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510(k) Data Aggregation
(88 days)
Cutera, Inc.
The AviClear Laser System is indicated for the long-term treatment of mild to severe inflammatory acne vulgaris.
The AviClear Laser System is an infrared diode laser device with a nominal wavelength of 1726 nm. Similar to other well-established infrared laser devices, the device uses a combination of the treatment spot size, beam characteristics, and tissue absorption and scattering coefficients at the output wavelength to deliver energy to tissues at depth. The wavelength of the laser energy, when combined with the pre, parallel (during energy delivery), and post cooling of epidermal and superficial dermal structures, causes selective heating of dermal tissue at different depths. The 1726 nm laser energy heats the chromophore, sebum within sebaceous glands, which results in controlled thermal injury of the sebaceous glands, the ultimate treatment target, thus reducing or eliminating sebum production and causing an improvement in acne vulgaris.
The diode laser and associated beam delivery optics, laser and electronics power supplies, control electronics, and cooling system are housed inside a console equipped with a touchscreen user interface. The laser treatment parameters are selected using the touchscreen. Two treatment handpieces are available. Each handpiece has an integrated scanner for delivering treatment spot(s) in an operator-selected pattern; a temperature-controlled skin-contact cooling window to provide thermal protection for the epidermis and superficial dermis and through which energy is delivered to the patient; and skin-contact pressure sensors that enable laser energy delivery when the system is in Ready mode and the footswitch is depressed.
The provided FDA 510(k) clearance letter and summary for the AviClear Laser System (K251149) indicate that this submission is for a modification of an already cleared device (K230660), rather than a completely new device or a device incorporating AI for diagnostic or predictive purposes. As such, the study described is a safety study comparing the modified device to the predicate device, not a performance study to prove the device meets specific diagnostic efficacy acceptance criteria in the way an AI/ML medical device would.
Therefore, many of the requested categories related to AI/ML device performance, such as MRMC studies, ground truth establishment for training sets, and detailed performance metrics (sensitivity, specificity, AUC), are not applicable to this specific submission type. The "acceptance criteria" here primarily relate to the comparable safety and thermal effects to the predicate device.
However, I will extract and present the information available from the provided text in the closest applicable format.
Device Acceptance Criteria and Study Overview for AviClear Laser System (K251149)
The AviClear Laser System (K251149) is a modified version of a previously cleared device (K230660). The Acceptance Criteria, in this context, are not about diagnostic performance metrics for an AI system, but rather demonstrating comparable safety and efficacy to the predicate device, specifically regarding its thermal effects and adverse event profile, despite changes to the handpiece and cooling duration.
1. Table of Acceptance Criteria and Reported Device Performance
Given this is a safety study for a modified laser system, the "acceptance criteria" are implied by the study's primary and secondary outcomes, focusing on comparability to the predicate.
| Acceptance Criterion (Implied) | Reported Device Performance (K2511149 vs. K230660) |
|---|---|
| No new or unexpected Adverse Device Effects (ADEs) observed. | No new or unexpected ADEs were observed with the modified device. Reported ADEs were consistent with the previously cleared device. |
| Incidence of blistering or scarring is not increased. | No cases of blistering or scarring were reported in any subjects. |
| Comparable thermal effect/extent of thermal impact (epidermal/dermal changes, cellular changes, inflammatory changes, overall tissue architecture). | Comparable thermal effects at highest available settings for both modified and previously cleared devices. No epidermal injury, similar depths of selective, noninvasive sebaceous gland destruction, no associated inflammation, and no denaturation of adjacent collagen. |
| Safety profile is not significantly different. | The thermal safety profile of the modified device is not significantly different from that of the previously cleared device. |
| Device can be safely and effectively used for the indicated treatment. | Modified device can be safely and effectively used for the long-term treatment of mild to severe inflammatory acne vulgaris. |
2. Sample Size and Data Provenance
- Test Set Sample Size: 10 subjects.
- Data Provenance:
- Country of Origin: Not explicitly stated, but assumed to be the United States as it is an FDA submission.
- Retrospective/Prospective: Prospective, comparative double-arm safety study. Subjects underwent procedures specifically for the study.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: At least one independent dermatopathologist.
