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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.

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

The document states under "IX. Non-Clinical Testing" that "Image quality testing validates that the OCT image quality of the modified EnFocus™ device is statistically equivalent to the original device." It does not specify the sample size of images used for this testing, nor does it mention the provenance (country of origin, retrospective/prospective) of these images. The study's primary goal was engineering validation of the modifications, not a new clinical performance study.

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)

No information is provided about experts establishing ground truth or their qualifications. The testing described focuses on technical performance metrics (electrical safety, optical performance, image quality equivalence), rather than diagnostic accuracy requiring expert interpretation.

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

No information about an adjudication method is provided, as the testing was not clinical diagnostic performance testing.

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 was performed or is mentioned. The device is an imaging system (SD-OCT), not an AI-assisted diagnostic tool, and the submission is for a modification to the device's hardware and software, not for a new AI feature.

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

This section is not applicable. The device is a diagnostic imaging instrument; its function is to acquire and display images for human interpretation, not to provide an automated diagnostic output. The "software" mentioned (InVivoVue™) controls data acquisition and imaging, not image analysis for diagnostic purposes in an AI sense.

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

Given the nature of the validation tests (electrical safety, optical performance, image quality equivalence), the "ground truth" would be established by technical measurement standards and comparison to the predicate device's measured performance. For "Image quality testing," it means establishing that the modified device's image quality metrics statistically match those of the predicate, rather than being compared against a clinical ground truth like pathology for a specific disease.

8. The sample size for the training set

This is not applicable since this is not an AI/machine learning device that requires a training set in that context. The "software" mentioned (InVivoVue™) is operating system and image acquisition/display software, not a deep learning model.

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

Not applicable for the reasons stated above.

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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:

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 (< 3.5 lbs), compact handheld scanner makes it possible to image pediatric patients, supine patients, or any patient that finds it difficult to sit upright or where it is clinically preferable to image without the constraint of a chin rest. Tabletop, chin-rest mediated imaging is enabled though a mounting accessory.

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.

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

No specific test set or data provenance (country, retrospective/prospective) explicitly described for a clinical study. The submission relies on:

• Non-clinical performance and safety data: This involves testing under established protocols (e.g., IEC standards, image resolution, image comparison, software validation).
• Clinical Literature Review: This review analyzed existing peer-reviewed publications on handheld SDOIS for pediatric populations, suggesting safety, non-invasiveness, and effectiveness.

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 establishment by experts for a test set is described, as a clinical study was not performed by Bioptigen.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set or adjudication method is described.

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 imaging system, not an AI-assisted diagnostic tool, and no MRMC study was conducted or described.

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

Not applicable. This device is an imaging system, not an algorithm, and no standalone algorithm performance was assessed.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance, in the context of this 510(k), was largely established by:

• Engineering specifications and measurements: Demonstrating that the device's technical specifications met or exceeded those of the predicate device.
• Compliance with recognized standards: Such as IEC-60601-1, IEC 60601-1-2, IEC 60825-1, and ISO 15004-2 for electrical, electromagnetic, optical emission, and safety.
• Referencing existing clinical literature: To support the safety and effectiveness of the technology (SDOIS) for its intended use, particularly for handheld operation in different patient populations.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning algorithm, so there is no concept of a "training set" in this submission.

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

Not applicable. No training set was used.

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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 <= 6 microns axial resolution. The Bioptigen System is capable of 20,000 A-Scans/second due to the nature of spectral domain optical coherence tomography. The Bioptigen Spectral Domain Ophthalmic system is composed of a host computer, engine, and probe. The OCT engine is driven by instrument cards in the computer. The device software will allow a user to create, display, load, and save image files (OCT files).

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.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the "acceptance criteria" (defined here as technical specifications substantially equivalent to or improved over predicate devices) is the non-clinical technical comparison and conformance to standards (ISO 10942, ISO 15004-1, and ISO 15005-2.2). The submission argues that even with technological differences (e.g., improved axial resolution, higher scan rate), these do not present new questions of safety and effectiveness, thus demonstrating substantial equivalence.

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

Not applicable. No clinical test set was required or used for this 510(k) submission.

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 clinical test set or expert-established ground truth was required for this 510(k) submission.

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

Not applicable. No clinical test set or adjudication was required for this 510(k) submission.

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 imaging system, not an AI-powered diagnostic aid or reader assistance tool. No MRMC study was performed or required.

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

Not applicable. This device is an imaging system, not an algorithm/AI with standalone diagnostic performance.

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

Not applicable. No clinical ground truth was required for this 510(k) submission, as it relied on technical specifications and conformance to international safety/performance standards.

8. The sample size for the training set

Not applicable. This device is an imaging system, not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is an imaging system, not an AI/ML algorithm requiring a training set.

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