Search Results

truSculpt flex is indicated to be used for:

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

truSculpt flex is an electrical muscle stimulator, which generates electrical impulses that are delivered through electrodes on the skin in direct proximity to the muscles to be stimulated. The device contracts muscles rhythmically to achieve the intended use of strengthening, firming, and toning the muscles of the abdomen, thighs, and buttocks.
truSculpt flex consists of a console with a touchscreen control panel and eight handpiece pairs. All system functions are controlled through the console. During a treatment session, one or more handpiece pairs are secured to the patient using disposable hydrogel pads and transparent silicone belts, and electrical stimulation is delivered to the treatment area at the selected treatment mode and intensity.

The provided text describes a 510(k) premarket notification for the truSculpt flex device, a powered muscle stimulator. The document primarily focuses on demonstrating substantial equivalence to a predicate device (Torc Body, K192039) through a comparison of technological characteristics and non-clinical bench testing.

However, the document does not contain any information about clinical studies that would involve a test set, human subjects, expert consensus for ground truth, or MRMC studies demonstrating improvement with AI assistance. It explicitly states:

"The device safety and efficacy was demonstrated by performance data and a comparison of technical characteristics between the modified device and the predicate device." (Page 6)
"The information and testing presented in this traditional 510(k) demonstrate that the truSculpt flex device performs as designed and intended, and is substantially equivalent to the predicate device (K192039). The changes made do not affect the safety and effectiveness of the device." (Page 16)

The submission details non-clinical bench testing to demonstrate compliance with various standards (e.g., IEC, ISO, CFR 820), reliability testing, and a comparison of output specifications between the modified and predicate devices. It emphasizes that fundamental scientific technology has not changed and reported differences in individual mode parameters are within acceptable limits as per regulatory guidance.

Therefore, an exhaustive answer to your request, based only on the provided text, would indicate the absence of information for many of your criteria concerning clinical performance studies.

Here's an analysis based on 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 clinical performance in the way one might expect for an image-based diagnostic AI device. Instead, the acceptance criteria for this 510(k) submission revolve around demonstrating substantial equivalence to the predicate device (Torc Body, K192039) through:

• Identical Indications for Use: "Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen. Strengthening, toning and firming of buttocks & thighs." (Page 6)
• Identical Fundamental Scientific Technology: "The fundamental scientific technology has not changed in the modified device." (Page 4) and "There are no changes to the indications for use, fundamental scientific principles, performance specifications, or operation of the device." (Page 16)
• Compliance with applicable voluntary standards and regulations: (IEC 60601-1, IEC 60601-1-2, IEC60601-2-10, ISO 14971, ISO 13485:2016, 21CFR820, IEC 62366, ISO 15233, ISO 10993-1). (Page 16)
• Bench testing demonstrating safety and performance: "The truSculpt flex device met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared device. No new safety or performance issues were raised during testing." (Page 16)
• Output specifications within acceptable limits: Minor differences in mode parameters are noted but are deemed to be "within the limits as per 'Guidance Document for Powered Muscle Stimulator 510(k)s', issued on June 9, 1999, ANSI/AAMI NS4:2013 (R2017) standard for electrical stimulators." (Page 16)

Since this is a substantial equivalence claim based on technical characteristics and bench testing, there are no reported "device performance" metrics in terms of clinical accuracy (e.g., sensitivity, specificity, AUC) from a clinical study on a test set. The performance is implied by its adherence to safety standards and comparable electrical output to the predicate.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document describes non-clinical bench testing and a comparison to a predicate device, not a clinical study involving human test subjects or a "test set" of patient data for performance evaluation in the context of an AI/diagnostic device.

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)

Not applicable. No clinical test set or human-established ground truth is mentioned for this device's 510(k) submission.

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

Not applicable. No clinical test set or adjudication method is mentioned.

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. No MRMC study was performed as this is not an AI/diagnostic imaging device and is not described as involving human "readers" or AI assistance in clinical interpretation.

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

Not applicable. This device is a physical powered muscle stimulator, not a standalone algorithm.

