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The CLARUS 700 ophthalmic camera is indicated to capture, display, annotate and store images to aid in the diagnosis and monitoring of diseases and disorders occurring in the retina, ocular surface and visible adnexa. It provides true color and autofluorescence imaging modes for stereo, widefield, ultra-widefield, and montage fields of view.

The CLARUS 700 angiography is indicated as an aid in the visualization of vascular structures of the retina and the choroid.

The CLARUS 700 is an active, software controlled, high resolution ophthalmic imaging device for In-vivo imaging of the human eye. Imaging modes include True color, Fundus Auto-fluorescence with green excitation, Fundus Auto-fluorescence with blue excitation, Fluorescein Angiography, Stereo External eye and Fluorescein Angiography- Indocyanine green angiography (FA-ICGA). All true color images can be separated into red, green and blue channel images to help enhance visual contrast of details in certain layers of the retina.

The CLARUS 700 angiography imaging aids in the visualization of the vascular structures of the retina and the choroid. With a single capture, CLARUS 700 produces a 90º high definition widefield image. Widefield images are automatically merged to achieve a 135º ultra-widefield of view. The CLARUS 700 makes use of a deep learning algorithm for Optic Nerve Head (ONH) detection. The ultra-widefield montage on CLARUS 700 is no longer dependent just on the patient accurately fixating their gaze on the internal fixation. With the ONH detection, the software will find the optic nerve and determine based on the image(s) captured where the patient was gazing at the point of capture. The CLARUS 700 device allows clinicians to easily review and compare high-quality images captured during a single exam while providing annotation and caliper measurement tools that allow in-depth analysis of eye health. CLARUS 700 is designed to optimize each patient's experience by providing a simple head and chin rest that allows the patient to maintain a stable, neutral position while the operator brings the optics to the patient, facilitating a more comfortable imaging experience. The ability to swivel the device between the right and left eye helps technicians capture an image without realigning the patient. Live IR Preview allows the technician to confirm image quality and screen for lid and lash obstructions, prior to imaging, ensuring fewer image recaptures.

The CLARUS 700 device's principle of operation is Slit Scanning Ophthalmic Camera also referred to as Broad Line Fundus Imaging (BLFI). During image capture, a line of illumination passes through the slit and scans across the retina. A 2D monochromatic camera captures the returned light to image the retina. A single sweep of the illumination is used to illuminate the retina for image capture. Repeated sweeps of near infrared light are used for a live retina view for alignment. Red, green and blue LEDs sequentially illuminate to generate true color images. Blue and green LED illumination enables Fundus Autofluorescence (FAF) imaging. Fluorescein Angiography images are captured with green LED illumination at a wavelength that stimulates fluorescence of the injected sodium fluorescein dye. The principle of operation of CLARUS 700 has not changed since the previous clearance, K191194.

The CLARUS 700 system is mainly comprised of an acquisition device, all-in-one PC, keyboard, mouse, instrument lift table and external power supply.

The device hardware is based on the predicate CLARUS 700 (K191194) hardware. The new ICGA imaging mode on the device required the following hardware changes as stated in the summary above:

• Lightbox for Infrared (IR) Laser
• Modified Slit filter – FA/ICG Slit Excitation Filter – new coating, no change to FA
• Modified Turret Filter 1- FA/ICG Dual Band barrier filter – new coating, no change to FA.
• Added Turret Filter 2 – Added second filter. Same coating as Turret Filter 1 to eliminate cornea reflex band in ICG images with a different shape.
• Added Large Alignment Tool (LAT)
• Added ICG Power Meter Tool

The CLARUS software provides the user the capability to align, capture, review and annotate images. The software has two installation configurations: Software installed on the Instrument (Acquisition & Review) as well as Software installed on a separate 'Review Station' (Laptop or Computer) (only Review).

The DEVICE software version 1.2 is based on the predicate CLARUS 700 software version 1.0 (K191194).

Added capability for DEVICE software version 1.2 include:

• Simultaneous capture of Fluorescein Angiography (FA) + Indocyanine Green Angiography (ICGA)
• Angiography Movie: Capture of multiple pictures in sequence, after a single press of a button. Available for FA, ICGA and Simultaneous FA+ICGA.
• Early Treatment Diabetic Retinopathy Study (ETDRS) – Manual placement of ETDRS grids (7 field ETDRS and Macula ETDRS) over the pictures:
  • The ETDRS 7-fields grid in CLARUS is a display of the standard 7-fields in Color Fundus Photography used to determine an ETDRS (Early Treatment Diabetic Retinopathy Study) level for patients with Diabetic Retinopathy. These 7-fields in and around the macular region are displayed in one single widefield image according to definitions followed by the gold-standard 7-field images using narrow-field fundus cameras.
  • The Macular ETDRS grids display assists in the identification of an ETDRS level in nine subfields centered around the fovea.
• ICGA Boost Mode: user-selectable option for ICGA capture that increase used light to obtain better picture at later phase.
• 8 up view: addition of the possibility to view eight pictures side by side (currently it is only possible to see 1, 2, 4, 16)

The CLARUS 700 device meets the requirements of ISO 10940:2009 standard. The device technical specifications are identical to the predicate device.

