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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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