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The intended use of the subject device as well as the predicate device empowers physically challenged persons a means of mobility. This includes temporary and permanent conditions in all ages, including but not limited to arthritis, paraplegic, multiple sclerosis, and other debilitating conditions. Our device and the predicate device provide the same function for occupants who are unable to move due to injuries or other medical conditions.

Manual Wheelchair

This document is a 510(k) clearance letter from the FDA for a manual wheelchair. It is not a study document that describes acceptance criteria and device performance data for a medical device that relies on AI or machine learning.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set size, and ground truth establishment for the training set).

The document states that the manual wheelchair is substantially equivalent to legally marketed predicate devices, meaning it has been deemed as safe and effective as a device already on the market without requiring new clinical trials or extensive performance studies typically seen with novel, often AI-driven, technologies.

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The intended use of the subject device as well as the predicate device empowers physically challenged persons a means of mobility. This includes temporary and permanent conditions in all ages, including but not limited to arthritis, paraplegic, multiple sclerosis, and other debilitating conditions. Our device and the predicate device provide the same function for occupants who are unable to move due to injuries or other medical conditions.

Manual Wheelchair

This document is a marketing clearance letter from the FDA for a manual wheelchair and does not contain the requested information regarding acceptance criteria, study details, or ground truth establishment for an AI/ML device. Therefore, I cannot provide the specific details you've asked for.

The letter states that the device, a "Manual Wheelchair," has been found "substantially equivalent" to predicate devices marketed before May 28, 1976. This classification (Regulatory Class: I) means it falls under general controls and does not require extensive clinical studies or performance data like those expected for novel or higher-risk devices, especially AI/ML-driven ones.

The information provided is primarily administrative and regulatory, confirming the device's clearance for market based on its similarity to existing manual wheelchairs, not on meeting specific performance metrics derived from a study as would be described for an AI/ML product.

Ask a specific question about this device

The intended use of the subject device as well as the predicate device empowers physically challenged persons a means of mobility. This includes temporary and permanent conditions in all ages, including but not limited to arthritis, paraplegic, multiple sclerosis, and other debilitating conditions. Our device and the predicate device provide the same function for occupants who are unable to move due to injuries or other medical conditions.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a Manual Wheelchair (K992035). This document does not describe acceptance criteria, performance studies, or any of the specific details requested in your prompt regarding a device's performance evaluation.

This type of FDA letter is an acknowledgement that a medical device manufacturer has demonstrated to the FDA that their device is substantially equivalent to a legally marketed predicate device. It signifies regulatory clearance to market the device, not a detailed technical performance report.

Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device

The intended use of the subject device as well as the predicate device empowers physically challenged persons a means of mobility. This includes temporary and permanent conditions in all ages, including but not limited to arthritis, paraplegic, multiple sclerosis, and other debilitating conditions. Our device and the predicate device provide the same function for occupants who are unable to move due to injuries or other medical conditions.

Not Found

This document is a 510(k) premarket notification from the FDA, specifically concerning the substantial equivalence of a medical device (Maxxim; Maxxim HD manual wheelchair). It does not contain information about acceptance criteria or a study proving that the device meets those criteria.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, or studies (MRMC or standalone) because such details are not present in the provided text. The document is about regulatory clearance based on substantial equivalence, not a detailed performance study.

Ask a specific question about this device