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The iMask Child's Face Mask is intended to be worn by the patient/child (recommended ages 4-12) to provide protection for the respiratory tract. This is a single use, disposable device, provided non-sterile. This Face Mask is recommended for use in a healthcare setting with appropriate adult supervision.

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The provided text describes an FDA 510(k) clearance for a child's face mask. It does not contain information about acceptance criteria for a device that relies on performance metrics such as accuracy, sensitivity, or specificity. Therefore, I cannot generate the requested table and answer the study-related questions ([2] through [9]).

The document is a regulatory letter confirming that the "iMask Child's Face Mask" is substantially equivalent to legally marketed predicate devices and outlines general regulatory compliance requirements. It does not include performance study data, details about a test set, expert involvement, or algorithm-specific information.

To elaborate, the product in question is a "Face Mask," which is a physical device (surgical apparel). The concept of acceptance criteria, test sets, ground truth, experts, and AI assistance, as outlined in your prompt, typically applies to diagnostic or AI-driven medical devices that output a result based on data processing (e.g., image analysis, signal processing). For a physical product like a mask, acceptance criteria would typically involve material safety, biocompatibility, filtration efficiency (for certain mask types), breathability, and fit, rather than algorithmic performance metrics.

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