(77 days)
The IOLMaster 700 is intended for biometric measurements and visualization of ocular structures. The measurements and visualization assist in the determination of the appropriate power and type of intraocular lens. The IOLMaster 700 measures:
- · Lens thickness
- · Corneal curvature and thickness
- · Axial length
- · Anterior chamber depth
- · Pupil diameter
- · White-to-white distance (WTW)
For visualization, the IOLMaster 700 employs optical coherence tomography (OCT) to obtain two-dimensional images of ocular structures of the anterior and posterior segments of the eye.
The Reference Image functionality is intended for use as a preoperative image capture tool.
The IOLMaster 700 is a non-invasive optical biometry instrument for visualization and measurement of ocular structures. The IOLMaster 700 is the latest generation device in the IOLMaster series. The version of the IOLMaster 700 that is the subject of this submission is a modified version of the IOLMaster 700 cleared under K143275.
The differences between the subject IOLMaster 700 and the predicate IOLMaster 700 that are the subject of this 510(k) submission are:
- . Labeling changes, including inclusion of additional clinical data and minor updates;
- Materials changes to the forehead rest and chin rest ●
The changes described in this submission do not affect how the hardware is used to acquire images, nor do these changes affect the principle of operation of the device.
The provided text is a 510(k) summary for the Carl Zeiss Meditec AG IOLMaster 700 device (K170171). It details a filing for a modified version of an already cleared device (K143275). The modifications are specifically listed as:
- Labeling changes, including inclusion of additional clinical data and minor updates.
- Materials changes to the forehead rest and chin rest.
The document explicitly states that "The changes described in this submission do not affect how the hardware is used to acquire images, nor do these changes affect the principle of operation of the device." This means that performance data related to the core biometric measurements (Lens thickness, Corneal curvature and thickness, Axial length, Anterior chamber depth, Pupil diameter, White-to-white distance, and OCT visualization) is not included as new testing for this specific 510(k) submission (K170171). The substantial equivalence is based on the new version having identical indications for use and principle of operation to the predicate device, with new testing focused on the biocompatibility and electrical safety of the material changes.
Therefore, many of the requested details, such as specific acceptance criteria for biometric performance, sample sizes for test sets, expert qualifications, ground truth establishment for the test set, MRMC studies, or standalone algorithm performance, are not applicable to this particular 510(k) submission (K170171) because the core performance of the device's measurement capabilities was not re-evaluated. The acceptance criteria and studies described here relate to the changes made to the device.
Here's a breakdown of what is provided and what is not provided in the text based on your request:
Acceptance Criteria and Reported Device Performance
Given that this 510(k) is for minor modifications (labeling and material changes) to an already cleared device with identical indications for use and principle of operation, the "acceptance criteria" discussed are primarily related to safety and maintainance of equivalence.
