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SOLIX™ is an optical coherence tomography system intended for the in vivo imaging, cross-sectional, and the threedimensional imaging and measurement of anterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, corneal epithelium, corneal stroma, pachymetry, and anterior chamber of the eye. With the integrated reference database. SOLIX™ is also a quantitative tool for the comparison of the retinal nerve fiber layer, and optic disc measurements in the human eye to a database of known normal subjects. It is indicated for use as a diagnostic device to aid in the detection and management of ocular diseases.

The SOLIX™ with the AngioVue software feature is indicated as an aid in the visualization of vascular structures of the retina and choroid in normal subjects with glaucoma and retinal diseases. The AngioAnalytics software feature of AngioVue is indicated for the measurement of vascular density, the foveal avascular zone, the thickness of retinal layers, and nerve fiber layer, and measurement of optic disc parameters in normal subjects with glaucoma and retinal diseases.

The non-mydriatic color fundus camera of SOLIX™ is an integrated non-contact. high resolution digital imaging component which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions. The SOLIX™ fundus camera component is indicated for in-vivo viewing of the posterior and external area of the images are intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health.

SOLIX is a computer-controlled, ophthalmic imaging system with combined spectral-domain optical coherence tomography (SD-OCT) and non-mydriatic, digital fundus camera. The SD-OCT employs non-invasive, non-contact, low coherence interferometry to acquire crosssectional tomograms of the anterior and posterior segment of the eye and motion-contrast images of the retinal microvasculature (i.e., OCT "angiography" [OCTA]). The fundus camera produces color internal and external ocular images.

The provided text details the 510(k) premarket notification for the Optovue SOLIX device, stating its substantial equivalence to predicate devices Avanti and iCam. It includes information on performance testing, but the document does not explicitly state defined acceptance criteria for many of the quantitative measurements (e.g., repeatability limits for OCT and OCTA parameters, quality metrics for fundus photography). Instead, it presents the results of these tests.

Therefore, the table below will present the reported device performance, and where an indirect acceptance can be inferred (e.g., for comparative image quality), that will be noted.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document primarily presents performance results without explicitly listing acceptance criteria with numerical targets for many parameters. Where an inference of acceptance can be made (e.g., general clinical utility, improvements over predicate), it is noted.

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The Avanti is an optical coherence tomography system intended for the in vivo imaging, cross-sectional, and threedimensional imaging and measurement of anterior ocular structures, including retina, retinal netve fiber layer, ganglion cell complex (GCC), optic disc, corneal epithelia, corneal stroma, pachymetry, corneal power, and anterior chamber of the eye. With the integrated normative database, Avantitative tool for the comparison of retinal nerve fiber layer, and optic disc measurements in the human eye to a database of a known normal subjects. It is indicated for use as a diagnostic device to aid in the detection and management of ocular diseases.

The Avanti with the AngioVue software feature is indicated as an aid in the visualization of vascular structures of the retina and choroid in normal subjects with glaucoma and retinal diseases. The AngioAnalytics software feature of AngioVue is indicated for the measurement of vascular density, the foveal avascular zone, the thickness of retinal layers, and nerve fiber layer, and measurement of optic disc parameters in normal subjects with glaucoma and retinal diseases.

The Avanti is a computer-controlled ophthalmic imaging system that acquires cross-sectional tomograms of the anterior and posterior ocular structures (including cornea, anterior chamber angle, retina, ganglion cell complex, retinal nerve fiber layer, and optic disc). It employs noninvasive, non-contact, low-coherence interferometry to obtain these high-resolution reflectance images and, by rapidly repeating the cross-sectional image at same location, to produce high resolution motion-contrast images of the retina microvasculature. Using this non-invasive optical technique, the Avanti 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-invasive angiographic imaging of the retinal microvasculature based on OCT angiography (OCTA). Qualitative analyses are provided for the cornea and layers of the cornea, the retina and layers of the retina, the optic disc and the nerve fiber layer, and the retinal microvasculature.

The provided text describes acceptance criteria and study details for the Optovue Avanti device. Here's a structured summary based on your request:

Acceptance Criteria and Device Performance

The document does not explicitly present a discrete "table of acceptance criteria and reported device performance" as typically found in clinical trial reports with pass/fail metrics against a predefined threshold. Instead, it details various performance metrics (repeatability, reproducibility, agreement) in descriptive tables (Tables 6-16 for AngioRetina scans, Tables 12-13 for AngioDisc scans, Tables 27-31 for Corneal Epithelial Thickness R&R, and Tables 39-43 for Corneal Epithelial Thickness Agreement with Manual measurements) that implicitly demonstrate the device's performance is acceptable for its intended use, especially when compared to predicate devices or manual methods.

The overall conclusion states: "The results from the software, non-clinical and clinical performance testing demonstrate that the Avanti device with software modification is as safe and effective as its predicate devices." This implies that the performance demonstrated in the various tables met the internal acceptance criteria for substantial equivalence.

