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The Axon-Bus Prosthetic System is to be used exclusively for exoprosthetic fittings of the upper limbs.

The Axon-Bus Prosthetic System is to be used exclusively for upper limb exoprosthetic fitting. The Axon-Bus Prosthetic System is suitable for unilateral amputations starting with the transradial/transhumeral amputation level or, in case of dysmelia, for forearm or upper arm fittings. The Axon-Bus prosthetic system was developed for everyday use and must not be used for unusual activities. The prosthesis is intended exclusively for use on one patient. Fitting a patient with the Axon-Bus prosthetic system may only be carried out by a prosthetist who has been authorized by Ottobock after completion of a corresponding training course.

System Components:

• Michelangelo Hand (terminal device)
• AxonFlexion Adapter (passive flexion)
• AxonRotation Adapter (passive rotation)
• AxonArm (passive elbow joint with mechanical and/or electrical lock)
• AxonEnergy Integral (battery)
• AxonCharge (charger)
• AxonMaster (control unit)
• Electrode (detecting EMG Input signals)
• AxonSoft (adjustment software)
• AxonSkin (prosthetic glove)

The provided text describes the Axon-Bus Prosthetic System and its performance testing, but it does not include a study proving that the device meets specific acceptance criteria in the format requested. The document primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to various performance standards.

Here's an attempt to extract and interpret the information based on the provided text, acknowledging where specific details for the requested format are missing:

The document states, "Extensive testing was performed (e.g. software testing and electrical safety tests including EMC). Also biocompatibility testing according to ISO 10993-1 was performed on all patient contacting materials. No clinical studies were performed. Since all samples tested met the acceptance criteria, substantial equivalence has been demonstrated through these tests." and "All tests that has been conducted on the Axon-Bus Prosthetic System to ensure that the device meets design specifications, operates as it is intended, and ensures that safety functions and features operate as they are intended were passed."

This indicates that internal performance testing against design specifications served as the "study" to prove acceptance criteria. However, the specific quantitative acceptance criteria for each "Performance Attribute" are not explicitly listed, only "Passed" as the test result.

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

The document also lists various standards adhered to (e.g., ISO 22523, IEC 60601-1, ISO 10993-1, etc.). The acceptance criteria for these would be compliance with the requirements of each standard. For example, for biocompatibility:

• Biocompatibility (patient contacting materials): Compliance with ISO 10993-1, ISO 10993-5, ISO 10993-10.
• Reported Device Performance for Biocompatibility: All patient contacting materials tested according to biocompatibility requirements of ISO 10993 and stated that "Titan (grade 1) is tested according to biocompatibility requirements of ISO 10993", "used Silicone Pad is certified according to USP Class VI. In addition, all used materials (ASA, Silicone Pad and Bonding Agent) are tested according to biocompatibility requirements of ISO 10993." (implicitly "Passed")

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "all samples tested met the acceptance criteria," but does not specify the number of units or components tested.
• Data Provenance: The testing was "internal testing regarding performance characteristics," implying it was conducted by the manufacturer, Otto Bock HealthCare Products GmbH in Austria. The nature of this testing (retrospective/prospective) and specific country of origin for any "data" beyond internal testing are not detailed. "No clinical studies were performed."

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

• This information is not provided as the testing described is primarily engineering/performance-based, not involving "ground truth" derived from expert interpretation in the clinical sense.

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

• This information is not applicable/provided for the type of engineering performance testing conducted.

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

• No MRMC comparative effectiveness study was done. The document explicitly states: "No clinical studies were performed." The device is a prosthetic system, not an AI-assisted diagnostic tool typically evaluated with MRMC studies.

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

• This question is not directly applicable as the device is a physical prosthetic system with embedded software, not a standalone algorithm. The "AxonSoft" (adjustment software) and "AxonMaster" (control unit) are integral parts of the system with human-in-the-loop interaction by the user and prosthetist. Internal testing ensured the device "operates as it is intended, and ensures that safety functions and features operate as they are intended," which implies standalone function within its control scheme.

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

• The "ground truth" for the internal performance testing was based on engineering design specifications and compliance with recognized international standards (e.g., ISO, IEC). It was not clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

• This information is not applicable/provided as the device is not described as utilizing machine learning or AI that requires a "training set" in the conventional sense. The "AxonSoft" is adjustment software, not explicitly an AI model trained on data.

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

• This information is not applicable/provided for the reasons stated in point 8.

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The STIWELL med4 is a neuromuscular electronic stimulator indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions.

As a powered muscle stimulator the STIWELL med4 is indicated for the following conditions:

• Relaxation of muscle spasm
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• Maintaining or increasing range of motion

As a transcutaneous electrical nerve stimulator for pain relief the STIWELL med4 is indicated for the following conditions:

• Symptomatic relief and management of chronic (long-term), intractable pain
• Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain

As a biofeedback device the STIWELL med4 is indicated for the following conditions:

• Biofeedback, relaxation and muscle re-education purposes

As an external functional neuromuscular stimulator the STIWELL med4 is indicated for the following conditions:

• Helps to relearn voluntary motor functions of the extremities

As a nonimplanted electrical continence device the STIWELL med4 is indicated for the following conditions:

• Acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Inhibition of the detruser muscles through reflexive mechanisms and strengthening of pelvic floor muscles
• Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles such as the abdominal and the gluteus muscles

The STIWELL med4 is powered by rechargeable batteries. It has four stimulation channels and two EMG measurement channels.

The STIWELL med4 is intended for stationary use in a hospital as well as home use by the patient. The physician/therapist has the flexibility to adjust the programs and monitors the progress of the therapy. Statistics regarding the completed treatments can be retrieved from the STIWELL med4 and from the PC.

The provided document is a 510(k) premarket notification for the STIWELL med4, a neuromuscular electronic stimulator. It focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies. Therefore, much of the requested information regarding clinical study design, performance metrics, and expert adjudication is not present in this type of submission.

Here's an analysis based on the available information:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily based on demonstrating substantial equivalence to legally marketed predicate devices, meaning the new device has the same intended use and the same technological characteristics as the predicate device, or has different technological characteristics but does not raise different questions of safety and effectiveness and is as safe and effective as a legally marketed device.

The document provides extensive tables comparing the STIWELL med4's technical characteristics across various stimulation programs (Functional Electrical Stimulation, Incontinence, TENS, Biofeedback) with its predicate devices. The "performance" in this context is the successful demonstration that these characteristics are similar enough to existing devices to not introduce new safety or effectiveness concerns.

Summary Table of Equivalence (Acceptance Criteria are inferred from predicate device characteristics):

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