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The Nidek Multicolor Laser Photocoagulator System MC-500 is intended to be used in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.

The Nidek Multicolor Laser Photocoagulator System MC-500 ("MC-500") is a conventional ophthalmic laser photocoagulator system with treatment light wavelengths of 532 um, 577 nm, and 647 nm. The system is comprised of a diode aim and treatment lasers, graphical user interface, slit lamp and binocular indirect ophthalmoscope delivery units, and a footswitch.

The provided text describes a 510(k) summary for the Nidek Multicolor Laser Photocoagulator System MC-500. This summary focuses on establishing substantial equivalence to a predicate device (Nidek Multi Color Laser Photocoagulator Model MC-300, K042785) through bench testing.

Based on the provided information, here's a breakdown regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria or provide a table of performance metrics. The assessment relies on a qualitative determination of "substantial equivalence" to a predicate device.

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

No specific "test set" in terms of patient data or clinical samples is mentioned. The testing conducted was "bench testing." Therefore, information on sample size and data provenance (e.g., country of origin, retrospective/prospective) for a test set is not applicable as it was not a clinical study.

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

As no clinical test set was used, there were no experts involved in establishing ground truth for such a set based on the provided information. The evaluation was focused on technical performance and equivalence.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set was used.

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

No MRMC study was performed or mentioned. The submission is based on bench testing to establish substantial equivalence. Therefore, there is no information on the effect size of AI assistance on human readers.

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

Not applicable, as this device is a laser photocoagulator system, not an AI algorithm. Its performance is evaluated based on its technical specifications and functional equivalence.

7. Type of Ground Truth Used:

The "ground truth" for the substantial equivalence determination was the performance and characteristics of the predicate device (Nidek Multi Color Laser Photocoagulator Model MC-300). The MC-500's performance was compared to the established performance of the legally marketed predicate device through bench testing.

8. Sample Size for the Training Set:

Not applicable, as this is a physical medical device (laser system), not an AI algorithm that requires a training set.

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

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

In summary, the provided document details a 510(k) submission for a medical device (a laser photocoagulator system) where substantial equivalence was demonstrated through bench testing against a predicate device. It does not involve AI, clinical efficacy studies with patient data, or expert-adjudicated ground truth as would be relevant for an AI/ML medical device.

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The OPD-Station software is indicated for use in analyzing the corneal shape and refractive powers measured by the OPD-Scan Models ARK-9000 or ARK-10000, and to display the data in the form of maps, and manage the data.

Nidek has developed a stand-alone software option for users of the OPD-Scan™ device called OPD-Station, which will run on an independent PC (i.e., separate from the OPD-Scan™ device). The OPD-Station software is able to access data measured by the OPD-Scan™ device via a separate Nidek data management software package called NAVIS.

The OPD-Station uses the same software as that used for the OPD-Scan device so that a physician can view OPD-Scan data on their PC of choice. However, the OPD-Station software has the following new functions:

• Maps of Point Spread Function (PSF), Modulation Transfer Function (MTF), MTF . graphing, and Visual Acuity mapping
• Improved color mapping .

The provided text describes the Nidek Incorporated OPD-Station software, which is a standalone software option for users of the OPD-Scan™ device. The software analyzes corneal shape and refractive powers measured by the OPD-Scan Models ARK-9000 or ARK-10000, displaying the data in various maps and managing the data.

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

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

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than setting specific performance acceptance criteria like sensitivity, specificity, or accuracy metrics. The primary "acceptance criterion" implied throughout this document is substantial equivalence to the predicate devices.

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

The document does not specify any sample size used for a test set (clinical or otherwise) or the data provenance (e.g., country of origin, retrospective/prospective). The performance data mentioned is described very generally as indicating "all specified requirements" without detailing the nature of this data or how it was gathered.

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

The document does not mention any experts used to establish ground truth or their qualifications. Given that this is a 510(k) for software intended to display and manage existing data from an already cleared device (OPD-Scan), the focus is on the software's functionality and its output being consistent with the predicate device's capabilities, rather than a clinical accuracy study requiring expert adjudication of a test set.

4. Adjudication method for the test set

The document does not describe any adjudication method.

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

An MRMC comparative effectiveness study was not conducted or mentioned. The OPD-Station software is not described as an AI-assisted device directly improving human reader performance but rather as a tool for analyzing and displaying existing data from another ophthalmic device.

