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The CellChek 20 rc is a software program intended to analyze ophthalmic images captured by the Konan Specular Microscope XVII for examination of corneal endothelium.

Konan Medical has developed the CellChek 20 rc to provide photographic data taken exclusively by the Konan Specular Microscope XVII, CellChek 20, which was cleared by FDA under 510(k) number K191558 on Mar 26, 2020, to research and learning centers for the advancement of ophthalmic sciences and practice. The CellChek 20 rc was developed based on the software program of CellChek 20.

CellChek 20 rc is a software program to analyze ophthalmic images for examination of corneal endothelium. This has the cell counting analysis program, and allows for analysis of the images of the cell distribution of the eye.

The software program is installed on a general-use computer to analyze corneal endothelial images photographed exclusively by the Konan Specular Microscope XVII, CellChek 20. The analysis function is to calculate mainly the cell density, the coefficient of variation of cell area, and the percent hexagonality. In the manual methods, cornea endothelial cells and cell boundaries are actually identified by users. In the automatic methods, this software detects cells and cell boundaries, however, users can modify the detection results. During operating, the users interact with the software by visually placing dots in the center of each of cells and/or by tracing cell boundaries displayed on a computer screen, or use the automatic algorithm.

The provided document primarily focuses on the FDA 510(k) clearance process for the Konan Medical CellChek 20 rc software, establishing its substantial equivalence to a predicate device. It does not contain detailed information about specific acceptance criteria or an explicit study proving performance against those criteria.

However, it does mention that "CellChek 20 rc was developed according to the harmonized standard for software, IEC 62304, and FDA requirements for software and cybersecurity for the 510(k) clearance." It also states that "The following testing was performed on the CellChek 20 rc which was the same software function standard as those for CellChek 20: CellChek 20 rc device was subjected to software testing in accordance with IEC62304."

Based on the information available, here's what can be extracted and what is NOT available:

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

No explicit table of acceptance criteria with corresponding performance metrics is provided in the document. The document focuses on demonstrating substantial equivalence to a predicate device and adherence to general software safety standards.

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

This information is not provided in the document.

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 in the document. The document mentions that users can identify cells and boundaries manually or modify automatic detections, implying human interaction with the software's analysis. However, it doesn't specify how ground truth for testing was established.

4. Adjudication method (e.g. 2+1, 3+1, none) 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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of an MRMC comparative effectiveness study in the document. The software allows for both manual and automatic methods for cell analysis, with user modification, but no study is described to quantify human performance improvement with AI assistance.

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

The document mentions both "manual methods" where "cornea endothelial cells and cell boundaries are actually identified by users" and "automatic methods" where "this software detects cells and cell boundaries, however, users can modify the detection results." This implies the algorithm can operate somewhat standalone, but the user is always in a position to review and adjust. However, no formal standalone performance study results, such as sensitivity, specificity, or accuracy, are presented for the algorithm itself.

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

This information is not provided in the document.

8. The sample size for the training set

This information is not provided in the document. The document states that "CellChek 20 rc was developed based on the software program of CellChek 20," suggesting that any machine learning components (if present and requiring training data) would have been integrated or refined from the existing CellChek 20 platform.

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

This information is not provided in the document.

Summary of available information regarding acceptance criteria and study:

The document primarily focuses on regulatory clearance through the 510(k) pathway, emphasizing "substantial equivalence" to a predicate device and adherence to general software development and safety standards (IEC 62304). It does not detail specific performance studies with quantitative acceptance criteria, ground truth establishment, or human reader performance metrics that are typical for demonstrating the effectiveness of an AI-driven medical device. The "study" mentioned is general "software testing in accordance with IEC62304," which is a standard for medical device software life cycle processes, focusing on safety and quality, rather than clinical performance metrics.

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The Konan Specular Microscope XVII, CellChek 20, 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 Konan Specular Microscope XVII, CellChek 20, is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of corneal endothelium and for measurement of the thickness of the cornea. Cell counting and analysis program are included, and allow for analysis of the images of the cell distribution of the eye.

When photographing the corneal endothelium, the device performs the alignment and automatically focuses by capturing the reflected light from patient's eye with the camera. The device permits visual inspection and photography of the corneal endothelium and measurement of the corneal thickness without any object contacting the eye. It features focusing by means of infrared techniques, as well as computer-assisted cell counting and cell analysis capabilities. The computer functions are also used to aid in setting up the various features of the machine and to aid in photography. Photographic images are temporarily stored in the system's memory and can be preserved by using a printer.

