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MA012 Aluminum wheelchair and MS019 steel wheelchair are intended for medical purpose to provide mobility to persons limited to a sitting position.

MA012 Aluminum wheelchair and MS019 Steel wheelchair are mechanical wheelchairs which is a manually operated, attendant propelled transport device in a health care environment such as a hospital, nursing home or extended care facility. It is intended for medical purpose to provide mobility to persons limited to a sitting position. The wheelchair is controlled, steered and operated completely by a trained caregiver. The wheelchair incorporates a main frame, a seat, two adjustable footrests and four wheels. There are two models of the wheelchair, MA012 and MS019. The MA012 Aluminum wheelchair has an aluminum frame, fixed armrest and a foldable back, while the MS019 Steel wheelchair has a steel frame, fixed back and a detachable, flip-back armrest. The wheelchair can support users of up to115 kg.

The provided text describes a 510(k) premarket notification for a mechanical wheelchair (MA012 Aluminum wheelchair, MS019 Steel wheelchair) and its substantial equivalence to a predicate device.

Crucially, this document is for a medical device (a wheelchair), not an AI/ML-driven device. Therefore, the standard questions related to acceptance criteria, test sets, ground truth, expert adjudication, MRMC studies, and training sets for AI/ML performance are not applicable to the information provided.

The "acceptance criteria" for this device are its compliance with various ISO standards related to wheelchair performance and biocompatibility with materials. The "study that proves the device meets the acceptance criteria" refers to the non-clinical tests conducted to demonstrate compliance with these standards.

Here's an attempt to answer the questions based on the provided document, highlighting why many AI-specific questions are irrelevant:

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

The document defines "acceptance criteria" as compliance with specific ISO standards and biocompatibility requirements. The "reported device performance" is a statement that the test results meet these standards.

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

This document details tests on physical products, not data. The sample size for the non-clinical tests (e.g., how many wheelchairs were tested for each ISO standard) is not specified in this submission. The origin of the testing data is implied to be from the manufacturer (Sichuan AST Medical Equipment Co., Ltd. in China), as they submitted the test results. These tests are conducted on the newly manufactured devices to demonstrate compliance, so it's akin to a prospective test of the product's design.

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)

This is not applicable. The "ground truth" for a mechanical wheelchair is based on objective measurements and established engineering standards (ISO standards) rather than expert consensus on subjective interpretations (like medical images). The tests are conducted by qualified personnel following the ISO standards, but their specific "qualifications" are not detailed in this submission in the way they would be for medical image interpretation.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in scenarios where human interpretation or consensus is needed for establishing ground truth (e.g., in medical image reading trials). For mechanical device testing, the results are determined by objective physical measurements against predefined limits outlined in the ISO standards.

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

This is not applicable. This is a submission for a mechanical wheelchair, not an AI/ML-driven device. Therefore, no MRMC study involving human readers and AI assistance was conducted or would be relevant.

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

This is not applicable. This device is a mechanical wheelchair, not an algorithm, so the concept of "standalone performance" for an algorithm does not apply.

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

The "ground truth" for this device is based on objective measurement against engineering standards (ISO standards). For biocompatibility, it's compliance with established biological safety requirements. For mechanical performance, it's about meeting specified physical parameters (e.g., static stability, brake effectiveness, strength) as defined and tested according to the ISO 7176 series.

8. The sample size for the training set

This is not applicable. The device is a mechanical product, not an AI/ML model that requires a training set.

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

This is not applicable. The device is a mechanical product, not an AI/ML model; therefore, no training set or its associated ground truth establishment is relevant.

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