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The RehaStim 2 stimulator is intended for general rehabilitation for:

1. Relaxation of muscle spasms
2. Prevention or retardation of disuse atrophy
3. Increasing local blood circulation
4. Maintaining or increasing range of motion
   The RehaStim 2 is an External Functional Neuromuscular Stimulator, designed for use as stand-alone device as well as in combination with exercise equipment for walking and cycling applications, that has been validated for compatibility by HASOMED GmbH and should be used under the supervision of a clinician.

RehaStim 2 is a 8 channel External Functional Neuromuscular Stimulator. RehaStim 2 can be used as a stand-alone device or in combination with an external motion trainer for cycling or walking applications, that has been validated for compatibility by HASOMED GmbH and should be used under the supervision of a clinician.
A connection cable enables the RehaStim 2 to receive motion data from the external movement exerciser device for walking or cycling applications in order to apply electrical stimulation synchronized with the movement. The stimulation is performed according to the motion data. The stimulation parameters can be configured inside the stimulator.
Electrode lead wires are used to connect RehaStim2 output and electrodes on skin.

The provided text describes the RehaStim 2 device, an External Functional Neuromuscular Stimulator. The text includes information about its indications for use, comparison to predicate devices, and performance data from non-clinical testing for 510(k) clearance.

Here's an analysis of the provided information concerning acceptance criteria and studies:

1. Table of acceptance criteria and the reported device performance:

The document does not explicitly state acceptance criteria in a quantitative, measurable format with corresponding device performance metrics. Instead, it relies on demonstrating equivalence to predicate devices and verifying that the device performs according to specifications.

The closest to "acceptance criteria" are the technical specifications listed in the comparison table, which the RehaStim 2 (2016) device meets by being largely identical or having differences that "do not raise new questions of safety and effectiveness."

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

• Sample Size for Test Set: The document explicitly states "no clinical testing was required." The performance data section refers to "Output characteristic measurement of new device" and "Control of system testing." These are non-clinical tests. Therefore, there is no "test set" in the sense of a patient cohort. The "sample" for these tests would be the devices themselves. The number of devices tested is not specified but would typically imply a representative number from manufacturing.
• Data Provenance: The testing is "non-clinical data," implying laboratory or bench testing performed by HASOMED GmbH ("proprietary testing protocol conducted by Hasomed GmbH"). The country of origin for the company is Germany.

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

This information is not applicable as no clinical ground truth was established for a patient test set, because "no clinical testing was required." The basis for the device's substantial equivalence is its technical characteristics and its similarity to predicate devices, supported by non-clinical verification and validation.

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

Not applicable, as no clinical test set requiring expert adjudication for ground truth was used.

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:

Not applicable. This device is an External Functional Neuromuscular Stimulator, not an AI-powered diagnostic imaging device that would typically undergo an MRMC study with human readers. The document states "no clinical testing was required."

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

The device itself is a "stand-alone device" meaning it can function on its own or in combination with exercise equipment. The performance data section describes "Output characteristic measurement of new device" and "Control of system testing" which are standalone performance assessments, but this is for the hardware and software of the device itself, not an algorithm separated from a human operator in a diagnostic context. The device is intended to be used "under the supervision of a clinician," indicating a human-in-the-loop for its clinical application.

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

No clinical "ground truth" was used for human-patient data because no clinical testing was required. The "ground truth" for the device's technical performance was its design specifications and the technical characteristics of the predicate devices. The safety and effectiveness were supported by:

• Extensive historical use of the single stimulator device RehaStim 2.
• Ongoing use of predicate devices (RehaStim 2 / ErigoPro (FES) and RehaStim 2 / RehaMove 2) in combination with movement exercisers.
• Hardware and software verification and validation against specifications.

8. The sample size for the training set:

Not applicable. The document does not describe the use of machine learning or AI models that would require a "training set." The device is a traditional medical device (neuromuscular stimulator), not an AI/ML algorithm-based device.

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

Not applicable, as there is no mention of a training set or machine learning.

