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Arkligners are indicated for use in the alignment of permanent teeth (i.e. all second molars) through orthodontic treatment of misalignment and malocclusion. The aligners guide teeth to their final position by way of continuous gentle forces.

The Arkligners device is fabricated of clear thin thermoformed Essix Ace plastic in sequential series to progressively reposition the teeth. Corrective force to straighten the teeth is delivered via minor changes into a position in each subsequent aligner.

Clinicians scan a patient, export the views needed for the patient model, and sends these scans to Arklign Laboratories. They import them into 3Shape Dental Manager 2020 to create a patient model. The patient model is imported into 3Shape Ortho System 2021 Clear Aligner Studio to design the models to make clear aligners for the treatment plan the clinician has ordered. This treatment plan (with models needed to make aligners for whichever treatment phases are being ordered) is then exported and sent to the clinician along with the original patient model file for them to approve. Then Arklign Laboratories exports the approved models needed to make the specific aligners ordered to Formlabs Form 2 3D printer running Formlabs PreForm 3.12.0. The aligner is thermoformed over the printed model. Every aligner is checked for fit on the printed patient model before sending to the clinician.

The provided text is a 510(k) summary for Arkligners, a type of orthodontic aligner. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report with acceptance criteria and device performance results. As such, the information needed to fully answer the request is not present in the provided text.

Specifically, the document states: "Arkligners were checked for fit on the relevant patient model by lab personnel doing measurements and two clinicians using clinical criteria for fit." This is the only mention of performance evaluation. It does not provide quantitative acceptance criteria, reported performance values, sample sizes, expert qualifications, or details about adjudication methods.

Therefore, I can only partially address your request based on the very limited information available.

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

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a table format. It only mentions that "Arkligners were checked for fit on the relevant patient model by lab personnel doing measurements and two clinicians using clinical criteria for fit."

Based on the limited information, a table cannot be constructed with specific acceptance criteria and reported numeric performance values.

Study Details for Device Performance

1. Sample size used for the test set and the data provenance:

   • Sample size: The document mentions "patient scans representing three specific clinical scenarios" were used for manufacturing validation and fit checks. This indicates a sample size of n=3 clinical scenarios. It's unclear if this equates to 3 individual patient models or more.
   • Data Provenance: The data provenance is not explicitly stated (e.g., country of origin). The study appears to be descriptive of a manufacturing validation process rather than a formal clinical study.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of experts: "two clinicians" were used for fit checks.
   • Qualifications: The qualifications of these clinicians are not explicitly stated, beyond being referred to as "clinicians working with Arklign."

3. Adjudication method for the test set:

   • The document states "lab personnel doing measurements and two clinicians using clinical criteria for fit." This suggests a process where both lab personnel and clinicians evaluated fit. However, no specific adjudication method (like 2+1 or 3+1 consensus) is described for resolving disagreements or establishing a definitive "ground truth" for fit.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, an MRMC comparative effectiveness study was not done. The document describes a manufacturing validation and fit check process, not a reader study involving human interpretation of data/images, nor does it involve AI assistance.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • No, a standalone algorithm performance study was not done. The device itself is the physical aligner, created through a digital workflow but ultimately a physical product. The "fit" was checked by human lab personnel and clinicians.

6. The type of ground truth used:

   • The "ground truth" for the fit check was based on "clinical criteria for fit" as judged by two clinicians, and "measurements" by lab personnel. This can be categorized as expert judgment/clinical criteria.

7. The sample size for the training set:

   • The document mentions "patient scans representing three specific clinical scenarios" were used for manufacturing validation and design. It's unclear if this refers to the training of the software workflow (3Shape Dental Manager, 3Shape Ortho System Clear Aligner Studio) or the aligner manufacturing process. However, no separate "training set" for a device performance study is described. The focus is on the manufacturing process and material safety/equivalence.

8. How the ground truth for the training set was established:

   • This information is not provided as there isn't a clearly defined "training set" for a performance study in the context of this 510(k) summary. The "treatment plan" for generating the aligners was determined by "Clinicians working with Arklign."

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