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The MB 103 Millennium blade is intended to be used as a replacement blade for the Moria CB Microkeratome.

The MB 103 Millennium Blade is a replacement blade designed to be used with the Moria CB Microkeratome. The MB 103 Millennium Blade is a single-use only, disposable device. The Blade material is similar to that used in predicate devices (stainless steel).

Acceptance Criteria and Study for Millennium Biomedical Inc. MB 103 Millennium Blades

Based on the provided document, the MB 103 Millennium Blade is a replacement blade for a microkeratome, not a diagnostic AI device requiring complex performance assessments. The acceptance criteria and supporting "study" are therefore focused on physical and functional equivalence to predicate devices, rather than typical AI performance metrics like sensitivity or specificity.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device, the "acceptance criteria" are primarily established by demonstrating substantial equivalence to predicate devices in terms of physical characteristics and performance, as presented in the "How the technological characteristics of the device compare to those of the predicate or legally marketed devices" section. The "reported device performance" refers to the results of the field study.

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

• Sample Size: Not explicitly stated as a number of devices or procedures. The study is referred to as a "market field study," implying real-world usage.
• Data Provenance: The study was "conducted in Korea and China." It is a prospective observational study, as it's a "market field study" assessing performance and adverse events during use.

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

This type of information is not applicable and not provided for this device. The "ground truth" here is successful performance in clinical use as a surgical blade, which would be assessed by the performing surgeons during the "market field study." No formal "experts" establishing "ground truth" on individual cases are mentioned in the context of an AI study.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically relevant for AI studies involving subjective human assessment for ground truth determination. This is not applicable here as the "ground truth" is direct device performance in a surgical context, rather than interpretive diagnostic outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study assesses how AI assistance impacts human reader performance, which is not relevant for a surgical blade.

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

No, a standalone performance study (in the context of an AI algorithm) was not performed. The device is a physical surgical blade, not an algorithm. Its performance is inherently "standalone" in its mechanical function, but evaluated in the context of human surgical use.

7. The Type of Ground Truth Used

The ground truth used was outcomes data and expert observation. The "market field study" essentially assessed the blade's performance in its intended use, with the primary outcome being "acceptable performance" and the absence of "adverse events" as reported by the users (surgeons) in the target markets. "Clinically tested and verified" for sharpness also implies a form of ground truth established by clinical observation of performance.

8. The Sample Size for the Training Set

This concept is not applicable. The device is a physical product, not an AI algorithm that requires a "training set." The design and manufacturing process would involve internal testing and validation, but this is distinct from "training data" for an algorithm.

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

Not applicable, as there is no "training set" in the AI sense for this device. The design and engineering process established the specifications based on predicate devices and presumably internal quality standards for surgical blades.

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