Search Results

The intended use of the MICOR 700 System with Auto I/A is fragmentation and removal of cataracts, as well as associated procedures such as irrigation and aspiration, as well as ancillary functions such as vitreous aspiration and cutting

Not Found

I am sorry, but the provided text from the FDA 510(k) Clearance Letter for the MICOR 700 with Auto I/A does not contain information regarding the acceptance criteria or the study that proves the device meets those criteria. The letter primarily focuses on the regulatory aspects of the clearance, such as the substantial equivalence determination, applicable regulations, and administrative requirements.

To answer your request, I would need access to a different document, such as the 510(k) summary or the full submission, which typically contains details about performance testing, validation studies, and the established acceptance criteria.

Ask a specific question about this device

The intended use of the MICOR® 700 Lens Removal System is fragmentation and removal of cataracts, as well as associated procedures such as irrigation and aspiration, as well as ancillary functions such as vitreous aspiration and cutting.

MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)

It appears there has been a misunderstanding. The provided FDA 510(k) clearance letter for the MICOR 700 System is for a Phacofragmentation System, which is a medical device used for surgery, specifically for cataract removal.

This document does NOT contain information about any AI/ML-based device, nor does it detail acceptance criteria, study data, ground truth establishment, or sample sizes related to AI/ML performance.

Phacofragmentation systems are mechanical and electronic devices, and their "performance" criteria are typically related to:

• Power output and control: How effectively and safely they fragment the lens.
• Aspiration rate and vacuum control: How efficiently they remove fragmented lens material.
• Irrigation flow: Maintaining proper eye pressure during the procedure.
• Safety features: Overpressure limits, heat generation, sterile components.
• Biocompatibility: Materials used.

Therefore, I cannot fulfill your request for information regarding AI/ML device acceptance criteria and study details based on this document. The information you're asking for (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance) is relevant to the evaluation of AI/ML algorithms, not to a traditional surgical device like the MICOR 700 System.

If you have a document describing an AI/ML-based medical device, I would be happy to analyze it according to your requested criteria.

Ask a specific question about this device

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.

Ask a specific question about this device

The INTRABEAM is intended for use in radiotherapy treatments.
The INTRABEAM SMART Spherical Applicator is used with the INTRABEAM to deliver a prescribed dose of intraoperative radiation to the treatment margin or tumor bed during intracavity and intraoperative radiotherapy treatments.
The safety and effectiveness of the INTRABEAM as a replacement for whole breast irradiation in the treast cancer has not been established.
The INTRABEM Needle Applicator (comprising the Needle Applicator and guide shafts) is intended for use in combination with the INTRABEAM to intraoperatively administer radiation to tissue including irradiation of intracranial tumors.
The INTRABEAM SMART Stand is designed as an instrument support and positioning unit for the INTRABEAM.
The INTRABEAM Spherical Sizer Set shall support the doctor (surgeon and/or radiation oncologist) in assessing which spherical-shaped applicator shall be used for the radiation therapy procedure, involving INTRABEAM.

The INTRABEAM 700 is a radiation therapy device intended for targeted treatments of selected lessions for minimally invasive, intraoperative, interstital, intracavity and contact radiation therapy of tumors or tumor beds within the body of cancer patients. By applying the radiation source in conjunction with various applicators, a prescribed dose of low energy radiation can be delivered to the target volume. The delivery of the radiation dose is controlled via the integrated control unit and software.
The INTRABEAM 700 is provided as a mobile workstation. Like the previously cleared versions of the INTRABEAM system, the INTRABEAM 700 provides several tools for Quality Assurance of radiation delivery, which are intended to verify the proper functioning of the radiotherapy treatment system.
The main components of the INTRABEAM 700 system are:

