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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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