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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:

2. Sample Sizes and Data Provenance

Study 1: Repeatability and Reproducibility (R&R) of Corneal Epithelial Thickness Mapping

• Sample Size (Test Set): 59 subjects (from 598 total acquired scans, 527 qualified for final analysis).
  • Normal Subjects: 12 subjects
  • Corneal Patients: 47 subjects (further stratified into 4 subgroups, each with 11-12 subjects: Contact Lens, Dry Eye, Post-Refractive Surgery, Keratoconus).
• Data Provenance: Not explicitly stated, but clinical studies are generally prospective. The multi-device, multi-operator protocol in Study 1 suggests it was a controlled, prospective collection. Given that Optovue is based in Fremont, CA, and the submission is to the FDA, it is highly probable the data was collected in the USA, although not explicitly stated.

Study 2: Agreement of Corneal Epithelial Thickness Mapping with iVue SD-OCT to Manual Measurement

• Sample Size (Test Set): 87 study eyes from 87 subjects.
  • Normal Subjects: 17
  • Contact Lens (normal): 16
  • Dry Eye: 18
  • Post-Laser Refractive Surgery: 20
  • Keratoconus: 16
• Data Provenance: Not explicitly stated, but the mention of "3 study sites" collecting OCT data suggests a prospective clinical study. Again, given the FDA submission, most likely USA.

3. Number of Experts and Qualifications for Ground Truth

• Study 1 (R&R): Ground truth was based on the iVue software's automated segmentation, with manual edits performed by operators when needed. The document states: "For qualified scans, the operators reviewed the thickness maps for obvious segmentation error and reviewed the individual corneal meridian images to verify segmentation for erroneous maps. Segmentation edit tools were used to perform manual correction and then the epithelial map was reprocessed. Noticeable segmentation errors were manually corrected by the operator and marked for "Manual Correction" in the case report form."

  • The qualifications of these "operators" are not explicitly detailed. It implies they are trained users of the device capable of identifying and correcting segmentation errors, but their specific certifications (e.g., ophthalmologist, optometrist, ophthalmic technician) or years of experience are not mentioned.
  • Number of operators: The study used "device-specific designated operator" for each of the three iVue devices, so a minimum of 3 operators.

• Study 2 (Agreement): Ground truth was established by manual measurements performed by "3 qualified graders."

  • The qualifications of these "qualified graders" are not specified (e.g., ophthalmologist, ophthalmic technician, years of experience). They used a "2-section caliper tool that was available in the previously cleared iVue software."

4. Adjudication Method for the Test Set

• Study 1 (R&R): There's no explicit mention of a formal multi-reader adjudication process (e.g., 2+1, 3+1). It states "manual edits were not required in Normal eyes scans, and ranged from 2.8% in Contact Lens sub-group to 17.9% in KCN sub-group...Noticeable segmentation errors were manually corrected by the operator and marked for "Manual Correction"". This suggests correction was done by a single operator per scan if needed, not a consensus or adjudicated process among multiple experts.
• Study 2 (Agreement): The "agreement to manual measurement of the software was evaluated based on the agreement between the software output and the manual measurements by 3 qualified graders." It appears each grader provided their measurement independently, and then the agreement between the software and their measurements (or a combined representation of their measurements, though "manual measurements" is singular in "agreement to manual measurement") was assessed. It doesn't describe an adjudication process amongst the 3 graders to establish a single ground truth for each case from the graders. The comparison is between the software and the individual manual measurements, then reported collectively.

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

• No MRMC comparative effectiveness study was done comparing human readers with AI vs. without AI assistance. The study focuses purely on the device's technical measurement performance (repeatability, reproducibility, and agreement with existing manual measurement methods). The iVue is a measurement device, not an AI diagnostic aid in the sense of 'improving human reader performance.'

6. Standalone (Algorithm Only) Performance

• Yes, standalone performance was evaluated. The core of both clinical studies is the performance of the iVue device's software (algorithm) in segmenting and measuring the corneal layers.
  • In Study 1, it assessed the repeatability and reproducibility of the "modified iVue software" directly.
  • In Study 2, it assessed the "agreement between the software output and the manual measurements." This is a direct evaluation of the algorithm's performance against a human-derived ground truth.

7. Type of Ground Truth Used

• Study 1 (R&R): The ground truth was the automated segmentation by the iVue software, potentially refined by "operator correction". This is a form of expert-corrected algorithmic output.
• Study 2 (Agreement): The ground truth was manual measurements performed by "qualified graders" using a digital caliper tool available in the predicate iVue software. This is a form of expert measurement. It's not pathology or outcomes data.

8. Sample Size for the Training Set

• Not specified in the provided document. The document describes clinical studies for validation and verification of a modified software, not the development or training of the original algorithm. Device approvals like 510(k) often focus on testing the finished product.

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

• Not specified in the provided document. As the training set size is not mentioned, neither is the method for establishing its ground truth. This information would typically be found in the algorithm's development and internal validation documentation, not necessarily in a 510(k) summary focused on post-modification performance.