The provided text is a 510(k) clearance letter and summary for the CLARUS 700 ophthalmic camera, particularly focusing on the new v1.2 software update. While it discusses the device's intended use, technical characteristics, and various tests performed, it does not contain detailed acceptance criteria or the specific results of a comprehensive clinical study in the format of "acceptance criteria vs. reported device performance."

The document mentions "clinical testing aimed at demonstrating the ability of the new model of CLARUS 700 to image a variety of retinal and choroidal conditions using simultaneous FA and simultaneous ICGA and standalone ICGA." It states that "Our analysis of the grading of angiography images showed that the quality of the images captured by the CLARUS 700 simultaneous FA, simultaneous ICGA, and standalone ICGA were clinically acceptable by three independent graders." However, this is a qualitative statement rather than quantitative acceptance criteria with specific performance metrics.

Therefore, I cannot populate a table of acceptance criteria and reported device performance from the provided text. I can, however, extract related information from the "Clinical Data" section:

Acceptance Criteria and Study Details (Based on provided text)

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The document states that the "quality of the images... were clinically acceptable by three independent graders." This implies an implicit acceptance criterion that images must be "clinically acceptable." However, no quantitative threshold (e.g., "90% of images must be clinically acceptable") is provided, nor are specific quantitative performance metrics (e.g., actual percentage of acceptable images).

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

• Test Set Sample Size: Not specified in the provided text.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The text only states "ZEISS conducted clinical testing."

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

• Number of Experts: Three independent graders.
• Qualifications of Experts: Not specified (e.g., "radiologist with 10 years of experience").

4. Adjudication Method for the Test Set:

• Adjudication Method: Not specified beyond "three independent graders." It does not mention if consensus, majority rule (e.g., 2+1), or another method was used for discordant readings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done and the Effect Size of how much human readers improve with AI vs without AI assistance:

• MRMC Study: No, an MRMC comparative effectiveness study was not described. The study focused on the image quality produced by the device as assessed by human graders, not on the improvement of human readers' performance with AI assistance.
• Effect Size: Not applicable, as no MRMC study comparing human readers with/without AI assistance was conducted or reported. The device's deep learning algorithm for ONH detection is noted, but its specific impact on reader performance or an MRMC study related to it is not detailed.

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

• Standalone Performance: Not explicitly detailed or quantified. The document notes that "The CLARUS 700 makes use of a deep learning algorithm for Optic Nerve Head (ONH) detection." However, no standalone performance metrics (e.g., specificity, sensitivity, accuracy) for this algorithm are provided in the clinical data summary.

7. The Type of Ground Truth Used:

• Type of Ground Truth: Expert grading/consensus from "three independent graders" on "clinical acceptability" of angiography images. It is not stated if this was against a pathology or outcomes data gold standard.

8. The Sample Size for the Training Set:

• Training Set Sample Size: Not specified in the provided text. The document refers to a "deep learning algorithm for Optic Nerve Head (ONH) detection." While this implies a training set was used, its size is not disclosed.

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

• Ground Truth for Training Set: Not specified.

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Clarus Viewer® Version 1.0 is a software solution intended to be used for viewing, manipulation, storage, 3D-visualization, and comparison of medical images from multiple imaging modalities and/or multiple timepoints. The application supports images and anatomical datasets, limited to CT and MR.

Clarus Viewer® supports the interpretation of examinations and follow-up documentation of findings within healthcare institutions, for example, in Radiology and other Medical Imaging environments. It is intended to provide image and related information that is interpreted by a trained professional but does not directly generate any diagnosis or potential findings.

Note: The medical professional retains the ultimate responsibility for making the perfinent diagnosis based on their standard practices. Clarus Viewer is a complement to these standard procedures. Clarus Viewer® is not intended for the displaying of digital mammography images for diagnosis.

Clarus Viewer® is a stand-alone software package that imports medical data in the Digital Imaging and Communications and Medicine (DICOM) standard, stored on local or remote PACS sources. Clarus Viewer® is intended to allow users to visualize and manipulate 2D and 3D images and models of CT and MRI datasets and visualize and manipulate 3D volumetric models. Clarus Viewer® can present the 2D and 3D images in either a desktop mode or in Virtual Reality.

Within Clarus Viewer®, users can strip away layers of bone and tissue, revealing the relevant images for evaluation. Users can view and evaluate the 3D model from any angle. In the same way a doctor may hold and rotate a physical anatomical model in the real world, within Clarus Viewer® the image can be rotated and examined, or sliced away or apart to examine interior structures, tissues, and fluids.

The Clarus Viewer® system is intended to be used as a supplemental viewer by trained medical professionals. It allows the user to view images, models, and related medical information that can then be interpreted by a trained professional. Clarus Viewer® does not directly generate any diagnosis. The medical professional retains the ultimate responsibility for making the diagnosis.

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

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

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like a typical validation report would. Instead, it lists the types of studies conducted to support substantial equivalence. The overall "acceptance criteria" can be inferred as demonstrating that the Clarus Viewer® performs as safely and effectively as the predicate device (ImmersiveTouch, K210726), and that any differences do not raise new questions of safety or effectiveness.

