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The Mini me is an over-the counter device intended for the removal of unwanted hair. The Mini me is also intended for permanent reduction in hair growth following an initial treatment regimen with or without maintenance when measured at 6, 9, and 12 months.

The Mini mē is a smaller version of its predicate device (K131649) and consists of a handheld unit that operates with an external power supply. Identical to its predicate device, the miniaturized version also delivers Intense Pulse Light (IPL) technology (output up to 4 J/cm²) to the treatment area for removing unwanted hair and also uses a skin contact sensor via low RF energy signal to establish skin contact prior to the emission of a pulse.

The provided text is a 510(k) summary for the Mini mē device. It states that the Mini mē is a smaller version of its predicate device (Mē System, K131649) and shares the same technological characteristics, including the use of Intense Pulse Light (IPL) technology (output up to 4 J/cm²), a skin contact sensor, and safety features.

The document does not contain a clinical study with acceptance criteria, reported device performance, sample sizes, ground truth establishment, or expert adjudication as typically found for new device efficacy claims. Instead, it relies on substantial equivalence to a predicate device.

Here's the breakdown of what the document does provide and why it doesn't fit the requested format for a study proving acceptance criteria:

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

This information is not present in the document for the Mini mē regarding efficacy for hair removal. The document focuses on demonstrating that the Mini mē functions as intended based on non-clinical testing and that its performance is equivalent to the predicate device.

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

No clinical test set data is provided. The performance data section refers to non-clinical testing: electrical safety, electromagnetic compatibility, software verification and validation, and system verification and validation. No sample sizes for these tests are mentioned, nor is data provenance in the context of clinical studies.

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 applicable as no clinical test set requiring expert ground truth establishment for efficacy is described. The document relies on engineering and system-level validation.

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

This information is not applicable as no clinical test set 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:

This information is not applicable. The device is an IPL hair removal system, not an AI diagnostic or assistance tool.

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

This information is not applicable as the device is a user-operated IPL hair removal system, not an algorithm.

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

This information is not applicable for clinical efficacy evaluations of the Mini mē, as no such evaluations are detailed in the provided text. For the non-clinical tests, the "ground truth" would be the engineering specifications and regulatory standards the device was tested against.

8. The sample size for the training set:

This information is not applicable. The Mini mē is a physical device, not an AI model requiring a training set.

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

This information is not applicable for the same reason as above.

In summary: The provided document is a 510(k) summary for a medical device seeking clearance based on substantial equivalence. It highlights the technological characteristics and non-clinical performance testing (electrical safety, EMC, software, system V&V) to demonstrate that the Mini mē is as safe and effective as its predicate device (Mē System, K131649). It does not describe a clinical study with acceptance criteria, patient sample sizes, or expert adjudication for proving efficacy, as it leverages the prior clearance of the predicate device.

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The me is an over-the-counter device intended for the removal of unwanted hair. Me is also intended for permanent reduction in hair growth following an initial treatment regimen with or without maintenance when measured at 6, 9, and 12 months.

The me device is a small over-the-counter, compact system comprised of a base unit assembly with power supply, and connected, via cable, to a handheld applicator with an air-cooling system. The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.

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

Acceptance Criteria and Device Performance for Syneron Beauty Ltd.'s mē Hair Removal System (K131649)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for "permanent reduction in hair growth" are explicitly stated as "at least 30% hair reduction measured at 12 months post-treatment compared to baseline." The study also reports on the percentage of subjects and body sites achieving this success.

• At least 30% hair reduction at 12 months post-treatment (Subject Success) | All Subjects (Table 1): 45% success observed in 44 subjects (those with long-term follow-up at 12 months)
  Subgroup of 21 Subjects (Table 3): 52% success observed in 21 subjects (those continuously followed for 6, 9, and 12 months) | All Subjects (Table 2): 59% success observed in 44 subjects (those with long-term follow-up at 12 months)
  Subgroup of 21 Subjects (Table 4): 62% success observed in 21 subjects (those continuously followed for 6, 9, and 12 months) |
  | Permanent reduction in hair growth defined as:
• At least 30% hair reduction at 12 months post-treatment (Body Site Success) | All Subjects (Table 1): 54% success observed in 72 sites (those with long-term follow-up at 12 months)
  Subgroup of 21 Subjects (Table 3): 68% success observed in 37 sites (those continuously followed for 6, 9, and 12 months) | All Subjects (Table 2): 72% success observed in 75 sites (those with long-term follow-up at 12 months)
  Subgroup of 21 Subjects (Table 4): 80% success observed in 40 sites (those continuously followed for 6, 9, and 12 months) |
  | No serious adverse events | No serious adverse events observed | No serious adverse events observed |

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

• Sample Size for Initial Study (3-Month Group): 87 healthy participants.
• Sample Size for Long-Term Follow-up (Test Set):
  • 6-Month Group: 40 participants
  • 9-Month Group: 26 participants
  • 12-Month Group: 44 participants
  • Total Evaluated Long-Term: 58 participants were evaluated in at least one follow-up time point (6, 9, or 12 months). A subgroup of 21 participants completed continuous follow-up at 6, 9, and 12 months.
• Data Provenance: The study was a "medically supervised clinical study" conducted in "Israel" (based on the submitter's address). It appears to be a prospective study, as participants were enrolled and followed over time with specific treatment regimens and evaluation points.

