(217 days)
The VX120 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 comea
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 cornea.
The VX120 is a multifunctional ophthalmic diagnostic device.
The VX120 combined wavefront aberrometer, corneal topographer, retro illumination device, Scheimpflug pachymeter, and non-contact tonometer is a single platform that contains five different measurement units.
The wavefront aberrometer works on 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.
Retro illumination is used to image ocular opacities.
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. An air puff non-contact tonometer is included for measurement of the intraocular pressure.
The device is fully automated and a number of different measurements can be performed by a single command including alignment and focusing.
The provided text describes the 510(k) summary for the VX120 Ophthalmic Diagnostic Device, focusing on its tonometry and pachymetry functions for substantial equivalence to predicate devices. It outlines performance data including bench and clinical testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the performance claims and the standards the device was tested against. The text explicitly states that the device meets the requirements of the specified standards.
| Acceptance Criterion (Implicit/Explicit from Text) | Reported Device Performance |
|---|---|
| Tonometry Function: | |
| Accuracy (against predicate/standard) | Equivalent to ±2mmHg or better (bench testing) |
| Repeatability (standard deviation) | ±1.2 mmHg or better (bench testing) |
| Compliance with ISO8612:2010 | Met all requirements of the standard, if eyes with astigmatism >3mm are excluded (Clinical evaluation) |
| Compliance with ANSI Z80.10-2009 | Met all requirements of the standard, if eyes with astigmatism >3mm are excluded (Clinical evaluation) |
| Pachymetry Function: | |
| No significant statistical difference in CCT measurements compared to Pentacam | No significant statistical difference between measurements of CCT with VX120 and the Pentacam (Comparison study). |
| General Device Performance: | |
| Electrical safety | Complies with IEC60601-1:2006 |
| EMC compatibility | Complies with IEC60601-1-2 |
| Software verification and validation | Done according to IEC62304 |
| Risk management | Evaluated according to ISO14971: 2009; all risks reduced to safe levels. |
| Ophthalmic product testing | Evaluated in accordance with ISO15004-1:2009 and ISO15004-2:2007; met all requirements. |
| Optical hazards | Evaluated in accordance with IEC60825-1: 2008; VX120 is laser class 1. |
Here's a breakdown of the study details based on the provided text:
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Sample size used for the test set and the data provenance:
- Tonometry: The text mentions "clinical evaluation" and "bench testing." It does not specify the sample size for either.
- Pachymetry: The text mentions a "comparison study" with Pentacam. It does not specify the sample size for this study.
- Data Provenance: The text does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. The manufacturer, Luneau SAS, is based in France. The predicates are from the UK (Keeler) and Germany (Oculus), implying international standards and potentially international data, but this is not confirmed.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document describes performance testing against standards (ISO, ANSI) and predicate devices. It does not mention the use of human experts or human readers to establish ground truth for the test sets for tonometry or pachymetry performance. The "ground truth" for tonometry appears to be established by the performance of the predicate device and the specified accuracy and repeatability limits from the standards. For pachymetry, the ground truth is implicitly the measurements from the Pentacam predicate.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as ground truth was not established by human experts requiring adjudication.
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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:
- No MRMC or human-in-the-loop study comparing human readers with and without AI assistance is described. The device is referred to as a "diagnostic device," but the performance studies focus on its intrinsic measurement accuracy and comparison to predicate devices, not its assistance to human interpretation or diagnosis.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the performance data presented (bench testing, clinical evaluation against standards, and comparison studies for tonometry and pachymetry) appear to represent the standalone performance of the VX120 device/algorithm. The focus is on the device's output accuracy and consistency.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Tonometry: The ground truth for the tonometry function appears to be established by:
- Benchmarking against industry standards: ISO8612:2010 and ANSI Z80.10-2009 for clinical evaluation, and internal specifications for accuracy (±2mmHg) and repeatability (±1.2mmHg) from bench testing.
- Comparison to predicate device performance: The "Pulsair tonometer" is also stated to have an accuracy of ±2 mmHg.
- Pachymetry: The ground truth for the pachymetry function is established by comparison to a legally marketed predicate device, the Pentacam, noted as demonstrating "no significant statistical difference."
- Tonometry: The ground truth for the tonometry function appears to be established by:
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The sample size for the training set:
- The document is a 510(k) summary, not a detailed technical report on the algorithm development. It does not mention a "training set" or specify its size. The device relies on established physical measurement principles (Shack-Hartmann, Placido disk, Scheimpflug, air puff tonometry) rather than machine learning that typically requires training data.
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How the ground truth for the training set was established:
- Not applicable, as a "training set" is not mentioned or implied for this type of device and its described validation. The device's operation is based on fundamental physics and established optical/measurement techniques rather than trained algorithms in the sense of AI/machine learning.
§ 886.1930 Tonometer and accessories.
(a)
Identification. A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.(b)
Classification. Class II.