• INTRABEAM Workplace - mobile cart containing the following:
  • Control Console 700 (CC700)
  • Computer with Software Version 5.0
  • Touchscreen monitor and mouse
  • UNIDOS Romeo Electrometer
  • V-guide
• XRS 4 X-ray Source
• Quality Assurance Tools: PAICH, PDA, and Ionization Chamber with Ionization Chamber Holder
• radiance Third party treatment planning simulation software
  The INTRABEAM SMART Stand is connected to the INTRABEAM 700 and is used to mount the X-ray generator (XRS 4) and the necessary applicator, in order to deliver the prescribed radiation dose at the target site.
  The INTRABEAM Spherical Applicator is a sterile disposable product that shall be placed in contact with the tumor mass and/or tumor resection cavity to deliver a prescribed dose of intraoperative radiation.
  The INTRABEAM Spherical Sizer Set is a sterile disposable product that shall be placed in contact with body part and/or tumor mass to help support the doctor (surgeon and/or radiation oncologist) in assessing which spherical-shaped applicator shall be used for the radiation therapy procedure, involving INTRABEAM.
  The INTRABEAM Needle Applicator has not been updated since the last clearance, K162568.

The provided document is a 510(k) Premarket Notification from the FDA, which assesses the substantial equivalence of a new medical device (INTRABEAM 700) to a legally marketed predicate device (INTRABEAM 600). The document focuses on regulatory compliance, safety, and performance testing to demonstrate equivalence, rather than providing details of a clinical study designed to prove the device meets specific acceptance criteria in a clinical setting with human subjects.

Therefore, the document does not contain the information requested regarding acceptance criteria and the specifics of a study proving the device meets those criteria, particularly in the context of AI assistance or human reader performance. The "Performance Testing - Bench" section describes non-clinical system testing, software verification, and compliance with various IEC standards (EMC, Electrical, Mechanical, Thermal Safety, Radiation Safety, Usability/Human Factors), which are important for device safety and functionality but are not clinical performance "acceptance criteria" as would be evaluated in a multi-reader multi-case (MRMC) study or a standalone AI performance study.

The document primarily relies on demonstrating substantial equivalence to a predicate device through:

• Identical or equivalent indications for use.
• Similar technological characteristics.
• Compliance with relevant safety and performance standards (e.g., IEC 60601-series).

In summary, none of the requested information regarding acceptance criteria for clinical performance, test set sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone AI performance, or training set details are present in the provided text. The document focuses on bench testing and regulatory compliance, not clinical efficacy or AI performance metrics.

Ask a specific question about this device

VISULAS combi is intended for use in photocoagulating and photodisrupting ocular tissues in the treatment of diseases of the eye, including:
• Photocoagulation of the retina

• Trabeculoplasty
• · Iridotomy
• · Posterior capsulotomy
  · Posterior membranectomy

This device is Prescription Use (Rx) only.

VISULAS combi is an ophthalmic laser used for standard photocoagulation treatments of ocular tissue with 532 nm wavelength and standard photodisruption treatments of ocular tissues at a wavelength of 1064 mm. VISULAS combi is operated in the following treatment modes:

• single-spot mode (software license VERTE) -
• multi-spot mode (software license VITE)
• YAG disruption mode (software license YAG). -

VISULAS combi consists of a laser console, touch control panel, optional laser light applicators such as laser slit lamp or laser indirect ophthalmoscope, foot switch and instrument table. The device can also be used with various accessories, such as SL Imaging Solution, contact lenses or Applanation Tonometer.

The provided text is a 510(k) premarket notification for the VISULAS combi ophthalmic laser. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a new device type through clinical studies. Therefore, much of the requested information, particularly regarding specific performance metrics, sample sizes for test sets, expert involvement for ground truth, MRMC studies, and detailed training set information, is not explicitly provided in this document.

However, based on the document, I can extract information related to the acceptance criteria in the context of demonstrating substantial equivalence and the types of studies performed.

Here's an analysis of the provided text:

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

The document primarily focuses on demonstrating substantial equivalence to predicate devices, VISULAS green (K232051) for photocoagulation and VISULAS yag (K230350) for photodisruption. The "acceptance criteria" are implied by the similarity to these predicate devices in terms of indications for use, technological characteristics, and principle of operation.