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

The document is about a standalone software ("OPD-Station software") that operates independently on a PC to analyze and display data from the OPD-Scan device. While it's standalone software, the performance described is its ability to access and process data from the OPD-Scan and display it; it's not an "algorithm only" performance in the sense of an AI algorithm making diagnostic decisions without human involvement. The software itself is the "device" in question operating independently.

7. The type of ground truth used

The document does not specify the type of ground truth used. The verification process appears to rely on comparing the new software's functionality and output with that of the predicate devices. This implies that the "ground truth" for demonstrating equivalence would be the established functionality and output of the cleared predicate devices.

8. The sample size for the training set

The document does not mention a training set or its sample size. This suggests that the software development did not involve machine learning or AI models that require training sets. The software's design likely follows deterministic algorithms based on established ophthalmic principles and data processing techniques from the original OPD-Scan.

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

As there is no mention of a training set, there is no information on how its ground truth would have been established.

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The Nidek Multi Color Laser Photocoagulator Model MC-300 is indicated to be used in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.

The Nidek Multi Color Laser Photocoagulator Model MC-300 is a diode pumped solid state laser (DPSSL) ophthalmic photocoagulation system that produces three treatment beams: a 532 nm (green) wavelength, a 561 (yellow) wavelength, and a 659 (red) wavelength. The Model MC-300 uses the same wavelength for the aiming beam as the treatment beams, so that the operator can recognize the selected wavelength by the color of the aiming spot. The Model MC-300 splits the pumped laser beam into the aiming and treatment beams so that they can both be controlled separately. The multi-color laser beam is aligned with the respective aiming laser beam in the optical system inside the unit and gathers them in a fiber optic cable. The laser beam is led to the delivery unit via the fiber-optic cable, shaped into the specified spot size in the optical system, and emitted to the affected area (the emission areas of both the therapeutic laser beam and the aiming beam are the same).

This document, a 510(k) summary for the Nidek Multi Color Laser Photocoagulator Model MC-300, does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria.

Instead, it is a premarket notification for a medical device seeking clearance from the FDA based on substantial equivalence to previously cleared predicate devices. Therefore, it does not typically include a standalone performance study with acceptance criteria in the way a new, high-risk device might.

Here's what can be extracted and what is explicitly not available:

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

• Not provided. This document does not specify quantitative acceptance criteria or report performance against such criteria. The approval is based on substantial equivalence, implying the device performs comparably to the predicate devices, rather than meeting specific performance metrics that are formally tested and reported here.

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

• Not provided. No test set or data derived from human or animal subjects is described. The evidence provided is based on a comparison of technological characteristics to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable. No test set or ground truth establishment is described for this type of submission.

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

• Not applicable. No test set or adjudication process is described.

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

• Not applicable. This device is a laser photocoagulator, not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI-related effectiveness metrics are irrelevant.

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

• Not applicable. This is a hardware device, not a standalone algorithm.

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

• Not applicable. No new ground truth was established for a performance study. The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate devices.

8. The sample size for the training set:

• Not applicable. This device does not use machine learning, so there is no training set in the context of AI development.

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

• Not applicable. As above, no training set is relevant.

Summary of available information relevant to "Acceptance Criteria" implicitly based on Substantial Equivalence:

The document states:

• "The Nidek Multi Color Laser Photocoagulator Model MC-300 has been designed and will be tested in accordance with applicable safety standards." (Section 7. PERFORMANCE DATA)
• "System and component testing was completed based on product specifications and hazard effects determined from the risk analysis." (Section 7. PERFORMANCE DATA)
• The conclusion is that the device "is equivalent to the predicate device with respect to intended use, technological characteristics, and safety and effectiveness." (Section 8. CONCLUSIONS)
• The "Basis of Approval" by the FDA reviewer includes "Predicate Device (PD)" and "Bench Test Data (BTD)" along with "Specifications (SPECS)".

This implies that the "acceptance criteria" for the MC-300 were primarily:

1. Conformance to Applicable Safety Standards: (e.g., electrical safety, laser safety - though specific standards are not listed here).
2. Meeting Product Specifications: (e.g., wavelength, power range, pulse width, repetition rate as listed later in the document).
3. Demonstrating "Substantial Equivalence" to Predicate Devices: This means showing that its intended use, technological characteristics, and safety and effectiveness profile are similar to devices already cleared by the FDA (Nidek Laser Photocoagulator Model GYC-1000 and Lumenis Novus Varia Ophthalmic Laser & Delivery Devices).

