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The EMS Sculpt Machine is indicated to be used for:

• · Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
• · Strengthening, Toning and Firming of buttocks and thighs.

The EMS Sculpt Machine is a non-invasive therapeutic device. The device produces electromagnetic field that interacts with the tissues of the human body. By muscle stimulation, the EMS Sculpt Machine helps to strengthen and firm the abdomen, buttocks and thighs.
The EMS Sculpt Machine is equipped with a LCD touch screen that significantly facilitates the use of the device. The user exchanges with the system by the LCD and the keys on it. The state of the system, the operation interface, the instructions and hints to the user will be shown on the LCD.

The provided text is a 510(k) Summary for a medical device (EMS Sculpt Machine). It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria through a clinical study.

Therefore, the document explicitly states: "No clinical study is included in this submission." This means that information regarding acceptance criteria, device performance against those criteria, test set details (sample size, provenance, ground truth, adjudication), MRMC studies, standalone performance, and training set details (sample size, ground truth establishment) is not present in the provided text.

The document relies on non-clinical tests (compliance with electrical safety, EMC, performance, and biocompatibility standards) and a direct comparison of technological characteristics to a predicate device to claim substantial equivalence.

Here's a breakdown of why the requested information cannot be extracted from the provided text:

• Acceptance Criteria and Reported Performance Table: Not applicable as no clinical performance study was conducted. The "Acceptance Criteria" here would be demonstrating compliance with specific safety and performance standards for non-clinical aspects, which are listed as "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device."
• Sample size and data provenance (test set): No test set for clinical performance.
• Number of experts and qualifications (ground truth for test set): Not applicable as no clinical performance study.
• Adjudication method (test set): Not applicable as no clinical performance study.
• MRMC comparative effectiveness study: Not done.
• Standalone performance study: Not done (no clinical study at all).
• Type of ground truth used: Not applicable as no clinical performance study.
• Sample size for training set: Not applicable as no AI/machine learning component or clinical training data is mentioned.
• How ground truth for training set was established: Not applicable.

Instead, the document highlights:

• Non-Clinical Test Conclusion: "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: ANSI/AAMI ES60601-1:2005/(R)2012 And A1:2012, Medical Electrical Equipment -Part 1: General requirements for basic safety and essential performance, IEC 60601-1-2:2014, IEC 60601-2-10:2016, IEC 60601-1-6:2020, ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-23:2021."
• Clinical Test Conclusion: "No clinical study is included in this submission."

The core argument for clearance is based on the device being technologically similar and conforming to the same safety and performance standards as a previously cleared predicate device (AM-100, K163165), rather than demonstrating a specific clinical performance metric against an acceptance criterion in a patient study.

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The Diode Laser System is intended for hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.

Permanent hair reduction is 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.

The proposed device, Diode Laser Hair Removal System, is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI);

Function module description
a. Control Panel
The module uses the microcontroller as the heart, utilizes the LCD screen to display all prompt information and the system state information to complete the human-machine interaction function, and realizes the device parameters settings and accurate control of the output laser energy by the operator.

b. Main Control Module
The module uses the microcontroller as the heart, receives the laser energy parameters and work instructions from the control panel and detects the footswitch state; Utilizes the sensors of temperature, humidity, liquid level and flow to detect the parameters such as temperature, humidity and water flow during system working, and according to the detected values to calculate the dew point temperature; Controls and detects the work state of constant current board module as well as the temperature and humidity control system; Uploads the state data and alarm information of water circulation system, cooling system, handpiece module and constant current board module during system working.

c. Constant current board module
The module uses the high-power MOS as the heart, receives the laser energy parameters from the main control module, supplies the semiconductor laser with constant drive current which corresponding to the received laser energy parameters to drive the semiconductor laser to emit light. The module also has the detection function of over-current, overvoltage, over-temperature and handpiece state, and uploads the detected data to the control module.

d. Temperature and humidity control system
The system mainly includes the condenser, cold plate, water circulation subsystem and fans. The microcontroller of main control module according to the temperature, humidity parameter detected by the sensors to control the working state of the condenser, cold plate and cooling fan to meet the temperature and humidity requirements during the semiconductor laser working.

e. Handpiece module
Handpiece module is the heart of the device, which is the execution unit of the device and completes the laser emission function. The module is mainly composed of semiconductor laser, sapphire, temperature and humidity sensor, data storage chips, cooling components and water flow path. The semiconductor laser emits light to output energy, temperature and humidity sensors detects the temperature and humidity parameters during handpiece working, the cooling components and water flow path take away the heat of the semiconductor laser to prevent it from being damaged caused by over-temperature, so prolongs the service life of the semiconductor laser.

This document is a 510(k) premarket notification for a medical device, specifically a Diode Laser Hair Removal System. It does not describe a study involving acceptance criteria for diagnostic performance outcomes (like sensitivity, specificity, accuracy) but rather focuses on verifying that the proposed device meets design specifications and is substantially equivalent to a predicate device.

Therefore, many of the requested categories (e.g., sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable to this type of submission. This document details engineering and safety compliance rather than a clinical performance study.

Here's a breakdown of the available information based on your request:

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

The document does not present acceptance criteria in terms of clinical performance metrics for diagnosis (e.g., sensitivity, specificity). Instead, the "acceptance criteria" are implied by compliance with various international standards for medical electrical equipment, laser safety, and biocompatibility, as well as comparison to a predicate device's technical specifications. The "reported device performance" is essentially that the device complies with these standards and its technical specifications are comparable to the predicate.

2. Sample size used for the test set and the data provenance

• Not Applicable: No clinical test set data is presented in this 510(k) submission for the proposed device's performance. The review relies on non-clinical testing for compliance with standards and a comparison of technical specifications to predicate devices. The section explicitly states "No clinical study is included in this submission."

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

• Not Applicable: No clinical test set and thus no ground truth established by experts is mentioned in this submission.

4. Adjudication method for the test set

• Not Applicable: No clinical test set requiring adjudication is mentioned.

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

• Not Applicable: This device is a laser hair removal system, not an AI-assisted diagnostic tool for "human readers." Therefore, an MRMC comparative effectiveness study is irrelevant.

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

• Not Applicable: This is a physical medical device (laser system), not a software algorithm.

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

• Not Applicable: For the purposes of this 510(k) submission, the "ground truth" for demonstrating substantial equivalence fundamentally relies on:
  • Compliance with recognized industry standards (e.g., IEC, ISO) through non-clinical testing.
  • Comparison of technical specifications and intended use to legally marketed predicate devices.
  • The "permanent hair reduction" definition references long-term stable reduction measured at 6, 9, and 12 months after treatment, but this is an indication for use definition and not performance data from the current submission.

8. The sample size for the training set

• Not Applicable: No training set data for an algorithm is relevant to this device submission.

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

• Not Applicable: No training set data for an algorithm is relevant to this device submission.

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