(271 days)
The MyOnyx System is indicated for acute and ongoing treatment of stress, urge, or mixed urinary incontinence, where urinary control may be improved through electrical stimulation that strengthens the pelvic floor muscles or inhibits the detrusor muscle through reflexive mechanisms. The system also uses EMG-based or pressure-based biofeedback to help control and strengthen the pelvic floor muscles in the treatment of urinary incontinence.
The MyOnyx System includes a palm-sized, multi-functional, 4-channel device with embedded firmware and accessories designed for use under medical supervision to provide:
- electromyographic (EMG) biofeedback;
- pressure biofeedback from pelvic floor muscles;
- electrical stimulation (ES); and
- ES with EMG biofeedback (EMG-triggered stimulation or ETS).
Up to two stimulation programs may run simultaneously. The device can send a gentle, clinician-adjustable electrical current via surface electrodes on purpose-designed probes. The specified off-the-shelf probes are suitable for EMG biofeedback and electrical stimulation. A small electronic pneumatic pump and pressure sensor device is used with a vaginal provide biofeedback from pelvic floor muscles.
The MyOnyx device may be used in one of the following operating modes: - as a standalone device for electrical stimulation only (autonomous mode); or
- with the MyOnyx Mobile App running on an off-the-shelf tablet for biofeedback, electrical stimulation and EMG-triggered stimulation (remote control mode); or
- with the company's BioGraph® Infiniti software running on a personal computer for biofeedback only (computerized mode).
The device is operated via a graphical interface on an LCD screen and a capacitive touch pad with haptic and audio feedback. The connection to a tablet or personal computer is wireless, via Bluetooth". Visual, audio and voice feedback and prompts are provided to facilitate device operation on the standalone device, the MyOnyx Mobile App and the BioGraph® Infiniti software.
When used in remote control mode for biofeedback or EMG-triggered stimulation, the device can record on the tablet root-mean-square (RMS) EMG signal and pressure data at 20 samples/s. Stimulation data are not recorded.
When used in computerized mode, up to 4 devices may be connected to a personal computer for physiological data acquisition and biofeedback. In this mode, the device can record on the PC raw EMG and pressure data at 2048 samples/s. For use in this mode with the BioGraph® Infiniti software the device must be configured through a firmware parameter setting ('extended' configuration).
The device is powered by an internal rechargeable Li-ion polymer battery or via a medical grade power supply / battery charger. The internal battery offers up to 8 hours of autonomous device operation.
The provided document, a 510(k) summary for the MyOnyx System (K201014), primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. It does not contain information about a clinical study involving human participants or a multi-reader multi-case (MRMC) comparative effectiveness study, which would typically involve human experts for ground truth and evaluation of AI assistance.
Therefore, many of the requested details, such as sample size for test and training sets, data provenance, number and qualifications of experts for ground truth, adjudication methods, and MRMC study effect sizes, are not present in this document because the device clearance was based on non-clinical engineering and performance testing rather than a clinical efficacy trial.
Here's an analysis based on the information available in the document:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
The document provides a table outlining acceptance criteria for various non-clinical tests. The "Reported Device Performance" is generally stated as "Conformity to applicable requirements" or meeting specific design specifications. While the table clearly lists the acceptance criteria, the detailed quantitative results of the tests themselves are not provided within this summary document, only the conclusion that they were met.