Study Proving Device Meets Acceptance Criteria:

The "study" described is a bench test and comparison to predicate devices.

• Bench Test Data (BTD): This is explicitly mentioned as a basis for approval. These tests would have verified the product specifications (e.g., accurate wavelength emission, power output within stated range, pulse duration, etc.) and adherence to safety standards. No specific details of these bench tests (e.g., number of units tested, specific tests performed, results) are provided in this summary, as is typical for a 510(k).
• Comparison of Technological Characteristics: The document outlines that the MC-300 and predicate devices are all Diode Laser Pumped Solid State Lasers (DPSSL) and use similar delivery systems. It states, "The fundamental technical characteristics and device specifications of the Nidek Multi Color Laser Photocoagulator Model MC-300 are the same as those of the predicate devices." (Section 3. SUBSTANTIAL EQUIVALENCE). It further specifies the wavelengths (532 nm, 561 nm, 659 nm), power range (50-2000 mW), pulse width (0.02-3.00 sec), and repetition rate (0.2-1.0 sec), noting that the power output is comparable to a predicate device (Nidek GYC-2000, K980547).

In essence, the "proof" is the successful completion of internal system and component testing to product specifications and a detailed technical comparison, demonstrating that the new device does not raise new questions of safety or effectiveness compared to legally marketed predicate devices.

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The Nidek Model NT-4000 is a non-contact tonometer that is indicated for use in the measurement of intraocular pressure of the human eye.

The Nidek Model NT-4000 non-contact tonometer optically detects the momentary state of the cornea (applanated by air pressure) and measures intraocular pressure without touching the cornea.

The Model NT-4000 is comprised of main unit and a measuring unit that are provided on a base unit. Each unit contains the following components:

• MAIN UNIT: A screen, control panel, and joystick are provided on this unit. .
• MEASURING UNIT: The air nozzle and photo-detector are provided on this unit. .
• BASE UNIT: The chinrest and a printer are provided on this unit. .

The Model NT-4000 has the following features:

• 1. Auto Alignment Mode: When the measuring unit approaches the center of the pupil in this mode, the instrument automatically performs alignment in the up, down, left, and right directions, and focuses in the back and forth directions. The measurement then starts automatically.
• 2. Automatic Puff Control (APC) Function: The intraocular pressure measurement can be performed with the air pressure as low as possible. When the measurement range is set to "APC 40" or "APC 60", in the first measurement, the automatic shut-off function (which is to stop puffing air as soon as the light reflected from the cornea is detected) activates in order to eliminate excessive puffing. In the subsequent measurement, the APC function activates to perform the measurement with the minimum air pressure based on the former measurement data. As the patient's eye is protected from excessive air pressure, the patient's comfort level increases and continuous measurement can be performed smoothly.
• 3. Pulse Synchronized Intraocular Pressure Measurement: In addition to the standard IOP measurement mode, the intraocular pressure measurement can be performed in synchronization with an arbitrary position of the pulse signal that is obtained by the detector in the forehead rest. When the signals of the pulse and the completion of the alignment are detected simultaneously, the pulse synchronized IOP measurement is executed. It is possible to select the point of a pulse (i.e., either peak, middle, or bottom) to which measurement will be synchronized.

The provided document describes the Nidek Non-Contact Tonometer Model NT-4000 and its substantial equivalence to a predicate device. However, it does not contain the detailed performance study information requested.

The document focuses on:

• Device Description: What the NT-4000 is and its features.
• Intended Use: Measurement of intraocular pressure.
• Technological Characteristics Comparison: A table comparing the NT-4000 to its predicate (NT-1000) highlighting similar functions and minor differences.
• Performance Data (General): States that the device was tested against specific electrical safety, electromagnetic compatibility, and ophthalmic instrument standards (EN 60601-1, EN 60601-1-2, EN 60601-1-4, ISO 15004, JIS T7312) and "was found to meet all requirements."
• Conclusion: The device is equivalent to the predicate in intended use, technological characteristics, safety, and effectiveness.
• FDA Clearance Letter: Confirmation of 510(k) clearance based on substantial equivalence.

