(192 days)
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.
| Test Category | Acceptance Criteria (Implied by equivalence) | Reported Device Performance (StarFormer) |
|---|---|---|
| Clinical Efficacy | Efficacy in rehabilitation of weak pelvic muscles and restoration of neuromuscular control for urinary incontinence in women, similar to K973096. | No direct clinical efficacy data or explicit performance metric is provided. Substantial equivalence to predicate (K973096) implies similar efficacy. |
| Electrical Safety | Compliance with IEC 60601-1: 2020 | Tests performed and successfully completed. |
| Mechanical Strength | Compliance with IEC 60601-1: 2020 | Tests performed and successfully completed. |
| Thermal Safety | Compliance with IEC 60601-1: 2020 | Tests performed and successfully completed. |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2: 2020 | Tests performed and successfully completed. |
| Software Verification & Validation | Compliance with FDA's 2023 guidance "Content of Premarket Submissions for Device Software Functions | FDA" |
| Cybersecurity | Compliance with FDA's 2023 guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions | FDA" |
| Magnetic Field Strength | No explicit acceptance criterion given, but performance bench data was submitted for comparison. | 1.8 T ± 20% |
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.
§ 876.5320 Nonimplanted electrical continence device.
(a)
Identification. A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).(b)
Classification. Class II (performance standards).