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The indications for use of the proposed device are the same as those for the predicate devices.
Ultrasound therapy:

• Relief of pain, muscle spasms and joint contractures
• Relief of pain, muscle spasms and joint contractures that may be associated with:
  • Adhesive capsulitis
  • Bursitis with slight calcification
  • Myositis
  • Soft tissue injuries
  • Shortened tendons due to past injuries and scar tissues
• Relief of pain, muscle spasms and joint contractures resulting from:
  • Capsular tightness
  • Capsular scarring
    Electrotherapy:
• 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
• Symptomatic relief or management of chronic, intractable pain
• Post-traumatic acute pain
• Post-surgical acute pain

The Soleoline has a clear contemporary color screen showing all parameters necessary for therapy as well as modem touch control. Individual program start configuration and clear, simple menu navigation make operation of the device easy and comfortable for users. 120 storage bins for individual program settings makes working with the Soleoline a lot easier. The compact design saves room in the practice and is highly suited for use in home visits. The combination of electrotherapy and ultrasound therapy in a single system enables the use of the established combination therapy. It is a prescription device administered to patients by a licensed healthcare provider in hospitals, post acute care facilities, nursing homes and outpatient clinics.
Soleoline is a device family consisting of Soleo Stim and Soleo SonoStim, Soleo Sono includes an ultrasound module, Soleo Stim includes a stimulation current therapy module and Soleo SonoStim includes a combination of a stimulation current module and an ultrasound module.
The stimulation current module is used for stimulation current therapy according to the standard medical practices. It offers multiple waveforms; Monophasic, High Voltage, Micro Current, Asymmetrical Biphasic, Interferential, Medium Frequency, Premodulated currents for nerve stimulation and muscle therapy for mono channel and dual channel operation. The regulated output of the current stimulation module may be chosen from Constant Current (CC) or Constant Voltage (CV).
The dual frequency ultrasound module (800kHz and 2.4MHz) offers two different size ultrasound heads, 1cm² and 5cm² and pulsed and continuous duty cycles.
At combination therapy (simultaneous procedure) the features for ultrasound can be used together with the different stimulation waveforms. All functions of the 0.8MHz and 2.4MHz ultrasound can be combined with the following waveforms:
Monophasic, High Voltage, Micro Current, Symmetrical Biphasic, Medium Frequency, Premodulated
The therapy menu helps the clinicians to assign the indications of each body region to the appropriate therapy program.

The provided document is a 510(k) Summary for the Zimmer MedizinSysteme Soleoline device family. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy from scratch through entirely novel clinical studies. Therefore, the information provided focuses on comparisons to existing devices and compliance with standards, rather than new studies with acceptance criteria and detailed performance metrics as one might find for a novel AI device.

Based on the provided text, here is an attempt to address the points, acknowledging the nature of a 510(k) summary:

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

The document doesn't present "acceptance criteria" in the typical sense of a novel device study (e.g., target sensitivity/specificity). Instead, substantial equivalence is demonstrated by showing that the new device (Soleoline) has the same intended use and similar technological characteristics as the predicate devices, and that any differences do not raise new questions of safety or effectiveness. The "reported device performance" is essentially a comparison of technical specifications against the predicate devices.

Here's a table summarizing key comparisons from the document, which implicitly serve as demonstration of equivalent performance to the established predicate devices:

Note: The "acceptance criteria" here are implied by the specifications of the predicate devices. The study demonstrating compliance is the "Non-clinical Tests Performed" which verified the device's technical characteristics against these standards.

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

This information is not provided in the 510(k) summary. For a 510(k) submission, the primary "test set" is often the comparison of technical specifications against predicate devices and adherence to recognized standards. It's likely that internal engineering and performance testing was conducted, but details on sample size, data provenance, and study design are not typically required or included in this summary document beyond stating that "Validation documentation, product testing and a comparison of the technical characteristics and features according to relevant standards were provided."

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 is not applicable/not provided. The document describes a medical device, not an AI or diagnostic tool that requires expert-established ground truth for its performance evaluation in the clinical sense. The ground truth for this type of device is its adherence to technical specifications and safety standards as verified by engineering tests and comparison to predicate devices, and its intended effect being recognized within standard medical practices.

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

This is not applicable/not provided. Adjudication methods are typically associated with resolving discrepancies in expert interpretations during the establishment of ground truth for diagnostic studies, which is not the nature of this 510(k) submission.

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 is not applicable/not provided. MRMC studies are used for evaluating the impact of AI on human reader performance for diagnostic tasks, which is not relevant to a powered muscle stimulator/ultrasound diathermy device. The study described is a technical comparison for substantial equivalence.

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

This is not applicable/not provided. This device is not an algorithm, but a physical medical device. Its "standalone" performance is its technical operation according to specifications, which was implicitly demonstrated through the non-clinical tests and comparison to predicates.

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

The "ground truth" for this 510(k) submission is the technical specifications and safety performance demonstrated by the predicate devices and the relevant voluntary standards (e.g., IEC/EN 60601 series, 21 CFR 898). The new device is considered substantially equivalent if it meets or has comparable technical characteristics within the established safety and effectiveness profile of these predicate devices and standards.

8. The sample size for the training set

This is not applicable/not provided. This device does not involve a "training set" in the context of machine learning or AI.

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

This is not applicable / not provided for the same reason as point 8.

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