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Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The 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.

Ice Cooling IPL Hair Removal Device is an over-the-counter, home-use and personal device for hair reduction by using Intense Pulsed Light (IPL). It is designed with a lamp that can emit single pulse, double pulse or triple pulse per shot. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with nearly painless pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product adopts sapphire treatment window that is suitable for multiple hair removal areas. It contains a skin sensor to detect appropriate skin contact, if the device is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the device has the ice cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.

Based on the provided FDA 510(k) clearance letter for the Ice Cooling IPL Hair Removal Device, here's a breakdown of the acceptance criteria and the study (performance data) that proves the device meets them:

Important Note: The provided document is an FDA Clearance Letter and a 510(k) Summary. These documents primarily focus on demonstrating substantial equivalence to predicate devices and detailing the safety and performance testing that supports this claim. They do not contain detailed clinical study results such as those typically found in a clinical trial report (e.g., specific hair reduction percentages, statistical significance, or details on human reader studies for AI). The performance data listed focuses on engineering and safety standards, not clinical efficacy metrics with human subjects.

Therefore, for aspects related to clinical efficacy (like "how much human readers improve with AI vs without AI assistance" or detailed ground truth establishment for a clinical outcome), the information below is derived from what can be inferred or is explicitly stated regarding the device's technical specifications and safety profile, rather than a direct clinical performance study with defined acceptance criteria for efficacy. The "acceptance criteria" primarily relate to safety, electrical performance, and biocompatibility, as evidenced by compliance with international standards.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is an IPL hair removal device, the "acceptance criteria" in this context are primarily related to safety, electrical performance, and biocompatibility standards, rather than direct efficacy metrics like those for an AI diagnostic device. Efficacy is typically established by comparing the device's operational characteristics and intended use to legally marketed predicate devices that have prior clearance for similar indications, and by showing that it achieves the "permanent reduction in hair regrowth" as stated in the Indications for Use. The "reported device performance" is then the successful demonstration of compliance with these standards and comparable technological characteristics.

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

The provided document does not specify a sample size for a clinical test set for hair reduction efficacy or any "test set" in the context of an AI/algorithm-driven diagnostic device. The performance data is primarily focused on engineering and safety testing conducted to established international standards.

• Sample Size for Testing: Not applicable in the context of a clinical test set for efficacy, as no such study is detailed. For electrical and biocompatibility testing, "samples" would refer to a statistically appropriate number of units or materials for the specified tests, but these numbers are not disclosed.
• Data Provenance: The manufacturer is Shenzhen Ulike Smart Electronics Co., Ltd., located in Shenzhen, China. The testing standards are international (IEC, ISO). The nature of the studies discussed (biocompatibility, electrical safety, light safety, software V&V, Usability) are laboratory-based and engineering assessments, not multi-center clinical trials. There is no indication of retrospective or prospective clinical data from human subjects mentioned.

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

This information is not applicable or provided in the context of the 510(k) summary for an IPL hair removal device. "Ground truth" established by experts (e.g., radiologists) is typically relevant for diagnostic devices that analyze medical images or data. For this device, "ground truth" for safety specifications is established by compliance with published international standards (IEC, ISO), and human factors/usability experts would likely assess the usability aspects. No details are given about such experts or their roles in establishing a "ground truth" for clinical efficacy.

4. Adjudication Method for the Test Set

Not applicable/provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies for diagnostic devices, especially when establishing ground truth from multiple expert readers. This type of clinical study is not detailed in the provided 510(k) summary for this device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done according to the provided 510(k) summary. MRMC studies are specific to evaluating the diagnostic performance of algorithms (often AI) in conjunction with human interpretation, and assessing the improvement in human reader performance with AI assistance. This device is an IPL hair removal device, not a diagnostic AI system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

While the device does contain software ("Software Verification and Validation" is listed as a performance data category), this is embedded control software for the device's functionality (e.g., controlling pulse emission, energy levels, safety features like the skin sensor). There is no indication of a "standalone" algorithm performance study in the sense of an AI model independently performing a diagnostic task without human interaction. The software functions to ensure the device operates safely and effectively as designed, not to perform an independent diagnostic or analysis function typically evaluated in a standalone study.

7. The Type of Ground Truth Used

For the technical and safety performance, the "ground truth" is adherence to established international standards (IEC, ISO). For example:

• Biocompatibility: In vitro and in vivo test results against material safety standards.
• Electrical Safety & EMC: Measurements of electrical parameters and electromagnetic emissions against IEC limits.
• Light Safety: Measurements of light output parameters against IEC limits for photobiological safety.
• Software V&V: Verification that software functions as specified and validation that it meets user needs/hazard mitigation requirements.
• Usability: Observational and empirical data from user testing against usability standards and FDA guidance.

