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Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model]: The Mirante SLO/OCT with scanning laser ophthalmoscope and optical coherence tomography function and with Image Filing Software NAVIS-EX is a non-contact system for imaging the fundus and for axial cross sectional imaging of ocular structures. It is indicated for in vivo imaging and measurement of:
· the retina, retinal nerve fiber layer, optic disc, and
· the anterior chamber and cornea (when used with the optional anterior segment OCT adapter)
and for color, angiography, autofluorescence, and retro mode imaging of the retina as an aid in the diagnosis and management. The Image Filing Software NAVIS-EX is a software system intended for use to store, manage, process, measure, and display patient data and clinical information from computerized diagnostic instruments through networks. It is intended to work with compatible NIDEK ophthalmic devices.

Scanning Laser Ophthalmoscope Mirante [SLO Model]: The Mirante SLO with scanning laser ophthalmoscope function and with Image Filing Software NAVIS-EX is a noncontact system for imaging the fundus. It is indicated for color, angiography, auto-fluorescence, and retro mode imaging of the retina as an aid in the diagnosis and management. The Image Filing Software NAVIS-EX is a software system intended for use to store, manage, process, measure, analyze and display patient data and clinical information from computerized diagnostic instruments. It is intended to work with compatible NIDEK ophthalmic devices.

The Nidek Mirante is an Optical Coherence Tomography (OCT) system intended for use as a non-invasive imaging device for viewing and measuring ocular tissue structures with micrometer range resolution. The Nidek Mirante is a computer controlled ophthalmic imaging system. The device scans the patient's eye using a low coherence interferometer to measure the reflectivity of retinal tissue. The cross sectional retinal tissue structure is composed of a sequence of A-scans. It has a traditional patient and instrument interface like most ophthalmic devices. The Nidek Mirante uses Fourier Domain OCT, a method that involves spectral analysis of the returned light rather than mechanic moving parts in the depth scan. Fourier Domain OCT allows scan speeds about 65 times faster than the mechanical limited Time Domain scan speeds. The Mirante utilizes Fourier spectroscopic imaging a Michelson interferometer. The interfering light of the reference light and the reflected light from the test eye obtained by the Michelson interferometer are spectrally divided by a diffraction grating and the signal is acquired by a line scan camera. The signal is inverse Fourier transformed to obtain the reflection intensity distribution in the depth direction of the patient's eve. The galvano mirror scans the imaging light in the XY direction to obtain a tomographic image. The Mirante includes scanning laser ophthalmoscope (SLO) functions as well as the OCT functions. The SLO component uses a confocal scanning system for image capture. The imaging light emitted from the laser oscillator passes through the hole mirror and enters the patient's eye. The reflected by the hole mirror and the signal is obtained by the detector. A resonant mirror and a galvanometer mirror placed in the imaging optical path scan the imaging light in the XY direction to obtain a flat surface image. The device includes Image Filing Software NAVIS-EX which is a software system intended for use to store, manage, process, measure, and display patient data and clinical information from computerized diagnostic instruments through networks. It is intended to work with compatible NIDEK ophthalmic devices.

The provided documentation describes the acceptance criteria and the study results for the Nidek Mirante Scanning Laser Ophthalmoscope and the Image Filing Software NAVIS-EX.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating "substantial equivalence" to previously cleared predicate devices through agreement and precision analyses, and superior or equivalent image quality. The performance is reported in terms of comparisons against these predicate devices.

Nidek Mirante (OCT Component) vs. Optovue Avanti (Predicate)

Nidek Mirante (SLO Component) vs. OPTOS P200DTx (Predicate)

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The OPHTHALMIC YAG LASER SYSTEM YC-200 consists of a slit lamp and the YAG Laser and is indicated for the performance of posterior capsulotomy, posterior membranectomy, pupillary membranectomy, iridotomy (hole in the iris) and selective laser trabeculoplasty.

The OPHTHALMIC YAG LASER SYSTEM YC-200 is an ophthalmic pulsed laser system using a 1,064 nm Q-switched pulsed Nd: YAG laser as the treatment beam source. The system consists of two types, differing only in the available types of laser emission. The two types are collectively referred to as "YC-200" throughout this 510(k). The operation mode(s) available differs depending on the type.

As shown in the above table, the YC-200 S Plus provides the operator with two treatment modes, YAG mode and SLT mode, whereas the YC-200 type provides the operator with a single treatment mode, YAG mode.

In YAG mode, treatment using the YAG treatment beam whose wavelength is 1,064 nm is available. This mode is used mainly for posterior capsulotomy and iridotomy. The 360-degree rotating two-aiming-beam system that separates the YAG aiming beam into two beams is used. The focus position is determined according to the alignment of the beams. In YAG mode, single irradiation mode and burst mode are available. In single mode, one shot of the treatment beam is emitted each time the trigger switch is pressed, whereas in burst mode, two or three shots of the treatment beam are emitted each time the trigger switch is pressed. In YAG mode, the focus shift function to shift the focal points of the YAG treatment beam on the basis of the YAG aiming beam is available. This function allows the operator to shift the focal point of the YAG beam to the posterior chamber side compared to the aiming beam in order to prevent pitting of the intraocular lens.

In SLT mode, treatment using the YAG treatment beam whose wavelength is 532 mm is available. This mode is used for selective laser trabeculoplasty. In this mode, a parfocal optical system is used. In the parfocal optical system, the image of an object surface is formed on the target surface. The SLT aiming beam is emitted from the fiber tip (the object surface) so that it appears as a sharply-edged spot on the target surface. The focus position is determined according to the projection status of the beams. In SLT mode, SLT-NAVI assists the operator in surgery by specifying the laser emission positions and sequence before the treatment is available. The progress status of laser treatment is intuitively displayed in real time in the SLT-NAVI area of the main screen based on the premise that the treatment is proceeding as scheduled.

The system is mainly comprised of the YC-200 main body that incorporates a laser source, and a slit lamp that is similar to the previously cleared SL-2000 (K163564), a head rest, a control box that controls laser emission, and a connector box.

