(88 days)
As a powered muscle stimulator the Biofeedback Nerve and Muscle Stimulator is indicated for the following conditions:
· Relaxation of muscle spasm
· Prevention or retardation of disuse atrophy
·Increasing local blood circulation
· Muscle re-education
·Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
· Maintaining or increasing range of motion
As a biofeedback device the Biofeedback Nerve and Muscle Stimulator is indicated for the following conditions: · Biofeedback, relaxation and muscle re-education purposes
As a nonimplanted electrical continence device the Biofeedback Nerve and Muscle Stimulator is indicated for the following conditions:
· Acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Inhibition of the detruser muscles through reflexive mechanisms and strengthening of pelvic floor muscles.
·Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles such as the abdominal and the gluteus muscles.
This Biofeedback Nerve and Muscle Stimulator is a new type of biofeedback and neuromuscular electrical stimulation therapy device through the evaluation of myoelectric signal acquisition, multimedia biofeedback training, electromyography triggered electrical stimulation, passive electrical stimulation training and treatment.
There are two models of Biofeedback Nerve and Muscle Stimulator which are KM530 and KM531. Their intended use, working principle, product structure and major parameters are all same, apart from the difference of product appearance, and KM531 has several more programs than KM530.
The device is battery-powered with a display screen and offers the user a choice of EMG Test (Only for EMG acquisition, not for electrical stimulation), EMG Game (6 biofeedback responsebased vivid games, active training for the user to contract the muscles of the treatment area, no electrical stimulation is generated), ETS (electromyography triggered stimulation; Only when the EMG value reaches the set threshold, the electrical stimulation is triggered; This module is a combination of active and passive treatment module, which exercise the self-contracting ability of the user), and STIM (Neuromuscular stimulation with fixed programs and customized programs of which parameters can be adjusted under the directions of physicians or professionals).
The device is supplied with vaginally inserted probe used with the device to stimulate the muscle of the pelvic floor (the probe is identical to that used in the model KM518 with 510(k) number K163288). Anal probe is optional, user can choose to purchase qualified probe. The device is supplied with biofeedback reference lead wire with skin electrodes. The device main unit connects directly to the vaginal electrode and reference wire by cable and plug. The device provides independent dual-channel EMG signals acquisition and dual-channel electrical stimulation output which is convenient for the treatment of different sites.
I am designed to extract acceptance criteria and information about studies that prove a device meets those criteria. However, the provided document is a 510(k) summary for a "Biofeedback Nerve and Muscle Stimulator" and does not contain acceptance criteria in the format typically associated with performance metrics for clinical studies.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices by comparing technical characteristics (e.g., electrical output specifications, EMG performance, safety standards compliance) and indications for use. It outlines the non-clinical tests performed to ensure the device meets design specifications and relevant safety standards.
Therefore, many of the requested fields regarding acceptance criteria, sample size for test sets, expert ground truth, adjudication methods, MRMC studies, or specific effect sizes are not applicable in this context, as the document does not describe a clinical performance study with such endpoints.
Here's a breakdown of the information that is available in the provided text:
1. A table of acceptance criteria and the reported device performance
The document doesn't present specific acceptance criteria in a table; rather, it compares the technical specifications and performance characteristics of the proposed device ("Targeted device") against a "Predicate device" and "Reference devices." The "acceptance" can be inferred as being "similar" or "within the range" of the predicate devices.
