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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)

General Acceptance (Safety)

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

• Test Set Sample Size: A total of 170 subjects were enrolled in the study.
  • 45 subjects in the Normal group
  • 46 subjects in the Glaucoma group
  • 47 subjects in the Retinal Disease group
  • 32 subjects in the Corneal Disease group
  • 167 subjects completed the study.
• Data Provenance: Prospective, comparative clinical study conducted at one clinical site in the United States.

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

The document mentions "Masked graders reviewing Anterior Chamber Angle (ACA) and SLO images were masked to the subject, device type, subject population, configuration order, device order and results from other graders."
However, the number of experts/graders and their qualifications are not explicitly stated in the provided text.

4. Adjudication Method for the Test Set

The document states: "Scan acceptability was by a 2-step process where the device operator identified acceptable scans and then an Investigator image reviews the scans making the final determination of which scans were acceptable or unacceptable." This implies a form of sequential review, with the "Investigator" making the final determination. It does not specify an adjudication method like 2+1 or 3+1 for resolving discrepancies between multiple graders for image quality assessment, as the number of graders is not mentioned. However, for "image quality" assessments (ACA and SLO), it states "The results from the 3 masked graders were documented," and uses "grader average." This suggests that if multiple graders were used, their averages were taken, rather than a formal adjudication process to resolve disagreements.

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

This was not a multi-reader, multi-case (MRMC) comparative effectiveness study comparing human readers with AI vs. without AI assistance. The study compared the Nidek Mirante device's performance (including image quality) to predicate devices, and involved masked graders assessing image quality, but not in the context of improving human reader performance with AI assistance.

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

The primary purpose of the study was to assess the agreement and precision of the Nidek Mirante OCT measurements in comparison with a predicate device and to assess its image quality in comparison to predicate devices for both OCT and SLO. While precision analyses evaluate the device's inherent measurement consistency, and image quality assessment involves human graders, these do not represent a standalone "algorithm only without human-in-the-loop performance" in the general sense of an AI diagnostic algorithm operating independently. The device itself is an imaging system used by humans, not an AI for diagnosis.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The study does not establish an independent ground truth (e.g., pathology, clinical outcomes) for the disease states. Instead, it uses comparative effectiveness against predicate devices and agreement/precision analysis for quantitative measurements and human-graded qualitative image quality. The study categorized subjects into Normal, Glaucoma, Retinal Disease, and Corneal Disease groups. This implies that the diagnosis of these disease states served as a basis for evaluating the device's performance within those groups, but the precise method of establishing these diagnoses (e.g., expert consensus, other gold-standard tests) is not detailed for the "ground truth" of the disease classification itself. The "ground truth" for the device's performance metrics appears to be the measurements and image quality of the predicate devices, or the consistency of the Mirante itself.

8. The Sample Size for the Training Set

The document describes a clinical study to demonstrate substantial equivalence, but it does not mention a training set sample size or the development of an AI/ML algorithm that would typically involve a separate training set. The device itself is a scanning laser ophthalmoscope and optical coherence tomography system, not inherently an AI diagnostic tool. However, the NAVIS-EX software later references a "B-scan Denoising software" which is a new function. The document mentions this function "denoises a single B-scan image to an averaged image of 120 images added," suggesting it uses a computational approach, but does not provide details of a training set for this denoising algorithm if it were an AI-based method.

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

As no training set is explicitly mentioned for an AI/ML algorithm in the context of the Nidek Mirante device itself, the method for establishing ground truth for a training set is not applicable or described in the provided text. For the B-scan Denoising software, the mechanism is described as "averaging 120 images," which is an algorithmic process rather than a machine learning model requiring a ground-truth labeled training set in the typical sense.

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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 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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The 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 provides non-contact, high magnification image capture of the endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images. The captured images and analysis results of the endothelium are used 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 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 built-in thermal printer or captured images can be transferred to a filing system via LAN connection. The Specular Microscope CEM-530 cleared in this 510(k) is identical to the Specular Microscope CEM-530 cleared in K130565 with the addition of a new analysis mode: Center Point Method. All other aspects of the cleared device remain unchanged.

