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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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The PTG-05 is intended for:

• Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen.
• Strengthening, toning and firming of buttocks & thighs.
• Strengthening, toning and firming of arms

The PTG-05 is a non-invasive therapeutic device. The device produces an electrical current that interacts with the tissues of the human body. The PTG-05 is intended to increase the musculature of the abdominals, buttocks, arms and thighs. The device is intended to be used with single-use electrodes from Zimmer MedizinSysteme GmbH (K140340) or equivalent. The output of biphasic and middle frequency currents for muscle stimulation with maximum 8 channels at a time allows to treat several treatment areas simultaneously.

For an efficient treatment the user is guided via user interface throughout the whole treatment. First, the user can select the treatment area with the device illustrating where to place the electrodes. The modules are automatically matched to the specific treatment area while highlighted in the color of the matching trunk cable of the module.

In the therapy screen, the user can select one of the 5 pre-set treatment protocols for each treatment region based on the training level of the patient.

During the treatment, an animation of the electrodes is shown in the screen that outlines if the protocol is in a "work-phase" which means a contraction phase or if the protocol is in a "relax-phase" which refers to a muscle relax phase.

Expert mode
In addition, all 4 modules can be split into 8 channels using "Expert mode" for a precise adjustment of the individual channels. This is ideal to set different intensities for the inner musculature than for the outer musculature of a specific treatment area, for example.

Link-mode
All of the modules can be linked together which enables the use of the remote control where the patient by itself can set the intensity and stop the therapy at any time.

The provided text is a 510(k) summary for the PTG-05 device. It describes the device, its indications for use, and a comparison to a predicate device. However, it does not contain information about acceptance criteria or a clinical study proving device performance against such criteria. The "Performance data" section only mentions that testing for electrical safety, performance testing, biocompatibility, and usability were conducted satisfactorily, along with specific waveform measurements and adherence to consensus standards. It explicitly states: "All required performance tests were conducted and show substantial equivalence with the predicate device." This indicates technical performance testing, not clinical performance against acceptance criteria for the indicated uses (strengthening, toning, firming of muscles).

Therefore, based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets them in the way requested. The document focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and adherence to safety and performance standards, rather than presenting a clinical study with acceptance criteria for the stated indications.

If this were a document providing clinical study results, the requested information would typically be found in sections describing clinical trials, performance goals, statistical analysis, and outcomes related to the stated indications for use (muscle tone improvement, strengthening, toning, firming).

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The RFG-01 is intended to:

• provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
• provide, with a massage device, a temporary reduction in the appearance of cellulite.

The RFG-01 is a mobile standalone equipment with four wheels and consists of a console (main unit), a color display with touch operation and three handpieces (small, medium, and large). The device develops localized heat to warm the subcutaneous tissue by means of radio frequency energy, delivered through electrodes in contact with the patient. The purpose of the treatment based on the radiofrequency system is to raise the temperature inside the tissues up to maximum of 45°C. Therefore, depending on the treatment and intended use, different parts of the body can be treated. The devices use RF electrodes of the resistive (or bipolar) types. Resistive RF electrodes have different sizes and plug into an RF handpiece that provides connection to the RF generator (through the electrode connectors). Handpieces of different shapes are available to facilitate use by the operator on different body parts. The use of different sizes allows efficient and effective treatment of various parts of the body. Two of the three handpieces can be used with or without vacuum, allowing an even deeper application of heat. The handpieces are to be used with a small amount of contact lotion, the purpose of which is to assist in heat transfer. The LEDs on every handpiece indicate the coupling and the correct temperature range during the treatment. The color touchscreen displays all treatment-related parameters.

The provided text is a 510(k) Summary for the Zimmer MedizinSysteme GmbH RFG-01 device. It details the device's characteristics and its substantial equivalence to predicate devices, but it does not contain a detailed study with acceptance criteria and reported device performance in the format requested.

