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The Intended Use of the Pride Mobility T3 Lift Chair is to provide lift assistance for persons who have difficulty rising from a seated position to a standing position.

The Pride Mobility T3 Lift Chair is an upholstered chair having welded steel frame construction. The chair upholstery (foam and fabric) are compliant to Cal 117 and BS5852 Flammability requirements. The upholstered chair is assembled to a weldedsteel lifting frame mechanism, and a Hand Control Switch Device engages motor / actuators to position the chair to recline, sitting, or standing positions. The system is a low voltage DC motor system that reduces the standard household alternating current of 110V AC / 240V AC to direct current (24 / 39V DC). The electrical components include the external transformer with battery backup, two motor / actuators, and the Hand Control.

The provided text describes a 510(k) submission for the Pride Mobility T3 Lift Chair. This is a medical device that assists individuals with mobility challenges in transitioning from a seated to a standing position.

Here's an analysis of the provided information, specifically addressing the acceptance criteria and study details:

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

For the Pride Mobility T3 Lift Chair, the "acceptance criteria" are based on its compliance with specific safety and flammability standards, and its substantial equivalence to a predicate device. The device's performance is demonstrated by passing tests related to these standards.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify a sample size for a "test set" in the context of clinical data. The testing performed was non-clinical testing of the device itself (flammability, electrical safety, mechanical fatigue). Therefore, "data provenance" in terms of subject data is not applicable. The tests were likely conducted in a controlled laboratory environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is not applicable to this device. The "ground truth" for the non-clinical tests (flammability, electrical, mechanical) is typically the standard itself (e.g., "does the material ignite within X seconds under Y conditions?"). Expert consensus in the medical or diagnostic sense is not relevant for these types of engineering and safety tests. The reports from the testing labs would serve as the attestations to compliance.

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

This is not applicable as there was no clinical test set requiring adjudication of findings. The tests were objective assessments against established engineering and safety standards.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (e.g., AI in radiology), not for a mechanical lift chair. The device's function is to directly provide lift assistance, not to assist humans in making a diagnostic interpretation.

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

No, a standalone algorithm-only performance study was not done. This device is a mechanical chair, not an algorithm.

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

The "ground truth" for the non-clinical tests was the objective pass/fail criteria defined by the respective safety and performance standards. For example, for flammability, the ground truth is whether the material meets the specified burn rates or self-extinguishing properties outlined in CAL 117 or BS5852. For fatigue testing, the ground truth is whether the components withstand the prescribed number of cycles or impact forces without failure. For substantial equivalence, the "ground truth" is whether the technical characteristics and intended use align sufficiently with the predicate device.

8. The sample size for the training set

This is not applicable as there is no "training set" in the context of an algorithm or AI model for this mechanical device.

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

This is not applicable for the same reason as above.

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