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

The EnFocus™ is indicated for use as an aid in the visualization of physiologic and pathologic conditions of the eye through non-contact optical imaging. It is indicated for use on patient populations from premature and neonatal infants to adult. The system is indicated for use in supine imaging, mounted to a surgical microscope, with cooperative patients or patients under anesthesia.

The EnFocus™ is a non-contact, noninvasive ophthalmic imaging device that includes an OCT engine, a scan head and a system computer with 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 microscope for OCT imaging during ophthalmic surgical procedures. The software, InVivoVue™, works with the hardware and the 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 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 provided document describes a 510(k) submission for the Bioptigen EnFocus™ 2300 and EnFocus™ 4400 devices, which are Spectral Domain Optical Coherence Tomography (SD-OCT) systems. The submission is for a modification to an already cleared device (K150722), involving repackaging optical and computing subsystems into a single enclosure.

The core of the submission is to demonstrate substantial equivalence to the predicate device, not necessarily to prove effectiveness against clinical outcomes in a new performance study. Therefore, traditional "acceptance criteria" for a new AI/CADe device, and a study proving those criteria, are not presented in the same way. Instead, the focus is on maintaining the safety and performance of the existing predicate device.

Here's an analysis based on the provided text, addressing your questions where possible:

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

The document does not explicitly state "acceptance criteria" with numerical targets for clinical performance (e.g., sensitivity, specificity for a diagnostic task) because this is a 510(k) for a hardware and software modification to maintain equivalence, not to establish new clinical performance.

Instead, the performance evaluation in this 510(k) is aimed at demonstrating that the modified device retains the same performance characteristics as the predicate device. The section "VII. Substantial Equivalence" provides a table comparing the predicate device and the subject (modified) device across various categories, noting "Same as predicate" for most performance metrics.

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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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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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The Bioptigen Spectral Domain Ophthalmic Imaging System is intended to acquire, process, display, and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography. It is primarily intended for the imaging of retinal tissue, but the cornea, sclera, and conjunctiva can also be imaged by changing the focal position. Indications for use include the evaluation of ophthalmic tissue in routine clinical examinations and as an aid in the diagnosis of conditions that affect the optical scattering properties of ocular tissue.

The Bioptigen Spectral Domain Ophthalmic Imaging System is a noninvasive imaging device which provides microscopic tomographic sectioning of the retina with

The provided text is a 510(k) summary for the Bioptigen Spectral Domain Ophthalmic Imaging System. It outlines the device's technical specifications and compares them to predicate devices to establish substantial equivalence. However, the document explicitly states that clinical tests were "Not required" and therefore does not contain information about acceptance criteria or a study proving the device meets those criteria using expert review of clinical data.

The device gained clearance based on non-clinical tests demonstrating conformance to safety and performance standards (ISO 10942, ISO 15004-1, and ISO 15005-2.2) and a technological comparison to predicate devices, showing that differences in resolution, acquisition rate, and internal fixation did not raise new questions of safety and effectiveness.

Therefore, many of the requested details cannot be extracted from this document, as they pertain to clinical performance evaluations which were not conducted or reported for this submission.

Here's a breakdown of what can and cannot be answered from the provided text:

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

Since no clinical performance study was conducted or required for this 510(k) submission, there are no acceptance criteria related to a specific clinical performance metric (e.g., sensitivity, specificity, accuracy against a clinical ground truth). The "performance" described pertains to technical specifications compared against predicate devices.

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