The parts of the device that come into contact with a patient are the forehead rest and the chin rest. Their material is acrylonitrile butadiene styrene (ABS), the same material used in reference device and one with proven biocompatibility.

The function of the software installed in the device is to calculate mainly the cell density, the coefficient of variation of cell area and the percent hexagonality. In the manual methods, Actual identification if the cells and cell boundaries is done by the (physician) user. In the automatic method, the software detects the cells and cell boundaries, however, the user is given the opportunity to make corrections. In use, the user interacts with the software by visually placing dots in the center of cells as or by tracing cell boundaries as they appear or on a screen or uses the automatic algorithm.

The provided text describes the 510(k) summary for the Konan Specular Microscope XVII, CellChek 20. The bulk of the performance study provided is focused on demonstrating agreement, accuracy and precision with a reference device (NONCON ROBO PACHY F&A) and comparing various analysis methods within the subject device itself. It does not present acceptance criteria in a quantitative format nor directly compare the device performance against specific, pre-defined thresholds for acceptance. Instead, it focuses on comparative equivalence.

However, based on the provided clinical study data and the overall goal of demonstrating "substantial equivalence," we can infer the implicit "acceptance criteria" through the statistical results presented, particularly the correlations and comparisons against the reference device and internal method consistency. The study design is primarily a comparative study rather than a standalone AI performance evaluation or a multi-reader, multi-case study with human readers.

Here's an attempt to structure the information based on the request, interpreting the "acceptance criteria" from the study's conclusions on "strong positive correlation" and "superiority/equivalence in precision."

Implicit Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly based on demonstrating "strong positive correlation" and "superiority to or equivalence with" the predicate/reference device and consistency across different analysis methods within the subject device for key metrics.

Table of Implicit Acceptance Criteria and Reported Device Performance

• CD: R² = 0.9193 (Strong Positive Correlation)
• CV: R² = 0.5677 (Strong Positive Correlation, although the R² value quantitatively is moderate)
• HEX: R² = 0.2460 (Strong Positive Correlation, although the R² quantitatively is weak)

Peripheral Area:

• CD: R² = 0.9209 (Strong Positive Correlation)
• CV: R² = 0.4974 (Strong Positive Correlation, although the R² quantitatively is moderate)
• HEX: R² = 0.1439 (Weak Positive Correlation, as stated in Table 14 conclusion) |
  | Agreement Across Internal Methods | Strong positive correlation (high R²) and acceptable limits of agreement between different analysis methods (e.g., Trace, Auto Trace) and the Center Method within the subject device. | Center Area - Center Method vs. Others:
• Trace: CD, CV, HEX all showed "Strong Positive Correlation" (R² range 0.8097 to 0.9973)
• Auto Trace: CD, CV showed "Strong Positive Correlation" (R²=0.8479, 0.5682), HEX showed "Positive Correlation" (R²=0.4050)
• Auto Center: CD, CV, HEX all showed "Strong Positive Correlation" (R² range 0.6055 to 0.8504)
• Flex Center: CD, CV, HEX all showed "Strong Positive Correlation" (R² range 0.7587 to 0.9971)
• Auto Flex Center: CD, CV showed "Strong Positive Correlation" (R²=0.8480, 0.6499), HEX showed "Positive Correlation" (R²=0.4564). This aligns with the "Strong/Positive Correlation" statements in Table 15. |
  | Precision (Repeatability & Reproducibility) vs. Reference Device | Repeatability and Reproducibility of the subject device should be superior or equivalent to the predicate/reference device. | Center Area (Center Method vs F&A): CD, CV, HEX for CellChek 20 (Subject Device) were "superior to" F&A (Reference Device) based on lower Repeatability SD, Reproducibility SD, and narrower limits. This general superiority was maintained across other CellChek 20 analysis methods (Auto Trace, Auto Center, Auto Flex Center are "very superior," and Trace/Flex Center are "partially superior or equivalent"). |

Detailed Study Information:

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

   • Sample Size: 80 subjects (patients).
   • Data Provenance: The study was a "prospective clinical study" conducted at an "ophthalmic clinic" that agreed to cooperate. The country of origin is not explicitly stated in the provided text, but Konan Medical, Inc. is based in Japan. Without that specific detail in the document, it's assumed to be from a clinical setting, but the geographical location of that clinic isn't mentioned beyond "ophthalmic clinic."