Therefore, a table of stated acceptance criteria and device performance cannot be directly extracted from the provided text. The document refers to "Performance Data" which includes various tests, implying successful completion of these tests serves as evidence of meeting unstated criteria for 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)

The document does not specify the sample size for any test set (e.g., number of medical images or patient cases). It also does not explicitly state the provenance of the data (e.g., country of origin, retrospective or prospective) for any of the studies mentioned.

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)

The document does not provide information on the number of experts used to establish ground truth or their specific qualifications for any of the performance tests. It states that the device is intended to provide image and related information that is "interpreted by a trained professional," implying that expert interpretation is involved in the clinical context, but not specifically for ground truth establishment in a test set.

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

The document does not mention any adjudication method for establishing ground truth or resolving discrepancies in expert interpretations during 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

The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was conducted, nor does it mention any AI assistance or effect sizes related to human reader improvement. The Clarus Viewer® is described as a "supplemental viewer" and states it "does not directly generate any diagnosis or potential findings," suggesting its role is primarily for visualization and manipulation, not AI-driven interpretation or diagnosis.

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

The Clarus Viewer® is a software solution for viewing, manipulating, and visualizing medical images. It does not generate diagnoses or findings independently. Therefore, a standalone (algorithm only) performance study in the context of generating diagnostic output would not be applicable, and the document does not suggest such a study was performed. The device's performance is tied to its capabilities for visualization and manipulation to aid trained professionals.

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

The document does not explicitly state the type of ground truth used for any of its performance evaluations. Given the device's function as a visualization and manipulation tool, the "Clinical Validation" and "Clinical Evaluation" likely involve assessing the accuracy and utility of the rendered 3D models and image aspects against observed anatomical structures or clinical findings, but the specific method of ground truth establishment is not detailed.

8. The sample size for the training set

The document does not provide information on the sample size for a training set. This is consistent with the device being described as a "viewer" and "image management and processing system" rather than an AI/ML diagnostic algorithm that typically requires extensive training data. The "Clarus data" mentioned in the software testing section likely refers to data processed by the viewer, not a training set for an algorithm.

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

Since the document does not mention a training set, it does not describe how ground truth for such a set was established.

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The Clarus Peel-Away Introducer Sheath is intended to be used in indications requiring access through the brain into the ventricular system.

The Clarus Peel-Away Introducer Sheath is a thin-walled, cylindrical device that is placed in position so that it provides a communicating passageway through brain tissue. This is accomplished by fitting the sheath securely over an obturator, advancing both devices through the tissue together as a unit. A hole through the distal tip of the obturator aids in placement by allowing pressurized cerebrospinal fluid to egress once the ventricular system is reached. The proximal hub on the obturator is rotated, unlocking it from the sheath, and the obturator is removed from the sheath, leaving the sheath alone in the desired position acting to hold the penetrated site in an open condition. The peel away sheath is capable of being pulled apart lengthwise to allow varying insertion depths into brain tissue. The proximal end of the sheath has tab handles that are provided to facilitate grasping and tearing. At this point, a regulatorily cleared device can be inserted through the sheath for patient procedures.

The provided text describes the Clarus Peel-Away Introducer Sheath and its substantial equivalence determination. Here's a breakdown of the acceptance criteria and study details based on the provided FDA 510(k) summary:

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

The acceptance criteria for the Clarus Peel-Away Introducer Sheath were based on demonstrating substantial equivalence to predicate and reference devices, primarily through biocompatibility and mechanical testing. The reported device performance indicates that the device passed all tests and had comparable results to the predicate/reference devices.

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

The document does not explicitly state the sample sizes used for the biocompatibility or mechanical testing. It mentions "Components of the Clarus Peel-Away Introducer Sheath and predicate devices were tested," implying that multiple units were tested, but no specific numbers are provided.

The data provenance is not specified regarding country of origin or whether studies were retrospective or prospective. Given this is a 510(k) submission for a medical device, the testing would generally be prospective to generate data for the 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)

This information is not applicable to the type of device and testing described. The acceptance criteria for this device are based on objective performance characteristics (biocompatibility, mechanical properties) rather than interpretation requiring expert consensus. There were no "ground truth" labels established by experts in the context of image interpretation or diagnostic accuracy studies.

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

Not applicable. As noted above, this device's evaluation relies on objective physical and material property tests rather than diagnostic interpretation requiring adjudication.

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 a physical introducer sheath, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are not relevant.

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

Not applicable. This is a physical medical device, not an algorithm.

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

For biocompatibility testing, the "ground truth" is adherence to established international standards (ISO 10993-1) and the successful completion of specific biological tests, with "acceptable" results serving as the ground truth for safety.

For mechanical testing, the "ground truth" is typically defined by engineering specifications, material properties, and comparison to the performance of predicate devices that are already deemed safe and effective. "Pass" results and "comparable results" to predicates served as the ground truth for performance.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this device is not based on machine learning or AI models that require training data.

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

Not applicable, as there is no training set for this type of device.