The provided document describes the predicate device and the clinical study conducted for the Nidek Specular Microscope CEM-530. It focuses on demonstrating substantial equivalence to a predicate device (Konan CellChek Plus) rather than establishing novel acceptance criteria for an AI algorithm. Therefore, many of the requested items related to AI-specific acceptance criteria and study methodologies (e.g., sample size for training set, number of experts for ground truth, MRMC study effect size) are not applicable as this submission predates the widespread use and specific regulatory requirements for AI/ML medical devices.

However, based on the information provided, we can infer and or extract the following:

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

The acceptance criteria are implicitly defined by demonstrating "agreement, accuracy and precision" with the predicate device. The performance data is presented as statistical measures comparing the CEM-530 with the Konan CellCheChek Plus. The key metrics studied are:

• Endothelial Cell Density (CD)
• Coefficient of Variation of Endothelial Cell Area (CV)
• % Hexagonality (% HEX)

Here's a summary derived from the "Device Comparisons" section in Table 2 for "All Subjects - Effectiveness Population":

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

• Test Set Sample Size:
  • Agreement Study: 74 subjects (28 non-pathologic young eye, 27 non-pathologic adult eye, 19 pathologic adult eye).
  • Precision Study: 47 subjects (15 non-pathologic young eye, 16 non-pathologic adult eye, 16 pathologic adult eye).
  • Historical Data (for comparison in precision study): 62 subjects (from CEM-530-US-001 study, for Konan CellChek Plus).
• Data Provenance: The study was a "prospective clinical study." The document does not explicitly state the country of origin, but given the sponsor (Nidek Co., Ltd. Japan) and the contact person (Ora, Inc. Massachusetts), it is likely an international or US-based study.

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 in the document. The ground truth for this device (a specular microscope) is the "manual measurements" performed by operators using the predicate device, or direct measurements from the Nidek CEM-530 and then compared. This is not an AI-based system where human experts would individually label data for ground truth in the same way. The document refers to "operators" and "machines" performing measurements, implying the ground truth is derived directly from the measurement devices themselves.

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

This information is not applicable as the ground truth is established by the device's measurements, not by expert consensus requiring adjudication.

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

This was not an MRMC comparative effectiveness study and does not involve AI assistance for human readers. It's a device comparison study evaluating agreement and precision between a new device and a predicate device in performing direct measurements of corneal parameters. Therefore, the effect size of human reader improvement with AI assistance is not applicable.

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

The device (Specular Microscope CEM-530) itself performs measurements, and the "Center Point Method" is an analysis mode within the device. The study evaluates the performance of this device in a clinical setting. While it's an "algorithm" making measurements, it's not described as a separate AI algorithm being tested in isolation. The study compares the device's performance (including its internal algorithms) against a predicate device. This is primarily a device-to-device comparison study, not a standalone AI algorithm performance study in the contemporary sense.

7. The type of ground truth used:

The ground truth is derived from the measurements obtained from a legally marketed predicate device (Konan CellChek Plus), against which the Nidek Specular Microscope CEM-530's measurements are compared for agreement and precision. This is essentially a "comparator device" ground truth.

8. The sample size for the training set:

This information is not applicable. The CEM-530 is a medical measurement device, not an AI/ML system that undergoes a separate training phase with a large dataset. The "Center Point Method" is an analysis mode, likely based on established algorithms for image analysis rather than a data-driven machine learning model requiring a "training set" in the common AI sense.

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

This information is not applicable as there is no mention of a traditional AI "training set" in the document.

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The OPTICAL BIOMETER AL-Scan is a medical device that optically measures eye components such as:

• axial length;
• corneal thickness;
• anterior chamber depth;
• corneal curvature radii;
• corneal cylinder axis;
• white-to-white distance; and
• pupil diameter.

Axial length and corneal thickness can also be measured using ultrasound.

The OPTICAL BIOMETER AL-Scan also performs calculations to assist physicians in determining the power of the intraocular lens for implantation.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic (A-mode)

The OPTICAL BIOMETER AL-Scan ("AL-Scan") measures ocular measurements including: axial length, corneal thickness, anterior chamber depth, corneal curvature radii, corneal cylinder axis, white-to-white distance, and pupil diameter. It measures these necessary values successively through a non-contact optical measurement method. The AL-Scan measures as a single unit the values necessary to calculate the power of an IOL for cataract surgery.

Two optional ultrasonic probes (A-scan Probe and Pachymetry Probe) are available for use in the event the optical measurement is unsuccessful. The A-scan probe scans the axial length, anterior chamber depth, lens thickness and the pachymetry probe scans the corneal thickness. Both probes utilize an ultrasonic measurement function by touching the probe to the cornea.

