Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)

• K Number: K182136
• Device Name: Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)
• Manufacturer: Shenzhen OSTO Technology Co., Ltd.
• Date Cleared: 2019-10-10 ( 430 days)
• Product Code: NUH , NGX
• Regulation Number: 882.5890
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: K131291 , K133929

Intended Use

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

Device Description

Intelligent Wireless Fitness Apparatus is indicated to be used for: Improvement of abdominal tone, strengthening of the abdominal muscles development of firmer abdomen. By muscle stimulation, the device helps to strengthen and firm the abdomen, arms and thighs. The device is including a main unit and 3 kinds of electrode pads. The therapeutic parameters are easily set using the buttons on the device. There are three buttons on the main unit, On/off button for on/off and mode selection, "+" button and "-" button for level adjustment. The accessories is electrode pads. The electrode pads connect to the main unit by buttons (which is permanent secured on the main unit and the electrode pad). All the accessories can only be changed by local distributor.

AI/ML Overview

This document is a 510(k) summary for the Intelligent Wireless Fitness Apparatus (Models: AST-301, AST-302, AST-303). It is a submission to the FDA demonstrating substantial equivalence to previously cleared predicate devices.

Based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific performance criteria in terms of accuracy, sensitivity, specificity, or human perception improvement (e.g., MRMC studies). This document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with general safety and performance standards, rather than a clinical performance study with specific acceptance criteria as you've described.

The "Test Summary" section (page 4, Section 6) outlines bench testing to ensure safety and functionality, but these are not performance studies in the context of diagnostic accuracy or human performance with AI assistance.

Therefore, I cannot provide the information requested in your bullet points regarding acceptance criteria, performance data, sample sizes, expert involvement, or MRMC studies, as this type of information is not present in the provided 510(k) summary for this particular device.

Here's an explanation for each of your points based on the absence of this information in the provided document:

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

   • Not provided. This document details technical characteristics and compliance with safety standards (e.g., electrical safety, EMC, usability), not performance against clinical acceptance criteria (e.g., accuracy for a diagnostic task).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not applicable for performance test sets as described. The "tests" here are bench tests for electrical safety, electromagnetic compatibility, usability, and software verification/validation, not clinical performance studies involving patient data. Therefore, there's no "test set" in the sense of patient data for clinical evaluation.

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. No ground truth establishment for a clinical test set is mentioned.

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

   • Not applicable. No clinical test set requiring adjudication 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, an MRMC comparative effectiveness study was not done or reported. This device is a muscle stimulator, not an AI-assisted diagnostic device, so such a study would not be relevant.

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

   • Not applicable. This is not an AI algorithm. Its performance is evaluated through physical and electrical bench testing, not algorithmic accuracy.

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

   • Not applicable. No clinical ground truth is established or used for performance evaluation in this 510(k) summary. The "truth" here relates to compliance with engineering and safety standards.

8. The sample size for the training set:

   • Not applicable. This device does not use a training set as it's not a machine learning/AI device.

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

   • Not applicable. No training set ground truth to establish.

In summary, the provided document is a 510(k) Premarket Notification for a Powered Muscle Stimulator. The focus is on demonstrating substantial equivalence to existing predicate devices based on technological characteristics, intended use, and compliance with recognized safety and performance standards through bench testing. It explicitly states, "The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness." This type of submission does not typically include the kind of clinical performance study details (like sensitivity, specificity, or MRMC studies) that would be found for a diagnostic device or an AI-powered medical device.

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).