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

• Number of Experts: Two independent evaluators.
• Qualifications: The document does not explicitly state the qualifications of these evaluators (e.g., dermatologists, trained technicians, etc.) beyond being "independent."

4. Adjudication Method for the Test Set

• The ground truth (hair reduction) was measured "by two independent evaluators through hair count on images taken from the treatment area that were subsequently averaged." This indicates a type of consensus by averaging rather than a formal adjudication method like "2+1" (where a third expert breaks ties) or "3+1."

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study compares the device's efficacy with and without maintenance treatments; it does not compare human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone (algorithm only) performance study was not done. The device is for user operation, and the study focuses on the clinical effectiveness of the device when used by participants. There is no mention of an AI algorithm operating independently to perform hair reduction.

7. Type of Ground Truth Used

• The ground truth used was expert consensus (through averaging) of hair count from images. These images were taken at baseline and subsequent follow-up visits, and the hair count reduction was calculated from these images.

8. Sample Size for the Training Set

• This information is not provided in the document. The document describes a "clinical study" which is typically considered the evaluation or test set for regulatory clearance. It does not elaborate on any prior "training" studies or datasets. Given the nature of this device (IPL technology), it is unlikely there was a "training set" in the context of machine learning, but rather prior clinical data for device development and predicate device clearances.

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

• As a training set is not explicitly mentioned or implied in the context of device development or machine learning, this information is not applicable/not provided. If the question refers to the development process for the device's underlying technology (IPL), then the ground truth for that would be established through a series of lab tests, animal studies, and initial human clinical trials to determine effective parameters for hair follicle targeting and destruction without excessive skin damage. However, these are not described as a "training set" for the present regulatory submission.

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The Tanda Mini Skincare System is generally indicated to treat dermatological conditions. Specifically, blue light modules are indicated to treat mild to moderate inflammatory acne.

The Tanda Mini Skincare System is a smaller version of its predicate device (K080951) that shares the same principal features and characteristics as the predicate. Both the devices are cordless, handheld units that have a single on/off push button that activates the units. The Tanda Mini Skincare System uses the same technology to deliver blue light at 414 nm to the treatment surface via light emitting diodes (LEDs) as its predicate. Furthermore, there have been no modifications to the safety features of its predicate, which includes a sensor for skin contact and temperature as well as sound indicators. The only changes made in the Tanda Mini Skincare System compared to the previously cleared predicate relates to additional ergonomic features such as a textured treatment surface, and a vibration indicator to signify the treatment is in progress. Furthermore, the total energy dose, dose rate, and treatment regimen remain the same as the previously cleared predicate device.

The provided text describes a 510(k) summary for the Tanda Mini Skincare System. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a new clinical study to establish efficacy. Therefore, much of the requested information regarding a study proving acceptance criteria for device performance is not explicitly available in the provided document.

Here's a breakdown of the information that can be extracted, and where limitations exist:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide specific acceptance criteria for clinical performance (e.g., reduction in acne lesion count) or a direct comparison of such performance between the Tanda Mini Skincare System and its predicate. Instead, the acceptance criteria are related to engineering and safety standards.

The document states, "In all instances, the Tanda Mini Skincare System functioned as intended," indicating that it met the acceptance criteria for these non-clinical tests. The core argument for substantial equivalence relies on the Tanda Mini having the same identical intended use and principle of operation and delivering energy at the same dose and dose rate as the predicate device.

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

This information is not provided. The document details non-clinical engineering and safety tests rather than a clinical trial with a "test set" of patients.

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

This information is not provided. As no clinical study against a ground truth is reported for the Tanda Mini Skincare System, this is not applicable.

4. Adjudication Method for the Test Set

This information is not provided. Not applicable due to the lack of a reported clinical test set.

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

An MRMC comparative effectiveness study was not performed. This device is a light-emitting diode therapy system for acne, not an AI-powered diagnostic or assistive tool, so this type of study is irrelevant.

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

A standalone performance study as described (algorithm only without human-in-the-loop) was not performed. This device is a direct application therapy device, not an algorithm.