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance/Compliance |
|---|---|---|
| Biocompatibility | New materials (forehead rest, chin rest) must be biocompatible for patient contact. Compliance with ISO 10993-10:2014 (skin irritation and sensitization) and ISO 10993-5:2009 (cytotoxicity). | "Testing demonstrated that the new materials are biocompatible for the proposed use." |
| Electrical Safety | Device must comply with electrical safety standards. Specifically, Edition 3.1 of IEC 60601-1 (IEC 60601-1:2005 + Amendment 1 (2012)), Edition 3.1 of IEC 60601-1-6 (IEC 60601-1-6:2010 + Amendment 1 (2013)), and Edition 1.1 of IEC 62366 (IEC 62366:2007 + Amendment 1 (2014)). | "The IOLMaster 700 was evaluated against the requirements of Edition 3.1 of IEC 60601-1 (...), Edition 3.1 of IEC 60601-1-6 (...), and Edition 1.1 of IEC 62366 (...), and found to comply." |
| EMC (Electromagnetic Compatibility) | Device must comply with EMC standards. Specifically, Edition 4.0 of IEC 60601-1-2 (IEC 60601-1-2:2014). | "The IOLMaster 700 was evaluated against the requirements of Edition 4.0 of IEC 60601-1-2 (...) and found to comply." |
| Performance (Functional Equivalence) | The changes (labeling, materials) must not affect how the hardware is used to acquire images or the principle of operation, ensuring previous performance characteristics are maintained. This is implied by the "substantial equivalence" claim. | "The changes described in this submission do not affect how the hardware is used to acquire images, nor do these changes affect the principle of operation of the device." The device maintains identical Indications for Use and Principle of Operation as the predicate. |
| Environmental Conditions | The device's specified ambient conditions for intended use, storage, and transport should be appropriate and maintained or improved compared to the predicate. | Minor changes noted for ambient conditions for intended use (relative humidity range change from 30%-90% to 30%-80%) and storage/transport (more detailed ranges provided for predicate, broader for proposed). The document implies these are considered acceptable to maintain equivalence for the specific modifications. |
Study Details for K170171 (Focus on Modifications)
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Sample sizes used for the test set and the data provenance:
- For Biocompatibility: The text doesn't specify sample sizes (e.g., number of material samples or animal tests) for the biocompatibility testing (ISO 10993-10, ISO 10993-5). The data provenance is not specified (e.g., country, retrospective/prospective).
- For Electrical Safety & EMC: These are compliance tests (pass/fail) against standards, not typically associated with "sample sizes" in the clinical data sense. A representative device unit would be tested.
- For core biometric performance: No new test set data is provided or relied upon for this specific 510(k) submission (K170171) because the core measurements and principle of operation were not changed.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for a 510(k) focused on material and labeling changes. The biocompatibility, electrical safety, and EMC tests rely on established laboratory standards and test methods, not expert consensus on image interpretation.
- For the original clearance of the device (K143275), clinical studies would have been performed, which might have involved experts, but those details are not provided in this summary.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as the testing described doesn't involve subjective interpretation that would require an adjudication process.
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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:
- Not applicable. The IOLMaster 700 is a biometric measurement device and imaging tool, not an AI-assisted diagnostic device. Its function is to provide objective measurements and images for human clinicians to use. This 510(k) in particular focuses on minor physical changes.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The IOLMaster 700 is a measurement device. Its "algorithm" is for biometric measurement (e.g., calculating axial length, lens thickness from OCT data). The output itself is a measurement or an image, not a diagnostic interpretation. The device's performance stands alone in its ability to accurately measure. No new standalone performance evaluation was required for the changes in K170171 beyond demonstrating that the material changes did not affect existing performance characteristics.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Biocompatibility: Ground truth is established by the specified ISO standards for cytotoxicity, skin irritation, and sensitization. These tests have defined endpoints (e.g., cell viability, irritation scores).
- For Electrical Safety & EMC: Ground truth is defined by the compliance criteria within the IEC standards themselves.
- For core biometric performance: While not detailed in this summary, the ground truth for biometric measurements (like axial length or corneal curvature) in the original device clearance (K143275) would typically involve comparison to established reference methods or highly accurate clinical gold standards (e.g., pachymetry for corneal thickness, A-scan ultrasonography for axial length, or phakometry for lens thickness, depending on the specific measurement). The document implies that the performance characteristics and measurements produced are identical to the predicate.
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The sample size for the training set:
- Not applicable. This device is not an AI/machine learning model that undergoes a "training" phase. Its measurement algorithms are based on optical principles and engineering.
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How the ground truth for the training set was established:
- Not applicable (see point 7).
In summary, the K170171 submission focuses on demonstrating substantial equivalence for minor modifications (labeling and materials) to an already cleared device. Therefore, the acceptance criteria and supporting studies are centered on ensuring these specific changes do not negatively impact safety or the previously established performance characteristics, rather than re-evaluating the foundational biometric measurement capabilities.
§ 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.