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MITEK Micro QuickAnchor is intended to attach suture into bone for the suspension of the nasal valve. MITEK Micro QuickAnchor is intended to attach suture into bone at the lower orbital rim.

MITEK anchors are titanium alloy implants used to anchor or lock suture within bony sites for firmly securing soft-tissue to bone.

The provided text is a 510(k) summary for the MITEK Micro QuickAnchor, a medical device. This document focuses on establishing substantial equivalence to previously cleared devices rather than presenting a novel study to determine acceptance criteria and device performance in the way a new diagnostic or AI-driven device might.

Therefore, many of the requested elements (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth used) are not applicable or extractable from this type of regulatory submission. The 510(k) process primarily relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often by comparing design, materials, and intended use.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the provided 510(k) summary in terms of quantitative performance metrics or acceptance criteria for a new study. The document focuses on regulatory clearance by demonstrating "substantial equivalence" to previously cleared devices.

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

Not applicable/provided. This device is a physical implant, not a diagnostic or AI algorithm that would typically involve a "test set" of data in this context. The substantial equivalence is based on device design, materials, and use, not a clinical data-driven performance study in the traditional sense for a new device.

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

Not applicable/provided. "Ground truth" in this context (a physical implant) would refer to clinical outcomes, which are not detailed as part of this 510(k) summary’s comparison to predicate devices.

4. Adjudication Method for the Test Set

Not applicable/provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

Not applicable/provided. MRMC studies are typically for diagnostic imaging interpretation or similar medical AI applications, not for physical implants.

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

Not applicable/provided. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

Not explicitly stated or applicable as for a diagnostic device. The "ground truth" for a physical implant would relate to its safety and effectiveness in surgical applications, which is typically addressed through clinical experience with similar predicate devices and, if necessary, clinical trials (though not detailed here for a 510(k)).

8. The Sample Size for the Training Set

Not applicable/provided. This is a physical device, not an AI model requiring a training set.

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

Not applicable/provided.

Summary of Extracted Information:

Acceptance Criteria and Device Performance:

• Acceptance Criteria: The primary "acceptance criteria" for this 510(k) submission are that the MITEK Micro QuickAnchor is "substantially equivalent" in terms of safety and effectiveness to predicate devices already on the market. This is a regulatory standard rather than a specific performance metric.
• Reported Device Performance: The document does not report specific performance metrics for the MITEK Micro QuickAnchor from a new study. Instead, its safety is referenced by its clearance through pre-market notifications (K962793, K962511, K982420) for its predicate devices, implying similar expected performance.

Study Type and Design:

• The text describes a 510(k) premarket notification process, which aims to demonstrate "substantial equivalence" to legally marketed predicate devices, rather than a de novo clinical study with specific acceptance criteria as you might see for a completely novel device or an AI/diagnostic tool.
• Predicates Referenced: K962793, K962511, K982420.

Device Description:

• Device Name: MITEK Micro QuickAnchor
• Classification Name: Staple, Fixation, Bone
• Common/Usual Name: Suture Anchor
• Device Description: Titanium alloy implants used to anchor or lock suture within bony sites for firmly securing soft-tissue to bone.
• Intended Use: To attach suture into bone for the suspension of the nasal valve and at the lower orbital rim.

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