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

For the non-clinical tests (electrical safety, EMC, software, biocompatibility), the ground truth is adherence to the specified international standards (e.g., IEC 60601-1, IEC 62304, IEC 10993). For the efficacy of treating acne, the device relies on the established efficacy of its predicate device with its identical treatment parameters. The predicate's efficacy would have presumably been established through clinical trials using outcomes data (e.g., lesion count reduction, global assessment scores) or expert consensus. This document, however, does not detail the specific ground truth strategy for the predicate.

8. The Sample Size for the Training Set

This information is not provided. The document describes a medical device, not a machine learning model that requires a "training set."

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

This information is not provided. Not applicable, as this is not an AI/machine learning device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study that proves the Tanda Mini Skincare System meets "acceptance criteria" is a series of non-clinical engineering and safety tests and a demonstration of substantial equivalence to a previously cleared predicate device (K080591).

• Study Design: The approach was to confirm that modifications (primarily ergonomic) to the device did not introduce new risks and that the device maintained the same fundamental technological characteristics and safety features as the predicate.
• Key Tests Conducted:
  • Electrical safety (IEC 60601-1: 2005)
  • Electromagnetic compatibility (IEC 60601-1-2: 2007)
  • Software verification and validation (IEC 62304: 2006)
  • Biocompatibility testing (IEC 10993)
• Outcome: "In all instances, the Tanda Mini Skincare System functioned as intended" for these tests, demonstrating compliance with the respective standards.
• Efficacy Argument: The efficacy for treating mild to moderate inflammatory acne is established by demonstrating that the Tanda Mini Skincare System has the same identical intended use, principle of operation, energy type, peak wavelength, dose rate, and dose as its predicate device, K080591, which was previously deemed safe and effective. The minor ergonomic differences were not considered to raise new questions of safety or effectiveness.

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The me is an over-the-counter device intended for the removal of unwanted hair.

The me device is a small over-the-counter, compact system comprised of a base unit assembly with power supply, and connected, via cable, to a handheld applicator with an air-cooling system. The device incorporates Intense Pulse Light (IPL) technology (output 2-4 J/cm'), like other OTC devices for hair removal. It also uses low RF energy (output 0.4-0.8 J/cm²) delivered through the RF electrodes. The RF signal serves primarily as a safety means to ensure skin contact before the IPL pulse is emitted. The only changes made in the current version compared to the previously cleared device relate to a minor electronics and software update, and ergonomic enhancements to the applicator and base unit control panel. All key characteristics, including energy source (IPL and radiofrequency), the output of energy, the settings and pulse duration remain unchanged.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Syneron Beauty Ltd.'s mê device:

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a novel device. Substantial equivalence is established by showing that the new device has the same intended use, similar technological characteristics, and does not raise new safety or effectiveness questions compared to a legally marketed predicate device.

Therefore, the document does not contain the level of detail typically found in a clinical study report that establishes performance metrics against predefined acceptance criteria for a de novo device.

Despite this, I will extract the information that is present and highlight what is missing based on your request.

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document strongly emphasizes that "All key characteristics, including energy source (IPL and radiofrequency), the output of energy, the settings and pulse duration remain unchanged" compared to the predicate. The "performance data" section refers to non-clinical testing to re-validate the updated version. This means the acceptance criteria were that the updated device would perform identically to the predicate device in these non-clinical aspects.

Detailed Breakdown of Study Information (Based on the Provided Text):

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

• Sample Size for Test Set: Not applicable. The "performance data" discussed refers to non-clinical engineering and software testing of the device itself (e.g., electrical safety, EMC, software V&V, system V&V), not a clinical test set of patients.
• Data Provenance: Not applicable, as this was non-clinical engineering testing.

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

• Not applicable. Ground truth for clinical efficacy or safety was not established for this submission as it relies on the predicate device's prior establishment. The testing mentioned (electrical, EMC, software, system) would involve engineers and testers confirming adherence to technical specifications and standards.

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

• Not applicable. No clinical test set or adjudication process 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. This is not an AI/software as a medical device (SaMD) submission involving human readers or comparative effectiveness for image interpretation. It's a re-submission for a physical device with minor updates based on substantial equivalence.

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

• Not applicable. This is not a software-only device. The "software verification and validation testing" refers to the embedded software within the physical device, not a standalone algorithm for diagnostic or prognostic purposes.

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

• For the non-clinical tests: The "ground truth" was adherence to established engineering standards (e.g., for electrical safety, EMC) and the functional specifications of the device's software and system.
• For the overall device's indication of hair removal effectiveness: The ground truth would refer to the data previously submitted and accepted for the predicate device (K121598), which established the efficacy of the underlying technology for hair removal. This current submission relies on the predicate's established effectiveness and safety.

8. The sample size for the training set

• Not applicable. This device does not use machine learning that requires a "training set" in the conventional sense. The "software verification and validation testing" refers to standard software development lifecycle testing, not AI model training.

