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To provide an optional means of mobility for physically challenged people.

PHFW-10 Folding Power Chair

The provided text is an FDA 510(k) clearance letter for a powered wheelchair, the PHFW-10 Folding Power Chair. This document does not contain any information about acceptance criteria for a medical device's performance, nor does it describe a study proving the device meets such criteria.

The 510(k) process is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than rigorous clinical performance studies with specific acceptance criteria that would typically be associated with AI or diagnostic algorithm submissions.

Therefore, I cannot provide the requested information from the given text. The text does not include details on:

1. Acceptance criteria and reported device performance: This document is about regulatory clearance, not performance metrics like sensitivity, specificity, accuracy, or similar measures that would imply acceptance criteria.
2. Sample size, data provenance: No study is described, so no sample size or data origin is mentioned.
3. Number/qualifications of experts, adjudication method: These pertain to ground truth establishment for a performance study, which is not present.
4. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable here, as it's not an AI or diagnostic device being evaluated in a clinical context in this document.
5. Standalone performance study: No such study is mentioned.
6. Type of ground truth used: Not applicable.
7. Training set sample size: No training data or AI algorithm is discussed.
8. Ground truth for training set: Not applicable.

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To provide an optional means of mobility for physically challenged people.

PHFW-10 Folding Power Chair

The provided documents are a 510(k) premarket notification letter from the FDA for a powered wheelchair (PHFW-10) and an "Indications for Use" statement.

This documentation does not contain any information regarding:

• Acceptance criteria table and reported device performance
• Details of a study proving the device meets acceptance criteria
• Sample size used for test set or data provenance
• Number of experts or their qualifications for ground truth establishment
• Adjudication method for the test set
• Multi-reader multi-case (MRMC) comparative effectiveness study
• Standalone (algorithm only) performance study
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• Sample size for the training set
• How ground truth for the training set was established

The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance study results with specific acceptance criteria in the manner often seen for AI/ML-based medical devices. The letter states that the FDA reviewed the premarket notification and determined the device is "substantially equivalent" for the stated indications for use.

Therefore, I cannot fulfill your request for the acceptance criteria and study details based on the provided text.

Ask a specific question about this device