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The AMYPOWER ALLTRACK power wheelchair's intended use is to provide mobility to persons limited to a seating position, that have the capability of operating a powered wheelchair. The AMYPOWER ALL TRACK power wheelchair empowers physically challenged individuals by providing a means of mobility.

The AMYPOWER ALLTRACK power wheelchair is a battery powered, motor driven device. It is a rigid or "non-folding" type power wheelchair design that offers functionality to be used as a mid wheel drive or a rear wheel drive base. The design offers a modular approach and can be configured in multiple versions to suit different client needs. The ALLTRACK series power wheelchair is designed to offer the ultimate in safety, stability, performance and comfort for the user. It features an active six wheel suspension as well as a seat suspension, and front and rear anti-tip casters which allow for surface contact of all six wheels at all times and prevents pitching on slopped terrain. The ALLTRACK power wheelchair utilizes components typically found on most wheelchairs, including but not limited to a rigid steel frame, a seat, armrests, front riggings, two main drive wheels, two electric drive motors, front & rear castors, two batteries, a charger, a positioning belt and a controller.

The provided text describes the submission for a power wheelchair, which is a medical device. Based on the information provided, this is not a device that relies on algorithms, AI, or specific performance metrics that would require an "acceptance criteria" table in the traditional sense of AI/ML-driven devices.

Instead, the acceptance criteria for this type of device are met through adherence to established industry standards and regulations for safety and functionality. The study that proves the device meets these criteria is the non-clinical testing described in the document.

Here's the breakdown of the requested information based on the provided text:

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

• Compliance with ISO EMC Standard 7176-14
• Compliance with ANSI/RESNA WC vol. 1 & vol. 2, Section 21:1998 amendments for powered wheelchairs and motorized scooters
• Functionality for active six-wheel suspension, seat suspension, front and rear anti-tip casters (surface contact of all six wheels, preventing pitching on sloped terrain) | - Met the required performance criteria and functioned as intended in all instances for ISO EMC Standard 7176-14 and ANSI/RESNA WC vol. 1 & vol. 2, Section 21:1998 amendments.
• Features an active six-wheel suspension, seat suspension, and front and rear anti-tip casters, allowing for surface contact of all six wheels at all times and preventing pitching on sloped terrain. |
  | Substantial Equivalence to Predicate Devices
• Similar intended use
• Similar technological characteristics (materials, controls, power source, operating speeds, maneuverability, power modules, hand controls, seat types, drive wheels, climbing ability, standard accessories) | - Demonstrated to be substantially equivalent to the predicate devices (Invacare Storm TDX K023589, Invacare Storm K940051) in terms of meeting performance criteria and functioning as intended.
• Differences in technological characteristics do not raise any concerns of safety or effectiveness. |
  | Safety for User Operation | - Considered to be safe for user operation. |

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 explicitly stated as a number of individual units. The testing involved "the AMYPOWER ALLTRACK series power wheelchair," implying potentially one or a representative sample of units undergoing the specified non-clinical tests.
• Data Provenance: The testing was conducted in accordance with international and North American standards (ISO & ANSI/RESNA). The manufacturer, Amylior Inc., is based in Quebec, Canada, suggesting the testing likely occurred to satisfy Canadian and US regulatory requirements for market clearance. The data is based on non-clinical testing, which is a prospective assessment of the device's physical performance characteristics against defined 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)

• This information is not applicable as the "ground truth" for this device is established by objective engineering and safety standards (ISO, ANSI/RESNA), not by expert consensus on clinical data interpretation. The evaluation is against measurable physical properties and functional requirements.

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

• Not applicable. Adjudication methods like "2+1" typically apply to cases where multiple human readers are interpreting complex data (e.g., medical images) and their disagreements need to be resolved by a third party. For a power wheelchair's non-clinical safety and performance testing, the results are objectively measured against established criteria; there is no subjective interpretation requiring adjudication.

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 device is a mechanical power wheelchair, not an AI/ML-driven diagnostic or assistive device that would involve human readers or comparative effectiveness studies with AI assistance.

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

• Not applicable. This device is a mechanical power wheelchair and does not contain artificial intelligence algorithms. Its performance is inherent in its design and construction, and validated through physical testing against standards.

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

• The ground truth is based on established international and national engineering, safety, and performance standards (ISO EMC Standard 7176-14 and ANSI/RESNA WC vol. 1 & vol. 2, Section 21:1998 amendments). Compliance with these objective standards serves as the "ground truth" for device acceptability.

8. The sample size for the training set

• Not applicable. This device is a mechanical power wheelchair; it does not involve machine learning or a "training set" in the context of AI/ML models.

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

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

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The intended use of the device is to provide posterior tilting for positioning and pressure relief in a powered wheelchair.

Not Found

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a power tilt system for wheelchairs. It confirms the device's substantial equivalence to a predicate device and its classification.

The document does not contain any information about:

• Acceptance criteria or reported device performance for a study.
• Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone studies, or ground truth details for any testing.
• Training set information.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided input.

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The intended use of the device is to provide posterior tilting for positioning and pressure relief in a powered wheelchair.

AmySystems PTS50CG Weight Shift Power Tilt System

The provided text is a 510(k) clearance letter from the FDA for a medical device called "AmySystems PTS50CG-50° Power Tilt System." This document grants market clearance based on substantial equivalence to a predicate device.

However, the letter does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or any of the other specific details requested in your prompt.

The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive de novo clinical studies with detailed performance metrics and statistical analyses as might be found in a PMA (Premarket Approval) application.

Therefore, I cannot populate the table or answer the specific questions based on the information provided in the input text. The document confirms the device's clearance for marketing and its intended use but does not delve into the technical study details you are asking for.

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