For clinical efficacy (hair reduction), the ground truth would inherently be a measured reduction in hair regrowth over time, typically observed by clinicians or participants. However, the document does not describe the detailed clinical study methodology (e.g., type of outcome data, how it was collected, or if it involved pathology/histology to confirm hair follicle damage) that would have been used to establish this clinical "ground truth" for the device, beyond stating the "permanent reduction in hair regrowth" as an indication for use, implying it was demonstrated previously by predicate devices.

8. The Sample Size for the Training Set

Not applicable/provided. The concept of a "training set" is relevant for machine learning or AI models. This 510(k) summary describes a physical medical device (an IPL hair removal device), not an adaptive AI system requiring a training data set for its primary function. While the device contains software, it's for control and safety, not for learning or diagnostic predictions from historical data.

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

Not applicable/provided. As there is no "training set" in the context of an AI/ML algorithm discussed, the establishment of ground truth for such a set is not relevant to this 510(k) submission.

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The CurrentBody Skin RF (ST030) device is an over-the-counter home-use device intended for non-invasive treatment of mild to moderate facial wrinkles for adults with Fitzpatrick skin types I-IV.

The CurrentBody Skin RF device is an OTC, home-use hand-held device generating pulses of radiofrequency (RF) energy that are emitted into the skin. RF energy heats the tissue to improve the appearance of wrinkles and rhytides. It is a non-invasive, non-ablative device consisting of: User Interface, Programmable logic controller (PLC, microcontroller) embedded in PCBA, RF power module, Power Supply, RF electrodes. The PLC (on the PCBA) is a specially configured software that, combined with hardware circuits, provides the operational and safety function of the system. The RF power module provides RF energy to the active tip electrodes, producing a signal of 1MHz frequency (power limited by hardware). This device is supplied non-sterile.

The provided text describes the regulatory clearance of the CurrentBody Skin RF device, focusing on its substantial equivalence to a predicate device. As such, it details non-clinical testing and comparisons rather than comprehensive acceptance criteria for a "study that proves the device meets the acceptance criteria" in the way one might expect for a new, AI-driven diagnostic device undergoing clinical trials.

The document emphasizes demonstrating substantial equivalence through bench tests, electrical safety, software validation, human factors, and thermal effects, rather than through a direct clinical performance study with specific effectiveness endpoints measured against acceptance criteria against a ground truth.

Therefore, many of the requested elements for a typical effectiveness study (e.g., sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in this submission. The device is not an AI-driven diagnostic.

Here's an analysis based on the information available:

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" in the traditional sense of clinical effectiveness endpoints. Instead, it demonstrates that the new device meets various safety and performance standards, and is substantially equivalent to a predicate device in its technical specifications and intended use. The "acceptance criteria" are implied by compliance with these standards and equivalence to the predicate.

• Frequency: 1 ± 0.05 MHz
• Operating RF Power (200 Ohms): $5W \pm 1$
• Total Power Density (fluence): $5 W/cm^2 \pm 1$ |
  | Temperature Control | Maintain temperature within target treatment range (e.g., maximal temperature of $40.5 \pm 0.5^\circ C$). | Two redundant thermistors constantly measure skin temperature and alter power to maintain constant temperature. |
  | Power Accuracy | Measured total power within error margin on a 200 Ω load. | Measured total power was within the error margin. |
  | Parameter Validation | Varied parameters (RF, pulse cycle, waveform, pulse duration) within acceptance criteria. | All results were within the acceptance criteria. |
  | Electrical Safety | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-2. | The device complies with these standards. |
  | Software Verification & Validation | Compliance with FDA Guidance for Software in Medical Devices ("moderate" level of concern). | Software verification and validation testing were conducted and documentation provided as recommended. |
  | Human Factors Validation | Users can safely and effectively self-select, prepare, and perform treatment. | A Self-Selection and Human Factors validation study was performed to demonstrate this. |
  | Thermal Equivalence | Spatio-temporal heating profile comparable to predicate device. | Measurements showed comparable (near identical) spatio-temporal tissue heating in porcine belly skin. |
  | Biocompatibility | All patient-contacting parts comply with ISO 10993-1. | Compliance with ISO 10993-1 demonstrated. |

Study Details

This submission relies on non-clinical testing and comparison to a predicate device, rather than a clinical effectiveness study.

