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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 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 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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