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The Manual Wheelchair is to provide mobility to persons limited to a sitting position.

The MASY23 manual wheelchair is a mechanical wheelchair which is a manually operated, attendant and self-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. It can be folded for transport by bring two sides together.

The MASY23 Manual Wheelchair incorporates a main frame, a seat, two hand rims and four wheels. The wheelchair is designed with two small rear wheels and two gearing with hand rim, it can be manually moved forward and in reverse. The wheelchair can support users of up to 136 kg.

The provided text is a 510(k) Premarket Notification from the FDA regarding a Manual Wheelchair (MASY23). It does not describe a study, acceptance criteria, or performance data for an AI/ML-driven medical device.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established, as these concepts are not applicable to the clearance of a manual wheelchair.

The document focuses on demonstrating substantial equivalence of the manual wheelchair to a predicate device through non-clinical performance and biocompatibility testing, primarily against ISO standards.

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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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The AST Model MA012 and MS019 Rehab Wheelchairs are to provide mobility to persons limited to a sitting position.

The AST Model MA012 and MS019 Rehab Wheelchair are manual wheelchairs. They have adjustable armrests, and multiple axle position. The casters are 6"/7"/8" PU wheels with height adjustable forks and the rear wheels are 20"/22"/24″*1-3/8″ polyurethane(MA012 and MS019). The wheelchair also has a shear reduction system: by carefully aligning the pivot points of the user, to minimize the sliding down of the user and also minimize the shear force and pressure against the back. The armrest height can be adjusted from 8" to 12" and it is detachable. The wheel for MA012 is quick release rear wheel. The AST MS019 Rehab Wheelchair has NO quick release rear wheel; The upholstery of the device complies with ISO 7176-16:2012 Resistance to ignition of postural support devices. The device can be operated indoors, or outdoors on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.

The provided document is a 510(k) summary for a medical device (AST Model MA012 and MS019 Rehab Wheelchair). It describes the process of demonstrating substantial equivalence to a predicate device, not the development and validation of an AI/ML powered device. As such, most of the requested information regarding acceptance criteria, study design for AI, expert involvement, and ground truth establishment is not applicable to this document.

However, I can provide information based on what is available in the document regarding the device's performance against non-clinical test standards, which serves as a form of acceptance criteria for this type of medical device submission.

Here's the breakdown of the information provided in the document:

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

For a traditional medical device like a manual wheelchair, "acceptance criteria" are tied to compliance with recognized consensus standards. The performance is reported as meeting 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 information is not provided in the document. The document describes compliance with international standards for wheelchair testing, which implies internal testing by the manufacturer. The country of origin of the manufacturer is China (Sichuan AST Medical Equipment Co., Ltd., Luzhou City, Sichuan, China). The type of testing (e.g., retrospective or prospective) is not applicable in the context of these device performance tests; they are typically conducted on manufactured units.

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 to a non-AI/ML device submission like this. The "ground truth" for a mechanical wheelchair's performance is determined by established engineering and medical device standards and test methods, not by expert consensus in a clinical diagnostic sense. The experts involved would be engineers and technical specialists responsible for conducting the ISO standard tests.

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

Not applicable. Adjudication methods are relevant for clinical studies or expert review processes, which are not described here. Device performance is determined by passing predefined test criteria 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

Not applicable. This is not an AI-powered device, and no MRMC comparative effectiveness study was performed or is relevant for this type of device.

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

Not applicable. This is not an AI-powered device.

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

For this medical device, the "ground truth" is defined by the objective performance criteria specified within the referenced ISO standards (e.g., static stability limits, brake effectiveness, dimensions within tolerance, strength requirements). Compliance with these standards confirms the device's fundamental safety and performance characteristics.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. This is not an AI/ML device.

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