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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 Bioptigen EnFocusTM device is intended to acquire, process, display and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography (SDOCT).

The EnFocusTM is indicated for use as an aid in the visualization of physiologic conditions of the eye through non-contact optical imaging. It is indicated for use on patient promotions from premature and neonant lintants to adult. The system is indicated for use in supine imaging, mounted to a superiod microscope, with coperative patients or patients under anesthesia.

The EnFocus™ is a non-contact, noninvasive ophthalmic imaging device that includes an OCT Engine, a scan head, a System Computer, an Uninterruptible Power Supply (UPS), a mobile Security Cart and the System Software. The EnFocus™ uses Spectral Domain Optical Coherence Tomography (SD-OCT) and a near infrared light source to image ocular tissue microstructures.

The EnFocus is coupled to a surgical micrsoscope for OCT imaging during ophthalmic surgical procedures. The EnFocus has been validated and found to be compatible for use with the Leica M844 Surgical Microscope and the Insight Instruments Super View™ Wide Angle Viewing System™ for retina visualization.

The software, InVivoVue™ Version 2.6, works with the hardware and the hardware controller to offer intuitive, flexible system control for high-speed volume data acquisition and imaging.

The EnFocus™ system includes two OCT-compatible objective lenses for use with the surgical microscope: a 175mm lens and 200mm lens. The system also offers a choice of accessory masks that may be deployed in the Leica M844 filter port to manage illumination glare artifacts when necessary.

Using the EnFocus™, OCT imaging may be acquired during the surgical procedure, without stopping a procedure or repositioning the surgical microscope. The surgical microscope position is stationary relative to the surgical procedure, and the surgical view is unaltered by the scanning of the OCT beam.

The Bioptigen EnFocus™ device aims to acquire, process, display, and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography (SDOCT). It's intended for visualizing physiological and pathological conditions of the eye through non-contact optical imaging, suitable for premature and neonatal infants to adults. The system is designed for supine imaging, mounted to a surgical microscope, with cooperative patients or patients under anesthesia.

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

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the EnFocus device are primarily based on demonstrating substantial equivalence to its predicate device, the Envisu™ SDOIS (Models C2200 and C2300), across three key areas:

1. Visualization of ocular physiology of the anterior and posterior segments of the eye.
2. Visualization of vascular blood flow in the retina with Doppler OCT.
3. Measurement of ocular features using manual placement of on-screen calipers, with agreement within a specified margin.

The reported device performance is presented in comparison to the predicate device, specifically for the EnFocus 2300 and EnFocus 4400 models.

Table of Acceptance Criteria and Reported Device Performance:

