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ARGOS is a non-invasive, non-contact biometer based on swept-source optical coherence tomography (SS-OCT). The device is intended to acquire ocular measurements as well as perform calculations to determine the appropriate intraocular lens (IOL) power and type for implantation during intraocular lens placement. ARGOS measures the following 9 parameters: Axial Length, Corneal Thickness, Anterior Clamber Depth, Lens Thickness, K-values (Radii of flattest and steepest meridians), Astigmatism, White (corneal diameter) and Pupil Size. The Reference Image functionality is intended for use as a preoperative and postoperative image capture tool.

It is intended for use by ophthalmologists, physicians, and other eye-care professionals and may only be used under the supervision of a physician.

The ARGOS is substantially equivalent to the predicate device identified previously:

• the ARGOS (Santec Corporation) that was cleared by the FDA on October 2nd, 2015(K150754) as the primary predicate as it has the most similar intended use and characteristics
• the IOLMaster 700 (Carl Zeiss Meditec) that was cleared by the FDA on June 29, ● 2015 (K143275, K170171) as an additional (secondary) predicate to support a new feature of reference image capture on the version of ARGOS in this submission.

The predicate devices are Class 2 devices to premarket notification, as defined per regulation number 21 CFR 886.1850. In addition, the predicate devices have product codes of MXK(ARGOS), and HJO(IOLMaster700).

The version of ARGOS in this submission is a modified version of the Argos cleared under K150754 which is substantially equivalent with regard to intended use, operating principle, function, materials, and energy source. The differences from the predicate ARGOS (K150754) that are subject of this 510(k) submission are:

• An additional feature of reference image capture function ●
• Labeling change including change in the intended use adding the feature of reference . image capture.
• . This image can be transferred to image guided devices in order to support the execution of preoperative plan.

The changes described in this submission do not affect how the hardware is used to acquire measurements as a biometer, nor do these changes affect the principle of operation of the device.

The provided document describes the ARGOS device, a non-invasive, non-contact biometer based on swept-source optical coherence tomography (SS-OCT), and its 510(k) submission for clearance. The document focuses on demonstrating substantial equivalence to predicate devices, particularly regarding the ARGOS ver1.5 which includes a new "Reference Image functionality."

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria and reported device performance" in terms of specific quantitative thresholds that the new ARGOS ver1.5 needs to meet for its added functionality. Instead, it argues for substantial equivalence primarily by:

• Comparing technological characteristics of the new ARGOS (ver1.5) with its primary predicate (ARGOS K150754) and a secondary predicate (IOLMaster 700 K143275, K170171).
• Stating that the new feature (reference image capture) is similar to a feature already present in a legally marketed predicate (IOLMaster 700).
• Referring to compliance with recognized consensus standards for performance and safety.
• Highlighting that the core biometry measurement capabilities did not change from the primary predicate. The in-vivo repeatability specifications for measured parameters (Axial Length, Corneal Thickness, Anterior Chamber Depth, Lens Thickness, Keratometry, Astigmatism, Pupil Size, White-to-White) are listed as identical to the primary predicate, implying these performance metrics were already accepted.

Implied Acceptance Criteria and Reported Performance (from comparison tables):

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size for any clinical test set in terms of patient data. It primarily relies on bench testing and software verification/validation. The comparison of in-vivo repeatability values references the existing performance of the predicate device, not new clinical data for the ARGOS ver1.5 to prove equivalent clinical performance.

• Sample Size for Test Set: Not explicitly stated for patient data. The "Performance Testing" section refers to "bench tests" and "software verification and validation," which typically involve internal testing and simulations rather than patient samples for the new features. The existing in-vivo repeatability data cited appears to be from the primary predicate, not new testing on the modified device regarding its core measurement functions.
• Data Provenance: The document does not provide details on the country of origin of data or whether it was retrospective or prospective. Given the focus on substantial equivalence through design and testing against standards rather than new clinical trials for the added feature, such details are not expected to be prominent.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

N/A. The document does not describe a clinical study involving human readers or expert-established ground truth for a test set, especially pertaining to the new "Reference Image functionality." The changes are assessed through engineering and software validation, and comparison to existing, already-cleared devices.