- Qualifications of Experts: Independent dermatopathologist. No further details on experience (e.g., years) are provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated. The histological assessment was done by "an independent dermatopathologist," suggesting a single expert's assessment was used, not a consensus or adjudication process involving multiple reads.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No, an MRMC comparative effectiveness study was not performed. This type of study (comparing human reader performance with and without AI assistance) is not applicable to a laser system clearance without AI integration. The study was a safety and comparability study of a medical device itself.
6. Standalone Performance (Algorithm Only)
- Was standalone performance done? Not applicable. This phrase typically refers to the performance of an AI algorithm on its own. The AviClear Laser System is a physical medical device (laser system), not primarily a software algorithm. Its "performance" is evaluated through clinical safety and histological outcomes rather than diagnostic metrics.
7. Type of Ground Truth Used
- Ground Truth Type:
- Observed Adverse Events (AEs) and Adverse Device Effects (ADEs): Self-reported or clinician-observed events during follow-up.
- Histological Tissue Evaluation: Microscopic examination of excised tissue by a dermatopathologist to assess thermal impact, cellular changes, etc. This is considered a pathology-based ground truth for thermal effects.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The device is a laser system hardware, not a machine learning algorithm that requires a "training set" in the conventional AI/ML sense. The "training" for the device, if any, would be its design and engineering iterations, followed by verification and validation testing (nonclinical and clinical) as described.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable for the same reason as above.
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(78 days)
Cutera, Inc.
IPL Hair Removal Device is indicated for the removal of unwanted hair. The IPL Hair Removal Device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
The subject device IPL Hair Removal Device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The IPL Hair Removal Device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon lamp and its built-in skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the treated skin, the device will not emit the light pulse. Also, the subject device is equipped with cooling function to cool down the skin temperature and give a user a better experience, but this function has no other therapeutic use. There are BR223, BR225 two models in this application. Their work principle, function, intended use, structure, and composition are the same, with difference being product appearance, but this difference does not affect or change the intended use of the device.
This document is a 510(k) summary for the Shenzhen Borria Technology Co., Ltd. IPL Hair Removal Device. It is a regulatory submission to the FDA, not a study report. Therefore, it does not provide the kind of detailed information about acceptance criteria and study results that you are asking for regarding device performance, particularly for AI/algorithm-based devices.
The document states that "Performance data supports that the device is safe and as effective as the predicate device for its intended use" and "the subject device was found to have a safety and effectiveness profile that is similar to the predicate device." However, it does not present the raw performance data, acceptance criteria, or details of a clinical study in the format you've requested.
The "Performance Data" section (VII) primarily lists safety testing (Biocompatibility, Electrical Safety, EMC Safety, Eye Safety) and software verification/validation, which are important for device safety and functionality, but not for demonstrating a clinical outcome like hair reduction effectiveness with specific performance metrics such as accuracy, sensitivity, or user improvement with AI.
To directly answer your questions based only on the provided text, many details are missing or not applicable, especially concerning an AI/algorithm component. This document describes a traditional medical device (IPL hair removal) rather than an AI-based diagnostic or treatment device that would typically involve acceptance criteria related to AI performance, ground truth establishment, and human-in-the-loop studies.
Here's an attempt to answer your questions based on what is and is not in the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria for clinical effectiveness (e.g., hair reduction percentage) or reported device performance against such criteria. It states that performance data was provided to support substantial equivalence to a predicate device, implying that its performance is considered comparable to the predicate.
The table in the document compares "technological characteristics" such as wavelength range, energy medium, energy density, spot size, pulse duration, and pulsing control between the subject device and predicate devices. This shows their technical specifications are similar, not performance against clinical outcomes.
2. Sample size used for the test set and the data provenance
The document does not describe a clinical test set or the sample size used for evaluating hair removal effectiveness, nor does it mention data provenance (e.g., country of origin, retrospective/prospective). The performance data listed (biocompatibility, electrical safety, etc.) refers to standard engineering and safety tests, not clinical efficacy trials with patient sample sizes.
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. Ground truth establishment with experts is typically relevant for diagnostic or AI-assisted devices where human interpretation is involved. For an IPL hair removal device, effectiveness is usually measured through objective means (e.g., hair counts, photographic assessment by non-interpreting personnel) rather than expert consensus on a diagnostic image.