Therefore, I cannot populate most of the requested fields because the necessary detailed information about acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement is not present in the provided text.

Here's what can be extracted and what cannot:

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

   Acceptance Criteria (Explicitly Stated in Document)	Reported Device Performance (As stated in Document)
   Compliance with EN 60601-1 (Electrical Safety)	"was found to meet all requirements of both standards."
   Compliance with EN 60601-1-2 (Electromagnetic Compatibility)	"was found to meet all requirements of both standards."
   Compliance with EN 60601-1-4 (Programmable Electrical Medical Systems)	"was found to meet all requirements of the standard."
   Compliance with ISO 15004 (Test Requirements and Test Methods for Ophthalmic Instruments)	"was found to meet all requirements of the standards."
   Compliance with JIS T7312 (Test Requirements and Test Methods for Ophthalmic Instruments - Japan)	"was found to meet all requirements of the standards."
   Substantial equivalence to predicate device (Nidek Model NT-1000)	"demonstrated through its evaluation...that the device is equivalent to the predicate device with respect to intended use, technological characteristics, and safety and effectiveness."

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

   • Information Not Provided. The document only mentions general compliance with standards, not specific clinical or performance test data on a patient/sample cohort.

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)

   • Information Not Provided. No mention of experts for ground truth establishment.

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

   • Information Not Provided. No details on any specific test set or 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

   • Information Not Provided. This device is a non-contact tonometer for measuring IOP, not an AI-assisted diagnostic imaging device that would typically involve human readers.

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

   • Information Not Provided. The device is a measurement instrument, not an algorithm in the sense of AI or software-only evaluation. Its "standalone" performance is implied by its ability to measure IOP.

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

   • Information Not Provided. For a tonometer, "ground truth" would ideally be a gold standard IOP measurement device (e.g., Goldmann applanation tonometer). This is not specified, but the device's accuracy is likely compared against such a standard during its development or validation as implied by "meets all requirements of the standards."

8. The sample size for the training set

   • Information Not Provided. Not applicable for this type of device, which relies on physical measurement principles rather than machine learning training sets.

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

   • Information Not Provided. Not applicable for this type of device.

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The Nidek Green Laser Photocoagulator Model GYC-1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.

The Nidek Green Laser Photocoagulator Model GYC-1000 is a frequency doubled diode pumped solid state (DPSS) laser ophthalmic photocoagulation system that produces a 532 nm (green) wavelength light as the treatment beam. The Model GYC-1000 uses a diode laser (red) with a wavelength of 635 nm as the aiming beam. The green laser beam is aligned with the red aiming laser beam in the optical system inside the unit and gathers them in a fiber-optic cable. The laser beam is led to the delivery unit via the fiber-optic cable, shaped into the specified spot size in the optical system, and emitted to the affected area (the emission areas of both the therapeutic laser beam and the aiming beam are the same).

The Model GYC-1000 can be used to coagulate the target tissue efficiently and safely, and the system can be applied to transpupillary photocoagulation procedures using a slit-lamp or indirect ophthalmoscope and intraocular photocoagulation procedures using an endophotocoagulation probe. The Model GYC-1000 is a smaller, modified version of the Models GYC-1500 and GYC-2000, which were the subject of premarket notification number K980547.

A protective filter may be attached to each delivery unit in the observation optical path so that the operator's eye can be protected from the laser beam if it is reflected from a patient's eve or contact lens during laser emission. The Model G Y C-1000 has a number of delivery units available for use in a variety of ophthalmic procedures:

• Endophotocoagulation Delivery Unit .
• NIDEK Slit-Lamp Delivery Unit
• ZEISS Slit-Lamp Attachable Delivery Unit ●
• HAAG Attachable Slit-Lamp Delivery Unit .
• Binocular Indirect Ophthalmoscope Delivery Unit .
• Combination Delivery Unit for Nidek Nd: YAG laser .

The Nidek Green Laser Photocoagulator Model GYC-1000 acceptance criteria and the study that proves the device meets them are described below based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is primarily assessed through its adherence to specified safety and performance standards for medical electrical equipment and laser products. The acceptance criteria are implicit in meeting the requirements of these standards.