4. Adjudication Method for the Test Set

N/A. No clinical study with human readers and adjudication is described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

N/A. No MRMC study is described. The device is not an AI/CADe device that assists human readers in diagnosis. It's a measurement device with an added image capture utility.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device itself is a standalone measurement instrument. Its "performance" is its ability to accurately measure ocular parameters and capture images. The "Performance Testing" section (12.1 and 12.2) effectively describes this standalone performance evaluation, focusing on:

• Bench tests: ISO standards, hardware specifications (axial/lateral distance, SNR, depth attenuation).
• Software verification and validation: According to FDA guidance and ISO standards.
• Cybersecurity review.

These tests demonstrate the device's capability to function as intended without human intervention for the measurement process itself, or for the image capture function. The usability evaluation ensures the human-device interaction is acceptable.

7. The Type of Ground Truth Used

• For biometric measurements: The "ground truth" for proving performance (cited from the predicate) would typically be established based on highly accurate reference devices or physical models, although the document doesn't detail the predicate's original ground truth methodology. For the new device, the claim is that its measurement capabilities have not changed and are thus equivalent to the predicate.
• For reference image functionality: The ground truth for this new feature would be its ability to capture and transfer an image. This is validated by functional testing and comparison to the secondary predicate (IOLMaster 700), which already has this function. There isn't a "ground truth" in the clinical diagnostic sense for an image capture tool beyond its intended function of capturing an image.
• For safety and performance standards: The "ground truth" is compliance with the specifications and limits defined by the international and national consensus standards (e.g., ISO, IEC, ANSI/AAMI).

8. The Sample Size for the Training Set

N/A. This is not an AI/ML device that requires a training set in the typical sense of machine learning. It's a measurement instrument. The "Vision Planner software package" and "Argos UI software" are traditional software applications that undergo verification and validation, not model training.

9. How the Ground Truth for the Training Set Was Established

N/A. No training set is involved.

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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.

Study Details for K170171 (Focus on Modifications)

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

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The PLEX™ Elite 9000 Swept-Source OCT [SS-OCT] is a non-contact, high resolution, wide field of view tomographic and biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional and three-dimensional imaging of posterior ocular structures. The device is indicated for visualizing posterior ocular structures including, but not limited to, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, optic nerve head, vitreous and choroid.

The PLEX™ Elite SS-OCT angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid.

The PLEX™ Elite 9000 SS-OCT is a computerized instrument that acquires cross-sectional tomograms of the posterior ocular structures (including cornea, retinal nerve fiber layer, macula, and optic disc). It employs non-invasive, non-contact, low-coherence interferometry to obtain these high-resolution images. Using this non-invasive optical technique, the PLEX Elite SS-OCT produces high-resolution cross-sectional tomograms of the eye without contacting the eye. It also produces images of the retina and layers of the retina from an en face perspective (i.e., as if looking directly in the eye) and non-contrast angiographic imaging of the retinal microvasculature.

The PLEX Elite 9000 SS-OCT is offered in one model, the Elite 9000 in a new compact desktop system. The PLEX Elite SS-OCT contains a swept source, Class 1 Laser system operating at 1060 nm and includes a new system computer and archive with up to 24 TB storage capacity. The PLEX Elite also contains an iris viewer, fixation system and the fundus camera is a similar line-scanning ophthalmoscope (LSO) as used on the CIRRUS HD-OCT system, model 4000.

The provided text describes the Carl Zeiss Meditec, Inc. K161194 submission for the PLEX Elite 9000 SS-OCT device. However, it does not explicitly detail a standalone study with acceptance criteria and reported device performance in the format requested. Instead, it focuses on demonstrating substantial equivalence to predicate devices through technological comparisons, bench testing, non-clinical tests, and a clinical case series.

Here's an attempt to extract and synthesize the information based on the provided document, acknowledging the limitations regarding the specific details of a formal "acceptance criteria and study" as might be found in a performance study report:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with specific quantitative targets and corresponding reported performance for a standalone clinical study. Instead, it describes general claims of improved performance compared to the predicate device.

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