To use the YC-200, the operator should first adjust the focus of the evepieces to the operator's refractive error and adjusts the evepieces to the operator's pupillary distance. The operator instructs the patient to place his or her chin on the chinrest, to rest his or her forehead on the forehead rest, and to hold the grips. The operator aligns the level of the patient's eye with the eye level marker, fasten the patient's head with the head belt, and instructs the patient to look at the fixation lamp to stabilize his or her visual axis. The operator looks through the microscope to observe the treatment site. The operator sets laser emission conditions such as laser power output through the control box of the YC-200, turns on the aiming beam, and set the YC-200 to the READY mode. Alignment is achieved when the operator adjusts the joystick and contact lens to align the aiming beam focus with the target position. Finally, the operator presses the hand switch or depresses the optional foot switch to emit the treatment beam in the READY mode while observing the operative field with the slit lamp.

One of the reasons for this 510(k) submission is to add the combination delivery unit to connect the subject device to the GYC-500 previously cleared in 510(k) No. K152603.

The combination delivery unit allows the operator to perform photocoagulation using the green laser beam (532 nm) or photodisruption using the Nd: YAG laser pulse beam (1064 nm, hereafter referred to as "YAG laser beam") or SLT laser (532 nm, for YC-200 S plus only) while observing the patient's eve with the slit lamp of the YC-200. The delivery unit is connectable to the previously cleared Green Laser Photocoagulator GYC-500, and the subject YC-200. The photocoagulation unit of the combination delivery unit is mounted on the subiect YC-200's slit lamp and is connected to the GYC-500 main body using a connecting cable and a fiber-optic cable.

The operator selects the laser beam to be emitted by switching the optical path using the laser beam selector of the combination delivery unit. The optical path of the combination delivery unit for the green laser beam is completely independent from that of the subject YC-200 for the Nd: YAG laser beam. When "YC" is selected by the laser beam selector to select the laser beam to be emitted, the laser refractive mirror is stored in the photocoagulation unit of the delivery unit. When "COAG" is selected by the laser beam selector, the laser refractive mirror comes out from the photocoagulation unit.

When the combination delivery unit is attached to the YC-200 and connected to the previously cleared GYC-500 (510(k) No. K152603), the YC-200 works strictly as a diagnostic slit lamp - all photodisruptor and SLT laser functions are disabled.

The combination delivery unit is comprised of the photocoagulation unit, and protective filter. The photocoagulation unit adjusts the spot size of the treatment beam and aiming beam emitted from the GYC-500, while the protective filter protects the operator's eve from the reflected green laser beam that can be emitted only when the protective filter is inserted in the optical path.

The green laser beam from the GYC-500 requires a delivery unit to be delivered to the patient's eye. The green laser beam is delivered to the patient's eve via the combination delivery unit when it is mounted on the YC-200. The combination delivery unit is intended to save the area occupied by the slit lamp of delivery unit for the GYC-500 by using the slit lamp of the YC-200 consistently during both photocoagulation and photodisruption.

Another reason for this 510(k) submission is to add "posterior membranectomy" is to expand treatment options. With the addition of "posterior membranectomy" to the indications for use, the split mirror illumination tower for posterior membranectomy is added as an optional accessory. The split mirror illumination tower was designed to irradiate the target with slit illumination so that the slit illumination is made incident from the center while allowing the YAG treatment beam to pass between the upper and lower mirrors. The previously cleared illumination tower equipped with a tilting function for SLT mode, and illumination tower with the base fixed for YAG mode do not allow the treatment beam to be delivered to the posterior segment of the eye while the operator observes the posterior segment because these illumination towers themselves interrupt the YAG treatment beam. Thus, the previously cleared ones are inappropriate for posterior membranectomy.

The provided text is a 510(k) summary for the Nidek Ophthalmic YAG Laser System YC-200. It focuses on demonstrating substantial equivalence to a predicate device, as required for FDA clearance. Consequently, it does not contain the detailed clinical study information (such as acceptance criteria, sample sizes, expert qualifications, or MRMC study results) that would typically be found in a clinical study report or a more comprehensive regulatory submission for a novel or high-risk device requiring such evidence.

The document primarily describes:

• Device Name: Ophthalmic YAG Laser System YC-200
• Indications for Use: Posterior capsulotomy, posterior membranectomy, pupillary membranectomy, iridotomy (hole in the iris), and selective laser trabeculoplasty.
• Predicate Devices: NIDEK OPHTHALMIC YAG LASER SYSTEM YC-200 (K192045) and Ellex Medical Pty. Ltd. LUMENIS SELECTA DUET (K021550).
• Reference Device: NIDEK Green Laser Photocoagulator GYC-500 (K152603).
• Key changes from predicate: Addition of a combination delivery unit to connect to the GYC-500, and the addition of "posterior membranectomy" to the indications for use, necessitating a new split mirror illumination tower.
• Testing performed: Bench testing for safety and performance standards (ISO, ANSI, IEC).

Conclusion regarding acceptance criteria and study data:

Based on the provided text, there is no detailed information about acceptance criteria or a clinical study (specifically, a human-in-the-loop or standalone AI study) that proves the device meets specific performance criteria against a ground truth.

The submission relies on:

1. Bench testing: Listed on page 9, affirming compliance with various safety and performance standards (e.g., ISO15004-1, IEC 60601-2-22). These are engineering performance metrics, not clinical performance metrics against a medical ground truth for a diagnostic or AI-driven device.
2. Substantial Equivalence: The primary argument is that the device is substantially equivalent to a previously cleared predicate device, meaning it has similar indications, technological characteristics, and does not raise new questions of safety or effectiveness. This regulatory pathway typically minimizes the need for extensive new clinical performance data if the changes are minor or the device operates on well-understood principles.

Therefore, I cannot provide the requested table or answer most of the specific questions about clinical study details (sample size, data provenance, expert ground truth, MRMC study, standalone performance, training set) because this information is not present in the provided FDA 510(k) summary. The device in question is a laser system for surgical procedures, not a diagnostic device relying on AI or image analysis that would typically involve the type of acceptance criteria and clinical validation described in your prompt.

The document states: "The collective performance testing demonstrates that the YC-200 does not raise any new questions of safety or effectiveness when compared to the primary predicate device. The results of the performance testing demonstrate that the YC-200 performs as intended and does not raise any new questions of safety or effectiveness." This statement refers to the bench testing and the argument for substantial equivalence, not a clinical trial with human subjects assessing performance against a clinical ground truth.

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The OPHTHALMIC YAG LASER SYSTEM YC-200 consists of a slit lamp and the YAG Laser and is indicated for the performance of posterior capsulotomy, pupillary membranectomy, iridotomy (hole in the iris) and selective laser trabeculoplasty.