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

The provided text only mentions "System and component testing" without specifying a sample size in terms of the number of devices tested. It also does not specify the provenance of any data (e.g., country of origin, retrospective/prospective clinical data). The testing appears to be primarily laboratory/bench testing against engineering specifications and international standards, rather than clinical trials with patient data.

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

Not applicable. The study described is primarily technical testing against established engineering and safety standards, not a study requiring expert-established ground truth for medical diagnoses or outcomes.

4. Adjudication Method for the Test Set

Not applicable. The study described involves compliance testing against technical standards, not a process of adjudicating medical interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This device is a laser photocoagulator, not an AI software intended for image interpretation or diagnostic assistance. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this submission.

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

Not applicable. This device is a physical medical instrument (laser photocoagulator), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is compliance with established international and Japanese electro-medical and laser safety standards (EN 60601-1, EN 60601-1-2, EN 60601-1-4, IEC 60601-2-22, JIS T1204, and JIS C6802) and product specifications derived from a risk analysis. There is no mention of expert consensus, pathology, or outcomes data as "ground truth" in this context.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical instrument and does not involve AI or machine learning algorithms that require a training set.

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

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

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The Nidek Advanced Vision Information System (NAVIS) is a software program intended for use in the collection, storage and clinical information management of patient data, diagnostic data and the images from computerized diagnostic instruments through direct connection with the instruments, or through networks.

The Nidek Advanced Vision Information System (NAVIS) is a computer technology software that collects, stores and maintains patient data information. NAVIS provides real-time review of diagnostic patient information from a number of ophthalmic medical instruments at any PC workstation. NAVIS incorporates patient data, examination data, office scheduling and billing into one system. The Nidek Advanced Vision Information System (NAVIS) contains a main core software program and a number of optional software modules that can be installed. The additional software modules support the number of application instruments that can be used with NAVIS in order to directly transfer and enhance the patient examination data. Additional software modules include the Cell Analysis Eyebank module, the Fundus Measurement module and a software module to allow for networking of several PC workstations and internet access.

The Nidek Advanced Vision Information System (NAVIS) 510(k) summary does not contain specific acceptance criteria with numerical targets. Instead, the performance data section states that "Performance testing was conducted on the Nidek Advanced Vision Information System. System and supported instrument testing was completed based on product specifications and hazard effects determined from the risk analysis. The Nidek Advanced Vision Information System performed as intended and has thus is deemed substantially equivalent to the predicate device and comparable to other ophthalmic patient database devices." This indicates a qualitative assessment against product specifications rather than predefined quantitative acceptance criteria.

The study presented is a substantial equivalence comparison to a predicate device, the AETmed Image Processing Software (K012093), and comparisons to IFA Systems ifa System device and Topcon Instruments Corporation IMAGEnet device.

Here's a breakdown of the requested information based on the provided text:

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

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

The document does not specify a sample size for a test set or data provenance (country of origin, retrospective/prospective). The performance testing description is high-level and refers to "system and supported instrument testing" based on specifications and risk analysis.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. The study focuses on substantial equivalence based on functionality and performance against product specifications, not on diagnostic accuracy requiring expert ground truth for a test set.

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

This information is not provided as the study does not involve a diagnostic test set 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

A multi-reader, multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or conducted. The device is described as an information management system, not an AI-powered diagnostic tool for human readers.

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

The device itself is a standalone software system for data management. Its performance was assessed based on its ability to collect, store, and manage data and images as intended, rather than a diagnostic algorithm's accuracy.

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

The concept of "ground truth" in the diagnostic sense (e.g., pathology, expert consensus) is not applicable to this device's performance evaluation. The "ground truth" for this device's performance would be its adherence to its own product specifications and its functional comparability to predicate data management systems.

8. The sample size for the training set

This information is not provided. The device is a data management system, not a machine learning model that would typically have a "training set" in the conventional sense of AI/ML development.

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

Not applicable, as the device is not an AI/ML system requiring a training set with established ground truth.

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The Nidek ECHOSCAN Model US-1800 is a diagnostic instrument that is intended for use in the measurement of the axial length of the eye and corneal thickness.

The EchoScan Model US-1800 is a diagnostic instrument that is indicated for use in the measurement of the axial length of the eye and corneal thickness.

