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The device is intended for medical purposes to provide mobility to person restricted to a sitting position.

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I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) clearance letter from the FDA for a mechanical wheelchair, indicating that the device is substantially equivalent to a legally marketed predicate device. It does not contain details about specific performance metrics, studies, or ground truth establishment.

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

The Taiwan King Strong Powered Wheelchair TP01 is an indoor / outdoor electric wheelchair that is battery operated. It has a base with four-wheeled with a seat and armrests. The movement of the powered wheelchair is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.

This is a 510(k) premarket notification for a powered wheelchair, not a medical device driven by an algorithm. Therefore, the requested information about acceptance criteria, study details, and AI performance metrics is not applicable in this context.

The document discusses performance testing in a general sense, focusing on electrical and mechanical safety standards for a physical device, not an algorithm.

Here's a breakdown of what the document does provide:

• Device Name: Taiwan King Strong Powered Wheelchair TP01
• Intended Use: To provide mobility to persons restricted to a seated position.
• Performance Testing Mentioned:
  • EMC Report
  • ANSI / RESNA WC/Vol.2-1998 (relevant to electrically powered wheelchairs)
  • CISPR 11: 1990
  • EN61000-3-2: 1995
  • IEC61000-3-3: 1995
• Substantial Equivalence Comparison: COMFORT Powered Wheelchair, Traveller LY-EB103 (K030356)
• Key finding: The electronic systems are the same and passed UL certification, assuring the same safety level. Differences are in controller, agility, ease of storage/transportation, overall dimension, tire size, and weight, but these do not affect safety.

In summary, as this is a physical product (a wheelchair) and not a software-driven device or diagnostic tool, the questions regarding acceptance criteria for algorithms, ground truth, expert adjudication, AI performance, multi-reader studies, and training/test set data provenance are not relevant. The "study" mentioned is the battery of compliance tests against established safety and performance standards for wheelchairs.

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The device is intended for medical purposes to provide mobility to person restricted to a sitting position.

TAIWAN KING STRONG TC03MECHANICAL WHEELCHAIR

I am sorry, but this document is an FDA 510(k) clearance letter for a mechanical wheelchair. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML powered medical device.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, rather than a performance study against specific acceptance criteria for a novel technology like AI.

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

TAIWAN KING STRONG Powered Wheelchair, TP02

The provided text is a U.S. FDA 510(k) clearance letter for a powered wheelchair (Taiwan King Strong Powered Wheelchair, TP02). This document focuses on regulatory approval based on "substantial equivalence" to a legally marketed predicate device.

It does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria, as typically found in a clinical performance study for AI/software as a medical device.

Therefore, I cannot extract the requested information regarding AI device performance. This document is related to a physical medical device (a powered wheelchair) and its regulatory clearance process, not an AI/software medical device.

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