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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 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 iVue is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retinal nerve fiber layer, optic disk, cornea, and anterior chamber of the eye as an aid in the diagnosis and management of ocular diseases.

iVue is a modification of its predicate device RTVue (K062552). The intent of use, system performance, majority sub-assemblies, and key components of the iVue are all the same as RTVue. The intention of this redesign is to make the size of the iVue more compact and more affordable.

iVue also has a cornea lens adapter, like the predicate device CA (K071250), which can be attached to the front of the instrument to enable the iVue to image the cornea and anterior chamber of the eye.

i Vue, based on the same Optical Coherence Tomography (OCT) technology that is using in the predicate device RTVue (K062552) and CA (K071250), is a non-invasive diagnostic device for viewing the ocular tissue structure with micrometer range resolution. Both iVue and RTVue are designed and manufactured by Optovue Inc. A brochure of the RTVue and CA system is in appendices [1].

Like RTVue, iVue is a computer controlled ophthalmic imaging system. RTVue uses a desktop computer while i Vue uses a laptop computer. The device scans a patient's eye and uses a low coherence interferometer to measure the reflectivity of the retinal tissue. The cross sectional retinal tissue structure is composed of 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 joystick to align the device to patient's eye. The computer has a graphic user interface for acquiring and analyzing the image.

i Vue also has similar scan patterns and analysis functions as used in RTVue.

The provided text describes a 510(k) summary for the Optovue iVue, an Optical Coherence Tomography (OCT) system. The document focuses on demonstrating substantial equivalence to predicate devices (RTVue and CA) rather than establishing new performance criteria for a novel device. Therefore, instead of "acceptance criteria," the document presents "precision results" and "agreement results" to show that the iVue performs comparably to its predicates.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state pre-defined "acceptance criteria" with numerical thresholds against which the iVue was measured. Instead, it presents precision results (repeatability and reproducibility standard deviations) and agreement results (mean differences and standard deviations of differences compared to the predicate RTVue). The implicit acceptance criteria are that these precision and agreement metrics demonstrate substantial equivalence to the predicate device.

Since there are no explicit acceptance values, I will present the reported device performance for several key measurements from the Glaucoma, Retina, and Cornea scans. Each section below represents a comparison between the iVue and the predicate RTVue.

Glaucoma Scan Performance (Avg RNFL thickness, Normal Patients)

Retina Scan Performance (Full Retina Fovea thickness, Normal Patients)

Cornea Scan Performance (Central Cornea 0-2mm thickness, Normal Patients)

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

• Test Set Sample Size: A total of 48 subjects were included in the study. This comprised:
  • 4 normal subjects for each of the 3 pairs of iVue/RTVue devices (12 total normal subjects across all pairs and operators).
  • 4 cornea patients for each of the 3 pairs.
  • 4 retina patients for each of the 3 pairs.
  • 4 glaucoma patients for each of the 3 pairs.
  • The document also states varying "number of scans" for different measurements after quality review: e.g., 72 scans for normal patients in Glaucoma scans, 70 for normal patients in Cornea scans. This indicates that while 48 subjects were enrolled, the actual number of analyzed scans varied due to quality control.
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the study was conducted at two clinical sites. No specific country is mentioned.
  • Retrospective or Prospective: The study was prospective. Subjects were enrolled and scanned for the purpose of this comparison study.

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

• Number of Experts: The ground truth for subject classification (normal, glaucoma, retina, cornea patients) was established by the Principal Investigator (PI) at each clinical site. The number of PIs is not explicitly stated, but since there were two clinical sites, there would be at least two PIs involved.
• Qualifications of Experts: The PIs diagnosed the patients' conditions (e.g., "glaucoma patients were diagnosed as having glaucoma by the PI at each site"). The specific qualifications (e.g., years of experience, subspecialty) of these PIs are not provided.

4. Adjudication method for the test set

• Adjudication Method: The document does not describe an explicit adjudication method for the test set in terms of multiple expert reviews and reconciliation. Subject inclusion criteria were reviewed by comparing the study protocol with the Case Report Forms (CRF) at the subject level. At the individual scan level, data was reviewed for quality (overall signal strength, localized weak signals, eye blink, data out of boundary, data off-center) and scans with poor image quality were excluded. This is more of a quality control process for the images than an adjudication of diagnostic outcomes.

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 study as described: This document describes a comparison between two medical devices (iVue and RTVue, both OCT systems) for their measurement precision and agreement. It is not an AI diagnostic device or a study evaluating human readers with or without AI assistance. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study focused on human reader improvement with AI assistance was not performed, and no effect size for such a scenario is provided.

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

• This is not an AI algorithm. The "device" (iVue) itself is an Optical Coherence Tomography system, which is an imaging device that produces measurements. The study evaluates the precision and agreement of these measurements between the new device (iVue) and a predicate device (RTVue). Therefore, the concept of "standalone performance" of an algorithm without human-in-the-loop is not applicable in this context. The reported performance is the standalone performance of the device's measurement capabilities.

7. The type of ground truth used

• Type of Ground Truth: The ground truth for classifying subjects into different patient groups (normal, glaucoma, retina, cornea) was based on clinical diagnosis by a Principal Investigator (PI) at each clinical site. The measurements generated by the OCT devices (RNFL thickness, retinal thickness, cornea thickness) were compared against each other, with the predicate device (RTVue) essentially serving as the reference for agreement. It's a comparison for substantial equivalence, not against a gold standard like pathology in all cases.

8. The sample size for the training set

• Not Applicable: This study is on a medical imaging device (OCT scanner), not an AI algorithm that requires a training set. The iVue is a modification of an existing device (RTVue), and the study aim is to demonstrate its measurement precision and agreement with the predicate. Therefore, there is no training set in the context of an AI/machine learning model.

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

• Not Applicable: As there is no training set for an AI algorithm, this question is not relevant to the described study.

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