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KOWA VK-2s is indicated for acquiring, displaying and storing image data from KOWA's mydriatic ophthalmic cameras.

The VK-2s consists of five types of software models including the:

• VK-2s Standard .
• . VK-2s VX-20
• VK-2s nonmyd ●
• VK-2s nonmydWX
• VK-2s Viewer .

The VK-2s Standard, VK-2s VX-20, VK-2s nonmyd, and VK-2s nonmydWX are all software executed on a capture PC. The software acquires images from a retinal camera that the control software captures and puts on the capture PC. The software acquires images of the eye, stores images and processes images. The software displays acquired and processed images which are stored in a Server's database. The only difference between these four software programs are the devices that are supported for providing images:

VK-2s Standard
This software only supports images from:

• KOWA VX series cameras, ●
• KOWA nonmyd series cameras .
• and supports file import.

VK-2s VX-20
This software only supports images from:

• . KOWA VX-20 series cameras,
• and supports file import. ●

VK-2s nonmyd
This software only supports images from the KOWA nonmyd series cameras.

VK-2s nonmydWX
This software only supports images from the KOWA nonmydWX cameras.

VK-2s Viewer
This is a software executed on a viewer PC. This software stores images, processes images and displays acquired and processed images which are stored in a server database. This software does not support image capture.

The VK-2s software also takes advantage of three software packages included with the VK-2s. These are:

VK-Montage Software
This software allows the operator to create montages using multiple images

VK-Scan
VK Scan is software which can be used to import images located in a specified folder.

VK-DDV
The detailed database viewer provides advanced searching, viewing, image processing, printing, and reporting for your VK-2s database.

This document describes a 510(k) premarket notification for the Kowa VK-2s, a Picture Archiving and Communication System (PACS) for ophthalmic images. The provided text is a summary of the 510(k) and focuses on demonstrating substantial equivalence to predicate devices, rather than detailing a specific clinical study with acceptance criteria for device performance.

Therefore, the following information cannot be fully extracted or is not applicable based on the provided text:

• A table of acceptance criteria and the reported device performance: No specific performance metrics or acceptance criteria are defined for the Kowa VK-2s in this document. The document focuses on comparing functions and features to predicate devices to establish substantial equivalence.
• Sample sized used for the test set and the data provenance: No test set or related sample size is mentioned, as this is a comparison to predicate devices, not a new performance study.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No MRMC study is mentioned.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone performance study information is provided.
• The type of ground truth used: No ground truth data is discussed.
• The sample size for the training set: Not applicable as no algorithm training is discussed.
• How the ground truth for the training set was established: Not applicable.

However, based on the provided text, here is what can be inferred about the device and its assessment:

1. Acceptance Criteria and Reported Device Performance:

While no numerical acceptance criteria or performance metrics are explicitly stated, the implicit acceptance criterion is "substantial equivalence" to the predicate devices. This means the Kowa VK-2s must have the "same indications for use, similar principles of operation, and similar technological characteristics" as the predicate devices, and the differences should not raise new questions of safety or effectiveness.

The "reported device performance" is a feature-by-feature comparison to predicate devices. The document highlights functional similarities and differences to argue for substantial equivalence.

Table 1: Comparison of KOWA VK-2s to Canon Ophthalmic Software Platform RX (Primary Predicate)

Table 2: Comparison of KOWA VK-2s to KOWA portable VK-2 in KOWA nonmyd a-DIII (Secondary Predicate)

The key conclusion stated is that the differences "do not raise new questions of safety or effectiveness," thus satisfying the substantial equivalence requirement.

9. How the ground truth for the training set was established:
The software was subject to "Software verification and validation testing," which is a standard procedure for medical device software to ensure it performs as intended and meets its specifications. The software was considered a "moderate" level of concern. This indicates that a risk assessment was performed, and the testing was conducted according to established software development and quality assurance protocols (e.g., unit testing, integration testing, system validation). However, specific details about the methods or data used in this verification and validation are not provided in this summary. There is no mention of a "training set" in the context of an AI/ML algorithm.

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KOWA SL-17 is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.

The KOWA SL-17 is a non-invasive ophthalmic device that is able to illumination, magnification and observation of the human eye. It consists of a hand-held, battery powered slit-lamp biomicroscope with viewing and illumination optical systems and a stand.