The instrument is used to measure the axial length of the eye and the thickness of the cornea by the application of an ultrasound pulse reflection method. During axial length measurement, the cornea is touched with a probe, and the ultrasonic pulse sent by the transducer in the probe is reflected within each part of the eye (cornea, anterior chamber, lens, vitreous body, retina, etc.) and their echoes are received by the same probe. The received echoes are converted to electronic acoustic signals and indicated on the LCD as an amplitude. In addition, the time difference of each echo is measured and the length of each tissue (AC depth, lens thickness, vitreous body length, and axial length) is calculated according to the time difference and known inherent sonic velocity of each tissue.

For corneal thickness measurement, the ultrasonic pulses are transmitted when the probe is put on the cornea. Part of the pulses are reflected and the front and rear surface of the cornea. When the probe receives the reflected echoes, the time difference of each echo is measured and the corneal thickness is calculated according to the time difference and known inherent sonic velocity of the cornea.

Here's an analysis of the Nidek ECHOSCAN Model US-1800 acceptance criteria and performance study based on the provided text, structured to answer your specific questions:

The document provided is a 510(k) summary for the Nidek ECHOSCAN Model US-1800, which is a submission to the FDA to demonstrate substantial equivalence to a predicate device. As such, the "acceptance criteria" discussed are primarily focused on demonstrating that the new device shares fundamental technological characteristics with, and is as safe and effective as, its predicate. This is not a clinical trial report with predetermined performance metrics for a novel AI algorithm. Instead, it's a comparison to an already cleared device.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The term "acceptance criteria" in this context refers to the technological specifications and performance characteristics that the new device (US-1800) must meet to be considered substantially equivalent to the predicate device (US-2000). The "reported device performance" is how the US-1800 measures up against these established characteristics of the predicate, or to relevant standards.

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

The provided document is a 510(k) summary focused on demonstrating substantial equivalence through technological comparison and compliance with standards. It does not describe a clinical study with a test set of patient data. Instead, the "testing" performed was:

• Electrical Safety Testing: In accordance with EN 60601-1 and EN 60601-1-2.
• Programmable Electrical Medical Systems testing: In accordance with EN 60601-1-4.
• Acoustic Output Test Measurements: In accordance with the Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment (May 1998).

Therefore, there is no patient-based test set or associated sample size, or data provenance (e.g., country of origin, retrospective/prospective) mentioned in this document. The "tests" were device-centric against engineering and safety standards.

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

As there was no patient-based clinical "test set" and no "ground truth" derived from patient data in the context of diagnostic accuracy, this information is not applicable to this document. The "ground truth" for the engineering performance tests would be the established values and limits within the specified international standards (EN 60601-1, EN 60601-1-2, EN 60601-1-4, and the Acoustic Output Measurement Standard). The experts involved would be the test engineers performing the measurements and verifying compliance with these standards.

4. Adjudication Method for the Test Set

Since there was no patient-based clinical "test set" requiring interpretation or consensus among experts for ground truth, an adjudication method like 2+1 or 3+1 is not applicable. The "adjudication" was based on whether the device's measured performance met the technical specifications and safety limits defined by the referenced standards.

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

No, an MRMC comparative effectiveness study was not done. The document is a 510(k) summary focusing on demonstrating substantial equivalence based on technological characteristics and compliance with safety standards, not a clinical study comparing the diagnostic performance of human readers with and without AI assistance. This device is an ultrasound measurement instrument, not an AI-powered diagnostic image interpretation tool.

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

This is not applicable. The Nidek ECHOSCAN Model US-1800 is a diagnostic ultrasound instrument that performs measurements (not an AI algorithm that renders a diagnostic interpretation). Its "performance" is its ability to accurately measure axial length and corneal thickness, which are direct physical measurements, not AI-driven interpretations. The intrinsic accuracy of these measurements (±0.1mm for axial length, ±5µm for corneal thickness) is a standalone performance metric for the device, but it's not an AI algorithm.

7. The Type of Ground Truth Used

For the performance metrics listed (e.g., Clinical Accuracy ± 0.1 mm, Accuracy ± 5 µm), the "ground truth" implicitly refers to the physical accuracy of the measurement when compared against a known standard or highly precise reference measurement. This is standard metrological practice, not expert consensus, pathology, or outcomes data in the clinical diagnostic sense. For the other tests (electrical safety, EMC, acoustic output), the "ground truth" is compliance with the limits and requirements set forth in the specific international and acoustic measurement standards referenced (EN 60601-1, EN 60601-1-2, EN 60601-1-4, and the Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment).

