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The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

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The provided document regarding the Justwin Scooter, Model JS-401 (K032277), is an FDA 510(k) clearance letter. This type of document primarily addresses the substantial equivalence of a device to a predicate device, allowing it to be marketed. It does not typically contain the detailed information about acceptance criteria, study design, or performance metrics that would be found in a clinical study report or a more comprehensive technical submission.

Therefore, many of the requested details cannot be extracted from this document.

Here's what can be inferred or stated based on the provided text:

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

   • Cannot be extracted. The document is an FDA clearance letter based on substantial equivalence, not a performance report with detailed acceptance criteria or test results.

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

   • Cannot be extracted. The document does not describe any specific test set or study data.

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):

   • Cannot be extracted. This information is not relevant to an FDA 510(k) clearance letter for a motorized scooter, which does not involve "ground truth" establishment in the context of diagnostic or interpretive tasks.

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

   • Cannot be extracted. Not applicable to this type of device and document.

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:

   • Cannot be extracted. This is a medical device (motorized scooter), not an AI-powered diagnostic or assistive technology for human readers. An MRMC study is not applicable here.

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

   • Cannot be extracted. Not applicable, as this is not an algorithm-based device.

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

   • Cannot be extracted. The concept of "ground truth" as typically used in the context of diagnostic or interpretive AI systems does not apply to a motorized scooter.

8. The sample size for the training set:

   • Cannot be extracted. A "training set" is not relevant for the type of documentation provided for this device.

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

   • Cannot be extracted. Not applicable.

What the document does tell us:

• Trade/Device Name: Justwin Scooter, Model JS-401
• Regulation Number: 21 CFR 890.3800
• Regulation Name: Motorized three-wheeled vehicle
• Regulatory Class: II
• Product Code: INI
• Intended Use: "The device is intended for medical purposes to provide mobility to persons restricted to a seated position."
• Basis for Clearance: Substantial equivalence to legally marketed predicate devices, meaning it has similar indications, technological characteristics, and safety and effectiveness profiles as a device already on the market. The FDA has "made a determination that the device is substantially equivalent... for the indications for use stated in the enclosure."

In summary, this document is an FDA approval letter for market clearance based on substantial equivalence, not a detailed technical report or study publication that would contain the specific performance metrics and study details requested.

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