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The CLARUS 700 ophthalmic camera is indicated to capture, display, annotate and store images to aid in the diagnosis and monitoring of diseases and disorders occurring in the retina, ocular surface and visible adnexa. It provides true color and autofluorescence imaging modes for stereo, widefield, ultra-widefield, and montage fields of view. The CLARUS 700 angiography is indicated as an aid in the visualization of vascular structures of the retina and the choroid.

The CLARUS™ model 700 is a new addition to the CLARUS product family consisting of existing model 500 (K181444). The CLARUS 700 is an active, software controlled, highresolution ophthalmic imaging device for In-vivo imaging of the human eye. Imaging modes include True color, Fundus Auto-fluorescence with green excitation. Fundus Auto-fluorescence with blue excitation. Fluorescein Angiography, Stereo and External eve. All true color images can be separated into red, green and blue channel images to help enhance visual contrast of details in certain layers of the retina. The CLARUS 700 angiography imaging aids in the visualization of the vascular structures of the retina and the choroid. With a single capture, CLARUS 700 produces a 90° high definition widefield image. Widefield images are automatically merged to achieve a 135° ultra-widefield of view. The CLARUS 700 makes use of a deep learning algorithm for Optic Nerve Head (ONH) detection. The ultra-widefield montage on CLARUS 700 is no longer dependent just on the patient accurately fixating their gaze on the internal fixation. With the ONH detection, the software will find the optic nerve and determine based on the image(s) captured where the patient was gazing at the point of capture. The CLARUS 700 device allows clinicians to easily review and compare high-quality images captured during a single exam while providing annotation and caliper measurement tools that allow in-depth analysis of eye health. CLARUS 700 is designed to optimize each patient's experience by providing a simple head and chin rest that allows the patient to maintain a stable, neutral position while the operator brings the optics to the patient. facilitating a more comfortable imaging experience. The ability to swivel the device between the right and left eye helps technicians capture an image without realigning the patient. Live IR Preview allows the technician to confirm image quality and screen for lid and lash obstructions, prior to imaging, ensuring fewer image recaptures.

The CLARUS 700 device's principle of operation is Slit Scanning Ophthalmic Camera also referred to as Broad Line Fundus Imaging (BLFI), same as the predicate CLARUS 500 (K181444). During image capture, a line of illumination passes through the slit and scans across the retina. A 2D monochromatic camera captures the returned light to image the retina. A single sweep of the illumination is used to illuminate the retina for image capture. Repeated sweeps of near infrared light are used for a live retina view for alignment. Red, green and blue LEDs sequentially illuminate to generate true color images. Blue and green LED illumination enables Fundus Autofluorescence (FAF) imaging. Fluorescein Angiography images are captured with green LED illumination at a wavelength that stimulates fluorescence of the injected sodium fluorescein dye.

The CLARUS 700 system is mainly comprised of an acquisition device, all-in-one PC, keyboard, mouse, instrument lift table and external power supply.

The CLARUS 700 hardware is based off the predicate CLARUS 500 (K181444) hardware. New FA imaging mode on the CLARUS 700 require the below hardware changes:

• Added filters to support FA imaging mode .
• Updated slim turret and motor with new positions for reliability, angiography filters and ● FPGA code
• Updated calibration tool for new turret positions and differentiation
• Change to lightbox board for reliability and support higher duty cycle in support of FA imaging
• Updated Onyx All-in-one Computer for 32GB RAM and 2TB HDD storage space
• Updated belt driven slit for reliability and to support FA imaging mode ●
• . Updated camera to support FA imaging mode

The CLARUS software provides the user the capability to align, capture, review and annotate images. The software has two installation configurations: Software installed on the Instrument (Acquisition & Review) as well as Software installed on a separate 'Review Station' (Laptop or Computer) (only Review).

The CLARUS software version 1.1 is based off the predicate CLARUS software version 1.0 (K181444). Added image capture modality includes Fluorescein Angiography. Other changes implemented in the software version 1.1 include:

• Automated Optic Nerve Head (ONH) detection for montaging ●
• Smart (Region of Interest) Focus ●
• Auto brightness for FA image series
• Calibration software update for DEVICE hardware changes ●
• . FORUM/ Other EMR connectivity updates for new FA imaging mode

The CLARUS 700 device meets the requirements of ISO 10940:2009 standard. The device technical specifications are identical to the predicate device. The performance specifications relevant to the user are summarized in the Table 1 below.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for the CLARUS 700:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document only provides the reported device performance as "passing rates" for the Fluorescein Angiography (FA) imaging mode, without explicitly stating numerical acceptance criteria for each point. The acceptance criteria are implied to be high percentages, demonstrating good clinical utility and image interpretability.

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

• Sample Size: 20 eyes from 13 subjects (11 male, 2 female)
• Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. However, based on the nature of a "clinical study to support indications for use," it is highly probable that it was a prospective study designed for regulatory submission. The location of the manufacturer (Dublin, California, USA) suggests the study might have been conducted in the US, but this is not explicitly stated for the clinical data itself.

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

The document does not explicitly state the number of experts used or their specific qualifications for establishing the ground truth of the test set images. It mentions "clinically useful image" and "ability to interpret image," implying expert evaluation, but the specifics are not provided in this summary.