1. Sample sizes used for the test set and data provenance:

   • Test Set Sample Size: Not applicable for a clinical effectiveness study. For non-clinical tests:
     • Power Accuracy, Parameter Validation: Not specified, likely small batches of devices for bench testing.
     • Human Factors Validation: Not specified, but involved a user group for self-selection and treatment performance.
     • Thermal Effects: "Porcine belly skin samples" – number not specified.
   • Data Provenance: Not explicitly stated, but testing appears to be conducted by the manufacturer or their contracted labs (implied through the submission). The "porcine belly skin" indicates animal tissue, not human.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for diagnostic AI studies (e.g., expert consensus on medical images, pathology results) is not relevant here. The "ground truth" for non-clinical tests would be the established performance standards or the predicate device's measured characteristics.

3. Adjudication method for the test set: Not applicable. There was no clinical effectiveness study requiring expert adjudication of results.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI-driven diagnostic and no MRMC study was conducted.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device for aesthetic treatment, not a standalone algorithm. The software component, however, underwent "standalone" verification and validation to ensure its proper functioning and safety.

6. The type of ground truth used:

   • For Non-Clinical Tests: Engineering specifications, compliance with international standards (IEC, ISO), and the measured performance of the predicate device.
   • For Thermal Equivalence: Direct comparative measurements against the predicate device on porcine tissue.

7. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set in the typical sense. Software verification and validation refer to testing the programmed logic and control, not training an AI model.

8. How the ground truth for the training set was established: Not applicable.

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The Sensilight Pro device is an over-the-counter device intended for the removal of unwanted body and/or facial hair. Sensilight Pro is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured 6,9 and 12 months after the completion of treatment regimen.

The Sensilight Pro is an intense pulse light hair reduction device. Phototherapy (Lightbased) hair reduction is based on the theory of selective photothermolysis in which optical energy is used to disable hair re-growth. The Sensilight Pro is composed of a hand-held applicator and an external power supply/charger. The spot size (treatment area) in the Sensilight Pro is 4.5 cm² or 2 cm² (for large and precise treatment windows, respectively).

The device contains a lamp, a skin proximity and pigmentation sensor allowing application only on compatible skin tones and while in full contact with the treated area. If the Sensilight Pro is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the device will provide indications on the faulty conditions and will not trigger a pulse.

The Sensilight Pro device, intended for over-the-counter hair removal and permanent hair regrowth reduction, did not report specific acceptance criteria in the provided text. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through various tests and comparisons.

Here's an analysis of the provided information, structured to address your points:

1. Table of Acceptance Criteria and Reported Device Performance

As specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy) were not explicitly defined in the provided text, they cannot be presented in a table. The performance evaluation primarily centered on safety, compliance with standards, and human factors validation.

However, we can infer some performance aspects from the human factors studies:

• IEC 60601-1:2012/EN 60601-1:2013 (Ed. 3.1) for basic safety and essential performance.
• IEC 60601-1-11:2015 (Ed. 2) for home healthcare environment.
• IEC 60601-2-57:2011 (Ed. 1) for non-laser light source equipment.
• FCC part 15, Subpart B, Class B.
• IEC 60601-1-2:2014 (Ed. 4) for electromagnetic compatibility.
• IEC 62471:2006 (Ed. 1) for photo-biological safety.
• IEC 62304:2006 for medical device software life cycle processes.
• ISO 10993-1:2009 for biological evaluation.
• ISO/IEC 14971:2007 (BS EN ISO 14971:2012) for risk management.
• CB IEC 62133:2012 and UN 38.3 for battery safety and transport. |

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

• Labeling Comprehension/Self-Selection Study:
  • Sample Size: 25 participants (4 men, 21 women).
  • Data Provenance: Not explicitly stated, but based on the overall context of a submission to the US FDA, it would typically be conducted within the US or a region compliant with US regulatory requirements. The study appears to be prospective as participants were "enrolled" and received materials for evaluation.
• Usability/User Interface Study:
  • Sample Size: 25 participants initially ("all tasks were completed by 100% of the participants"), but the follow-up satisfaction questionnaire was filled by 18 of the 20 users. This suggests that the study may have involved 20 users for the primary usability tasks with 18 completing the satisfaction survey, or 25 for tasks and 18 for satisfaction. Clarification is needed, but 25 is the stated size for task completion.
  • Data Provenance: Not explicitly stated regarding country, but appears prospective as participants performed tasks with the device.

