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The ErigoPro is intended for medical purposes such as to increase to an upright or standing position in patients with circulatory, neurological, or musculoskeletal conditions.

ErigoPro is also used for:

• 1. Relaxation of muscle spasms
• 2. Prevention or retardation of disuse atrophy / redevelop muscles
• 3. Increasing local blood circulation
• 4. Maintaining or increasing joint range of motion

The ErigoPro is for prescription use only.

The Erigo is an early rehabilitation robotic device consisting of a verticalization table and an integrated leg movement mechanism. By moving the patient's legs, cyclic leg loading is applied to the lower limbs of the patient during early verticalization. The Erigo is controlled via a PC.

The ErigoBasic offers all basic functionalities to perform early and safe patient mobilization. With the ErigoPro, patient stimulation is additionally enhanced by the synchronized FES.

The FES - stimulation controller RehaStim 2 generates impulses, on up to 8 channels simultaneously, to activate paralyzed muscles via surface electrodes. A connection cable enables the RehaStim 2 to receive the stimulation parameters from the ErigoPro control system. The electrode lead wires are used to connect ErigoPro-FES-Socket/RehaStim2 output and electrodes on skin. Every connected lead wire should connect to two electrodes (1 channel) for ErigoPro and 2x 4 channels for RehaStim2, respectively.

Here's a breakdown of the acceptance criteria and study information for the RehaStim 2 / ErigoPro (FES) device based on the provided text:

Acceptance Criteria and Device Performance

The provided document (K132416) is a Special 510(k) submission for the RehaStim 2 / ErigoPro (FES). This type of submission generally relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with explicit acceptance criteria for performance metrics (like sensitivity, specificity, or AUC).

Instead, the acceptance criteria are implicitly defined by demonstrating that the modified device (RehaStim 2 / ErigoPro (FES)) has the same intended use and same output characteristics as the predicate device (RehaStim 2 / RehaMove 2), and that any technological differences do not raise new questions of safety and effectiveness.

Therefore, the "acceptance criteria" here are met by the successful demonstration of substantial equivalence through technical comparisons and non-clinical testing.

Table: Acceptance Criteria (Implied) and Reported Device Performance

• A review of user documentation for the predicate device to confirm equivalent functionality.
• Review of 510(k) submissions for the predicate device to confirm technical specifications.
• Output characteristic measurements of the new device.
• Control of system testing to verify performance to specification. |
  | Safety and Effectiveness of Components Demonstrated | The submission states:
• "The safety and effectiveness of using gradual verticalization, robotic leg movement, and cyclic leg loading has been extensively demonstrated in particular by the ongoing clinical use of the device without the stimulation component both in the European Union and the U.S.A."
• "The safety and effectiveness of the controller has been demonstrated over the development period of the RehaStim 2 and ErigoPro (FES) and many clinical applications." |
  | Overall Substantial Equivalence to Predicate Device | HASOMED concludes that clinical and non-clinical testing demonstrated that the RehaStim 2 and ErigoPro (FES) are "as safe and effective as the predicate device." |

Study Details Based on Provided Information:

The provided document describes a Special 510(k) submission, which typically focuses on demonstrating substantial equivalence of a modified device to a predicate device, rather than new clinical trials with primary endpoints and acceptance criteria in the traditional sense. The "study" here is primarily a comparative technical and performance assessment against a predicate device.

1. Sample size used for the test set and the data provenance:

   • No specific "test set" with a defined sample size (e.g., number of patients or images) is mentioned in the context of a clinical study or data analysis in this document. The assessment is based on technical comparisons, existing clinical use of the predicate, and non-clinical testing.
   • Data Provenance: The document refers to "ongoing clinical use of the device without the stimulation component both in the European Union and the U.S.A." indicating existing market data and experience from these regions. This would generally be considered retrospective.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable as this submission outlines a technical equivalence assessment rather than a diagnostic device evaluation requiring expert-derived ground truth.

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

   • Not applicable for a technical equivalence submission.

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:

   • No MRMC or AI-assisted study was conducted or reported in this submission. The device is a "Powered Muscle Stimulator" and the submission is about its FES component, not an AI diagnostic or assistance tool.

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

   • This is not an AI algorithm. The performance assessment described is of the device's technical specifications and safety profile, not an algorithm's standalone performance.

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

   • The "ground truth" for this submission is implicitly the established safety and effectiveness profile of the predicate device (RehaStim 2 / RehaMove 2) and the technical specifications and performance measurements of both the predicate and the modified device. For the "safety and effectiveness of using gradual verticalization, robotic leg movement, and cyclic leg loading," the "ground truth" is stated as having been "extensively demonstrated by the ongoing clinical use of the device without the stimulation component."

7. The sample size for the training set:

   • Not applicable. This is not an AI or machine learning device requiring a training set.

8. How the ground truth for the training set was established:

   • Not applicable.

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