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

• Not applicable, as there is no training set for a machine learning model.

Summary of what the document does provide:

The 510(k) submission for the Syneron Beauty Ltd.'s mê device (K123845) is focused on demonstrating substantial equivalence to its predicate device (K121598). The changes in the current version are described as "minor electronics and software update, and ergonomic enhancements."

To support substantial equivalence, the submission references the following non-clinical performance testing:

• Electrical safety
• Electromagnetic compatibility testing
• Software verification and validation testing
• System verification and validation testing

These tests were conducted to re-validate the updated device against the same test methods and criteria used on the predicate device. The reported outcome is that "In all instances, the modified me device functioned as intended," meaning it met the technical and safety standards required for such a device and performed comparably to the predicate for these non-clinical aspects.

The document explicitly states that "The modified me device has the same intended uses and same indications as the predicate. The technological characteristics and principles of operation are also very similar to its predicate device. The minor differences in aesthetics, software and electronics between the modified device and its predicate device do not raise any new types of safety or effectiveness questions..." This is the core argument for its acceptance under the 510(k) pathway.

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The Tanda Pearl is an over-the-counter device intended for teeth bleaching. The Tanda Pearl uses low electrical current to accelerate the action of the bleaching agent to improve the whitened appearance of teeth.

The Tanda Pearl device consists of a double biting mouth tray made of silicone for fitting both the upper and bottom teeth simultaneously. A bleaching agent is applied to each side of the mouth tray. The device is battery operated and turned on using a button located on the handle. Once initialized, the device delivers low amounts of electrical current (4 to 15 mA) into the bleaching medium to accelerate the teeth whitening effect caused by the bleaching medium. Once the treatment cycle has been completed, the device is automatically shut off.

Here's an analysis of the provided text regarding the Tanda Pearl device's acceptance criteria and studies:

Summary of Acceptance Criteria and Device Performance for Tanda Pearl

The provided 510(k) summary for the Tanda Pearl device does not explicitly list quantitative acceptance criteria in a dedicated section with pass/fail thresholds. Instead, it describes performance testing conducted to support substantial equivalence and confirm that the Tanda Pearl performs as intended.

Based on the information, the implicit acceptance criteria are that the device:

• Meets relevant safety and performance standards (electrical, EMC, software, integrity, biocompatibility, risk management).
• Demonstrates clinical efficacy in teeth whitening.
• Demonstrates clinical safety with no significant concerns or severe adverse events.

Here's a table summarizing the reported device performance in relation to these implicit criteria:

Detailed Information about the Studies:

1. A table of acceptance criteria and the reported device performance: (Provided above)

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

   • Sample Size (Test Set): The document states "the results of a single site IRB clinical study". While it confirms a clinical study was performed, the exact sample size for this clinical study is not provided in the given text.
   • Data Provenance:
     • Country of Origin: Not explicitly stated, but the original technology developer is "Fluorinex Active Ltd.", which could be an indicator but is not definitive for the study location.
     • Retrospective or Prospective: "single site IRB clinical study" indicates it was a prospective study.

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):

   • Number of Experts: Not mentioned.
   • Qualifications of Experts: Not mentioned.
   • The "Vita Shade scores and the Vita Shade Delta-E scores" typically rely on standardized shade guides and visual assessment, which implies trained assessors, but their number and qualifications are not specified.

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

   • Adjudication Method: Not mentioned. It's unclear how discrepancies in Vita Shade scoring, if any, were handled.

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:

   • MRMC Study: No, there is no indication of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This device is not an AI/imaging diagnostic device that would typically involve human readers interpreting images. The study rather compares the device to a control for tooth whitening efficacy.
   • Effect Size of AI Assistance: Not applicable, as no AI assistance is mentioned or evaluated in the context of human readers.

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

   • Standalone Study: The clinical study evaluated the device (Tanda Pearl) against a control, demonstrating its efficacy and safety. This can be considered a "standalone" evaluation of the device's performance, but not in the context of an "algorithm only" as typically applied to AI/software as a medical device. The device is a physical product directly used by humans.

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

   • Type of Ground Truth: The efficacy ground truth was established by objective measurements of tooth whitening using "Vita Shade scores and the Vita Shade Delta-E scores." These are widely accepted clinical metrics for tooth shade changes. Safety involved tracking "reported events" and their severity to resolution. This aligns with clinical outcomes data based on standardized clinical assessments.

8. The sample size for the training set:

   • Sample Size (Training Set): Not applicable. This device is not an AI/machine learning device that typically involves a distinct "training set" in the context of model development. The provided clinical study is a performance study to demonstrate the device's function, not to train an algorithm.

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

   • Ground Truth (Training Set): Not applicable, as there is no training set for an AI algorithm.

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