The document provided (K133755) describes the KOWA SL-17, a non-invasive ophthalmic device intended for eye examination of the anterior eye segment. The submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a legally marketed predicate device (KOWA SL-15, K063640), rather than proving the device meets specific performance criteria for novel claims.

Therefore, the study described is a substantial equivalence comparison to a predicate device, not a performance study against acceptance criteria in the typical sense for a new clinical claim. The "acceptance criteria" here refer to conformance with various standards and safety requirements to demonstrate that the new device is as safe and effective as the predicate.

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

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for substantial equivalence, the "acceptance criteria" are compliance with relevant safety and performance standards, and the "reported device performance" is the confirmation that the device met these standards. There are no specific clinical performance metrics (e.g., sensitivity, specificity) listed for the KOWA SL-17 itself, as its function is observation and illumination, and its equivalency is largely based on technical specifications and safety.

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

This submission focuses on engineering and safety testing. There is no clinical "test set" or patient data mentioned for validating clinical performance in the provided document. The testing involved compliance with various international standards for medical devices (ISO, IEC, FDA guidance), which typically involve laboratory or bench testing rather than patient data.

• Sample Size for Test Set: Not applicable as no clinical test set is described.
• Data Provenance: Not applicable as no patient data (country of origin, retrospective/prospective) is described.

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

Not applicable. This type of submission relies on engineering standards and comparisons, not on expert-established ground truth for clinical performance.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical test set requiring adjudication.

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

No. The document does not describe an MRMC comparative effectiveness study. The submission is for substantial equivalence to a predicate device, focusing on technical and safety aspects, not on improving human reader performance with AI assistance.

• Effect size of human readers improve with AI vs without AI assistance: Not applicable.

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

No. The KOWA SL-17 is a physical medical device (a slit lamp biomicroscope) used directly by a human operator, not an algorithm that performs standalone analysis.

7. The Type of Ground Truth Used

Not applicable as there is no mention of a ground truth for clinical performance. The "ground truth", in this context, would be the requirements of the standards (e.g., ISO, IEC) which were met by the device.

8. The Sample Size for the Training Set

Not applicable. The KOWA SL-17 is a physical optical device, not an AI/ML algorithm that requires a training set of data.

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

Not applicable.

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The KOWA VX-20 is intended for taking pictures of retinal images with mydriatic or without mydriatic.

The KOWA VX-20 is a retinal image shooting device which can take images with Mydriatic, Non-mydriatic, Fluorescein Angiography (FA), Red Free (RF), and Fundus AutoFluorescence angiography (FAF). The KOWA VX-20 is equipped with the filing function of captured images and the stored retinal images can display in the LCD monitor. The KOWA VX-20 is equipped with USB ports and an Ethernet port to be able to transfer images to the external device.

The KOWA VX-20 is a retinal image shooting device. The provided text describes the performance testing conducted to ensure its safety and effectiveness.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a particular "test set" in terms of subject or image count for performance validation. Instead, the device's performance is demonstrated through adherence to various international and FDA standards, which typically involve testing the device itself rather than its performance on a dataset. The studies described are engineering and safety compliance tests, not clinical studies with patient data.

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

Not applicable. The "ground truth" here is compliance with technical standards, which is assessed through testing procedures defined by those standards, not through expert review of clinical data.

4. Adjudication Method for the Test Set

Not applicable. Technical standard compliance is determined by test results against predefined limits, not by expert adjudication.

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

No. An MRMC comparative effectiveness study was not performed. The submission focuses on device safety and technical performance, not on demonstrating improved human reader performance with the device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in a sense. The testing described for electrical safety, electromagnetic compatibility, optical safety, and software validation are assessments of the device's standalone performance against established technical and safety standards. There is no "algorithm only" performance reported in the context of an AI-powered diagnostic system, as this device's primary function is image acquisition.

7. The Type of Ground Truth Used

The ground truth used for this submission is based on technical standards and regulations. This includes:

• Specifications and requirements outlined in ISO10940, IEC60601-1, IEC60601-1-2, ISO15004-2.
• FDA guidance for software validation.
• Material safety data.
• Risk management principles from ISO14971:2007.