As a representative example, here's how some of the reported performance metrics could be conceptualized in a table:

Detailed Study Information:

1. A table of acceptance criteria and the reported device performance:
   As noted above, explicit pass/fail acceptance criteria are not presented in a direct table. The document demonstrates performance across various metrics and clinical populations. The overall "acceptance" is implied by the FDA's clearance of the device based on the provided data and the statement of substantial equivalence to predicate devices. The tables throughout the document (e.g., Tables 6-16, 27-31, 39-43) present the reported device performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Clinical Performance Testing (Section 1 - AngioVue R&R):
     • Sample Size: 67 participants (15 Normal, 16 Glaucoma, 36 Retinal conditions).
     • Provenance: Prospective, observational study conducted at a single clinical U.S. site.
   • FAZ Parameter Validation (Section 2 - non-vascular FAZ Parameters):
     • Sample Size: 30 eyes of 26 subjects.
     • Provenance: Case series from 3 clinical sites (country not specified, but likely U.S. given the FDA submission). Data origin (retrospective/prospective) is not explicitly stated, but the "case series" implies existing data.
   • FAZ Parameters Agreement between 3-mm AngioRetina and 6-mm HD AngioRetina Scans (Section 3):
     • Sample Size: 62 subjects/eyes (from the R&R study data set, after exclusions).
     • Provenance: Derived from the prospective R&R study data.
   • Retinal Thickness, RNFL Thickness, and Disc Measurements Agreement Evaluation (Section 4):
     • Sample Size: 67 subjects for Full and Inner Retina thickness; 31 subjects for RNFL thickness and optic disc measurement.
     • Provenance: Subset of the prospective R&R study data.
   • Evaluation of the Repeatability and Reproducibility of Corneal Epithelial Thickness Mapping with SD-OCT (Section 5):
     • Sample Size: 60 participants (12 Normal, 12 Contact Lens, 11 Dry Eye, 12 Post-LRS, 13 Keratoconus).
     • Provenance: Prospective, observational study conducted at a single clinical U.S. site.
   • Evaluation of the Agreement of the Corneal Epithelial Thickness Mapping with SD-OCT (Section 6):
     • Sample Size: 85 subjects (17 Normal, 15 Contact Lens, 18 Dry Eye, 19 Post-LRS, 16 Keratoconus).
     • Provenance: Prospective, observational study conducted at three study sites (country not specified, but likely U.S.).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • FAZ Parameter Validation (Section 2): "Three readers experienced in FA image grading performed FAZ measurements." Specific qualifications (e.g., years of experience, board certification) are not provided.
   • Corneal Epithelial Thickness Agreement (Section 6): "Manual measurements performed by three qualified graders." Specific qualifications are not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • FAZ Parameter Validation (Section 2): Graders were "masked to each other's results through the entire grading process". No explicit mention of an adjudication process (e.g., tie-breaking by a senior reader) if reader consensus was needed. It seems individual reader measurements were compared against the device.
   • Corneal Epithelial Thickness Agreement (Section 6): Similar to FAZ, graders were masked. No explicit mention of an adjudication process.

5. 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 comparative effectiveness study involving human readers with/without AI assistance is described in this document. The studies primarily focus on the device's technical performance (repeatability, reproducibility, and agreement with human or phantom measurements) rather than its impact on human reader performance.

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

   • Yes, a standalone performance evaluation was done for the Non-clinical Performance Testing (phantoms) to validate the accuracy of the software's vessel density measurements (Section 7, page 7-8). The tables (e.g., for 3-mm AngioRetina Scan) present the difference between software-reported values and "expected 'vascular' density values computed directly from the model." This represents an algorithm-only performance assessment against a known ground truth.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Non-clinical Performance Testing (Phantoms): "Known ground truth" from 3D phantom models with predefined vessel densities.
   • Clinical Performance Testing (R&R of AngioVue, Retinal/RNFL/Disc Measurements): Implicitly, the Avanti software's measurements were compared against its own repeated measurements (for R&R) and against the predicate device's measurements (for agreement), establishing consistency and comparability rather than an external "ground truth" like pathology.
   • FAZ Parameter Validation: Manually graded FAZ measurements from fluorescein angiography images by "three readers experienced in FA image grading." This is a form of expert consensus/manual measurement ground truth.
   • Corneal Epithelial Thickness Mapping Agreement: Manual measurements performed by "three qualified graders" using a caliper tool on a previously cleared device. This is a form of expert consensus/manual measurement ground truth.

8. The sample size for the training set:

   • The document does not specify the sample size of any training set used for the device's algorithms. This information is typically proprietary to the manufacturer and not included in 510(k) summaries unless directly relevant to a specific re-training or modification evaluation.

9. How the ground truth for the training set was established:

   • Since the training set size is not provided, the method for establishing its ground truth is also not detailed in this document.

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The iVue is a non-contact, high resolution tomographic imaging device. It is intended for in-vivo imaging, axial crosssectional, and three-dimensional imaging and measurement of anterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, corneal epithelia, corneal stroma and anterior chamber of the eye. With the integrated normative database, the iVue is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.

The iVue is used to capture, store, display and print spectral domain-optical coherence tomography (SD-OCT) images of the posterior and anterior structure of the eye. The device software includes a Normative Database (NDB), consisting of OCT data from a range of known normal subjects that can be used to compare a new patient's measurements in relation to the normal distribution.

iVue is a computer-controlled ophthalmic imaging system using either a laptop computer or "All-in-One" computer. For laptop systems there are two control box options of 120 or 230 volts. The control box interfaces between the motorized table column and the medical-grade power supply for the computer.

iVue System Key Functional Components:

• Scanner Head
• Computer
• Control Box
• Joystick and Chinrest Assembly
• Footswitch (optional)
• Motorized Table (optional)
• Cornea Adapter Module

The provided document is a 510(k) Premarket Notification for the Optovue iVue device, seeking clearance for a software modification that allows automated segmentation and measurement of corneal epithelial and stromal layer thickness. The document describes two clinical studies conducted to support the substantial equivalence claim.

