(159 days)
The Athena Pelvic Muscle Trainer is intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women.
The Athena Pelvic Muscle Trainer is a vaginal two electrode stimulation probe operated through a FM remote control device. The probe is stored in an activator box that turns the probe on automatically when the probe is removed from the box.
The provided text is a 510(k) Premarket Notification for the Athena Pelvic Muscle Trainer. It focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a standalone study with acceptance criteria and detailed performance metrics of the device itself. Therefore, many of the requested details about a study and its results cannot be fully extracted.
Here's an analysis based on the provided text, addressing the points where information is available and indicating where it is not:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define "acceptance criteria" in the context of a performance study for the Athena Pelvic Muscle Trainer. Instead, it compares the device's technical specifications to those of legally marketed predicate devices to establish substantial equivalence.
| Feature | Athena Pelvic Muscle Trainer (Reported Performance - as described in 510(k)) | Predicate Devices (Reference for Substantial Equivalence) |
|---|---|---|
| Intended Use | Treatment of urinary incontinence | Treatment of urinary incontinence (for all listed predicates) |
| Programmable Features | Intensity | Intensity, Session length (Pathway CTS 2000); Channel, Intensity, Continuous-Intermittent (Liberty PFS-200); Intensity (InCare Microgyn II) |
| Channel Switch | Yes | Yes (Pathway CTS 2000, Liberty PFS-200); No (InCare Microgyn II) |
| Intensity Adj. | Yes | Yes (for all listed predicates) |
| Duty Cycle | 2.5 sec stim / 2.5 sec rest | 2 sec stim/1 sec rest (Pathway CTS 2000); 5 sec stim/ 10 rest (Liberty PFS-200); 2 sec stim /4sec rest (InCare Microgyn II) |
| Duration | 15 minutes | 0-30 minutes (Pathway CTS 2000); 30 minutes (Liberty PFS-200); 15 minutes (InCare Microgyn II) |
| Power Source | (Probe) 1 3.6 volt lithium battery (Remote) 3 AAA alkaline batteries | Unknown (Pathway CTS 2000); (2) 3 volt lithium batteries (Liberty PFS-200); 9V alkaline (InCare Microgyn II) |
| Treatment Protocol | 15 min/twice day | Set by physician (Pathway CTS 2000); 15 min/twice day (Liberty PFS-200, InCare Microgyn II) |
| Mode of Operation | Intermittent | Intermittent (Pathway CTS 2000, Liberty PFS-200, InCare Microgyn II); Continuous (Liberty PFS-200) |
| Ingress Protection | IP67 – Protected from Dust and liquid ingress | Unknown (Pathway CTS 2000); IPXO-no protection (Liberty PFS-200); Unknown (InCare Microgyn II) |
| Output Current | 0 – 70 mA | 0-100 mA (Pathway CTS 2000); 0-65 mA (Liberty PFS-200); Unknown (InCare Microgyn II) |
| Pulse Width | $200 \mu S$ | $300 \mu s$ (Pathway CTS 2000); $300 \mu s$ (Liberty PFS-200); $50-300 \mu s$ (InCare Microgyn II) |
| Output Type | Constant voltage over range of 100 to 1000 Ohms | Constant current over unknown range (Pathway CTS 2000); Constant current over range of 100 to 1000 Ohms (Liberty PFS-200); Unknown (InCare Microgyn II) |
| Output Isolation | $>10^8$ Ohms | Unknown (Pathway CTS 2000); $>10^8$ Ohms (Liberty PFS-200); $>10^{12}$ (InCare Microgyn II) |
| Number of Electrodes | 2 stimulators | Unknown (Pathway CTS 2000); 2 stimulators (Liberty PFS-200); 4 stimulators (InCare Microgyn II) |
| Usage Conditions | Reusable-single patient use | Reusable-single patient use (for all listed predicates) |
| Electrode Orientation | Circular | Circular (for all listed predicates) |
| Probe Length | 3.3 in. nominal | 2.9 in nominal (Pathway CTS 2000); 2.8 in. nominal (Liberty PFS-200); 4.5 in. nominal (InCare Microgyn II) |
| Probe Diameter | .99 in. nominal | .70 in. nominal (Pathway CTS 2000); .95 in. nominal (Liberty PFS-200); 1 in. nominal (InCare Microgyn II) |
| Electrode material | Stainless steel | Unknown (Pathway CTS 2000); Stainless steel (Liberty PFS-200); Metal (InCare Microgyn II) |
| Device Connection | RF Remote | Attached cord (for all listed predicates) |
| Electrode Placement | Vaginal | Vaginal (for all listed predicates) |
| Waveform Type | Square | Square (for all listed predicates) |
| Waveform Shape | Asymmetrical | Asymmetrical (Pathway CTS 2000); Symmetrical (Liberty PFS-200, InCare Microgyn II) |
| Frequency | 12.5Hz/50 Hz | 12.5Hz/50/100/200Hz (Pathway CTS 2000); 12.5Hz/50 Hz (Liberty PFS-200); 10-400 Hz (InCare Microgyn II) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a clinical performance study with a test set. This 510(k) is based on demonstrating substantial equivalence through comparison of technical specifications and intended use to predicate devices. No patient data or clinical study results for the Athena Pelvic Muscle Trainer are provided.
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)
Not applicable, as no clinical performance study involving a test set and ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical performance study involving a test set 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 vs without AI assistance
Not applicable. This device is an electrical stimulator, not an AI-powered diagnostic tool, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is an electrical stimulator, not an algorithm, and its performance is assessed against predicate devices' technical specifications, not by an algorithm's standalone performance.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable, as no clinical performance study with defined ground truth is described. The "ground truth" in this context is the established safety and effectiveness of the predicate devices based on their prior clearance, to which the new device claims substantial equivalence.
8. The sample size for the training set
Not applicable, as no AI model or training set is mentioned for this device.
9. How the ground truth for the training set was established
Not applicable, as no AI model or training set is mentioned for this device.
§ 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).