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

There is no mention of experts being used to establish ground truth in the context of these human factors studies for the Sensilight Pro. The "ground truth" for these studies was the ability of the general public (participants) to comprehend labeling and successfully operate the device without assistance.

4. Adjudication Method for the Test Set

• Labeling Comprehension/Self-Selection Study: Answers were "further validated by the moderator." This implies a form of human review/adjudication. The text states "with correct answers: 'Yes' or 'No', explenation and further validation by the moderator."
• Usability/User Interface Study: The adjudication method for tasks was based on direct observation of task completion, with the "success rate (pass criteria) was 100% per each task scenario." No specific expert adjudication process beyond the moderator's observation is described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was performed or reported. This device is an IPL hair removal device, not an AI-assisted diagnostic or interpretive system that would typically involve human "readers" or an MRMC study.

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

Not applicable in the AI sense. The Sensilight Pro is a medical device, not an AI algorithm. Its "standalone" performance is established through bench testing (safety, electrical, mechanical, photobiological, etc.) and compliance with various standards (listed in point 1). These tests ensure the device functions correctly and safely on its own.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• For Human Factors Studies:
  • Labeling Comprehension: The "ground truth" was predefined correct answers to comprehension questions, potentially established by the device manufacturer's regulatory/clinical team.
  • Usability: The "ground truth" was verifiable task completion based on the device's design and instructions.
• For Clinical Efficacy (Hair Reduction): The document explicitly states: "No new clinical performance data is reported in this submission."
  Therefore, the ground truth for hair reduction efficacy for this submission was not directly established via new clinical studies. Instead, substantial equivalence to predicate devices (which presumably had established clinical efficacy) was argued based on similar technology and parameters. The stated definition of "permanent reduction in hair regrowth" (measured 6, 9, and 12 months after treatment) implies that outcomes data would be the typical ground truth for this claim, but this was not provided for the Sensilight Pro in this submission.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML product requiring a training set in the conventional sense. The "training" for the device's design and features would be through engineering development, safety testing, and compliance with standards.

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

Not applicable, as there's no "training set" for this type of device. The design and safety features (like skin proximity and pigmentation sensors) were developed and validated through internal testing and compliance with recognized standards, which serve as the implicit "ground truth" for their proper functioning.

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The RF-Relief is an over the counter hand held device intended to emit energy in RF spectrum to provide topical heating for the purpose of elevating tissue temporary relief of minor muscular and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and temporary relaxation of muscles.

The RF-Relief is an OTC, home use device, designed to deliver RF energy and mechanical skin massaging. RF energy does not cause thermal damage to the treated skin and the subdermal adipose layer. The level of the RF power, to achieve maximum comfort is user selectable. The ergonomic hand held device allows efficient treatment of the indicated body areas. It is a non-invasive, non-ablative device and it is supplied as non-sterile.

The RF-Relief device consists of power supply, RF power generator, Programmable Logic Controller (PLC, microcontroller) embedded in PCBA and user interface. The device also includes four Bi-polar (2 pairs) electrodes, two redundant temperature sensors and a vibration motor. The PLC (on the PCBA) is especially configured software combined with hardware circuits that provides the operational and safety function of the system.

The RF-Relief device is operated while continuously moving it over the treatment area. This ensures a uniform distribution of the RF energy together with mechanical massage over the entire treatment area.

The RF-Relief device is an over-the-counter handheld device intended to emit radio frequency (RF) energy for topical heating to temporarily relieve minor muscular and joint pain and stiffness, minor arthritis pain or muscle spasms, temporarily increase local blood circulation, and temporarily relax muscles.

Here's an analysis of the acceptance criteria and supporting studies, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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The micro IPL is an over the counter device intended for the removal of unwanted body and/ or facial hair in adults. The micro IPL is also intended for permanent reduction in unwanted hair reduction is defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.

The micro IPL device is pulsed light hair removal device. Light-based hair removal is based on the theory of selective photothermolysis in which optical energy is used to disable hair growth. The micro IPL device is composed of a hand held applicator and an external power supply. The spot size (treatment area) in the micro IPL device is 3 cm . The device contains a lamp, a skin proximity sensor and a skin pigmentation sensor to detect appropriate skin tones. If the micro IPL is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned. the micro IPL will not trigger a pulse.

The provided document is a 510(k) summary for the micro IPL device, an over-the-counter Intense Pulsed Light (IPL) device intended for hair removal and permanent hair reduction.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria & Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative manner (e.g., "device must achieve X% hair reduction"). Instead, it focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and safety. The performance claims are qualitative, primarily related to meeting recognized standards and having similar specifications to already cleared devices.