| Item | Acceptance Criteria (Implied: Similar to/within range of Predicate) | Reported Device Performance (Targeted Device) | Predicate Device (STIWELL med4) Performance | Reference Device 1 (MyoTrac Infiniti System) Performance | Reference Device 2 (Kegel8) Performance |
|---|---|---|---|---|---|
| General | |||||
| Regulation number | Same as Predicate | 21 CFR 890.5850, 876.5320, 882.5050 | 21 CFR 890.5850, 876.5320, 882.5050, 882.5890, 882.5810 | 21 CFR 890.5850, 882.5050, 876.5320 | 21CFR876.5320 |
| Regulation description | Same as Predicate | Powered muscle stimulator; Nonimplanted electrical continence device; Biofeedback device | Powered muscle stimulator; Nonimplanted electrical continence device; Biofeedback device; Transcutaneous electrical nerve stimulator for pain relief; External functional neuromuscular stimulator | Powered muscle stimulator; Biofeedback device; Nonimplanted electrical continence device | Non-implanted electrical continence device |
| Product code | Same as Predicate | IPF, KPI, HCC | IPF, KPI, HCC, GZJ, GZI | IPF, HCC, KPI | KPI |
| Class | Same as Predicate | II | II | II | II |
| Indications for use | Similar to Predicate | As listed in section (6) | As listed in section (7) of comparison table in document | As listed in section (7) of comparison table in document | As listed in section (7) of comparison table in document |
| Patient population | Adult | Adult | Adult | Adult | Adult |
| Location for use | Prescription | Prescription | Prescription | Prescription | Prescription |
| Basic unit specification | |||||
| Power supply | Similar | 7.4V DC/1200mAh rechargeable lithium battery | Battery Pack Li-lon 11.1V | 4X AAA 1.5 Alkaline or rechargeable NiMH Battery pack 6VDC-15W Medical Class II power adapter | 9V PP3 |
| Method Line Current Isolation | Same | N/A | Medical Class II Power Adapter | N/A | N/A-powered |
| Leakage current | Same | N/A (Battery) | N/A (Battery) | N/A | N/A-powered |
| Number of output modes | Similar (Note 2) | 2 | 1 | / | 1 |
| Number of output channel | Same | 2 | 4 | / | 2 |
| Synchronous or Alternating? | Similar | Synchronous | Alternating | / | Synchronous/Alternating |
| Method of channel isolation | Same | Transformer | Transformer, inductive couplers | / | Individually isolated circuits |
| Software/Firmware/Microprocessor/Control? | Yes | Yes | Yes | Yes | Yes |
| Automatic Overload trip | Yes | Yes | Yes | / | Not publicly available |
| Automatic no-load trip | Yes | Yes | Yes | / | Not publicly available |
| Patient override control method | Yes (similar to Predicate) | Yes | Yes (Stop Button) | / | Not publicly available |
| Indicator display | Yes | Yes | Yes | / | Yes |
| Automatic Shut Off | Yes | Yes | Yes | / | Yes |
| Timer range | Similar | 1-99min, adjustable | 2-120min | / | Up to 90 |
| Dimensions | Different (Note 3) | KM530: 140.5×25.5×69mm; KM531: 146.5×29×74mm | 175×95×30mm | / | 6.2cm W x 2.3cm D x 10.8cm H |
| Weight | Different (Note 3) | KM530: 192 g; KM531: 230g | 440g | / | 0.07 Kg without battery, 0.1KG with battery |
| Housing material and construction | Plastic | Plastic | Plastics | / | / |
| Compliance with voluntary standards | Same | IEC 60601-1, 60601-1-2, 60601-1-11, 60601-2-10, 60601-2-40 | IEC 60601-1, 60601-1-2, 60601-2-10 | / | IEC 60601-1, 60601-1-2, 60601-2-10 |
| Compliance with 21CFR 898 | Yes | Yes | Yes | Yes | Yes |
| Output specifications | |||||
| Waveform | Similar | Pulsed symmetric, asymmetric, biphasic square wave | Pulsed symmetrical, rectangular wave | Asymmetrical Balanced Pulsed Current | Biphasic, Rectangular |
| Maximum output voltage | Similar (within range of predicate) | 47.2V @ 500Ω, 108V @ 2kΩ, 150V@ 10kΩ | 50V @500Ω, 115V@2kΩ, N/A | / | 45V @ 500Ω, 100V @ 2kΩ, 190V @ 10kΩ |
| Maximum output current | Similar (within range of predicate) | 94.4mA @ 500Ω, 54mA @ 2kΩ, 15mA@ 10kΩ | 100mA@500Ω, 58mA@2kΩ, N/A | 100mA | 90mA @ 500Ω, 50mA @ 2kΩ, 19mA @ 10kΩ |