Here's an analysis 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 doesn't explicitly state quantitative acceptance criteria in a table format with pass/fail thresholds. Instead, it presents the results of repeatability, reproducibility, and agreement studies, and then concludes whether these results demonstrate "good repeatability and reproducibility" and "good agreement."

Based on the summaries provided, the implicit acceptance criteria seem to be related to achieving clinically acceptable levels of repeatability, reproducibility, and agreement with manual measurements for corneal pachymetry, epithelial thickness, and stromal thickness, across various patient groups.

Table of Implicit Acceptance Criteria and Reported Device Performance:

• Normal Group: 1.7 to 7.6 µm (across zones)
• Corneal Patients (pooled): 3.3 to 8.6 µm
• Subgroups (Contact Lens, Dry Eye, Post-LRS, KCN): Ranged from 1.5 to 13.4 µm (max in Dry Eye S_5_6_Pachy).
  Epithelial Thickness:
• Normal Group: 0.8 to 1.4 µm
• Corneal Patients (pooled): 1.2 to 1.9 µm
• Subgroups: Ranged from 0.6 to 2.9 µm (max in Dry Eye I_5_6_Epi and IT_5_6_Epi, and Post-LRS C2 Epi)
  Stromal Thickness:
• Normal Group: 1.6 to 7.6 µm
• Corneal Patients (pooled): 2.8 to 8.8 µm
• Subgroups: Ranged from 1.4 to 13.4 µm (max in Dry Eye S_5_6_Stroma) |
  | Reproducibility (SD) | Demonstrated "good reproducibility" | Pachymetry:
• Normal Group: 2.2 to 7.7 µm
• Corneal Patients (pooled): 3.6 to 8.8 µm
• Subgroups: Ranged from 1.8 to 13.7 µm (max in Dry Eye S_5_6_Pachy).
  Epithelial Thickness:
• Normal Group: 0.9 to 1.5 µm
• Corneal Patients (pooled): 1.2 to 1.9 µm
• Subgroups: Ranged from 0.7 to 2.9 µm (max in Dry Eye I_5_6_Epi and IT_5_6_Epi, and Post-LRS C2 Epi)
  Stromal Thickness:
• Normal Group: 2.0 to 7.6 µm
• Corneal Patients (pooled): 3.1 to 9.0 µm
• Subgroups: Ranged from 1.8 to 13.7 µm (max in Dry Eye S_5_6_Stroma).
  The report notes: "Repeatability standard deviation was similar to the Reproducibility standard deviation for all study parameters and therefore is not detailed separately in the summary tables below." The tables for each parameter show Reproducibility SD values. |
  | Agreement (Mean of Differences) | Demonstrated "good agreement" | Mean of differences between software output and manual measurements for all zonal parameters:
• Corneal Epithelial Mapping:

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The RTVue XR OCT Avanti with Normative Database is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retinal nerve fiber layer, and optic disc as a tool and aid in the diagnosis and management of retinal diseases by a clinician. The RTVue XR OCT Avanti with Normative Database is also a quantitative tool for the comparison of retinal nerve fiber layer, and optic disk measurements in the human eve to a database of known normal subjects. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases.

The RTVue XR OCT Avanti with AngioVue Software is indicated as an aid in the visualization of vascular structures of the retina and choroid.

The RTVue XR OCT Avanti is a non-invasive diagnostic device for imaging the cornea, anterior chamber, and measurement of the retinal nerve fiber layer and optic disc with micrometer range resolution as a tool and aid in the diagnosis and management of retinal disease. Imaging and measurements include but are not limited to the internal limiting membrane (ILM), the retinal nerve fiber layer (RNFL), the ganglion cell complex (GCC), the retinal pigment epithelium (RPE), the outer retinal thickness, the total retinal thickness and optic disc structures including the cup and neuroretinal rim as an aid in the diagnosis and management of retinal disease. The measurements for the ILM and RPE are height measurements relative to the RPE reference plane. The RNFL, GCC and outer retinal thickness and total retinal thickness are thickness measurements where RNFL is the thickness of the RNFL layer, the GCC is the thickness from the ILM to the inner plexiform layer (IPL), the outer retinal thickness is the thickness from the IPL to the RPE, and total retinal thickness is the thickness from the ILM to the RPE.

The RTVue XR OCT Avanti is a computer controlled ophthalmic imaging system. The device scans the patient's eye using a low coherence interferometer to measure the reflectivity of the retinal tissue. The cross sectional retinal tissue structure is composed of a sequence of A-scans. It has a traditional patient and instrument interface like most ophthalmic devices. The computer has a graphic user interface for acquiring and analyzing the image. The line-scan camera operates at approximately 70,000 A-lines per second.

The RTVue XR OCT Avanti offers three scan types: Retina, Glaucoma, and Cornea. For the cornea and anterior eye scans, a lens must be attached to the front of the device for proper scanning. This lens is called the CAM auxiliary attachment (Cornea Anterior Module). The CAM software module provides for menu selections in the graphical user interface, which are selected by the operator to label corresponding corneal landmarks instead of those of the retina.

With the normative database (NDB), the RTVue XR OCT Avanti can compare the measured data from the GCC, the RNFL, the full retinal thickness, optic disc cup and optic disc rim measurements to the normative database. The device will provide the analysis information to he used as a clinical reference to aid in the diagnosis and management of ocular diseases.

The RTVue XR OCT with AngioVue™ has an additional software module to aid in the visualization of vascular structures of the retina and choroid using a motion-contrast techniques without the need for intravenous dyes.