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

   • The study states: "Three analysts analyzed the examinees' images with each of the 6 methods, Center Method, Auto Center Method, Trace Method, Auto Trace Method, Flex Center Method, Auto Flex Center Method, of CellChek 20, and Center Method of F&A."
   • The qualifications of these "analysts" are not specified. It is implied they are trained individuals capable of performing these analyses, but their explicit qualifications (e.g., "radiologist with 10 years of experience" or similar) are not provided. The document mentions that in manual methods, "Actual identification if the cells and cell boundaries is done by the (physician) user," implying physicians are involved in the process, but it doesn't state if the "three analysts" were physicians.

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

   • The document does not describe any adjudication method for establishing a single "ground truth" or reference standard. The "three analysts" each performed their analysis, and the study then compares the subject device's methods (analyzed by these three) with the reference device's method (also analyzed by these three). It appears to be a direct comparison of device outputs without an independent, adjudicated ground truth.

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:

   • No, a multi-reader, multi-case (MRMC) comparative effectiveness study involving human readers improving with AI assistance vs. without AI assistance was not performed. The study evaluates the device's measurements (Corneal Endothelial Cell Density, Coefficient of Variation, and Hexagonality) against a reference device and compares different analysis methods within the device. There is no mention of human-in-the-loop performance improvement.

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

   • Yes, in a sense. The study assesses the performance of the device's various analysis methods (Trace, Auto Trace, Center, Auto Center, Flex Center, Auto Flex Center) in terms of agreement, accuracy, and precision compared to a reference device. While analysts operate the device and its software, the measurements themselves are output by the device's algorithms. The "Auto Trace," "Auto Center," and "Auto Flex Center" methods specifically involve automated detection, and their performance is evaluated. Thus, the performance of the built-in algorithms for measurement is evaluated.

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

   • The "ground truth" or reference standard for comparison was the output from a legally marketed predicate/reference device, the NONCON ROBO PACHY F&A (K062763), specifically using its Center Method, which was also analyzed by the "three analysts." It is an instrument-based reference standard rather than an independent clinical ground truth like pathology or long-term patient outcomes.

7. The sample size for the training set:

   • The document describes a clinical performance study for the Konan Specular Microscope XVII, CellChek 20 (test set of 80 subjects). It does not provide any information regarding the training set size or methodology for the software algorithms embedded in the device. The algorithms were likely developed and validated internally by the manufacturer prior to this submission study.

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

   • As no information about the training set is provided, how its ground truth was established is also not described in this document.

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The Konan Specular Microscope XIV, Cellchek Plus, 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 Konan Specular Microscope XIV, CellChek Plus, 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. Cell counting and analysis programs are included, and allow for analysis of the cell distribution of the eye (the same analysis software present in the predicate device is also present in the modified device).

When photographing the corneal endothelium, the equipment performs the alignment and automatically focuses by capturing the reflected light from the patient's eye with the CCD camera. The device permits visual inspection and photography of the corneal endothelium and measurement of the corneal thickness without any object contacting the eye. It features focusing by means of infrared techniques, and computer-assisted cell counting and cell analysis capabilities. The computer functions are also used to aid in setting up the various features of the machine and to aid in photography. Photographic images are temporarily stored in the system's memory, and are preserved by using a printer.

Both the image of the corneal endothelium and the various computerized control functions are displayed on the touch screen.

The parts of the device that come into contact with a patient are the forehead rest and the chin rest. The head rest is comprised of Polytetrafluoroethylene (PTFE), which is known as Teflon®, and the material that comprises the chin rest is Acrylonitrile butadiene styrene (ABS).

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

Device: Konan Specular Microscope XIV, Cellchek Plus

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state "acceptance criteria" in a numerical or pass/fail format for the clinical study. Instead, it focuses on demonstrating the agreement and variability of different analysis methods (Manual, PC-Assist with redrawing, PC-Assist without redrawing, and Center) for Cell Density, Coefficient of Variation, and Percent Hexagonality. The implied acceptance is that the agreement and variability between these methods, particularly when compared to a 'Manual' or 'exact' method, are within acceptable ranges for clinical use, or comparable to the predicate device.

Since explicit numerical acceptance criteria are not given, the table below presents the reported performance metrics that would likely be evaluated against such criteria if they were defined. The goal of the study was to show substantial equivalence, suggesting that these values align with what is considered acceptable for the predicate device.

Note from the text: "These tables indicate that cell density has a good correlation with the Manual Method (an exact method); the other parameters are only weakly-correlated, especially without redrawing." This serves as a qualitative acceptance criterion, indicating that strong correlation for cell density is considered important, while weaker correlation for other parameters might be acceptable depending on their clinical significance.

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

• Sample Size: 40 images (of eyes)
• Data Provenance: Not specified, but the study was performed using the Konan predicate device. It is a retrospective analysis of previously acquired images.