| Net Charge (per pulse) | Similar (Note 4) | For pulsed symmetric, biphasic: 0µC @ 500Ω; For pulsed asymmetric, biphasic: 15.68μC @ 500Ω | 0µC @ 500Ω | / | 0 [μC] @ 500Ω |
| Maximum Phase Charge (500Ω) | Similar | 51.4µC @ 500Ω | EMS: 40µC @500Ω, Incontinence: 50µC @ 500Ω | 60μC | 40.5µC @ 500Ω |
| Maximum current density (500Ω) | Similar | 6.01mA/ cm²@ 500Ω | EMS: 12.5mA/cm²@ 500Ω, Incontinence: 4.7mA/cm²@ 500Ω | St-Cloud Vaginal 6.76mA/cm², Femelex Vaginal 4.76mA/cm², St-Cloud Rectal 19.72mA/cm² | 14.1 [mA/cm²] |
| Maximum power density (500Ω) | Similar | 0.012W(12mW) cm2@ 500Ω | EMS: 7.9mW/cm²@ 500Ω, Incontinence: 23.5μW/cm²@ 500Ω | St-Cloud Vaginal 22.84mW/cm², Femelex Vaginal 11.32mW/cm², St-Cloud Rectal 194mW/cm² | 57 [mW/cm²] |
| Pulse frequency | Similar | 2-100Hz | 1-140Hz | 12.5,50,100,200Hz | 2 to 100Hz |
| Pulse duration | Similar | 50-450μs | 50-400μs | 0.2ms | 50 to 450 [μsec] Program dependent |
| Biofeedback performance | |||||
| Number of EMG channel | Same | 2 | 2 | 2 | / |
| EMG sampling rate | Same | 3kHZ | 3kHz | / | / |
| EMG detection | Same | Bipolar | Bipolar | Bipolar | / |
| EMG range (μV) | Similar | 0.2-2000μV | 1-2000μV | 0-5, 0-10, 5-10, 0-20, 5-20, 10-20, 0-50, 10-50, 0-100, 50-100,0-200, 50-200, 100-200, 0-500,100-500, 0-1000, 0-2000 | / |
| EMG bandwidth | Same | 20Hz-500Hz | 70-480Hz | 20Hz-500Hz | / |
| EMG signal processing | Same | Root mean square (RMS) | AVR (Average Rectified Value) | Root mean square (RMS) | / |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. The document describes non-clinical engineering and bench tests, not a clinical study involving human subjects or data sets that would have a "sample size" or "data provenance" in the traditional sense. Tests were conducted to verify compliance with design specifications and relevant standards.
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. Ground truth, in this context, would refer to defined engineering specifications and international standards, not expert assessments of clinical cases. The "experts" would be the engineers and regulatory compliance personnel who developed and tested the device and verified its adherence to the standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are relevant for studies where there is ambiguity or disagreement in truth determination, typically in clinical assessments. This document pertains to objective engineering and electrical performance tests.
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 a Biofeedback Nerve and Muscle Stimulator, not an AI-assisted diagnostic or interpretive device for human "readers." No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This device is not an algorithm, but a physical medical device. Its "standalone" performance refers to its ability to meet its technical specifications and safety standards independent of user interaction (e.g., electrical output, EMG acquisition accuracy, battery performance), which was evaluated through the non-clinical tests mentioned. Specific quantitative standalone performance metrics beyond "meets design specifications" are not provided in this summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical tests, the "ground truth" was based on:
- Design Specifications: The manufacturer's own internal design requirements for the device.
- International Standards: Compliance with recognized international standards for medical electrical equipment (e.g., IEC 60601 series) and biological evaluation of medical devices (e.g., ISO 10993 series).
- Predicate Device Characteristics: The performance parameters and characteristics of legally marketed predicate devices, against which the new device was compared to establish substantial equivalence.
8. The sample size for the training set
- Not Applicable. This document does not describe the development of an AI algorithm or a study with a training set.
9. How the ground truth for the training set was established
- Not Applicable. No training set was used.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).