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 mini-Medic™ system is comprised of a minimum of one Forehead Sensor Unit and one Handheld Display Unit, and is intended for use on patients who are eighteen (18) years and over.

The mini-Medic™ system is indicated as a single or multi-parameter vital signs monitor for SpO2 and pulse rate via an integrated SpO2 forehead sensor, and/or heart rate from ECG electrodes, and forehead skin surface temperature from an infrared temperature sensor. Pulse wave transit time (PWTT) is obtained utilizing pulse measurements from the integrated SpO2 forehead sensor and ECG electrodes placed on the upper chest. Pulse wave transit time (PWTT) is used to track changes in blood pressure. Skin temperature is used as an adjunct to other clinical diagnostic procedures in the diagnosis, quantifying, and screening of relative skin surface temperature for hyperthermia and hypothermia conditions.

Patient data may be entered on the Handheld Display Unit. The mini-Medic™ system provides vital parameter alarms and a patient composite/summary alarm.

Patient information and system commands are transmitted using wireless radio communications between the Forehead Sensor Unit and the Handheld Display Unit. Stored patient data may be output, printed, downloaded and saved via a dedicated mini-Medic™ PC Software application.

Typical locations for the use of the mini-Medic™ system are: pre-hospital (i.e., at the point of injury or trauma scene), hospital, healthcare facility, emergency medical application, and during ground or air transport. The monitor is intended to be used by trained healthcare providers in military and civilian roles including doctors, nurses, combat medics, combat lifesavers, EMT's, and paramedics.

The Athena GTX mini-Medic™ wireless vital signs monitor system is a small, lightweight, rugged, and highly portable patient monitor designed to measure SpO₂, cardiotachometer, skin temperature and pulse wave transit time (PWTT). Vital signs are displayed directly on the forehead sensor and transmitted wirelessly to a handheld display unit. Reports and data file saving is done via wireless download to a PC.

Here's an analysis of the provided text regarding the acceptance criteria and study for the mini-Medic™ device:

The provided document, K113165 P1/3, is a 510(k) Summary of Safety and Effectiveness for the Athena GTX mini-Medic™ wireless vital signs monitor. It describes the device, its intended use, and states that testing was completed to verify compliance with standards, concluding that the device is safe, effective, and substantially equivalent to listed predicate devices. However, it does not explicitly detail specific acceptance criteria or the numerical results of studies demonstrating performance against such criteria. The document focuses on regulatory compliance and substantial equivalence, rather than a detailed performance study report with acceptance criteria and their fulfillment.

Therefore, much of the requested information regarding specific acceptance criteria, reported performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, and detailed study methodologies is not present in the provided text.

Here's what can be extracted and what is missing:

Description of Acceptance Criteria and Device Performance Studies

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

• Acceptance Criteria: Not explicitly stated in the provided document. The document indicates that testing was completed "to verify compliance with recognized national and international standards for safety and performance for medical devices, and particular requirements applicable to this device." However, the specific numerical or qualitative acceptance criteria derived from these standards are not detailed.
• Reported Device Performance: Not explicitly reported in numerical or quantitative terms for individual vital signs measurements. The document states that the mini-Medic™ is "capable of the same heart rate, functional oxygen saturation, pulse rate, pulse wave transit time and IR temperature measurements as have been provided by the combination of predicate devices referenced above." This implies performance is comparable to the predicate devices, but no concrete metrics are given.

2. Sample sized 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 specified.
• Data Provenance: Not specified.

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 specified.
• Qualifications of Experts: Not specified.

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

• Adjudication Method: Not specified.

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: Not applicable. This device is a physiological monitor, not an AI-assisted diagnostic imaging device requiring human reader interpretation in the context of an MRMC study. The concept of "human readers improve with AI" does not align with the nature of this device.

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

• Standalone Performance: The core function of the mini-Medic™ is to measure and display vital signs automatically. The 'testing' mentioned in the summary would inherently assess the standalone performance of these measurement capabilities against established standards (e.g., accuracy of SpO2, heart rate, temperature). While not detailed as an "algorithm only" study, the validation of such a device's measurements is by definition a standalone assessment of its sensory and processing capabilities. However, actual performance metrics are not provided.

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

• Type of Ground Truth: Not specified. For physiological monitors, ground truth typically comes from reference gold-standard devices or established clinical methods (e.g., arterial blood gas analysis for SpO2, EKG for heart rate, calibrated thermometers for temperature). The document only states "compliance with recognized national and international standards for safety and performance."

8. The sample size for the training set

• Sample Size for Training Set: Not applicable/Not specified. This device is a physiological monitor, not an AI/Machine Learning algorithm that typically requires a distinct "training set" in the same sense as image recognition or predictive models. Its parameters are likely based on established physiological principles and sensor calibration, not learned from a large dataset.

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

• How Ground Truth for Training Set was Established: Not applicable/Not specified, for the reasons stated above.

Summary of what the document does indicate:

• The mini-Medic™ is a standalone physiological monitor designed to measure SpO₂, cardiotachometer (heart rate), skin temperature, and pulse wave transit time (PWTT).
• It is intended for use on patients 18 years and over by trained healthcare providers in various settings (pre-hospital, hospital, emergency medical, transport).
• The manufacturer states that "testing on the mini-Medic™ has been completed to verify compliance with recognized national and international standards for safety and performance for medical devices," and that it is "substantially equivalent" to listed predicate devices in its capabilities.
• The 510(k) clearance by the FDA indicates that the agency found the device to be substantially equivalent to legally marketed predicate devices, implying that its safety and effectiveness profiles are similar.

Conclusion:

The provided 510(k) summary (K113165) gives a high-level overview of the mini-Medic™ device and the regulatory determination of its substantial equivalence. However, it does not contain the detailed data for specific acceptance criteria and study results in the quantitative format requested. Such detailed performance data is typically found in the full 510(k) submission, which is not publicly available in this format, or in associated scientific publications or internal company reports.

Ask a specific question about this device