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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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The Elevation Manual Wheelchair is intended to provide mobility to persons limited to a seated position.

The PDG Product Design Group, Inc. Elevation Manual Wheelchair (Elevation) is a manually operated, user propelled, manual, mechanical wheelchair. Its intended function and use is to provide mobility to persons ages 12 and up (adolescents and adults) limited to a seated position. It is an ultra-light, rigid (non-folding frame) type wheelchair.

The device consists primarily of a lower frame assembly, a seat sling, a back rest and back upholstery, large rear wheels with hand rims for self-propelling the chair and front swivel type pivoting casters for turning.

The Elevation also has seat height and back rest recline angle adjustment capability that allow the user to self-adjust either the seat to floor height or the back rest recline angle while seated in the wheelchair. The Elevation is capable of up to 5 inches of rear to front seat height difference.

This document describes the premarket notification for the Elevation Manual Wheelchair (K140023). Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices, particularly those in Class I, the "acceptance criteria" often refer to meeting established safety standards (like ISO standards) and demonstrating substantial equivalence to a predicate device. The "reported device performance" indicates how the new device fulfills these standards and compares to the predicate.

The study that proves the device meets the acceptance criteria is a series of non-clinical tests conducted according to international ISO standards. The document explicitly states: "The Elevation Manual Wheelchair has been tested to the following standards."

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

• Test Set Sample Size: Not explicitly stated as a numerical sample size of devices, but rather indicated by testing "The Elevation Manual Wheelchair" against the listed ISO standards. This implies at least one device was tested to each standard, which is typical for mechanical device performance and safety testing.
• Data Provenance: The testing was non-clinical. The standards are international (ISO), making the origin of the testing methodology international. The manufacturer (PDG Product Design Group, Inc.) is based in Vancouver, British Columbia, Canada, suggesting the device and possibly the testing might have originated there, or at a contracted testing facility. The data is prospective in the sense that the testing was performed on this specific device to demonstrate its compliance.

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 type of device. The "ground truth" for a mechanical wheelchair's performance and safety is established by its adherence to internationally recognized engineering and safety standards (ISO standards), rather than expert medical consensus or interpretation of images. The tests themselves are objective measurements against specified criteria within the ISO standards.

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

Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to expert review processes for clinical data or image interpretation where there's subjectivity. For objective mechanical testing against ISO standards, the results are derived directly from the test procedures.

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. An MRMC study is relevant for diagnostic imaging AI devices, not for a manual mechanical wheelchair.

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

Not applicable. This device is a mechanical wheelchair, not an algorithm or AI system.

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

The "ground truth" for this device's performance and safety is its conformance to established international safety and performance standards (ISO standards). These standards define the acceptable mechanical properties, stability, braking effectiveness, dimensions, material ignition resistance, etc. The results of non-clinical tests against these standards serve as the objective evidence of "ground truth."

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI or algorithm that requires a training set.

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

Not applicable. As noted above, there is no "training set" for this type of device.

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The intended use of the PDG Models Fuze T20 and T50 manual wheelchairs is to provide mobility to persons that may be limited to a seated position.

To provide mobility to persons limited to a seated position.

The PDG Models Fuze T20 and T50 wheelchairs are manually operated, self propelled mechanical wheelchairs. Their intended function and use is to provide mobility to persons that may be limited to a seated position. They may also be used as attendant propelled transport devices in a health care environment such as a hospital, nursing home or extended care facility.

Both wheelchairs include a tilt mechanism which allows the upper frame of the wheelchair to be tilted. This feature is used to provide pressure relief as well as comfort to those users who may be confined to the wheelchair for extended periods of time. The tilt mechanism can also serve as an attendant aid in those situations where a patient needs to be tilted for attendant access.

The provided text describes a 510(k) premarket notification for the Fuze T20 and T50 Manual Wheelchairs. This type of regulatory submission is for medical devices, not artificial intelligence (AI) or software-as-a-medical-device (SaMD). Therefore, the questions related to AI/SaMD performance criteria, study design, and ground truth establishment are not applicable.

The performance data for the Fuze T20 and T50 Manual Wheelchairs focuses on their compliance with established physical standards for wheelchairs.

Here's the breakdown based on the provided information, addressing the relevant sections:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• The document does not explicitly state the sample size (number of wheelchairs tested) or the provenance (country of origin, retrospective/prospective) of the data for these performance tests. It only states that the devices are "designed to meet" these standards, implying that testing was conducted or the design principles align with these standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

• This question is not applicable. The "ground truth" for a physical medical device like a wheelchair is compliance with established engineering and safety standards (ISO and ANSI/RESNA). These standards are developed by consensus of technical experts in the field, not through a process of individual expert adjudication of device performance in a clinical setting.

4. Adjudication Method for the Test Set

• This question is not applicable. Adjudication methods like "2+1" or "3+1" are used for interpreting ambiguous data, often in the context of image analysis or medical expertise. For mechanical device testing against fixed standards, the results are typically objective (pass/fail for specific tests) and do not require expert adjudication in this manner.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• This question is not applicable. MRMC studies are used to evaluate the diagnostic accuracy of imaging or other medical tests, often comparing human readers with and without AI assistance. This is irrelevant for a manual wheelchair.

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

• This question is not applicable. A manual wheelchair does not involve an algorithm or AI component to be tested in a standalone manner.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is adherence to established international and national safety and performance standards for wheelchairs, specifically ISO 7176 and ANSI/RESNA WC-19.

8. The Sample Size for the Training Set

• This question is not applicable. Manual wheelchairs do not have "training sets" in the context of AI or machine learning. The design and manufacturing processes are informed by engineering principles, material science, and regulatory requirements, not by training data.

9. How the Ground Truth for the Training Set Was Established

• This question is not applicable for the same reasons as #8.

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To provide mobility to individuals limited to a sitting position.

Not Found

This document is a 510(k) premarket notification letter from the FDA regarding a mechanical wheelchair. It does not contain information about the acceptance criteria or a study proving device performance as it pertains to a software algorithm or AI-driven medical device.

Therefore, I cannot provide the requested information based on the given text.

The document is a regulatory approval letter for a physical product (a manual wheelchair), not a description of a study for a diagnostic or AI-driven medical device. The typical information requested (e.g., sample sizes, ground truth, expert qualifications, MRMC studies) are specific to the evaluation of software or AI performance, which is not applicable here.

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The intended use of the device is in providing mobility to persons restricted to a sitting position.

The Stellar Tilt, Manually Operated Wheelchair

The provided document is a 510(k) premarket notification letter from the FDA for "The Stellar Tilt, Manually Operated Wheelchair." It is a regulatory approval letter, not a study report, and therefore does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for an AI/device performance study.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It discusses regulatory classifications and general controls but does not include any performance metrics or study details in the context of your questions.

Therefore, I cannot extract the requested information from this document.

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Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device