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The Kudu is a wheelchair intended purposes to provide mobility to children limited to a sitting position. It is designed for indoor and outdoor use over smooth surfaces.

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I'm sorry, but the provided text from the FDA 510(k) letter for the "Kudu" mechanical wheelchair does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The document is a substantial equivalence determination letter. It indicates that the device is substantially equivalent to legally marketed predicate devices. It lists the device name, regulation number, regulation name, regulatory class, and product code. It also includes the "Indications for Use" for the Kudu wheelchair, stating it's "intended purposes to provide mobility to children limited to a sitting position. It is designed for indoor and outdoor use over smooth surfaces."

However, there is no information in this document regarding:

1. Acceptance criteria table or reported device performance.
2. Study details (sample size, data provenance, ground truth establishment, expert involvement, adjudication, MRMC studies, standalone performance).
3. Training set sample size or ground truth.

This type of FDA letter typically confirms substantial equivalence based on comparisons to predicate devices and adherence to general controls, but it does not usually detail the specific performance studies and acceptance criteria in the way you are asking for. That information would typically be found in the 510(k) summary or the full 510(k) submission, which is not provided here.

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The Multi Frame's intended function and use is provide mobility to children limited to a sitting position.

The Wheelchair consists primarily of an aluminum frame, large rear wheels with hand rims for propelling the wheelchair or smaller rear wheels for attendant-only use, and smaller front privoting casters for steering and turning.

I am sorry, but the provided document is a letter from the FDA regarding a 510(k) premarket notification for a Multi Frame Wheelchair. It does not contain information about acceptance criteria, device performance studies, or details relevant to artificial intelligence or machine learning model validation. Therefore, I cannot extract the requested information.

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The Cougar Wheelchair's intended function and use is to provide mobility to persons limited to a sitting position.

The wheelchair consists primarily of an aluminum frame, large rear wheels with hand rims for propelling the wheelchair or smaller rear wheels for attendant-only use, and smaller front pivoting casters for steering and turning.

This looks like a 510(k) clearance letter from the FDA for a mechanical wheelchair, not a document describing an AI/ML medical device. Therefore, the questions about acceptance criteria, study details, ground truth, and training data are not applicable to this document.

The document states:

• Trade/Device Name: Cougar Wheelchair
• Regulation Number: 21 CFR 890.3850
• Regulation Name: Mechanical wheelchair
• Regulatory Class: I
• Product Code: IOR

This device is a mechanical wheelchair, which falls under Class I (general controls) and does not involve AI or algorithms. The FDA's determination is based on substantial equivalence to legally marketed predicate devices, not on a performance study against specific acceptance criteria in the manner you've described for AI/ML products.

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The Cheetah Wheelchair is designed for children who have physical impairments that require the use of a device to assist them with their mobility needs. This device is intended solely for pediatric use.

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The provided document is an FDA 510(k) clearance letter for a medical device: the "Cheetah Wheelchair." This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone AI performance) of the kind requested.

The letter is a regulatory document confirming that the FDA has reviewed the manufacturer's premarket notification and determined that the device is substantially equivalent to legally marketed predicate devices. It grants permission to market the device subject to general controls.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving the device meets them because this information is not present in the provided text.

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The Rabbit Mobile Standing Frame is a mobile transport device for a child who needs to The itabolt Moone Banding, Frances anding, and requires anterior support from feet to sternum during incremental weight bearing from prone to upright standing. The Rabbit is storiall daring meremental whigh cood head, neck, and upper body control, and is atmized by a chird the dasping of their own volition, but requires support and alignment in weight bearing.

Rabbit Mobile Standing Frame

The provided text is a U.S. FDA 510(k) clearance letter for a medical device. This type of document declares a device to be substantially equivalent to a predicate device already on the market, thereby allowing it to be marketed.

However, a 510(k) clearance does not typically include detailed acceptance criteria or a study proving device performance in the way requested for software or AI medical devices. The FDA's substantial equivalence determination for this physical medical device (a mobile standing frame) is based on demonstrations of similarity in intended use, technology, and safety/effectiveness principles to existing devices, rather than a clinical trial demonstrating specific performance metrics against an acceptance criterion.

Therefore, the requested information (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) is not present in this document because it is not a requirement for this type of 510(k) clearance for this device.

To directly address your request, based solely on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not applicable. This document is a 510(k) clearance letter, confirming substantial equivalence, not a performance study report. Specific quantitative acceptance criteria or performance metrics for this physical device (Rabbit Mobile Standing Frame) are not detailed within this letter. The FDA's review for this device would have focused on its design, materials, and intended use being substantially equivalent to a predicate device, rather than statistical performance metrics like sensitivity/specificity often seen with diagnostic AI/software.

2. Sample Size Used for the Test Set and Data Provenance:

• Not applicable. No test set or associated data provenance is described in this regulatory clearance letter.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

• Not applicable. This document does not describe a test set or ground truth establishment process involving experts.

4. Adjudication Method for the Test Set:

• Not applicable. No test set or adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. An MRMC study is typically for evaluating the impact of AI on human reader performance in diagnostic tasks. This device is a "Mobile Standing Frame," a physical assistive device. This document does not mention any such study.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Not applicable. This device is a physical mobile standing frame, not an algorithm. This document does not mention any such study.

7. Type of Ground Truth Used:

• Not applicable. No ground truth (expert consensus, pathology, outcomes data, etc.) is mentioned as being used for performance evaluation in this clearance letter.

8. Sample Size for the Training Set:

• Not applicable. This document does not describe a training set for an algorithm.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. This document does not describe a training set or how its ground truth was established.

In summary: The provided document is a regulatory clearance letter for a physical medical device, not a technical report detailing performance studies or acceptance criteria typically associated with software or AI medical devices. Therefore, the requested information regarding acceptance criteria, study methodologies, and data specifics is not present.

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