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MTM® Clear Aligner is indicated for the treatment of anterior tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of incremental minor tooth movements, MTM® Clear Aligner sequentially positions teeth by way of continuous gentle force.

MTM® Clear Aligner consists of a series of custom made removable plastic orthodontic appliances that sequentially positions teeth by way of continuous gentle force.

The provided document is a 510(k) premarket notification for a medical device (MTM® Clear Aligner) and does not contain the information required to answer your request about acceptance criteria and a study that proves the device meets those criteria.

Here's a breakdown of why and what the document does include:

• Type of Document: This is an FDA 510(k) clearance letter and summary. It's a regulatory document demonstrating that a new device is "substantially equivalent" to an existing, legally marketed device (predicate device).
• Focus of 510(k): The primary goal of a 510(k) is to prove equivalence, not to establish new performance acceptance criteria or conduct new, exhaustive efficacy studies. It often relies on previously cleared devices and existing scientific literature.
• Information Absent:
  • Acceptance Criteria Table: No such table is present. The document focuses on comparing the proposed device's characteristics and intended use to predicate devices.
  • Reported Device Performance: While it discusses the device's function (sequentially positions teeth by continuous gentle force), it doesn't provide specific quantitative performance metrics (e.g., accuracy of movement, patient satisfaction rates, failure rates) against defined acceptance criteria.
  • Sample Size for Test Set/Data Provenance: No new test set data is provided, so these details are absent.
  • Experts for Ground Truth/Qualifications: Not applicable, as there's no new study generating ground truth for a test set.
  • Adjudication Method: Not applicable.
  • MRMC Comparative Effectiveness Study: No such study is mentioned or reported. The document does not discuss human reader performance with or without AI.
  • Standalone Performance Study: No new standalone (algorithm-only) performance study is reported.
  • Type of Ground Truth: Not applicable for new data. The "ground truth" for the 510(k) is essentially the established safety and effectiveness of the predicate devices and existing scientific literature.
  • Training Set Sample Size/Ground Truth Establishment for Training Set: Not applicable. This document is not about an AI/ML algorithm development or validation.

What the document does say about performance data:

• Non-Clinical Performance Data: "No additional non-clinical bench testing has been included in this submission. Nonclinical data was previously submitted and reviewed to support clearance of the primary predicate MTM® Clear Aligner under premarket notification K132145." (Section 7)
• Clinical Performance Data: "No new human clinical data has been included in this submission; however a literature review was conducted. Clinical data was previously submitted and reviewed to support clearance of the primary predicate MTM® Clear Aligner under premarket notification K132145, as well as in a prior submission for the MTM® Clear Aligner In-Office system under premarket notification K123925. This data demonstrated performance of the predicate MTM® Clear Aligner for sequential minor incremental tooth movements using Raintree Essix plastics with force point technology. A literature review was conducted in support of the proposed device modification. The literature review is included in this submission to provide valid scientific evidence for intrusive and extrusive orthodontic tooth movements achieved with clear aligner therapy." (Section 8)

In summary, this document does not contain the specific information you requested regarding acceptance criteria and a study proving those criteria are met for the device. It's a regulatory filing based on substantial equivalence to previously cleared devices and a literature review, not a new performance study with defined criteria.

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