Search Results

The GEN 2 Mechanical Wheelchair is intended to provide mobility to persons restricted to a seated position. The GEN 3 Mechanical Wheelchair is intended to provide mobility to persons restricted to a seated position.

The GEN 2 mechanical wheelchair is a highly adaptable allpurpose wheelchair created for use in developing countries, while allowing for a healthy, personalized fit. The wheelchair features adjustable seating, large castor wheels, an extra-thick cushion and adjustable footrests.

The GEN 3 Mechanical Wheelchair is a folding, non-rigid type wheelchair designed for use over rough terrain in developing countries. The wheelchair features adjustable seating, large castor wheels, an extra-thick cushion and adjustable footrests.

This document is a 510(k) premarket notification for mechanical wheelchairs (GEN 2 and GEN 3 models). It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than a study on an AI/ML powered device.

Therefore, many of the requested elements (acceptance criteria, sample size for test/training sets, ground truth establishment, expert qualifications, MRMC comparative effectiveness, standalone performance, etc.) are not applicable or not provided in this document.

However, I can extract information related to the performance testing conducted for these mechanical wheelchairs.

Acceptance Criteria and Reported Device Performance

The document describes non-clinical testing performed to establish the safety and effectiveness of the modified GEN 2 and GEN 3 mechanical wheelchairs. The specific acceptance criteria are implied by adherence to the ISO 7176-1:2014 standard for static stability.

Note: The document explicitly states "The information provided supports a substantial equivalence decision based on the repeat pre-clinical testing of the forward, rearward and lateral static stability tests performed in accordance with ISO 7176-1:2014." This implies that the devices met the requirements of this standard.

The other questions are not relevant to this document as it pertains to physical medical devices (mechanical wheelchairs) and not an AI/ML powered device.

Ask a specific question about this device

The GEN_3 Mechanical Wheelchair is intended to provide mobility to persons restricted to a seated position.

The GEN 3 Mechanical Wheelchair is a folding, non-rigid type wheelchair designed for use over rough terrain in developing countries. The wheelchair features adjustable seating, large castor wheels, an extra-thick cushion and adjustable footrests.

The provided document is a 510(k) summary for the GEN 3 Mechanical Wheelchair, seeking substantial equivalence to the predicate device, the GEN 2 Mechanical Wheelchair. The document outlines acceptance criteria as the device's ability to meet specific ISO standards for wheelchairs and presents the results of non-clinical testing to demonstrate this.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and reported device performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: The document does not explicitly state the sample size (number of GEN 3 wheelchairs) used for the non-clinical retesting. It generally refers to "retesting" and "non-clinical test results" without specifying the quantity of devices tested.
• Data Provenance: The data provenance is from non-clinical laboratory testing performed in support of this 510(k) submission. It is prospective in the sense that the testing was conducted specifically for the GEN 3 device to demonstrate compliance with standards. The country of origin of the data is not specified in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the study is a non-clinical performance study based on international standards (ISO). Ground truth established by experts is typically relevant for studies involving human interpretation (e.g., image analysis, clinical diagnoses). The "ground truth" here is the adherence to the technical specifications and performance requirements of the ISO standards.

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

This is not applicable as the testing is non-clinical and objective, based on standardized measurement and mechanical testing protocols. Adjudication methods are typically used in clinical studies or studies involving human readers/interpreters where there might be disagreement in assessments.

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-powered diagnostic device. Therefore, no MRMC study or AI assistance evaluation was performed.

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

This is not applicable. This submission is for a mechanical wheelchair, which does not involve an algorithm or AI.

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

The "ground truth" for this non-clinical study is defined by the ISO standards (technical specifications and performance requirements) listed in the document (e.g., ISO 7176-1, 5, 7, 8). The device is considered to meet the acceptance criteria if it successfully passes the tests outlined in these standards.

8. The sample size for the training set:

This is not applicable. There is no "training set" as this is a non-clinical evaluation of a physical device against predefined performance standards, not a machine learning model.

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

This is not applicable for the reasons stated in point 8.

Ask a specific question about this device

The GEN 2 Mechanical Wheelchair is intended to provide mobility to persons restricted to a seated position.

The GEN 2 mechanical wheelchair is a highly adaptable all-purpose wheelchair created for use in developing countries, while allowing for a healthy, personalized fit. The wheelchair features adjustable seating, large castor wheels, an extra-thick cushion and adjustable footrests.

This is a 510(k) premarket notification for a mechanical wheelchair, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and study details relevant to AI/ML device performance (like sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not applicable or present in the provided text.

The document discusses the substantial equivalence of the GEN 2 Mechanical Wheelchair to a predicate device based on design, materials, intended use, and non-clinical performance data against international standards for mechanical wheelchairs.

Here's the relevant information that can be extracted:

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

The document doesn't present a table of "acceptance criteria" in the typical sense for a pass/fail study like an AI/ML device. Instead, it compares the technological characteristics of the GEN 2 wheelchair to a predicate device (Ki Mobility Catalyst Wheelchair) to establish substantial equivalence.

The reported device performance for the GEN 2 Mechanical Wheelchair is that it underwent non-clinical testing to international standards, as listed below. The conclusion is that "The non-clinical test results demonstrate the GEN 2 Mechanical Wheelchair does not raise any issues regarding safety and effectiveness" and "supports a determination of substantial equivalence to mechanical wheelchairs previously cleared by FDA."

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

This information is not applicable to this type of device submission. The testing performed is non-clinical, focusing on mechanical properties and compliance with safety standards, rather than evaluating performance on a test set of data with human subjects or a dataset similar to AI/ML evaluations. There's no "test set" in the context of data used for algorithm evaluation.

The provenance of the data is that it comes from non-clinical testing against specified ISO standards.

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. There is no test set with ground truth established by experts as would be the case for an AI/ML diagnostic device. The evaluation is based on engineering and materials testing against international standards for wheelchair safety and performance.

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

Not applicable. No adjudication method is described because there isn't a test set with expert-established ground truth.

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/ML device, and no MRMC study was conducted.

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

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

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

The "ground truth" in this context refers to the international standards for mechanical wheelchairs (e.g., ISO 7176 series and their specified test methods, ASTM, JIS standards). The device's performance is compared against these engineering standards to ensure safety and effectiveness.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set or its associated ground truth establishment.

Ask a specific question about this device