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The intended use of this device (manual, rigid wheelchair) is the same as the predicate device, the TiSport Cross-Sport (manual, rigid wheelchair) manufactured by TiSport, LLC. The intended use for the manual, rigid wheelchair is to provide mobility to physically persons. The manual wheelchair is intended for ongoing daily use.

This device is indicated for individuals with the specific medical conditions listed, but the indications are not necessarily limited to such conditions:

• Amputee;

• Arthritis;

• Arthrogriposis;

• Cerebral Palsy;

• Geriatric conditions;

• Head injury or trauma;

• Hemiplegic;

• Multiple Sclerosis;

• Muscular Dystrophy;

• Paraplegic;

• Polio;

• Quadraplegic;

• Spina Bifida;

• Stoke/CVA;

• Tetraplegic; and

• Other immobilizing or debilitating conditions, including spinal cord injuries and other lower and upper extremity paralysis

The TiLite Evo wheelchair is a rigid manual titanium wheelchair.

The TiLite Evo manual, rigid wheelchair met its acceptance criteria by complying with several international standards for wheelchairs.

1. Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:
The document does not specify the sample sizes used for the testing or the data provenance (e.g., country of origin, retrospective/prospective). The testing refers to compliance with ISO standards, which typically involve standardized laboratory testing rather than clinical data from human subjects.

3. Number and Qualifications of Experts:
Not applicable. The study involved engineering and performance testing against international standards, not expert review of medical images or diagnostic outputs.

4. Adjudication Method:
Not applicable. The study involved compliance testing against predefined international standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This device is a manual wheelchair, and the testing focused on its physical properties and compliance with safety and performance standards, not diagnostic efficacy or human reader performance.

6. Standalone Performance (Algorithm only):
Not applicable. This device is a physical product, not a software algorithm.

7. Type of Ground Truth:
The "ground truth" in this context is the set of objective performance and safety requirements specified by the ISO 7176 series of standards for wheelchairs. Compliance is determined through laboratory testing and engineering assessments.

8. Sample Size for Training Set:
Not applicable. This is a physical device, and the concept of a "training set" is not relevant in the context of its regulatory submission.

9. How Ground Truth for Training Set was Established:
Not applicable. There is no training set for this type of device. The ISO standards represent established international consensus on test methods and performance criteria for wheelchairs.

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