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

Not applicable in the context of a clinical test set. The "ground truth" for this 510(k) submission is primarily based on:

• Engineering specifications and measurements: Comparing the electrical output parameters (voltage, current, pulse width, frequency, etc.) of the modified device to the predicate device and ensuring they fall within acceptable ranges as per relevant standards (e.g., ANSI/AAMI NS4:2013).
• Compliance with recognized voluntary standards: Meeting the requirements of standards like IEC 60601-1, ISO 14971, etc., which are inherently designed to ensure basic safety and performance.

8. The sample size for the training set

Not applicable. The document does not describe the use of machine learning or AI models with training sets.

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

Not applicable. No training set is mentioned.

Ask a specific question about this device

The truSculpt RF energy 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 and muscle spasms and increase in local circulation.

Additionally, the 2MHz setting for the 40 cm2 handpiece is indicated for reduction in circumference of the abdomen and non-invasive lipolysis (breakdown of fat) of the abdomen.

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

The truSculpt iD device consists of a console, one or more RF handpieces that connect to the console with umbilical cables, and a truGlide massage roller. All system functions are controlled through the console. The handpieces deliver RF energy to generate a heating profile that produces a moderate temperature rise in the subcutaneous tissue, while monitoring epidermal temperature. The truGlide is a separate mechanical roller that can be used as a massager.

The provided text describes a 510(k) premarket notification for the truSculpt iD device, which includes a new 2 cm² RF applicator. The focus of the performance data is on demonstrating the safety and effectiveness of this new applicator for therapeutic heating.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

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

• Sample Size: 3 human subjects.
• Data Provenance: The study was conducted on human subjects, implying a prospective study. The country of origin is not specified in the provided text.

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

The document does not mention the use of experts to establish ground truth for the skin temperature testing. The criteria for therapeutic temperature (40°-45°C) and maximum safe temperature (45°C) are established medical knowledge for this type of device. The test appears to directly measure these physical parameters.

4. Adjudication method for the test set

Not applicable. The study involved direct measurement of skin temperature, not subjective evaluations requiring adjudication.

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 an electrosurgical cutting and coagulation device, not an AI-assisted diagnostic or imaging device that would typically involve human readers.

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

Not applicable. This is a physical device that performs a therapeutic action, not a software algorithm. The "performance data" refers to the device's physical interaction with human tissue.

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

The ground truth for this specific performance testing is objective physiological measurements: skin temperature values. The criteria (40°-45°C therapeutic, ≤45°C maximum) are based on established safety and efficacy thresholds for therapeutic heating devices.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set. The performance testing is a direct validation of the device's physical characteristics.

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

Not applicable as there is no training set mentioned or implied for this device.

Ask a specific question about this device

The truSculpt iD device is intended to generate heat within body tissues for the treatment of selected medical conditions, such as the relief of minor aches, pain, and muscle spasms; an increase in local circulation; a reduction in circumference of the abdomen; and non-invasive lipolysis (breakdown of fat) of the abdomen. The truGlide roller is intended to provide temporary reduction in the appearance of cellulite.

The truSculpt RF energy 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 and muscle spasms and increase in local circulation.

Additionally, the 2MHz setting for the 40cm2 handpiece is indicated for reduction in circumference of the abdomen and non-invasive lipolysis (breakdown of fat) of the abdomen.

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

The truSculpt iD device consists of a console, one or more RF handpieces that connect to the console with umbilical cables, and a truGlide massage roller. All system functions are controlled through the console. The handpieces deliver RF energy to generate a heating profile that produces a moderate temperature rise in the subcutaneous tissue, while monitoring epidermal temperature. The truGlide is a separate mechanical roller that can be used as a massager.

The provided text describes the regulatory clearance of the Cutera truSculpt iD device, focusing on its substantial equivalence to predicate devices, rather than a clinical study establishing specific acceptance criteria for a new AI/performance claim.

Based on the available information, the truSculpt iD device is an electrosurgical cutting and coagulation device intended for:

• Topical heating to elevate tissue temperature for relief of pain and muscle spasms and increase in local circulation.
• Specifically, the 2MHz setting for the 40cm² handpiece is indicated for reduction in circumference of the abdomen and non-invasive lipolysis (breakdown of fat) of the abdomen.
• The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite.

The "acceptance criteria" discussed in the document are primarily related to safety and technological equivalence compared to its predicate devices, rather than performance metrics of a novel clinical claim. The study mentioned is a technical performance study, not a clinical trial with specific performance endpoints for new indications.