The document states that "Performance data" and "The following testing has been conducted with satisfactory results:" followed by a list of tests and standards. However, it does not provide specific numerical acceptance criteria or the measured performance results from these tests. It only lists the types of tests performed and the standards met.

Therefore, I cannot populate the table with specific acceptance criteria and reported device performance, nor can I provide details on sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set information. The document focuses on demonstrating substantial equivalence through compliance with recognized standards and comparison of technological characteristics, not through clinical performance metrics against defined acceptance criteria.

The information regarding acceptance criteria and reported device performance would typically be found in detailed test reports for the validation tests (e.g., RF Power Accuracy, Vacuum Pressure Accuracy, Thermal Effect on Skin testing), which are not included in this 510(k) Summary.

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MFG-05 is intended to provide entirely non-invasive electromagnetic stimulation of the pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of male and female urinary incontinence.

The MFG-05 is a non-invasive therapeutic device produces a magnetic field that interacts with the tissues of the human body. By stimulation of the pelvic floor musculature, the MFG-05 helps to treat of male and female urinary incontinence. The device housing protects the patient from electrical shock and mechanical injuries. The device is a mobile standalone equipment with four wheels. One applicator is available for therapy and is positioned centrally under the pelvic floor of the patient while the patient is wearing sport pants or any other pants without metallic parts. The device is for prescription use and used by a trained medical professional in a professional healthcare facility. The main body of MFG-05 is used to control the function of magnetic stimulation. It is operated with parameters such as frequency, time and intensity. These parameters can be controlled by the user on screen display and with the help of a rotary knob at the user control panel.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The testing described is primarily device performance testing (e.g., electromagnetic compatibility, electrical safety, magnetic field intensity measurement, tissue heating simulation), not clinical studies involving patient data.

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

This information is not applicable or provided in the context of this regulatory submission. The document focuses on technical performance and compliance with recognized standards rather than expert-derived ground truth from clinical cases.

4. Adjudication Method for the Test Set

This information is not applicable or provided. The testing described is against technical specifications and standards, not a review of clinical cases requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. The device, MFG-05, is a therapeutic device for muscle stimulation, not an imaging or diagnostic device that typically involves human readers or AI assistance in interpretation. The document compares the device to a predicate based on technical characteristics and performance standards.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable to the MFG-05. The device is a physical therapeutic device, not an AI algorithm. Its performance is evaluated through physical and electrical testing.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing is based on:

• Compliance with established voluntary standards: These standards define acceptable limits and testing methodologies for medical devices.
• Engineering specifications and design requirements: The device's performance (e.g., magnetic field intensity, temperature rise) is compared against its own design specifications.
• Comparison to predicate device's established performance: The safety and effectiveness are established by demonstrating that the MFG-05 performs comparably or within acceptable deviations from the legally marketed predicate device (HPM-6000UF).

8. The Sample Size for the Training Set

This information is not applicable as the MFG-05 is a physical medical device, not a machine learning or AI model that requires a training set.

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

This information is not applicable for the same reason as above.

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The ThermoTK device is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.

The ThermoTK massage device is intended to provide a temporary reduction in the appearance of cellulite.

ThermoTK is a medical diathermy device for external tissue heating on the human skin with the purpose of increasing tissue temperature by applying electromagnetic fields of 460 or 540 KHz.

The device includes a plastic housing with a capacitive touch display which guarantees an easy handling to select and start a treatment. In this housing, an electronic power module is implemented which drives the electromagnetic energy into the connected handpiece. By using the two adjusters, it is possible to set the treatment intensity and treatment time. Two handpieces for two different treatment modes are attached and can be connected to the control unit depending on which treatment mode the therapy has to be performed. An electrode (resistive or capacitive) has to be plugged on the handpiece for treatment. The device also includes two different electrode cables which can be connected with attached common electrodes (self-adhesive or reusable). For a better stability while using the handpiece during application, a silicone spacer can be put between handpiece and electrode.