8. The Sample Size for the Training Set

Not applicable. This device is an image acquisition device, not an AI model requiring a training set of data.

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

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

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KOWA nonmyd WX is intended for use with plane and stereo retinal image capturing without mydriatic. The retinal image can be stored to an image filing device through serial interface.

The KOWA nonmyd WX is a retinal camera without mydriatic. Plane retinal image capturing function, that is normal image capturing, is equipped and furthermore, stereo image capturing function is done. The stereo images are able to take simultaneously in shingle shot, as these images are captured without image/parallax shifts.

The KOWA nonmyd WX consists of a device body and external digital SLR camera, Single-Lens Reflex camera.

The KOWA nonmed WX uses Xenon flash lamp as an image capturing light and Infrared LED lamp as an observation light.

The KOWA nonmyd WX can be sued even in case which pupil has not been completely dilated in plane image capture mode, if it is more than 3.7mm in diameter.

The KOWA nonmyd WX is equipped with a USB port to be able to transfer images to a computer.

The KOWA nonmyd WX is designed to be able to link up to a filling system (KOWA portable VK-2), which can manage the digital images.

This 510(k) summary for the KOWA nonmyd WX is for an ophthalmic camera and does not contain information about acceptance criteria and a study proving a device meets them in the context of an AI/ML powered device. The studies described are for electrical safety, electromagnetic compatibility, optical safety, software evaluation, biocompatibility, and risk management, which are standard regulatory requirements for medical devices but do not involve performance metrics like sensitivity, specificity, or human-in-the-loop improvements typically associated with AI/ML systems.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be answered:

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

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

Not applicable. The document describes compliance with electrical, optical, and software standards, not a clinical performance study using a test set of patient data.

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

Not applicable. The "ground truth" here relates to engineering standards and software functionality, not clinical diagnoses made by experts.

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

Not applicable.

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

No MRMC study was mentioned. The device is a camera, not an AI assistance tool for human readers.

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

This refers to an ophthalmic camera, not an algorithm. Therefore, "standalone performance" in the context of an algorithm is not applicable. The software evaluation confirmed the embedded software and filing software's validity as part of system function tests.

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

The "ground truth" for the tests performed relates to:

• Electrical Safety: Standards set by IEC60601-1.
• Electromagnetic Compatibility: Standards set by IEC60601-1-2.
• Optical Safety: Group 1 instrument requirements in ISO15004-2.
• Software Validity: Requirements outlined in FDA guidance for software in medical devices and internal system functional specifications.

8. The sample size for the training set

Not applicable. This is not an AI/ML device with a training set.

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

Not applicable.

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KOWA GENESIS-Df is a device intended to capture and save fundus images with mydriatic.

KOWA GENESIS-Df is a hand-held mydriatic retinal camera which captures fundus image. It is equipped with a highly sensitive CCD camera, does not require film for photography, and allows for immediate viewing of the image after image is captured. It uses a lower flash light intensity than previous cameras requiring film, thereby providing greater user comfort. Compared to the predicate device, the KOWA GENESIS-Df uses less power during observation by using a visible LED light for observation lighting. Various weight savings were achieved with the KOWA GENESIS-Df camera to allow the user to be able to hold it in one hand with ease.

This 510(k) notification describes a device (KOWA GENESIS-Df) that is substantially equivalent to a predicate device (KOWA GENESIS-D). The acceptance criteria and supporting study information are therefore focused on demonstrating this substantial equivalence, rather than establishing de novo performance metrics for a novel device.

1. Table of Acceptance Criteria and Reported Device Performance

• Intended Use, Use Condition, Picture Angle, Working Distance, Observation, Storage Media, Camera Spec., Image Data Format, Diopter Compensation, Observation Light Source, Weight of Camera unit: All are explicitly stated as "SAME to GENESIS-D".
• Photographing Light Source: Xenon flash lamp 23WS (same as predicate) but "with improved optical system" for fluorescence angiography. This is an enhancement within a substantially equivalent framework.
• Power Consumption: 150VA (higher than predicate's 60VA) due to enlarged power supply for fluorescence function, but this change was evaluated for safety. |

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

This 510(k) notification does not describe a clinical study with a "test set" in the traditional sense of evaluating diagnostic accuracy or performance against a ground truth dataset of patient images. Instead, it focuses on technical and safety comparisons to a predicate device.

