Search Results

The iPUPc is appropriate for use by any wheelchair user, who requires regular, periodic positioning changes without the aid of an attendant. These reqular, periodic positioning changes are needed for, but not limited to:

Pressure relief or reduction by shifting the user's body weight from the buttocks to the thighs and the lower back.

The iPUPc seating system could provide pressure relief by postural change for persons having the following condition or injury: an existing pressure sore, or an individual at extreme risk of developing a pressure sore.

Any individual who needs pressure relief through regular periodic positional changes, who is unable to do so independently, can accomplish this through the iPUPc device.

Not Found

Here's an analysis of the provided text, focusing on acceptance criteria and study details.

Missing Information:
The provided text contains a clearance letter for the iPUPc device but lacks specific details about acceptance criteria, device performance metrics, or any formal study results validating those criteria. The letter confirms the device's substantial equivalence to a predicate device, but it doesn't offer the detailed study information sought in the prompt. This type of information is typically found in the 510(k) summary submitted by the manufacturer, which is not included here.

Therefore, I cannot populate most of the requested fields accurately based solely on the provided document.

However, I can extract the following:

1. Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

• The document doesn't mention any specific study or sample size used to demonstrate performance. The clearance is based on substantial equivalence to a predicate device.

3. Number and Qualifications of Experts for Ground Truth:

• Not applicable, as no specific study data or ground truth establishment is detailed.

4. Adjudication Method:

• Not applicable, as no specific study data or ground truth establishment is detailed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Not mentioned or implied in the provided document. The device, an "Intelligent Pressure Ulcer Prevention Cushion," is a physical medical device, not typically evaluated through MRMC studies that assess human reader performance with or without AI assistance in image interpretation.

6. Standalone Performance Study:

• Not mentioned or implied in the provided document. Device clearance is based on substantial equivalence.

7. Type of Ground Truth Used:

• Not applicable, as no specific study data or ground truth establishment is detailed. The substantial equivalence pathway relies on demonstrating similar technological characteristics and performance to a legally marketed predicate device.

8. Sample Size for Training Set:

• Not applicable, as this is a physical medical device. The concept of a "training set" is usually relevant for AI/machine learning models, which is not the case here.

9. How Ground Truth for Training Set Was Established:

• Not applicable, for the same reasons as above.

Summary of available information from the document:

• Device Name: iPUPc (Intelligent Pressure Ulcer Prevention Cushion)
• 510(k) Number: K063175
• Regulatory Class: Unclassified
• Product Code: MOC
• Indications for Use: For use by any wheelchair user who requires regular, periodic positioning changes without the aid of an attendant for pressure relief or reduction. Specifically for individuals with an existing pressure sore or at extreme risk, and those unable to independently perform positional changes.
• Regulatory Pathway: Substantial Equivalence to a legally marketed predicate device. The document does not provide details of the predicate device.
• Date of Clearance: March 14, 2008

Ask a specific question about this device