(397 days)
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.
| Feature/Function | Predicate Acceptance Criteria (Inferred from comparison) | InControl InTone (Reported Device Performance) | Comparison to Predicate Devices (Otto Bock, MyoTrac, Hollister) |
|---|---|---|---|
| Intended Use | Equivalent to predicate devices | Treatment of female urinary incontinence, electrical stimulation to pelvic floor, muscle re-education. Acute and ongoing treatment of mixed urinary incontinence. | Equivalent |
| Method of line current Isolation | Battery operated | n/a (battery) | Identical (to Otto Bock, MyoTrac) |
| Patient leakage current | Battery operated | n/a (battery) | Identical (to Otto Bock, MyoTrac) |
| Number of output modes | 1 | 1 | Identical (to all) |
| Number of output channels | 1 | 1 | Identical (to all) |
| Regulated current or Voltage | Regulated current / voltage (equivalent or within range of predicates) | Regulated voltage | Equivalent |
| Firmware controlled | Yes | Yes | Identical (to all) |
| Automatic Overload Trip | Yes | Yes | Identical (to Otto Bock) |
| Automatic No-Load Trip | Yes | Yes | Identical (to Otto Bock) |
| Automatic Shut Off | Yes | Yes | Identical (to Otto Bock) |
| Indicator Display On/Off Status/Low Battery | Yes | Yes | Identical (to Otto Bock, MyoTrac) |
| Waveform, shape | Biphasic symmetrical rectangular / asymmetric balanced pulse / balanced biphasic | dual phase, rectangular pulses | Identical (to Otto Bock, Hollister) |
| Frequency (Mixed, Stress, Urge) | Within range of predicate values | 50 Hz | Identical (to MyoTrac, Hollister specifically mentions 50Hz) / Within range |
| Pulse width (Mixed, Stress, Urge) | Within range of predicate values | 200 µs/phase | Within range |
| Time (On, Off, Total Session Time) | Within range of predicate values | On: 20 secs, Off: 10 secs, Total: 12 mins | Within range |
| Max output voltage (500Ω) | 50 Vdc | 50 Vdc | Identical (to Otto Bock) |
| Max output current (500Ω) | 100 mA | 100 mA | Identical (to Otto Bock) |
| Maximum phase charge (500Ω) | 50-60 µC | 50 µC | Identical |
| Electrode surface area | Equivalent to predicate values | 10.5 cm² x 2 | Equivalent |
| Max current density | Equivalent to predicate values | 4.7 mA/cm² | Identical |
| Maximum power density (500Ω) | Equivalent to predicate values | 14.3 µW/cm² | Equivalent |
| Biofeedback | EMG, pressure, or combination | Air pressure, 0-2 psi | Equivalent (to Hollister) |
| Dimensions | Equivalent to predicate sizes | 8 x 5 x 4 inches | Equivalent |
| Control housing materials | Plastics | ABS plastics | Equivalent |
| Insertion material | Plastics | Silicone, plastics | Equivalent |
| Packaging or Expiration Dating | N/A or 1 year | 1 year for insertion unit | |
| Sterilization | N/A | N/A | |
| Operational Method (Clinical Use) | Clinic or Home use, under direction of physician | Clinic or Home use, under direction of physician | Identical (to all) |
| Patient Interaction: Functions Controllable | Starting/stopping of sessions (auto-stop for completion) | Patient controls start/stop, device auto-stops | Equivalent |
| Patient Interaction: Programming Capability | None, programmed by clinician | None, programming by clinician | Equivalent (to Otto Bock, MyoTrac) |
| Override | Yes | Yes | Identical (to Otto Bock) |
| Patient Interaction: Operator Requirements | No special knowledge/training, instruction manual, physician coaching | No special knowledge/training, instruction manual, physician coaching | Identical (to all) |
| Software Level of Concern | (Not explicitly stated for predicates, but "Moderate" for new device) | Moderate | |
| Environmental Specifications | For indoor use only | For indoor use only | Identical (to all) |
| Power Source | Various (Li-Ion, AAA alkaline, AC power) | Nickel metal hydride battery | Equivalent |
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.
§ 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).