• Sample Size: Not applicable in the context of a "test set" for diagnostic performance. The submission relies on technical specifications, engineering comparisons, and safety/EMC testing.
• Data Provenance: Not applicable for patient data. The provenance relates to engineering test data and specifications, likely from Kowa Company, Ltd. (Japan) where the device is manufactured and designed. The submission itself is prospective, detailing a new device based on an existing one.

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

Not applicable. This submission does not involve evaluation of diagnostic performance against expert-established ground truth. The "ground truth" for the claims made in this document relates to the technical specifications and safety profile of the predicate device, against which the new device is compared. This would involve internal engineering expertise at Kowa Company, Ltd.

4. Adjudication Method for the Test Set

Not applicable, as no clinical "test set" was described for diagnostic performance evaluation.

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 an ophthalmic camera, not an AI-powered diagnostic tool. The submission is a 510(k) for substantial equivalence based on hardware and functional comparison, not a comparative effectiveness study involving human readers or AI.

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

Not applicable. This is a hardware device (ophthalmic camera) and does not involve a standalone algorithm for diagnostic or screening purposes.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is the established technical specifications, safety data (light hazard, electrical safety, EMC), and functional performance of the predicate device, KOWA GENESIS-D (K050271). The new device (KOWA GENESIS-Df) is compared directly against these documented characteristics to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. There is no machine learning or AI algorithm being trained as part of this device submission.

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

Not applicable, as there is no training set for an AI algorithm.

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KOWA FM-600 is an instrument to measure the protein level contained in aqueous humor of the anterior chamber of human eye.

KOWA FM-600, here after refer to as FM-600, is a noninyasive flare photometry device that is able to assess anterior protein level quantitatively.

FM-600 consists of three units, Measurement unit, Operating unit and Power supply unit. The measurement unit is contained optical system including Laser, photo receiver and CCD camera for observation. The operating unit is contained Observation monitor. Analyzer of detected photon intensity, printer for output and migratory mechanism of the units. The power supply unit is contained Power unit.

Here's an analysis of the KOWA FM-600's acceptance criteria and study, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for the FM-600. Instead, it demonstrates the device's technical characteristics and performance through precision measurements (repeatability and reproducibility) and a comparison to predicate devices. The implicit acceptance is that these performance metrics are acceptable for its intended use, especially given its substantial equivalence to previously cleared devices.

I will formulate "acceptance criteria" based on the reported precision of the device and its claimed substantial equivalence.

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

• Sample Size: The precision study used Bovine Serum Albumin (BSA) solutions at 8 different concentrations (ranging from 0 to 2000 mg/dL). For each concentration, there were:
  • 3 instruments
  • 10 replicate measurements per instrument
  • Total measurements = 8 concentrations * 3 instruments * 10 replicates = 240 measurements.
• Data Provenance: The data is from an in-vitro study using Bovine albumin solution, not human patient data. It is from the device manufacturer, Kowa Company, Ltd., located in Japan. The study is prospective in the sense that the measurements were actively performed for the premarket notification.

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

This device measures a biophysical parameter (protein level/flare). The "ground truth" for the test set (BSA solutions) was established by the known concentrations of the prepared Bovine albumin solutions. Therefore, no human experts were used to establish ground truth for the test set in the way radiologists or pathologists would for diagnostic imaging. The accuracy of the BSA preparation would be verified by standard laboratory practices.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the ground truth was based on prepared chemical concentrations, not expert interpretation requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. The study focuses on the device's technical precision and its comparison to predicate devices based on flare value measurements from BSA solutions, not on human reader performance with or without AI assistance. The KOWA FM-600 is a measurement device, not an AI diagnostic tool.

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

Yes, the device's performance as described (repeatability and reproducibility) represents its standalone performance. The FM-600 directly measures the flare value; human interpretation of the measurement itself is not part of its core functionality, though a clinician would interpret the result in the context of a patient's condition. The "algorithm" here is the device's internal measurement system.

7. Type of Ground Truth Used

The ground truth used for the precision study was the known, prepared concentrations of Bovine albumin solutions (BSA). This is a controlled experimental "ground truth" rather than clinical ground truth (e.g., pathology, outcomes data, or expert consensus from patient cases).