This document does not contain the detailed acceptance criteria or a study proving the device meets specific performance criteria in a quantitative manner as typically presented for AI/ML device submissions. This is a 510(k) summary for a medical device (RTVue XR OCT Avanti with AngioVue Software) filed in 2016, which predates the FDA's specific guidance for AI/ML medical devices.

The submission focuses heavily on demonstrating substantial equivalence to a predicate device (Optovue, Inc. RTVue XR OCT, K120238) rather than presenting a performance study with detailed acceptance criteria and corresponding results for the AngioVue software module.

However, based on the provided text, here's an attempt to answer your questions, highlighting the limitations of the available information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly define quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) for the AngioVue software's performance in visualizing vascular structures. Instead, the performance is described qualitatively by comparing AngioVue scans with fluorescein angiography images.

2. Sample size used for the test set and the data provenance

The document states: "In case examples of a variety of retinal diseases, RTVue XR OCT Avanti with AngioVue Software cube scans were compared with fluorescein angiography images." This implies a qualitative comparison using a case series, rather than a formal, statistically powered test set with a specified sample size.

• Sample size: Not specified. The phrase "case examples" suggests a small, illustrative set of cases, not a statistically robust sample.
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not specified in the document. The ground truth appears to be implicitly established by "fluorescein angiography images," which are a recognized clinical standard for vascular visualization. It's not stated whether these images were reviewed by experts for an adjudicated ground truth for the purpose of this submission.

4. Adjudication method for the test set

Not explicitly stated. The comparison was made against "fluorescein angiography images," which serve as a reference. There is no mention of a formal expert adjudication process (e.g., 2+1, 3+1).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study is not mentioned in this document. The focus is on the device's capability to visualize structures, not on how its assistance improves human reader performance.

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

The "AngioVue software module" is described as providing "visualization of vascular structures." The performance discussed ("can give non-invasive three-dimensional information") refers to the output of the algorithm. Therefore, the visualization capability of the algorithm itself was assessed, but not against quantitative standalone performance metrics like sensitivity/specificity for detecting specific pathologies. The comparison to fluorescein angiography implies a standalone assessment of the image output.

7. The type of ground truth used

The ground truth used for comparison with the AngioVue images was fluorescein angiography images. This is an established clinical imaging modality for visualizing retinal and choroidal vasculature.

8. The sample size for the training set

The document does not provide any information about a training set or its sample size. This is typical for submissions of this era and type, where the software functionality is described as a "visualization aid" rather than a classification or diagnostic algorithm requiring extensive training data disclosures. The motion correction technology (MCT) is proprietary, and its development (which would involve data for "training" or optimization) is not detailed.

9. How the ground truth for the training set was established

Since there is no mention of a training set, the method for establishing its ground truth is also not provided.

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The iVue 500 with normative database is an optical coherence tomography system intended for in vivo imaging, axial crosssectional, three-dimensional imaging and measurement of anterior and posterior ocular structures.

The iVue 500 with normative database is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue 500 with normative database is a quantitative tool for the comparison of retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue 500 with normative database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population. (identical to predicate device)

The iVue 500 is a modification of its predicate device iVue with Normative Database (NDB) (K121739). The intended use, system performance, sub-assemblies, and key components of the iVue with NDB are all the same as the iVue with NDB. The intent of this redesign was to make the iVue a more compact desktop device, so it is more convenient to use and set-up in a typical office. Additionally operation via touchscreen or mouse driven technology, makes it simpler for a technician to use.

The iVue 500 is a non-invasive device for imaging the cornea, anterior chamber, and retinal tissue structure with micrometer range resolution.

Here's a breakdown of the acceptance criteria and the study details for the Optovue iVue 500 (K133892) based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

Study Details

1. Sample Size used for the test set and the data provenance:

   • Sample Size: The document mentions using "2 model eyes" for the bench testing. This is a very limited sample size, suggesting the testing was highly controlled and focused on mechanical and alignment capabilities rather than diverse clinical data.
   • Data Provenance: Not explicitly stated, but given the use of "model eyes" and the nature of the bench test, it is not clinical data from human subjects. It represents a controlled laboratory environment. Retrospective or prospective study types are not applicable here as it's not a clinical study.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not provided. Given that the testing involved "model eyes" and focused on alignment within mechanical tolerances, it's unlikely that clinical experts were involved in establishing "ground truth" in the typical sense (e.g., diagnosing disease). The "ground truth" for this test was the predefined mechanical tolerances.

3. Adjudication method for the test set:

   • This information is not provided and is not applicable given the nature of the bench test with model eyes. Adjudication methods are typically used in clinical studies where expert consensus is needed to establish a clinical ground truth.

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:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a modified version of an existing OCT device, focusing on mechanical and alignment performance rather than clinical diagnostic efficacy with human readers or AI assistance. The document does not describe any AI component or human reader performance evaluation.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, in a sense, a "standalone" test of the device's alignment capabilities was performed. The "software assisted motorized iVue 500" was tested to ensure it could align to the appropriate working distance and pupil centering with model eyes. This is an evaluation of the device's automated functions without human diagnostic interpretation in the loop. However, it's not a standalone diagnostic algorithm performance test as might be seen for an AI-powered diagnostic tool. The device itself is the "algorithm only" in this context of automated alignment.

6. The type of ground truth used:

   • The ground truth used was predefined mechanical tolerances (e.g., "±1mm tolerance") for working distance, centering, and pupil distance. This relates to the physical positioning and alignment capabilities of the device in a controlled setting, not clinical diagnosis.

