(30 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 system 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 the abdomen, buttocks and thighs.
The device is a mobile, standalone unit with four wheels and the control unit housing protects the patient from electrical shock and mechanical injury.
Two large applicators are connected to the control unit and can be used simultaneously depending on the treatment. CoolTone is a medical device that generates a magnetic field by applying a strong current to an applicator. It is equipped with the securement system, designed to maintain the position of the applicator 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 variable parameters such as frequency, time and intensity. Three, pre-set treatment options are available for users to choose from: Abdomen, buttocks and thighs.
This document is a 510(k) Premarket Notification for the CoolTone device. It states that the device is substantially equivalent to a previously cleared predicate device (K192940). As such, the purpose of this submission is not to prove new efficacy or safety but rather to demonstrate that modifications made to the device do not change its substantial equivalence to the predicate. Therefore, this document does not contain a new clinical study from which to extract acceptance criteria and performance data in the typical sense of a de novo device or a device with new indications.
The relevant sections to address your request will derive from the comparison to the predicate device and the performance testing conducted to show the current device continues to meet the predicate's performance.
Based on the provided text, here's an attempt to answer your questions, but many points will indicate that a new study to prove the device meets acceptance criteria was not required for this 510(k) submission, as it's establishing substantial equivalence to an existing cleared device with minor modifications.
Here's the analysis of the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" for a new clinical study. Instead, it demonstrates that the modified device maintains the same performance characteristics as the predicate device (CoolTone K192940). The performance data section primarily focuses on compliance with voluntary standards and the effects of the engineering changes.
| Acceptance Criterion (Implicitly referring to predicate device performance) | Reported Device Performance (Subject CoolTone) |
|---|---|
| Magnetic Field Intensity: 0.5-1.35T ± 20% | 0.5 – 1.35T +/- 20% The System Level Testing confirmed that the two applicators, either operated separately or simultaneously, performed within this range. |
| Tissue Temperature Rise: No appreciable rise in temperature at maximum intensity to cause patient risk. | The System Level Testing confirmed that "the tissue being treated by the device is not subjected to an appreciable rise in temperature at maximum intensity to cause a risk to the patient." |
| Electrical Safety: Compliance with ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R) 2012 and A2:2010/(R)2012 | Complies The system (control unit and applicator) underwent electrical and mechanical safety performance testing and complies with this standard. |
| Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2:2014 (Edition 4.0) | Complies The control unit underwent electromagnetic compatibility testing and complies with this standard. The applicator did not require additional EMC testing because the changes did not affect its electromagnetic compatibility. |
| Software Verification & Validation: Meeting requirements as per FDA guidance | Met all acceptance criteria. Software verification was performed in three steps: verification of the software requirements, verification of the design specifications and verification of the software architecture. All tests, including Integration Tests and System Level Test, were performed successfully and met their acceptance criteria. |
| Biocompatibility: No changes to patient-contacting materials, thus maintaining previous biocompatibility. | No changes There were no changes to patient-contacting materials in comparison with the previously cleared predicate device, implying continued biocompatibility. |
| Cybersecurity: No impact on cybersecurity from software changes. | No impact. Cybersecurity risk management was performed. The changes made to the predicate's system software have no impact on cybersecurity. |
| Therapy Time: Up to 30 min | Same as predicate. |
| Pulse Repetition Rate: 1 - 150 Hz | Same as predicate. |
| Pulse Duration: 370 µs ± 20% | Same as predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not applicable for a clinical test set from this document. The "test set" here refers to engineering and performance verification tests of the device itself (e.g., electrical safety, EMC, software). Specific numbers are not provided for electrical and mechanical safety performance testing or EMC testing, but it states these were "undergone." The system level testing mentioned refers to device performance parameters (magnetic field, temperature) and not a patient-based clinical study.
- Data Provenance: Not applicable for a clinical test set. The testing is for the device's technical specifications.
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)
This 510(k) submission is for modifications to a physical therapeutic device, not an AI/imaging device requiring expert interpretation of outputs. Therefore, there are no "experts" establishing ground truth in the sense of medical image annotation or diagnosis. The "ground truth" for the device's performance is its technical specifications and compliance with established engineering and safety standards (e.g., IEC, ANSI AAMI).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an image-based or diagnostic study requiring adjudication of expert interpretations.
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, not an AI or imaging device, and no clinical MRMC study was conducted or required for this 510(k) submission (as stated in Section VII: "No clinical testing was required for these changes.").
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the device's functional performance tests (e.g., magnetic field output, temperature control) as described under "Performance Testing" and compliance with engineering standards. It is a standalone device in that its primary function is to directly stimulate muscles, not provide algorithmic analysis to a human. The document confirms that the device's physical performance characteristics (e.g., magnetic field intensity, temperature rise) were tested.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" here is based on:
- Engineering Specifications and Standards: The device's technical parameters (e.g., magnetic field intensity, pulse duration, frequency) were verified against its design specifications and relevant international standards (e.g., ANSI AAMI ES 60601-1, IEC 60601-1-2, ISO 62304).
- Predicate Device Performance: The primary "ground truth" for substantial equivalence is that the modified device performs identically or equivalently to the predicate device (CoolTone K192940) for its intended use.
- Safety and Biocompatibility Standards: Compliance with standards like ISO 10993 for biocompatibility and IEC 60601 series for electrical safety.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device with a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device and submission.
§ 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).