4. Adjudication method for the test set
Not applicable/not provided. There is no mention of a test set requiring adjudication in the context of clinical performance.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No. This type of study is relevant for AI-assisted diagnostic tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. This document describes an IPL hair removal device, which is not an imaging or diagnostic AI product, so an MRMC study would not be applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical IPL hair removal device, not an algorithm.
7. The type of ground truth used
For the safety tests listed (biocompatibility, electrical safety), the "ground truth" would be adherence to the specified ISO and IEC standards. For the clinical effectiveness of hair removal, while not detailed in this summary, the typical ground truth in such studies involves objective hair counts or validated photographic scales taken at specified time points after treatment. However, the document does not specify how effectiveness was measured or what "ground truth" was used for the substantial equivalence claim beyond technical specifications and comparison to predicate.
8. The sample size for the training set
Not applicable. The IPL Hair Removal Device is not an AI/machine learning model, so there is no "training set" in this context.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI model.
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(88 days)
Cutera, Inc.
The AviClear Laser System is indicated for the long-term treatment of mild to severe inflammatory acne vulgaris.
The AviClear Laser System is an infrared diode laser device with a nominal wavelength of 1726 nm. Similar to other well-established infrared laser devices, the device uses a combination of the treatment spot size, beam characteristics, and tissue absorption and scattering coefficients at the output wavelength to deliver energy to tissues at depth. The wavelength of the laser energy, when combined with the pre, parallel (during energy delivery), and post cooling of epidermal and superficial dermal structures, causes selective heating of dermal tissue at different depths. The 1726 nm laser energy heats the chromophore, sebum within sebaceous glands, which results in controlled thermal injury of the sebaceous glands, the ultimate treatment target, thus reducing or eliminating sebum production and causing an improvement in acne vulgaris.
The diode laser and associated beam delivery optics, laser and electronics power supplies, control electronics, and cooling system are housed inside a console equipped with a touchscreen user interface. The laser treatment parameters are selected using the touchscreen.
The treatment handpiece has an integrated scanner for delivering treatment spot(s) in an operator-selected pattern; a temperature-controlled skincontact cooling window to provide thermal protection for the epidermis and superficial dermis and through which energy is delivered to the patient; and skin-contact pressure sensors that enable laser energy delivery when the system is in Ready mode and the footswitch is depressed.
This document describes the regulatory clearance (K230660) for the AviClear Laser System. It is a 510(k) summary, which means the manufacturer is asserting their device is substantially equivalent to a legally marketed predicate device. In this case, the predicate device is a previous version of the AviClear Laser System (K213461). The current submission (K230660) appears to be primarily for minor design modifications to the handpiece and user interface, while leveraging clinical data from the prior clearance for efficacy and safety.
Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are related to the clinical study supporting the original clearance (K213461), which is then referenced to support the current substantial equivalence claim.
Here's the breakdown based on the provided text, focusing on the clinical study details:
1. A table of acceptance criteria and the reported device performance
The document primarily focuses on a single primary effectiveness objective and several secondary objectives rather than a predefined "acceptance criteria" table in the typical sense of a rigorous statistical hypothesis test with predefined alpha or beta. However, based on the primary effectiveness objective, we can construct the following:
| Acceptance Criteria (Primary Effectiveness Objective) | Reported Device Performance |
|---|---|
| Objective: Show that more than 50% of subjects enrolled were Responders who achieved Treatment Success. | Primary Endpoint (12-weeks): Results for this primary endpoint are not explicitly reported in the provided text for K230660, but are stated to have resulted in FDA 510(k) clearance for K213461, implying the criterion was met. The document states: "The study's primary effectiveness objective was to show more that than 50% of subjects enrolled were Responders who achieved Treatment Success, where Treatment Success was defined as a subject with ≥50% fewer inflammatory acne lesions with respect to baseline." |
| Long-Term Effectiveness (52-weeks): | Reported: At the 52-week post-final treatment follow-up visit, 91.5% of subjects achieved treatment success (p |
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(31 days)
Cutera Inc.
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Maintain therapeutic temperatures on the skin surface with the 2 cm² RF applicator | The 2 cm² RF applicator maintained therapeutic temperatures of 40°-45°C on the skin surface. |
| Maximum skin temperatures do not exceed 45°C during treatment with the 2 cm² RF applicator | Maximum skin temperatures did not exceed 45°C during the course of the treatment with the 2 cm² RF applicator. |
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.
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(58 days)
Cutera Inc.