4. Adjudication Method for the Test Set:

The document does not mention any specific adjudication method (e.g., 2+1, 3+1). Expert consensus or independent review by a single expert is implied by the evaluation of "clinical utility" and "interpretability," but the process is not detailed.

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

• Was an MRMC study done? No, a traditional MRMC comparative effectiveness study involving human readers with and without AI assistance was not explicitly conducted or reported for the performance of AI on human readers.
• Effect Size: Therefore, no effect size for human reader improvement with AI assistance is reported.

Note on AI: The device does make use of a deep learning algorithm for Optic Nerve Head (ONH) detection to improve montage creation, but the clinical study described focuses on the overall performance of the Fluorescein Angiography imaging mode, not specifically on the impact of ONH detection AI on reader performance.

6. Standalone (Algorithm Only) Performance:

The document does not present separate standalone (algorithm-only) performance metrics for the deep learning algorithm (ONH detection). The clinical study evaluates the device's ability to capture useful images, which would indirectly incorporate the functionality of the device's software, but it's not a standalone performance evaluation of the AI component in isolation.

7. Type of Ground Truth Used:

The ground truth used for evaluating the clinical utility of the Fluorescein Angiography images appears to be expert clinical judgment/interpretation of the images. The criteria like "Area and lesion of interest is visible on the angiogram" and "Clinically useful image" strongly suggest evaluation by a medical professional or panel thereof. The study's objective was to demonstrate the device's ability to capture images useful for "diagnosis and monitoring of diseases and disorders," further supporting expert clinical judgment as the ground truth.

8. Sample Size for the Training Set:

The sample size for the training set of the deep learning algorithm (ONH detection) is not specified in the provided document.

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

The document briefly mentions "deep learning algorithm for Optic Nerve Head (ONH) detection" but does not detail how the ground truth for training this algorithm was established. It can be inferred that it would involve expertly annotated images for ONH location, but the specifics are not provided.

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The CLARUS 500 ophthalmic camera is indicated to capture, display, annotate and store images to aid in the diagnosis and monitoring of diseases and disorders occurring in the retina, ocular surface and visible adnexa. It provides true color and autofluorescence imaging modes for stereo, widefield, ultra-widefield, and montage fields of view.

The CLARUS™ 500 is an active, software controlled, high-resolution ophthalmic imaging device for In-vivo imaging of the human eye. Imaging modes include True color, Fundus Autofluorescence with green excitation, Fundus Auto-fluorescence with blue excitation, Stereo and External eye. All true color images can be separated into red, green and blue channel images to help enhance visual contrast of details in certain layers of the retina. With a single capture, CLARUS 500 produces a 90° high definition widefield image. Widefield images are automatically merged to achieve a 135° ultra-widefield view. The technology allows clinicians to easily review and compare high-quality images captured during a single exam while providing annotation and caliper measurement tools that allow analysis of eye health. CLARUS 500 is designed to optimize each patient's experience by providing a simple head and chin rest that allows the patient to maintain a stable, neutral position while the operator brings the optics to the patient, facilitating a more comfortable imaging experience. The ability to swivel the device between the right and left eye helps technicians capture an image without realigning the patient. Live Infrared Preview allows the technician to confirm image quality and screen for lid and lash obstructions, prior to imaging, ensuring fewer image recaptures.

The CLARUS 500 device's principle of operation is based on Slit Scanning Ophthalmoscope also referred to as Broad Line Fundus Imaging (BLFI). During image capture, a broad line of illumination is scanned across the retina. A monochromatic camera captures the returned light to image the retina. A single sweep of the illumination is used to illuminate the retina for image capture. Repeated sweeps of near infrared light are used for a live retina view for alignment. Red, green and blue LEDs sequentially illuminate to generate true color images. Blue and green LED illumination enables Fundus Autofluorescence (FAF) imaging.

The CLARUS 500 system is mainly comprised of an acquisition device, all-in-one PC, keyboard, mouse, instrument lift table and external power supply.

The CLARUS software provides the user the capability to align, capture, review and annotate images. The software has two installation configurations: Software installed on the Instrument (Acquisition & Review) as well as Software installed on a separate 'Review Station' (Laptop or Computer) (only Review).

The CLARUS 500 technical features relevant to the user are: Field of View (FoV), Image Resolution, Pixel Pitch and Focusing Range. The device meets the requirements of ISO 10940:2009 standard. The performance specifications are summarized in the Table 1 below.

The provided document describes the Carl Zeiss Meditec CLARUS 500 ophthalmic camera. However, it does not explicitly state acceptance criteria or a detailed study proving the device meets specific performance criteria in the format requested. The document focuses on demonstrating substantial equivalence to predicate devices for FDA clearance.

Despite this, I can extract information related to performance and testing:

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

The document doesn't provide a formal "acceptance criteria" table like one might find in a clinical trial protocol for an AI device. Instead, it lists technical specifications and states that the device meets an ISO standard and passed various verification and validation tests.

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 mentions "A clinical study was conducted" for both general imaging modes and FAF imaging modes.

