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1. Relaxation of muscle spasms
1. Prevention or retardation of disuse atrophy
1. Increasing local blood circulation
1. Muscle re-education
1. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
1. Maintaining or increasing range of motion

Device Description

The Smartwave MS 2000 Muscle Stimulator is a Square wave generator designed for neuromuscular electrical stimulation (NMES). The MS 2000 stimulates neuromuscular tissues through cutaneous electrodes connected by lead wires to the generator.

AI/ML Overview

This 510(k) submission (K041063) for the Smartwave MS 2000 Muscle Stimulator does not contain a study that demonstrates the device meets specific acceptance criteria through performance evaluation. Instead, the submission relies on demonstrating substantial equivalence to a predicate device (Staodyn EMS +2, K926510).

The acceptance criteria are implied by the comparison to the predicate device, where the new device is expected to have similar technological characteristics and performance specifications for its intended use. There are no explicit performance metrics stated as "acceptance criteria" against which the new device's performance is measured in a clinical or analytical study within this document.

Here's an breakdown of the information based on the provided text, keeping in mind the absence of a direct study proving performance against explicit acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

As there are no explicit "acceptance criteria" presented as objective performance targets in this document, and no direct performance study, this table cannot be fully populated as requested. However, a comparison of the new device's specifications against the predicate device's specifications (which serve as the de-facto "acceptance criteria" for substantial equivalence) can be presented:

Feature/Parameter	Acceptance Criteria (Predicate Device K926510 - Staodyn EMS +2)	Reported Device Performance (Smartwave MS 2000)
Power Source	9V	9V
Optional Wall Adapter	No	Yes (100-120vac, 50-60Hz)
Method of Line Current Isolation	Transformer coupled	Transformer coupled
Patient Leakage Current	Not specified	Normal condition: 3.2uA; Single fault: 6.5uA (with adapter)
# of Output Modes	Pulsed DC, AC	Pulsed DC, AC, Russian Stim
# of Output Channels	1 or 2	1 or 2
Synchronous Output	Yes	Yes
Reciprocal Output	No	No
Computerized	No	No
Software Provided	No	No
Constant Current (+5%)	Yes	Yes
Constant Voltage	No	No
Max Output Current (500Ω)	95.2mA	57.2mA
Max Output Current (2KΩ)	46.8mA	17.8mA
Max Output Current (10KΩ)	9.63mA	3.8mA
Max Output Voltage (500Ω)	47.6V	28.6V
Max Output Voltage (2KΩ)	93.6V	35.5V
Max Output Voltage (10KΩ)	96.3V	38.3V
Channel Isolation	Capacitor coupled	Independent isolation transformer
Line Current Isolation	N/A	Transformer coupled
Automatic Overload Trip	No	No
Automatic No Load Trip	No	Yes (turns off after 10 min if not used)
Patient Override Control	Yes (by turning off unit)	Yes (by turning off unit)
Indicator Display	No (rotary dials)	LCD (0 to 35 displayed intensity level)
Unit Functioning Indicator	Yes (red LEDs)	Yes
Low Battery Indicator	Yes (yellow LED on)	Yes (Lo b displayed @ <6.0V)
UL544 Compliance	Not specified (implied by predicate)	Yes (complies with UL544 Safety Standard for Medical Equip.)
Timer Settings (range)	15, 30, 60 min, constant on	0-60 min, 0 is constant on
Automatic Shut Off	Yes	Yes
Weight	9.8 oz.	6.24 oz.
Dimensions	5.4L x 3.2W x 1.15H	4.68L x 2.77W x 1.01H
Housing Materials	ABS plastic vacuum molded	ABS plastic injection molded

2. Sample Size Used for the Test Set and Data Provenance

No specific test set or associated sample size is reported for a performance study. The submission relies on comparative analysis of specifications against a legally marketed predicate device (Staodyn EMS +2, K926510).
Data Provenance: The data provided is from the device manufacturer (Newwave Medical, LLC) comparing its product's technical specifications to those of a predicate device. This is a retrospective comparison based on existing device specifications rather than prospective data collection from a new study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. There was no formal "test set" in the context of a clinical or performance study requiring a ground truth established by experts. Substantial equivalence is determined by regulatory review based on documented technical specifications.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring expert adjudication was conducted.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study was not performed. This type of study is typically used for diagnostic devices to assess human reader performance with and without AI assistance, which is not relevant for a muscle stimulator based on this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a hardware muscle stimulator, not an algorithm, so a standalone algorithm performance study is not relevant.

7. The Type of Ground Truth Used

Not applicable. As there was no performance study with a test set, there was no ground truth to be established in the context of pathology, outcomes data, or expert consensus. The "truth" in this submission relates to the adherence of the new device's specifications to those of the predicate and generally accepted electrical safety and performance standards for a muscle stimulator.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an artificial intelligence/machine learning device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set or associated ground truth.

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