(153 days)
Atalante X is intended to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation institutions under the supervision of a trained operator for the following populations:
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Individuals with hemiplegia due to cerebrovascular accident (CVA).
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Individuals with spinal cord injuries at levels T5 to L5 (SCI).
The operator must complete a training program prior to use of the device.
Atalante X is intended to be used on adolescents of 18 years and older, and adults able to tolerate a stand-up position. The device is not intended for sports or stair climbing.
Atalante X is a completely self-balancing walking system for people with mobility disabilities. It is a fully powered hip-knee-ankle lower body exoskeleton with 12 actuated degrees of freedom. Atalante X is selfbalancing and includes dynamic-walking control. Dynamic-walking allows the Atalante X to consume significantly less power and have a more natural gait.
The provided text describes the Wandercraft SAS Atalante X, a powered lower extremity exoskeleton. The document is an FDA 510(k) premarket notification. It does not contain information about the acceptance criteria or a specific study proving the device meets those criteria, as typically found in a clinical study report. Instead, it focuses on demonstrating substantial equivalence to predicate devices through a comparison of characteristics and non-clinical/clinical performance data.
Therefore, many of the requested details about acceptance criteria, specific study design for ground truth, sample sizes for test/training sets, adjudication methods, and MRMC studies are not available in the provided document.
However, based on the information available, a summary of the performance demonstration is provided below, focusing on what can be extracted.
Table of Acceptance Criteria (Inferred from Performance Data) and Reported Device Performance
Since explicit acceptance criteria are not stated, the "acceptance criteria" are inferred from the safety and effectiveness claims made and the reported outcomes.
| Acceptance Criteria (Inferred) | Reported Device Performance (Atalante X) |
|---|---|
| Safe operation (general) | Passed all non-clinical safety tests (Cytotoxicity, Irritation, Sensitization, Electrical safety, EMC, Software V&V, System V&V, Electronics V&V, Mechanics V&V, Cycling, Thermal, Useful Life, Transportation). |
| Effective in enabling ambulatory functions and mobility exercises for SCI patients at levels T5-L5. | The device could ensure ambulatory functions with comparable speed to that of the predicates while leaving upper limbs free for additional tasks. |
| Acceptable adverse event rate | 24 adverse events in two clinical studies (majority minor skin lesions, one nausea, one incontinence). None serious. |
Study Details
Detailed aspects of the clinical studies are limited in this summary.
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Sample size used for the test set and data provenance:
- Test Set (Clinical Studies): 21 patients with spinal cord injury (SCI) across two clinical studies.
- Data Provenance: Not specified (e.g., country of origin). The document mentions "real world evidence of use." It is implied to be prospective for the two clinical studies.
- Real-world evidence: Over 481 patients, including 40 SCI patients at levels C3-L3, who performed 3 or more sessions. This broader "real-world" data is mentioned to support findings, not as a primary "test set" with a pre-defined ground truth assessment for evaluation.
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Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- Not specified. The clinical studies would likely have involved trained clinical staff to assess patient performance and adverse events, but the number and qualifications are not detailed. The device is intended to be used under the supervision of a "trained operator."
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Adjudication method for the test set:
- Not specified.
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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 device is an exoskeleton, not an imaging AI diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A (not directly applicable in the same sense as an AI diagnostic tool). The device itself is the "algorithm only" in terms of its automated function (dynamic-walking control). The performance claims relate to the device operating in its intended environment with human supervision. The "comparable speed to that of the predicates" is a standalone performance metric for the exoskeleton's function.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the clinical studies, the "ground truth" would be related to clinical measures of ambulatory function (e.g., ability to perform tasks, speed, mobility exercises) and safety events (e.g., skin lesions, other adverse events). These are clinical observations and patient outcomes, likely assessed by clinicians or trained operators.
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The sample size for the training set:
- Not specified. The document mentions "Wandercraft Customer Care" visits and a "training program" for operators, but this "training set" refers to personnel training, not machine learning model training data. The device's control algorithms (dynamic-walking control) are developed through engineering and likely extensive non-clinical testing and internal validation, but a "training set" in the machine learning sense is not explicitly discussed as part of this submission summary.
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How the ground truth for the training set was established:
- Not specified. As above, a traditional "training set" with ground truth in the context of machine learning is not detailed. The device's functionality is based on its mechanical and software design, which would be validated against engineering specifications and performance targets rather than a specific ground truth dataset for training a learning algorithm described in this document.
§ 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).