Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device