The provided text is a 510(k) summary for the Zimmer MedizinSysteme GmbH ThermoTK device. It outlines the regulatory clearance process, device description, indications for use, and a comparison to a predicate device (Winback Back 3SE).

However, the document focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance data for the device itself.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not directly available in the provided text. The focus is on showing equivalence through technological characteristics and compliance with general safety and performance standards.

Here's a breakdown of what can and cannot be extracted from the provided document based on your request:

Information NOT available in the document (and why):

• A table of acceptance criteria and the reported device performance specific to a clinical study: The document states "No direct comparison was made since there are no significant differences in operation and test results indicate identical safety." and "According to this comparison table all required performance tests were conducted and show substantial equivalence with the predicate devices." This indicates that performance was assessed against standards for substantial equivalence, not against specific pre-defined clinical acceptance criteria in a study.
• Sample size used for the test set and data provenance: No clinical testing specific to the ThermoTK device's indications of use (pain relief, muscle spasms, cellulite reduction) is described with a test set, sample size, or data provenance. The document only lists compliance with general electrical safety, EMC, usability, software, risk management, and biocompatibility standards.
• Number of experts used to establish ground truth and qualifications: Not applicable as no
  clinical study with ground truth establishment is detailed.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study is not mentioned or implied.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an AI algorithm.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable as there is no mention of machine learning or AI models with training sets.
• How the ground truth for the training set was established: Not applicable.

Information that CAN be inferred or extracted from the document:

The document primarily highlights the acceptance criteria for regulatory clearance through substantial equivalence, which includes:

1. Compliance with recognized voluntary standards: This is the primary "performance data" presented.
2. Technological equivalence to a predicate device.
3. Identical Indications for Use.

Here's how to structure the available information:

Acceptance Criteria and Study for ThermoTK Device (Based on 510(k) Summary K213256)

The provided 510(k) summary for the ThermoTK device emphasizes demonstrating substantial equivalence to a predicate device (Winback Back 3SE - K162828) rather than presenting a standalone clinical performance study with specific acceptance criteria related to its stated indications for use (relief of pain, muscle spasms, increased local circulation, and reduction in cellulite appearance). The "study" in this context refers to the comprehensive testing and comparison performed to secure regulatory clearance.

1. Table of Acceptance Criteria (for Substantial Equivalence) and Reported Device Performance:

• Provide topical heating for elevating tissue temperature to treat selected medical conditions (relief of pain, muscle spasms, increase local circulation).
• Provide temporary reduction in the appearance of cellulite. |
  | Technological Characteristics Equivalence | The device's technological characteristics should be substantially similar to the predicate device, or any differences should not raise new questions of safety or effectiveness. | Similarities: Both are medical diathermy devices for external tissue heating (460/540 KHz vs 300 kHz-1 MHz RF), operate in unipolar/multipolar modes, have intensity adjustments (0-100%), and utilize resistive/capacitive modes.
  Differences: Max RF power (115VA vs 300W), presence of a patient safety switch (No vs Yes for predicate), specific electrode dimensions.
  Conclusion: "There are no significant technological differences... Those differences have been discussed and do not affect device safety or performance. The subject device has all features of the predicate device. ThermoTK does not raise any new types of safety or effectiveness questions." |
  | Voluntary Standards Compliance | The device must meet recognized industry standards for safety and performance relevant to its classification. | The ThermoTK device complied with the following standards:
• ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) (General requirements for basic safety and essential performance)
• IEC 60601-1-2:2014 (Electromagnetic disturbances)
• IEC 60601-1-6:2013 (Usability)
• IEC 62366-1:2015 (Usability engineering)
• IEC 62304:2015 (Medical devices software)
• ISO 14971:2019-12 (Application of risk management)
• ISO 15223-1:2016 (Symbols)
• ISO 10993-1:2018, 10993-5:2009, 10993-10:2010 (Biological evaluation/Biocompatibility) |
  | Safety Testing | Demonstrates electrical safety and biocompatibility. | "Electrical safety and biocompatibility have been established for both devices." Compliance with 60601-1 and 10993 series standards is listed as evidence. "Testing has been performed and all components, subassemblies and/or full devices and systems have met the required specifications for the completed tests." |