7. The sample size for the training set:

   • This information is not applicable/not provided. The iVue 500 is a modification of an existing OCT system (K121739), not an AI algorithm that typically requires a separate training set. The existing normative database mentioned in the indications for use would have been developed previously, but details on its training set size are not part of this 510(k) submission. The current submission focuses on verifying the mechanical integrity and performance of the modified hardware.

8. How the ground truth for the training set was established:

   • This information is not applicable/not provided for this 510(k) submission. As mentioned above, this submission is for hardware modification. The existing "normative database" (which might be considered a form of a "training set" for comparison) would have had its ground truth established based on measurements from "known normal subjects," but the details of that establishment are not within the scope of this submission.

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The iFusion connects the iCam (K122572) and iVue (K121739) devices via a sliding bracket mechanism (iShuttle), to facilitate switching between the two devices. The iShuttle provides position adjustment ability of the iCam or iVue device during use.

The iFusion interfaces with the iCam and iVue devices to enable the operation of the iCam and iVue devices from one computer unit.

iFusion is a combination of the cleared iVue with NDB (K121739)("iVue") and the cleared iCam Fundus Camera (K122572)("iCam") on a shuttle platform, called the iShuttle. The iShuttle mounts to a joystick assembly using a central nut and bolt and four adjustable set screws. The iShuttle consists of a sliding metal plate supporting the iVue and the iCam. The iShuttle travels on tracks fitted to the X-Y-Z joystick assembly which helps position the iVue and the iCam devices. A release button is located at the front of the iShuttle to lock the iShuttle in position for the iVue and the iCam device. The iCam can be switched in position by pressing on the release button to unlock the iShuttle platform, then the iVue or the iCam can be pushed to slide to an opposite end until it is locked into position. In addition, the software of the iFusion system is created to allow the user to switch between the iVue and the iCam programs with the same computer. The iVue and the iCam programs use the same data communication and programming storage with a single shared database.

The provided document is a 510(k) summary for the Optovue iFusion device. This submission is for a combination device that integrates two previously cleared predicate devices (iVue and iCam) onto a new sliding bracket (iShuttle) and includes minor software changes. The primary goal of this type of submission is to demonstrate substantial equivalence to existing legally marketed devices, rather than to prove clinical effectiveness and safety through de novo clinical studies with specific acceptance criteria related to disease diagnosis or treatment.

Therefore, the information typically found in acceptance criteria tables and detailed study reports for showing diagnostic/predictive performance (like sensitivity, specificity, AUC) or comparative effectiveness (like MRMC studies) is not present in this document. This submission focuses on demonstrating that the changes (the iShuttle and minor software updates) do not negatively impact the safety and effectiveness of the already cleared component devices.

Here's an breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not contain a table of acceptance criteria and reported device performance in the typical sense for diagnostic or prognostic claims (e.g., sensitivity, specificity, accuracy for a particular disease). Instead, the "acceptance criteria" for this 510(k) were focused on demonstrating that the new iFusion system, with its integrated iShuttle and minor software changes, maintained the safety and effectiveness of the predicate devices.

The "performance data" section states:

"Verifications and validations were performed for mechanical and functional testing according to IEC 60601-1 and 60601-1-2 for the new iShuttle bracket and the software changes."
"The results demonstrated that the changes in iFusion did not affect the intended use or alter the fundamental technological characteristics of the predicate devices and that the iFusion is substantially equivalent to its predicate devices."

This implies that the acceptance criteria for these tests would have been along the lines of "meet IEC 60601-1 and 60601-1-2 standards" and "no degradation in function or safety of iVue and iCam components." However, the specific quantitative results or acceptance thresholds for these engineering tests are not provided in this summary.

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

Not applicable in the context of this 510(k) submission. This is not a study assessing diagnostic performance on a patient dataset. The "test set" would have been the iFusion device itself subjected to mechanical and software integrity tests.

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

Not applicable. There's no clinical ground truth established for this submission as it's not a study on diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable for this type of submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study was not described or performed for this 510(k) submission. The iFusion device is essentially a physical integration and software interface for two existing devices, not a new diagnostic algorithm requiring human-in-the-loop performance measurement.

6. If a Standalone Study Was Done

Not applicable in the sense of an algorithm-only diagnostic performance study. The "standalone" testing here refers to the verification and validation of the iShuttle's mechanical and functional aspects, and the software changes, to ensure they didn't compromise the existing functionalities of the iVue and iCam.

7. The Type of Ground Truth Used

Not applicable in the context of a clinical ground truth. The "ground truth" for this engineering/integration submission would be adherence to safety standards (IEC 60601-1, 60601-1-2) and confirmation that the iVue and iCam components function as intended when integrated into iFusion.

8. The Sample Size for the Training Set

Not applicable. There is no mention of an algorithm being "trained" in this submission. The software changes are "minor" and related to user interface and data communication/storage, not a new AI/ML algorithm.

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

Not applicable, as there was no training set for an AI/ML algorithm.

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The iVue with Normative Database is an optical coherence tomography system intended for in vivo imaging, axial cross-sectional, three-dimensional imaging and measurement of anterior and posterior ocular structures.