• Parafoveal nerve fiber layer: 100.0% agreement
• Inner nuclear layer: 100.0% agreement
• Outer plexiform layer: 100.0% agreement
• External limiting membrane: 100.0% agreement
• IS/OS Ellipsoids: 100.0% agreement
• End Tips Photoreceptor: 98.6% agreement
• Retina pigment epithelium: 100.0% agreement
• Choriocapillaris: 100.0% agreement
• Chorioscleral interface: 66.7% agreement
• Cornea epithelium: 100.0% agreement
• Bowman's layer: 94.3% agreement
• Cornea endothelium: 98.6% agreement
• Scleral corneal junction: 98.6% agreement
• Schlemm's canal: 60.0% agreement
• Iridocorneal angle: 81.7% agreement | - Inner limiting membrane: 80.6% agreement
• Parafoveal nerve fiber layer: 100.0% agreement
• Inner nuclear layer: 100.0% agreement
• Outer plexiform layer: 100.0% agreement
• External limiting membrane: 100.0% agreement
• IS/OS Ellipsoids: 100.0% agreement
• End Tips Photoreceptor: 94.4% agreement
• Retina pigment epithelium: 100.0% agreement
• Choriocapillaris: 100.0% agreement
• Chorioscleral interface: 62.5% agreement
• Cornea epithelium: 100.0% agreement
• Bowman's layer: 98.6% agreement
• Cornea endothelium: 98.6% agreement
• Scleral corneal junction: 97.2% agreement
• Schlemm's canal: 57.7% agreement
• Iridocorneal angle: 63.9% agreement | Generally Met (High agreement for most features).
  Notably, Chorioscleral interface, Schlemm's canal, and Iridocorneal angle show lower agreement percentages, though specific thresholds for "acceptance" are not explicitly defined beyond "demonstrate substantial equivalence." The overall performance across numerous features implies general competence. |
  | 2. Visualization of Vascular Blood Flow (Doppler OCT) | Ability to visualize and identify Doppler flow, showing high percentage agreement with the predicate. | - Doppler flow, superior: 93.1% agreement
• Doppler flow, central: 88.9% agreement
• Doppler flow, inferior: 95.8% agreement | - Doppler flow, superior: 95.8% agreement
• Doppler flow, central: 88.9% agreement
• Doppler flow, inferior: 95.8% agreement | Met. All Doppler flow locations demonstrated high percentage agreement (88.9% - 95.8%). |
  | 3. Caliper Measurements | Agreement of manual caliper measurements with the predicate device against a target equivalence margin of +/- 15 µm (0.015 mm) at the 95% confidence level. Also, linearity in agreement across the range of measurements (20 µm to 630 µm). | - 95% CI for mean difference for all 6 measured features (parafoveal peak inferior/superior, fovea, nerve fiber layer, cornea, cornea epithelium) within +/- 0.015 mm.
• Pooled Graders (ENF23=f(Pred)): A=99.0%, B=-2.0 µm, R²=99.8% | - 95% CI for mean difference for all 6 measured features (parafoveal peak inferior/superior, fovea, nerve fiber layer, cornea, cornea epithelium) within +/- 0.015 mm.
• Pooled Graders (ENF44=f(Pred)): A=100.2%, B=1.4 µm, R²=99.8%
• Pooled Graders (ENF44=f(ENF23)): A=101.2%, B=3.5 µm, R²=99.8% | Met. All individual measurement 95% CIs were within the +/- 0.015 mm equivalence margin. High linearity (R²=99.8%) also indicates good agreement in measurements. |

2. Sample Size and Data Provenance

• Test Set Sample Size: 24 eyes of twelve adult subjects.
• Data Provenance: The study was conducted in an office setting. While a specific country of origin is not explicitly stated, the context of the FDA 510(k) submission strongly suggests the United States. The study was prospective in nature, as images were "collected" and "evaluated."

3. Number and Qualifications of Experts for Ground Truth

• Number of Experts: Three ophthalmic graders.
• Qualifications: "Ophthalmic graders" are mentioned. No specific experience level (e.g., "radiologist with 10 years of experience") or board certification is provided in the document.

4. Adjudication Method for the Test Set

The document states that the three ophthalmic graders "independently reviewed the images and documented evaluations." For the "Ocular Physiology and Presence of Doppler Flow," they "identified the presence or absence of physiologic features in a binary test of agreement." This method implies a comparison of each grader's evaluation against the predicate, and then likely an agreement statistic was calculated among the graders relative to the predicate's findings. However, a specific adjudication method like "2+1" or "3+1" to establish a consensus ground truth from the graders themselves is not explicitly stated. The "Percent Agreement with Predicate" suggests each grader's individual agreement with the predicate's established findings.

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

No explicit MRMC comparative effectiveness study that assesses how much human readers improve with AI vs. without AI assistance was done. The study evaluated the device's performance (EnFocus 2300 and EnFocus 4400) in terms of agreement with a predicate device, not in comparison to human readers or an AI-assisted workflow. Although human graders were involved in the evaluation of the images from the new devices, their role was to evaluate the images in comparison to the predicate, not to measure an improvement in their own performance with AI assistance.

6. Standalone (Algorithm Only) Performance

Based on the provided text, the EnFocus device itself is the system under evaluation, which includes its image acquisition, processing, display, and saving capabilities. The performance metrics (e.g., visualization agreement and measurement accuracy) evaluate the device's output rather than a separate algorithm's performance in isolation. The study design does not present a standalone algorithm's performance independent of the full device system. The "Key Performance Attributes" section also mentions "Optical performance testing" conducted in accordance with established requirements, suggesting standalone technical performance, but the clinical data focuses on device output.

