes: Cybernic Autonomous Control (CAC) mode and Cybernic Impedance Control (CIC) mode. CAC mode provides assistive torque leg trajectories based on postural cues and sensor shoe measurements. CIC mode provides torque to compensate for frictional resistance of the motor based on joint motion. CIC mode does not provide torque assistance for dictating joint trajectories. A trained medical professional (i.e., physician, physical therapist, etc.) can configure, operate, and monitor the device during gait training to make adjustments as needed.
The provided document is a 510(k) Summary for the HAL for Medical Use (Lower Limb Type) device. It describes the device, its intended use, and substantial equivalence to a predicate device (K171909). The document focuses on demonstrating safety and effectiveness, particularly for new patient populations.
It's important to note that this document is an FDA 510(k) summary, which typically presents summarized findings rather than a detailed breakdown of all study methodologies. Therefore, some specific details for each point requested might not be explicitly stated or might require inference from the provided text.
Here's an analysis of the provided information against your requested points:
Acceptance Criteria and Device Performance
The acceptance criteria are not explicitly stated as distinct numerical targets for each performance metric in a single table. Instead, the document demonstrates meeting acceptance criteria through compliance with recognized standards, successful bench testing, and consistent or improved clinical outcomes compared to baseline or control groups across various studies. The "results" sections for non-clinical and clinical data effectively serve as proof of meeting implicit or explicit acceptance criteria related to safety, functionality, and efficacy.
Table of Acceptance Criteria and Reported Device Performance:
| Category | Acceptance Criteria (Implicit/Explicit) | Reported Device Performance/Results |
|---|---|---|
| Non-Clinical Performance | ||
| Safety Standards Compliance | Conformance with AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62366, IEC 62133, IEC 60335-1, IEC 60335-2-29, ANSI/UL 1012, IEC 62304. | "Subject devices demonstrate conformance with the following recognized standards" (listed above). "Results of all non-clinical testing support the safety and effectiveness of the subject devices." |
| Stopper Strength Test (Durability) | Mechanical stopper endures mechanical force applied by patient and maintains conformance after 100 cycles. | Conformance was maintained after 100 cycles. "The mechanical stopper is expected to endure the impact in the joints." |
| Consecutive Landing Test (Durability) | HAL mechanical/electrical systems withstand repeated impacts for 5-years worth of service life (1,000,000 cycles) without missing parts, cracks, loosening, abnormal noises, etc. | All 3 samples withstood 3,000,000 cycles, with no issues. "it is sufficiently durable." |
| Effective Output Test (Torque/Velocity) | Actuator meets specifications for effective output torque and provides maximum angular velocity within human knee joint tolerance. | Output verified to meet specification and risk management requirements. Angular velocity verified within human tolerance. |
| Driving Parts Performance Test | Actual torque output falls within performance criteria range compared to control algorithm's intended output. | Test results show actual torque output falls within criteria range, meeting expected performance. |
| Joint Angle Measurement (Accuracy) | Accuracy of joint angle sensing meets specification. | "Accuracy of joint angle measurement was verified to meet specification." |
| Body Trunk Absolute Angle Measurement (Accuracy) | Accuracy of body trunk absolute angle sensing allows sufficient detection of stable posture for safety and effectiveness. | Measurement results "can sufficiently detect the stable posture... thus ensuring the safety and effectiveness." |
| Plantar Load Measurement (Accuracy) | Accuracy of plantar load measurement allows sufficient detection of planting/lifting of sole to determine leg phase for safety and effectiveness. | Measurement results "can sufficiently detect the planting and lifting of the sole... thus ensuring the safety and effectiveness." |
| Surface Electromyography Bioelectrical Signal Measurement (Accuracy) | Accuracy of sEMG bioelectrical signal measurement performance meets specifications (input impedance, CMRR, frequency characteristics). | "Accuracy for all measurements were verified to meet specifications." |
| Ankle Durability Test | Ankle parts withstand repeated twisting impacts for 5-years worth of service life (implied ~300,000 impacts for turning movements) without missing parts, cracks, loosening, abnormal noises, etc. | All 3 samples withstood 300,000 impacts, with no issues. "The ankle part of the device is sufficiently durable." |
| Clinical Performance (Effectiveness) | ||
| SCI - Gait Improvement (10MWT speed) | Significant improvement in 10MWT speed. (e.g., from ~0.25-0.28 m/s pre to ~0.50 m/s post) | Reported differences range from +0.22 m/s to +0.25 m/s, or time improvements of 28.99s to 35.23s (faster). "meaningful improvements for SCI patients in terms of walking ability." |
| SCI - Gait Improvement (6MWT distance) | Significant improvement in 6MWT distance. (e.g., from ~70-90m pre to ~140-160m post) | Reported differences range from +22.75m to +93.2m. "meaningful improvements for SCI patients in terms of walking ability." |
| Stroke - Gait Improvement (10MWT speed) | Overall improvement in 10MWT speed, especially in control-inclusive studies or where natural recovery is accounted for. MCID (Minimum Clinically Important Difference) as a benchmark. | Chronic stage: Reported differences up to +0.21 m/s (p |
§ 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).