(280 days)
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:
- A table of acceptance criteria and reported device performance (since these are not specified beyond a general statement of compliance).
- Sample size used for a test set or data provenance (as no clinical test set is described).
- Number of experts or their qualifications for ground truth establishment.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study, nor the effect size on human readers.
- Stand-alone performance (algorithm only) as this is a device and not an AI algorithm being evaluated in a clinical "standalone" sense.
- Type of ground truth used (as no clinical study is detailed).
- Sample size for the training set (as no AI/ML model training is described in the context of clinical performance evaluation).
- 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.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).