7. Type of Ground Truth Used

The ground truth for comparison was the predicate device, Envisu 2300. The study measures "Percent Agreement with Predicate" for visualization tasks and "Mean Difference (Predicate - New Device)" for caliper measurements. This indicates that the evaluations from the EnFocus devices were compared against what was already established or visible in images from the predicate device.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. This is a 510(k) submission for a medical device which is largely based on substantial equivalence to a predicate, rather than an AI/ML device that typically requires extensive training data. The "Software Verification and Validation Testing" indicates compliance with guidance for "Software Contained in Medical Devices" but does not detail machine learning model development.

9. How Ground Truth for the Training Set Was Established

Since no information regarding a training set is provided, there is no mention of how ground truth for a training set was established. The clinical study described served as a validation/test set to demonstrate equivalence to the predicate device.

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OptoMedical Technologies OCT-Camera is intended to acquire, process, display and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography (SD-OCT). The OCT-Camera is indicated for the use as an aid in the diagnosis of physiologic conditions of the eye through non-contact optical imaging of the various tissues of the eye is supported through the use of interchangeable lenses. It is indicated for use on patient populations from premature and neonatal infants to adult, and is suitable for patients ambulatory or confined. The system is indicated for use in supine imaging, mounted to a surgical microscope HS Hi-R NEO 900A NIR (Haag-Streit), and is suited for imaging patients under anesthesia.

The OCT-Camera can be attached to the camera port of surgical microscopes. The OCT-Camera is completely integrated into the surgical procedure by enabling the OCT imaging before, during, and after microsurgery without disrupting the microscopic view. The individual steps and the outcome of the surgical procedures, such as transplantation of the thin membranes or micro implants, are visualized in real time.

The OCT-Camera by OptoMedical Technologies GmbH facilitates the intraoperative use of OCT (iOCT). It is called OCT-Camera because it can be attached to the camera port of an operating microscope like any common camera that are used for the purpose of providing live view images of the surgical field.

The provided text is a 510(k) summary for the OptoMedical Technologies OCT-Camera. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device, the Bioptigen Envisu™ SDOIS.

However, the document states that NO clinical performance data was required or performed for this device (OCT-Camera). Therefore, the device inherently does not have acceptance criteria or a study that proves it meets acceptance criteria in the way you've requested regarding performance metrics like accuracy, sensitivity, or specificity, which would typically come from clinical evaluations.

The "acceptance criteria" discussed in this document refer to the device meeting specific non-clinical requirements (e.g., electrical safety, compliance with laser safety standards, and overall design and performance functionality) to demonstrate substantial equivalence to the predicate device, not its diagnostic performance against a ground truth.

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

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

Since no clinical performance study was conducted to establish diagnostic acceptance criteria (e.g., sensitivity, specificity, accuracy), this table cannot be populated with such metrics. The acceptance criteria and "performance" are framed in terms of meeting regulatory and safety standards, and demonstrating substantial equivalence to a predicate device through non-clinical testing.

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

• Sample size for test set: Not applicable (no clinical testing was performed).
• Data provenance: Not applicable.

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)

• Number of experts: Not applicable.
• Qualifications of experts: Not applicable.

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

• Adjudication method: Not applicable.

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

• MRMC study: No. The device is not an AI-assisted diagnostic tool discussed in this context; it's an imaging device. The document explicitly states no clinical testing was required or performed.
• Effect size: Not applicable.

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

• Standalone performance: No. The device is not an algorithm, but an imaging camera for human use. No clinical performance testing against ground truth was conducted.

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

• Type of ground truth: Not applicable. No clinical ground truth was established as no clinical studies were performed.

