(28 days)
CoolTone is indicated to be used for:
• Improvement of abdominal tone, strengthening of the abdominal muscles, development for firmer abdomen.
• Strengthening, Toning and Firming of buttocks and thighs.
The CoolTone is a non-invasive therapeutic device. The device produces an electromagnetic field that interacts with the tissues of the human body. By muscle stimulation, the CoolTone helps to strengthen, tone and firm abdomen, buttocks and thighs.
The device housing protects the patient from electrical shock and mechanical injuries. The device is a mobile standalone equipment with four wheels.
Two large applicators are connected to the control unit and can be used simultaneously depending on the treatment. The device is a medical equipment that generates a magnetic field by applying a strong current to an applicator. The CoolTone is equipped with the securement system which is designed to maintain applicator position throughout treatment.
A large color touch screen facilitates the use of the device. The on-screen information guides the user step-by-step through the entire treatment process. The treatment is operated through parameters such as frequency, time and intensity. Three pre-set treatment options are available for users to choose from: Abdomen, buttocks and thighs.
Here's a breakdown of the acceptance criteria and study information for the CoolTone device, based on the provided FDA 510(k) summary:
The document states: "No clinical testing was required for this change." This indicates that a formal clinical study with specific acceptance criteria and performance metrics for the device's indications for use was not performed within this submission.
Therefore, I cannot provide a table of acceptance criteria and reported device performance directly from a clinical study for the CoolTone in relation to its intended use (improvement of abdominal tone, strengthening of abdominal muscles, development of firmer abdomen; strengthening, toning, and firming of buttocks and thighs).
The performance data presented focuses on verifying that changes made to the device (compared to its predicate) do not raise new questions of safety and effectiveness, rather than proving the device meets specific clinical performance acceptance criteria.
However, I can extract information related to the device's technical specifications and how its performance was verified against its predicate:
Acceptance Criteria and Reported Device Performance (Technical Verification - Not Clinical Outcomes)
While no clinical performance acceptance criteria are explicitly stated and met in a human study, the technical performance of the device was verified against its design specifications, particularly concerning the magnetic field intensity when using two applicators simultaneously.
| Acceptance Criteria (Technical) | Reported Device Performance (Technical) |
|---|---|
| Magnetic field intensity for two large applicators (operated separately or simultaneously) within 0.5 – 1.35T +/- 20% | Confirmed: The two applicators, operated separately or simultaneously, performed within the magnetic field intensity of 0.5 – 1.35T +/- 20%. Magnetic Field at applicator center surface measured as 1.43T. |
| Tissue being treated by the device does not present an appreciable rise in temperature at maximum intensity. | Confirmed: The tissue being treated by the device does not present an appreciable rise in temperature at maximum intensity to cause a risk to the patient. |
| Compliance with software requirements, design specifications, and software architecture. | All tests (Integration Tests and System Level Test) were performed successfully and met their acceptance criteria. |
| Biocompatibility of new securement system materials (applicator covers, strap, connection piece) per ISO 10993-5 and -10. | The securement system complies with ISO 10993-5: 2009, and ISO 10993-10: 2010. |
| Electrical safety and electromagnetic compatibility (EMC) per IEC 60601-1 and IEC 60601-1-2. | The system complies with IEC 60601-1:2005 + CORR: 1:2006 + CORR. 2:2007 + A1:2012 (Edition 3.1), and IEC 60601-1-2:2014 (Fourth Edition). |
Study Information (Based on the Provided Document)
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable for clinical performance. The document explicitly states, "No clinical testing was required for this change." The "testing" mentioned pertains to technical verification (software, biocompatibility, electrical safety, essential performance of magnetic field). These tests are typically conducted in a lab environment.
- For the technical verifications, specific sample sizes (e.g., number of devices tested, number of material samples for biocompatibility) are not detailed but are assumed to meet relevant standard requirements.
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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 for clinical ground truth. Since no clinical study was performed for this submission, no expert consensus was established for patient-reported or clinically observed outcomes.
- For technical ground truth (e.g., software functionality, magnetic field strength), the "experts" would be the engineers and technicians involved in performing the verification tests against established technical specifications and compliance standards. Their qualifications are inherent in their professional roles within the device manufacturer and testing labs.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for clinical adjudication. As no clinical study was conducted, there was no need for clinical adjudication.
- For technical tests, the "adjudication" is typically against the pre-defined test protocols, acceptance criteria, and compliance standards. This review is usually performed by quality assurance and regulatory personnel.
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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 and does not involve "readers" or "cases" in the context of medical imaging or AI assistance for diagnostic tasks. It's a therapeutic device.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable in the usual sense of diagnostic algorithms. The "algorithm" here refers to the device's software control of the magnetic field. Its "standalone performance" is validated through the essential performance testing that confirms the magnetic field intensity and temperature safety without human intervention in the physical operation, once parameters are set.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this submission is based on technical specifications, compliance with recognized voluntary standards (e.g., IEC, ISO), and engineering measurements.
- For example:
- Magnetic field intensity measurements are compared against the specified range (0.5 – 1.35T +/- 20%).
- Temperature rise on tissue is compared against safety thresholds.
- Biocompatibility is assessed against ISO 10993 standards.
- Software functionality is validated against documented software requirements and design specifications.
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The sample size for the training set:
- Not applicable. This device is a physical therapeutic device, not an AI/ML-driven diagnostic or predictive algorithm that typically uses a "training set." The software controls the device's physical operation.
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How the ground truth for the training set was established:
- Not applicable. As there is no training set in the context of AI/ML, there's no ground truth established for it.
§ 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).