Search Results

The Millenium II wheelchairs are intended to provide mobility to persons limited to a seated position that are capable of operating a manual wheelchair.

The Millenium II wheelchairs are intended to provide mobility to persons limited to a seated position that are capable of operating a manual wheelchair.

The provided text describes the 510(k) summary for the MILLENIUM II mechanical wheelchair. This document focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics and performance standards rather than clinical performance or AI algorithm validation. Therefore, many of the requested categories for AI/clinical study evaluation are not applicable.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document indicates testing was performed on the device ("a 100 kg dummy (plus 12.4 kg) as specified in ISO 7176 - 11 was used"). This suggests a single device may have been tested using a standardized dummy setup.
Data Provenance: The tests are "Non-Clinical Tests," implying they were conducted in a laboratory or engineering setting by the manufacturer (NEXT Mobility LLC). There is no information on country of origin of the data beyond the manufacturer's location in Canton, MI, USA. The testing is for mechanical performance and safety, not involving human subjects or clinical data in the traditional sense. It's likely considered prospective testing of the device prototypes or production samples.

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

Not applicable. The ground truth for mechanical wheelchair testing is established by adherence to specified parameters within international standards (ISO 7176 series), not by expert human interpretation.

4. Adjudication method for the test set

Not applicable. The testing involves standardized mechanical performance tests, which yield objective measurements against defined criteria. It does not involve human interpretation requiring adjudication.

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 a mechanical wheelchair, not an AI-powered diagnostic or assistive technology.

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

Not applicable. This is a mechanical wheelchair, not an AI algorithm.

7. The type of ground truth used

The ground truth used for mechanical wheelchair testing is defined by the objective performance criteria and methodologies outlined in the ISO 7176 standards. This includes measures of strength, stability, durability, and other physical characteristics, with pass/fail criteria typically specified by the standard. The "ground truth" is adherence to these engineering standards.

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI model requiring a training set.

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

Not applicable. This is a mechanical device, not an AI model.

In summary, the provided document is a 510(k) premarket notification for a mechanical wheelchair, which relies on demonstrating compliance with recognized international performance standards (ISO 7176) and substantial equivalence to a predicate device. It does not involve AI or clinical studies in the typical sense that would necessitate the detailed categories requested for human-AI interaction or algorithm validation.

Ask a specific question about this device

The RTm and Oval wheelchairs are intended to provide mobility to persons limited to a seated position that are capable of operating a manual wheelchair.

The RTm and Oval wheelchairs are mechanical wheelchairs.

The provided document is a 510(k) summary for a medical device, specifically the RTm and Oval manual wheelchairs. This type of document is for regulatory submission and focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report of performance against specific acceptance criteria for AI/software-as-a-medical-device (SaMD).

Therefore, much of the requested information regarding detailed acceptance criteria, specific study designs for performance, sample sizes for test and training sets, expert qualifications, and adjudication methods (which are standard for SaMD validation) are not applicable to this document. This submission pertains to a physical, mechanical device, not an algorithm or AI product.

Here's an analysis based on the provided text, addressing what can be inferred or explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table of numerical acceptance criteria with corresponding device performance values as would be expected for an AI/SaMD product. Instead, the acceptance criteria are implicitly defined by compliance with established international and national standards for manual wheelchairs, and the performance is reported as successful passage of these tests.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: The document states, "Where applicable a 100 kg dumm / (plus 12.4 kg) as specified in ISO 7176 -11 was used." This refers to a test dummy used for physical testing, not a "test set" of data or patient cases in the context of AI/SaMD. The number of physical units tested is not explicitly stated, but typically for such evaluations, a representative sample of manufactured devices would be tested, or a prototype.
• Data Provenance: Not applicable in the context of an AI/SaMD. The "data" here comes from physical tests of the wheelchair itself, not from patient records or imaging.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Not applicable. This is not a study requiring expert readers to establish ground truth for a diagnostic or prognostic task. The "ground truth" for the performance of the physical wheelchair is determined by the physical properties of the wheelchair and its behavior under standardized testing conditions.

4. Adjudication Method for the Test Set:

Not applicable. There is no "adjudication method" in the sense of resolving discrepancies between expert opinions, as this is not an interpretive diagnostic study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This is not an AI/SaMD. Therefore, no MRMC study, human reader improvement with AI, or effect size is discussed.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

Not applicable. This is a physical device, not an algorithm.

7. Type of Ground Truth Used:

The "ground truth" for compliance of the RTm and Oval wheelchairs is established through physical testing against recognized industry standards. For example, the static stability of the wheelchair (a performance characteristic) is evaluated according to the procedures outlined in ISO 7176-1. The successful completion of these tests serves as the "ground truth" for compliance with the standards.

8. Sample Size for the Training Set:

Not applicable. This is a physical device. There is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As above, this is a physical device, not an AI/ML system requiring a training set with established ground truth.

Ask a specific question about this device