8. Sample Size for the Training Set

The document does not describe a separate "training set" in the context of machine learning. The KOWA FM-600 is a measurement device, not an AI algorithm that undergoes distinct training. Its design and calibration would be based on engineering principles and potentially internal testing data, but this is not typically referred to as a "training set" in the same way as for AI.

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

Not applicable, as there's no explicitly described "training set" for an AI algorithm. The device's fundamental measurement capabilities would be established through engineering design, calibration using known standards (like the BSA solutions), and quality control processes.

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The KOWA VX-10a is intended for taking pictures of fundus images with mydriatic or without mydriatic.

The KOWA VX-10a is a simplified version of the predicate device [KOWA VX-10i (K062021)] by removing the indocyanine green (ICG) angiography mode, removing the use of Polaroid film as a recording media, and changing the availability of the data card for writing patient information as an optional accessory. In addition the lens coating was changed.

The provided text describes a 510(k) premarket notification for the KOWA VX-10α fundus camera. This document is a submission to the FDA demonstrating that a new device is substantially equivalent to a legally marketed predicate device. As such, it does not contain acceptance criteria for device performance based on a study, nor does it present results from a clinical or standalone effectiveness study.

The primary "study" proving the device meets acceptance criteria in this context is a comparison to a predicate device and a series of safety tests.

Here's a breakdown of the requested information based on the provided text, with explanations for what is missing or not applicable to this type of submission:

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

This document does not present acceptance criteria in the form of performance metrics for a clinical study or functional performance against specific thresholds. Instead, the "acceptance criteria" are implied by the substantial equivalence argument, meaning the new device must perform at least as well as (or equivalently to) the predicate device for its intended use, and demonstrate compliance with relevant safety standards.

Therefore, the "reported device performance" is essentially that the KOWA VX-10α is comparable to the KOWA VX-10i.

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

• Test Set Sample Size: Not applicable. This submission relies on a comparison to a predicate device and engineering/safety tests, not a clinical test set of patient images or data.
• Data Provenance: Not applicable for a traditional clinical test set. The safety test reports (ISO standards) would have their own data provenance, likely from internal testing by Kowa Company, Ltd. in Japan.

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 clinical test set requiring expert ground truth was evaluated in this submission.

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

Not applicable. No clinical test set requiring adjudication was evaluated.

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 fundus camera, an imaging acquisition device, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance is not relevant or described.

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

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

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

Not applicable. For the purpose of this 510(k) submission, the "ground truth" for the device's functionality is its equivalency to the predicate device and compliance with established international safety standards for ophthalmic instruments.

8. The sample size for the training set

Not applicable. This is hardware, not an AI/ML algorithm that requires a training set.

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

Not applicable. This is hardware, not an AI/ML algorithm that requires a training set.

Summary of the Study Proving Acceptance Criteria:

The "study" conducted for the KOWA VX-10α to meet acceptance criteria (in the context of a 510(k) submission) primarily involved:

• Predicate Device Comparison: A detailed feature-by-feature comparison demonstrating that the KOWA VX-10α is substantially equivalent to the KOWA VX-10i (K062021), with any differences being simplifications that do not raise new questions of safety or effectiveness.
• Safety Testing: Specific tests were performed to address the impact of a change in lens coating:
  • Test Report for ISO10940, 1998: Ophthalmic instruments - Fundus cameras
  • Test Report for ISO 15004-1, 2006: Ophthalmic instruments-Fundamental requirements and test methods Part 1: General requirements applicable to all ophthalmic instruments
  • Test report for ISO 15004-2:2007 Ophthalmic instruments-Fundamental requirements and test methods Part 2: Light hazard protection

The results of these safety tests demonstrated conformity to the listed ISO standards, confirming that the lens coating change did not introduce any new optical hazards or safety concerns. This, combined with the substantial equivalence argument, formed the basis for the FDA's clearance.

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KOWA nonmyd ct-DIII, fundus camera, is intended for use with retinal image capturing without mydriatic. The retimal image can be stored to an image filing drive through serial ınterface

KOWA nonmyd a-DIII, fundus camera, is intended for use with retinal image capturing without mydriatic The retinal image can be stored to an image filing drive through serial ınterface

The provided text does not contain acceptance criteria or a study proving that the device meets acceptance criteria.

