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The Hippocampe Wheelchair is a versatile, mechanical wheelchair intended for use on various terrains including sand, grass, gravel, snow, foot/hiking paths, and in water.

The Hippocampe Wheelchair is an all terrain wheelchair suitable for use on various terrains and in water. It can be used on surfaces such as the beach, seaside, snow, mountain pathways, forest, hiking paths, gardens and grass. The Hippocampe Wheelchair is a versatile durable wheelchair that is comprised of the following components.

• Wheel chair t
• Pushbar .
• Trunk harness (optional) .
• Armrest (optional) .
• Headrest (optional) .
• . Skiing kit (optional)
• . Traction kit
• Transport bag (optional) .
  The Hippocampe is available in small, medium, large and extra large configurations which all vary in length but have the same seat wydth, total width and seat height dimensions. Two versions of the Hippocampe, standard and pool, are available. The standard Hippocampe is intended for use in natural water (beaches, ponds, lakes). The pool Hippocampe is only intended for pool use by children and thin adults and is only available in a small size.

The provided text is a 510(k) summary for the Vipamat Technologie Hippocampe Wheelchair. It describes the device, its intended use, technological characteristics, and performance testing. However, it does not contain detailed information about specific acceptance criteria or a comprehensive study that proves the device meets those criteria in the way a medical AI/ML device submission would.

Instead, the document states: "Testing has been performed to evaluate the overall stability, dimensions and mechanics of the Hippocampe Wheelchair. The testing showed that the Hippocampe is safe and effective for its intended use."

This indicates that general safety and effectiveness testing was conducted, but specific metrics, thresholds, or detailed study designs are not provided. The information typically requested for AI/ML device performance studies (like sample sizes for test/training sets, expert adjudication methods, MRMC studies, etc.) is not applicable to this type of mechanical device submission from 2005.

Therefore, I cannot fulfill the request with the provided information in the format requested for an AI/ML device.

However, I can extract the general "performance testing" information that is available:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance: Not specified. The document only mentions "testing has been performed."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a mechanical device, not one requiring expert human interpretation for "ground truth."
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.
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. The "ground truth" for a mechanical device would be compliance with engineering standards and functional specifications through direct measurement and observation.
8. The sample size for the training set: Not applicable. This is a mechanical device, not an AI/ML algorithm.
9. How the ground truth for the training set was established: Not applicable.

Summary based on the provided text:

The Vipamat Technologie Hippocampe Wheelchair underwent "performance testing" to evaluate its overall stability, dimensions, and mechanics. The outcome of this testing was a determination that the device is "safe and effective for its intended use." The 510(k) summary does not elaborate on the specific acceptance criteria, testing methodologies, sample sizes, or detailed results of these tests, which is typical for mechanical device submissions around 2005. It focuses on demonstrating substantial equivalence to predicate devices based on design and intended use, supported by general safety and effectiveness testing.

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