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.
| Acceptance Criterion Type (Implied) | Description / Reported Performance |
|---|---|
| Safety - Electrical & Mechanical | Criterion: Adheres to international standards for medical electrical equipment safety. |
| Reported Performance: Compliance with IEC 60601-1/A1:2012, IEC 60601-2-2:2009, IEC 60601-1-6:2010/A1:2013, and IEC 60601-1-2:2014 demonstrated. This confirms the device meets general safety, specific safety for high-frequency surgical equipment, usability, and electromagnetic compatibility standards. | |
| Safety - Biocompatibility | Criterion: Patient-contact materials are biocompatible. |
| Reported Performance: Biocompatibility testing of patient-contact materials (Polyvinylidene fluoride (PVDF), liquid resin adhesive, silicone, hydrogel, stainless steel) according to ISO-10993-1:2018 demonstrated. | |
| Safety - Skin Temperature Control | Criterion: Skin temperatures do not exceed a safe threshold (e.g., 45°C) during treatment, while maintaining therapeutic temperatures (40°-45°C). |
| Reported Performance: Skin temperature testing on 3 human subjects demonstrated that skin temperatures do not exceed 45°C during treatment and that the device can maintain therapeutic temperatures of 40°-45°C on the surface of the human skin. | |
| Software Verification & Validation | Criterion: Software functions correctly and safely. |
| Reported Performance: Software Verification and Validation Testing completed. (No specific metrics provided, but implies successful completion.) | |
| Technological Equivalence | Criterion: Device has equivalent technological characteristics and principles of operation to predicate devices, and any differences do not raise new safety or effectiveness questions. |
| Reported Performance: Detailed comparison tables (provided in the source text) show equivalence in energy type, RF frequency, RF type, max RF power, temperature sensing, active control, and massage function. Differences were identified in patient contact materials and attachment methods for hands-free handpieces, but these were deemed not to raise new safety/effectiveness questions, supported by biocompatibility and skin temperature testing. |
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.
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(148 days)
Cutera, Inc.
The AviClear Laser System is indicated for the treatment of mild to severe inflammatory acne vulgaris.
The AviClear Laser System is an infrared Indium Phosphide (InP) diode laser device with a nominal wavelength of 1726 nm. Similar to other well-established infrared laser devices, the device uses a combination of the treatment spot size, beam characteristics, and tissue absorption and scattering coefficients at the output wavelength to deliver energy to tissues at depth. The wavelength of the laser energy, when combined with the pre, parallel (during energy delivery), and post cooling of epidermal and superficial dermal structures, causes selective heating of dermal tissue at different depths. The 1726 nm laser energy heats the chromophore, sebum within sebaceous glands, which results in controlled thermal injury of the sebaceous glands, the ultimate treatment target, thus reducing or eliminating sebum production and causing an improvement in acne vulgaris.
The diode laser and associated beam delivery optics, laser and electronics power supplies, control electronics, and cooling system are housed inside a console equipped with a touchscreen user interface. The laser treatment parameters are selected using the touchscreen.
The treatment handpiece has an integrated scanner for delivering treatment spot(s) in an operator-selected pattern; a temperature-controlled skincontact cooling window to provide thermal protection for the epidermis and superficial dermis and through which energy is delivered to the patient; and skin-contact pressure sensors that enable laser energy delivery when the system is in Ready mode and the footswitch is depressed.
The provided text describes a clinical study for the AviClear Laser System, which is indicated for the treatment of mild to severe inflammatory acne vulgaris.
Here's an analysis of the acceptance criteria and study data:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria for Primary Effectiveness Endpoint:
"to show more than 50% of subjects enrolled were Responders who achieved Treatment Success, where Treatment Success was defined a subject with ≥50% fewer inflammatory acne lesions 12 weeks after their final treatment visit than at baseline."
| Metric | Acceptance Criteria | Reported Device Performance (ITT Cohort) | Reported Device Performance (Per-Protocol Cohort) |
|---|---|---|---|
| % of subjects achieving Treatment Success at 12 weeks post-final treatment | >50% | 77.9% (n=81; 95% Cl 69%-85%) | 79.8% (n=71; 95% Cl 70%-88%) |
The Primary Effectiveness Endpoint was met in both the ITT and Per-Protocol cohorts.
