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The MB 105 Millennium blade is intended to be used as a replacement blade for the Moria M2 Non-Disposable Microkeratome.

The MB 105 Millennium Blade is a replacement blade designed to be used with the Moria M2 Non Disposable Microkeratome. The MB 105 Millennium Blade is a single-use only, disposable device. The Blade material is similar to that used in predicate devices (stainless steel).

The provided document is a 510(k) Premarket Notification for the Millennium Biomedical Inc. MB 105 Millennium Blades. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than comprehensive clinical studies with detailed acceptance criteria and performance data like those found in a PMA (Premarket Approval) application.

Therefore, the document does not contain the requested information regarding specific acceptance criteria for device performance, or a study proving the device meets said criteria in the way a clinical trial report would.

Here's why and what can be inferred from the document:

• Type of Device: The MB 105 Millennium Blade is a replacement blade for a microkeratome, a Class I device (regulated under 21 CFR 886.4370 as a Keratome). Class I devices typically have lower risk and do not require extensive clinical data for market clearance.
• 510(k) Process: The 510(k) pathway demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing device characteristics (design, materials, intended use, performance testing, etc.) rather than conducting de novo clinical trials to establish safety and effectiveness against explicit performance criteria.
• Content of the Document: The summary focuses on:
  • Identifying the submitter and device.
  • Listing predicate devices.
  • Describing basic physical and performance characteristics (blade material is stainless steel, similar to predicates).
  • Stating the intended use (replacement blade for a specific microkeratome).
  • The FDA's decision letter confirming substantial equivalence.

Therefore, I cannot populate the table or answer the specific questions as the required information is not present in the provided text. The document does not describe:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number/qualifications of experts for ground truth.
• Adjudication methods.
• MRMC studies or effect sizes.
• Standalone algorithm performance.
• Types of ground truth used.
• Sample size for training sets.
• How ground truth for training sets was established.

The absence of this information is typical for a 510(k) submission for a Class I device where substantial equivalence is demonstrated through non-clinical means (e.g., material testing, mechanical testing) rather than extensive clinical efficacy or diagnostic performance studies.

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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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The MB 102 Millennium blade is intended to be used as a replacement blade for the Hansatome™ Microkeratome.

The MB 102 Millennium Blade is a replacement blade designed to be used with the Hansatome™ Microkeratome. The MB 102 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 MB 102 Millennium Blades

The provided document describes the premarket notification for the Millennium Biomedical Inc. MB 102 Millennium Blades, which are intended as replacement blades for the Hansatome™ Microkeratome. The primary method of demonstrating safety and effectiveness is through substantial equivalence to a predicate device, the B&L Accuglide™ Blade.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantitative manner but are implied through the comparison of technological characteristics to the predicate device and the successful functional performance testing. The "reported device performance" is essentially the determination of substantial equivalence based on these comparisons and tests.

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

• Sample Size: The document does not specify a numerical sample size for the functional performance testing. It refers to "test results of the functional performance testing" but provides no quantitative details on how many blades were tested or under what conditions.
• Data Provenance: The document does not specify the country of origin of the data. The data appears to be retrospective in the sense that it relies on a comparison to an already marketed predicate device and likely internal testing to confirm equivalence. There is no mention of a prospective clinical trial.

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

The document does not mention the use of experts to establish a "ground truth" in the traditional sense for the functional performance testing. The comparison is made against the established characteristics and performance of the predicate device, which is already FDA-cleared.

4. Adjudication Method for the Test Set

No adjudication method is described. The assessment appears to be based on direct comparison of technological characteristics and internal functional performance testing.

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

No MRMC study was done. The device is a surgical blade, and the evaluation relies on its physical and functional equivalence to a predicate device, not on comparative effectiveness with human readers or AI assistance.

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

This concept is not applicable to the device, which is a physical surgical blade. Therefore, no standalone study in this context was performed.

7. Type of Ground Truth Used

The "ground truth" for the MB 102 Millennium Blade's performance is implicitly the established performance and characteristics of the predicate device (B&L Accuglide™ Blade). The study's goal was to demonstrate that the MB 102 Millennium Blades are "substantially equivalent" to this predicate.

8. Sample Size for the Training Set

This concept is not applicable to this device. As a physical medical device, there is no "training set" in the context of an algorithm or AI.

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

Not applicable, as there is no training set for this device.

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