• Trabeculoplasty
• Iridotomy
• Posterior capsulotomy
• Posterior membranectomy (combines indications of both predicates) |
  | Laser Type | Solid state laser, frequency-doubled (for photocoagulation) Q-switched Nd:YAG laser (for photodisruption) | - Photocoagulation: solid state laser, frequency-doubled
• Photodisruption: Q-switched Nd:YAG laser |
  | Wavelength | 532 nm (for photocoagulation) 1064 nm (for photodisruption) | - Photocoagulation: 532 nm
• Photodisruption: 1064 nm |
  | Power/Energy | 50 to 1500 mW (photocoagulation) 9.0 mJ to 45.0 mJ (photodisruption) | - Photocoagulation: 50 to 1500 mW
• Photodisruption: Pulse Mode 1 (Single Pulse): 9.0 mJ to 13.0 mJ
  Pulse Mode 2 (Double Pulse): 18.0 mJ to 28.0 mJ
  Pulse Mode 3 (Triple Pulse): 29.0 mJ to 45.0 mJ |
  | Pulse Duration/Length | 10 - 2500 ms and cw (photocoagulation)

Ask a specific question about this device

BLUE 400 and BLUE 400 S are accessories to the surgical microscope and allow the fluorescence observation of fluorophores with an excitation peak between 400 nm and the fluorescence emission observation comprising the spectrum in a spectral band of 620 - 710 nm.

The ZEISS BLUE 400 and BLUE 400 S are surgical microscope accessories used in fluorescent visualization of suspected grade III and IV gliomas during neurosurgery.

The BLUE 400 and BLUE 400 S are fluorescence accessories to qualified surgical microscopes, intended to allow intraoperative viewing of malignant glioma tissue grade III and IV under fluorescence. The overall system is comprised of excitation (illumination) and emission (observation) filters to detect fluorescence and are optimized in conjunction with the drug to pass light between 620 – 710 nanometers. The BLUE 400 S filters allow the surgical microscope to produce excitation light in a wavelength range covering at least 400 - 410 nanometers that excites an approved optical imaging agent and enables the surgeon to observe the emitted fluorescent signal in the oculars or on a display. Fluorescence of marked brain tissue helps visualization of tissue associated with Grade III & IV glioma during neurosurgeries.

Compared to the blue visualization of the surrounding non-fluorescent tissue in the BLUE 400 image, BLUE 400 S is designed to visualize the surrounding nonfluorescent tissue more similar to white light impression, while tumor visualization of grade III and IV glioma remains consistent. With the visualization of non-fluorescent anatomy in an almost white light impression, BLUE 400 S is expected to allow PplX visualization with less frequent switching between fluorescence and white light imaging modes.

BLUE 400 and BLUE 400 S can be installed only into qualified ZEISS surgical microscopes. For these accessories to be used with a qualified ZEISS surgical microscope, the critical components of the surgical microscope need to fulfill the clinically relevant parameters for the Indications for Use of BLUE 400 and BLUE 400 S.

The provided FDA 510(k) summary (K240215) describes the Carl Zeiss Meditec AG BLUE 400 and BLUE 400 S accessories to surgical microscopes for fluorescent visualization of grade III and IV gliomas.

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

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence to a predicate device (BLUE 400, K211346) through technical and performance testing, rather than defining explicit clinical acceptance criteria in terms of sensitivity, specificity, or other diagnostic measures for identifying gliomas. The acceptance criteria used are in the form of "Passed" results for various technical and functional tests.

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

The document describes non-clinical performance testing (bench testing) using "ZEISS fluorescence target," "spatial test target," "photometric resolution test target," "test target with a circle," "white sheet of paper," and "ZEISS BLUE 400 test phantom."

• Sample Size: Not explicitly stated for each test, but implied to be sufficient for bench validation of optical and system parameters. These are physical components being tested, not patient samples.
• Data Provenance: The tests are described as bench/non-clinical system testing. This indicates the data was generated in a lab setting by the manufacturer (Carl Zeiss Meditec AG, Germany, based on manufacturer details). It is not derived from patient data.
• Retrospective/Prospective: Not applicable as it's bench testing, not clinical studies.