The OPHTHALMIC YAG LASER SYSTEM YC-200 is an ophthalmic pulsed laser system using a 1,064 nm Q-switched pulsed Nd: YAG laser as the treatment beam source. The system consists of the types, differing only in the available types of laser emission. The two types are collectively referred to as "YC-200" throughout this 510(k). The operation mode available differs depending on the type.

As shown in the above table, the YC-200 S Plus provides the operator with two treatment modes, YAG mode and SLT mode, whereas the YC-200 type provides the operator with a single treatment mode, YAG mode. Hereafter, these two types are collectively referred to as "YC-200".

In YAG mode, treatment using the YAG treatment beam whose wavelength is 1,064 nm is available. This mode is used mainly for posterior capsulotomy and iridotomy. The 360-degree rotating two-aiming-beam system that separates the YAG aiming beam into two beams is used. The focus position is determined according to the alignment of the beams. In YAG mode, single irradiation mode and burst mode are available. In single mode, one shot of the treatment beam is emitted each time the trigger switch is pressed, whereas in burst mode, two or three shots of the treatment beam are emitted each time the trigger switch is pressed. In YAG mode, the focus shift function to shift the focal points of the YAG treatment beam on the basis of the YAG aiming beam is available. This function allows the operator to shift the focal point of the YAG beam to the posterior chamber side compared to the aiming beam in order to prevent pitting of the intraocular lens.

In SLT mode, treatment using the YAG treatment beam whose wavelength is 532 nm is available. This mode is used for selective laser trabeculoplasty. In this mode, a parfocal optical system is used. In the parfocal optical system, the image of an object surface is formed on the target surface. The SLT aiming beam is emitted from the fiber tip (the object surface) so that it appears as a sharply-edged spot on the target surface. The focus position is determined according to the projection status of the beams. In SLT mode, SLT-NAVI that assists the operator in surgery by specifying the laser emission positions and sequence before the treatment is available. The progress status of laser treatment is intuitively displayed in real time in the SLT-NAVI area of the main screen based on the premise that the treatment is proceeding as scheduled.

The system is mainly comprised of the YC-200 main body that incorporates a laser source, and a slit lamp that is similar to the previously cleared SL-2000 (K163564), head rest, the control box that controls laser emission, and a connector box.

To use the YC-200, the operator should first adjust the focus of the eyepieces to the opera-tor's refractive error and adjusts the eyepieces to the operator's pupillary distance. The operator instructs the patient to place his or her chinrest, to rest his or her forehead on the forehead rest, and to hold the grips. The operator aligns the level of the patient's eye with the eye level marker, fasten the patient's head with the head belt, and instructs the patient to look at the fixation lamp to stabilize his or her visual axis. The operator looks through the microscope to observe the treatment site. The operator sets laser emission conditions such as laser power output through the control box of the YC-200, turns on the aiming beam, and set the YC-200 to the READY mode. Alignment is achieved when the operator adjusts the joystick and contact lens to align the aiming beam focus with the target position. Finally, the operator presses the hand switch or depresses optional foot switch to emit the treatment beam in the READY mode while observing the operative field with the slit lamp.

This document is a 510(k) Premarket Notification from the FDA regarding the Nidek Ophthalmic Yag Laser System YC-200. This type of document is a regulatory approval, not a clinical study report or a technical performance testing report for an AI/ML device.

Therefore, the document does not contain the information required to answer the prompt regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/ML device's performance.

The provided text describes the regulatory clearance process for a traditional medical device (a laser system), focusing on its substantial equivalence to previously cleared predicate devices based on indications for use, technological characteristics, and various bench tests related to laser safety, electrical safety, and usability. It does not involve AI/ML performance metrics, ground truth establishment, expert adjudication, or MRMC studies.

To directly answer your request based on the provided document, the following points would be "Not Applicable" or "Not Provided":

1. A table of acceptance criteria and the reported device performance: Not applicable for AI/ML performance metrics. The document reviews safety and performance of a laser device against standards (e.g., ISO, IEC).
2. Sample sized used for the test set and the data provenance: Not applicable. The testing described (bench testing) is for device safety and functional performance, not AI model validation on a clinical dataset.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for AI models is not relevant here.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable. This device is not an AI/ML model.
9. How the ground truth for the training set was established: Not applicable.

Summary of what the document does provide:

• Device Name: OPHTHALMIC YAG LASER SYSTEM YC-200
• Indications for Use: Performance of posterior capsulotomy, pupillary membranectomy, iridotomy (hole in the iris), and selective laser trabeculoplasty.
• Regulatory Class: Class II (Product Code: HQF, HJO)
• Predicate Device: Quantel Medical OPTIMIS FUSION YAG, and OPTIMIS FUSION YAG/SLT (K140336)
• Reference Devices: Lightmed Corporation LightLas SeLecTor Deux (K090774), NIDEK Slit Lamp SL-2000 (K163564)
• Testing Conducted (Bench Testing): ISO15004-1 (Ophthalmic), Z80.36 and ISO15004-2 (Light Hazard), ISO 10939 (Slit Lamp), IEC 60601-2-22 and IEC 60825-1 (Laser Product Safety), IEC 62366-1 (Usability), ANSI AAMI ES60601-1 (Electrical Safety), IEC60601-1-2 (Electromagnetic Compatibility). These tests are typically defined by engineering and performance standards, not clinical performance metrics for AI.

Therefore, for the specific request about AI acceptance criteria and study details, this document is not relevant.

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The MICROPERIMETER MP-3 and MICROPERIMETER MP-3 Type S are indicated for use as: Color retinography Fixation examiner Fundus-related microperimetry Visual rehabilitation

The modified NIDEK Microperimeter MP-3 type S measure the visual sensitivity of a specified area on the fundus and captures color fundus images. The fundus image overlaid with the retinal sensitivity mapping is displayed on the screen for fundusimage-correlated evaluation. With reference to the Microperimeter MP-3, cleared with K152729, a rehabilitation function and the capability to performs exams in scotopic environments (only MP-3 type S) have been added.

Visual sensitivity mapping function
Visual sensitivity mapping can be displayed using static perimetry principle.
Stimuli and a fixation target are displayed by the built-in LCD projector. While focusing on the fixation target, the response button to indicate that they saw a stimulus projected at the location and light intensity specified by the internal measurement program or the operator. The patient's response signals are computed by the device and measurement results are displayed on the LCD.

