Search Results

Date Cleared

2023-12-15

(78 days)

Product Code

GEX,OHT

Regulation Number

Type

Panel

Reference & Predicate Devices

K160968,K230021

Predicate For

N/A

Intended Use

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.

Device Description

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.

AI/ML Overview

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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K Number

K230660

Device Name

AviClear Laser System

Manufacturer

Date Cleared

2023-06-06

(88 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K213461

Predicate For

K251149

Intended Use

The AviClear Laser System is indicated for the long-term treatment of mild to severe inflammatory acne vulgaris.

Device Description

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.

AI/ML Overview

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<0.001).

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<0.001).

Secondary Effectiveness Analyses & Safety Performance:

Assessment	Reported Performance
Improvement in Investigator's Global Assessment (IGA)	By the 52-week follow-up visit, the number of subjects had increased to 66.2% for the "Clear or Almost Clear" skin categories.
Improvement from Baseline in Non-Inflammatory Lesion Counts	Reduced from 25% (p=0.001) at 12-week mark to 57.6% reduction from Baseline at the 52-week follow-up assessment (p<0.001).
Subject Satisfaction	Approximately 70% of subjects reported they were either "Very likely" or "Likely" to have the laser treatment again at both the 12- and 52-week follow-up visits.
Treatment Discomfort	All treatment sessions were well tolerated with an average discomfort score of 5.23 ± 1.15. No treatment sessions ended prematurely due to excessive treatment discomfort.
Serious Adverse Events (SAEs) & Unanticipated Adverse Device Effects (UADEs)	No reports of SAEs and unanticipated adverse device effects of any severity (SUADEs/UADEs). No residual adverse events at the 52-week mark.
Common Adverse Events (at 12-weeks)	- Mild, transient erythema (all subjects) - Edema (98.1% of subjects); self-resolved within hours to days - Mild acne purging/flare-up (45.2% of subjects); typically resolving with no medical intervention - Mild dryness (18.3% of subjects); typically resolving with topical skin moisturizers
Lack of Specific Adverse Events	No reports of blistering, hyper- or hypopigmentation, or scarring adverse events in any subjects.

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

Sample Size: 104 subjects
Data Provenance:
- Country of Origin: Not explicitly stated in this document but typically for FDA submissions, clinical trials are often conducted in the US or under ICH GCP guidelines.
- Retrospective or Prospective: Prospective, multi-center, clinical study.

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

The document does not explicitly state the number of experts or their specific qualifications. For acne studies, the "Investigator's Global Assessment (IGA)" is typically determined by a qualified dermatologist or clinical investigator. The primary effectiveness measure ("≥50% fewer inflammatory acne lesions") would likely be a count performed by study personnel or automated systems, validated by clinical examination.

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

The document does not describe any specific adjudication method for establishing ground truth, such as multi-reader consensus.

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 is a laser system for acne treatment, not an AI-assisted diagnostic device that would typically involve human readers interpreting images.

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

Not applicable. This is a direct treatment device, not an algorithm.

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

The ground truth for effectiveness was based on:

Clinical Assessment: Reduction in inflammatory acne lesions (counted), and Investigator's Global Assessment (IGA) scores.
Patient Reported Outcomes: Subject Satisfaction data.
Safety Data: Adverse event reporting and discomfort scores.

8. The sample size for the training set

Not applicable. This is a direct treatment device, not a machine learning algorithm that requires a "training set" in the computational sense. The "training set" for the device's development would be the pre-clinical research and engineering associated with its design.

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

Not applicable for the same reason as point 8. The "ground truth" for the device's design would stem from scientific understanding of laser-tissue interaction and acne pathophysiology.

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K Number

K213461

Device Name

AviClear Laser System

Manufacturer

Date Cleared

2022-03-24

(148 days)

Product Code

Regulation Number

Type

Panel

enlighten III Laser System

Reference & Predicate Devices

K041242

Predicate For

K230660

Intended Use

The AviClear Laser System is indicated for the treatment of mild to severe inflammatory acne vulgaris.

Device Description

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.

AI/ML Overview

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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K Number

K182997

Device Name

Manufacturer

Date Cleared

2018-12-12

(43 days)

Product Code

Regulation Number

Type

Panel

truSculpt RF Device; truSculpt; truSculpt 3D

Reference & Predicate Devices

K172077,K170597

Predicate For

N/A

Intended Use

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

Device Description

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).

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.

