Search Results

The InControl InTone device is a non-implanted electrical stimulator indicated for use in the treatment of female urinary incontinence. It applies electrical stimulation to the pelvic floor musculature and surrounding structures. It is intended for acute and ongoing treatment of mixed urinary incontinence where the following results may improve urinary control: strengthening of pelvic floor muscles, inhibition of the detrusor muscle through reflexive mechanisms. The biofeedback feature can be used for muscle re-education purposes.

The device includes three parts; an insertion probe and a hand-held control unit. The insertion The device includes three parts, an inoortion provides more adaptable fit for intra-vaginal use. The probe includes stainless steel electrodes to deliver electro-stimulation. The hand-held control probe includes stainless steel clours and displays the results of electro-stimulation and patient and ulsplay device records, storos, and alspiary one to select and lock in the correct amount generated pervic noor excressor from to the contraction. It also stores data on contraction of current necessary to stimulate pervice noor ochination to select and lock in the correct amount of current necessary to stimulate pelvic floor contraction.

The provided document is a 510(k) summary for the InControl InTone device, a non-implantable electrical stimulator for treating female urinary incontinence. The claims are for "substantial equivalence" of the InControl InTone device to predicate devices on the market and do not detail any clinical studies. Therefore, this document does not contain information to answer the bulk of your questions regarding acceptance criteria, study sizes, ground truth establishment, or clinical performance metrics.

However, based on the provided tables comparing the InControl InTone device to its predicate devices (Otto Bock STIWELL med4, MyoTrac Infiniti, and Hollister evadri), we can infer the acceptance criteria were based on demonstrating equivalence in intended use, technology, engineering, and performance specifications.

Here's the information that can be extracted from the provided text:

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

The acceptance criteria are not explicitly stated with numeric thresholds or targets for device performance. Instead, the "Comparison" column indicates whether the InControl InTone's features are "Identical," "Equivalent," or "Within range" compared to predicate devices. The "Reported Device Performance" for the InControl InTone is simply its listed specifications.

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

This information is not present in the provided 510(k) summary. The document describes a substantial equivalence submission based on technical features and intended use comparison to predicate devices, not clinical studies with test sets.

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)

This information is not present in the provided 510(k) summary. No test sets or ground truth establishment by experts are mentioned.

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

This information is not present in the provided 510(k) summary. No test sets or adjudication methods are mentioned.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done and is not mentioned in the provided document. The device is a direct patient treatment device, not an AI diagnostic tool that assists human readers.

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

This is not applicable as the InControl InTone is an electrical stimulator device, not an AI algorithm. Its performance is related to its physical and electrical specifications, which were assessed through "EMC, electrical, mechanical, safety (operator and patient), temperature/humidity, and software testing."

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

This information is not present in the provided 510(k) summary for any clinical performance. The "ground truth" for the device's technical performance seems to be established through engineering compliance testing against applicable standards (e.g. EMC, electrical, mechanical safety).

8. The sample size for the training set

This information is not present in the provided 510(k) summary. No training sets are mentioned.

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

This information is not present in the provided 510(k) summary. No training sets or ground truth establishment for them are mentioned.

Ask a specific question about this device