2. Sample Size and Data Provenance
- Test Set Sample Size:
- Clinical Study Participants: 104 subjects were enrolled and entered the Treatment Phase.
- Primary Effectiveness Analysis (ITT Cohort): n=104
- Supportive Analysis (Per-Protocol Cohort): n=89
- Data Provenance:
- Country of Origin: The study was conducted at 7 US sites.
- Retrospective/Prospective: The study was prospective. It was an "IDE-approved, prospective, multi-center, significant-risk clinical study".
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts:
- IGA Grading: A panel of three trained expert physicians.
- Acne Lesion Counting: Three trained and experienced acne lesion counters.
- Qualifications of Experts:
- IGA Grading: "trained expert physicians" (specifically for Investigator Global Assessment grading).
- Acne Lesion Counting: "trained and experienced acne lesion counters". (The document doesn't specify if they were physicians, but they were trained for the specific task.)
4. Adjudication Method for the Test Set
- IGA Grading: The "median of the three baseline IGA grades" was used for enrollment, and the "median of the three IGA grades" was assigned for follow-up timepoints. This indicates a median consensus (3-reader median) approach.
- Acne Lesion Counting: The "median of the three count values for each facial side and lesion type was assigned to the subject for each study timepoint." This also indicates a median consensus (3-reader median) approach.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done to evaluate how human readers improve with AI vs. without AI assistance. The study described focuses on the device's effectiveness in treating acne, using expert readers to establish ground truth for clinical outcomes (IGA, lesion counts), not to evaluate an AI's impact on human reading performance.
6. Standalone (Algorithm Only) Performance
This question is not applicable. The device is a laser system for treating acne directly, not an AI algorithm for image analysis or diagnosis. Therefore, there is no "algorithm only" performance to evaluate in this context. The clinical study assessed the laser system's treatment efficacy and safety.
7. Type of Ground Truth Used
The ground truth for effectiveness was established through:
- Expert Consensus (Clinical Assessment):
- Investigator Global Assessment (IGA) grades: Determined by a panel of three trained expert physicians.
- Inflammatory and noninflammatory acne lesion counts: Performed by three trained and experienced acne lesion counters.
- Outcomes Data:
- Treatment Success: Defined as ≥50% fewer inflammatory acne lesions at 12 weeks post-final treatment, based on the expert-counted lesion data.
- Subject Satisfaction: Self-reported by subjects.
8. Sample Size for the Training Set
This question is not applicable in the typical sense of an AI model's training set. The "training" here refers to the development and refinement of the physical device and its treatment parameters. The document describes a clinical study to test the device's safety and effectiveness in humans, not to train a machine learning model. There is no mention of a separate "training set" of patient data used to develop an algorithm embedded in the device.
9. How the Ground Truth for the Training Set was Established
As mentioned above, this is not directly applicable to a traditional AI training set. The ground truth for the clinical study (which serves as the "test set" for regulatory approval) was established by:
- Physician-based IGA grading: By multiple trained expert physicians taking the median.
- Trained personnel-based lesion counting: By multiple trained and experienced acne lesion counters taking the median.
- Baseline measurements: Used as the reference point for evaluating treatment effectiveness.
The document describes the study design and assessment methods to evaluate the performance of the physical laser device. It does not indicate the use of machine learning or an AI model that would typically have a "training set" with established ground truth.
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(43 days)
Cutera, Inc.
The enlighten III laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
1064 nm
The 1064 nm wavelength of the enlighten III laser system is indicated for:
- treatment of benign pigmented lesions on patients with all skin types (Fitzpatrick I-VI)
- tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI)
- treatment of acne scars on patients with Fitzpatrick skin types II-V when used with the Micro Lens Array handpiece attachment
532 nm
The 532 nm wavelength of the enlighten III laser system is indicated for:
- treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-IV
- tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III
670 nm
The 670 nm wavelength of the enlighten III laser system is indicated for:
- treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-III
- tattoo removal for lighter colored tattoo inks, including green and blue inks, on patients with Fitzpatrick skin types II-IV
The enlighten III laser system is a multi-wavelength, pulsed laser system. A key feature of the device is its ability to produce multiple laser wavelengths and pulse widths (1064 and 532 nm: 750 ps and 2 ns; 670 nm: 660 ps and 2 ns).