8. The Sample Size for the Training Set

Not applicable. This document describes a medical device, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of machine learning.

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

Not applicable. As there is no AI algorithm and no training set, this question does not apply.

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The Nidek Non-Mydriatic Fundus Camera Model NM-1000 is intended for use in capturing images of the retina and the anterior segment of the eye. This fundus camera can transfer images to a personal computer.

Nidek Co., Ltd. has developed the Model NM-1000, which is a stationary-type ophthalmic non-mydriatic fundus camera. Without using 35mm or instant films, this fundus camera incorporates a full digital video capturing system with memory functions, and can transfer captured images to a personal computer. The NM-1000 is designed to deliver its full performance as a fundus camera specializing in digital video capturing as a stand-alone unit or in combination with an image filing system.

In the same manner as other conventional fundus cameras, the Model NM-1000 fundus camera projects the fundus using invisible infrared beams of light during alignment and monitors patient's eye using an infrared video system which does not burden the patient's eye. As a high-sensitivity CCD chip captures an image during use, only a very small amount of flash is used as compared to the flash intensity used with instant film, therefore only giving a mild shock to the patient. The Model NM-1000 fundus camera can capture images with a very low amount of light as compared to a conventional fundus camera that uses an instant film.

The Model NM-1000 fundus camera design incorporates the camera unit and power unit into a single integrated table-top unit. During alignment, the camera displays (on the video monitor) patient ID number, as well as focusing functions such as a working distance detection spot and the focusing indicator.

The captured image is temporarily saved in the camera unit just after being captured, and is displayed as a color still image on the video monitor in real time. This allows the operator to immediately judge if the captured image is satisfactory or not. Furthermore, a large-scale 6.4-inch LCD display is used to enhance ease of operation.

Various terminals are provided to allow the operator to output and use the temporarily saved images for various purposes. The Model NM-1000 fundus camera can interface with other devices through the use of a USB port, RGB analog output and composite video output (NTSC) connections.

The Nidek Non-Mydriatic Fundus Camera Model NM-1000 is an ophthalmic camera. The acceptance criteria and the study performed to prove the device meets these criteria are outlined below.

1. Acceptance Criteria and Reported Device Performance:

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

The provided document does not specify a separate "test set" in the context of clinical or diagnostic performance evaluation. The testing performed focused on electrical safety, electromagnetic compatibility, programmable electrical medical systems, and ophthalmic instrument standards. These types of tests typically do not involve patient data or retrospective/prospective studies.

3. Number of Experts and Qualifications:

Not applicable. The study did not involve expert review or establishment of ground truth by clinical experts, as it focused on engineering and performance standards rather than clinical diagnostic accuracy.

4. Adjudication Method:

Not applicable. There was no clinical data requiring adjudication.

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

No MRMC comparative effectiveness study was conducted. The device is a fundus camera, a tool for capturing images, and the study focused on its adherence to safety and performance standards. It was not designed to assess human reader improvement with AI assistance (as the device itself is a camera, not an AI diagnostic tool).

6. Standalone Performance Study:

A standalone performance study was conducted in the sense that the device was tested on its own against various engineering and performance standards (EN 60601-1, EN 60601-1-2, EN 60601-1-4, ISO 15004). This was an "algorithm only" or "device only" performance evaluation against established technical benchmarks.

7. Type of Ground Truth Used:

The ground truth for the evaluations were the specific requirements and standards outlined in:

• EN 60601-1 (Electrical Safety)
• EN 60601-1-2 (Electromagnetic Compatibility)
• EN 60601-1-4 (Programmable Electrical Medical Systems)
• ISO 15004 (Test Requirements and Test Methods for Ophthalmic Instruments)

These standards define objective technical and performance criteria for the device.

8. Sample Size for the Training Set:

Not applicable. The document describes the product as a fundus camera and does not mention any machine learning or AI components that would require a "training set" for model development. The focus was on demonstrating compliance with technical standards.

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

Not applicable, as no training set for machine learning was used. The ground truth for the device's performance was established by international and European standards for medical device safety, electromagnetic compatibility, and ophthalmic instrument performance.