8. The sample size for the training set

• Sample size for training set: Not applicable. The device is not described as an AI/ML algorithm that requires a training set in the context of diagnostic performance studies. Non-clinical testing was performed for safety and effectiveness, but this doesn't involve a "training set" in the AI sense.

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

• Ground truth for training set: Not applicable.

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Propper Insight™ Binocular Indirect Ophthalmoscope is an AC-adapter powered or rechargeable battery powered device for medical professionals containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, vitreous) and the retina of the eye

The Propper Insight™ Binocular Indirect Ophthalmoscope is an AC-powered or rechargeable battery-powered indirect ophthalmoscope that complies with standard ISO 10943:2012, Ophthalmic Instruments - Indirect Ophthalmoscopes.

The Propper Insight 100 is a Binocular Indirect Ophthalmoscope (abbreviated - BIO), worn on the medical professional's head containing illumination and viewing optics intended to examine the media and the retina of the eye when used in conjunction with an ophthalmic lens.

The illumination part of the Propper Insight™ Binocular Indirect Ophthalmoscope consists of a LED (Light Emitting Diode) source, lenses, a selection of red-free, amber and cobalt blue filters, three sizes of light apertures, diffuser and illumination mirror. The device has optomechanical system for adjustment of illumination level, which is based on the relative positions of two polarizer filters.

The viewing part consists of viewing lenses, and mirrors that are adjustable to obtain views of the patient eye fundus.

The illumination part and the viewing part are combined in the metal housing (BIO Module) which is attached to the headband with the pivot bracket mechanism. The attachment mechanism allows the BIO Module to be pivoted between in-use (down) and out-of-use positions (up). The attachment mechanism also allows adjustment of the BIO Module relative to the user's eyes for the most optimal viewing path. The attachment mechanism includes a magnetic securement of the BIO Module in both in-use and out-of-use positions. Part of the magnetic securement operates an electric contact to automatically provide power to the illumination source in the in-use position.

The BIO Module and the power cable connector (AC-powered version), or the BIO Module and the rechargeable battery are attached to the adjustable headband.

This is a medical device submission for a Binocular Indirect Ophthalmoscope (BIO), not an AI/ML device. Therefore, the questions related to AI/ML specific criteria like acceptance criteria tables, sample sizes for training/test sets, ground truth establishment methods, expert adjudication, MRMC studies, and standalone performance are not applicable.

The document describes the device, its intended use, and establishes substantial equivalence to a predicate device.

Here's what information can be extracted based on the provided text, and why other parts of your request are not applicable:

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

• Not Applicable. This device is a traditional medical instrument, not an AI/ML diagnostic or predictive tool. As such, there aren't "acceptance criteria" in the sense of performance metrics (like sensitivity, specificity, accuracy) that are common for AI/ML algorithms. Instead, regulatory approval for such a device is based on demonstrating safety, effectiveness, and substantial equivalence to a legally marketed predicate device. This involves meeting recognized standards (like ISO 10943:2012), conducting bench testing, and verifying manufacturing quality. The document states the device "complies with standard ISO 10943:2012, Ophthalmic Instruments - Indirect Ophthalmoscopes," which acts as the primary "acceptance criteria" for its design and performance characteristics.

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

• Not Applicable. As this is a traditional medical hardware device (an ophthalmoscope), there is no "test set" of data in the context of AI/ML or image analysis. The evaluation for substantial equivalence would involve engineering bench testing, electrical safety testing, and potentially user studies for usability, but not a dataset for an algorithm.

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)

• Not Applicable. No "ground truth" or expert review of data is involved in the evaluation of this hardware device in the way it would be for an AI/ML algorithm.

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

• Not Applicable. No test set or data adjudication process as described for AI/ML.

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

• Not Applicable. This is not an AI-assisted device, so no MRMC study comparing human readers with and without AI assistance would have been performed or is relevant.

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

• Not Applicable. This is a standalone hardware device used by a human clinician; it does not involve a standalone algorithm.

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

• Not Applicable. No "ground truth" in the context of clinical data assessment is relevant for this hardware device submission. Its performance is assessed against engineering standards and functional requirements.

