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The Stellar LEAP Manual Tilt Wheelchair is intended to provide mobility to persons restricted to a seated position.

The Stellar LEAP manual tilt wheelchair is an indoor / outdoor, manually operated, Tilt-in-Space wheelchair. Its intended function and use is to provide mobility to persons ages 16 and up (adolescents and adults). The Stellar LEAP manual tilt wheelchair consists of metal frame architecture with a backrest, seat, and rear wheels, which allow for occupant or attendant propelling of the device. Smaller caster wheels are also mounted on the front of the frame to facilitate steering and turning. The Stellar LEAP consists of three (3) metal frame subassemblies: a lower frame, upper seat frame, and sub-frame assembly. The manual Tilt-in-Space operation is achieved using a gas strut mechanism connected between the upper seat frame and sub-frame. The Stellar LEAP Manual Tilt Wheelchair is available in a standard configuration, which allows 20° Tilt-in-Space (posterior) tilt, with a maximum weight capacity of 250 lbs.

PDG offers optional features / options to be added to the Stellar LEAP wheelchair, including the two below features:

• Stellar LEAP Anterior Tilt Feature (0° 30°): Functional reach extension & transfer . assist
• Stellar LEAP Dynamic Recline Backrest Tilt Feature: 30° range of dynamic recline for the backrest combined with the anterior tilt

Other available options / accessories to complete the Stellar LEAP configuration include: seat width / depth / height, armrests, casters, frog leg suspension forks, rear wheel / tire, hand rim, wheel locks, anti-tippers, back post style, back options, back upholstery, headrest, tilt control, recline control, front rigging, foot plates, footrest / leg rest accessories, position straps, IV pole, 02 holder.

The provided text describes the 510(k) summary for the Stellar LEAP manual tilt wheelchair (K163432). It details the device, its intended use, comparison to predicate devices, and performance data. However, the requested information focuses on performance criteria and studies for AI/ML-driven devices, which is not applicable to this submission for a mechanical wheelchair.

Therefore, most of the specific points in the request cannot be answered from the provided document.

Here's a breakdown of what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

The acceptance criteria for the Stellar LEAP wheelchair are defined by its compliance with various ISO 7176 standards. The reported performance is that the device "meets the requirements" or "performed compliant" to these standards.

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

• Sample Size for Test Set: Not applicable/not specified for a mechanical device. The testing described is based on engineering verification and validation according to international standards, typically involving a set number of units or prototypes to test specific characteristics.
• Data Provenance: Not applicable for this type of device. The provenance is the testing conducted by the manufacturer against established ISO standards.

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" in the context of AI/ML is not relevant here. Compliance with ISO standards is verified through defined test methods and measurements, not expert consensus on data interpretation.

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

Not applicable. This concept is for diagnostic performance assessment, not mechanical device testing.

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. This is for AI/ML diagnostic devices.

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

Not applicable. This is for AI/ML systems.

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

Not applicable. The "ground truth" for a mechanical device is its adherence to specified engineering, safety, and performance standards as determined by standardized tests and measurements, as well as risk analysis and biocompatibility assessment.

8. The sample size for the training set

Not applicable. The Stellar LEAP is a mechanical medical device, not an AI/ML product that requires a training set for algorithm development.

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

Not applicable. No training set is used for this device.

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