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The Nidek DC-3300 Laser Diode Photocoagulator is indicated for all retinal photocoagulation procedures, such as limited and pan-retinal, transpupillary laser photocoagulation, endophotocoagulation and transscleral photocoagulation, and glaucoma procedures, such as laser trabeculoplasty and iridotomy. The DC-3300 is used in combination with various delivery systems, such as slit lamps, binocular indirect ophthalmoscopes, endoprobes, and transscleral probes.

The DC-3300 Laser Diode Photocoagulator is an 808 nm continuous wave device. The DC-3300 consists of a compact, lightweight main console, footswitch and carrying case. The aiming laser of the DC-3300 is a red diode with a wavelength of 633 nm. A number of delivery systems are available with the DC-3300. A Slit Lamp Delivery Unit (Nidek SL-1600) Multipurpose Delivery Unit for the attachment of slit lamps (Nidek SL-1600), Endophotocoagulation Set, Binocular Indirect Ophthalmoscope (Models A and B), and Transscleral Photocoagulation probes.

The Nidek DC-3300 Laser Diode Photocoagulator is a device for ophthalmic photocoagulation procedures.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

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

The provided text does not specify a sample size for a test set in the context of clinical performance data for patients. The performance data described relates to compliance with safety standards and functional specifications of the device itself.

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

Not applicable. The study is based on engineering and safety standard compliance, not clinical ground truth established by experts.

4. Adjudication method for the test set

Not applicable. There is no clinical test set requiring adjudication in the provided information.

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

Not applicable. This is a medical device for laser photocoagulation, not an AI-assisted diagnostic or imaging device requiring human reader assessment.

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

Not applicable. This is a standalone medical laser device, and its performance is evaluated in terms of its technical specifications and compliance with safety standards, not as an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is its conformance to established international and national safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-22, IEC 60825-1, UL 2601-1) and its adherence to product specifications and risk analysis findings.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model for which a training set would be required.

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

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

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The Epi-Star Surgical Laser System is intended to be used for Plastic Surgery and Dermatology, with the intended uses for the treatment of vascular and pigmented lesions and for the removal of hair in skin types I - VI.

The Epi-Star Surgical Laser System is an 800 nm continuous wave device coupled with cooling accessory. The Epi-Star laser is self-limiting in the size of spots (2, 3, 4, and 5mm), output power, dwell time, density and fluence rates. The Epi-Star Surgical Laser can achieve fluence rates of up to 400 J/cm² when coupled with the cooling accessories. The treatment parameters for the classifications of various skin types is provided. The Epi-Star laser can be coupled with either a scanner handpiece that has a cooling window (Model A) or with a scanner and cold air system (Model B).

Here's an analysis of the provided text regarding the acceptance criteria and study for the Nidek Epi-Star Surgical Laser System:

Based on the provided text, the device is the "Epi-Star Surgical Laser System, Models A and B." This submission is an amendment (K013864) to a previously cleared device (K990119) to allow for higher fluence rates.

1. Table of acceptance criteria and the reported device performance:

The document primarily focuses on the modification of increasing the allowed fluence rates. It does not explicitly state acceptance criteria in a quantitative, measurable format with target values. Instead, it describes performance in terms of safety and intended function.

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

• Sample size for test set: Not specified beyond "preclinical animal study."
• Data provenance: Preclinical animal study. The country of origin is not specified, but given the submitter's location (Fremont, CA, USA) and FDA submission, it's likely the study was conducted in the US or under protocols adhering to US standards. It is a prospective study as it was conducted to determine safety with higher fluence rates.

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 the animal study would likely be based on pathological examination of tissue samples from the treated animals, but the experts involved are not detailed.

4. Adjudication method for the test set:

This information is not provided in the document.

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

This device is a surgical laser system, not an AI-powered diagnostic or interpretive device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not reported.

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

This is a physical medical device (surgical laser), not a standalone algorithm. Therefore, a standalone algorithm performance study is not applicable and was not reported.

7. The type of ground truth used:

For the preclinical animal study, the ground truth would have been established through direct observation and histopathological examination of the treated animal tissues to assess safety and efficacy (e.g., degree of lesion treatment, hair follicle damage, absence of adverse tissue reactions) at the higher fluence rates.

8. The sample size for the training set:

This information is not applicable as the device is not an AI/machine learning model that requires a training set in the typical sense. Performance testing and the animal study evaluate the physical device's function.

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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