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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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Both the RehaMove 2 and RehaStim 2 are intended for general rehabilitation for:

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

The RehaMove 2 is a portable Functional Electrical Stimulation (FES) system based on a cycle ergometer and a stimulator. It consists of: a motorized movement exerciser (MOTO Med viva II) produced by Reck-company and a stimulator unit (RehaStim 2) produced by Hasomed GmbH. For alternative training of upper extremities a motorized arm crank with same characteristics can be used. The stand-alone mode of RehaStim 2 allows training without movement exerciser.

The system RehaMove 2 allows training for person with impaired functions of lower and upper extremities in two modes:
active mode - using FES support for muscle contractions and if necessary motor power of movement exerciser
passive mode - only movement by motorized movement exerciser

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 to receive angle-parameters and to control the Reck Viva II movement exerciser. Two electrode cables (at maximum 16 cutaneous electrodes for 8 channels) connect the RehaStim 2 with the electrodes on the skin. A USB interface gives the possibility to connect the RehaStim 2 to the PC e.g. connect to patient database.

The RehaStim 2 can be used as a portable (contains a battery) or stationary device for training and rehabilitation applications.

The provided text describes a Special 510(k) submission for the RehaStim 2 / RehaMove 2 devices. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies or trials to establish acceptance criteria and prove device performance against them.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance studies is not available in this document because it is not part of a Special 510(k) submission like this.

The submission focuses on comparing the new device's technological characteristics and intended use to a predicate device (RehaStim; RehaMove (Version 1), K073237). The acceptance criteria, in this context, relate to demonstrating that the modifications do not raise new questions of safety and effectiveness and that the device is as safe and effective as its predicate.

Here's an attempt to answer the questions based only on the provided text, highlighting what is implicitly or explicitly stated:

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

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

• Not explicitly stated for a formal test set with numerical sample size. The submission refers to non-clinical testing and technical comparisons rather than a specific clinical trial with a defined test set.
• Data provenance: Not specified, but the submitter (Hasomed GmbH) is from Germany. The document mentions "ongoing clinical use of the movement exerciser without the stimulation component both in the European Union and the U.S.A." as evidence for the movement exerciser's safety and effectiveness.

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)

• Not applicable/Not stated. This type of information is typically collected for clinical performance studies, not for a 510(k) submission focused on substantial equivalence based on technological characteristics and intended use.

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

• Not applicable/Not stated. See point 3.

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

• Not applicable. This device is a Powered Muscle Stimulator, not an AI-assisted diagnostic or imaging system involving human "readers." The submission makes no mention of such a study.

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

• Not explicitly applicable in the context of an "algorithm only" study. The device is a physical medical device (stimulator and movement exerciser). Performance testing mentioned is for the device's technical specifications and controls, not a standalone algorithm. The "stand-alone mode of RehaStim 2 allows training without movement exerciser" refers to the stimulator unit functioning independently, but this is not an "algorithm-only" performance study.

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

• Implicitly, the "ground truth" for this 510(k) is the established safety and effectiveness profile of the predicate device. The new device's performance is compared against the predicate's known characteristics and acceptable functionality, as well as its own "performance to specification" (which would be internal technical standards). The document also cites "ongoing clinical use" as evidence for safety and effectiveness.

8. The sample size for the training set

• Not applicable/Not stated. Training sets are relevant for machine learning algorithms or AI, which is not the primary focus or a described component of this device in the context of this submission.

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

• Not applicable/Not stated. See point 8.

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Both the RehaMove and RehaStim are intended for general rehabilitation for:

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

The RehaMove is a portable Functional Electrical Stimulation (FES) system based on a cycle ergometer and a stimulator. It consists of:
(1) a motorized movement exerciser (MOTOTMed viva II) produced by Reckcompany
(2) for alternative training of upper extremities a motorized arm crank with same characteristics can be used
(3) FES stimulation controller RehaStim, that generates impulses, on up to 8 channels simultaneously, to activate paralyzed muscles via surface electrodes. The RehaStim can be used as a portable (contains a battery) or stationary device for training and rehabilitation applications.
(4) an information cable (RS232) connects the RehaStim and the movement exerciser
(5) 4 electrode cables (at maximum 16 cutaneous electrodes for 8 channels) connected the RehaStim with the electrodes on the skin
(6) an USB interface to connect the RehaStim to PC
(7) The stand-alone mode of RehaStim allows training without movement exerciser.
The system RehaMove allows training for person with impaired functions of lower and upper extremities in two modes:
(1) active mode, using FES support for muscle contractions and if necessary motor power of movement exerciser
(2) passive mode only movement by motorized movement exerciser