Here's an breakdown based on the information provided, acknowledging its limitations regarding specific AI performance acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is an equivalence submission for a traditional medical device, there aren't explicit clinical performance acceptance criteria in the typical sense of metrics like sensitivity, specificity, AUC as would be seen for an AI diagnostic algorithm. Instead, the acceptance is based on demonstrating substantially equivalent safety and effectiveness through technical characteristics and a limited performance study.

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

• Test Set Sample Size: 3 human subjects for skin temperature testing.
• Data Provenance: Not explicitly stated, but typically such performance/safety testing might be done in a single-center setting, likely in the country of manufacture or where the regulatory submission is made (USA, given the FDA context). It is a prospective performance/safety study.

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

• This information is not provided. For a technical performance study like skin temperature monitoring, the "ground truth" is measured by the device itself and validated against a calibrated external measurement system (e.g., a thermometer). Clinical "ground truth" from experts is not applicable here as it's not a diagnostic or treatment outcome study with expert interpretation.

4. Adjudication method for the test set

• Not applicable as this was a technical performance/safety study (skin temperature measurement), not a clinical trial requiring adjudication of outcomes or expert review of images/diagnoses.

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 MRMC study was done. This device is a therapeutic energy-based device, not an AI-powered diagnostic or interpretative system that would involve human readers.

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

• Not applicable. This is a traditional medical device, not an AI algorithm. The device has software for control, but its "performance" is its ability to deliver RF energy and monitor temperature, not to perform a diagnostic or interpretive task standalone or with human-in-the-loop.

7. The type of ground truth used

• For the skin temperature testing, the ground truth would be direct physical measurement of skin temperature using a calibrated reference thermometer, compared against the device's internal temperature sensing and control.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that requires a training set in that context. The device's software is developed and validated through traditional software engineering processes.

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

• Not applicable for the same reason as above.

Ask a specific question about this device

The truSculpt RF energy is intended to provide topical heating tissue temperature for the treatment of selected medical conditions, such as relief of pain and increase in local circulation.

Additionally, the 2 MHz setting for the 40 cm handpiece is indicated for reduction in circumference of the abdomen and non-invasive lipolysis (breakdown of fat) of the abdomen.

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

The truSculpt RF Device consists of a console, one or more RF handpieces that connect to the console with an umbilical cable, and a truGlide massage roller. All system functions are controlled through the console. The handpieces deliver RF energy to generate a heating profile that produces a moderate temperature rise in the subcutaneous tissue, while monitoring epidermal temperature. The truGlide is a separate mechanical roller that can be used as a massager.

Here's a summary of the acceptance criteria and study information for the truSculpt RF Device, based on the provided text:

Device: truSculpt RF Device

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the clinical study endpoints and the "Summary Results" in the study tables.

Ask a specific question about this device

The truSculpt RF energy 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 and muscle spasms and increase in local circulation.

Additionally, the 2 MHz setting for the 40 cm² handpiece is indicated for temporary reduction in circumference of the abdomen.

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

The modified truSculpt RF device consists of a console; one 16 cm² RF handpiece; up to six 40 cm² puck-style RF handpieces that can attach to belts configured for hands-free abdominal and flank treatments for circumferential reduction; adjustable patient belts; a patient comfort switch; and a truGlide massage roller. All system functions are controlled through the console. The handpieces deliver RF energy to generate a heating profile that produces a moderate temperature rise in the subcutaneous tissue, while monitoring epidermal temperature. In addition, there is a separate mechanical roller that can be used as a massager.

The provided document K172004 is a 510(k) premarket notification for a medical device called "truSculpt". It primarily focuses on demonstrating substantial equivalence to predicate devices and describes modifications to the existing truSculpt RF device. The document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI-powered diagnostic device, which is what the prompt is implicitly asking for (e.g., using terms like "human readers improve with AI vs without AI assistance", "standalone (i.e. algorithm only without human-in-the-loop performance)", "ground truth").

The truSculpt device is an electrosurgical cutting and coagulation device, specifically an RF energy device for topical heating, temporary reduction in circumference of the abdomen, and temporary reduction in the appearance of cellulite, and a massage device. This is a physical device used for treatment, not an AI-powered diagnostic tool.

