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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:

• Individuals with hemiplegia due to cerebrovascular accident (CVA).

• 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.

Study Details

Detailed aspects of the clinical studies are limited in this summary.

1. 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.

2. 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."

3. Adjudication method for the test set:

   • Not specified.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

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The Atalante exoskeleton is intended to enable individuals with hemiplegia due to cerebrovascular accident (CVA) to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation under the supervision of a trained operator. The operator must complete a training program prior to use of the device.

The Atalante system 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.

The Atalante 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 is self-balancing and includes dynamic-walking control. Dynamic-walking allows the Atalante to consume significantly less power and have a more natural gait.

The provided text describes the Atalante exoskeleton and its substantial equivalence submission to the FDA. However, the document does not contain acceptance criteria for device performance in the format of a table, nor does it detail a study specifically designed to prove the device meets such criteria with precise metrics like accuracy, sensitivity, or specificity.

Instead, the document focuses on:

• Non-Clinical Performance Data: Demonstrating that the device meets internal, national, and international standards for electrical safety, EMC, software validation, mechanical verification, thermal testing, and useful life. This is reported as "Passed" for each test.
• Clinical Performance Data: Highlighting two clinical studies and real-world evidence to show safety and effectiveness in improving functional ambulation and overall balance in CVA patients. It states that all subjects completed performance outcome measures successfully and there were no serious adverse events.

Since the request asks for specific information that is not present in the provided text (such as a table of acceptance criteria with reported performance, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and detailed ground truth information for training sets), I will have to state where the information is absent.

Here's the breakdown of the information requested, based only on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria with specific quantitative performance metrics (e.g., accuracy, sensitivity, specificity, or numerical thresholds for functional improvement) and corresponding reported device performance. It generally states that the device "Passed" various tests or that clinical studies "demonstrated" safety and effectiveness.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Clinical Studies (Test Set): "Two clinical studies with a total of 43 patients with cerebrovascular accident (CVA) were undertaken."
• Data Provenance: Not specified in terms of country of origin or whether the studies were retrospective or prospective. Given they are referred to as "clinical studies," they are typically prospective, but this is not explicitly stated. The mention of "real world evidence of use by over 250 patients" suggests a broader patient base but does not specify its provenance or use as a formal "test set" for performance evaluation in the same way as the 43 patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The clinical studies evaluated patient outcomes, but there's no mention of specific experts establishing a "ground truth" in the context of diagnostic or interpretive performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

5. 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

This type of study is not mentioned in the document. The device is a powered exoskeleton, not an AI-assisted diagnostic or interpretive tool where "human readers" would be involved in interpretation. The clinical studies assessed patient functional improvements.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is a "Powered Lower Extremity Exoskeleton" intended to be used "under the supervision of a trained operator." Therefore, a "standalone" algorithm-only performance assessment in the context of diagnostic AI is not applicable. The device's performance is intrinsically tied to its use by a patient under operator supervision.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the clinical studies, the "ground truth" or primary outcome measured would be outcomes data related to functional ambulation abilities and overall balance improvement in CVA patients. These improvements are assessed through standard rehabilitation performance outcome measures.

8. The sample size for the training set

The document explicitly mentions clinical studies (test set) and real-world evidence, but does not provide a specific sample size for a "training set" in the context of machine learning model development. This device, as an exoskeleton, may undergo continuous calibration or adaptation, but the concept of a distinct "training set" for an AI model's ground truth, as typically understood in diagnostic AI, is not detailed.

9. How the ground truth for the training set was established

As no specific "training set" for an AI model is detailed, the method for establishing its "ground truth" is not provided. The documentation focuses on engineering validation and clinical outcomes for device performance.

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