AI/ML Overview

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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K Number

K180709

Device Name

Manufacturer

Date Cleared

2018-06-06

(79 days)

Product Code

PBX,GEI

Regulation Number

878.4400

Type

Panel

Cutera enlighten III Laser System

Reference & Predicate Devices

K162512,K163415

Predicate For

K221407

Intended Use

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.

Device Description

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.

AI/ML Overview

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 < 0.001). The 18-month circumferential-measurement data when compared with the 12-week circumferential-measurement data showed a 0.17 ± 0.49 cm increase in circumference of the abdomen for this cohort of 15 subjects (p = 0.36), suggesting long-term maintenance of reduction.
Safety: Incidence and severity of treatment-related adverse effects developing after the final 12-week follow-up visit of C-16-TS11. (At which point all treatment-related expected side effects had resolved without medical intervention).	No treatment-related adverse effects were observed or reported developing after the 12-week follow-up visit of C-16-TS11.

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

Non-invasive Lipolysis Study (C-17-TS13):
- Sample Size: 12 subjects (92% females, 8% males; aged 24-58 years).
- Data Provenance: Single-center, prospective, non-randomized, open-label study conducted in an unspecified country (likely USA, given FDA submission). The study involved subjects scheduled for abdominoplasty surgery, and biopsies were harvested during these surgeries.
Long-term Follow-up Circumferential Reduction Study (C-17-TS15):
- Sample Size: 15 subjects were enrolled for the 18-month follow-up (out of 46 potential subjects from the previous study C-16-TS11).
- Data Provenance: Single-center, observational, prospective study. Follow-up data collected 18 months after initial treatment in a previous study (C-16-TS11). Country of origin is unspecified, but likely USA.

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

Non-invasive Lipolysis Study (C-17-TS13):
- Number of Experts: One
- Qualifications: "board-certified dermatopathologist"
Circumferential Reduction Study (C-17-TS15): The ground truth was based on physical measurements (circumferential measurements) taken by study personnel, not interpreted by experts in the same way as histological slides.

4. Adjudication Method for the Test Set

Non-invasive Lipolysis Study (C-17-TS13): Not explicitly stated. Given that a single "board-certified dermatopathologist" performed the examination, it implies direct assessment rather than a formal adjudication process between multiple readers. However, the study design included treated vs. contralateral (untreated) control areas on the same subject, effectively allowing for internal comparison.
Circumferential Reduction Study (C-17-TS15): Not applicable for measurements. The initial C-16-TS11 study (data previously submitted) included comparative outcomes from treatment and sham treatment arms.

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

No MRMC comparative effectiveness study was done to evaluate human readers' improvement with AI vs. without AI assistance. The truSculpt RF device is not an AI-assisted diagnostic device, but rather a therapeutic device.

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

This question is not applicable as the truSculpt RF is a physical device used by a human practitioner for treatment, not an AI algorithm. The performance studies evaluate the device's effect on patients.

7. The Type of Ground Truth Used

Non-invasive Lipolysis Study (C-17-TS13):
- Ground Truth: Histological evaluation (biopsies examined by a board-certified dermatopathologist) for evidence of adipocyte necrosis and inflammatory response. This is a form of pathology ground truth.
Circumferential Reduction Study (C-17-TS15):
- Ground Truth: Quantitative physical measurements (circumferential measurements of the abdomen). This is a form of outcomes data.

8. The Sample Size for the Training Set

The provided text describes clinical studies for validation, not the development of an AI algorithm with a distinct training set. Therefore, this information is not applicable in the context of this device and report.

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

As this is not an AI/algorithm-based device with a separate training set, this information is not applicable.

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K Number

K172077

Device Name

Manufacturer

Date Cleared

2017-10-27

(109 days)

Product Code

Regulation Number

Type

Panel

K170936,K160480,K170597,K133254

Reference & Predicate Devices

Predicate For

K173700,K182997

Intended Use

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

Device Description

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.

AI/ML Overview

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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K Number

K172004

Device Name

truSculpt

Manufacturer

Date Cleared

2017-08-02

(30 days)

Product Code

PBX,GEI

Regulation Number

878.4400

Type

Special

Panel

Cutera enlighten III Laser System

Reference & Predicate Devices

K160470,K162512,K163415

Predicate For

K221407

Intended Use

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.

Device Description

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.

AI/ML Overview

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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K Number

K170936

Device Name

Manufacturer

Date Cleared

2017-04-25

(26 days)

Product Code

Regulation Number

Type

Special

Panel

Reference & Predicate Devices

K163222,K133254,K160488

Predicate For

K172077

Intended Use

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-III
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 pigments with Fitzpatrick skin types I-III.

Device Description

The modified Cutera 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).

