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LightLas 577/670 is an ophthalmic laser instrument intended for use by ophthalmologists. The 577 mm wavelength laser is indicated for retinal and pan-retinal photocoagulation. endophotocoagulation, macular photocoagulation to treat leaking vessels. and laser trabeculoplasty. The 670 mm wavelength laser is indicated for retinal and pan-retinal photocoagulation.

LightLas577/670 Multi-Wavelength Medical Laser System consists of a Laser Console where the Laser is housed along with the Electronic Control system and Power Supplies and various Laser Delivery Units (LDU's). The LDU's include: Slitlamp Integrated into CSO model SL980. (K992836) . Sirilamp Attachment for CSO model SL990 (K992836) and other Haag Streit clones. . Sittlamp Attachment for Zeiss model SL30 Stitlamp (K862004) . Laser Indirect Ophthalmoscope (LIO) using a Heine Omega 500. (K123316) ● . Laser Indirect Ophthalmoscope (LIO) using a Keeler All pupil II (K854244) 0 . Endophotocoagulation Handpieces (K122905) The LightLas 577/670 Multi-Wavelength Medical Laser System may be used at either the 577 nm wavelength or the 670 nm wavelength. The 577 nm wavelength source can be delivered through both output ports (Ports 1 and 2) of the laser console, while the 670 mm wavelength source is delivered through Port 1 only. Users may choose either wavelength from a LCD touch screen, and only one output port and one wavelength may be selected for use at a time. Laser wavelength selection of the system is indicated on the panel and controlled by system software.

The provided text describes a 510(k) summary for the LightLas577/670 Multi-Wavelength Medical Laser System. This document focuses on demonstrating substantial equivalence to a predicate device through technical comparison and compliance with recognized standards. It does not contain information about clinical studies with acceptance criteria or reported device performance in those terms.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document.

However, based on the provided text, here's what I can extract regarding the study information (or lack thereof):

1. Table of Acceptance Criteria and Reported Device Performance:

• Not applicable. The document does not describe specific acceptance criteria tied to clinical performance metrics (e.g., sensitivity, specificity, accuracy) or present reported device performance against such criteria. The "Performance Data" section indicates compliance with recognized standards (IEC, ISO) and successful bench testing, which are engineering/safety criteria, not clinical performance metrics.

2. Sample Size Used for the Test Set and Data Provenance:

• No information provided. The document does not refer to a "test set" in the context of clinical data, nor does it mention sample sizes or data provenance (country of origin, retrospective/prospective). The "test results" mentioned refer to bench testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• No information provided. Since no clinical test set is described, there's no mention of experts or expert consensus for ground truth.

4. Adjudication Method:

• No information provided. No clinical test set means no adjudication method is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No MRMC study was done or reported. The document does not mention any studies involving human readers, AI assistance, or comparative effectiveness.

6. Standalone (Algorithm Only) Performance:

• Not applicable. This device is a laser system, not an AI algorithm. "Standalone performance" as typically applied to algorithms is not relevant here.

7. Type of Ground Truth Used:

• Not applicable. For the bench testing mentioned, ground truth would be established by validated measurement equipment and engineering standards, not clinical outcomes or pathology.

8. Sample Size for the Training Set:

• Not applicable. This device is a laser system and does not involve AI models that require training sets.

9. How the Ground Truth for the Training Set was Established:

• Not applicable. As above, no training set for an AI model.

Summary of Device Evaluation from the Text:

The device's safety and effectiveness were evaluated through:

• Bench testing: This involved assembly, testing, calibration, and alignment of the laser console and delivery units. The results demonstrated compliance with specifications and requirements.
• Compliance with recognized consensus standards: IEC60601-1, IEC60601-1-1, IEC60601-1-2, IEC60825-1, IEC60601-1-4, IEC60601-2-22, and ISO14971.

The conclusion drawn from this evaluation was that the "LightLas 577/670 Multi-Wavelength Medical Laser System demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device." This statement refers to demonstrating substantial equivalence to the predicate device (K103547) based on technical characteristics, intended use, and compliance with general safety and performance standards for ophthalmic lasers, rather than presenting a clinical study with performance metrics against acceptance criteria.

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