• Sample Size: Not specified.
• Data Provenance: Not specified (country/region, retrospective/prospective). It simply states "A clinical study was conducted."

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 specified. The document only mentions that the study "concluded that similar amount of clinical features can be resolved." There is no detail on how this "ground truth" or comparison was established by experts.

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

Not specified.

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, this is not an AI device, and therefore no MRMC comparative effectiveness study involving AI assistance for human readers was done or described. The clinical study mentioned compares the device's imaging modes to a reference device. The focus is on the performance of the imaging capture, not an AI interpretation aid.

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

The CLARUS 500 is an imaging device, not an AI algorithm for interpretation. Its performance is inherent in the quality of the image capture. The "standalone" performance would be the image quality itself, which is verified through technical specifications and ISO compliance. The clinical study compares the "performance of the CLARUS 500 imaging modes" (standalone imaging output) to a reference device.

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

For the clinical study on imaging modes, the "ground truth" seems to be the ability to resolve "clinical features" when compared to images from a reference device. This implies a qualitative assessment, likely by clinicians, but the specific method or standard for "ground truth" (e.g., expert consensus on feature visibility, comparison to an actual disease state) is not detailed.

8. The sample size for the training set:

Not applicable, as this is an imaging device, not a machine learning algorithm that requires a training set in the typical sense. The software verification would involve testing against requirements, not "training data."

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

Not applicable, as it's not a machine learning algorithm with a training set.

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FOR VISUALIZATION OF AIRWAY ANATOFILY AND INDICATED PLACING AND CONFIRMING PLACEMENT of AID IN THE To ARTIFICIAL AIRWAYS

The Model 30000-V endoscope is a tubular device with a malleable shaft. The optical element of the endoscope consists of a small diameter camera bonded into the distal tip of the endoscope shaft. The removable shaft of the endoscope is attached to the battery and video screen by means of various electrical connectors. Illumination light is provided at the tip of the endoscope for direct viewing. The removable shaft of the endoscope is soakable and can be high-level disinfected. A waterproof cap is provided to protect the connector during the cleaning/disinfection process.

The provided text describes a 510(k) summary for the Clarus Model 30000-V Video Endoscope. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive new clinical studies with defined acceptance criteria and statistical analysis of performance against ground truth. Therefore, much of the requested information, particularly regarding detailed performance metrics, ground truth establishment, expert involvement, and MRMC studies, is not present in this document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for substantial equivalence, formal acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity) against a specific ground truth are not provided. The acceptance criteria for this submission are based on demonstrating equivalence to predicate devices and meeting physical and biocompatibility requirements.

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

• Test Set Sample Size: Not applicable/Not explicitly stated. The submission primarily relies on demonstrating substantial equivalence to predicate devices and meeting physical and biocompatibility testing. There is no mention of a clinical test set with a specific sample size used to evaluate performance against ground truth in a clinical setting.
• Data Provenance: Not applicable.

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

• Number of Experts: Not applicable. No clinical test set requiring ground truth establishment by experts is described in this 510(k) summary.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No clinical test set requiring expert adjudication is described in this 510(k) summary.

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

• MRMC Study: No. The document does not describe any MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated, nor does it quantify any effect size. This type of study is more common for AI-driven diagnostic or screening tools.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• Standalone Study: No. The device is a video endoscope, a tool used by a human practitioner for visualization. Its performance is intrinsically linked to human-in-the-loop operation, and the concept of an "algorithm only" standalone performance is not relevant to this device type as described.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable for clinical performance evaluation. The "ground truth" implicitly used for this 510(k) is the established safety and effectiveness of the identified predicate devices, as well as the successful completion of standard physical and biocompatibility testing.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is a traditional medical device (video endoscope), not an AI/ML-driven device that requires a training set for model development.

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

• Ground Truth for Training Set Establishment: Not applicable. As stated above, this is not an AI/ML device requiring a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets the "acceptance criteria" (in the context of a 510(k) submission) is the demonstration of substantial equivalence to legally marketed predicate devices and the successful completion of physical and biocompatibility testing.

The key elements of this "study" are:

• Comparison to Predicate Devices: The Clarus Model 30000-V Video Endoscope was compared to Vision-Sciences ENT-5000 and ENT-5100 Video ENTS (K072073), Karl Storz Video Bronchoscope System (K071530), Clarus 2127 Murphy Pen (K962255), and ETVIEW Tracheoscopic Ventilation Tube System (TVT), K052233. The submission asserts equivalence in materials, sizes, configurations, packaging, disinfection methods, and especially in the "Indications for Use: visualization of airway anatomy to aid in the placing and confirming placement of artificial airways."
• Physical Testing: Included dimensional inspection, visual examination for workmanship, bond strength testing, optical clarity, light transmittance, and distal tip temperature study. While specific results are not detailed in this summary, the completion of these tests suggests they met internal specifications.
• Biocompatibility Testing: Confirmed that all materials in contact with human tissue are biocompatible and suitable for the application.

The conclusion drawn from these comparisons and tests is that "this product do not raise any new safety or effectiveness issues," thereby satisfying the requirements for 510(k) clearance by demonstrating substantial equivalence.