8. The sample size for the training set

• Not Applicable. No training set, as this is not an AI/ML device.

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

• Not Applicable. No training set or ground truth establishment relevant to AI/ML.

Summary of what is present in the document:

• Device Name: Propper Insight™ Binocular Indirect Ophthalmoscope (BIO) Kits (Models 199185 and 199285)
• Regulatory Class: II (Product Code: HLI)
• Intended Use: "Propper Insight™ Binocular Indirect Ophthalmoscope is an AC-adapter powered or rechargeable battery powered device for medical professionals containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, vitreous) and the retina of the eye."
• Predicate Device: Heine OMEGA 500 binocular Indirect ophthalmoscope, LED version (K123316)
• Substantial Equivalence Basis: The Propper Insight™ BIO is deemed substantially equivalent to the predicate device because:
  • Both are designed for the same purpose.
  • Both use similar light sources (LED).
  • Both have the same indications for use.
  • Both have very similar operational principles and design.
  • The new device does not introduce new potential hazards or safety risks.
  • The device "complies with standard ISO 10943:2012, Ophthalmic Instruments - Indirect Ophthalmoscopes." This compliance serves as the primary technical validation for the device's performance and design.

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The Macular Integrity Assessment (MAIA™) is intended for measuring macular sensitivity, fixation stability and the locus of fixation, as well as providing infrared retinal imaging. It contains a reference database that is a quantitative tool for the comparison of macular sensitivity to a database of known normal subjects.

MAIA™ integrates in one device an automated perimeter and an ophthalmoscope, providing:

• images of the central retina over a field of view of 36° x 36°, acquired under infrared illumination and a confocal imaging set-up;
• . recordings of eye movements obtained by "tracking" retinal details in the live retinal video, acquired at 25 fps, providing a measure of a patient's fixation capabilities;
• . measurements of differential light sensitivity (or threshold sensitivity) at multiple locations in the macula, obtained as in fundus perimetry by recording a patient's subjective response (see / do not see) to a light stimulus projected at a certain location on the retina;
  MAIA™ works with no pupil dilation (non-mydriatic).
  MAIA™ integrates a computer for control and data processing and a touch-screen display and it is provided with a power cord and a push-button. MAIA™ works with a dedicated software application running on a custom Linux O.S.
  MAIA is composed of:
• 1. An optical head;
• 2. A chin-rest and head-rest;
• 3. A base, including a touch-screen display.
     The optical head comprises:
• An infrared source at 845 nm (SLD) 1.
• 2. A line-scanning confocal imaging system of the retina. The line, generated by means of an anamorphic lens, is scanned on the retina while the back-reflected light is de-scanned and revealed by a linear CCD sensor;
• 3. A projection system comprising visible LEDs to generate Goldmann stimuli and background at controlled luminance values;
• A fixation target in the shape of a red circle (two different dimensions available); 4.
• 5. An auto-focus system.
     The base of the MAIA includes:
• 1. A 3-axis robot that moves the optical head;
• 2. An embedded PC that hosts the control software and related interface ports;
• 3. The power supply.

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

Acceptance Criteria and Device Performance

The provided document doesn't explicitly state "acceptance criteria" in a quantitative performance metric table. Instead, it details a precision study to demonstrate the consistency and reliability of the device's measurements for macular sensitivity. The study's results are presented as "Precision results:" and "Individual Grid Point Results:". These values represent the device's demonstrated performance in terms of repeatability and reproducibility.

Table of Acceptance Criteria (Implied by Precision Study) and Reported Device Performance

Table of Individual Grid Point Results (Implied Acceptance Criteria and Reported Device Performance)

• Repeatability SD: Estimate of the standard deviation among measurements taken on the same subject using the same operator and device in the same testing session with repositioning.
  ** Reproducibility SD: Estimate of the standard deviation among measurements taken on the same subject using different operators and devices, including repeatability.

The document implicitly suggests that these precision values are acceptable and demonstrate that the device performs consistently, which is a key aspect of meeting its intended purpose for measuring macular sensitivity.