The AL-Scan also has the function to calculate the power of an IOL using measured values such as axial length.

The Nidek Optical Biometer AL-Scan (K133132) was tested for agreement with predicate devices (LenStar LS 900 and PacScan 300A for ultrasound measurements) and its own precision (repeatability and reproducibility).

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for each measurement were implicitly defined by demonstrating agreement with the predicate devices within calculated 95% Confidence Intervals (CI) for the mean difference and 95% Limits of Agreement (LoA), as well as by achieving acceptable reproducibility and repeatability (measured by Standard Deviation (SD) and Coefficient of Variation (CV)).

Here's a summary of the reported device performance, highlighting key metrics, particularly for the "All Eye Populations Combined" data from Tables 1, 3, and 5. The agreement values represent the difference between the AL-Scan and the predicate device. The precision values (reproducibility and repeatability) are for the AL-Scan itself.

Assessment: The clinical study concluded that the OPTICAL BIOMETER AL-Scan demonstrated agreement to the predicate device, LenStar LS 900, for axial length, keratometry, corneal cylinder axis, central corneal thickness, white-to-white distance, and pupil diameter, and to the PacScan 300A for axial length. Agreement was also shown for anterior chamber depth with both predicates, except for eyes without a natural lens, where the AL-Scan was unable to determine ACD. The precision (reproducibility and repeatability) of the AL-Scan was considered comparable to the predicate device. These findings support that the device meets the implicit acceptance criteria by performing comparably to established devices already on the market.

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

• Test Set Sample Size:
  • Agreement Portion: 80 subject eyes (20 eyes in each of four eye populations: Normal, Cataract, Aphakic/Pseudophakic, and Corneal Abnormality).
  • Precision Portion: 40 subject eyes (10 eyes in each of the four eye populations).
• Data Provenance: Prospective clinical study conducted at a single U.S. clinical site.

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

The study does not explicitly state the number of experts or their qualifications for establishing the "ground truth" for the test set. Instead, the study uses predicate devices (LenStar LS 900 and PacScan 300A) as the reference or "truth" for comparison, which are already legally marketed and established devices for ophthalmic measurements. This is a common approach in 510(k) submissions where substantial equivalence to existing devices is being demonstrated.

4. Adjudication Method for the Test Set

The study summary does not describe any specific "adjudication method" involving multiple human readers for disagreements. The comparison is between the AL-Scan measurements and the predicate device measurements. Discrepancies are quantitatively analyzed using statistical methods like 95% Confidence Intervals for the mean difference and 95% Limits of Agreement, rather than qualitative adjudication between human observers.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. The study focuses on comparing the AL-Scan's measurements directly to predicate device measurements and assessing its own precision, not on evaluating how human readers' performance improves with or without AI assistance. This device is an optical biometer, a diagnostic measurement device, rather than an AI-assisted interpretation or detection system, so an MRMC study would generally not be applicable in this context.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the study data presented primarily represent the standalone performance of the OPTICAL BIOMETER AL-Scan. The device mechanically measures ocular components, and its measurements are compared directly to those of other devices. While a human operator uses the device, the reported performance metrics (agreement and precision) are for the device's output itself, not for a human-plus-AI system. The "clinical accuracy and system sensitivity testing," "acoustic output testing," and "software verification and validation" further support its standalone performance.

7. Type of Ground Truth Used

The "ground truth" in this study is established by measurements obtained from legally marketed predicate devices: the LenStar LS 900 (an optical biometer) and the PacScan 300A (an ultrasound reference device). This approach is used to demonstrate substantial equivalence to existing technology, rather than comparing to a histological or pathology-confirmed "true" state.

8. Sample Size for the Training Set

The provided 510(k) summary does not mention a training set sample size. This is expected because the AL-Scan is a measurement device that performs optical and ultrasound biometry, not a machine learning or AI-driven diagnostic algorithm that requires a separate training phase with labeled data. Its underlying physics-based measurement principles do not necessitate a "training set" in the machine learning sense. The clinical study data described above served as verification and validation for its performance.

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

As explained in point 8, the concept of a "training set" and associated "ground truth" for training purposes is not applicable to this device, which relies on established physical measurement principles rather than machine learning algorithms.

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