Therefore, I cannot provide the requested information from this document. The document describes:

1. Device: truSculpt (RF energy device and massage device).
2. Modifications: Addition of a multiplexor board to power up to six treatment handpieces sequentially, a patient-activated treatment termination switch, and belts for hands-free operation of 40 cm² handpieces for circumferential reduction.
3. Safety and Performance Data: Reference to compliance with IEC 60601-1 standards (general safety, usability, electromagnetic disturbances, high-frequency surgical equipment) and AAMI/ANSI ES60601-1. It also mentions software verification and validation (V&V) for the patient comfort switch and multiplexor board.
4. Clinical Trial Mention: States that "the identical treatment parameters are available for selection as used in the clinical trial to gain this indication for use, including area treated and RF dose (time and temperature)" for abdominal circumferential reduction treatments. However, it does not provide details of this clinical trial or specific performance metrics from it in a way that relates to the prompt's request for AI acceptance criteria.

Based on the provided document, I cannot fill out the requested table or answer the specific questions related to AI device performance and ground truth establishment. The document is about a physical device's electrical safety and functional equivalence, not an AI model's diagnostic performance.

Ask a specific question about this device

The truSculpt RF energy 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 and muscle spasms and increase in local circulation.
Additionally, the 2 MHz setting for the 40 cm² handpiece is indicated for temporary reduction in circumference of the abdomen.
The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite.

The truSculpt device consists of a console, one or more RF handpieces that connect to the console with an umbilical cable, and a truGlide massage roller. All system functions are controlled through the console. The handpieces deliver RF energy to generate a heating profile that produces a moderate temperature rise in the subcutaneous tissue, while monitoring epidermal temperature. In addition, there is a separate mechanical roller that can be used as a massager.

The TruSculpt device from Cutera, Inc. (K162512) underwent a clinical study to demonstrate its safety and effectiveness for temporary circumferential reduction of the abdomen and flank regions.

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

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

The truSculpt device consists of a console, one or more RF handpieces that connect to the console with an umbilical cable, and a truGlide massage roller. All system functions are controlled through the console. The handpieces deliver RF energy to generate a heating profile that produces a moderate temperature rise in the subcutaneous tissue, while monitoring epidermal temperature. In addition, there is a separate mechanical roller that can be used as a massager.

The provided text is a 510(k) summary for the truSculpt device. It focuses on establishing substantial equivalence to a predicate device based on technological characteristics and safety standards. It explicitly states "Results of Clinical Study: None", which means the document does not contain information about a study proving the device meets specific acceptance criteria based on clinical performance.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance in the format you've outlined, as that data is not present in the provided document.

Here's a breakdown of why each point cannot be addressed:

1. A table of acceptance criteria and the reported device performance: No clinical acceptance criteria or performance metrics are reported.
2. Sample sized used for the test set and the data provenance: No clinical test set or data provenance is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment related to clinical performance is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as there's no clinical test set.
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 not an AI-assisted diagnostic tool, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no clinical efficacy data is presented.
8. The sample size for the training set: Not applicable as no machine learning model or training set is discussed.
9. How the ground truth for the training set was established: Not applicable.

The document primarily focuses on:

• Establishing substantial equivalence to a predicate device (Cutera truSculpt RF Device K122389).
• Listing safety requirements (IEC 60601-1-2).
• Software verification and validation testing (truSculpt Software Verification and Validation Testing Report (V0005 rN)).
• Comparing technological features with the predicate device.

The "Results of Clinical Study: None" statement is key here, indicating that this submission does not include data from a clinical efficacy study.

Ask a specific question about this device

The truSculpt infrared(optional) and RF energies are 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 truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite.

Not Found

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA, which confirms that the truSculpt device is substantially equivalent to legally marketed predicate devices.

The letter mentions:

• Device Name: truSculpt
• Regulation Number: 21 CFR 878.4400 (Electrosurgical cutting and coagulation device and accessories)
• Indications For Use:
  • Topical heating for elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.
  • Temporary reduction in the appearance of cellulite (when used as a massage device).

However, it does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any tests.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. Information about MRMC comparative effectiveness studies or effect sizes.
6. Results from standalone (algorithm only) performance studies.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

To obtain this information, you would typically need to refer to the 510(k) submission summary or the actual study reports that were submitted to the FDA as part of the clearance process, which are not included in this document.

Ask a specific question about this device