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K Number
K172876
Device Name
PowerDot PD-01M
Manufacturer
Smartmissimo Technologies Pte Ltd
Date Cleared
2017-12-04

(74 days)

Product Code
NGX
Regulation Number
890.5850
Type
Special
Panel
PM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

PowerDot PD-01M device, used with PowerDot Mobile Application, is intended for the stimulation of healthy muscles in order to improve or facilitate muscle performance.

PowerDot PD-01M device and PowerDot Mobile Application is not intended to be used in conjunction with therapy or treatment diseases of medical or medical conditions of any kind.

Device Description

PowerDot PD-01M device, used with PowerDot Mobile Application

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding the PowerDot PD-01M device. This document primarily focuses on the regulatory clearance for a powered muscle stimulator and its indications for use. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria related to an AI/ML algorithm or automated diagnostic task.

Therefore, I cannot extract the requested information points, such as:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes for test sets, training sets, or data provenance.
  • Number of experts, their qualifications, or adjudication methods for ground truth.
  • Details of MRMC comparative effectiveness or standalone studies.
  • Types of ground truth used or how it was established.

The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has been cleared based on a comparison to existing, cleared devices, rather than through a new, comprehensive performance study that would generate the kind of data you are asking for. The clearance is for a "Powered Muscle Stimulator" intended for "stimulation of healthy muscles in order to improve or facilitate muscle performance," not for diagnostic or complex AI-driven tasks.

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).