(287 days)
The Myopia Master is an interferometer indicated for measuring the axial length of the eye and is intended as an aid to eye care providers.
The OCULUS Myopia Master integrates the axial length measurement function of the cleared OCULUS Pentacam AXL (K152311) into the cleared PARK 1 device (K073508), which is an ocular device that includes Scheimpflug imaging, autorefractometry and keratometry functionalities. The Myopia Master combines the following measuring functions in one unit: Axial length, Auto-Refractometer, Keratometer.
Here's a breakdown of the acceptance criteria and the study proving the Myopia Master device meets them, based on the provided FDA 510(k) summary:
It's important to note that the provided document is a 510(k) summary for a combination device (Myopia Master integrates functionalities from two previously cleared predicate devices: PARK 1 and Pentacam AXL). The focus of this 510(k) is on demonstrating substantial equivalence to existing devices, rather than establishing de novo performance for a novel device. Therefore, the depth of clinical study details for acceptance criteria might differ from a full PMA or de novo submission. The document primarily emphasizes that the integrated functionalities maintain the safety and effectiveness of the individual predicate devices.
Acceptance Criteria and Reported Device Performance
The document doesn't explicitly lay out "acceptance criteria" in a typical table format with specific numerical targets for accuracy, precision, sensitivity, or specificity. Instead, the "acceptance" is implied through the demonstration of substantial equivalence to predicate devices. The performance data section refers to compliance with safety and technical standards and software validation, but not specific clinical performance metrics with target values for this combined device's primary function of axial length measurement in a clinical population.
Implied Acceptance Criterion: The primary implied acceptance criterion is that the Myopia Master's performance, particularly for axial length measurement, is comparable in safety and effectiveness to its predicate device, the Pentacam AXL.
Reported Device Performance (as demonstrated by comparison to predicate):
| Performance Measure/Characteristic | Myopia Master (Applicant Device) | Predicate Device (Pentacam AXL) | Meeting Indication |
|---|---|---|---|
| Primary Indication: | Measures axial length of the eye, aid to eye care providers. | Measures axial length (by optical biometry). Also designed to take photos of the anterior segment of the eye (cornea, pupil, anterior chamber, lens) to evaluate corneal shape, lens condition, anterior chamber angle/depth/volume, cortical opacity, cataract location, corneal thickness, and white-to-white distance. Also performs calculations to assist physicians in determining IOL power. | Yes |
| Measurement Range - Axial Length | 14 - 40 mm | 14 - 40 mm | Yes |
| Light source for interferometer | IR Super luminescence diode (SLD) | IR Super luminescence diode (SLD) | Yes |
| Wavelength | 880 nm | 880 nm | Yes |
| SLD-Power for measurement | 0.7 mW | 0.84 mW | Yes (minor difference, deemed not to raise new questions of safety/effectiveness) |
| SLD-Power for alignment | None | None | Yes |
| Pulse width | 520 ms | 400 ms | Yes (minor difference, deemed not to raise new questions of safety/effectiveness) |
| IEC 60825-1 classification | Class 1 laser product | Class 1 laser product | Yes |
| Embedded laser class | 3R | 3R | Yes |
| Safety and Electrical Standards | IEC 60601-1; IEC 60601-1-2, ISO 15004-1, ISO 15004-2, ISO 2265, IEC 60825-1 (demonstrated compliance) | Presumably similar, as it's a predicate. The Myopia Master demonstrated compliance. | Yes |
| Software Level of Concern | Moderate (failure could indirectly result in minor injury) | Not explicitly stated for predicate in this summary, but implied low/moderate. Myopia Master's software is based on PARK 1 and incorporates Pentacam AXL algorithms, deemed safe. | Yes |
| Clinical Performance | "Bench and Clinical testing demonstrate that the Myopia Master is as safe and effective as its predicate devices." | Predicate devices were previously cleared based on their safety and effectiveness. | Yes |
Study Details Proving Device Meets Acceptance Criteria
The document states: "Only eyes without any ocular disease were evaluated during the clinical study performed for FDA clearance of this device, so it is unknown whether accuracy and precision when used in patients with ocular pathology will yield acceptable results." This indicates a clinical study was performed, but the details are very brief.
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "clinical study," but does not provide the number of subjects or eyes included in the test set.
- Data Provenance: Not explicitly stated (e.g., country of origin). It states "clinical study performed for FDA clearance of this device," which usually implies data from a regulated clinical trial, likely involving human subjects. The retrospective/prospective nature is also not specified, though clinical studies for clearance are often prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. For a device like this, the "ground truth" for axial length measurement is typically established by comparative measurements against a highly accurate, established gold standard biometer, rather than expert consensus on images.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided. Given the nature of a biometry device, adjudication methods as typically used for image-based diagnostic AI (e.g., radiologists reviewing images) are less relevant. The "ground truth" would be the measurement from a reference device.
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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, an MRMC study was not indicated or described. This device is an interferometer for measuring axial length, not an AI-assisted diagnostic imaging tool that would typically involve human readers interpreting images. Its clinical value is in providing an objective measurement.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The device functions as a measurement tool. The "performance" refers to its ability to accurately and precisely measure axial length. While a human operates the device to capture the measurements, the "algorithm only" performance would be its measurement accuracy and precision compared to a gold standard, which would have been evaluated in bench and clinical testing. The document states: "Bench and Clinical testing demonstrate that the Myopia Master is as safe and effective as its predicate devices."
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not explicitly stated, but highly likely comparative measurements against a clinical gold standard biometer. For devices that measure parameters like axial length, ground truth is typically a direct measurement from a highly accurate, established clinical reference device (e.g., another clinically validated optical biometer) rather than expert review of images or pathology. The document's statement about only eyes without ocular disease suggests a focus on establishing accuracy in a "healthy" or "normal" population.
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The sample size for the training set:
- Not provided. As a non-AI measurement device (combining existing technologies), the concept of a "training set" in the context of deep learning models isn't directly applicable for its primary function. If there were internal software algorithms that involved data-driven optimization (e.g., for image processing to find edges for white-to-white), the data used for development or "training" of these algorithms is not detailed. The software uses algorithms adopted from previously cleared devices.
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How the ground truth for the training set was established:
- Not applicable in the context of a typical AI training set. For established measurement technologies, the "ground truth" is defined by the physical principles of measurement and validated against known standards and other devices. The document highlights that "The algorithms and functions for measuring, keratometry and refraction determination are unchanged from the PARK 1, while the algorithms and functions for measuring the axial length were adopted from the Pentacam AXL software." This implies leveraging the pre-established validity of the predicate devices' internal algorithms.
§ 886.1850 AC-powered slitlamp biomicroscope.
(a)
Identification. An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.(b)
Classification. Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.