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The Clarus Model 1150 Straight Firing Laser Fiber may be used both intraoperatively and percutaneously through regulatory cleared delivery systems.

The Clarus Model 1150 Straight Firing Laser is for use in general, urological, OB-GYN, orthopedic (including lumbar and cervical), and ENT laser surgical procedures for cutting, vaporizing, or coagulating in any soft tissue application for which Ho:YAG lasers have been cleared.

Model 1150 Clarus Straight Firing Laser Fiber

The provided text is a 510(k) summary for the "Model 1150 Clarus Straight Firing Laser Fiber." It details general information, predicate devices, intended use, and the FDA's regulatory response. However, it does not include any information about detailed acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot provide the requested table and study summary. The document is solely a regulatory submission and approval notification, not a performance study report.

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The Clarus Straight Firing Laser Fiber and the Clarus Side Firing Lasers Fiber are for use in general, urological, OB-GYN, orthopedic, and ENT laser surgical procedures for cutting, vaporizing, or coagulating in any soft tissue application for which Ho:YAG lasers have been cleared.

This 510(k) submission is a modification of the existing Clarus Model 1150 Lascr Fiber previously filed as K922881 and found to be substantially equivalent by the FDA on November 16, 1992. The original 510(k) device was a single-use, straight firing laser fiber with a fiber indicated for laser disc decompression where the laser is used to remove inner disc material. The laser fiber core ranges from 380 -- 600 microns. The modifications represented by this submission are the addition of a reusable fiber, a side firing version (Model 1160), increased indications for any soft tissue application for which Ho:YAG lasers have been cleared, and an increased laser fiber core size range from 200 – 1000 microns.

The Model 1150 Clarus Straight Firing Fiber is identical in materials, methods of manufacture, sterilization, and dimensions to the currently marketed Clarus Model 1150 Laser Fiber (K922881) with the following exceptions. These exceptions are: making the fiber assembly reusable, increasing the range of the laser fiber core size from 380 - 600 microns to 200 - 1000 microns, and the indications for use. The distal end is polished flat and the laser energy is transmitted in a forward direction. The low OH fiber is terminated on the proximal end with a standard compatible laser connector. These devices consist of an optical fiber, which may be contained in a catheter tube, cannula. needle, handpiece or handle.

The Model 1160 Clarus Side Firing Laser Fiber is built identical to the Model 1150 Clarus Straight Firing Fiber listed above with the following exceptions. The exceptions being that the entire working length of the fiber is in a protective sheath and the distal end is polished at an angle, and then terminated in a quartz. cap. The distal tip includes an exit beam indicator that is easily visible to the operator when the fiber is placed through an endoscope. On the proximal end, the low OH fiber is terminated with a standard compatible laser connector.

The Clarus Model 1150 Straight Firing and the Clarus Model 1160 Side Firing Laser Fibers are supplied sterile (ETO) and are intended for reuse.

The Clarus Straight Firing and the Clarus Side Firing Laser Fibers may be used both intraoperatively and percutaneously through regulatory cleared delivery systems.

The provided text does not contain information related to acceptance criteria, a study proving device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

The document is a 510(k) summary for laser fibers, detailing general information, predicate devices, intended use, and device description. It also includes the FDA's substantial equivalence letter. There is no mention of a clinical or performance study with defined acceptance criteria.

Therefore, I cannot fulfill your request for these specific details based on the provided input.

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The Clarus 6000 SITEtrac Discectomy System is intended for surgical use in the lumbar spine. It is supplied non-sterile and is intended for reuse. The Model 6020 Dilators and Model 6021 Retractors are intended to be used to dilate then retract the tissue in the region of the lumbar spine. This will provide an access point to apply surgical techniques through the tubular retractor under endoscopic visualization.

The Model 6000 Discectomy System is a set of gradually increasing dilators and retractors (4.67mm to 20mm) that dilate then retract tissue in the region of the lumbar spine. This will provide as access point to apply surgical techniques through the tubular retractor under endoscopic visualization.

These reusable dilators and retractors are equivalent to those used in Sofamor Danek MED(****) MicroEndoscopic Discectomy System" The comparisons of these devices are shown in Table I These retractors and dilators will be sold as a kit (See Kit Certification- Attachment F).

Cleaning and sterilization procedures for the, dilators, retractors, and spinal needle, are contained in the Directions for Use ( See Attachment A).

The provided text is a 510(k) summary for the Clarus Model 6000 Discectomy System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to fully answer all components of your request regarding acceptance criteria and a study proving device performance, especially in the context of AI/ML-based medical devices.

Here's a breakdown of what can be extracted and what cannot, based on the provided text:

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

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds or performance metrics with numerical targets. The primary "acceptance criteria" for a 510(k) submission is demonstrating substantial equivalence to a predicate device.
• Reported Device Performance: The document states: "The Clarus Model 6000 Discectomy System contains a set of dilators and retractors that is similar to the Sofamor Danek (K unknown) dilators and retractors in their MED MicroEndoscopic Discectomy System." and "Clarus believes these products do not raise any new safety or effectiveness issues and are substantially equivalent to existing marketed devices." This is the core "performance" claim in a 510(k) – that it performs equivalently to an already approved device. The "performance" is implicitly tied to its mechanical function (dilating and retracting tissue) being similar to the predicate.

