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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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