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The P.R.O. CG® Manual Wheelchair is intended to provide mobility to persons ages 12 and up (adolescents and adults) with a weight capacity of 250lbs.

This Traditional 510(k) submission is being supplied to the U.S. FDA to obtain authorization to Market the P.R.O. CG® Manual Wheelchair. The P.R.O. CG® Manual Wheelchair is a rigid, non-folding, manually operated, center of gravity shifting (CG) tilt-in-space wheelchair. The design incorporates a fixed width base frame that is connected to a width and depth adjustable seat frame with struts connected to tilt arcs. This design allows the seat frame to change its position using a CG shifting tilt motion. The shift moves to reposition the seat frame angle from 0° to 50° in a smooth, downward, forward, and backward motion with little change in the overall center of gravity of the frame and the occupant. The device is not marketed with upholstery in the standard or optional configurations. The subject device intended use is to provide mobility to persons ages 12 and up (adolescents and adults) with a weight capacity of 2501bs.

This document is a 510(k) premarket notification for the P.R.O. CG® Manual Wheelchair. The primary purpose of this submission is to demonstrate substantial equivalence to a legally marketed predicate device, not to determine the performance against specific acceptance criteria for a novel AI/medical device.

Therefore, the requested information regarding acceptance criteria, study details for proving device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information cannot be extracted from the provided text.

The document discusses the substantial equivalence of the P.R.O. CG® Manual Wheelchair to a predicate device (Manual Rigid Mobility Wheelchair K080270). The performance data presented refers to non-clinical laboratory testing to ensure the new device meets established safety and performance standards for manual wheelchairs, which are different from acceptance criteria for AI-powered devices.

Here's an overview of what the document does provide regarding "performance," which is related to substantial equivalence for a medical device:

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

This document does not present "acceptance criteria" in the way one would for an AI-enabled device (e.g., minimum sensitivity/specificity/AUC). Instead, it lists the ISO and ANSI/RESNA standards against which the device was tested to demonstrate safety and performance for a manual wheelchair. The reported device performance is that the testing "demonstrated that the subject P.R.O. CG® Manual Wheelchair is substantially equivalent to the marketed predicate device." This implies that the wheelchair met the requirements of each standard.

Missing Information (Not Applicable to this Document Type):

2. Sample size used for the test set and the data provenance: Not applicable. This refers to physical wheelchair testing, not a dataset of patient information.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is not an AI/diagnostic device.
4. Adjudication method: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable. The "ground truth" for a manual wheelchair is whether it meets engineering standards for safety and structural integrity.
8. The sample size for the training set: Not applicable. There is no AI model or training set involved.
9. How the ground truth for the training set was established: Not applicable.

In summary, this document describes a traditional medical device (manual wheelchair) submission, not an AI or diagnostic device that would have the requested acceptance criteria and study details.

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This wheelchair is designed as a transport base for pediatric and adult clients.

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This document is a 510(k) clearance letter for the CGX Wheelchair (K080270). It states that the device is substantially equivalent to legally marketed predicate devices. However, this type of FDA clearance letter for a mechanical wheelchair does not typically include detailed information about acceptance criteria, study designs, sample sizes, expert qualifications, or comparative effectiveness studies related to performance metrics like accuracy, sensitivity, or specificity. These types of detailed performance evaluations are generally required for more complex devices, particularly those involving algorithms, diagnostics, or therapeutic effects.

Therefore, most of the requested information cannot be extracted from this document because it is not present. This document primarily focuses on regulatory clearance based on substantial equivalence to existing devices, not on a detailed analysis of a new device's performance against specific quantitative acceptance criteria or its impact on human reader performance.

Here's a breakdown of what can be confirmed or inferred from the provided text, and what cannot:

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

• Cannot be provided. This document does not list specific acceptance criteria or quantitative performance metrics for the CGX Wheelchair. For mechanical wheelchairs, acceptance criteria are typically related to safety, durability, and basic functionality, which are demonstrated through testing that isn't detailed in this 510(k) letter.

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

• Cannot be provided. The document does not mention any specific test set, sample sizes, or data provenance. The substantial equivalence determination for a mechanical wheelchair would involve testing based on recognized standards (e.g., ISO for wheelchairs).

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/Cannot be provided. "Ground truth" as understood in the context of diagnostic AI/ML devices (e.g., expert consensus on medical images) is not relevant for a mechanical wheelchair's 510(k) submission.

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

• Not applicable/Cannot be provided. This concept is not relevant for the type of device and submission described.

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/Cannot be provided. An MRMC study is relevant for diagnostic imaging devices where human interpretation is involved. This is a mechanical wheelchair.

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

• Not applicable/Cannot be provided. "Standalone algorithm performance" is not relevant for a mechanical wheelchair.

