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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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