The iVue is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The i Vue with Normative Database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.

iVue with Normative Database (NDB) is a modification of its predicate device iVue (K091404) through the inclusion of the database collected with the iVue. The intent of use, system performance, majority of sub-assemblies, and key components of the iVue with NDB are all the same as iVue and RTVue with NDB.

iVue with NDB, based on the same Optical Coherence Tomography (OCT) technology that is used in the predicate device iVue (K091404) and RTVue with NDB (K101505), is a noninvasive diagnostic device for viewing the ocular tissue structure with micrometer range resolution. Both iVue and RTVue with NDB are designed and manufactured by Optovue, Inc.

The device is currently cleared for in vivo imaging and measurement of the various retinal layers (K091404). The current submission is for a software modification through the addition of a normative database feature, similar to the NDB feature on the cleared predicate device RTV ue with NDB (K101505). With the addition of the normative database (NDB), the iVue can compare the measured data from the Retina Map scan, the Nerve Fiber scan, and the iWellness scan, to the normative database. The iVue/RTVue with Normative Database provide a comparison of the scanned measurements to a database of known normal subjects to provide a reference of where the patient's measurement stands in relation to the normative distribution. The iVue with normative database provides analysis information to be used as a clinical reference to aid in the diagnosis and management of ocular health and diseases. There is no hardware change from the 510(k) cleared iVue System (K091404). Additional scan patterns and acquisition of 3-D disc scan as ONH scan reference, optic disc analysis, and modification of the blood vessel extraction for the retina map scan are other software changes implemented in the current submission. These software changes are similar to features in the predicate RTVue device (K101505) and do not impact the safety and effectiveness of the system.

The device scans a patient's eye and uses a low coherence interferometer to measure the reflectivity of the retinal and corneal tissue. The cross sectional B-scan of the retinal tissue structure is composed of a sequence of A-scans. It has a traditional patient and instrument interface like most ophthalmic devices. The patient will rest their head on the forehead and chin rest while the operator uses a joystick to align the device to the patient's eve. The computer has a graphic user interface for acquiring and analyzing the image.

iVue with NDB has similar scan patterns and analysis functions as the predicate device RTVue with NDB.

Here's a breakdown of the acceptance criteria and study information for the Optovue iVue NDB, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the repeatability and reproducibility of the iVue with NDB. While explicit "acceptance criteria" for performance are not directly stated in the traditional sense (e.g., a specific target for reproducibility SD), the study's goal is to show that the iVue's performance is "reasonably similar" and "substantially equivalent" to the predicate RTVue with NDB. The reported performance is captured in tables of repeatability and reproducibility, as well as comparison against the predicate device.

Implicit Acceptance Criteria (Performance should be "reasonably similar" and "substantially equivalent" to predicate):

2. Sample size used for the test set and the data provenance:

• Repeatability and Reproducibility Study:

  • Test Set Sample Size: 14 normal subjects, 13 patients with glaucoma, 13 patients with retina disease. Only one eye per subject was included.
  • Data Provenance: Not explicitly stated (e.g., country of origin). The study design indicates it was a "repeatability and reproducibility study... conducted with IRB approval," suggesting a prospective clinical study environment.

• Comparison to Predicate Device Study:

  • Test Set Sample Size:
    • GCC comparison: 21 subjects (normal group), 24 subjects (glaucoma group).
    • ONH (Disc Parameters) comparison: 21 subjects (normal group), 23 subjects (glaucoma group).
    • ONH (RNFL Parameters) comparison: 21 subjects (normal group), 23 subjects (glaucoma group).
    • Retina Map comparison: 21 subjects (normal group), 19 subjects (retina group).
    • iWellness (GCC Parameters) comparison: 21 subjects (normal group), 23 subjects (glaucoma group).
    • iWellness (Retina Parameters) comparison: 21 subjects (normal group), 16 subjects (retina group).
  • Data Provenance: Not explicitly stated (e.g., country of origin). The comparison study implicitly uses data collected with the iVue and the predicate RTVue from the same or similar populations to assess equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• The document describes studies for repeatability and reproducibility of measurements and comparison against a predicate device. These types of studies typically do not involve experts establishing "ground truth" for diagnosis in the test set. Instead, the "ground truth" for these studies is the actual measurement obtained by the device (or predicate device) itself.
• The subjects are categorized as "normal," "glaucoma," or "retina disease," implying that these diagnoses were established clinically, presumably by ophthalmologists, but the document does not specify the number or qualifications of these diagnostic experts.

4. Adjudication method for the test set:

• No explicit adjudication method is mentioned for the test set in the context of establishing a diagnostic ground truth. The studies focus on device measurement precision and equivalence.

5. 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 comparative effectiveness study was done, as this submission is for an Optical Coherence Tomography (OCT) system that provides quantitative measurements and a normative database comparison, not an AI-assisted diagnostic tool that human readers would interpret. The device itself performs the measurements and comparisons.

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

• Yes, the performance presented is standalone in the sense that the device's measurement repeatability, reproducibility, and comparison to a known database are evaluated directly. The iVue with NDB is an imaging device that provides quantitative data and a normative comparison; its output (color-coded percentile categories) is directly generated by the algorithm based on the acquired OCT images. Human operators acquire the images, but the measurement and comparison algorithms function independently.

7. The type of ground truth used:

• For Repeatability and Reproducibility studies: The "ground truth" is the device's own measurement. The studies assess how consistently the device produces these measurements under repeated conditions.
• For Comparison to Predicate Device studies: The "ground truth" for comparison is the measurement obtained by the predicate device (RTVue with NDB). The iVue with NDB's measurements are compared to the predicate's measurements to establish substantial equivalence.
• The normative database used by the device serves as a reference "ground truth" for defining "normal," "borderline," or "outside normal" ranges for patient measurements. The database was populated using data from "known normal subjects."