Fixation function
The MicroperimeterMP-3 can measure fixation and determine the preferred retinal locus, simply by having the patient fixate on a target. Any change in fixation can be compared pre- and post-treatment because the patiently tracked during microperimetry.

Fundus photography function
Auto alignment is performed while observing on the LCD, the front of the patient's eye illumination LED (infrared light). After the alignment is roughly complete, the mode automatically changes to the fundus observation mode. The fundus of the patient's eye is illumination LED (infrared light). After alignment and focusing are automatically performed on the fight from the xenon flash lamp is emitted on the fundus. The light reflected from the fundus is captured by the built-in color CCD camera for fundus image capture.

Visual rehabilitation
Visual rehabilitation is a collective name of Fundus-related microperimetry, Feedback exam, They are used to support the fixation training for patient.
Feedback exam: similar function with the Fixation exam. The same as those in Fixation exam, Feedback exam, and Fixation exam, and differ only in the following characteristics: in the Feedback exam, a sound is heard and the appearance of the fixation target changes when the patient's vision inside the circle specified by the operator (TRL Trained[tarqet] Retinal Locus, which the patient cannot see).

The provided text does not contain detailed information about specific acceptance criteria for performance, nor does it describe a study that explicitly proves the device meets such criteria with quantitative results.

Instead, the document primarily focuses on regulatory approval (510(k) summary) and establishes substantial equivalence to a predicate device. It states that the device has undergone non-clinical testing to verify its functions and performance requirements and compliance with applicable international standards. However, it does not provide the specific performance metrics (e.g., sensitivity, specificity, accuracy) that would constitute "acceptance criteria" in the context of diagnostic device validation.

Here's a breakdown of what is and isn't present, addressing your numbered points:

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

• Not provided. The document states that "performance tests... demonstrate that the subject device is effective and performs as well as the predicate device" but does not define specific acceptance criteria (e.g., minimum accuracy percentages, sensitivity/specificity thresholds) or report quantitative performance metrics for the device or its predicate.

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

• Not provided. The document mentions "non-clinical testing" but does not describe a clinical test set, its sample size, or data provenance.

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. Since no clinical test set or diagnostic efficacy study is detailed, there's no mention of experts establishing ground truth for such a test.

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

• Not applicable/Not provided.

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/Not provided. This document does not describe AI assistance or MRMC studies. The device itself is a Microperimeter and Ophthalmic Camera, not an AI-driven diagnostic system in the sense of assisting human readers.

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

• Not applicable/Not provided in the context of diagnostic performance. The device is a diagnostic tool, and its "standalone" performance would likely refer to its ability to measure visual sensitivity and capture images, which are assessed through engineering and design validation, not typically through standalone diagnostic accuracy studies described in this type of summary.

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

• Not provided/Not explicitly applicable. For a device acting as a measurement tool (microperimeter) and an imaging device (ophthalmic camera), ground truth during its development and validation would primarily relate to the accuracy of its measurements against known standards or the fidelity of its image capture. The document states "We have verified and validated that the Microperimeter MP-3 meets its functions and performance requirements," implying internal validation against engineering specifications and applicable standards, but not a "ground truth" derived from clinical diagnostic outcomes.

8. The sample size for the training set

• Not applicable/Not provided. The device is not described as an AI/machine learning system that requires a "training set."

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

• Not applicable/Not provided.

Summary of what is present regarding "acceptance criteria" and "study":

The core of the documentation provided is a 510(k) Summary for a medical device (Microperimeter MP-3, Microperimeter MP-3 Type S). A 510(k) submission aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific clinical acceptance criteria in the same way a PMA (Premarket Approval) would require.

• Acceptance Criteria (Implied): The implied acceptance criteria are that the device performs "as well as the predicate device" and complies with relevant international standards.

  • "Effective and performs as well as the predicate device." (from section "Non-Clinical and/or Clinical Tests Summary & Conclusions").
  • Compliance with international standards: IEC 60601-1-2, ISO 15004-1, ANSI Z80.36, ISO 12866, ISO 10940, IEC 62366-1, and IEC 62304 (for software). These standards address safety, performance, and usability aspects. The document states, "The results demonstrate that the subject device complies with applicable international standards... and it is safe as the predicate device."

• Study Proving Acceptance Criteria: The "study" mentioned is non-clinical testing (bench testing, software verification and validation).

  • Type of Study: Non-clinical testing, including bench testing and software verification and validation.
  • Purpose: To "verify and validate that the Microperimeter MP-3 meets its functions and performance requirements, and complies with applicable international standards."
  • Clinical Data: The document explicitly states "Clinical Summary: Not Applicable," indicating no new clinical studies were conducted for this 510(k) submission to demonstrate performance in a patient population. Substantial equivalence relies on the known performance and safety profile of the predicate device and the demonstration that the new device's differences do not raise new questions of safety or efficacy.

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The Image Filing Software NAVIS -EX is a software system intended for use to store, manage, process, measure, analyze and display patient data and clinical information from computerized diagnostic instruments through networks. It is intended to work with compatible NIDEK ophthalmic devices.

The NAVIS-EX is an application of client-server model. Patient information and examination data are managed in a server database. These data are saved in the database from a device connected with the NAVIS-EX or from software related to the NAVIS-EX. In the client, the examination data can be displayed and analyzed, and the images can be processed. In addition, those results can be printed or be transferred to an external system in the form of a report. The NAVIS-EX system includes specific optional viewers AL-Scan Viewer, CEM Viewer, and Data Acquisition Service (DAS).

The provided 510(k) submission for the Nidek Image Filing Software NAVIS-EX focuses on establishing substantial equivalence to a predicate device (FORUM, FORUM Archive, FORUM Archive and Viewer by Carl Zeiss Meditec AG). It does not contain an independent clinical study with specific acceptance criteria and detailed performance data in the typical sense of a diagnostic Artificial Intelligence (AI) device.

Instead, the submission primarily relies on:

1. Comparison of Technological Characteristics: Demonstrating that the NAVIS-EX has similar functions (filing, external interface, image acquisition, image processing) to the predicate and reference devices.
2. Compliance with Standards: Stating that testing according to ISO 14971 (risk management), AAMI/ANSI/IEC 62304 (software life cycle processes), and IEC 62366-1 (usability) was performed and showed the device performs as intended and is safe.