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

• Not applicable. This submission relies on technical bench testing against predefined engineering specifications and comparison to a legally marketed predicate device. The "ground truth" for these tests is the physical measurement of optical properties and system functions, validated against engineering requirements, not clinical expert consensus on patient data.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies for establishing ground truth (e.g., determining disease presence in an image) based on multiple readers. This submission describes bench testing where the outcome is a "Passed" result based on meeting physical specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. The submission focuses on non-clinical technical equivalence and performance of the device's optical and system functions. It does not evaluate human reader performance with or without AI assistance. The device itself (BLUE 400/BLUE 400 S) is a filter accessory, not an AI-powered diagnostic tool aiming to improve reader interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No, a standalone algorithm performance study was not done. This device is an accessory to a surgical microscope. It enhances visualization for a human surgeon; it is not a standalone algorithm that provides diagnoses or interpretations. The software verification testing mentioned is for the device's control software, not a diagnostic algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for the performance testing is engineering specifications and measurements of optical, electrical, and mechanical properties. For example, excitation wavelength range is validated against the known excitation peak of PpIX, and image properties (resolution, brightness, lack of deformation) are validated against defined standards for surgical microscopes. The comparison to the predicate device also serves as a benchmark for equivalence.

8. The Sample Size for the Training Set

• Not applicable. The BLUE 400 and BLUE 400 S are physical filter accessories for a surgical microscope, not an AI/machine learning device that requires a training set. The software mentioned is for the device's operation and control, not for image analysis or diagnostic inference that would necessitate a training set.

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

• Not applicable. As the device is not an AI/ML system requiring a training set, there is no ground truth established for such a set.

Ask a specific question about this device

The CIRRUS™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device. It is indicated for in-vivo viewing, axial cross-sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures, including cornea, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, and optic nerve head.

The CIRRUS™ HD-OCT Reference Database is a quantitative tool used for the comparison of retinal nerve fiber layer thickness, macular thickness, ganglion cell plus inner plexiform layer thickness, and optic nerve head measurements to a database of healthy subjects.

CIRRUS™ HD-OCT AngioPlex angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid.

The CIRRUS™ HD-OCT is indicated for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration, and glaucoma.

The subject device is a computerized instrument that acquires and analyses cross-sectional tomograms of anterior ocular structures (including comea, retinal nerve fiber layer, macula, and optic disc). It employs non-invasive, non-contact, low-coherence interferometry to obtain these high-resolution images. CIRRUS 6000 has a 100kHz scan rate for all structural and angiography scans.

The subject device uses the same optical system, and principle of operation as the previously cleared CIRRUS 6000 (K222200) except for the reference database functionality.

The subject device contains a newly acquired reference database which was collected on K222200. This study data compares macular thickness, ganglion cell thickness, optic disc and RNFL measurements to a reference range of healthy eyes as guided by the age of the patient and /or optic disc size. Reference database outputs are available on Macular Cube 200x200, and Optic Disc Cube 200x20 scan patterns. All other technical specifications have remained the same as the predicate K222200.

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

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly met by the successful development of the CIRRUS™ HD-OCT Reference Database (RDB) and its ability to provide normative data for comparison. The study aims to establish these reference limits.

Study Details

1. Sample Size and Data Provenance:

   • Test Set (for RDB establishment): 870 subjects had one eye included in the analysis from an initial enrollment of 1000 subjects.
     • Data Provenance: Prospective, multi-site study conducted at eight (8) clinical sites across the USA.

2. Number of Experts and Qualifications for Ground Truth:

   • The document does not specify the number or qualifications of experts used to establish the ground truth for the test set regarding the "healthiness" of the subjects. The eligibility and exclusion criteria (e.g., "presence of any clinicant vitreal, retinal optic nerve, or choroidal disease in the study eye, including glaucoma or suspected glaucoma. This was assessed based on clinical examination and fundus photography.") imply that ophthalmologists or optometrists would have made these clinical judgments, but the specific number or their experience level is not detailed.

3. Adjudication Method for the Test Set:

   • The document does not explicitly describe an adjudication method for determining the "healthy" status of the subjects. It states that inclusion/exclusion was "assessed based on clinical examination and fundus photography" by unnamed personnel at the clinical sites. There is no mention of a consensus process, independent review, or other adjudication for the ground truth.

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

   • No MRMC comparative effectiveness study was done to assess how human readers improve with AI vs. without AI assistance. The study focuses solely on establishing the normative reference database for the device's measurements. The RDB itself is a tool to be used by clinicians, but its impact on clinical decision-making or reader performance was not evaluated in this submission.

5. Standalone Performance:

   • This is a standalone performance study in the sense that the device, equipped with the new reference database, generates the normative values and compares patient data to them. It's the performance of the device's RDB calculation and display, not an AI algorithm performing diagnostic tasks without human input.