8. The sample size for the training set:

• The document states that the iVue normative database was established using a "nearly identical methodology as that of the predicate RTVue with NDB." It also mentions "the total number of normal subjects is also similar in the two normative databases."
• For the RTVue with NDB (predicate), which the iVue NDB is compared to, the previous 510(k) (K101505) would contain the detailed training set information. This document does not explicitly state the training set size for the iVue NDB itself, other than implying it's similar to the RTVue NDB. A previous submission for RTVue NDB (K101505) described collecting data from 300 normal subjects (as mentioned in other similar submissions).

9. How the ground truth for the training set was established:

• The "ground truth" for the normative database (which can be considered the training set for the "normal" ranges) was established by collecting data from "known normal subjects."
• Specific details mentioned:
  • "The iVue normative database collection was based on a similar study design, study protocol, and data collection method as those of predicate RTVue NDB data collection."
  • "The inclusion and exclusion criteria are identical in the two protocols."
  • Image quality review criteria were similar.
  • The database contains a "mixture of ethnicities, and have similar age, gender, and refractive error range coverage."
  • Regression models were employed to estimate normative limits, taking into account covariates such as age, signal strength, and optic disc size.
  • The comparison is displayed in color-coded percentile categories ('within normal', 'borderline', or 'outside normal') based on cut-off levels of 5% and 1%, which would have been derived from the statistical analysis of this normative database.

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The iCam takes digital images of the posterior and external structures of the eye without the use of a mydriatic agent and is intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health.

The iCam is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions.

iCam is indicated for in-vivo viewing of the posterior and external area of the eye and the images are intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health.

iCam provides images only and does not provide any diagnostic, pathological analysis or classification of ocular health or disease.

The iCam is a non-mydriatic fundus camera for capturing, storing and displaying color fundus images with 1.3 MP @ 12 bits per color channel up to 45 degree (axial arc) field of view. It was designed to provide an acceptable area for broad range, high resolution viewing of most retinalbased and optic nerve pathologies. The design allows for the acquisition of high quality images that are of comparable quality to other predicate ocular cameras. The design incorporates the use of an LED light sources providing two advantages over the flash lamp light source of other cameras: 1) longer life expectancy of the LED compared to the typical Xenon flash lamp, and 2) reliability of solid state devices that allow for more reproducible light characteristics over time.

The LED light source provides lower voltage operation, a higher efficiency overall and allows for smaller design of the system based on the relatively small size of the LEDs compared to the Xenon bulb. LED light source has a considerably longer lifespan than a Xenon light source, while emitting minimal heat compared to the heat generating Xenon source.

The LED light source also reliability of solid state devices that allow for more reproducible image quality over time. Solid state devices that function via an on-or-off state are known to maintain light characteristics such as color temperature, lumens of output, and distribution of light. This characteristic of no demonstrable degradation results in more reproducible images over time.

Here's a breakdown of the acceptance criteria and the study details for the Optovue iCam Fundus Camera, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the iCam was "substantial equivalence" to its predicate device (Centervue DRS) in terms of image quality and clinical usefulness.

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

• Test Set Sample Size: A total of 120 evaluable subjects were targeted for enrollment. For each subject, images were collected on the study eye (2 central field fundus and 1 external eye) using both the iCam and the DRS.
• Data Provenance: The study was a multi-center, open-label, prospective study. While specific countries are not mentioned, the manufacturer's address (Fremont, CA, USA) suggests it was likely conducted in the USA.

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

• Number of Experts: Two independent reviewers (graders) were used.
• Qualifications of Experts: Both reviewers were licensed practitioners in optometry.

4. Adjudication Method for the Test Set

The reported method indicates that the best image out of two repeat fundus photos was selected for assessment. Although two reviewers graded the images to assess inter-rater agreement, the text does not explicitly detail a formal adjudication method (like 2+1 or 3+1 consensus) for discrepancies if they occurred. It states: "Agreement between PI and independent graders with regards to clinically usefulness of images was concluded to be at an acceptable level in all cases."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Yes, a multi-reader multi-case (MRMC) comparative effectiveness study was performed. The study aimed to evaluate the non-inferiority of the iCam relative to the predicate (Centervue DRS) regarding image quality.

• Effect Size of Human Reader Improvement (AI vs. without AI assistance): The study design does not involve AI assistance to human readers. It's a direct comparison of images captured by two different devices (iCam vs. DRS), with human readers evaluating the image quality from both devices. Therefore, there's no data to report on how much human readers improve with AI vs. without AI assistance. The study focuses on the inherent quality of images produced by the iCam compared to the predicate, as judged by human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone (algorithm only) performance study was not conducted or reported. The "effectiveness" of the iCam was evaluated by comparing its captured images to the predicate device, with physicians (licensed practitioners in optometry) assessing the clinical usefulness of the images. The iCam "provides images only and does not provide any diagnostic, pathological analysis or classification of ocular health or disease."

7. Type of Ground Truth Used

The ground truth for clinical usefulness was established by expert consensus (or at least expert grading with high inter-rater agreement). Specifically, a 5-point image quality grading scale was used by licensed optometry practitioners, and then dichotomized at a threshold of ≥3 for "clinically useful."

8. Sample Size for the Training Set

The document does not provide information about a separate training set or its sample size. This is a 510(k) for a medical imaging device (camera), not an AI algorithm that requires training data in the traditional sense. The performance evaluation focuses on the image acquisition capabilities of the camera.

