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

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

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

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

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

2. Sample Size and Data Provenance

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

3. Number of Experts and Qualifications for Ground Truth

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

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

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

4. Adjudication Method

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

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

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

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

6. Standalone Performance Study

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

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

7. Type of Ground Truth Used

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

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

8. Sample Size for the Training Set

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

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

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

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The EM-4000 Specular Microscope 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 Tomey EM-4000 Specular Microscope is a non-contact ophthalmic microscope and camera intended for corneal endothelium imaging. Its operating principle is based on the Specular optical principle. This device is used for imaging the corneal endothelium. The EM-4000 analyzes and displays data such as cell number, cell density, coefficient of variation and percent hexagonality. 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. Infrared LEDs are used as the light source for the alignment. Operation with the iovstick also makes it possible to focus manually. The green LED light radiates to the cornea, and the endothelium image is captured with the CCD camera by the reflected light from the cornea. The endothelium images are stored in internal memory.

Furthermore, the EM-4000 is able to measure the central corneal thickness. The corneal endothelium is photographed first followed by measuring the central corneal thickness. The infrared LED light for measurement of corneal thickness radiates to the cornea through the objective lens for photographing the cornea, and the central corneal thickness can be calculated by measuring the distance on the optical line sensor between the reflected light from front surface and back surface of cornea.

Here's an analysis of the acceptance criteria and study detailed in the provided document:

The document describes the Tomey EM-4000 Specular Microscope, 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 study aims to demonstrate substantial equivalence to a predicate device, the Konan Medical, Inc. Cellchek XL (K120264).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical thresholds in this document for all parameters beyond pachymetry. Instead, the study aims to show "agreement, accuracy and precision" with the predicate device, demonstrating substantial equivalence. For pachymetry, a specific accuracy is mentioned.

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

The Nidek Specular Microscope CEM-530 provides non-contact, high magnification image capture of the endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images. The captured images and analysis results of the endothelium are used in intraocular or corneal surgery, postoperative follow-up, and corneal observation such as for endothelial disorders or the corneal state of patients who wear extended-wear contact lenses. Observation is possible in the central area (visual angle: 5°) and peripheral area (visual angle: 27°) using a periphery capture function as well as in the center of the captured images and analysis results can be printed on the built-in printer or optional video printer, or output to an external device over LAN connection. In addition to the specular microscopy, the corneal thickness can be optically measured in a non-contact method. The CEM-530 has auto-tracking and auto-shooting functions. Results can be printed using the built-in thermal printer or captured images can be transferred to a filing system via LAN connection. The Specular Microscope CEM-530 cleared in this 510(k) is identical to the Specular Microscope CEM-530 cleared in K130565 with the addition of a new analysis mode: Center Point Method. All other aspects of the cleared device remain unchanged.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

7. The type of ground truth used:

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

8. The sample size for the training set:

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

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

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

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The Specular Microscope SP-1P 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.

This instrument is a photographic device dedicated to photograph and record corneal endothelial cells as an electronic image without contacting the eye. The Specular Microscope SP-1P also allows for measuring corneal thickness at the same time as corneal endothelial cells photography. The Specular Microscope SP-1P has functions that permit users to analyze photographed corneal endothelial cells and to calculate the area and form of corneal endothelial cells. It automatically performs alignment, photography and analysis. The Specular Microscope SP-1P contains multiple fixation targets, and allows users to photograph both central and peripheral corneal endothelial cells depending upon which fixation target is used. The Specular Microscope SP-1P has a manual image alignment function which allows the operator to utilize the internal function of the SP-1P to focus on the cornea and obtain the image. The manual image alignment can be utilized in difficult lighting or cases where the subject has a difficult time fixating. The Specular Microscope SP-1P also has a manual editing function which allows the clinician to modify the cells selected on the automatically captured image. Photographed images, images for observation and analysis results are displayed on the color LCD monitor with touch panel. An internal printer allows for printing photographed images and analysis results.

