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The ReGenesis EMS Chair is intended to provide non-invasive electromagnetic stimulation to a weak pelvic floor muscle for the purpose of rehabilitation. The procedure is intended to strengthen the pelvic floor muscle and restore the neuromuscular control for the treatment of urinary incontinence in both male and female patients.

The ReGenesis Chair is an electromagnetic muscle stimulation device. It is intended to provide non-invasive electromagnetic stimulation to a weak pelvic floor muscle for the purpose of rehabilitation. The procedure is intended to strengthen the pelvic floor muscle and restore the neuromuscular control for the treatment of urinary incontinence in both adult male and female patients. This is intended to be operated by trained professionals only.
The ReGenesis EMS Chair consists of the main unit (the chair) and a wired, color, touch screen, control Panel. The device consists of a control unit that internally houses a power supply, cooling system, user interface, and control system. The electromagnetic coil is contained in the chair applicator, which is fashioned as a seat for the patient. The subject device uses electromagnetic fields to stimulate the muscles of the pelvic floor.

This document is a 510(k) clearance letter for a medical device and does not contain the acceptance criteria or results of a study demonstrating the device meets those criteria. The primary purpose of a 510(k) summary is to establish substantial equivalence to a predicate device, not necessarily to detail comprehensive clinical performance or specific acceptance criteria.

The "Non-Clinical Testing" section mentions that "All pre-determined acceptance criteria were met," but it does not list what those criteria are nor does it provide a table of acceptance criteria versus reported performance.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is what can be inferred or explicitly stated from the provided document:

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

• Acceptance Criteria: Not explicitly stated in the document. The document mentions "All pre-determined acceptance criteria were met" for non-clinical and performance bench testing, but does not provide the criteria themselves.
• Reported Device Performance: Not explicitly stated in a quantitative manner against specific acceptance criteria. The document only confirms that the non-clinical tests were "successfully completed" and "All pre-determined acceptance criteria were met."

2. Sample size used for the test set and the data provenance:

• Since no clinical study results are detailed, there is no information provided on the sample size for a clinical test set or its provenance. The testing mentioned is non-clinical bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable based on the provided document. The document describes non-clinical bench testing, not a study involving human experts to establish ground truth for a test set.

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

• Not applicable based on the provided document. No clinical study with adjudicated ground truth establishment is described.

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 versus without AI assistance:

• No, an MRMC comparative effectiveness study was not done or is not reported in this document. The device is an electromagnetic muscle stimulation device, not an AI-assisted diagnostic tool for human readers.

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

• Not applicable in the context of an "algorithm." The ReGenesis EMS Chair is a physical device that delivers electromagnetic stimulation. The "Software Verification and Validation Testing" indicates software is involved, but "standalone" performance in the sense of an algorithm making a diagnosis or prediction is not relevant here. The device's primary function is a physical intervention.

7. The type of ground truth used:

• For the non-clinical testing, the "ground truth" would be defined by engineering specifications and recognized standards (e.g., electrical safety limits, electromagnetic compatibility limits, mechanical durability expectations, temperature thresholds).

8. The sample size for the training set:

• Not applicable. The document describes a physical medical device. It does not mention any machine learning or AI components that would require a "training set" in the typical sense.

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

• Not applicable. As above, no training set for an AI algorithm is mentioned.

Summary of what is available from the document regarding acceptance criteria and study:

The document states that non-clinical testing was performed to demonstrate substantial equivalence to the predicate device. These tests included:

• Electrical Safety testing (per IEC 60601‐1: 2020)
• Electromagnetic Compatibility testing (per IEC 60601‐1-2: 2020)
• Nerve and muscle stimulator specific requirements (per IEC 60601-2-10:2016)
• Software Verification and Validation Testing (per FDA guidance)
• Performance bench data, including:
  • Service life verification test
  • Stimulation Coil Surface Temperature Rise Test

The document explicitly states: "All pre-determined acceptance criteria were met." However, the specific quantitative acceptance criteria for each of these tests and the reported quantitative performance are not detailed in this 510(k) summary. The sample size for these bench tests (e.g., how many units were tested for service life or temperature rise) is also not provided.

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