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The Norlase ECHO Photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy, and trabeculoplasty.

The Norlase ECHO device is a modification to the Norlase Leaf Photocoagulator (K190083) and also consists of a laser unit, a wireless control unit and a foot switch. The laser unit must be attached to the Doctors own compatible slit lamp to work as a full system. The Norlase ECHO Device is controlled by the wireless control unit that allows the Doctor to set the desired parameters for treatment. A shrouded foot switch is connected to the laser unit to control the emission of laser light. The Doctor will use the user supplied slit lamp to identify the area to be treated and after setting the appropriate parameters, will target the ophthalmic tissue utilizing a visible red aiming laser. The foot switch will be pressed by the Doctor to deliver therapeutic green laser light to the target tissue. A mechanically fixed eve safety filter is built into the Laser Unit to protect the Doctor from any stray or reflected green laser light travelling along the visual path of the slit lamp. The Norlase Echo device consists of the following modules: Laser unit + power supply + power cable, Foot switch + cable, Control unit (Tablet computer with installed Software) + power supply + USB cable. The wavelength of the treatment beam is centered around ~520 nm, and the maximum optical output power is 1.5W (to tissue). The laser is operated in continuous wave (CW) mode and electronically pulsing the laser output power to achieve durations from 50 usec to 1 second. Laser parameters are controlled by a Control Unit (tablet) User Interface that utilizes a touchscreen control to select or change a setting. Voice Control of selected parameters is an optional feature that can assist in the increment or selection of a parameter. The ECHO modification consists of capability for pattern scanning.

The provided text is a 510(k) summary for the Norlase ECHO Photocoagulator. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria based on clinical study performance. Medical devices cleared via the 510(k) pathway often rely on bench testing, engineering verification, and comparison to legally marketed predicate devices, especially when the changes are related to technological characteristics rather than new indications for use or significant safety/efficacy concerns.

The document explicitly states: "Clinical data was not required for this type of device." This means there was no clinical study conducted to evaluate device performance against specific acceptance criteria in a human population. Instead:

• Engineering verification and validation were performed.
• Bench testing was conducted to demonstrate compliance with various safety and performance standards.
• Software testing was performed.
• Human factors evaluation was carried out in a simulated use environment.
• The key finding for substantial equivalence is that the differences (primarily the addition of pattern scanning) do not introduce new issues related to safety and efficacy.

Therefore, I cannot provide an answer that aligns with the structure of your requested output (acceptance criteria and proof from a clinical study) because the provided document does not contain that information. The performance data discussed is limited to engineering and bench testing, not clinical performance against ground truth established by experts.

To directly address your points based on the provided text, while acknowledging the lack of clinical study data:

1. A table of acceptance criteria and the reported device performance:
   The document does not present "acceptance criteria" in the sense of a clinical study endpoint (e.g., sensitivity, specificity, accuracy). Instead, it lists standards the device complies with and types of testing performed. The "performance" is stated as successful verification and validation according to documented procedures.

   Acceptance Criteria (as implied by testing)	Reported Device Performance (as stated in submission)
   Compliance with electrical and mechanical safety standards (e.g., IEC 60601-1)	Successful bench testing for electrical and mechanical safety in compliance with cited standards.
   Compliance with laser performance standards (e.g., IEC 60825-1)	Successful bench testing for laser performance in compliance with cited standards.
   Compliance with ophthalmic device standards (e.g., ISO 15004-2)	Successful bench testing specific to ophthalmic devices in compliance with the cited standard.
   Specified performance of pattern scanning feature	Successful bench testing for verification and validation of the specified performance of the pattern scanning feature.
   Software compliance (e.g., IEC 62304), including cybersecurity	Successful software testing (verification and validation), including test cases for off-the-shelf software and cybersecurity features.
   Usability in simulated environment	Successful human factors evaluation to demonstrate usability in a simulated use environment when used by healthcare professionals.
   Risk mitigation effectiveness (ISO 14971)	All risk mitigations satisfactorily verified and validated.
   Device meets design requirements and user needs	Results of performance testing demonstrated that the device met the design requirements and user needs.

2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set. The data provenance is from internal company verification and validation testing, not from a patient population.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set requiring expert ground truth in this context.

4. Adjudication method for the test set: Not applicable. No clinical test set.

5. 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 applicable. This device is a laser photocoagulator, not an AI diagnostic or assistance tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an AI algorithm. Its "performance" is related to its physical and software functionality, which was tested during engineering verification.

7. The type of ground truth used: For the engineering and bench testing, "ground truth" would be established by validated measurement equipment, engineering specifications, and compliance with industry standards. For instance, a power meter would provide the "ground truth" for laser power output, and test protocols would define the "ground truth" for software functionality. There is no clinical "ground truth" (e.g., pathology, outcomes data) relevant to this 510(k) submission.

8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

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