Study Details

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

• Test Set Sample Size: 24 subjects (12 with normal eyes and 12 with retinal pathologies). Each subject was tested on one eye only.
  • Each subject/eye was tested 3 times within a session.
• Data Provenance: The subjects were enrolled at two different clinical sites. The document doesn't specify countries, but the manufacturer is based in Italy. The study appears to be prospective for the purpose of this precision testing.

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

• Number of Experts: One "ophthalmologist" per site (implied by "Diagnosis of retinal pathology was made by a complete eye examination by an ophthalmologist"). The total number of ophthalmologists across the two sites is not explicitly stated but would be at least two (one per site).
• Qualifications of Experts: Ophthalmologists. No specific years of experience are provided, but they conducted a "complete eye examination" including "dilated funduscopic examination and pertinent history."

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

• The document does not describe an adjudication method for the diagnoses of pathology. It states that "Diagnosis of retinal pathology was made by a complete eye examination by an ophthalmologist". This suggests a single expert's diagnosis was used to classify subjects into normal or pathology groups, rather than a consensus or adjudication process for the test set.

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 comparing human readers with and without AI assistance was not done. This submission is for a perimetry device that measures visual function, not an AI diagnostic tool that assists human readers in interpreting images. The closest related activity is the precision study of the device itself.

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

• The device performs automated perimetry, which involves a patient's subjective response ("subjective response (see / do not see) to a light stimulus"). Therefore, it's not a purely standalone algorithm without human-in-the-loop in the context of interpretation, but the measurements themselves are automated. The precision study evaluates the standalone performance of the device's measurement capabilities without human interpretation variability being a primary variable (though operator influence is considered in reproducibility).

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

• For classifying subjects into "normal" or "pathology" groups for the precision study, the ground truth was based on a clinical diagnosis by an ophthalmologist, specifically a "complete eye examination by an ophthalmologist, including dilated funduscopic examination and pertinent history."
• For the data collected within the study itself (macular sensitivity measurements), the device produces its own quantitative data which is then assessed for precision rather than against an external ground truth for each specific measurement.

7. The sample size for the training set:

While not explicitly called a "training set" for an AI model, the document refers to a "Reference Database" which is analogous to a training or normalisation set.

• Reference Database Sample Size: 494 eyes of 270 normal subjects.

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

• For the "Reference Database" (normal subjects), the ground truth was established by defining "normal subjects" from whom threshold sensitivity data was obtained. The criteria for being considered "normal" are not explicitly detailed beyond being "normal subjects," but typically this implies healthy individuals without ocular pathology. This data was used to create a "reference database that is a quantitative tool for the comparison of macular sensitivity to a database of known normal subjects."

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An ophthalmoscope is intended to be used to examine the cornea, aqueous, lens, vitreous and retina of the eye.

The ophthalmoscope is an AC powered hand-held device containing illumination and viewing optics to examine the cornea, aqueous, lens, vitreous, and the retina of the eye.

This K131939 submission describes a traditional ophthalmoscope, which is a manually operated viewing device, not an AI or algorithm-driven device. Therefore, many of the requested categories related to AI performance, ground truth, and training sets are not applicable.

Here's an analysis based on the provided text, focusing on the device's technical performance and regulatory acceptance:

Acceptance Criteria and Reported Device Performance

Study Details (Non-Applicable/Not Provided for AI Device):

2. Sample size used for the test set and the data provenance: Not applicable. This is a physical device, not an AI algorithm tested on a dataset. The "test set" would refer to the physical devices themselves and their performance characteristics. The provenance refers to the testing standards (ISO, IEC, UL) and comparison to a legally marketed predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/diagnostic algorithms (e.g., expert consensus on image findings) is not relevant here. Device functionality and safety are evaluated against technical standards.
4. Adjudication method for the test set: Not applicable. This is not a study assessing diagnostic accuracy of an algorithm requiring adjudication of results.
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: Not applicable. This is a standalone physical ophthalmoscope, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical hand-held direct ophthalmoscope, which is inherently used with a human in the loop. There is no "algorithm only" component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of diagnostic performance "ground truth." The "ground truth" for this device's acceptance is its conformity to established performance standards (ISO 10942, ISO 15004-2) and electrical safety standards (IEC 60601-1, UL60601-1-2), and its substantial equivalence to a predicate device.
8. The sample size for the training set: Not applicable. There is no training set for a non-AI physical device.
9. How the ground truth for the training set was established: Not applicable.

