Search Results

Panthera mechanical wheelchairs are manually operated multifunctional wheelchairs designed for indoor/outdoor use and intended to provide mobility to persons that have the capability of operating a mechanical wheelchair

Panthera mechanical wheelchairs are manually driven, lightweight, performance type of wheelchairs that have been designed and developed to be used in both indoor and outdoor environments, and to transport one (1) person at a time These wheelchairs are made available by Panthera Production AB in five (5) different top-level models, with each model designed for a specific end-user application The five different models of chairs are the S2, U2, Bambino, Micro, and BT. There are no basic differences in the general construction of each model wheelchair frame, or the materials and components used to make them The Chassis are made form chrome-molly steel, while their Pushrims and Footrests are made from a titanium alloy Wheels are of a spoke and hub design using metal components and rubber tires, while the casters are of a semi-solid polymer base design The seat cushion and back are made from flame retardant polyurethane coated polyester fabric, over a foam core The primary differences in the models of wheelchairs are in their dimensions, gross weights, weight carrying capacities, adjustability features, wheels, accessories and hardware options

The provided text describes a 510(k) summary for Panthera Mechanical Wheelchairs. However, it does not include information about acceptance criteria, detailed study designs, sample sizes, expert ground truth establishment, or comparative effectiveness studies of the kind requested in the prompt. The document focuses on demonstrating substantial equivalence to predicate devices based on regulatory standards.

Therefore, most of the information requested cannot be extracted from the given text.

Here is what can be inferred or explicitly stated from the provided document:

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

• Acceptance Criteria: Not explicitly stated as pass/fail metrics in the document. The general acceptance criterion is demonstrating substantial equivalence to predicate devices (Invacare Top End Terminator Titanium wheelchair and Invacare Top End Terminator SS wheelchair) concerning safety and effectiveness.
• Reported Device Performance: "Panthera mechanical wheelchairs passed all required consensus standards testing for conformance to the FDA's Guidance Document for the Preparation of Premarket Notification [510(K)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles." No specific performance metrics (e.g., durability, maneuverability test scores) are provided. The document also states the wheelchairs "have been designed, manufactured and tested for conformance to the applicable ISO and EN standards as referenced in this submission."

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

• Sample Size: Not specified. The document refers to "testing for conformance to the applicable ISO and EN standards" but does not detail the number of units tested or the nature of the test subjects (if any human subjects were involved, which is unlikely for a mechanical wheelchair's primary performance testing).
• Data Provenance: Not specified.

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)

• Not applicable. Ground truth as typically defined in AI/diagnostic studies (e.g., expert consensus on medical images) is not relevant for the type of device and testing described (mechanical wheelchair performance against standards).

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

• Not applicable. This concept is for diagnostic accuracy studies, not for mechanical device performance testing against regulatory 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. This type of study is for diagnostic or AI-assisted medical imaging devices, not for mechanical wheelchairs.

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

• Not applicable. This is not an AI device.

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

• For a mechanical wheelchair, "ground truth" would generally relate to objective measurements of physical performance (e.g., weight capacity, stability, maneuverability, durability) against defined engineering standards (ISO, EN, FDA guidance). The document confirms testing against these standards.

8. The sample size for the training set

• Not applicable. This is not an AI device, so there is no "training set."

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

• Not applicable. As above, there is no training set for this mechanical device.

In summary, the provided document is a regulatory submission for a mechanical wheelchair, focusing on demonstrating substantial equivalence to existing predicate devices by conforming to established safety and performance standards. It does not contain the detailed clinical study information often found for diagnostic devices or AI-powered tools.

Ask a specific question about this device