(72 days)
ApexM is a non-implanted muscle stimulator designed to treat stress, urge and/or mixed urinary incontinence in women. It applies stimulation to the pelvic floor muscles and surrounding structures to improve strength and support.
ApexM is a hand-held, home-use device designed to treat female urinary incontinence. The device includes an inflatable probe. The inflatable probe is inserted into the vagina and manually inflated by the end user to ensure a customized fit. Electrical stimulation is delivered via stainless steel electrodes on the inflatable probe to induce a contraction of the pelvic floor muscles. Muscle stimulation is used to train and strengthen the pelvic floor muscles in a controlled manner. Muscle stimulation is used to improve the ability of muscles to hold a contraction for an extended period of time and is a treatment for urinary incontinence. During a session, high and low frequency stimulation is delivered by the device. The higher frequency stimulation is delivered to specific muscles to encourage their contraction, strengthening the muscles and helping the end user recognize which muscles to activate during self-directed contractions. Lower frequency stimulation calms the detrusor muscle, decreasing symptoms of urgency. The level of electrical stimulation is easily controlled by the end user using manual, push-button controls.
This document, K150183 for the ApexM device, focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study for the new device itself. The information provided is primarily a comparison between the new device (ApexM) and two predicate devices (InTone and Apex) to show that the ApexM is equally safe and effective.
Therefore, many of the requested elements for acceptance criteria and a study proving the device meets them cannot be directly extracted as if a new, standalone performance study was conducted for ApexM with specific quantitative acceptance criteria. Instead, the document relies on comparing features and prior testing of predicate devices.
Here's an attempt to answer your questions based on the provided text, while acknowledging its limitations:
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission, explicit "acceptance criteria" for the new device's performance (e.g., "device must achieve X% sensitivity") are not stated in the provided text. The "reported device performance" is essentially that its features and technical specifications are substantially equivalent to the predicates, which have presumably met their own performance and safety requirements.
We can, however, extrapolate the implicit "acceptance criteria" as being "identical or substantially equivalent to the predicate device Apex (K141158) or InTone (K110179) without introducing new safety or effectiveness concerns." The "reported device performance" is that it meets this equivalence across various characteristics.
| Feature/Function | Implicit Acceptance Criterion (based on predicate) | Reported Device Performance (ApexM) |
|---|---|---|
| Intended Use | Treat female urinary incontinence (stress, urge, mixed, or a combination thereof) | Treat stress, urge and/or mixed urinary incontinence in women. Identical to Apex (K141158) in its application of stimulation, but broader in the types of incontinence treated compared to Apex alone. Substantially equivalent. |
| Primary Function | Delivery of electrical stimulation | Delivery of electrical stimulation. Identical. |
| Warnings/Precautions | Identical to Apex (K141158) | Identical to Apex. No new safety concerns. |
| Contraindications | Identical to Apex (K141158) | Identical to Apex. No new safety concerns. |
| Labeling Summary (User Manual) | User manual based on predicate Apex, adequate for safe and effective use. | User manual based on predicate Apex, which was validated through Human Factors/Usability testing. Substantially equivalent. |
| Environmental Specifications | For indoor use only. | For indoor use only. Identical. |
| Power Source | 4 AAA Alkaline battery (identical to Apex) | 4 AAA Alkaline battery. Identical to Apex, leveraging ease of use and acquisition for end user. |
| Method of line current isolation | N/A (battery) | N/A (battery). Identical. |
| Patient leakage current | N/A (battery) | N/A (battery). Identical. |
| Number of output modes/channels | 1 mode, 1 channel. | 1 mode, 1 channel. Identical. |
| Regulated current or voltage? | Regulated voltage. | Regulated voltage. Identical. |
| Firmware controlled? | Yes. | Yes. Identical. |
| Automatic Overload Trip? | No (identical to Apex) | No. Identical to Apex. Circuit design ensures self-limiting max stimulation, no injury. |
| Automatic No-Load Trip? | No (identical to Apex) | No. Identical to Apex. Circuit design ensures self-limiting max stimulation, no injury. |
| Automatic Shut Off? | Yes. | Yes. Identical. |
| Indicator Display (On/Off, Low Battery) | On/Off via display illumination (Yes), Low Battery (No). Identical to Apex. | Yes (via display illumination), No. Identical to Apex. Device powers off with low battery, so no safety risk. |
| Waveform, shape | Monophasic, alternating polarity, square pulse (identical to Apex) | Monophasic, alternating polarity, square pulse. Identical to Apex. Dual phase and monophasic alternating polarity both provide balanced positive/negative alternating waveforms. |
| Frequency (Mixed, Stress, Urge) | 50 Hz for stress (Apex); 50 Hz mixed (InTone). New frequency 13Hz is added for urge. | 13, 50 Hz. Combination of frequencies supported by literature for stress, urge, and mixed incontinence. Substantially equivalent. |
| Pulse width | 200 µs/phase. | 200 µs/phase. Identical. |
| Time (On, Off) | 1 second On, 2 seconds Off (for 50Hz, identical to Apex). Additional on/off times for 13Hz. | 1 second at 50 Hz, 2 seconds no stimulation; 2 seconds at 13 Hz, 2 seconds no stimulation. Substantially equivalent, with added times for the new frequency. |
| Total Session Time | 10-15 minutes (identical to Apex) | 10-15 minutes (5-10 minutes stimulation, 5 minutes self-directed). Identical to Apex. Small variances allowed. |
| Max output voltage (500Ω) | 40 Vdc (identical to Apex), meets IEC60601-2-10. | 40 Vdc. Identical to Apex, meets IEC60601-2-10. |
| Max output current (500Ω) | 80 mA (identical to Apex), meets IEC60601-2-10. | 80 mA. Identical to Apex, meets IEC60601-2-10. |
| Maximum phase charge (500Ω) | 16 µC (identical to Apex), meets IEC60601-2-10. | 16 µC. Identical to Apex, meets IEC60601-2-10. Pulse width identical. |
| Electrode surface area | 6.00 cm² ± 0.5 cm² (x 2) (identical to Apex). | 6.00 cm² ± 0.5 cm² (x 2). Identical to Apex. |