2. Sample Size for the Test Set and Data Provenance

The document explicitly states: "No new clinical performance data is reported in this submission." This indicates that no new clinical test set with human subjects was used for this submission to directly prove the device meets acceptance criteria. The data presented is primarily "bench" (laboratory) testing data and comparison to predicate devices. Therefore, there is no sample size for a clinical test set or data provenance in terms of country of origin or retrospective/prospective nature for this submission.

3. Number of Experts and Qualifications for Ground Truth

Since no new clinical performance data was provided, there was no "ground truth" established by experts for a clinical test set in this submission. The submission relies on the established safety and efficacy of the predicate devices and bench testing to demonstrate equivalence.

4. Adjudication Method

Not applicable, as no new clinical test set requiring expert adjudication was conducted or reported in this submission.

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

No MRMC comparative effectiveness study was done or reported. This device is for direct consumer use for hair removal, not an imaging diagnostic tool that would typically involve multiple readers.

6. Standalone (Algorithm Only) Performance Study

No standalone performance study of an algorithm without human-in-the-loop performance was done. The device description focuses on its hardware components and safety features for user interaction (skin proximity/pigmentation sensors), not on an autonomous algorithm's diagnostic or predictive performance.

7. Type of Ground Truth Used

As stated under point 2, no new clinical ground truth (e.g., expert consensus, pathology, or outcomes data) was generated for this specific submission. The "ground truth" for the device's safety and effectiveness relies on the demonstrated substantial equivalence to already cleared predicate devices, whose efficacy and safety would have been established through prior studies. The compliance with various international standards serves as a form of "ground truth" for certain performance aspects (e.g., electrical safety, EMC).

8. Sample Size for the Training Set

No training set (for a machine learning algorithm) or clinical training data for human subjects is mentioned or implied, as no new clinical studies or AI/ML algorithm development are detailed.

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

Not applicable, as no training set or associated ground truth establishment is described.

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The sensiFirm device is intended for the following medical conditions using non thermal RF combined with massage:

Temporary reduction in the appearance of cellulite.

The sensiFirm is an OTC, home use device, designed to deliver non-thermal RF energy and mechanical skin massaging. RF energy does not cause thermal damage to the treated skin and the subdermal adipose layer. The level of the non-thermal RF power, to achieve maximum comfort is user selectable. The ergonomic hand held device allows efficient treatment of the indicated body areas. It is a noninvasive, non-ablative device and it is supplied as non-sterile.

The sensiFirm device consists of power supply, RF power generator, Programmable Logic Controller (PLC, microcontroller) embedded in PCBA and user interface. The device also includes a vibration motor, four Bi-polar (2 pairs) electrodes and two redundant temperature sensors. The PLC (on the PCBA) is specially configured software combined with hardware circuits that provides the operational and safety function of the system.

The sensiFirm device is operated while continuously moving it over the treatment area. This ensures a uniform distribution of the non-thermal RF energy together with mechanical massage over the entire treatment area.

The document describes the acceptance criteria and the study that proves the device, sensiFirm, meets these criteria for the temporary reduction in the appearance of cellulite.

Here’s the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Clinical Study (Effectiveness):
  • Sample Size: 33 women (age 29-63, average 46 ± 9 years).
  • Data Provenance: Prospective, interventional, single-arm clinical study conducted in a home-use environment. Country of origin not explicitly stated but implied to be where the company is located (Israel) or a clinical site arranged by them.
• Human Factors Validation Testing (Usability/Label Comprehension):
  • Labeling Comprehension/Self-Selection Study: 47 participants (5 men, 42 women, age 24-71, average 42 ± 12 years).
  • Usability/User Interface Study: Not explicitly stated for this particular subsection, but it's part of the broader Human Factors testing which implies it leveraged the participants from the Human Factors study. (The document states "None of the participants required assistance from the moderator while performing the tasks," suggesting it refers to the same participant pool).
  • Data Provenance: Not explicitly stated for Human Factors studies, but typically prospective.

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

• Clinical Study (Effectiveness):
  • Number of Experts: 3 evaluators.
  • Qualifications: 3 board-certified dermatologists and plastic surgeons.

4. Adjudication Method for the Test Set

• Clinical Study (Effectiveness):
  • Adjudication Method: "A participant was considered a success if at least 2 out of the 3 independent evaluators agreed that the participant had shown at least one degree of improvement in the cellulite appearance." This is a form of 2-out-of-3 consensus or 2/3 agreement.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study was a single-arm clinical trial assessing the device's efficacy, with a comparison to an untreated control side of the body. There was no AI component to assist human readers described in this document.

