(90 days)
Laser beam generated by MC-7000 is to be used for photocoagulation in ophthalmic indications in transpupillary and inter operative areas as in:
Transpupillary Retinal Photocoagulation, either limited or Pan-Retinal
Macular Photocaogulation
Trabeculoplasty for Open Angle Glaucoma
Iridotomy for Acute Angle Closure Glaucoma
Inter Operative Retinal Photocoagulation, either limited or Pan-Retinal
Macular Photocoagulation
The Nidek MC-7000 now combines the benefits of Red, Yellow, Yellow-Green, and Green wavelengths into one single laser photocoagulation system. It's designed to work with the variety of slit lamp delivery systems in ophthalmology, and performs extended applications in endo and laser indirect photocoagulation.
The MC-7000's design provides reliablility and ease of use. Its self-contained cooling eliminates the need for external cooling fixtures. The display panel attaches to the front of the console, or detaches to function as a remote, either way providing clear, concise information on settings and energies during every procedure.
Laser Source: Multi-wavelength Single Tube Krypton Laser
Wavelength: Red: 647.1nm, Yellow: 568.2nm, Green: 520.8 - 530.9nm
Power To Cornea: Red: 50 - 1000mw, Yellow: 50 - 600mw, Yellow/Green: 50 - 1500mw, Green: 50 - 900mw
Exposure Times: .02 sec to continuous (21 steps)
Auto - Repeat: .2 - 1.0 sec between exposures (9 steps)
Aiming Beam: 670nm Diode red, .8mw or less to the cornea.
Deliver Systems: Nidek SL1600, Zeiss SL130 Full System, 30SL Adaptor, Haag 900BQ Full System, BIO, MIO, Combo, Endoprobe, OM adaptor
Spot Sizes: Nidek SL1600 (50 - 1000mic.m Parfocal, 1000 - 2000mic.m Defocused), Zeiss SL130 (50 - 1000mic.m Parfocal, 1000 - 2000mic.m Defocused) Haag 900BQ (50 - 990mic.m Parfocal) Slit Lamp Adaptor (50 - 500mic.mParfocal) 50mic.m Fiber, 2.5m Light Cable
Cooling: Internal Water Cooling
Power Requirements: 190 -245V AC, 3 Phase, 50 Amp
Size: Console - 16 x 39 x 48
Weight: 389lbs
The provided text is a 510(k) summary for the Nidek MC-7000 Photo coagulator and does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria. The document focuses on establishing substantial equivalence to predicate devices, describing the device, its intended use, and software validation processes. It lacks the quantitative performance data, sample sizes, expert qualifications, and study design details typically found in a clinical or performance study report.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance
- Sample sizes used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method for the test set
- Multi-reader multi-case (MRMC) comparative effectiveness study details or effect size
- Standalone performance study details
- Type of ground truth used
- Sample size for the training set
- How the ground truth for the training set was established
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.