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

As no training set is mentioned for an AI algorithm, the method for establishing its ground truth is not applicable here. The "ground truth" in this context refers to the expert assessment of the images captured by the device itself.

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The RTVue XR with Normative Database is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retinal nerve fiber layer, and optic disc as a tool and aid in the diagnosis and management of retinal diseases by a clinician. The RTVue XR with Normative Database is also a quantitative tool for the comparison of retina, retinal nerve fiber laver, and optic disk measurements in the human eye to a database of known normal subjects. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases.

The RTVue XR is a non-invasive diagnostic device for imaging the cornea, anterior chamber, and retinal tissue structure with micrometer range resolution. The RTVue XR OCT is based on the same Optical Coherence Tomography (OCT) technology used in its predicate device, RTVue with NDB OCT. The RTVue XR is a computer controlled ophthalmic imaging system. The device scans the patient's eye using a low coherence interferometer to measure the reflectivity of the retinal tissue. The cross sectional retinal tissue structure is composed of a sequence of Ascans. It has a traditional patient and instrument interface like most ophthalmic devices. The computer has a graphic user interface for acquiring and analyzing the image. RTVue XR offers three scan types: Retina, Glaucoma, and Cornea. For the Cornea scan, a lens must be attached to the front of the device for proper scanning. This lens is called the CAM (Cornea Anterior Module-cleared under K111505). The upgrade of the line scan camera is designed to provide faster image acquisition. The RTVue XR is an updated version of RTVue with NDB that operates at ~70,000 A-lines per second while the RTVue-100 operates at ~27,000 A-lines per second. The RTVue XR machines will be equipped with new line-scan cameras capable of operating at ~70,000 Alines per second while delivering equivalent imaging results as the older generation RTVue line-scan cameras operating at ~27,000 A-lines per second.

The provided 510(k) summary for the Optovue RTVue XR OCT describes a special 510(k) notice for an upgrade to an existing device (RTVue with NDB). The primary change is the inclusion of a new line scan camera for faster image acquisition.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

Study Details:

1. Sample size used for the test set and the data provenance:

   • The document mentions a "Bench test" for comparing the RTVue XR with the predicate device. However, it does not specify the sample size of the test set (e.g., number of images, number of patients) or the data provenance (e.g., country of origin, retrospective/prospective nature of the data) for this bench test. The focus of this submission is on hardware upgrade and the claim of "equivalent imaging results."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not provided. The submission focuses on technical equivalence rather than a clinical performance study requiring expert ground truth for interpretation.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • This information is not provided. As there's no mention of a human-centric clinical study requiring ground truth establishment, adjudication methods are not discussed.

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:

   • No MRMC comparative effectiveness study was done or reported. This device is an imaging system, not an AI-assisted diagnostic tool for interpretation, and the submission's purpose (hardware upgrade) does not necessitate such a study.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • No standalone algorithm performance study was done or reported. The RTVue XR is an imaging device, not an algorithm, and the submission focuses on its technical performance (image acquisition speed and equivalence).

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the bench test, the ground truth would inherently be instrument specifications and image quality metrics for comparing the new camera's output to the predicate device's output. It is not expert consensus, pathology, or outcomes data.

7. The sample size for the training set:

   • Not applicable/Not mentioned. This submission is for a hardware upgrade of an imaging device, not an AI/algorithm-driven device requiring a training set. The device itself uses a "Normative Database" for comparison, but details about its construction (sample size, ground truth, etc.) are outside the scope of this specific 510(k) for a camera upgrade.

8. How the ground truth for the training set was established:

   • Not applicable/Not mentioned. As a training set for an algorithm is not discussed, the establishment of its ground truth is also not. For the "Normative Database" mentioned in the Intended Use, the document states it's "a database of known normal subjects," implying a classification based on clinical normality, but further details are not provided in this submission.

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The CA, an auxiliary lens adapter, when used in conjunction with RTVue, is indicated for in vivo imaging and measurement of the cornea and the other ocular structures of the anterior segment of the eve, including pachymetry and corneal power.

The already cleared (K071250) RTVue CA Module (CAM) is an instrument based on Fourier-Domain Optical Coherence Tomography (OCT) for in vivo imaging and measurement of the cornea and other ocular structures of the anterior segment of the eye with US FDA 510(k) clearance (K071250) in 2007. The RTVue CAM has been used in clinical practice for imaging the cornea, measuring corneal thickness, and visualizing the anterior segment angle. The RTVue CAM device uses the same Optical Coherence Tomography (OCT) technology that was previously cleared by FDA (K101505). The CAM adapter gives the user an option to use the RTVue device as previously approved for retina scans, or to use it for cornea and anterior eye scans. Aside from the CAM auxiliary attachment, the RTVue is virtually unchanged for the CAM use except the CAM software module provides for menu selections in the graphical user interface, which are selected by the operator to label corresponding corneal landmarks instead of those of the retina. The system scans a beam into patient's eye and uses a low coherence interferometer to measure the reflectivity of the ocular tissue. The cross-sectional ocular tissue structure is composed of sequence of A-scans. The RTVue has a traditional patient and instrumentinterface like most ophthalmic devices. The device is mounted on a motorized patient table. The patient will rest their head on the forehead and chin rest. The operator uses joystick to align the device to patient's eye. The computer has a graphic user interface for acquiring, and displaying the acquired image. The RTVue image acquisition speed and image resolution remain the same when used in conjunction with CAM.

The provided document describes the RTVue CAM with Corneal Power Measurement device and its performance data to support substantial equivalence. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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