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The VX650 is a multi-function diagnostic device combining wavefront aberometer, corneal topographer, retro-illuminator, tonometer and pachymeter, indicated for:

• · Measuring the refraction of the eye giving both lower and higher order aberrations
• · Measuring the shape of the cornea
• · Retro-illumination imaging of the eye
• Measuring the intraocular pressure without contacting the eye for glaucoma evaluation
• · Photographing the eye and taking images of the eye to evaluate the thickness of the central cornea
• Full cornea thickness map
• · Scheimpflug imaging
• · Anterior chamber imaging
• · Pupil Image
• · Image of the cornea relative to the iris
• · Automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatio agent

The VX650 is based on the VX130 (already cleared 510(k), number K162067) which is a combined wavefront aberrometer, corneal topographer, Scheimpflug pachymeter, non-contact tonometer and cataract screening device in a single platform that contains five different measurement units. The VX650 also contains a non-mydriatic fundus camera for retinal photography. The wavefront aberrometer uses the Shack-Hartmann principle and is used as an advanced autorefractometer that measures both lower and higher order aberrations of the refraction of the eye.

The corneal topographer uses a Placido disk to measure keratometry and the detailed shape of the cornea. The Scheimpflug pachymeter measures the thickness of the central cornea by illuminating it with a slit of light and photographing it using the Scheimpflug technique, there is also a scanning mode that allows measurement of the whole corneal surface and can provide detailed tomography maps of both corneal surfaces and the corneal thickness.

An air puff non-contact tonometer is included for measurement of the intraocular pressure and retro illumination is present for cataract screening.

The fundus camera contains an infra-red LED for alignment and focusing and a white LED flash for the photography to give colour images. The fundus image covers an angle of 45° on the retina so a regular image will contain both the macula and the optic nerve. The fundus camera also has a seven-position fixation target to increase the field of view as the patient can fixate in different directions.

The device is fully automated and a number of different measurements can be performed by a sinqle command including alignment and focusing. The fundus imaging function is also fully automatic including automatic alignment, focusing and image capture.

The provided document describes the VX650, a multi-function diagnostic device. The bulk of the submission focuses on demonstrating substantial equivalence to predicate devices through comparison of technical characteristics and compliance with standards. However, the document does not describe specific acceptance criteria and a study proving the device meets those criteria for clinical performance.

Instead, it relies on:

• Bench tests and compliance with recognized standards: This demonstrates the device's adherence to general safety and performance requirements for ophthalmic instruments and software.
• Comparison to predicate devices: The manufacturer argues that the VX650 is substantially equivalent to existing devices (VX130 for core functions, and Nexy/CenterVue DRS for the fundus camera module) which are already cleared for market. The claim is that the differences are minor and do not raise new questions of safety or effectiveness.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and reported device performance (as no specific performance metrics with acceptance limits are defined and reported from a clinical study).
• Sample size for the test set or data provenance (as no clinical test set is described).
• Number and qualifications of experts for ground truth (as no ground truth establishment for a test set is described).
• Adjudication method.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done or the effect size of human readers with/without AI assistance.
• If a standalone (algorithm only) performance was done.
• The type of ground truth used.
• The sample size for the training set.
• How the ground truth for the training set was established.

Summary of what the document does provide regarding testing:

1. Bench Tests and Standard Compliance:

   • Acceptance Criteria (Implicit): Compliance with various ISO and IEC standards related to medical devices, ophthalmic instruments, electrical safety, electromagnetic compatibility, and software verification/validation.

   • Reported Device Performance: The device "complies with" and "meets" these standards. The collective performance testing "demonstrates that the VX650 device does not raise any new questions of safety or effectiveness when compared to the predicate devices" and "performs as intended."

   • Specific Standards Mentioned:

     • ISO 14971 (Risk Management)
     • AAMI ANSI ES60601-1 (Electrical Safety)
     • IEC 60601-1-2 (EMC)
     • ISO 15004-1 (Ophthalmic instruments - Fundamental requirements and test methods)
     • ISO 10940 (Ophthalmic Instruments - Fundus Cameras)
     • IEC 62471 (Photobiological safety of lamps and lamp systems)
     • IEC 60825-1 (Safety of laser products)
     • ISO 10993-1 (Biological evaluation of medical devices)
     • IEC 62366-1 (Usability)
     • IEC 60601-1-6 (Usability for medical electrical equipment)
     • IEC 62304 (Medical device software - Software life cycle processes)
     • ANSI Z80.36-2016 (Light Hazard Protection)
     • ISO 8612:2009 (Tonometers)
     • ISO 10342:2010 (Eye refractometers)
     • ISO 10343:2014 (Ophthalmometers)
     • ISO 19980:2012 (Corneal topographers)
     • ISO 24157:2008 (Reporting aberrations of the human eye)
     • ISO 15004-2 (Ophthalmic Instruments - Requirements and test methods for fundus cameras)

2. Software Verification and Validation:

   • Level of Concern: "Moderate" based on FDA's guidance for software in medical devices.
   • Proof: Performed "per AAMI/ANSI/IEC 62304."

In conclusion, the document provides evidence of engineering and regulatory compliance testing rather than clinical performance studies with specific acceptance criteria. The substantial equivalence argument negates the need for new clinical performance studies by demonstrating that the new device is fundamentally similar to already cleared devices and performs as intended according to established technical standards.

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