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The Hippocampe Marathon and Trail is indicated to provide mobility to persons restricted to a seated position on various terrains, including footpaths and trails.

The Hippocampe Marathon and Trail is an occupant or care provider propelled manual operated wheelchair. The Hippocampe Marathon and Trail is designed for everyday use as well as recreational activity such as running and trail running, in the following environments:

• Indoors and outdoors;
• Over smooth, rough, and uneven ground;
• Over soft and hard surfaces;
• Over small obstacles, like door jams; and
• Up, down and across slopes.

The Hippocampe Marathon and Trail is a three-wheel triangular wheelchair comprised of bent aluminum tubing frame that are bent, joined, fastened, and/or coupled with connectors to form a frame. The frame consists primarily of a lower frame, adjustable height seat back frame, adjustable headrest, push bar and push bar frame, tubing clamp connectors, footrest, arm rests, rear axle assembly, and front fork and axle assembly. Once assembled, the wheelchair frame is fixed. The recline of the seat back frame can be adjusted with depth adjustment screws at the base of the seat back frame. The upholstery is attached to the frame using nylon straps and buckles and is fire resistant. A rigid plastic open basket-like structure located in the middle of the lower frame and behind the front fork assembled provides the occupant a footrest and has a removable layer of foam. On the push bar are control levers for disc brakes of the rear wheels which are operated by the occupant's care provider. The disc brakes also act as parking brakes and are activated by the care provider. The Hippocampe Marathon and Trail can be easily assembled and disassembled for stowage or storage by detaching the lower frame of the armrest and folding the seat back frame forwards. The wheelchair is available in three sizes: medium, large and extra-large. The maximum weight capacity of Hippocampe Marathon and Trail is 220 lbs.

This document is a 510(k) clearance letter for the Hippocampe Marathon and Trail wheelchair, which is a physical device, not an AI/software device. Therefore, the questions regarding acceptance criteria and study data for AI/software performance metrics (like sensitivity, specificity, MRMC studies, ground truth establishment, etc.) are not applicable to this submission.

The clearance is based on demonstrating substantial equivalence to a predicate device (Hippocampe Wheelchair K051709) through non-clinical validation testing of physical properties and performance (e.g., static stability, braking effectiveness, static/impact/fatigue strengths, resistance to ignition).

Here's how to address the request based on the provided document, acknowledging its nature as a physical device clearance:

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

   Since this is a physical device subject to ISO standards for wheelchairs, the "acceptance criteria" are the specific pass/fail requirements defined within each of the listed ISO standards, and the "reported device performance" is that the device passed these tests. The document doesn't provide specific numerical results or detailed pass/fail thresholds within the clearance letter itself; it states that the tests were "performed" and "demonstrates that the Hippocampe Marathon and Trail is substantially equivalent in safety, effectiveness, and performance to the predicate device."

   Acceptance Criterion (ISO Standard)	Reported Device Performance
   ISO 7176-1: Static Stability	Device passed
   ISO 7176-3: Effectiveness of Brakes	Device passed
   ISO 7176-5: Dimensions, Mass, Maneuvering Space	Device passed
   ISO 7176-7: Seating & Wheel Dimensions	Device passed
   ISO 7176-8: Static, Impact, Fatigue Strengths	Device passed
   ISO 7176-11: Test Dummies	Not applicable (test method)
   ISO 7176-13: Coefficient of Friction of Test Surfaces	Not applicable (test method)
   ISO 7176-15: Information Disclosure, Documentation, Labeling	Device passed
   NF ISO 7176-16: Resistance to Ignition of Postural Support Devices	Device passed
   NF ISO 7176-22: Set-up Procedures	Not applicable (test method)

   (Note: ISO 7176-11, -13, and -22 are standards for test methodologies or components, not direct performance criteria of the end device in the same way as the others.)

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

   • Sample Size: Not explicitly stated for each test, but typically, testing against ISO standards for medical devices involves a representative sample of manufactured units. It's usually a small number (e.g., 1-3 units) per specific test as per the standard's requirements, due to the destructive nature of some tests.
   • Data Provenance: The testing was "non-clinical validation testing". The applicant is "Vipamat Sarl" from "Ploemeur 56270 France." The testing was likely conducted in a lab, potentially by the manufacturer or a third-party testing facility, in a prospective manner to demonstrate compliance.

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

   • Not Applicable. For a physical device like a wheelchair, "ground truth" isn't established by human experts in the same way it is for medical image interpretation or diagnostic AI. The "ground truth" is typically defined by the objective, quantifiable parameters of the ISO standards themselves (e.g., brake force, stability limits, material strength). Compliance is determined by whether the device's performance meets these predefined engineering and safety specifications, measured by calibrated equipment.

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

   • Not Applicable. Adjudication methods like 2+1 or 3+1 are used in subjective expert review scenarios, common in AI/radiology studies. For physical device performance testing against objective standards, the outcome is typically a direct measurement and comparison against a numerical threshold, or a pass/fail determination based on observable performance (e.g., no breakage under load).

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. MRMC studies are specific to evaluating the clinical performance of AI algorithms, often in medical imaging, and their impact on human reader performance. This device is a physical wheelchair, not an AI diagnostic tool.

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

   • Not Applicable. This question relates to AI algorithm performance. The device is a manual wheelchair, so there is no "algorithm only" performance to evaluate.

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

   • Objective Engineering Standards / Bench Testing Results. The "ground truth" here is the objective, measurable performance of the wheelchair against the defined physical and mechanical limits specified in the ISO standards (e.g., forces applied, distances traveled, angles achieved, material integrity). This is determined by controlled bench testing with appropriate load application and measurement equipment.

8. The sample size for the training set:

   • Not Applicable. There is no "training set" in the context of a physical device like this. Training sets are relevant for machine learning algorithms.

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

   • Not Applicable. As there is no training set, there's no ground truth to establish for one.

In summary, the provided document is a 510(k) clearance for a physical medical device (a wheelchair), not a software or AI device. Therefore, many of the questions asked, which are highly relevant to AI/software validation studies, do not apply. The device's "acceptance criteria" and "proof" come from demonstrating compliance with established international physical performance and safety standards for wheelchairs (ISO 7176 series).

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