(226 days)
Tone-A-Maticis indicated to be used for
L Russian and EMS for:
- . Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy .
- . Increase local blood circulation
- Muscle re-education .
- . Maintaining or increasing range of motion
- Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.
TENS for:
ロ - Symptomatic relief of chronic, intractable pain.
- · Management of pain associated with post-traumatic or post-operative conditions.
The Tone-A-Matic is a Tone-A-Matic Device is Non-TRANSIT-OPERABLE and PORTABLE micro-controller operated device not to be Worn by patient. It generates electrical impulses and effectively transfers your desired choice of these pre-programmed electrical impulses directly through the electrode adhesive pads to the suggested area of the body where the electrodes are placed. Tone-A-Matic was developed based on physics, electro biology and modern micro-electronic technology. You will be more than pleased with this state-of-the-art device.
The Tone-A-Matic is very user friendly with a large liguid crystal display (LCD) screen that displays the treatment mode in use, a countdown timer and battery indicator. The intensity of the treatment can be increased or decreased by Keypads. User can set the time of the treatment from available choice of 1 min. to 60 min.
It is a clinical model with easy user interface and versatility to treat different body areas simultaneously. This aesthetically designed clinical model has 3 selectable modes(Russian, TENS, EMS) and treatment parameters. The state of the art Tone-A-Matic is light weight (1.78 Kg), small in size (10.3" X 7.5" X 3.5", LxWxH) and battery powered which allows it to be easily moved to any location for immediate use.
This descriptive study compares the Tone-A-Matic device to a predicate device, Winstim (K102190). It does not present a standalone clinical study with an acceptance criterion and reported device performance in the traditional sense of a diagnostic or therapeutic efficacy trial. Instead, it relies on demonstrating substantial equivalence to a legally marketed device through non-clinical testing and comparison of technical specifications and intended uses.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission focused on substantial equivalence rather than a clinical performance study with predefined acceptance criteria for a specific outcome, a direct "acceptance criteria" table for device performance (e.g., sensitivity, specificity, accuracy) is not applicable or provided. Instead, the acceptance criteria for a 510(k) are typically met by demonstrating that the new device has "the same intended use" and "similar technological characteristics" as a predicate device and raises "no new questions of safety or effectiveness."
The "reported device performance" in this context is the technical specifications and safety/EMC compliance, which are compared to the predicate device to justify substantial equivalence.
| Feature | PREDICATE DEVICE (Winstim) Performance | NEW DEVICE (Tone-A-Matic) Performance | Acceptance Criteria (Implied by Substantial Equivalence) |
|---|---|---|---|
| Intended Use | Relax muscle spasms, prevent disuse atrophy, increase local blood circulation, muscle re-education, increase range of motion, prevent venous thrombosis (Russian & EMS); Symptomatic relief of chronic/intractable pain, manage post-traumatic/post-operative pain (TENS); Therapeutic deep heat (Ultrasound). | Relax muscle spasms, prevent disuse atrophy, increase local blood circulation, muscle re-education, increase range of motion, prevent venous thrombosis (Russian & EMS); Symptomatic relief of chronic/intractable pain, manage post-traumatic/post-operative pain (TENS). | Identical or highly similar intended uses. (Met, excluding Ultrasound function). |
| Power Source | 24 VDC Adaptor and rechargeable battery | 24 VDC Adaptor and rechargeable battery operated | Equivalent power source. (Met) |
| Waveform | Russian: Sinusoidal; TENS: Square Wave; EMS: Square Wave | Russian: Square Wave; TENS: Square Wave; EMS: Square Wave | Similar waveforms or justification for differences not impacting safety/effectiveness. (Difference noted for Russian, but considered insignificant for overall equivalence). |
| Max Output Voltage | Russian: 50 Vpp @ 500Ω; TENS: 57 Vpp @ 500Ω, 225 Vpp @ 2KΩ; EMS: 57 Vpp @ 500Ω, 225 Vpp @ 2KΩ | Russian: 50 Vpp @ 500Ω, 60Vpp @2KΩ; TENS: 57 Vpp @ 500Ω, 90Vpp @2KΩ; EMS: 57 Vpp @ 500Ω, 90Vpp @2KΩ | Output voltage within comparable and safe ranges. (Comparability assessed). |
| Max Output Current | Russian: 100 mA @ 500Ω; TENS: 114 mA @ 500Ω, 112.5 mA @ 2KΩ; EMS: 114 mA pp @ 500Ω, 112.5 mA @ 2KΩ | Russian: 100 mA pp @ 500Ω, 30mA pp @ 2KΩ; TENS: 114 mA @ 500Ω, 45mA pp @ 2KΩ; EMS: 114 mA pp @ 500Ω, 45mA pp @ 2KΩ | Output current within comparable and safe ranges. (Comparability assessed). |
| Number of Outputs | 7 modes (for Winstim, unclear if this means outputs) | 8 outputs | Number of outputs/channels comparable or justified difference. (Difference, but likely not impact to safety/effectiveness). |
| Channels | Synchronous; Ch 1&2 isolated; Electrotherapy & Ultrasound isolated | Synchronous; Ch 1&2 isolated | Isolation features for safety. (Met, except for Ultrasound specific isolation which new device lacks). |
| Net Charge | All modes: 0 μC | All modes: 0 μC | No net charge for safety. (Met) |
| Max Phase Charge | Russian: 20.00 μC; TENS: 22.5 μC; EMS: 22.5 μC | Russian: 20.00 μC; TENS: 22.5 μC; EMS: 22.5 μC | Max phase charge within safe limits. (Met) |
| Max Current Density | Russian: 3.87 mA/cm2; TENS: 4.41 mA/cm2; EMS: 4.41 mA/cm2 | Russian: 3.87 mA/cm2; TENS: 4.41 mA / cm2; EMS: 4.41 mA / cm2 | Current density within safe limits. (Met) |
| Max Power Density | Russian: 0.246 Watt/cm²; TENS: 0.064 Watt/cm²; EMS: 0.064 Watt/cm² | Russian: 0.193 Watt/cm2; TENS: 0.251 Watt / cm2; EMS: 0.251 Watt / cm2 | Power density within safe limits. (Comparability assessed). |
| Treatment Time | 1 - 100 MINUTES | 1 - 60 MINUTES | Treatment time range acceptable. (Difference, but within typical usage and safe limits). |