| Test | Acceptance Criteria | Reported Device Performance (as stated) |
|---|---|---|
| Biocompatibility of vaginal pressure probe | Cytotoxicity: Noncytotoxic or Mildly cytotoxic (Grades 0-1) per ISO 10993-5; | |
| Sensitization: No delayed contact sensitization per ISO 10993-10; | ||
| Irritation: Non-irritant per ISO 10993-10 | (Implicitly stated as conforming in "Comparison / Brief SE justification" column of table on page 7, "The biocompatibility of the vaginal pressure probe and the basic safety and essential performance of the device have been verified...") | |
| Electrical safety (IEC 60601-1 / ES60601-1:2012) | Conformity to applicable basic safety and performance requirements | Conformity (Implied by inclusion in "Summary of Non-Clinical / Performance Testing" and SE conclusion) |
| EMC (IEC 60601-1-2:2014, 4th Ed.) | Conformity of device emissions and device immunity to EM disturbances for use in a professional healthcare facility | Conformity (Implied by inclusion in "Summary of Non-Clinical / Performance Testing" and SE conclusion) |
| Basic safety and essential performance of nerve and muscle stimulators (IEC 60601-2-10:2012+A1:2016) | Conformity of electrical stimulation programs to applicable requirements | Conformity (Implied by inclusion in "Summary of Non-Clinical / Performance Testing" and "Basic safety and essential performance have been verified with preloaded programs" on pg 7) |
| Basic safety and essential performance of electromyographs and electrical stimulators (IEC 60601-2-40:2016) | Conformity of electrical stimulation programs to applicable requirements for accuracy of controls and protection against hazardous stimulation output | Conformity (Implied by inclusion in "Summary of Non-Clinical / Performance Testing" and "Basic safety and essential performance have been verified with preloaded programs" on pg 7) |
| Verification of hardware device controls and interfaces | Test results must meet or exceed hardware design specifications | Meeting or exceeding hardware design specifications (Implied by inclusion in "Summary of Non-Clinical / Performance Testing" and SE conclusion) |
| Usability (IEC 60601-1-6:2010+A1:2013, IEC 62366-1:2015) | Conformity of the Usability Engineering Process and related outputs. Acceptance of the modified device by representative end-users operating the device as per accompanying instructions for use. | Conformity (Implied by inclusion in "Summary of Non-Clinical / Performance Testing" and "The performance of the device has been verified and validated with the new firmware, user interface, Mobile App and specified biofeedback software" on pg 7) |
| Software life-cycle processes (IEC 62304:2006+A1:2015) | Firmware development in conformity with requirements for Class B software ('Moderate Level of Concern') | Conformity (Implied by inclusion in "Summary of Non-Clinical / Performance Testing" and SE conclusion) |
| Stimulation firmware unit testing | The device responds with expected outputs meeting software design specifications when supplied with predefined test inputs | Expected outputs meeting software design specifications (Implied by inclusion in "Summary of Non-Clinical / Performance Testing" and SE conclusion) |
| Firmware and system-level functional verification testing | The device responds with expected outputs meeting software design specifications under anticipated use conditions and inputs | Expected outputs meeting software design specifications (Implied by inclusion in "Summary of Non-Clinical / Performance Testing" and SE conclusion) |
| MyOnyx Mobile App verification testing | The device responds with expected outputs meeting software design specifications when operated remotely under anticipated use conditions and inputs | Expected outputs meeting software design specifications (Implied by inclusion in "Summary of Non-Clinical / Performance Testing" and SE conclusion) |
Study Proving Acceptance Criteria:
The study that proves the device meets the acceptance criteria is a series of non-clinical performance tests conducted by the manufacturer, Thought Technology Ltd. These include electrical safety, electromagnetic compatibility (EMC), biocompatibility, hardware verification, usability, and software life-cycle processes, as detailed in the "Summary of Non-Clinical / Performance Testing" section on page 5.
2. Sample Size Used for the Test Set and the Data Provenance:
- Sample Size: Not applicable in the context of human patient data for an AI/ML device, as this summary describes engineering and performance testing of the device hardware and software, not a clinical trial with patient data. The "sample size" here refers to the number of units or components tested. This information is not specified in this summary document.
- Data Provenance: Not applicable in the context of patient data. The tests are general engineering and performance tests of the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Not applicable as this is a non-clinical submission. Ground truth, in the AI/ML context, usually refers to labeled data for diagnostic tasks established by human experts. Here, "ground truth" for the device's technical performance is the expected behavior and measurements based on engineering specifications and international standards (e.g., IEC standards).
4. Adjudication Method for the Test Set:
- Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving discrepancies in expert labeling of clinical data, which is not relevant for this type of non-clinical device clearance. The "adjudication" for these tests would be the comparison of test results against predefined acceptance criteria.
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:
- No. The document makes no mention of an MRMC study or AI assistance. The device in question is a biofeedback and electrical stimulation system for incontinence, not an AI-powered diagnostic or assistive 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 AI/ML algorithm performance. The "standalone" mode mentioned in the document (page 4) refers to the device's ability to operate for electrical stimulation only without being connected to a mobile app or computer. This is a functional description, not an AI/ML performance metric.
7. The Type of Ground Truth Used:
- The "ground truth" for this device's performance is established by engineering specifications, international consensus standards (e.g., ISO, IEC), and established medical device testing protocols. For example, for biocompatibility, the ground truth is "noncytotoxic, non-sensitizing, non-irritant" as defined by ISO standards. For electrical safety, the ground truth is "conformity to applicable basic safety and performance requirements" of IEC standards.
8. The Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device that requires a training set of patient data. The "firmware development" mentioned (page 5) refers to traditional software engineering processes, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no AI/ML training set, there is no ground truth establishment process for it.
§ 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).