The laser, power supplies, and control electronics are housed inside a console equipped with a touchscreen control panel. The laser treatment parameters are selected using the control panel. Laser emission is activated by depressing a footswitch.
An articulated arm with rotational mirror knuckles delivers the laser beam from a laser head inside the console to a handpiece. The handpiece is equipped with an optical zoom assembly that determines the spot size of the laser beam on the treatment surface, as well as an optional Micro Lens Array handpiece attachment, which can be attached to the distal end of the handpiece to fractionate the treatment beam. The beam of a low-power blue diode laser is also transmitted through the arm to provide an aiming beam.
This document describes the Cutera enlighten III Laser System and its expanded indications for use, specifically for the treatment of acne scars with the Micro Lens Array handpiece attachment.
Here's an analysis of the provided information concerning acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Efficacy Endpoint: Demonstrate improvement in acne scars. | 93.9% of subjects showed improvement in acne scars as assessed by correct identification of the temporal order of randomized baseline and follow-up visit images by at least two of three blinded dermatologist evaluators. |
| Secondary Efficacy Endpoint: Patient satisfaction with treatment results. | 76% of subjects reported being very satisfied or satisfied with the treatment results. 91% of subjects would likely have the investigational treatment again. |
| Safety Endpoints: No unexpected adverse events. | The safety endpoints of the clinical study were met, with subjects experiencing no unexpected adverse events. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 33 subjects
- Data Provenance: The study was a prospective, multicenter, pivotal study. The country of origin of the data is not explicitly stated, but as the submission is to the U.S. FDA, it is generally assumed to be from the U.S. or international sites adhering to similar regulatory standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Three blinded dermatologist evaluators.
- Qualifications of Experts: They were identified as "dermatologist evaluators," implying they are medical doctors specializing in dermatology. No specific details on their years of experience are provided.
4. Adjudication Method for the Test Set
- Adjudication Method: "at least two of three blinded dermatologist evaluators." This indicates a 2/3 consensus or majority rule for assessing improvement.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- A MRMC comparative effectiveness study was not directly reported in terms of comparing human readers with and without AI assistance. The study described is a clinical trial assessing the device's efficacy and safety for treating acne scars; it is not focused on an AI component for diagnosis or evaluation by human readers.
6. Standalone (Algorithm Only) Performance Study
- A standalone algorithm-only performance study was not applicable/not performed as this device is a laser system for treatment, not an AI diagnostic or assistive algorithm.
7. Type of Ground Truth Used
- The ground truth for the efficacy endpoint (improvement in acne scars) was established by expert consensus (at least two of three blinded dermatologist evaluators) based on the visual assessment of randomized baseline and follow-up images.
- Patient satisfaction and willingness to undergo treatment again serve as a form of patient-reported outcomes data.
8. Sample Size for the Training Set
- The document describes a clinical study for the validation of the device's efficacy and safety for a new indication. It does not mention a "training set" in the context of an algorithm. The 33 subjects are part of the evaluative study, not a training set for an AI model.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no mention of a "training set" for an algorithm in this submission. The 33 subjects were part of the prospective clinical study to assess the device's performance for the expanded indication.
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(79 days)
Cutera, Inc.
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.
| Acceptance Criteria (Implicit from Study Endpoints) | Reported Device Performance |
|---|---|
| Non-invasive Lipolysis (Study C-17-TS13) | |
| Efficacy: Histological evaluation of tissue for selective fat necrosis, with sparing of the dermis and epidermis, following truSculpt treatment vs. untreated contralateral control. | Met endpoints. Epidermal and dermal tissues were unaffected by RF treatment and were equivalent and indistinguishable in all subject biopsies. Biopsies from the control areas showed normal subcutaneous adipose tissue structures with no indication of changes from the contralateral RF treatment area. Biopsies from treated areas showed adipocyte necrosis and/or inflammatory immune cell response. Acute inflammation was present immediately and out to 20 days. Peak adipocyte death and fat necrosis observed 30 days post-treatment. |
| Safety: Incidence and severity of adverse device effects during the study period, including subject pain level during RF treatment. | No adverse events were observed. Immediate responses included mild to moderate erythema and edema, which resolved with no intervention. |
| Circumferential Reduction (Study C-17-TS15, follow-up to C-16-TS11) | |
| Efficacy: Difference in circumferential measurement at the 18-month follow-up visit when compared with the baseline and 12-week follow-up visits, as measured and reported in C-16-TS11 (K162512). | The difference between the circumferential measurements recorded during the 18-month follow-up visit when compared with the subjects' baseline circumferential measurements showed a **sustained reduction in the circumference of the abdomen of 2.30 ± 0.51 cm (p |
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(109 days)
Cutera, Inc.