Given the nature of this submission (a 510(k) for a mechanical surgical device from 1998, not an AI/ML device), the concept of "acceptance criteria" and "reported device performance" as you might expect for an AI model (e.g., sensitivity, specificity, AUC thresholds) is not applicable here. The evaluation focuses on design, materials, and intended use as being equivalent to a known device.

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 / Not provided. This document does not describe a clinical study or a test set as would be used for an AI/ML device. The "test" for a 510(k) of this type is primarily a comparison against a predicate device.

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 / Not provided. This information is relevant for studies involving human interpretation or ground truth establishment, which is not described in this 510(k) summary for a mechanical device.

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

• Not applicable / Not provided. Same as above.

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. This is a 510(k) for a mechanical surgical tool, not an AI-assisted diagnostic or therapeutic device. Therefore, no MRMC study or AI-related effectiveness claim is present.

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

• Not applicable. This device is a manual surgical tool; there is no algorithm or AI component.

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

• Not applicable / Not provided. For this type of mechanical device, "ground truth" would be related to its manufacturing specifications and mechanical function meeting design requirements, which are implicitly covered by demonstrating equivalence to a predicate. There's no diagnostic component requiring a ground truth in the usual sense.

8. The sample size for the training set

• Not applicable / Not provided. There is no "training set" for a mechanical device.

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

• Not applicable / Not provided. There is no "training set" for a mechanical device.

Summary of what is present in the document relevant to a 510(k) for a mechanical device:

The "study" that proves the device meets (implicitly, the substantial equivalence) criteria is the comparison presented in "Summary of Equivalence" and "Table I" (though Table I content is not provided).

• Acceptance Criteria (Implicit): That the Clarus 6000 SITEtrac Discectomy System is "substantially equivalent" to the Sofamor Danek "MED(*tm) MicroEndoscopic Discectomy System" in terms of design, materials, intended use, and performance, raising no new safety or effectiveness issues.
• Study Proving Acceptance: The submission itself acts as the "study." It provides a comparison of the Clarus Model 6000 Discectomy System (specifically the dilators and retractors) to the predicate Sofamor Danek MED MicroEndoscopic Discectomy System. This comparison is primarily based on:
  • Device Description: "The Model 6000 Discectomy System is a set of gradually increasing dilators and retractors (4.67mm to 20mm) that dilate then retract tissue in the region of the lumbar spine."
  • Equivalence Claim: "These reusable dilators and retractors are equivalent to those used in Sofamor Danek MED(*) MicroEndoscopic Discectomy System." The submission explicitly states "The comparisons of these devices are shown in Table I" (though Table I itself is missing from the provided text). This table would have detailed the specific features or specifications demonstrating the equivalence.
  • Safety/Effectiveness Claim: "Clarus believes these products do not raise any new safety or effectiveness issues and are substantially equivalent to existing marketed devices."

In essence, for this type of medical device 510(k), the "study" is the detailed technical comparison and rationale provided by the manufacturer to the FDA, demonstrating that the new device functions similarly to a legally marketed predicate device. This is a regulatory pathway for devices that pose no new questions of safety or efficacy.

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The Model 2127-900 Series Endoscope Adapter is an accessory for the Clarus Medical Systems Model 2127 Endoscope. It is intended to be reusable. It is used to temporarily clamp or hold the endoscope when mounting to an airway catheter.

MOUNT AND 450 ENDOSCOPE ACCESSORY TEST PORARILY 00 USED AIRWAY CATHETER APPRODUATE TOGETHER ENDOSECHE ADD AN

The Model 2127-900 Series Endoscope Adapter is a machined or molded plastic piece used to hold an endoscope and airway catheter together. The endoscope adapter has a machined or molded tapered hub designed to fit firmly into the proximal end of various airway catheters. Additionally the endoscope adapter has a central hole designed to fit the outside diameter of the shaft on the appropriate legally marketed Clarus Model 2127 Endoscope.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria in the format you requested.

The document describes a 510(k) submission for the Clarus Model 2127-900 Series Endoscope Adapter and primarily focuses on:

• Device Description: What the device is and how it works.
• Intended Use: The purpose of the device.
• Testing: It mentions "Biocompatibility testing" and "Physical testing" (disinfecting solution exposure, workmanship examination, dimensional measurements, material certification) as having been performed, and that the material "passed biocompatibility testing and is suitable for this application."
• Substantial Equivalence: It explains how the device is substantially equivalent to a predicate device.
• FDA Clearance Letter: The formal letter from the FDA stating clearance for marketing.

However, the text does not include:

• A table of specific acceptance criteria.
• Reported device performance against numerical thresholds.
• Details about a study design, sample sizes (for test or training sets), data provenance, expert qualifications, or adjudication methods for establishing ground truth.
• Any information about multi-reader multi-case (MRMC) studies or standalone algorithm performance.

It merely states that certain tests were done and passed, which is a high-level summary rather than a detailed study report with specific acceptance criteria and performance data.

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