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510(k) Data Aggregation
(208 days)
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.
| Category | Acceptance Criteria (Implied by Standards/Equivalence) | Reported Device Performance |
|---|---|---|
| Intended Use | Non-invasive treatment of mild to moderate facial wrinkles for adults with Fitzpatrick skin types I-IV (OTC home use) | Matches the predicate device's intended use. |
| RF Energy Specifications | Similar RF frequency and electrical power to predicate device. | - Maximal power output: 5 ± 1 Watt - 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.
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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.
- Test Set Sample Size: Not applicable for a clinical effectiveness study. For non-clinical tests:
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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.
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Adjudication method for the test set: Not applicable. There was no clinical effectiveness study requiring expert adjudication of results.
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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.
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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.
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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.
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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.
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How the ground truth for the training set was established: Not applicable.
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(115 days)
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:
| Performance Aspect | Reported Device Performance |
|---|---|
| Label Comprehension/Self-Selection | 100% of 25 participants reported correct answers regarding intended use, treatment areas, and contraindications. |
| Usability/User Interface | 100% success rate for all tasks (25 tasks across 4 scenarios) completed by participants without moderator assistance. Average satisfaction with ease of use: 4.4 ± 0.2 (on a 1-5 scale). Average labeling and instructions comprehension: 4.1 ± 0.2. Overall satisfaction: 4.1 ± 0.2. Minimal negative feedback (two found it heavy, one found triggerless mode unnecessary). |
| Safety (via standards compliance) | The device has been tested and complies with numerous international and industry standards, including: - 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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(175 days)
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.
| Acceptance Criteria (from Intended Use) | Reported Device Performance (as stated for substantial equivalence) |
|---|---|
| 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 document states: "EL Global Trade Ltd's sensiLight has been successfully tested through bench, usability and safety tests to support the determination of substantial equivalence with predicate devices." And "Tests results are supporting all labeling claims in order to establish substantial equivalency." This implies the device meets the performance requirements for permanent hair reduction, as substantial equivalence means it is as safe and effective as the predicate devices that already meet these claims. The device relies on the same technology (IPL), wavelength (475-1200 nm), and maximum energy (5 joules/cm²) as the predicate devices, which are already cleared for the same indication. |
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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(149 days)
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."
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Safety: | |
| - Biocompatibility | Body contact materials evaluated for biocompatibility per FDA Memorandum #G95 1 and ISO 10993-1:2009. |
| - Electrical & Mechanical Safety | Complies with IEC 60601-1:2005/EN 60601-1:2006, IEC 60601-1-11:2010, IEC 60601-2-57:2011. |
| - Electromagnetic Compatibility (EMC) | Complies with FCC part 15. Subpart B, Class B, and IEC 60601-1-2:2007. |
| - Software Safety | Software Validation conducted according to IEC 62304:2006 and FDA Guidance for Software Contained in Medical Devices (May 11, 2005). |
| - Risk Management | Complies with ISO/IEC 14971:2007 (BS EN ISO 14971:2012). |
| - Safety Features (skin proximity/pigmentation) functionality | Device contains a skin proximity sensor and a skin pigmentation sensor. Will not trigger a pulse if not properly applied or if skin tone is too dark/tanned. These features are "the same" as predicate devices. |
| Usability & Effectiveness: | |
| - Intuitive Use / Self-Selection | Usability Study demonstrated that potential end users could self-select appropriately, and 100% of enrolled subjects successfully completed all tasks using the device and instructions in a simulated home environment. |
| - Effectiveness claims supported (hair removal, permanent | "Tests results are supporting all labeling claims in order to establish substantial equivalency." (The specific hair reduction percentages or clinical equivalency data are not provided in this document, but rather a claim that supporting test results exist). Predicate devices provide the basis for these claims. |
| hair reduction) | |
| Technological Equivalence to Predicate Devices: | |
| - Wavelength of light emitted | Same as predicate devices (475 - 1200nm). |
| - Fluence/flux (energy per area) | Same as predicate devices (5 joules/cm² maximum energy). |
| - Pulse duration | Same as predicate devices. |
| - Design and components | Similar to predicate devices (K131870 and K103184). |
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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