Summary of Acceptance and Study:

The acceptance criteria for the Amico DH-W35 Ophthalmoscope Series were primarily based on demonstrating substantial equivalence to a previously cleared predicate device (K950461 - Welch Allyn Ophthalmoscope) and compliance with relevant performance and safety standards.

The study that proves the device meets these criteria involved:

• A performance comparison of the subject device against the predicate device to ensure "the same fundamental technological characteristics" and no "significant differences... that raise new questions of safety or efficacy."
• Performance testing conducted according to:
  • FDA Ophthalmoscope Guidance Document (Direct and Indirect) Version 1.0, July 8, 1998.
  • ISO 10942 (Ophthalmic instruments — Direct ophthalmoscopes)
  • ISO 15004-2 (Ophthalmic instruments — Fundamental requirements and test methods — Part 2: Light hazard protection)
• Electrical safety testing conducted according to:
  • IEC 60601-1 (Medical electrical equipment — Part 1: General requirements for basic safety and essential performance)
  • UL 60601-1-2 (Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral standard: Electromagnetic disturbances — Requirements and tests)

The results of these tests, as reviewed by the FDA, demonstrated that the Amico Ophthalmoscope is "as safe as or safer than the predicate device for its intended use," leading to its 510(k) clearance based on substantial equivalence. Specific quantitative data from the performance and electrical safety tests are not provided in this summary but were included in Sections 17 and 18 of the original submission.

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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 indirect ophthalmoscope HEINE OMEGA® 500 is an AC-powered or battery powered device for medical professionals, containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, vitreous) and the retina of the eye.

The HEINE OMEGA® 500 is an indirect ophthalmoscope, worn on the user's head to provide illumination and viewing optics in order to examine the retina of a patient's eve. The ophthalmoscope can be operated either by rechargeable battery or directly by mains power supply. The HEINE OMEGA® 500 allows wireless comfortable movement for the user and mobile charging (depending on chosen power source).

The provided document is a 510(k) summary for the HEINE OMEGA® 500 indirect ophthalmoscope. This type of submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance criteria through clinical studies. Therefore, the information regarding acceptance criteria and performance studies in the traditional sense of a clinical trial (e.g., sample size, expert reader qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment) is not present.

However, the document does provide information that can be interpreted as demonstrating the device meets certain performance expectations by showing its similarity to already cleared predicate devices. The "acceptance criteria" here are effectively the characteristics and performance levels of the predicate devices which the HEINE OMEGA® 500 aims to match or justify as equivalent.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission uses a comparative table to demonstrate substantial equivalence to predicate devices across various technical and safety parameters. The "Acceptance Criteria" for the HEINE OMEGA® 500 are implied by the characteristics of the predicate devices, and the "Reported Device Performance" is the stated characteristic of the HEINE OMEGA® 500.

Justification for differences (Justification 1, 2, 3):

• Justification 1 (Light Output/Irradiance): The HEINE OMEGA® 500 has lower maximum light output (lx) and retinal irradiance (mW/cm²) compared to some predicate devices. The justification argues that this lower output is acceptable because:
  • The FDA guidance advises using the minimal brightness needed for visualization.
  • Lower levels allow for longer exposure durations and reduce potential ocular damage.
  • Referenced literature ([12b]) suggests a minimum retinal irradiance of 6.3 mW/cm² is needed for viewing human fundi. The HEINE OMEGA® 500's measured irradiance (323.54 mW/cm² for LED and 465.77 mW/cm² for Halogen) is significantly higher than this minimum (51-74 times higher).
  • Therefore, the lower light output is considered safe and effective, and the device is equivalent.
• Justification 2 (Light apertures): The HEINE OMEGA® 500 has a slightly smaller "small circle" diameter for light apertures compared to the NEITZ IO-a. This difference is stated not to affect the safety or effectiveness of the device.
• Justification 3 (Interpupillary distance adjustment): The HEINE OMEGA® 500 allows for a smaller minimum interpupillary distance (46 mm) compared to predicate devices, benefiting users with eyes that are close together. This is stated not to affect the safety or effectiveness of the device.