| Safety Standards | Not explicitly listed, but implied by 510(k) clearance | IEC 60601-1. Ed3.0, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11, ISO 14971: 2007 | Compliance with relevant international safety and EMC standards. (Met) |
| Software Guidance | Not explicitly listed, but implied by 510(k) clearance | FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices | Compliance with relevant software guidance. (Met) |
The study (the 510(k) submission) "proves" the device meets acceptance criteria by presenting a detailed comparison of its technical specifications and intended use against a legally marketed predicate device (Winstim, K102190). The conclusion states: "The electrical stimulation provided by the Tone-A-Matic device is similar to that of Predicate Device Winstim... Tone-A-Matic has same intended use and similar technological characteristics... and the verification and validation tests contained in this submission demonstrate that the differences... still maintain the same safety and effectiveness as that of the cleared predicate."
2. Sample Size Used for the Test Set and the Data Provenance
This is not a clinical study involving human or animal subjects for performance testing in the sense of a "test set." The "test set" here refers to the data generated from non-clinical bench testing of the device's electrical characteristics and compliance with standards. Therefore:
- Sample size: Not applicable in the context of a clinical test set. The submission refers to non-clinical tests performed on the Tone-A-Matic device itself to verify its specifications and compliance with standards. The number of individual devices tested or the extent of that testing is not specified, but it would typically involve one or more production units subjected to comprehensive engineering tests.
- Data provenance: The data would be generated in a laboratory setting by the manufacturer, Tone-A-Matic International Inc., during the design, development, and verification stages of the device. It is retrospective in the sense that these tests were performed to support the premarket submission. The country of origin for the data generation would be where the manufacturer conducted these tests (likely Canada or the manufacturing location, if different).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is a non-clinical submission. Ground truth, in the context of clinical studies, refers to definitive diagnoses or outcomes. For this type of submission, "ground truth" for the device's performance is established by engineering measurements and compliance with established international standards (e.g., IEC 60601 series). The "experts" involved would be the engineers and quality assurance professionals performing and reviewing these tests, ensuring they align with the device's design specifications and regulatory requirements. Their qualifications would be in electrical engineering, biomedical engineering, and regulatory compliance.
4. Adjudication Method for the Test Set
Not applicable. As no human readers or clinical interpretations are involved in establishing performance or ground truth for this non-clinical submission, there is no adjudication method. The outcome is determined by direct measurement and comparison to predefined technical standards.
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 powered muscle stimulator/TENS unit, not an AI-assisted diagnostic or therapeutic technology that would typically be evaluated with MRMC studies comparing human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable in the typical sense of AI algorithm performance. This device is an electrotherapy device. Its "performance" is its ability to generate specific electrical waveforms and outputs as designed and comply with safety standards. The non-clinical tests performed (electrical safety, EMC, software verification) represent the standalone assessment of the device against its specifications and applicable standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" used for this submission is based on:
- Engineering specifications and measurements: The device is designed to produce specific electrical parameters (voltage, current, waveforms, phase charge, etc.). The non-clinical tests verify that the device's actual output matches these design specifications within acceptable tolerances.
- International safety and performance standards: Compliance with standards like IEC 60601 series, ISO 14971, and FDA software guidance serves as a "ground truth" for safe and effective design and manufacturing.
- Predicate device characteristics: The ground truth for demonstrating substantial equivalence is the established safety and effectiveness of the legally marketed predicate device (Winstim, K102190). The new device is compared directly to these known characteristics.
8. The Sample Size for the Training Set
Not applicable. As this device does not involve machine learning or AI algorithms, there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device.
§ 890.5860 Ultrasound and muscle stimulator.
(a)
Ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies. The device also passes electrical currents through the body area to stimulate or relax muscles.(2)
Classification. Class II (performance standards).(b)
Ultrasound and muscle stimulator for all other uses —(1)Identification. An ultrasound and muscle stimulator for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and applies to the body electrical currents and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues and the stimulation or relaxation of muscles as described in paragraph (a) of this section.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999 for any ultrasound and muscle stimulator described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an ultrasound and muscle stimulator described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasound and muscle stimulator described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.