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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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