Therefore, many of the requested details about acceptance criteria, specific device performance metrics, sample sizes, ground truth establishment, and MRMC studies are not available in this document.

Here's a breakdown of what can be gleaned from the document regarding your request:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or report specific performance metrics (e.g., accuracy, sensitivity, specificity, AUC) for the NAVIS-EX as an AI/CAD-like device. The "performance" claimed is primarily functional equivalence and safety as demonstrated by compliance with general medical device standards.

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

No information regarding a specific "test set" in terms of patient data or images used for clinical performance evaluation is provided. The testing mentioned refers to engineering and software validation tests against standards, not a clinical performance study on a dataset.

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

Not applicable, as no clinical test set using expert-established ground truth is described in this submission.

4. Adjudication Method for the Test Set:

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:

No MRMC comparative effectiveness study is mentioned in this submission. The device is image filing software, not a diagnostic AI that would typically undergo such a study for improved reader performance.

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

No standalone clinical performance study is described. The "performance" assessment is based on functional equivalence and safety/software standards compliance.

7. The Type of Ground Truth Used:

Not applicable, as no clinical performance study with defined ground truth is described.

8. The Sample Size for the Training Set:

Not applicable, as this is not an AI/ML device that requires a training set in the conventional sense for diagnostic performance.

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

Not applicable.

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

The "study" that proves the device meets its (implied) acceptance criteria is a combination of:

• Functional Benchmarking/Comparison: The device's features for image filing, management, processing, and display were compared against those of a predicate device (Carl Zeiss Meditec AG's FORUM) and several NIDEK reference devices (K132323, K113451, K152729, K133132, K173980). This comparison (detailed in the tables on pages 6-7 of the document) served to demonstrate that the NAVIS-EX has substantially similar technological characteristics.
• Compliance with International Standards: The submission states that testing according to ISO 14971 (Medical devices – Application of risk management to medical devices), AAMI/ANSI/IEC 62304 (Medical device software – Software life cycle processes), and IEC 62366-1 (Medical devices – Application of usability engineering to medical devices) was performed. These tests are intended to ensure the software is safe, functions reliably, and is usable, thus implying the performance necessary for its intended use without raising new safety or effectiveness concerns.

The conclusion is that the "test results and comparison results show that the proposed device is substantially equivalent to the predicate device in performance." This suggests that the "acceptance criteria" were met by demonstrating an equivalent level of function and safety through these comparisons and standard compliance, rather than through specific quantitative clinical performance metrics typical of AI diagnostic tools.

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The NIDEK Specular Microscope CEM-530 is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of the corneal endothelium and for measurement of the thickness of the cornea.

The NIDEK Specular Microscope CEM-530 which is the subject of this 510(k) is a modification to the NIDEK Specular Microscope CEM-530 cleared in K151706. The only change to the cleared device is to the software which has been revised to improve the accuracy of the automated analysis method. All other aspects of the cleared device remain unchanged. The NIDEK Specular Microscope CEM-530 provides non-contact. high magnification image capture of the endothelium enabling observation of the size and shape of cells. Information such as the corneal endothelial cell density(CD), the coefficient of variation of corneal endothelial cell area (CV), % hexagonality of cells (%HEX), is analyzed through the captured images. The captured images and analysis results of the endothelium are used to assist in intraocular or corneal surgery, postoperative follow-up, and corneal observation such as for endothelial disorders or the corneal state of patients who wear extended-wear contact lenses. Observation is possible in the central area (visual angle: 5°) and peripheral area (visual angle: 27°) using a periphery capture function as well as in the Center of the cornea. The captured images and analysis results can be printed on the built-in printer or optional video printer, or output to an external device over LAN connection. In addition to the specular microscopy, the corneal thickness can be optically measured in a non-contact method. The CEM-530 has auto-tracking and auto-shooting functions. Results can be printed using the the built-in thermal printer or captured images can be transferred to a filing system via LAN connection.

Here's a summary of the acceptance criteria and study details for the NIDEK Specular Microscope CEM-530, based on the provided text:

1. Table of Acceptance Criteria (Inferred from comparison with predicate) and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate device, Konan Medical, Inc. Cellchek Plus (K120264). The study aimed to show agreement and precision between the CEM-530's automated analysis and the Konan Cellchek Plus's manual center method. The tables provided present the direct comparisons that demonstrate this.

2. Sample Size and Data Provenance

• Test Set (Effectiveness Population): 74 subjects
  • Subgroups: 28 non-pathologic young eyes, 27 non-pathologic adult eyes, 19 pathologic adult eyes.
  • Precision Population Subset: 45 subjects (15 from each subgroup).
• Data Provenance: Prospective clinical study conducted at one clinical site in the United States.
• Training Set: Not explicitly mentioned in this document for the new auto-cell count algorithm. However, the study states that "Endothelial image data captured on the CEM530(Ver1.09) in the previous study, CEM-530-US-0002 were imported for auto analysis based on a new auto-cell count algorithm." This implies that the algorithm was trained using data from the prior study.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number of experts used or their specific qualifications for establishing the ground truth of the test set against which the automated CEM-530 was compared.

However, for the agreement study, the CEM-530's automated analysis results were compared against "manual center method measurements performed with the Konan predicate device." This implies that the Konan device's manual measurements served as the comparative 'ground truth' for this specific comparison. It's not stated how many operators performed these manual measurements or their qualifications, but these are inherently human-derived and subject to human variability.

An "Additional Manual Comparison" was conducted by comparing the CEM-530 automated analysis to CEM-530 manual analysis methods across three machines/operators. This indicates that at least 3 operators were involved in generating the manual ground truth for this internal comparison. Their qualifications are not specified beyond being "operators."

4. Adjudication Method

The document does not specify an adjudication method like 2+1 or 3+1 for resolving discrepancies in ground truth establishment. Given that one of the ground truth comparators was the "manual center method measurements performed with the Konan predicate device" and the other was "CEM-530 manual analysis methods across three machines/operators," it suggests either:

• No formal adjudication process was used, and the direct manual measurements were considered the ground truth.
• If multiple operators performed the manual measurements on the Konan, their agreement would likely be part of the precision analysis but not explicitly an adjudication of a single measurement.

