(180 days)
The Heated Eye Pad ophthalmic warmer is a powered heating pad for the application of localized heat therapy. Use for treatment when the current medical community recommends the application of a warm compress to the eyelids. Such applications would include Meibomian Gland Dysfunction (MGD), Dry Eye, Blepharitis, Stye, or Chalazia.
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The provided document is an FDA 510(k) clearance letter for a device called "Heated Eye Pad." This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.
The content is a regulatory clearance stating that the device is "substantially equivalent" to legally marketed predicate devices. It outlines:
- The device name, regulation number, regulatory class, and product code.
- General controls provisions of the Act that apply.
- Contact information for further guidance.
- Indications for Use: The Heated Eye Pad is a powered heating pad for localized heat therapy, recommended for conditions like Meibomian Gland Dysfunction (MGD), Dry Eye, Blepharitis, Stye, or Chalazia, and is approved for Over-The-Counter use.
Therefore, I cannot fulfill your request for information on acceptance criteria and device performance studies based on the provided text. The document is strictly a regulatory clearance, not a technical report detailing performance studies.
§ 890.5740 Powered heating pad.
(a)
Identification. A powered heating pad is an electrical device intended for medical purposes that provides dry heat therapy for body surfaces. It is capable of maintaining an elevated temperature during use.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E part 807 of this chapter subject to § 890.9.