Here's an analysis of the provided text, focusing on the acceptance criteria and study information:

Analysis of K073237 for RehaStim and RehaMove

Acceptance Criteria and Device Performance:

The provided document does not explicitly present a table of numerical acceptance criteria (e.g., target accuracy, precision, or other specific performance metrics) for the RehaStim and RehaMove devices. Instead, the "acceptance criteria" are implied through the concept of substantial equivalence to a predicate device, the "RT300-S"; "RT300-SP" (K060032).

The core of the study presented here is a comparison with a predicate device to demonstrate that the new device is "as safe and effective" as the legally marketed predicate. Therefore, the "reported device performance" is framed in terms of its technological characteristics and intended use being similar to the predicate, and that any differences do not raise new questions of safety or effectiveness.

Implied Acceptance Criteria and Reported Performance (based on substantial equivalence):

• The safety and effectiveness of the controller has been demonstrated over its development and many clinical applications.
• The remote database enhances safety and effectiveness by ensuring correct therapy settings.
• HASOMED's clinical and non-clinical testing have demonstrated that the RehaStim and RehaMove are as safe and effective as the predicate device. |

Detailed Study Information:

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

   • Test set sample size: Not explicitly stated as a separate "test set" in the context of a clinical trial with a defined number of subjects. The performance data primarily relies on a technical comparison with the predicate device and ongoing clinical use of components (the movement exerciser without FES).
   • Data provenance: The document mentions "ongoing clinical use of the movement exerciser without the stimulation component both in the European Union and the U.S.A." This suggests historical data or real-world evidence from these regions. The "development period of the RehaStim and RehaMove and many clinical applications" for the controller also points to potentially internally generated data or general experience rather than a formal, distinct "test set" for this specific 510(k) submission.

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

   • This information is not provided in the document. The submission focuses on technical specifications, equivalence to a predicate, and pre-existing evidence of component safety/effectiveness, rather than a de novo clinical study requiring expert-established ground truth.

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

   • This information is not applicable and therefore not provided, as the study described is not a clinical trial or image review requiring an adjudication process for a test set.

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, an MRMC comparative effectiveness study was not conducted and is not applicable. This device is a functional electrical stimulator and movement exerciser, not an AI-powered diagnostic tool that human readers would interpret.

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

   • The term "standalone" in this context is ambiguous. If it refers to the performance of the RehaStim stimulator without the movement exerciser, the document states: "The stand-alone mode of RehaStim allows training without movement exerciser." This implies that its functionality as a stimulator was considered independently.
   • However, if "standalone" refers to an algorithm's performance without human interaction, that is not applicable as this is a medical device for therapeutic use, not an AI algorithm for interpretation or decision support.

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

   • The "ground truth" for this submission is heavily based on demonstrating equivalence to the predicate device and leveraging the established safety and effectiveness of the predicate and component technologies (e.g., the movement exerciser component's prior clinical use, and the controller's development history).
   • There is no mention of explicit "ground truth" derived from expert consensus, pathology, or specific outcomes data collected for a novel clinical trial in this submission to establish the device's efficacy against a gold standard. Instead, the argument is that its performance and safety are comparable to a device already deemed safe and effective.

7. The sample size for the training set:

   • This information is not provided and is not applicable to the type of submission described. This is not an AI/machine learning device that involves a "training set." The development process mentioned for the controller ("development period of the RehaStim and RehaMove and many clinical applications") might imply iterative testing and refinement, but not a formal "training set" in the AI sense.

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

   • This information is not provided and is not applicable, as there is no "training set" in the context of an AI/machine learning algorithm for this device.

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