The document is a 510(k) premarket notification for the KOWA nonmyd α-DIII (Type 2), a fundus camera. Its primary purpose is to demonstrate substantial equivalence to a predicate device (KOWA nonmyd α-DIII (Type 1), K082767), rather than to present a performance study with defined acceptance criteria.

The information provided describes:

• Device Name: KOWA nonmyd α-DIII (Type 2)
• Intended Use: Retinal image capturing without mydriatic, with image storage capabilities.
• Comparison: The new device is compared to a predicate device (KOWA nonmyd α-DIII (Type 1)).
• Modifications: The modifications made to the new device are listed as:
  • Change in power supply.
  • Change in CCD camera to one with the same resolution (8.3M pixels) and sensitivity from another manufacturer.
  • Addition of montage function in associated software.
  • Addition of advanced search function in associated software.
• Conclusion: The FDA determined substantial equivalence, meaning the new device has the same fundamental technology and safety performance as the predicate device.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth, as this information is not present in the provided text.

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The KOWA hand-held retinal camera, KOWA GENESIS-D is a device intended to capture and save fundus images with mydriatic.

The KOWA hand-held retinal camera, KOWA GENESIS-D is a device intended to capture and save fundus images with mydriatic.

Here's a summary of the acceptance criteria and study information based on the provided text, though it's important to note that the document is a 510(k) submission for a modification, not a detailed clinical study report with performance metrics in the typical sense.

The core of this submission is a comparison to a predicate device, arguing substantial equivalence rather than presenting new performance data for specific clinical metrics.

Description of the Device and Modification:

The device is the KOWA GENESIS-D, a hand-held mydriatic retinal camera intended to capture and save fundus images. The specific submission (K080681) is for a modification: the addition of an indirect diagnostic lens holder (K9L-LH51) as an optional accessory to the previously cleared KOWA GENESIS-D (predicate device K0530271).

Acceptance Criteria and Device Performance (Based on Substantial Equivalence to Predicate):

The "acceptance criteria" in this context are implicitly that the modified device (KOWA GENESIS-D with indirect diagnostic lens holder) performs equivalently in its intended use as the original KOWA GENESIS-D. The submission argues that the modification (the lens holder) does not change the fundamental technology, safety, or effectiveness of the device.

Study Details:

The provided document does not describe a clinical performance study in the typical sense (e.g., measuring sensitivity, specificity, accuracy against a reference standard). Instead, it's a 510(k) premarket notification focused on demonstrating substantial equivalence to a predicate device. This means the "study" is a comparison of technical specifications and intended use.

1. Sample size used for the test set and the data provenance: Not applicable. No clinical test set data is presented. The "test" consists of comparing specifications. The data provenance for the original device (K0530271) is not in this document.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring expert ground truth was performed for this submission. The "ground truth" here is that the modified device has the same properties as the predicate device, which is established by the manufacturer's engineering comparison and verification.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication was performed.
4. 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 not an AI/CADe device, and no MRMC study was conducted.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device. It's a medical imaging hardware device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a clinical performance study. The "truth" for this submission is that the technical specifications of the modified device are the same as the predicate, which is a manufacturing and design verification process.
7. The sample size for the training set: Not applicable. This is not a machine learning/AI device, and no training set was used.
8. How the ground truth for the training set was established: Not applicable. See point 7.

Summary of the "Study" (Substantial Equivalence Argument):

• Objective: To demonstrate that the KOWA GENESIS-D hand-held retinal camera with the addition of the indirect diagnostic lens holder (K9L-LH51) is substantially equivalent to the predicate device (KOWA GENESIS-D without the accessory).
• Methodology: A direct comparison of technical specifications, intended use, operating principles, basic design, materials, power supply, light source, and packaging was conducted between the modified device and the predicate.
• Conclusion: The submitter concluded that the KOWA GENESIS-D with the indirect diagnostic lens holder shares the "same fundamental technology and maintain the same level of safety performance" as the predicate device, therefore having "no significant differences in the technological characteristics and safety." The FDA concurred with this assessment, hence the 510(k) clearance.

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