The enlighten III laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
1064 nm:
The 1064 nm wavelength of the enlighten III laser system is indicated for:
- treatment of benign pigmented lesions on patients with all skin types (Fitzpatrick I-VI)
- tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI)
532 nm:
- The 532 nm wavelength of the enlighten III laser system is indicated for:
- treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-IV
- tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III
670 nm:
- The 670 nm wavelength of the enlighten III laser system is indicated for:
- treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-III
- tattoo removal for lighter colored tattoo inks, including green and blue inks, on patients with Fitzpatrick skin types II-IV
The enlighten III laser system is a multi-wavelength, pulsed laser system. A key feature of the device is its ability to produce multiple laser wavelengths and pulse widths (1064 and 532 nm: 750 ps and 2 ns; 670 nm: 660 ps and 2 ns).
The laser, power supplies, and control electronics are housed inside a console equipped with a touchscreen control panel. The laser treatment parameters are selected using the control panel. Laser emission is activated by depressing a footswitch. An articulated arm with rotational mirror knuckles delivers the laser beam from a laser head inside the console to a handpiece. The handpiece is equipped with an optical zoom assembly that determines the spot size of the laser beam on the treatment surface. The beam of a low-power diode laser is also transmitted through the arm to provide an aiming beam.
The Cutera enlighten III Laser System was studied to assess the safety and efficacy of its 670 nm wavelength for clearing tattoos containing green and/or blue ink.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Primary Efficacy Endpoint) | Reported Device Performance (670 nm wavelength for green/blue ink) |
|---|---|
| ≥ 50% clearing of green and blue inks in ≥ 80% of patients | Greater than 50% clearing was seen in green and blue ink in the tattoos for 84% of subjects. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 27 subjects were initially enrolled. Data analysis was conducted on 25 subjects (2 subjects voluntarily withdrew).
- Data Provenance: The study was an IRB-approved, prospective, two-center clinical study. The country of origin is not explicitly stated in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Three blinded dermatologists.
- Qualifications: "Blinded dermatologists" is the only qualification mentioned. Specific experience levels (e.g., years of experience) are not provided.
4. Adjudication Method for the Test Set
- The text states that "Before and after images of the twenty-five subject tattoos were randomized and sent to three blinded dermatologists for correct identification of the before from after image, and grading of the clearing of the green and/or blue ink."
- It then mentions that "All blinded dermatologists correctly identified the before image for all subjects."
- Regarding grading, the aggregated result is reported (84% of subjects achieved >50% clearing). The specific adjudication method for combining the dermatologists' individual grading scores (e.g., simple majority, average, or if discrepancies were resolved) is not explicitly stated. However, the fact that an overall performance metric is given implies a consensus or combined outcome.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing AI-assisted vs. non-AI-assisted human readers was not conducted. This study focused on the device's standalone performance in a clinical setting.
6. Standalone Performance Study
- Yes, a standalone study was conducted. The clinical trial assessed the safety and efficacy of the enlighten III laser system (the algorithm/device) for tattoo removal when used by medical professionals. This is a direct measure of the device's performance without specific "human-in-the-loop" AI assistance considerations.
7. Type of Ground Truth Used
- Expert Consensus (Blinded Dermatologist Assessment): The ground truth for tattoo clearing was established through the photographic assessment and grading by three blinded dermatologists.
- Investigator Assessment: There was also an investigator assessment of tattoo clearing at six-week post-treatment.
8. Sample Size for the Training Set
- The document does not provide information about a separate training set or its sample size. The clinical study described appears to be a validation/test set for the device's performance.
9. How the Ground Truth for the Training Set Was Established
- As no information about a separate training set is provided, the method for establishing its ground truth is not applicable from this document. The device's performance in the clinical study was evaluated against the ground truth established by the blinded dermatologists and investigators using the actual subjects' tattoos.
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(30 days)
Cutera, Inc.
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:
- Device: truSculpt (RF energy device and massage device).
- 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.
- 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.
- 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.
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