Here's an analysis of the provided text regarding the acceptance criteria and study for the TopCon SP-1P Specular Microscope:

The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate device, Konan Cellchek Plus (K120264), particularly in terms of agreement and precision for key corneal measurements. The study aims to show that the TopCon SP-1P performs similarly to the predicate device across various metrics.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are based on the agreement and precision of four key variables compared to the predicate device. The tables below outline the reported performance relative to the predicate device. The underlying acceptance criterion for each metric is that the TopCon SP-1P measurements should demonstrate substantial equivalence to the Konan CellChek XL (Plus), meaning the differences, LOA intervals, and correlation should indicate a strong agreement and comparable precision.

Agreement Data (Explicitly Stated in "Device Comparisons" section of Table 1)

Precision Data (Repeatability/Reproducibility Ratios, Implicitly aiming for ratios close to 1 or better)

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

• Sample Size (Effectiveness Population): 69 subjects.
  • 21 Non-pathologic young adult (NPY; 18-28 years of age)
  • 27 Non-pathologic adult (NPA; 29-80 years of age)
  • 21 Pathologic adult (PA; 29-80 years of age)
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the submission is to the U.S. FDA, and manufacturers often conduct clinical studies in the country where they seek approval or in international sites that adhere to similar regulatory standards. No specific country is mentioned for the study site.
  • Retrospective or Prospective: Prospective, open label, randomized, single-center study.

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

The study compares the TopCon SP-1P results to those obtained with a commercially available predicate device, the CellChek XL (Plus), manufactured by Konan Medical, Inc. This implies the predicate device provides the "ground truth" or a well-established reference for comparison.

• Number of Experts: Not applicable in the sense of independent expert adjudication of images to establish ground truth. The comparison is between automated measurements of two devices. The "ground truth" for the predicate device's measurements (CellChek XL (Plus)) is its established and accepted clinical performance.
• Qualifications of Experts: Not applicable, as no human experts were used to establish ground truth for individual cases in this comparative study. However, the study involved multiple machines/operators: "Machines were tested in three configurations, each with its own operator".

4. Adjudication Method for the Test Set

The adjudication method is not described as a formal consensus among experts. Instead, the study uses the predicate device's measurements as the reference for comparison for agreement. The "Center Method" is mentioned in relation to the predicate device's analysis, but not as an adjudication method for the test set's ground truth.

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

• MRMC Comparative Effectiveness Study: No, this was not an MRMC comparative effectiveness study involving human readers assisting with or without AI. This study compared one automated device (SP-1P) to another (predicate CellChek XL Plus).

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

• Standalone Performance: Yes, the study evaluates the performance of the TopCon SP-1P, which "automatically performs alignment, photography and analysis." The clinical performance data "evaluates the precision and accuracy of the automatic analysis performed by the Specular Microscope SP-1P compared to the Center Method for the predicate device." While the device has manual editing and manual image alignment functions, the reported clinical performance data specifically relates to the "automatic analysis" mode in comparison to the predicate. This indicates a standalone evaluation of the device's automated capabilities.

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

The "ground truth" for this study is the measurements obtained from a legally marketed predicate device (Konan CellChek XL Plus). The study assesses the agreement and precision of the TopCon SP-1P's measurements relative to the predicate device, rather than against an independent, absolute "gold standard" ground truth like pathology or expert consensus on a per-image basis.

8. The Sample Size for the Training Set

The document does not provide any information about a training set for the device's algorithms. This information is typically proprietary to the manufacturer and not usually disclosed in 510(k) summaries unless directly relevant to a specific AI/ML claim requiring such detail. The device performs "automatic analysis," implying algorithms are used, but their training data is not described.

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

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

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

The Nidek Specular Microscope CEM-530 provides non-contact, high magnification image capture of the endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images. The captured images and analysis results of the endothelium are used in intraocular or corneal surgery, postoperative follow-up, and corneal observation such as for endothelial disorders or the corneal state of patients who wear extended-wear contact lenses. Observation is possible in the central area (visual angle: 5°) and peripheral area (visual angle: 27°) using a periphery capture function as well as in the center of the captured images and analysis results can be printed on the built-in printer or optional video printer, or output to an external device over LAN connection. In addition to the specular microscopy, the corneal thickness can be optically measured in a non-contact method. The CEM-530 has auto-tracking and auto-shooting functions. Results can be printed using the the built-in thermal printer or captured images can be transferred to a filing system via LAN connection.