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

• Was one done? Yes, in a sense. The study compares the NIDEK CEM-530's automated analysis against the Konan Cellchek Plus's manual method (predicate device) and also against the CEM-530's own manual analysis method. This involves multiple "readers" (automated algorithm vs. human operators) and multiple "cases" (subjects).
• Effect size of human readers improve with AI vs without AI assistance: The study focuses on demonstrating the equivalence of the automated CEM-530 to existing manual methods (Konan) and its own manual methods. It does not provide an effect size for how much human readers improve with AI assistance. Instead, it evaluates the standalone performance of the AI (automated analysis) in comparison to manual benchmarks. The precision ratios (e.g., Repeatability Ratio, Reproducibility Ratio) illustrate how the CEM-530's automated precision compares to the Konan's and its own manual precision, often showing better or comparable precision for the automated method for CV and %Hex, and somewhat higher (less precise) for CD in the CEM-530 auto vs. manual comparison.

6. Standalone Performance Study

Yes, a standalone performance study of the algorithm (automated analysis without human-in-the-loop performance) was done explicitly. The "Agreement study" and "Precision study" sections detail the performance of the NIDEK Specular Microscope CEM-530 using its automated analysis method. These results are then compared to:

• The performance of the predicate device, Konan CellChek Plus (manual center method).
• The performance of the NIDEK CEM-530's own manual analysis method.

7. Type of Ground Truth Used

The ground truth used was human-derived manual measurements / expert consensus. Specifically:

• For the comparison against the predicate, it was "manual center method measurements performed with the Konan predicate device."
• For the internal comparison, it was "CEM-530 manual analysis methods across three machines/operators."

8. Sample Size for the Training Set

The document does not provide the specific sample size for the training set. It mentions that "Endothelial image data captured on the CEM530(Ver1.09) in the previous study, CEM-530-US-0002 were imported for auto analysis based on a new auto-cell count algorithm." This indicates that a dataset from a prior study (CEM-530-US-0002) was used for training/development of the new algorithm, but the size of that dataset is not specified.

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

The method for establishing ground truth for the training set is not explicitly detailed in the provided text. However, given that the algorithm's purpose is to automate cell counts, it's highly probable that the ground truth for training data would have been established through meticulous manual cell counting and analysis by human experts, similar to how the comparison ground truth was established.

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The YELLOW LASER PHOTOCOAGULATOR SYSTEM YLC-500 is intended to be used in ophthalmic surgical procedures including retinal and macular photocoagulation, iridotomy and trabeculoplasty. The YELLOW LASER PHOTOCOAGULATOR SYSTEM YLC-500 is intended to work in conjunction with the following delivery units in ophthalmic photocoagulation procedures: NIDEK SL-1800, SL-1600, ZEISS SL 130, HAAG BQ900, HEINE OMEGA 500

The Yellow Laser Photocoagulator System YLC-500 (hereafter referred to as "YLC-500") is a laser photocoagulator for ophthalmology using the 577 nm optically-pumped semiconductor laser (yellow laser beam) as the treatment beam and 635 nm diode laser (red laser beam) as the aiming beam. Like other conventional laser photocoagulation systems, the YLC-500 can be used in ophthalmic surgical procedures including retinal and macular photocoagulation, iridotomy and trabeculoplasty. The YLC-500 is a modified version of the GYC-500 as the primary predicate device and MC-500 Vixi which were the subjects of premarket notification numbers K152603 and K111493.

The YLC-500 is mainly comprised of the main body that incorporates a laser source, the control box that controls laser emission, and a delivery unit that guides the laser beam emitted from the main body to the patient's eye.

To use the YLC-500, the operator sets laser emission conditions such as laser power output, spot size, and exposure time according to the condition of treatment site through the control box of the YLC-500 or operation part of the connected delivery unit. When using an (attachable) slit lamp delivery unit, the operator observes the treatment site with the slit lamp, and aligns the treatment beam and aiming beam to the site. Then the operator presses the foot switch to emit the treatment beam and aiming beam to the treatment site from the exit end of the YLC-500 system in a READY status while observing the operative field with the slit lamp. As the treatment beam is optically coaxial to the aiming beam, alignment is achieved when the operator aligns the aiming beam to the treatment site. When the foot switch is pressed under the condition, the treatment beam of the set spot size is irradiated at which the aiming beam is projected. The operator can also select the laser irradiation pattern from a single laser spot and multiple laser spots in a scanning manner when a scan (attachable) delivery unit is connected to the YLC-500.

Various types of the delivery units are available for the YLC-500. As the delivery units using a slit lamp, broadly speaking, two types of delivery units are available. One is called "Slit lamp delivery unit" integrating a slit lamp and a laser delivery unit. The other is called "Attachable delivery unit" that is the laser delivery unit integrative filer and so on for connection to the slit lamp owned by the user.

Furthermore, the slit lamp delivery units are classified into "Slit lamp delivery unit" that delivers a single laser spot only, and "Scan slit lamp delivery unit" that delivers multiple laser spots in a predetermined pattern while scanning the laser spots as well as the single laser spot. In a similar manner, the attachable delivery units are further classified into "Attachable slit lamp delivery unit" that delivers a single laser spot only, and "Scan attachable slit lamp delivery unit" that delivers multiple laser spots in a predetermined pattern while scanning the laser spots as well as the single laser spot. The YLC-500 connected with a scan (attachable) delivery unit is called "Yellow Scan Laser Photocoagulator YLC-500 Vixi".

Various slit lamp delivery units are available that allow for the adaptation of the YLC-500 to a slit lamp. An optical fiber cable is connected from the YLC-500 main body to the slit lamp, thereby allowing the laser beam to be sent to the delivery unit. With the delivery unit, the patient can be treated in a seated position. The following slit lamp delivery units are available: Slit lamp delivery unit (NIDEK SL-1800 type), Scan slit lamp delivery unit (NIDEK SL-1800 type), Attachable delivery unit (NIDEK SL-1800/SL-1600 type, ZEISS SL 130 type), and Scan attachable delivery unit (NIDEK SL-1800/SL-1600 type, ZEISS SL 130 type, HAAG BQ900).

Other than the (scan and/or attachable) slit lamp delivery units, a binocular indirect ophthalmoscope (B.I.O.) delivery unit is available.