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

• Not applicable. The sensiFirm device is a physical device that delivers RF energy and massage; it is not an AI algorithm. Its performance is evaluated through its direct physical effects and user interaction, not as a standalone AI algorithm.

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

• Clinical Study (Effectiveness): Expert consensus of 3 board-certified dermatologists and plastic surgeons using the Modified Neurenberg-Muller Cellulite Grading Scale, combined with participant satisfaction questionnaires (outcomes data). The design included "subject as her own control" and a concurrent untreated control side for objective comparison.
• Human Factors Validation Testing: Expert observation and qualitative assessment by a moderator for correct task completion and labeling comprehension, along with participant self-reporting/satisfaction.

8. The sample size for the training set

• This information is not provided in the document. The document describes a clinical study and human factors testing for device validation, not the development or training of an AI model.

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

• Not applicable, as no AI model training is described in the provided document.

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The sensiLift is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles for adult women who have Fitzpatrick Skin Types I-IV.

The sensiLift is an OTC, home use hand held device generating pulses of radiofrequency (RF) energy that are emitted into the skin. RF energy heats the tissue to improve the appearance of wrinkles and rhytides. It is a non-invasive, non-ablative device consisting of:

• . User Interface
• Programmable logic controller (PLC, microcontroller) embedded in PCBA ●
• RF power module
• Power Supply ●
• RF electrodes ●

The provided document describes the SensiLift device, an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles. The document outlines the studies conducted to demonstrate its safety and effectiveness for FDA 510(k) clearance.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the SensiLift device are inferred from the safety and effectiveness endpoints of the clinical study, as well as the successful completion of various non-clinical bench tests and human factors studies.

Study Details

The document primarily describes a single-arm, prospective, interventional clinical study for effectiveness and safety, along with several non-clinical studies.

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

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

   • Clinical Study (Effectiveness & Safety):

     • Enrollment: 40 female participants (ages 40-64).
     • Completed Study: 35 participants (total of 87 treatment areas) completed 8 treatments and the 3-month follow-up.
     • Provenance: Not explicitly stated, but presumable from the location of the submitting company (Israel) or where a clinical trial would be conducted. The study is described as "prospective" and "interventional."

   • Human Factors Validation Testing:

     • Labeling Comprehension/Self-Selection Study: 43 participants (2 men, 41 women), ages 18-65 (45 ± 13 years old).
     • Usability/User Interface Study: Not explicitly stated but implies a subset of the 43 participants or a similar number based on "14 out of 20" and "7 out of 20" comments. Assuming it's at least 20 participants for this part.
     • Provenance: Not specified, but likely conducted in a simulated environment.

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

   • Clinical Study (Effectiveness): 3 independent physicians (apart from the PI - Principal Investigator).
   • Qualifications: "3 board certified dermatologists or plastic surgeons."

4. Adjudication method for the test set:

   • Clinical Study (Effectiveness): Wrinkles appearance was assessed independently by the 3 physicians. There is no explicit mention of an adjudication process (e.g., 2+1 or 3+1 consensus). The percentages of improvement are reported for each reviewer separately (e.g., "89%, 95% and 95% of the study participants (as assessed by 3 reviewers, respectively)"). This implies independent assessment rather than a combined adjudicated score for each participant.

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 comparative effectiveness study involving AI assistance for human readers was conducted or described. This device is a direct-to-consumer physical device for wrinkle treatment, not an AI diagnostic tool.

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

   • This question is not applicable. The device is a physical electrosurgical aesthetic device, not an algorithm. Bench tests and a clinical trial evaluated the device's standalone performance in a human-in-the-loop setting (users operating the device).

7. The type of ground truth used:

   • Clinical Study (Effectiveness): Expert assessment using the Fitzpatrick Wrinkles Severity Scale. Improvement was defined as a decrease of at least one score on this scale. This is a clinical outcome observed by qualified experts.
   • Clinical Study (Safety): Observation of adverse events.
   • Human Factors Study: Direct observation of task completion and user responses to questions.

8. The sample size for the training set:

   • The document implies that the clinical study was conducted for final validation and performance assessment. There's no separate mention of a distinct "training set" for an algorithm, as this is a physical device submission. If the device's software had any machine learning components, details about a training set would typically be provided under software V&V. The software concern level is "moderate," indicating potential harm from errors, but it's not described as an AI/ML algorithm.

