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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.

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For transportation of disabled persons.

The device consists of a chromed steel frame with cross bars, slung fabric seat and back, fixed or removable armrests, fixed or removable foot/legrests. Front caster wheels for steering, rear push handles for attendant-assisted propulsion, rear drive wheels with handrims for self-propulsion, and lever-style wheel locks.

The provided text describes a 510(k) summary for a manual wheelchair and the FDA's clearance letter. It does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device. The device described is a physical manual wheelchair, and the 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on design features and compliance with a flammability test for its fabric, not performance metrics common to AI/ML devices.

Therefore, I cannot provide the requested information for an AI/ML device based on the given input.

If the request was intended for a medical device in general, the provided text includes some information relevant to product specifications and a single test:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" consists of comparing the specifications of one submitted device model to a predicate device and a single fabric flammability test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Specifications like dimensions and weight limits are objective measurements. Fabric flammability is determined by standardized tests, not expert consensus in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Performance is based on direct measurement and standardized testing.

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 physical wheelchair, not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical wheelchair, not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
* For physical dimensions and weight: Direct measurement/specification.
* For fabric flammability: Results from a standardized ignitability test (NFPA 701-89).

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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For transportation of disabled persons.

The device consists of a folding chromed steel frame with cross braces, slung fabric seat and back, fixed or removable armrests, fixed or removable foot/legrests, front caster wheels for steering, rear push handles for attendant-assisted propulsion, rear drive wheels with handrims for self-propulsion, and lever-style wheel locks.

It appears this document describes a 510(k) summary for a Manual Wheelchair manufactured by G. Hirsch and Company, Inc., submitted on July 24, 1998.

This document is a regulatory filing for a medical device (a manual wheelchair) to demonstrate its substantial equivalence to previously marketed devices. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in the way a clinical or technical validation study would for a diagnostic or AI-based device.

The provided text focuses on the following:

• Substantial Equivalence: The primary goal of a 510(k) submission is to demonstrate that a new device is as safe and effective as a legally marketed predicate device. This is typically done through a comparison of design features, materials, and intended use, rather than extensive performance testing against defined acceptance criteria.
• Comparison of Design Features: The document provides a table comparing key physical characteristics of the G. Hirsch wheelchair to an Invacare Tracer Wheelchair (K935398) to show similarity.

Therefore, the requested information elements related to formal acceptance criteria, device performance results from a study, sample sizes, ground truth establishment, expert adjudication, or MRMC studies are not present in this document.

The context of this document is a regulatory submission for a simple mechanical device (a wheelchair), where substantial equivalence demonstration typically relies on design similarity and known performance of predicate devices, not on data-driven performance studies as one would expect for, say, an AI diagnostic algorithm.

Summary of what can be extracted from the document:

• 1. A table of acceptance criteria and the reported device performance: Not applicable. The document presents a comparison of physical specifications for demonstrating substantial equivalence to a predicate device, not performance against acceptance criteria from a validation study.
• 2. Sample sized used for the test set and the data provenance: Not applicable. No test set or data provenance is mentioned as this is a comparison of design features.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth or experts for performance evaluation are discussed.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 device is a manual wheelchair, not an AI-based diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• 8. The sample size for the training set: Not applicable. This is not an AI/machine learning device.
• 9. How the ground truth for the training set was established: Not applicable.

In conclusion, this document details a 510(k) premarket notification for a manual wheelchair and does not contain the type of acceptance criteria or study results typically found for performance-driven devices, especially those involving AI or advanced diagnostics.

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