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With handheld applicators:

PMS mode:

Fotona StarFormer is intended for muscle conditioning, used for stimulating muscles including abdomen muscles in order to improve or facilitate muscle performance.

Fotona StarFormer is intended to be used under medical supervision for adjunctive therapy. Fotona StarFormer is intended for stimulating neuromuscular tissue for bulk muscle excitation in arms, legs, buttocks and thighs for rehabilitative purposes - Prevention of disuse atrophy and increasing local blood circulation.

TENS mode:

Fotona StarFormer is intended to stimulate peripheral nerves for relief of chronic intractable, post traumatic and post-surgical pain for patients 18 years or older.

Fotona StarFormer is to be used for the temporary relief of pain associated with sore or aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

With Chair Back applicator:

TENS mode:

Fotona StarFormer is intended to stimulate peripheral nerves in the back for relief of chronic intractable, post traumatic and post-surgical pain for patients 18 years or older. Fotona StarFormer is to be used for the temporary relief of pain associated with sore or aching muscles in the back due to strain from exercise or normal household work activities.

StarFormer is a non-invasive therapeutic device. The device comprises of a magnetic stimulation coil located in the handheld applicators and in the back of a chair. During the treatment, an alternating electric current is sent into the stimulation coil. The coil builds up a rapidly changing magnetic waves which propagate into the underlying tissue where they induce a secondary electric current. This current stimulates neurons and activates muscle contractions. The device consists of a system controller board which also drives the touchscreen and the GUI, a high voltage current power supply, handheld applicators and a chair.

The provided document is a 510(k) summary for the Fotona StarFormer (M008-3T) device, a transcutaneous electrical nerve stimulator. However, it does not contain the specific details about acceptance criteria or a comparative effectiveness study that demonstrates how the device meets acceptance criteria.

The document indicates that:

• Nonclinical testing was performed, including electrical safety, mechanical strength, thermal safety, electromagnetic compatibility, software verification and validation, and cybersecurity testing. It explicitly states, "All pre-determined acceptance criteria were met" for these tests.
• No premarket clinical investigations were conducted. The rationale provided is that "performance of StarFormer is based on the well-established magnetic stimulation technology and does not carry significant residual risk for patients."

Therefore, I cannot provide details on:

1. A table of acceptance criteria and reported device performance (since these are not specified beyond a general statement of compliance).
2. Sample size used for a test set or data provenance (as no clinical test set is described).
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication method for the test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study, nor the effect size on human readers.
6. Stand-alone performance (algorithm only) as this is a device and not an AI algorithm being evaluated in a clinical "standalone" sense.
7. Type of ground truth used (as no clinical study is detailed).
8. Sample size for the training set (as no AI/ML model training is described in the context of clinical performance evaluation).
9. How ground truth for the training set was established.

The document focuses on demonstrating substantial equivalence to predicate devices primarily through comparison of technological characteristics and compliance with nonclinical performance standards, rather than clinical efficacy studies with specific acceptance criteria that might be seen for novel AI/ML devices.

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Fotona StarFormer is intended to provide entirely non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of urinary incontinence in women.

StarFormer is a non-invasive therapeutic device. The device comprises of a magnetic stimulation coil located in the seat of a chair. During the treatment, an alternating electric current is sent into the stimulation coil. The coil builds up a rapidly changing magnetic waves which propagate into the underlying tissue where they induce a secondary electric current which causes muscle contraction in the entire pelvic floor area, increasing the strength and endurance of the pelvic floor. The device consists of a system controller board which also drives the touchscreen and the GUI, a high voltage current power supply and a chair.

This document describes the StarFormer device, a non-invasive electromagnetic stimulator for pelvic floor muscles, and its substantial equivalence to a predicate device (Neotonus Model 100 Muscle Stimulator System).

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria for clinical efficacy and corresponding device performance. Instead, it relies on demonstrating substantial equivalence to a predicate device (Neotonus Model 100 Muscle Stimulator System). The acceptance criteria were met for nonclinical testing.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a clinical study for the StarFormer device's efficacy, nor does it specify a test set for clinical performance. The clearance is based on substantial equivalence to a predicate device and non-clinical bench testing. Therefore, there is no sample size for a clinical test set or data provenance related to a clinical study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since no clinical study is described for the StarFormer device itself, there is no mention of experts used to establish ground truth for a clinical test set.

4. Adjudication Method for the Test Set

As there is no described clinical test set for the StarFormer device's efficacy, there is no adjudication method mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study was mentioned or performed. The clearance is based on non-clinical testing and substantial equivalence to a predicate device, not on a clinical trial comparing human readers with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The StarFormer device provides electromagnetic stimulation; it is a therapeutic device, not an AI-based diagnostic tool or analysis algorithm meant to operate standalone in a diagnostic context. Therefore, a standalone algorithm-only performance study, as typically understood for AI/ML devices, was not performed or relevant. The device's performance relies on its physical output (magnetic fields) and its mechanism of action on the human body.

7. The Type of Ground Truth Used

For the non-clinical tests (electrical safety, EMC, software, cybersecurity), the ground truth is established by adherence to recognized international and FDA standards/guidances. For the magnetic field strength, the "ground truth" would be the measured output of the device itself compared to its design specifications.

There is no ground truth described for clinical efficacy for the StarFormer device, as no clinical study for its efficacy is presented. The substantial equivalence argument relies on the predicate device's proven efficacy for similar indications.

8. The Sample Size for the Training Set

The StarFormer device is described as a non-invasive therapeutic device that uses electromagnetic stimulation; it is not presented as an AI/ML-based diagnostic or predictive system that typically requires "training sets." Therefore, there is no mention of a training set or its sample size.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for an AI/ML component, this question is not applicable.

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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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