Search Results

The intended use of the Model-Allure (HP6), powered wheelchair is to provide mobility to adults, weighing up to 350 pounds, with the ability to place themselves in a sitting position in the wheelchair and have the capacity to operate a standard joy stick hand control.

Not Found

This document is a 510(k) premarket notification for a powered wheelchair, not a study report for an AI/ML medical device. Therefore, it does not contain the information required to answer the questions about acceptance criteria, device performance, study design, or ground truth for an AI/ML device.

Specifically, the document:

• Approves the IMC Heartway Model-Allure (HP6) Electric Power Wheelchair.
• States its intended use and specifications (mobility for adults up to 350 pounds, who can sit themselves and operate a joystick).
• Confirms its classification as a Class II device.
• Refers to substantial equivalence to legally marketed predicate devices.

It does not involve any AI/ML components, and thus, the requested details about acceptance criteria, study methodologies, sample sizes, expert involvement, and ground truth establishment for an AI/ML algorithm are not present in this document.

Ask a specific question about this device

The intended use of the Rumba SR (P4R), is to provide mobility to adults weighing up to 300 Pounds and the ability to place themselves in a seated position on the chair and have the capacity to operate a standard joy stick hand control.

Not Found

This is a letter about the FDA's decision regarding a 510(k) premarket notification for a powered wheelchair. This type of document, particularly older ones, typically does not contain detailed information about acceptance criteria or specific studies in the way you've outlined for AI/ML devices. The focus here is on substantial equivalence to a predicate device.

Therefore, I cannot provide the information requested in your prompt based on the provided text. The document does not describe:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone performance studies.
• Type of ground truth used.
• Sample size for training sets.
• How ground truth for training sets was established.

This document is a regulatory approval letter for a medical device (a powered wheelchair) based on its substantial equivalence to previously marketed predicate devices, not a study report for an AI/ML device.

Ask a specific question about this device

The intended use of the Vision (P13) lift wheelchair is to provide forward and reverse mobility and up and down movement for greater accessibility to surroundings. This chair is designed for occupants weighing up to 350 pounds, whom have the capacity to operate a standard joy stick hand control.

Not Found

The provided text is a letter from the FDA regarding a 510(k) premarket notification for an "Electric Powered Lift Wheelchair, Model Vision (P13)". This document describes the device, its intended use, and the FDA's marketing approval. However, it does not contain any information about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the device's performance.

Therefore, I cannot provide the requested information. The document focuses solely on the regulatory approval process and not on the technical performance data that would typically be generated for a device study.

Ask a specific question about this device

The intended use of the Rumba S (HP4) powered wheelchair is to provide mobility to adults, weighing up to 300 pounds, with the ability to place themselves in a sitting position in the wheelchair and have the capacity to operate a standard joy stick hand control.

Not Found

The provided text is a 510(k) premarket notification approval letter for a powered wheelchair. It confirms that the device, the IMC-Heartway, LLC Model Rumba S (HP4), is substantially equivalent to a legally marketed predicate device.

However, this document does not contain any information about acceptance criteria, device performance, study details (sample sizes, expert qualifications, adjudication methods, ground truth, MRMC studies, or standalone performance), or training set information.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them, as this information is not present in the provided text.

Ask a specific question about this device

The intended use of the Model-Tiara (P4AS) powered wheelchair is to provide mobility to adults, weighing up to 300 pounds, with the ability to place themselves in a sitting position in the wheelchair and have the capacity to operate a standard joy stick hand control.

Not Found

This document is a 510(k) premarket notification letter from the FDA regarding a powered wheelchair (IMC-Heartway, LLC Model-Tiara (P4AS)). It confirms substantial equivalence to a predicate device and allows the device to be marketed.

The document does not contain any information about acceptance criteria, studies, device performance metrics, sample sizes, ground truth establishment, expert qualifications, or adjudication methods for an AI/ML powered medical device. The information requested pertains to the evaluation of AI/ML performance, which is not applicable to this 510(k) clearance for a powered wheelchair.

Ask a specific question about this device

The intended use of the Mini (P14) powered wheelchair is to provide a light weight chair with good maneuverability in and out of buildings. This chair is designed for occupants weighing up to 250 pounds, whom have the capacity to operate a standard joy stick hand control.

Not Found

I am sorry, but this document is a 510(k) clearance letter from the FDA for a powered wheelchair. It does not contain information about acceptance criteria or a study that proves a device meets those criteria, as it is not a technical report or scientific publication describing a clinical study or algorithm performance. Therefore, I cannot extract the requested information.

Ask a specific question about this device

The intended use of the HP-7 provide mobility to adults limited to thing position that have the to operates a simple han Capa

Model HP-7 Power Wheelchair

The provided text is a 510(k) Premarket Notification letter from the FDA concerning a power wheelchair (Model HP-7). This type of document does not contain information about acceptance criteria, study designs, sample sizes, expert qualifications, or detailed performance data for the device.

The FDA 510(k) process is primarily focused on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving a device meets specific performance criteria through a detailed clinical study in the way typically seen for novel medical devices or AI algorithms.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) from the provided text. The letter only confirms that the FDA has reviewed the submission and determined the device is substantially equivalent to a predicate device.

Ask a specific question about this device

The intended use of the PF-2 is to provide mobility to adults with the ability to place themselves in a sitting position on the scooter and have the capacity to operate a simple hand control.

Model PF-2, Four Wheel Electric Scooter

I am sorry, but the provided text from the FDA 510(k) summary for the "Model PF-2, Four Wheel Electric Scooter" does not contain the detailed information about acceptance criteria and a study proving device performance as requested.

The document is a standard FDA 510(k) clearance letter, which primarily states that the device has been found substantially equivalent to a legally marketed predicate device. It defines the device name, regulation number, regulatory class, and indications for use.

It does not provide:

• A table of acceptance criteria or reported device performance.
• Details about a study (sample size, data provenance, expert numbers/qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types for test or training sets, or how ground truth was established).

This type of information is typically found in a more detailed 510(k) summary document or clinical study reports, which are not included in the provided text.

Ask a specific question about this device

The intended use of the IMC- Heartway Model HPS Wheelchair is to provide mobility to adults with the ability to place themselves or be placed in a sitting position and have the capacity to operate a simple hand control.

Not Found

I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets specific criteria for the IMC-Heartway Model HPS Electric Powered Wheelchair.

The document is a 510(k) substantial equivalence determination letter from the FDA. It states that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory responsibilities. However, it does not detail:

1. Acceptance criteria
2. Reported device performance
3. Sample sizes
4. Data provenance
5. Number or qualifications of experts
6. Adjudication method
7. MRMC comparative effectiveness studies
8. Standalone algorithm performance
9. Type of ground truth used
10. Training set sample size
11. Ground truth establishment for training set

The "Indications for Use Statement" simply describes the intended user and purpose of the wheelchair, not performance metrics or study results.

Ask a specific question about this device

The intended use of the IMC-Heartway HP-3 HD wheelchair is to provide mobility to adults, limited to a sitting position and have the capability to operate a simple hand control.

Model HP-3 HD Electric Wheelchair

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for an electric wheelchair. It does not contain information about the acceptance criteria or a study that proves a device meets those criteria, as it pertains to AI/ML or diagnostic devices.

The document is a regulatory approval for a physical medical device (a powered wheelchair) and focuses on substantial equivalence to a predicate device, not on specific performance metrics or clinical study results in the context you've described.

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

Ask a specific question about this device