(48 days)
The MP-1 MICRO PERIMETER is indicated for use as :
- Color retinography
- Fixation examiner
- Fundus-related microperimetry
The Nidek Technologies Srl MP-1 MICRO PERIMETER is an instrument for the diagnosis of retinal diseases. It is able to capture infrared live sequences and color images of the patient retina through CCD cameras and at the same time to project light stimuli on the retinal positions chosen by the operator.
The MP-1 MICRO PERIMETER is supplied with Xenon light and Halogen light sources suitable for performing the above described examinations.
The system includes also a suitable Insulation transformer, a 15-inch LCD S-VGA Monitor and an IBM Personal Computer, which incorporates the dedicated NAVIS software (with Windows 2000 operative system).
I am sorry, but the provided text does not contain the detailed information necessary to complete the table and answer all the questions regarding the acceptance criteria, specific study design, and performance data for the Nidek Technologies Srl MP-1 MICRO PERIMETER.
The document is a 510(k) premarket notification summary and an FDA clearance letter. It states:
- "The performance data indicate that the MP-1 MICRO PERIMETER device meets all specified requirements, and is substantially equivalent to the predicate device." This general statement confirms that performance data was submitted and found acceptable, but it does not provide the specific acceptance criteria or the reported device performance values.
- It primarily focuses on establishing substantial equivalence to predicate devices (NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000; HUMPHREY FIELD ANALYZER; CONFOSCAN 2 CONFOCAL MICROSCOPE). This typically means showing that the new device is as safe and effective as the legally marketed predicate devices, often through comparison of technological characteristics and intended use, rather than extensive new clinical efficacy studies.
Therefore, I cannot extract the specific details for the following requested information:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample sized used for the test set and the data provenance: Not described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not described.
- Adjudication method for the test set: Not described.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not described. The device is not an "AI" device as we understand it today; it's an ophthalmic imaging and perimetry device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not described.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not described.
- The sample size for the training set: Not described (and likely not applicable in the context of an "AI training set" for a device from 2002).
- How the ground truth for the training set was established: Not described.
The document indicates that the device's performance was deemed sufficient for substantial equivalence based on a comparison to predicate devices, but the specifics of how that performance was measured and what the exact criteria and results were are not included in this summary. Such details would typically be found in the full 510(k) submission, not the publicly available summary.
§ 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.