6. Type of Ground Truth Used:

   • Clinical Ground Truth: The ground truth for defining "healthy subjects" was based on extensive clinical examination, fundus photography, and adherence to strict inclusion/exclusion criteria (e.g., no known ocular disease, specific visual acuity, IOP, refraction limits). This represents a clinically defined healthy population.

7. Sample Size for the Training Set:

   • The term "training set" is not explicitly used in the context of a machine learning model, as the primary objective was to establish a statistical reference database. The entire dataset of 870 subjects (with qualified scans) was used to develop the reference database. So, the sample size for developing the reference database was 870 subjects.

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

   • The "ground truth" for the subjects included in the reference database was established by defining them as "healthy subjects" through rigorous inclusion and exclusion criteria applied at 8 clinical sites across the USA. These criteria included:
     • Age 18 years and older
     • Best corrected visual acuity (BCVA) of 20/40 or better in either eye
     • IOP

Ask a specific question about this device

RESCAN 700 provides non-contact, high resolution optical coherence tomographic (OCT) and biomicroscopic imaging of the anterior and posterior segment of the eve via an ophthalmic surgical microscope. The RESCAN 700 is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging of posterior ocular structures, including retina, macula, and optic disc, as well as imaging of anterior ocular structures, including the cornea, lens and anterior chamber angle.

RESCAN 700 uses the assistance system (CALLISTO eye) that provides non-diagnostic video documentation and image capture for ophthalmic surgeries. The assistance system allows the remote control of RESCAN 700.

RESCAN 700 brings Spectral Domain OCT technology to the ZEISS ophthalmic surgical microscopes (e.g. ARTEVO 800). Used in conjunction with the assistance system, CALLISTO eye, OCT images taken intra-operatively are presented on the monitor and may also be seen within the surgeon's oculars using the surgical microscopes integrated data injection system (IDIS). OCT images may be stored for subsequent retrieval using CALLISTO eye's data management system. RESCAN 700 can be controlled via the touch panel of the assistance system or via the foot control panel of an ophthalmic surgical microscope

This document is a 510(k) summary for the RESCAN 700 (SW 3.0), a medical device used for ophthalmic imaging. It outlines the reasons for the 510(k) submission, primarily focusing on minor software and component changes, and argues for its substantial equivalence to a previously cleared predicate device (RESCAN 700 Software Version 2.0).

Based on the provided text, the device in question (RESCAN 700 SW 3.0) is an imaging device that captures OCT (Optical Coherence Tomography) and biomicroscopic images of the eye. It is not an AI/ML-driven diagnostic device that would have acceptance criteria based on diagnostic performance metrics like sensitivity, specificity, or AUC, or studies involving human readers improving with AI assistance.

The 510(k) submission is for a software and minor component update to an already cleared device, arguing for substantial equivalence. Therefore, the "acceptance criteria" discussed in this document are primarily related to software verification and validation, electrical safety, and electromagnetic compatibility (EMC), ensuring that the updated device remains safe and effective with its existing intended use. It is not a de novo submission for a novel AI/ML algorithm.

Given this context, I will address your prompt based on the information available within the document, explaining why some of your requested points are not applicable to this type of regulatory submission and focusing on the relevant criteria and studies mentioned.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria for RESCAN 700 (SW 3.0)

Context: The RESCAN 700 (SW 3.0) is an updated version of an already cleared ophthalmic imaging device. The 510(k) submission primarily addresses minor software changes and component updates. This is a substantial equivalence claim, not a new AI/ML diagnostic or assistive device that would typically involve comparative effectiveness studies with human readers or complex ground truth establishment for novel algorithms. The "acceptance criteria" here refer to regulatory and engineering standards rather than clinical diagnostic performance metrics for an AI algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

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

This is not applicable in the context of this 510(k) summary. The document describes a software and hardware update for an imaging device, not a diagnostic AI/ML algorithm requiring a clinical test set of patient data with a specific sample size for performance evaluation (e.g., sensitivity, specificity). The "testing" referred to is primarily engineering verification and validation (V&V) of the software and hardware changes (e.g., unit testing, integration testing, system testing, safety testing), not clinical performance testing on patient data.