The Nidek Specular Microscope CEM-530 performed a clinical study to demonstrate substantial equivalence to the predicate device Konan Medical, Inc. Cellchek Plus (K120264).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria were not explicitly stated as numerical thresholds in the provided text. Instead, the study aimed to demonstrate "agreement, accuracy, and precision" between the Nidek CEM-530 and the predicate device, with results being "acceptable" and "substantially equivalent." The key metrics evaluated were:

Summary of Device Performance against Implicit Acceptance Criteria:

• Agreement: The study reported that "Agreement of the measurements with the CEM-530 and the predicate device was found to be acceptable." Bland-Altman plots generally showed LOAs including 0, indicating no overwhelming systematic bias.
• Accuracy: Differences were generally small (3-5% for CD, CV, CCT) except for % Hexagonality (15%). Deming regression plots showed good agreement for CD, CCT, and CV (especially after outlier removal for CV).
• Precision: "Overall, within eye/subject variability was acceptable, and similar for both machines." Repeatability was notably better for Nidek CEM-530 for CCT, and comparable for other endpoints.
• Substantial Equivalence: The overall conclusion was that the Nidek CEM-530 is "substantially equivalent" to the predicate device based on these performance metrics.

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

• Sample Size for Agreement Assessment: 74 eyes
  • 24 non-pathologic young eyes (18-28 years of age)
  • 25 non-pathologic adult eyes (29-80 years of age)
  • 25 pathologic adult eyes (29-80 years of age)
• Sample Size for Precision Assessment: 62 evaluable eyes
  • 20 non-pathologic young eyes
  • 22 non-pathologic adult eyes
  • 20 pathologic adult eyes
• Data Provenance: The study was a prospective clinical study. The country of origin of the data is not explicitly stated, but the sponsor and manufacturer are NIDEK Co., Ltd. in Japan, and the contact person is in Andover, MA, USA. It's common for such studies to be conducted in multiple locations, but this information is not provided.

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

The document does not specify the number of experts used or their qualifications for establishing the ground truth. The "ground truth" for this study was established by comparing the Nidek CEM-530's automatic measurements against the predicate device (Konan Cellchek Plus)'s manual measurements. It is implied that the manual measurements from the predicate device serve as the reference standard.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for the test set. The comparison was primarily between the automated measurements of the Nidek CEM-530 and the (presumably expert-performed) manual measurements from the predicate device.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed to assess the improvement of human readers with AI vs. without AI assistance. This study focused on the performance of a new automated device (Nidek CEM-530) compared to an existing predicate device (Konan Cellchek Plus), which primarily involved a comparison of device measurements rather than human reader performance with or without AI assistance.

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

Yes, a standalone performance study was done. The Nidek Specular Microscope CEM-530 is described as having "auto-tracking and auto-shooting functions" and "automatic image analysis." The clinical study reported on the "agreement, accuracy and precision of the CEM-530 by comparing results across three machines/operators to those obtained with the predicate device," and specifically "evaluates the precision and accuracy of the automatic analyses performed by the CEM-530 compared to manual measurements performed with the predicate device." This indicates that the CEM-530's automatic analysis was tested in a standalone capacity. An additional analysis was performed on 24 images comparing the automated method to a manual method on the same image.

7. Type of Ground Truth Used

The primary "ground truth" used for comparison was the manual measurements performed with the predicate device, the Konan Cellchek Plus. For the additional analysis on 24 images, the "manual method of analysis on the same image" served as the comparison for the automated method.

8. Sample Size for the Training Set

The document does not provide information regarding a separate training set or its sample size. The clinical study was conducted to assess the performance of the already developed CEM-530 device.

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

Since information about a specific training set or its sample size is not provided, the method for establishing ground truth for a training set is not available in the 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 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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