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

• The document does not describe a specific clinical "test set" or sample size for validating the efficacy of the ThermoTK device for its indications for use.
• Data provenance is related to compliance with general international standards and internal testing procedures for electrical safety, EMC, usability, and biocompatibility, rather than human clinical data from a specific country or nature (retrospective/prospective).

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

• Not applicable. The clearance is based on technological equivalence and compliance with standards, not on "ground truth" established by experts for clinical performance outcomes in a study.

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

• Not applicable, as no clinical test set requiring adjudication of outcomes is described.

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:

• No, an MRMC comparative effectiveness study was not done. This device is a physical therapeutic device, not an AI-assisted diagnostic tool for human readers.

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

• Not applicable, as this is a physical medical device, not an algorithm.

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

• Not applicable for the regulatory clearance process described. The "ground truth" for substantial equivalence is derived from established predicate devices and recognized international standards for device safety and performance.

8. The sample size for the training set:

• Not applicable, as there is no mention of machine learning or AI models with training sets.

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

• Not applicable, as there is no mention of machine learning or AI models with training sets.

In summary, the provided FDA 510(k) summary demonstrates regulatory acceptance primarily through engineering, electrical, and biocompatibility testing against defined standards and a detailed comparison showing substantial equivalence in technological characteristics and indications for use to a legally marketed predicate device, rather than through a traditional clinical trial with efficacy endpoints and human-based ground truth.

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clTrac is intended to provide relief for the management of pain and symptoms from a variety of pressures on muscular or skeletal structures. clTrac may be used to treat pain and symptoms associated with the following conditions: herniated discs, bulging or protruding intervertebral disc disease, posterior facet syndrome, acute facet problems, radicular pain, prolapsed discs, spinal root impingement, hypomobility, degenerative joint disease, facet syndrome, compression fractures, joint pain, and discogenic pain.

The clTrac is powered traction equipment that offers both static and intermittent traction. Spinal traction is a form of decompression that relieves the pressure on the spine. Traction is a non-surgical, non-invasive and non-pharmaceutical treatment for the management of pain and symptoms from a variety of pressures on muscular or skeletal structures. The clTrac is intended to be used by healthcare professionals (HCP) on their patients. When device is operational, the applied force shall not exceed +/-10% of the target force as set by the operator. clTrac applies a specific force onto the traction cord. The applied force is set by the operator by means of the touch screen and rotary knob. A patient interrupt button is available for the patient to pause the therapy. The cl Trac is a non-invasive therapeutic device. The device consists of a console with ABS housing. The console consists of an aluminium ground plate, an ABS outer shell, a 7" touch screen and a steel central control knob. A 2.9m long cord with a plastic patient interrupt button is plugged into the console. The console is intended to be fastened to a standardized traction table using screws that are tightly screwed into its aluminium ground plate, with holes in a standardized pattern. The implemented motor-gear unit applies traction via a traction cord that is fixed into the console with a 360° swivel head with guide pulley. The traction cord is intended to be attached to hip and thoracic traction belts that are sold separately.

The provided document is an FDA 510(k) clearance letter for the clTrac device, a powered traction equipment. It focuses on demonstrating substantial equivalence to a predicate device (Eltrac 471) rather than a deep dive into specific performance study details with acceptance criteria for an AI/ML-based medical device.

Therefore, many of the requested details regarding acceptance criteria, specific study types (MRMC, standalone), sample sizes for test and training sets, expert qualifications, and ground truth establishment methods for an AI/ML device are NOT present in this document.