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

This is not applicable. As explained in point 2, this submission is for an updated imaging device, not a new AI/ML diagnostic algorithm that would require expert-established ground truth for its performance evaluation on a clinical test set. The validation focuses on engineering and regulatory compliance.

4. Adjudication Method for the Test Set

This is not applicable for the same reasons as points 2 and 3. There is no mention of "adjudication" in the context of a clinical test set for this device.

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

No, an MRMC comparative effectiveness study was not done. The RESCAN 700 is an imaging device, providing high-resolution OCT and biomicroscopic images. It is used for in-vivo viewing, axial cross-sectional, and three-dimensional imaging of ocular structures. It is not an AI-assisted diagnostic tool designed to improve human reader performance in interpreting images. The document explicitly states that the "assistance system (CALLISTO eye)" provides "non-diagnostic video documentation and image capture."

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

This is not applicable. The RESCAN 700 is an imaging system, not a standalone AI algorithm. Its function is to acquire images, not to provide automated diagnostic interpretations that would be evaluated for standalone performance.

7. The Type of Ground Truth Used

For software verification and validation, the "ground truth" implicitly used would be the functional and performance specifications of the software and hardware. For electrical safety and EMC, the "ground truth" is adherence to international consensus standards (IEC 60601-1-2). There is no patient-data derived "ground truth" (like expert consensus, pathology, or outcomes data) mentioned for the purpose of demonstrating the device's acceptable performance, as this is related to a software update for an imaging system, not a diagnostic AI.

8. The Sample Size for the Training Set

This is not applicable. The RESCAN 700 (SW 3.0) is not an AI/ML algorithm that requires a "training set" of data in the sense of machine learning model development. The software updates are described as "minor software changes" and "changes to components and parts," indicating traditional software development, testing, and hardware modifications, not the training of a learning algorithm.

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

This is not applicable, as there is no mention of a "training set" for an AI/ML algorithm. The "ground truth" for the device's functionality and safety would be established through engineering design specifications, adherence to quality system regulations, and compliance with relevant international standards.

Ask a specific question about this device

CALLISTO eye Software is a software device intended for remote control of ophthalmic surgical microscopes of ARTEVO 750/850 and RESCAN 700, and display images of the anterior and posterior segment of the eye.

CALLISTO eye Software is indicated as graphical guidance aid to insert, align, position, and register an intraocular lens (IOL) including toric IOLs, limbal relaxing incisions, and capsulorhexis during anterior segment surgical procedures.

CALLISTO eye software version 5.0 is a new release sporting a new user interface but carries the clinical feature set of software version 3.7.2: it supports the digital visualization technology and connectivity of ARTEVO 750 / ARTEVO 850 and provides connectivity to the QUATERA700. CALLISTO eye enables the video visualization of the anterior segments of the eye and allows the connection and remote control of a surgical microscope with and without OCT Camera. It is designed for high patient throughput and can be used for teaching purposes.

CALLISTO eye is an assistance system that processes real-time video images that can be displayed on the CALLISTO eye Panel PC for viewing by the surgeon and the surgical staff in the operating room. The same video images can be viewed by the surgeon through the eyepiece of the connected surgical microscope. CALLISTO eye provides Assistant Functions displaying treatment templates as screen overlays and Cockpits displaying patient and device information as screen overlays. Both functions assist the surgeon during procedures such as limbal relaxing incisions, capsulorhexis, and alignment of toric intraocular lenses (TIOL). All treatment templates are based on preoperative clinical data of a particular patient and shall be defined by the surgeon prior surgery. These templates can be displayed on the CALLISTO eye Panel PC, through the eyepiece of the surgical microscope equipped with a data injection system (IDIS (WITH VERSION 5.0 RELABELED AS ADVISION)) of the ARTEVO 750 or on a 3D monitor connected to the ARTEVO 850. While using "ASSISTANCE markerless" configuration, CALLISTO eye can utilize the preoperative diagnostic data from the Zeiss IOLMaster and may provide the reference and target axis as required to align a toric intraocular lens without the otherwise required ink marks.

Transmission of the diagnostic data from the IOLMaster to CALLISTO eye takes place via USB stick or via a data network connected to a DICOM compatible MIMPS server such as FORUM. The DICOM functionality allows the indirect communication with other DICOM compatible diagnostic devices and patient information systems to exchange patient data (e.g. medical devices work lists).

