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Fotona StarFormer is intended to be used under medical supervision for therapy for the treatment of medical diseases and conditions.

Fotona StarFormer is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes.

-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.

Fotona StarFormer is indicated for improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen

-Strengthening, Toning and Firming of buttocks and thighs

StarFormer is a non-invasive therapeutic device. The device comprises a magnetic stimulation coil located in the applicator which is placed over the treatment area. During the treatment, an alternating electric current is sent into the stimulation coil. The alternations in the electric current produce electromagnetic field that interacts with the tissues of the human body. The device consists of a system controller board which also drives the touchscreen and the GUI, a high voltage current power supply and an applicator with electromagnetic coil.

The provided text is a 510(k) summary for the Fotona StarFormer device. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with defined performance metrics. In the context of a 510(k), "acceptance criteria" are typically related to the device's ability to perform as intended and raise no new questions of safety or effectiveness compared to a predicate device.

Therefore, the requested information regarding acceptance criteria and a study proving those criteria are met is not directly present in this document in the format you've requested for AI/software performance. The information provided is about the device's technical specifications and the comparison to predicate devices to establish substantial equivalence.

Here's an attempt to extract and interpret the information based on the premise of the FDA 510(k) process for this type of medical device:

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

Since this is a 510(k) for a physical medical device (muscle stimulator) rather than an AI/software device with measurable performance metrics like sensitivity/specificity, the acceptance criteria are not in the form of numerical performance targets. Instead, the acceptance criteria for a 510(k) revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device and does not raise new questions of safety or effectiveness.

Indications for Use Comparison Table (Extracted from the document, relevant to equivalence):

• 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 | - Improvement of abdominal tone, strengthening of abdominal muscles, development of firmer abdomen.
• Strengthening, Toning and Firming of buttocks and thighs. | - 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.
• Improvement of abdominal tone, strengthening of abdominal muscles, development of firmer abdomen.
• Strengthening, Toning and Firming of buttocks and thighs. | Same (StarFormer combines the indications of both predicates)

Technological Comparison (Selected key parameters from the document):

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

The document explicitly states: "No premarket clinical investigations were conducted since the performance of StarFormer is based on the well-established magnetic stimulation technology and does not carry significant residual risk for patients." Therefore, there is no clinical test set, sample size, or data provenance to report. The evaluation relies on non-clinical testing and comparison to predicates.

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, as no clinical investigations were conducted.

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

Not applicable, as no clinical investigations were 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

Not applicable. This device is a physical muscle stimulator, not an AI-assisted diagnostic or interpretive device that would involve human readers or an MRMC study.

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

Not applicable. This is a physical device, not an algorithm.

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

Not applicable, as no clinical investigations were conducted. The "ground truth" for a 510(k) submission for a physical device is primarily the established safety and effectiveness of the legally marketed predicate devices and their underlying technology.

8. The sample size for the training set

Not applicable, as no clinical investigations were conducted and this is not an AI/ML device that requires a training set.

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

Not applicable.

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