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The C.T.M. Mobility Scooter HS-528 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.

The C.T.M. Mobility Scooter HS-528 is an indoor/outdoor scooter that is battery operated. It has a base with four wheels, a padded seat with adjustable armrests, and a steering column allowing the rider to control the scooter. It is capable of transport and is provided with an off-board battery charger.

This document is a 510(k) summary for the C.T.M. Mobility Scooter HS-528. It states that "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." Therefore, there is no information in the provided text for acceptance criteria or specific study details proving the device meets those criteria.

However, the document does state: "Tests listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Scooters, and Motorized Three Wheeled Vehicles, July 1995, were conducted and the results included in the submission." This implies that the device was tested against the standards outlined in that guidance document, even if the specific results are not provided.

Without the actual study results and acceptance criteria from the guidance document, I cannot complete the table or answer most of the requested questions.

Here's a breakdown of what can be extracted and what cannot:

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

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

• Sample Size for Test Set: Not provided.
• Data Provenance: Not provided.

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)

• Not applicable as no clinical or comparative performance testing was submitted, and therefore no ground truth established by experts for a test set is mentioned.

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

• Not applicable as no clinical or comparative performance testing was submitted.

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

• No. The document explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." This device is a mobility scooter, not an AI-assisted diagnostic tool, so an MRMC study is not relevant here.

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

• Not applicable. This is a physical device (mobility scooter), not an algorithm.

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

• Not applicable as no clinical or comparative performance testing was submitted to require a ground truth. Performance would have been measured against engineering standards specified in the guidance document.

8. The sample size for the training set

• Not applicable. This is a physical device, and the testing described references compliance with guidance documents for physical product safety and performance, not machine learning model training.

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

• Not applicable for the same reasons as #8.

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