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

   • Not applicable, as a discrete training set for an AI/ML algorithm is not described. The clinical study acts as the primary validation of the device's performance against ground truth established by expert consensus (dermatologists/plastic surgeons) using a recognized severity scale.

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The sensiLight Mini is an over the counter device intended for the removal of unwanted hair. The sensiLight Mini is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.

The sensiLight Mini device is a pulsed light hair removal device. Light-based hair removal is based on the theory of selective photothermolysis in which optical energy is used to disable hair growth. The sensiLight Mini device is composed of a hand held applicator and an external power supply. The spot size (treatment area) in the sensiLight Mini device is 3 cm2.

The device contains a lamp, a skin proximity sensor and a skin pigmentation sensor to detect appropriate skin tones. If the sensiLight Mini is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the sensiLight Mini will not trigger a pulse.

This document is a 510(k) premarket notification for the sensiLight Mini, which is a pulsed light hair removal device. The device described in this submission (K161089) is stated to be identical to a previously cleared device (K140527). Therefore, no new performance data, non-clinical data, or clinical data are reported in this specific submission. The substantiation relies on the data from the predicate devices.

However, based on the information provided, we can infer some details about the clinical performance for the original device that K161089 references (K140527), particularly regarding its "permanent reduction in hair regrowth" claim.

Here's an attempt to answer your questions based on the available information and reasonable inferences:

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

Since this submission explicitly states "No new clinical performance data is reported in this submission" and "The sensiLight Mini device is identical in all details to the sensiLight Mini device cleared under K140527," the acceptance criteria and performance would be associated with the original K140527 submission. The document defines "permanent reduction in hair regrowth" as:

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

This information is not provided in the K161089 document as it refers back to a previous submission (K140527). To obtain these details, one would need to consult the K140527 submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the K161089 document. Clinical studies for hair removal devices often involve trained technicians or physicians for evaluation, but specifics are missing here.

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

This information is not provided in the K161089 document.

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

Hair removal devices like the sensiLight Mini are typically consumer-use devices and do not involve "readers" in the context of diagnostic imaging. Therefore, an MRMC study and AI assistance as described are not applicable to this type of device.

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

This device is a physical light-based hair removal device for consumer use, not an algorithm. Therefore, "standalone (algorithm only)" performance is not applicable. The device's performance is inherently tied to human use and application according to instructions.

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

For hair removal studies of this nature, the "ground truth" for efficacy (hair reduction) is typically established by outcomes data in the form of objective measurements of hair count or hair density in treated vs. untreated areas, often performed by trained personnel or experts following a standardized protocol. This would be observed at specified time points (6, 9, and 12 months as indicated by the definition).

8. The sample size for the training set

The device described is a physical medical device, not an AI/ML algorithm that requires a "training set" in the conventional sense of machine learning. Therefore, a "training set" as it applies to AI/ML is not applicable. Its development would involve engineering, safety, and clinical testing, not algorithmic training.

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

As explained in point 8, the concept of a "training set" with ground truth establishment for an AI/ML algorithm is not applicable to this device.

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The sensiLight™ Plus device is an over-the-counter device intended for the removal of unwanted hair. The sensiLight™/sensiLight™ Plus is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of treatment regimen.

The sensiLight devices are pulsed light hair removal device. Light-based hair removal is based on the theory of selective photothermolysis in which optical energy is used to disable hair growth. The sensiLight devices are composed of a hand held applicator and an external power supply. The spot size (treatment area) in the sensiLight devices is 3 cm². The device contains a lamp, a skin proximity sensor and a skin pigmentation sensor to detect appropriate skin tones. If the sensiLight is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the sensiLight will not trigger a pulse. (*) The sensiLight Plus model contains in addition, a movement sensor to prevent pulse overlapping.

The provided text is a 510(k) summary for the sensiLight/sensiLight Plus device, which is an over-the-counter device intended for the removal of unwanted hair and permanent reduction in hair regrowth. As such, it does not describe a study involving an AI algorithm and human readers, but rather a direct comparison of a new medical device to existing predicate devices to demonstrate substantial equivalence.

Therefore, many of the requested categories for AI/human reader studies are not applicable to this document. I will provide information based on what is available in the text.

Acceptance Criteria and Device Performance (Not directly applicable to AI/Human Reader Study, but to device equivalence)

The acceptance criteria for "permanent reduction in hair regrowth" is defined as a long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of treatment regimen. The document states that the sensiLight device underwent various tests to support its substantial equivalence to predicate devices, implying it meets this intended use.