3. Number of Experts and Qualifications

• Number of Experts: 4 "classifiers" (referred to as a group)
• Qualifications: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Each of the 4 "classifiers" analyzed each image three times. The analyses were then used to calculate agreement and variability. There is no mention of a consensus process (e.g., 2+1, 3+1) to establish a single ground truth per image from disagreement among classifiers. Instead, the study assessed agreement between analysis methods and variability within each analysis method.

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

• Was an MRMC study done? No, not in the traditional sense of comparing human readers with and without AI assistance. This study focused on assessing agreement and variability between different analysis methods (Manual, PC-Assist, Center) and within each method by repeated readings from classifiers, all done using the predicate device's analysis capabilities. It was a comparison of analysis features, not a human vs. AI assistance study for diagnostic improvement.
• Effect size of human readers with AI vs. without AI assistance: Not applicable, as this was not the design of the study.

6. Standalone (Algorithm Only) Performance

• Was standalone performance done? The "PC-Assist" and "Center" methods represent algorithmic or automated analysis capabilities embedded within the device. Their performance characteristics (agreement, correlation, variability) are reported individually and in comparison to the "Manual" method. Therefore, the study did assess aspects of standalone algorithmic performance by evaluating these automated methods.

7. Type of Ground Truth Used

• Type of Ground Truth: The "Manual" method appears to be treated as an "exact method" or reference standard for comparison, particularly for cell density. The text states, "cell density has a good correlation with the Manual Method (an exact method)". This suggests that the ground truth for evaluating the automated methods was established by a manual analysis considered to be precise.

8. Sample Size for the Training Set

• Sample Size: Not specified. The document describes a clinical test but does not provide details about a training set for the device's algorithms. It's possible the algorithms were developed prior to this study and this study served as a validation.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth Was Established: Not specified, as training set details are not provided.

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The KSS-400 Image Storage System is a software product intended to be used for automatic image analysis and data storage for corneal images taken with Specular Microscopes The program analyzes cell density, coefficient of variation, and hexagonality using images taken by the specular microscopes

The KSS 400 Image Storage System is a software product that permits users to analyze corneal images made by Konan specular microscopes in a separate computer and to store them in the computer's memory

This document is a 510(k) summary for the Konan KSS-400 Image Storage System, submitted to the FDA in 2009. It describes a software product designed for automatic image analysis and data storage of corneal images captured by Konan specular microscopes. The software analyzes cell density, coefficient of variation, and hexagonality.

Based on the provided text, the following information can be extracted regarding acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly state specific acceptance criteria or provide a table outlining them. It generally states that "The software has been extensively validated and tested." and "Extensive clinical tests were performed for this system as part of the clearance of one of the predicate devices."

The conclusion drawn is that the "Konan KSS 400 is equivalent in safety and efficacy to the legally marketed predicate devices." This implies that the performance of the KSS-400, in terms of safety and efficacy for analyzing corneal images (cell density, coefficient of variation, and hexagonality), meets the established standards set by its predicate devices. However, the specific quantitative metrics are not provided.

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

This information is not provided in the document. The text only states that "Extensive clinical tests were performed for this system as part of the clearance of one of the predicate devices," but no details about the sample size, type of study (retrospective/prospective), or data provenance are given for either the KSS-400 or the predicate device's tests.

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 in the document. The details about ground truth establishment are absent.

4. Adjudication method (e.g. 2+1, 3+1, none) 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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done, nor is there any mention of comparing human readers with and without AI assistance. The device is a "software product intended to be used for automatic image analysis," suggesting a standalone analysis rather than an AI-assisted human reading workflow.

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

Yes, the description strongly implies a standalone performance evaluation. The device is described as "automatic image analysis," and its intended use is to "analyze cell density, coefficient of variation, and hexagonality using images taken by the specular microscopes." This suggests the algorithm performs these analyses without direct human intervention in the analysis process itself (though a human would interpret the output). The performance data section refers to "Non-clinical tests" and "Clinical tests" for "this system," implying evaluation of the software's inherent analytical capabilities.

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

This information is not explicitly stated in the document. Given that the software analyzes "cell density, coefficient of variation, and hexagonality," the ground truth for these features would likely involve manual expert measurements or validated reference methods for these specific corneal endothelial cell characteristics, but the document does not specify.

8. The sample size for the training set

This information is not provided in the document. The 510(k) summary focuses on the device's performance validation rather than its development or training details.

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

This information is not provided in the document, as details about the training set itself are absent.

