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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.

The provided FDA 510(k) clearance letter pertains to the CoolTone device (K251378). It states that this device is substantially equivalent to a previously cleared CoolTone device (K220601).

Crucially, the document explicitly states: "No clinical testing was required for this change." This means that for the K251378 submission, no new studies were performed to prove the device meets acceptance criteria. Instead, the clearance relies on its substantial equivalence to the predicate device, which presumably had clinical data supporting its initial clearance.

Therefore, many of the requested information points regarding acceptance criteria and study details cannot be directly extracted from this specific 510(k) clearance letter. The information below reflects what can be inferred or directly cited from the provided text about K251378, with an acknowledgement that the core "proof" resides within the documentation for the predicate device (K220601).

1. Table of Acceptance Criteria and Reported Device Performance

As stated, no new clinical study was conducted for this specific 510(k) submission (K251378). Therefore, there are no new acceptance criteria or reported device performance for this updated device. The clearance is based on the identical technological characteristics and indications for use to the predicate device (K220601). The "acceptance criteria" for K251378 are implicitly met by demonstrating substantial equivalence to the predicate device, meaning it performs as safely and effectively for the stated indications.

2. Sample size used for the test set and the data provenance

Not applicable for K251378 as no new clinical testing was performed for this submission. The substantial equivalence argument relies on prior data for the predicate device (K220601).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable for K251378 as no new clinical testing was performed for this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for K251378 as no new clinical testing was performed for this submission.

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 for K251378. The CoolTone device is a powered muscle stimulator, not an AI-assisted diagnostic or imaging device that would typically involve human readers or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable for K251378. The CoolTone is a physical device for muscle stimulation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable for K251378 as no new clinical testing was performed. For the predicate device (K220601), clinical trials would likely have used objective measurements (e.g., imaging to assess muscle thickness, physical measurements for circumference changes, or patient/physician reported outcomes on tone/firmness) to establish the ground truth for muscle strengthening, toning, and firming.

8. The sample size for the training set

Not applicable for K251378 as no new clinical testing or algorithm training was performed for this submission.

9. How the ground truth for the training set was established

Not applicable for K251378 as no new clinical testing or algorithm training was performed for this submission.

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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.

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.

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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.

Study Information (Based on the Provided Document)

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

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