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

Not applicable. This is a 510(k) submission based on substantial equivalence, not a clinical study involving a test set of patient data to evaluate algorithmic performance. The "testing" referred to is non-clinical performance and safety testing (e.g., electrical safety, optical radiation hazard).

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

Not applicable. No ground truth was established by experts for a test set in the context of this 510(k) submission.

4. Adjudication method for the test set

Not applicable. No test set requiring adjudication was used.

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

Not applicable. This device is an ophthalmoscope, a diagnostic instrument that is directly used by a medical professional. It does not incorporate AI or provide assistance to human readers in the way an AI-powered image analysis tool would. Therefore, an MRMC comparative effectiveness study regarding AI assistance is irrelevant.

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

Not applicable. The HEINE OMEGA® 500 is a physical medical device, an indirect ophthalmoscope, and does not have an "algorithm-only" or "AI" component to be evaluated in standalone performance.

7. The type of ground truth used

Not applicable in the context of a clinical performance study. The "ground truth" here is the established performance and safety characteristics of the predicate devices and relevant industry standards (e.g., IEC 60601-1, ISO 10943). The device's compliance with these standards and its similarity to predicate performance data are the basis for equivalence.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device requiring a training set.

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

Not applicable. This is not an AI/machine learning device requiring a training set.

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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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Bioptigen Envisu™ Spectral Domain Ophthalmic Imaging System (SDOIS) is intended to acquire, process, display and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography (SD-OCT).

The Envisu SDOIS is indicated for use as an aid in the diagnosis of physiologic and pathologic conditions of the eye through non-contact optical imaging of the various tissues of the eye is supported through the use of interchangeable lenses. It is indicated for use on patient populations from premature and neonatal infants to adult, and is suitable for patients ambulatory or confined. The system is indicated for use in upright or supine imaging, handheld or mounted, and is suited for imaģing patients under anesthesia.

The Envisu™ SDOIS is a non-contact, non-invasive and mobile ophthalmic imaging device that can be used to view ocular tissue physiology and pathology through the interaction of light with the optical scattering properties of structures of the eye.

Like its predicate, the Envisu™ Spectral Domain Ophthalmic Imaging System (SDOIS) is a nearinfrared scanning imaging medical device designed to capture depth-resolved images of ocular tissue microstructure. It is available in "high (HR)" and "very-high (VHR)" resolution based on the SLED light source chosen. Each option includes an optical engine, a scanning head, an interchangeable lens set, a computer and the InVivoVue™ Clinic software for imaging of ocular tissue microstructures. The smaller system footprint and mobile security cart easily accommodate any clinical environment.

The optical engine includes a low power broadband LED light source with bandwidths of 40 - 100 nm operating in the wavelength range between 760 - 930 nm and a spectrometer that detects backscattered radiation. The scanning head is flexibly designed to be used mounted or handheld for the mutual convenience and comfort of patient and ciinician. Handheld use of the light-weight (

The Bioptigen Envisu™ Spectral Domain Ophthalmic Imaging System (SDOIS) (K120057) did not involve a clinical study to prove its acceptance criteria. Instead, the submission leveraged non-clinical performance and safety data, as well as a review of existing clinical literature, to establish substantial equivalence to a predicate device (K063343).

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this was a 510(k) submission based on substantial equivalence to a predicate device, the "acceptance criteria" were primarily defined by the performance characteristics of the predicate device. The "reported device performance" refers to the Envisu™ SDOIS meeting or exceeding these characteristics, with specific design modifications noted.

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