The document details the device's indications for use, technological characteristics, and compliance with various voluntary general and electrical safety standards. It explicitly states:

• Clinical Performance: Not applicable. This device does not require clinical testing for demonstration of substantial equivalence and safety/effectiveness."

This means the 510(k) clearance was based on non-clinical performance (bench testing, electrical safety, software validation, usability, risk management, and biocompatibility) and comparison to a predicate, not on a study demonstrating clinical performance with specific metrics like sensitivity, specificity, or reader improvement, which are typical for AI/ML device clearances.

Here's a breakdown of what can be extracted or inferred based on the provided text, and where the information is missing:

1. A table of acceptance criteria and the reported device performance

The document doesn't present "acceptance criteria" in the way one would for an AI/ML diagnostic or prognostic device (e.g., target specificity, sensitivity thresholds). Instead, it refers to compliance with established medical device standards and the device's operational specifications.

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

• Sample Size: Not applicable. No clinical test set. The performance testing was primarily bench testing and engineering verification/validation against standards.
• Data Provenance: Not applicable for clinical data. The testing mentioned (electrical safety, EMC, usability, software, risk, biocompatibility) would be performed in a lab setting by the manufacturer.

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

• Not applicable. There was no clinical test set requiring expert-established ground truth.

4. Adjudication method for the test set

• Not applicable.

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

• No. This device is a powered traction equipment, not an AI/ML diagnostic aid for human readers.

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

• No. This device is electro-mechanical, not an AI/ML algorithm. Its "performance" refers to its physical operation and safety, not an intelligent diagnostic output.

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

• Not applicable. Ground truth for an AI/ML algorithm is not relevant here. The "ground truth" for the device's functionality would be engineering specifications and measurements (e.g., force output measured by a calibrated sensor, electrical safety limits).

8. The sample size for the training set

• Not applicable. This device does not use an AI/ML algorithm that requires a training set.

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

• Not applicable.

In summary, the provided document is for a medical device clearance (clTrac, a powered traction equipment) that relies on demonstrating substantial equivalence to a predicate device and compliance with general device safety and performance standards. It explicitly states that clinical testing was "not applicable." As such, the detailed requirements for AI/ML device clearances (like test set/training set sizes, expert ground truth establishment, MRMC studies) are not relevant to this specific FDA submission and are not found in this document.

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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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The Cryo 7 is indicated to be used to: Minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.

The Cryo 7 is a non-invasive Therapeutic device. The cold air therapy device cools and dehumidifies the air, which can be used to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections. The cold air therapy device is intended to cool the patient's skin locally and is intended to be used contactless. The subject Cryo 7 device is the same as the currently-cleared Cryo 6 (K060395), except for branding and state-of-the-art updates. Both the subject device and predicate device are manufactured by Zimmer MedizinSysteme GmbH. The mechanical assembling consists of a housing, a chassis with 4 rotating rollers and a shelf plate. The chassis includes all technical components, like compressor, evaporator, condenser, fans and all electrical power components. On the upper front cover, the user interface control it operated via touchscreen. The software controls the device initialization, the hardware components for the cooling circuit as well as the user interface. The user interface can be controlled via capacitive touch display. The software controls the device initialization, the hardware components for the cooling circuit as well as the user interface.

The provided text describes the Zimmer MedizinSysteme Cryo 7 device, its intended use, and its comparison to a predicate device (Cryo V6.0, K060395). It also details the performance data and testing conducted to support its substantial equivalence.

Here's an analysis of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a quantitative table format with corresponding device performance values as typically found in a clinical study report comparing a device against specific thresholds for accuracy, sensitivity, or specificity.

Instead, the performance characteristics are described in comparison to the predicate device in a qualitative manner, and compliance with various standards is listed. The key performance comparison is for the air temperature and speed.

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

The document does not describe a clinical study with a "test set" of patient data in the conventional sense for evaluating diagnostic accuracy or treatment effectiveness using AI. The Cryo 7 is a non-invasive therapeutic device for cooling, and the evaluation focuses on its physical and functional performance, safety, and substantial equivalence to a predicate device.