In summary:

The document primarily focuses on establishing substantial equivalence to predicate devices based on the device's intended use and general performance claims. It lacks the specific, quantitative details regarding acceptance criteria, study design (sample sizes, provenance, ground truth establishment, expert qualifications, adjudication methods), or comparative effectiveness studies that would typically be found in a more detailed technical report or clinical study summary. The claim of "extensive validation and testing" and "extensive clinical tests" is made, but without the supporting data.

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The Noncon Robo Pachy F&A is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of corneal endothelium and for measurement of the thickness of the cornea.

The Noncon Robo Pachy F&A specular microscope and optical pachymeter 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. It is an improvement to the original Konan Noncon Robo Pachy, K980357. The device permits visual inspection and photography of the corneal endothelium and measurement of the corneal thickness without any object contacting the eye. It features focusing by means of infrared techniques, and computer-assisted cell counting and cell analysis capabilities. The computer functions are also used to aid in setting up the various features of the machine and to aid in photographic images are temporarily stored in the system's memory, and are preserved in video form on magnetic tape or by using a video printer. The memory can store two endothelial cell images and two anterior segment images, which are usually those of the left and right eyes.

Konan NonCon Robo Pachy F&A: Acceptance Criteria and Study Details

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Konan NonCon Robo Pachy F&A are based on the agreement and variability of its analysis methods for corneal endothelial cell density, coefficient of variation, and percent hexagonality, when compared to manual and center methods. The reported performance is presented as the mean difference and 95% limits of agreement between these methods for agreement, and standard deviation (within-image) for variability.

Acceptance Criteria & Reported Performance Table:

Note on Acceptance Criteria: The document does not explicitly state numerical acceptance criteria thresholds. Instead, it presents the "Agreement Between Methods of Analysis" and "Variability Associated with the Analysis Methods" as performance data to demonstrate substantial equivalence to the predicate device. The implied acceptance is that the device's performance, as measured by these metrics, is comparable to, or an improvement on, the predicate device and clinically acceptable.

Additionally, the study explicitly states: "Agreement and variability of the analysis methods was obtained using a sample that included virtually no eyes with Percent Hexagonality 0.41, or Cell Density

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The Konan Kerato Analyzer ("EKA") is a specular microscope used to make cell counts of preserved corneas in eye banks and to measure the thicknesses of the corneas without removing the corneas from their storage vials.

The Konan Kerato Analyzer ("EKA") is a specular microscope used to make cell counts of prescrved corneas in eye banks and to measure the thicknesses of the corneas without removing the corneas from their storage vials. The basic structure of the EKA is similar to that of an inverted laboratory microscope. With the EKA, all focusing is done manually by the operator. For the EKA, vials containing the corneas are placed in a receptacle in the unit.

The Konan Kerato Analyzer (EKA) is a specular microscope intended to make cell counts of preserved corneas in eye banks without removing the corneas from their storage vials.

1. Acceptance Criteria and Reported Device Performance:

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

The document explicitly states "Cell counts on eye bank samples were done with the Noncon Robo and the EKA." However, it does not specify the sample size of eye bank samples used for this comparison.

The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data mentioned.

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

The document does not detail the use of experts to establish ground truth for a test set. The comparison was made directly between the EKA and a predicate device (Noncon Robo). It's implied that the predicate device's measurements serve as the reference or "ground truth" for comparison.

4. Adjudication Method for the Test Set:

No adjudication method is mentioned, as the comparison was direct between the two devices.

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

No, an MRMC comparative effectiveness study was not done. The study focused on the agreement between the EKA and a predicate device, not on human reader performance with or without AI assistance.

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

Yes, a standalone performance assessment was done. The EKA, as a device for automated cell counting, was evaluated on its own ability to perform these counts and was compared directly to a predicate device, without a human operator's interpretation as part of the core performance metric. While an operator manually focuses the EKA, the cell counting itself is an automated function of the device being assessed.

7. The Type of Ground Truth Used:

The ground truth for the comparison was established by the measurements obtained from a legally marketed predicate device, the Konan Noncon Robo. The assumption is that the Noncon Robo provides accurate cell counts.

8. The Sample Size for the Training Set:

The submission document does not specify a separate training set or its sample size. The focus is on the performance comparison of the new device (EKA) against a predicate device. This suggests a direct validation approach rather than a machine learning model that would require a distinct training set.

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

Not applicable, as a separate training set with its own ground truth establishment is not described in this 510(k) summary. The study is a comparative performance assessment against an existing device rather than the development and validation of a new algorithm requiring a training phase.

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