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

• Not applicable/Cannot be provided. The concept of "ground truth" in the context of medical efficacy or diagnosis is not applicable to an entirely mechanical device like a wheelchair in its 510(k) submission. Safety and performance are typically assessed through engineering tests and adherence to standards.

8. The sample size for the training set

• Not applicable/Cannot be provided. This concept is only applicable to AI/ML or statistical models, not a mechanical wheelchair.

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

• Not applicable/Cannot be provided. This concept is only applicable to AI/ML or statistical models, not a mechanical wheelchair.

Information that can be extracted from the document:

• Device Name: CGX Wheelchair
• 510(k) Number: K080270
• Applicant: Freedom Designs, Inc. (Mr. Bob Gardner)
• Regulation Number: 21 CFR 890.3850
• Regulation Name: Mechanical wheelchair
• Regulatory Class: Class I
• Product Code: IOR
• Date of Decision/Letter: April 16, 2008
• Indications For Use: "This wheelchair is designed as a transport base for pediatric and adult clients."
• Prescription Use/Over-The-Counter Use: Marked as "Over-The-Counter Use".

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This wheelchair is designed as a transport base for pediatric and adult clients. This device will not diagnose, treat, prevent, oure or pollarity and autor chems. I hus devi users users.

Not Found

This is a 510k clearance letter for a medical device called "Tri Pod", a mechanical wheelchair. The letter states that the device is substantially equivalent to legally marketed predicate devices, meaning it does not require a new premarket approval (PMA) application.

However, the provided document does not contain any information about acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, or study methodologies.

Therefore, I cannot answer your specific questions as the relevant data is not present in the provided text. The document is solely an FDA clearance letter and does not include technical specifications or study details.

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Ask a specific question about this device

This wheelchair is designed as a transport base for pediatric clients. This device will not diagnose, treat prevent, cure or mitigate any of the population of its' intended users.

Not Found

The provided document is a 510(k) clearance letter from the FDA for a device named "Gizmo," which is a mechanical wheelchair. This document does not contain any information about acceptance criteria or a study that proves the device meets those criteria, as it is not an AI/ML medical device submission.

The document explicitly states: "This wheelchair is designed as a transport base for pediatric clients. This device will not diagnose, treat prevent, cure or mitigate any of the population of its' intended users." This indicates that the "Gizmo" device is a simple mechanical device, not a sophisticated diagnostic or AI-powered tool.

Therefore, I cannot fulfill your request for information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details for an AI/ML device, as this document is not relevant to such a request.

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Folding Mobility Wheelchair. This wheelchair is designed as a transport base for pediatric clients. This device will not diagnose, treat, prevent, cure or mitigate any of the population of its' intended users.

Folding Mobility Wheelchair

The provided text is a 510(k) premarket notification letter from the FDA for a wheelchair, the "Spectrum Libre Wheelchair." This document is not a study report and therefore does not contain information about acceptance criteria, device performance, sample sizes for training or test sets, expert qualifications, or adjudication methods for an AI/ML device.

The letter explicitly states:
"We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

This indicates that the device was cleared based on substantial equivalence to a predicate device, not on meeting specific performance criteria demonstrated through a clinical study as would be required for an AI/ML device.

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

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This wheelchair is designed as a transport base for ... . . pediatric clients. This device will not diagnose, treat, prevent, cure or mitigate any of the population of its' intended users.

Spectrym Small Fry Manual Folding Mobility Wheelchair

This document is a 510(k) premarket notification from the FDA, approving a "Manual Folding Mobility Wheelchair". It does not contain information about acceptance criteria or a study proving the device meets said criteria, in the way one would describe for a diagnostic or AI-powered medical device.

The document is a regulatory approval for a physical medical device (a wheelchair), not a software or diagnostic device. Therefore, the questions related to performance metrics like sensitivity, specificity, sample sizes, expert ground truth, MRMC studies, or training sets are not applicable to this type of submission.

The FDA's approval for this device is based on a determination of "substantial equivalence" to devices already marketed, not on a clinical performance study with statistical endpoints.

Therefore, I cannot provide the requested information from the provided text.

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This wheelchair is designed as a transport base for pediatric and adult clients. This device will not diagnose, treat, prevent, cure or mitigate any of the population of its' intended users.

Manual Folding Mobility Wheelchair

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or a study that proves the device meets acceptance criteria.

The document is a letter from the FDA to Freedom Designs, Inc., regarding the substantial equivalence of their "Manual Folding Mobility Wheelchair." It primarily discusses regulatory aspects, such as classification, general controls, and marketing authorization. It does not contain any technical specifications, performance metrics, or details of a scientific study evaluating the device's performance against specific criteria.

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