Therefore, there is no sample size for a test set of patient data mentioned, nor is there information on data provenance (country of origin, retrospective/prospective). The study described is primarily a bench testing and engineering verification study rather than a clinical trial.

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

Since there is no "test set" of patient data requiring clinical ground truth established by experts, this information is not applicable and not provided in the document.

4. Adjudication Method

As there is no clinical test set requiring ground truth establishment, no adjudication method (e.g., 2+1, 3+1) is mentioned or relevant.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size

No MRMC study was conducted. The device is not an AI-assisted diagnostic or therapeutic aid for human readers. Its function is to provide cold air. Therefore, evaluating human reader improvement with AI assistance is not applicable to this device.

6. Standalone (Algorithm Only) Performance Study

The Cryo 7 is a physical medical device, not an algorithm, so a standalone algorithm-only performance study is not applicable. The software integral to the device was verified, but this is different from an "algorithm only" study for AI.

7. Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily based on engineering specifications, compliance with recognized standards (e.g., electrical safety, EMC, software lifecycle, usability), and physical performance measurements (e.g., air temperature and speed) compared to its predicate and its own design requirements. It's not a clinical ground truth like pathology or outcome data.

8. Sample Size for the Training Set

There is no "training set" in the context of machine learning or AI algorithms mentioned for this device. The development process would involve standard engineering design, testing, and verification.

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

As there is no training set as understood in AI/ML, this question is not applicable. The device's design and performance are based on established engineering principles and regulatory standards, not on learning from a dataset.

In summary: The provided document describes a 510(k) premarket notification for the Cryo 7 device, which is a physical cold air therapy device. The evaluation presented is focused on demonstrating substantial equivalence to a predicate device through engineering and performance comparisons, safety testing, and compliance with general medical device standards. It does not involve AI/ML components or clinical studies that would require the establishment of complex ground truth for patient data by experts.

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The emField is indicated to be used for:

*Relaxation of muscle spasms;

*Prevention or retardation of disuse atrophy;

*Increasing local blood circulation;

*Muscle re-education;

*Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and

*Maintaining or increasing range of motion.

emField is a non-invasive therapeutic device. The device produces a magnetic field that interacts with the tissues of the human body. By muscle stimulation, the emField is indicated for bulk muscle excitation in the legs or arms for rehabilitative purposes.

The device housing protects the patient from electrical shock and mechanical injuries. The device is mobile standalone equipment with four wheels. Two applicators are available for therapy: a large and a small one. The main body of emField is used to control function of magnetic stimulation. It is operated with parameters such as Frequency, Time and Intensity. These parameters can be controlled by the user on LCD and with the help of a rotary knob at the user control panel.

The provided document is a 510(k) Pre-market Notification from the FDA regarding the Zimmer MedizinSysteme GmbH emField device. It outlines the device's indications for use, technological characteristics, and performance data to demonstrate substantial equivalence to a predicate device.

However, the document does not contain information about acceptance criteria for a study proving device performance in the context of an AI/ML medical device. The emField device is a "Powered Muscle Stimulator" that generates a magnetic field for therapeutic purposes, which falls under conventional medical devices, not AI/ML-driven devices.

Therefore, I cannot provide the requested information about acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance, training set details) for an AI/ML device, because this document is not about such a device.

The "Performance data" section (starting on page 7) refers to the device's compliance with voluntary standards (like IEC 60601-1 for electrical safety, IEC 60601-1-2 for electromagnetic compatibility, and IEC 60601-2-10 for nerve and muscle stimulators) and preclinical testing for magnetic field output and tissue heating. These are standard performance tests for electromechanical medical devices, not AI/ML performance metrics.

In summary, the provided document does not contain the information needed to answer the prompt, as it concerns a non-AI/ML medical device.

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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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