| Max current density | 13.3 mA/cm² (identical to Apex), meets IEC60601-2-10. | 13.3 mA/cm². Identical to Apex, meets IEC60601-2-10. Electrode surface area is identical. |
| Max average power density (500Ω) | 5.33 mW/cm² (identical to Apex), meets IEC60601-2-10. | 5.33 mW/cm². Identical to Apex, meets IEC60601-2-10. Electrode surface area, pulse width, max frequency identical. |
| Biofeedback | None (Identical to Apex, removed feature). | None. Biofeedback is a removed feature on both Apex and ApexM; omission does not adversely impact safety. |
| Dimensions (Insertion Unit) | Insertion Unit (overall): 12.2" x 2.5" x 4.0"; Inflatable Probe (avg. inflated): 5.5" x 2.2" x 2.5". Identical to Apex. | Insertion Unit (overall): 12.2" x 2.5" x 4.0"; Inflatable Probe (avg. inflated): 5.5" x 2.2" x 2.5". Identical. |
| Control housing material | N/A (identical to Apex; no separate control unit). | N/A. Identical to Apex. No separate control unit, as ApexM is OTC and controlled by end user. |
| Insertion material | Silicone, plastics. | Silicone, plastics. Identical. |
| Packaging or Expiration Dating | N/A (identical to Apex). | N/A. Identical to Apex. No expiration date needed as components are stable. |
| Sterilization | N/A. | N/A. Identical. |
| Operational Method: Clinical Use | Home use, Over-the-counter (identical to Apex). | Home use, Over-the-counter. Identical to Apex. Over-the-counter indication does not impact safety due to user control, safety features. |
| Patient Interaction: Functions Controllable | End user controls electrical stimulation levels and duration (identical to Apex). | End user controls electrical stimulation levels and duration. Identical to Apex. Stimulation controlled by end user per response, with safety features. |
| Patient Interaction: Programming Capability | Electrical stimulation levels set by end user (identical to Apex). | Electrical stimulation levels set by end user. Identical to Apex. Stimulation controlled by end user per response, with safety features. |
| Override | No (identical to Apex). | No. Identical to Apex. Device is single unit, powered off to stop stimulation and reset. |
| Patient Interaction: Operator Requirements | Over-the-counter device. No special knowledge or training required; instruction manual provided (identical to Apex). | Over-the-counter device. No special knowledge or training required; instruction manual provided. Identical to Apex. Designed for intuitive use without physician oversight, validated by Apex Human Factors study. |
| Software Level of Concern | Moderate. | Moderate. Identical. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- For ApexM specifically: No new separate clinical or human factors study was conducted for ApexM. Its "test set" and provenance are based on the studies or evaluations of its predicate devices.
- For the predicate Apex (K141158): A human factors/usability study was conducted.
- Sample size: Not explicitly stated but the study was designed for a "general population of women."
- Data provenance: Not specified in terms of country of origin but was a prospective "human factors / usability study."
- For predicate InTone (K110179) and InToneMV (K131420): Biocompatibility testing was performed on InToneMV, and electrical safety and EMC testing for InTone and Apex. These are generally lab-based tests, not human subject studies with a "test set" in the sense of clinical performance endpoints.
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)
- The document mentions "InControl Medical collaborated with the supervising physician to make further labeling enhancements" for the predicate Apex's human factors study.
- Number of experts: At least one "supervising physician" mentioned.
- Qualifications: "Supervising physician" implies medical expertise, but specific qualifications (e.g., years of experience, specialty) are not detailed.
- No other expert involvement for "ground truth" on test sets is mentioned for ApexM or its predicates in the context of device performance, as the studies are focused on usability, safety, and technical equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The human factors/usability study for Apex was not a clinical trial requiring adjudication of outcomes by multiple experts. It assessed self-diagnosis, self-limiting usage based on contraindications, and safe use based on instructions. The results were deemed "favorable."
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
Not applicable. This device is an electrical muscle stimulator, not an AI-assisted diagnostic tool or imaging device that would involve human "readers" or an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a muscle stimulator used by a human user. Software verification and validation were performed for algorithms within the device (if any, as it's firmware controlled), but not a standalone "algorithm only" performance study in the AI sense. The "standalone performance" is covered by the electrical safety, EMC, and biocompatibility testing of the hardware components which demonstrated compliance with relevant standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the human factors/usability study on predicate Apex: The "ground truth" was whether users could successfully self-diagnose, self-limit usage, and use the device safely as intended based on their understanding of the labeling. This implicitly relies on the medical accuracy of the diagnostic criteria presented in the labeling, which would be based on established medical knowledge and expert input in the development of those materials.
- For the clinical literature evaluation: The "ground truth" was derived from "evidence of the safety and efficacy of electrical stimulation for the treatment of female urinary incontinence" from published scientific literature, which would be based on clinical outcomes data from those studies.
8. The sample size for the training set
Not applicable. This device is not an AI/ML device that requires a training set in the conventional sense. The "training" for the device's technical specifications and safety parameters comes from engineering design, adherence to standards, and prior testing of predicate devices.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device with a training set. The "ground truth" for the underlying principles of electrical stimulation and device safety were established through decades of medical and engineering science, published literature, and regulatory standards.
§ 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).