The B.I.O. delivery unit enables photocoagulation using a vellow laser beam (577 mm) while observing the patient's eye with a binocular indirect ophthalmoscope. With the delivery unit, the patient can be treated in a supine position. The delivery unit (Heine Omega 500 type) connects to the YLC-500 main body via an optical fiber cable. The delivery unit consists of a binocular indirect ophthalmoscope (with headband), a 20 D condensing lens, illumination lamp, and stand. The headband fits over the operator's head and has height and circumference adjustment knobs. A working distance control sets the distance among the operator, the patient, and 20 D condensing lens, which can be varied within a range of 300 to 700 mm. The treatment and aiming beam spot size can also be selected by changing working distance (with the 20D condensing lens).

The delivery units allow transpupillary photocoagulation using a slit lamp or binocular indirect ophthalmoscope. The operator chooses the optimal delivery unit for the purpose of photocoagulation of the patient's eye.

The provided document is a 510(k) premarket notification for a medical device, the Yellow Laser Photocoagulator System YLC-500. This type of regulatory submission establishes substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study in the way an AI/ML diagnostic software might.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria for an AI/ML diagnostic. It describes:

• Device Type: A laser photocoagulator for ophthalmic surgical procedures. This is a hardware device, not an AI/ML diagnostic software.
• Purpose of Submission: To demonstrate substantial equivalence to existing predicate devices (other laser photocoagulators), not to prove performance against specific diagnostic accuracy metrics.
• Testing: The testing conducted (bench testing, safety, electrical, software verification/validation, usability) is aimed at demonstrating the device's basic functionality, safety, and effectiveness compared to the predicate, but it does not involve diagnostic performance metrics, expert adjudication, or MRMC studies as would be seen for an AI/ML diagnostic.

In summary, this document is irrelevant to the prompt asking about acceptance criteria and studies for an AI/ML diagnostic device, as it describes a hardware therapeutic device and its 510(k) submission based on substantial equivalence.

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The SLIT LAMP SL-2000 is intended for use in eye examination of the anterior eye segment, from the corneal epithelium to the posterior capsule. This device is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.

The SLIT LAMP SL-2000 is used to magnify the eyeball, eyelid, and eyelash of patients for observation, using slit illumination light.

The SL-2000 comprises the main unit that incorporates the microscope unit, illumination unit, base plate unit, and power supply box.

This document is a 510(k) premarket notification for the Nidek Co., Ltd. Slit Lamp SL-2000. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific clinical acceptance criteria. Therefore, much of the requested information regarding specific performance metrics, clinical study design, and ground truth establishment is not present in this document because it is not typically required for a 510(k) submission for a device like a slit lamp.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity) for the slit lamp, as it is a diagnostic tool observed by a human, not an automated diagnostic system. Instead, it focuses on demonstrating that the device meets safety and performance standards equivalent to predicate devices. The "performance" mentioned primarily refers to compliance with international standards for ophthalmic instruments and electrical safety.

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

The document does not detail specific "test set" sample sizes in the context of clinical performance data for diagnosis of diseases. The testing described is primarily limited to bench testing and compliance with engineering and safety standards. There is no mention of clinical data or patient samples being used in the validation tests outlined.

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

Not applicable, as a clinical test set with ground truth established by experts is not described in this document for a device like a slit lamp in a 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable, as a clinical test set with expert adjudication is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement

Not applicable. The Slit Lamp SL-2000 is a manual observation device, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI improvement metrics are relevant or discussed.

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

Not applicable, as this is a manually operated medical device without an AI algorithm.

7. The Type of Ground Truth Used

Not applicable in the context of clinical diagnostic accuracy. The "ground truth" for the tests performed would be the specifications and requirements outlined in the referenced ISO, IEC, and AAMI/ANSI standards (e.g., a specific light intensity, magnification, or electrical characteristic).

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/machine learning device that requires a training set.

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

Not applicable, as this is not an AI/machine learning device.

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The Microperimeter MP-3 is indicated for use as: Color retinography Fixation examiner Fundus-related microperimetry

The Microperimeter MP-3performs the following basic functions: Color retinography Fixation examiner Fundus-related microperimetry

The provided text does not contain detailed acceptance criteria or a study that proves the device meets specific acceptance criteria in the way typically expected for a medical device efficacy study (e.g., sensitivity, specificity, accuracy targets).

Instead, the document is a 510(k) premarket notification summary for the Nidek Microperimeter MP-3, asserting substantial equivalence to a predicate device (MP-1 MICROPERIMETER). The "testing" referred to is primarily bench testing to demonstrate that the modified device (MP-3) meets its functional specifications, performance requirements, and complies with applicable international standards for safety and electrical compatibility, and that its performance is "as well as" the predicate device.

Here's an attempt to answer your questions based on the provided text, highlighting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. It focuses on the device's functional integrity and compliance with safety standards, and equivalence in performance to the predicate device.

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

The document refers to "bench testing" and "all necessary safety tests" and "all the necessary performance tests." It does not specify a sample size, test set, or data provenance (e.g., country of origin, retrospective/prospective clinical data). This suggests that the testing was likely internal engineering and quality assurance testing rather than a clinical study with human subjects.

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

This information is not provided. Given that the testing mentioned is primarily "bench testing" and "functional specifications," it's unlikely that external experts were involved in establishing "ground truth" in a clinical sense.

4. Adjudication method for the test set

This information is not provided.

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

There is no indication of an MRMC comparative effectiveness study, AI assistance, or human reader improvement in the provided text. The device described does not appear to be an AI-driven diagnostic aid that would typically involve such a study design. It's a diagnostic instrument for acquiring images and microperimetry data.

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

This concept is not applicable to the device described. The Microperimeter MP-3 is an instrument operated directly by a human. The "automatic alignment and focusing" mentioned are features of the device's operation, not a standalone AI algorithm generating interpretations.

7. The type of ground truth used

The concept of "ground truth" in a clinical diagnostic sense (e.g., pathology, outcomes data) is not explicitly addressed. The testing focused on verifying the device's functional integrity, compliance with technical standards, and performance against its own specifications and the predicate device's established performance. For example, light hazard compliance would be against ISO standards, and image acquisition would be verified against internal specifications for image quality.

8. The sample size for the training set

This information is not applicable as the device is not described as having an AI component that would require a "training set."

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

This information is not applicable for the same reason as above.

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The Green Laser Photocoagulator GYC-500 is intended to be used in ophthalmic surgical procedures including retinal and macular photocoagulation, iridotomy and trabeculoplasty.