1. Sample sized used for the test set and the data provenance:

The document does not provide details on the sample size for a test set related to hair regrowth efficacy or data provenance (e.g., country of origin, retrospective/prospective). It mainly focuses on technical specifications and safety testing to demonstrate substantial equivalence.

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

Not applicable, as this document is not describing a study with human expert interpretation for device performance evaluation in the context of an AI/human reader study.

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

Not applicable.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This document describes a medical device (IPL hair removal device), not an AI algorithm intended for interpretation by human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance is not applicable.

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

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

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

The document implicitly relies on the established "ground truth" of comparable predicate devices that have already demonstrated efficacy for permanent hair reduction. Efficacy for hair removal devices is typically assessed through quantitative measurements of hair count reduction over time (outcomes data). However, specific details on how this "ground truth" was established for the sensiLight device's equivalence study are not provided. It mentions "bench, usability and safety tests."

7. The sample size for the training set:

Not applicable, as this is a physical medical device, not an AI algorithm requiring a training set.

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

Not applicable.

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The sensiLight Mini is an over the counter devices intended for the removal of unwanted hair. The sensiLight Mini is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.

The sensiLight Mini device is pulsed light hair removal device. Light-based hair removal is based on the theory of selective photothermolysis in which optical energy is used to disable hair growth. The sensiLight Mini device is composed of a hand held applicator and an external power supply. The spot size (treatment area) in the sensiLight Mini device is 3 cm2. The device contains a lamp, a skin proximity sensor and a skin pigmentation sensor to detect appropriate skin tones. If the sensiLight Mini is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the sensiLight Mini will not trigger a pulse.

The provided document describes the sensiLight Mini, a pulsed light hair removal device. However, it does not include specific acceptance criteria or a study that directly proves the device meets those criteria in the typical sense of a clinical trial with predefined endpoints and statistical analysis.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through various tests and comparisons of technological characteristics. The "Performance Data" section primarily lists compliance with recognized standards and non-clinical testing.

Here's an attempt to extract and synthesize the requested information based on the provided text, acknowledging the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

As explicit acceptance criteria with numerical targets are not stated, I will infer them from the safety and usability tests described and the claim of "substantial equivalence."

Regarding the studies: The document describes one non-clinical "Usability Study" as part of the performance data. It does not describe a clinical study in the traditional sense to prove efficiency for hair removal, but rather relies on substantial equivalence to previously cleared predicate devices for those claims.

2. Sample Size and Data Provenance (for the described Usability Study)

• Sample size: 20 potential device end-users were enrolled in the Usability Study. (3 participants were excluded during self-selection screening).
• Data provenance: Not explicitly stated, but it was a simulated home-use environment, indicating a prospective study specifically for this device. The country of origin for the data is not mentioned, but given the company's location (Israel), it's plausible the study was conducted there.

3. Number of Experts and Qualifications (for the Usability Study)

• No experts were used to establish ground truth for the usability study. The study objective was to test the device's self-selection and usability by potential end-users (lay users), not experts.

4. Adjudication Method (for the Usability Study)

• There was no mention of an adjudication method. The study involved participants completing tasks, and "All of the 20 enrolled subjects (100%) completed all tasks successfully." This suggests direct observation and binary outcome (task completed/not completed) rather than a need for expert adjudication.

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

• No, an MRMC comparative effectiveness study was not done. The device is a user-operated hair removal device, not an imaging or diagnostic AI tool that would typically involve multiple human readers interpreting cases.

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

• The document implies standalone performance of the device's safety mechanisms (skin proximity and pigmentation sensors) as they automatically prevent pulsation if conditions are not met. However, the overall device function requires human operation. The document doesn't detail an "algorithm-only" performance in the context of an AI device, as this is a physical light-based device. If we interpret "standalone" as the device operating as intended without human intervention in its safety features, then yes, those features function standalone.

7. Type of Ground Truth Used (for the Usability Study)

• For the Usability Study, the "ground truth" was the successful completion of predetermined tasks by the lay users. It was based on direct observation of user interaction with the device and instructions, not expert consensus, pathology, or outcomes data in a medical sense.

8. Sample Size for the Training Set

• The document does not describe the development of an AI algorithm with a training set for this device in the common sense. It's a light-based physical device with embedded software and sensors. Therefore, there's no "training set" sample size to report for an AI model.

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

• As there's no mention of a traditional AI training set, this question is not applicable to the information provided. The "ground truth" for the device's safety features (e.g., what constitutes appropriate skin tone or proper contact) would have been established during engineering design and testing, likely through physical measurements and pre-defined parameters rather than a data-driven training set for an AI model.

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