The Carl Zeiss Meditec AG's CALLISTO eye Software, version 5.0, did not conduct a clinical study to prove that the device met the acceptance criteria and was substantially equivalent to the predicate device, CALLISTO eye Software, version 3.7.2.

The submission states: "Animal and Clinical testing was not conducted."

Instead, the submission relied on non-clinical performance testing and risk management to demonstrate substantial equivalence.

Here's the information about the acceptance criteria and the study that was not performed in the traditional sense:

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

The submission does not explicitly state "acceptance criteria" for clinical performance as no clinical testing was performed. However, the basis for equivalence is the identical indications for use and equivalent technological characteristics and risk profile compared to the predicate device. The performance is deemed to be equivalent to the predicate.

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

Not applicable, as no clinical test set was used for patient data. The "test set" for non-clinical testing refers to software test cases and system verification, not patient data.

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, as no clinical ground truth was established by experts for a test set. Non-clinical software verification relies on defined specifications and requirements as the "ground truth" for expected software behavior.

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

Not applicable, as no clinical test set requiring adjudication was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. No MRMC comparative effectiveness study was done as no clinical testing was performed. The device is a "graphical guidance aid" and not an AI that independently diagnoses or drives clinical decisions, nor does it quantify human reader improvement.

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

Not applicable for clinical performance. The device is intended as an assistance system with human-in-the-loop (the surgeon). The non-clinical testing focused on software functionality and integration, not standalone clinical performance.

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

For the non-clinical performance testing (software verification and validation), the "ground truth" was established by the pre-defined specifications, requirements, and design documents of the software. Compliance with these internal standards and relevant international standards (ISO 14971, IEC 62366-1, IEC 62304, NEMA PS 3.1-3.20) was the basis for verifying performance.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model that requires a training set in the conventional sense. It is a software update to an existing medical image management and processing system.

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

Not applicable. See point 8.

Ask a specific question about this device

VISULAS green is intended for use in photocoagulating ocular tissues of the treatment of diseases of the eve, including

• · Photocoagulation of the retina
• Trabeculoplasty
• · Iridotomy

VISULAS green is an ophthalmic laser used for standard photocoagulation treatments of ocular tissue with 532 nm wavelength. VISULAS green is operated in single-spot mode or in multi-spot mode.
VISULAS green consists of a laser console, touch control panel, optional laser light applicators such as laser slit lamp or laser indirect ophthalmoscope, foot switch and instrument table. The device can also be used with various accessories, such as SL Imaging Solution, contact lenses or Applanation Tonometer.

The provided FDA 510(k) summary for the VISULAS green device (K232051) focuses on establishing substantial equivalence to a predicate device (VISULAS green, K181682) rather than presenting a study demonstrating the device meets a specific set of clinical performance acceptance criteria. Therefore, much of the requested information regarding a comparative effectiveness study, standalone performance, ground truth, and expert involvement is not present in this document.

However, I can extract information about the types of testing performed and the general conclusion of substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria for clinical performance that the device was tested against. Instead, it states that the device underwent various forms of testing to demonstrate equivalence and compliance with standards.

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

Not applicable. The document describes engineering and software verification and validation, as well as biocompatibility testing, but does not detail a clinical test set for evaluating device performance against diseases of the eye. The focus is on demonstrating equivalence to a predicate device through technical specifications and non-clinical testing.

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

Not applicable. As no clinical test set is described, there's no mention of experts establishing a ground truth for such a set.

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

Not applicable. No clinical test set 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. The device (VISULAS green) is an ophthalmic laser for photocoagulation, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device's submission.

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

Not applicable. The VISULAS green is a medical device (laser system), not a standalone algorithm. Its performance is inherent to its physical operation and interaction with ocular tissues, guided by a human operator.

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

For the technical testing detailed (biocompatibility, safety, software, bench testing), the "ground truth" would be the established engineering specifications, recognized industry standards, and the performance characteristics of the predicate device. No clinical "ground truth" (e.g., pathology, outcomes) is described as being directly used to measure the subject device's efficacy in treating specific diseases in a clinical study.

8. The sample size for the training set

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

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

Not applicable. This device is a laser system, not an AI/ML algorithm.

Ask a specific question about this device