The Green Laser Photocoagulator GYC-500 ("GYC-500") is a laser photocoagulator for ophthalmology using the 532 nm diode-pumped solid-state laser (green laser beam) as the treatment beam and 635 nm diode laser (red laser beam) as the aiming beam. Like other conventional laser photocoagulation system, the GYC-500 can be used in ophthalmic surgical procedures including retinal and macular photocoagulation, iridotomy and trabeculoplasty. The GYC-500 is a modified version of the GYC-1000 which was the subject of premarket notification number K 032085.

The GYC-500 is mainly comprised of the main body that incorporates a laser source, the control box that controls laser emission, and a delivery unit that guides the laser beam emitted from the main body to the patient's eye.

To use the GYC-500, the operator sets laser irradiation conditions such as laser output and laser application time according to the condition of treatment site through the control box of the GYC-500 or operation part of the connected delivery unit. When using a (attachable) slit lamp delivery unit, the operator observes the treatment site with the slit lamp, and aligns the treatment beam and aiming beam to the site. Then the operator presses the foot switch to emit the treatment beam and aiming beam to the treatment site from the exit end of the GYC-500 system in a READY status while observing the operative field with the slit lamp. As the treatment beam is optically coaxial to the aiming beam, alignment is achieved when the user aligns the aiming beam to the treatment site. When the foot switch is pressed under the condition, the treatment beam of the set spot size is irradiated at which the aiming beam is projected. The operator can also select the laser irradiation pattern from a single laser spot and multiple laser spots in a predetermined pattern in a scanning manner.

Various types of the delivery units are available for the GYC-500. As the delivery units using a slit lamp, broadly speaking, two types of delivery units are available. One is called "Slit lamp delivery unit" integrating a slit lamp and a laser delivery unit. The other is called "Attachable delivery unit" that is the laser delivery unit integrating a protective filer and so on for connection to the slit lamp owned by the user. Either the slit lamp delivery units or attachable delivery units are divided into three types: 1) the unit only with the fixed protective filter that remains inserted into the optical path and without the micromanipulator (used for fine adjustment of the laser beam position), 2 ) the unit with the fixed protective filter or electrically-powered one (either filter is factory configured) and with the micromanipulator, and 3) the unit only with the electrically-powered protective filter, with the micromanipulator, and with the spot size control which is different from the aforementioned two types in mechanical structure.

Furthermore, the slit lamp delivery units are classified into "Slit lamp delivery unit" that delivers a single laser spot only, and "Scan slit lamp delivery unit" that delivers multiple laser spots in a predetermined pattern while scanning the laser spots as well as the single laser spot. In a similar manner, the attachable delivery units are further classified into "Attachable slit lamp delivery unit" that delivers a single laser spot only, and "Scan attachable slit lamp delivery unit" that delivers multiple laser spots in a predetermined pattern while scanning the laser spots as well as the single laser spot. The GYC-500 connected with a scan (attachable) delivery unit is called "Green Scan Laser Photocoagulator GYC-500 Vixi".

Various slit lamp delivery units are available that allow for the adaptation of the GYC-500 to a slit lamp. A fiber optic cable is connected from the GYC-500 main body to the slit lamp, thereby allowing the laser beam to be sent to the delivery unit. With the delivery unit, the patient can be treated in a seated position. The following slit lamp types are available: Slit lamp delivery unit (NIDEK SL-1800 type), Scan slit lamp delivery unit (NIDEK SL-1800 type), Attachable delivery unit (NIDEK SL-1800/SL-1600 type, ZEISS SL 130 type, ZEISS 30 SL/M type, HAAG 900BM/900BQ type), and Scan attachable delivery unit (NIDEK SL-1800/SL-1600 type, ZEISS SL 130 type, ZEISS 30 SL/M type, HAAG 900 BQ type).

Other than the (scan and/or attachable) slit lamp delivery units, a binocular indirect ophthalmoscope (B.I.O.) delivery unit and a combination delivery unit are available.

The B.I.O. delivery unit allows the operator to perform photocoagulation while observing the fundus with a binocular indirect ophthalmoscope. With the delivery unit, the patient can be treated in a supine position. The B.I.O. delivery unit (Heine Omega 500 type and Keeler All Pupil II type) connects to the GYC-500 main body via a fiber optic cable. The B.I.O. delivery unit consists of a binocular indirect ophthalmoscope (with headband), a 20 D condensing lens illumination lamp, and stand. The headband fits over the operator's head and has height and circumference adjustment knobs. A working distance control sets the working distance, which can be varied within a range of 300 to 700 mm. The treatment and aiming laser spot size can also be selected by changing working distance (with the 20D condensing lens).

The combination delivery unit is mounted on the NIDEK Ophthalmic YAG Laser System YC-1800's slit lamp and is connected to the GYC-500 main body using a connecting cable and a fiber-optic cable. The delivery unit allows the operator to perform photocoagulation using the green laser beam (532 nm) or photodisruption using an Nd: YAG laser beam while performing observation of the eye with the slit lamp of the YC-1800. The optical path for the green laser beam is completely independent from that for the Nd: YAG laser pulse beam. The operator selects the laser beam to be emitted by switching the optical path using the laser beam selector of the delivery unit. This delivery unit is intended to save the area occupied by the slit lamp for the GYC-500 and that for the YC-1800 by using the slit lamp of the YC-1800 consistently for both photocoagulation and photodisruption.

The delivery units allow transpupillary photocoagulation using a slit lamp or binocular indirect ophthalmoscope. The operator chooses the optimal delivery unit for the purpose of photocoagulation of the patient's eye.

The provided text describes a 510(k) premarket notification for a medical device called the Green Laser Photocoagulator GYC-500. This document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered device.

Instead, this document is a regulatory submission for a traditional medical device (a laser photocoagulator) and focuses on demonstrating substantial equivalence to previously cleared predicate devices. The "testing in support of substantial equivalence determination" mentioned are standard bench tests for electrical safety, software validation, and ophthalmic device-specific standards, not performance metrics related to diagnostic accuracy, sensitivity, or specificity that would be typical for an AI-powered device.

Therefore, I cannot provide the requested information for an AI-powered device based on this document. The document pertains to a device where performance is evaluated against established technical and safety standards for laser systems, not against accuracy metrics for an AI algorithm.

If this were an AI-powered device, the requested information would typically include details about classification performance (e.g., sensitivity, specificity, AUC) and an evaluation of its clinical impact, which are absent here.

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