AI/ML Overview

This document is an FDA 510(k) premarket notification for a modification to the Cutera enlighten III Laser System. It focuses on demonstrating substantial equivalence to a previously cleared device. Therefore, it does not contain the kind of detailed study data (like sample sizes, expert qualifications, or comparative effectiveness with human readers) that would be present in a clinical trial report for a new device.

Here's an analysis of what is and isn't provided based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for clinical performance. Instead, it details modifications to the device's operational parameters and then asserts that these modifications do not introduce new risks or change the intended use, implying that the device, with these modifications, still meets the safety and effectiveness profile of its predicate.

However, the key performance data discussed relates to the device's technical specifications and compliance with safety standards.

Acceptance Criteria (Implied / Stated Compliance)	Reported Device Performance (with modifications)
Safety and Electrical Standards Compliance	Complies with: - IEC 60601-1 (Edition 3.1, 2012) - IEC 60601-1-6 (Edition 3.1, 2013) - IEC 62366 (Edition 1.1, 2014) - IEC 60601-2-22 (Edition 3.1, 2012) - IEC 60825-1 (Edition 2.0, 2007) - AAMI/ANSI ES60601-1:2005+A2 (R2012)+A1 - IEC 60601-1-2 (Edition 3, 2007)
Maximum Delivered Energy	1064 nm: Increased from 600 mJ to 800 mJ (maintaining 10 J/cm² max fluence) 532 nm: Increased from 300 mJ to 400 mJ (maintaining 2.5 J/cm² max fluence)
Maximum Treatment Fluence	1064 nm: Maintained at 10 J/cm² 532 nm: Maintained at 2.5 J/cm²
Spot Sizes	Added 9 mm and 10 mm incremental spot sizes for 1064 nm and 532 nm wavelengths.
Pulse Duration	Added 2 ns pulse duration for the 670 nm wavelength.
No New Risks Introduced	Affirmed based on unchanged maximum treatment fluence and no changes to intended use or indications for use.
Equivalence in Intended Use/Indications	Identical to predicate device.
Equivalence in Technical Specifications	Similar or within range of predicate and reference devices in spot sizes, wavelengths, pulse widths, laser types, and repetition rates.
Equivalence in Operating Performance	Similar to predicate and reference devices.
Equivalence in General Design	Similar to predicate and reference devices.

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

The document refers to a "Performance Data: enlighten III Software Verification and Validation Testing Report (V0140 rA1)". This report likely contains the details of the test set and data provenance for the software modifications. However, the FDA letter does not provide any specific sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for clinical or performance data related to the device's efficacy in treating patients.

The "testing" mentioned primarily concerns software verification and validation and compliance with electrical and safety standards, not a clinical study on human subjects with a "test set" in the context of diagnostic accuracy.

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 in the document. As this is a 510(k) for a laser system modification, the "ground truth" would likely refer to the physical output parameters of the laser, verified by engineering and metrology, rather than expert clinical consensus on patient outcomes, which is typical for AI diagnostic devices.

4. Adjudication method for the test set

This information is not provided. Given the nature of the device (a laser system for treatment), "adjudication method" in the context of reconciling expert opinions (as described by "2+1, 3+1") is not relevant here. The "testing" pertains to engineering standards and device performance specifications.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done or described in this document. This type of study is relevant for evaluating the impact of AI algorithms on human reader performance, typically in diagnostic imaging, which is not the function of this laser system.

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

This concept is not applicable to this device. The Cutera enlighten III is a physical laser system, not a diagnostic algorithm. The "algorithm" here refers to the control software that dictates the laser's operational parameters, and its "performance" is judged by its ability to control the hardware within specified tolerances and safety limits.

7. The type of ground truth used

The implicit "ground truth" for this device's performance is its technical specifications and adherence to international safety and electrical standards (e.g., IEC 60601-1, IEC 60825-1, etc.), as well as the accurate output of laser parameters (energy, fluence, spot size, pulse duration). This is established through engineering measurements and metrology, not pathology, outcomes data, or expert clinical consensus on patient diagnosis.

8. The sample size for the training set

This information is not applicable and therefore not provided. The device's "software modification" does not involve machine learning or AI models that require a "training set" in the typical sense of classifying data or predicting outcomes. The software is a set of control logic and algorithms to operate the laser system.

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

This information is not applicable for the same reasons as #8.

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K Number

K162512

Device Name

truSculpt

Manufacturer

CUTERA, INC.

Date Cleared

2016-12-09

(92 days)

Product Code

PBX,GEI

Regulation Number

878.4400

Type

Panel