(69 days)
Nidek's HANDY NM-l00 is a hand-held non-mydriatic fundus camera which captures images of the retina electronically.
Nidek's HANDY NM-l00 is a hand-held non-mydriatic fundus camera which captures images of the retina electronically.
The provided text is an FDA 510(k) clearance letter for the Nidek Handy NM-100 Fundus Camera. It explicitly states that the device is substantially equivalent to legally marketed predicate devices, meaning it does not require new performance studies to prove safety and effectiveness.
Therefore, this document does not contain information regarding acceptance criteria or a study proving the device meets those criteria, as a new study was not required.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Sample size or data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- Information on a multi-reader, multi-case (MRMC) comparative effectiveness study or effect sizes.
- Information on standalone performance.
- The type of ground truth used (as no new performance study was conducted).
- Sample size for a training set.
- How ground truth for a training set was established.
The FDA's determination of substantial equivalence (K973218) for the Nidek Handy NM-100 Fundus Camera is based on its similarity to existing devices, specifically stating: "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... "
§ 886.1120 Ophthalmic camera.
(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.