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Oral Image QuickAligners are indicated for the alignment of teeth in patients with permanent dentition (i.e. all second molars) during orthodontic treatment of malocclusion. QuickAligners position teeth by way of continuous gentle force.

The Oral Image QuickAligners are a series of prescription-only clear plastic removable aligners intended to incrementally move a patient's teeth from an initial state to a different end state using a softwaregenerated sequence of intermediate states. Based on a clinician's prescribed treatment plan, each aligner in the set is used for the specified period of time to exert gentle force to achieve progressive realignment of the final correction has been achieved. Standard treatment time for each aligner tray is 2-3 weeks, worn by patient for 22 hours per day.

This document is a 510(k) Premarket Notification from the FDA for a device called "QuickAligners." It is a regulatory clearance document, not a scientific study report. As such, it does not contain the detailed clinical study data or acceptance criteria that would typically be found in a clinical trial report or a performance evaluation study.

The FDA's 510(k) clearance process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring new clinical efficacy or performance studies unless deemed necessary.

Based on the provided text, here's an analysis of the requested information:

Key Takeaway: The approval for QuickAligners was based on substantial equivalence to an existing predicate device (ClearPath Aligner, K202857). This means that extensive, new clinical performance studies, as one might perform for a novel device, were explicitly deemed not required for this clearance.

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: The document does not explicitly state quantitative performance acceptance criteria in terms of metrics like sensitivity, specificity, accuracy, or any specific numerical targets for device performance. The acceptance criterion for 510(k) clearance in this context is "substantial equivalence" to the predicate device in terms of indications for use, technological characteristics, materials, mode of action, and safety profile.

• Reported Device Performance: The document states that "Bench testing was performed to validate the manufacturing process. An assessment was performed to validate aligner fit and performance." However, it does not report specific numerical performance data from these bench tests (e.g., precise measurements of fit, force exerted, or aligner performance metrics). It also mentions "Aligner sheet physical properties testing was conducted and provided for review by the material manufacturer." Again, specific numerical results from this testing are not provided in this document.

  Table (as inferred from the document's focus on equivalence):

  Acceptance Criterion (Regulatory)	Reported Device Performance (as stated by FDA)
  Substantial Equivalence to Predicate Device (ClearPath Aligner K202857) in:
  - Indications for Use	- "highly similar" to Predicate, "differing slightly in wording and device name. These differences do not change the intended use...and supports a finding of substantial equivalence." (p. 5)
  - Technological Characteristics	- Mode of action/use is "the same as the Predicate device" (p. 5). Both use 510(k)-cleared software for treatment planning and 3D printing of models. Software validated for use with the Subject device. Fabricated from non-sterile, biocompatible thermoplastic material (same as Predicate). (p. 5)
  - Materials	- "non-sterile, biocompatible thermoplastic material" validated according to ISO 10993-1. (p. 5-6) Aligner sheet physical properties testing conducted by material manufacturer. (p. 6)
  - Performance (Bench Testing)	- "Bench testing was performed to validate the manufacturing process." (p. 6) - "An assessment was performed to validate aligner fit and performance." (p. 6) - Mentions "difficulty in evaluating this type of dental device in a laboratory environment, no direct performance bench testing of the aligners to an established standard was performed." (p. 6) - However, the "assessment" and "manufacturing validation" were deemed sufficient.
  - Biocompatibility	- Biocompatibility testing conducted successfully per ISO 10993-1. (p. 6)

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Test Set Sample Size: Not applicable / Not specified for clinical performance. The document explicitly states: "Therefore, there no clinical testing is required to support Oral Image QuickAligners, as the Indications for Use is equivalent to the Predicate device, which also was not subject to clinical testing. No clinical data is included in this submission." (p. 6)
• Data Provenance: Not applicable for a clinical test set since no clinical testing was performed for this 510(k). The "bench testing" and "assessments" for manufacturing validation, fit, and performance are not described with sample sizes or provenance in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not applicable. As no clinical testing was performed to establish new ground truth for performance, no experts were used in this capacity for a clinical test set. The ground truth for the predicate device's historical clearance (if any clinical data was used then) is not detailed here.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable. No clinical test set or human reader study was mentioned as part of this 510(k) submission for the QuickAligners device.

5. 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. This document does not mention any MRMC comparative effectiveness study. The device as described is a physical appliance (aligner trays), not an AI-assisted diagnostic or treatment planning software that humans would use to "improve" their reading. While software is used to design the aligners, the 510(k) focuses on the physical device's equivalence, not on the comparative effectiveness of the software tool for human users.

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

• Not applicable in the typical sense of an AI algorithm. The device is a physical aligner. While the manufacturing process involves "specialized orthodontic CAD/CAM software" to develop treatment plans and generate 3D files (p. 4), the performance assessment mentioned is for the physical aligner and its manufacturing process, not a standalone performance evaluation of the software as a diagnostic or treatment outcome prediction tool. The software's role is described as a tool for design and manufacturing, not as a standalone interpretable algorithm that would have its own "standalone performance" evaluated in the way AI diagnostics are.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the equivalence claim: The "ground truth" for the clearance was the legal clearance and established safety/efficacy profile of the predicate device (ClearPath Aligner, K202857), against which the QuickAligners were compared for "substantial equivalence."
• For the bench testing/validation: The "ground truth" would be related to predefined specifications for manufacturing quality, fit, and material properties. The document does not detail how these "technical ground truths" were established, only that the testing was performed and "The results of the tests satisfy the requirements of the study protocols." (p. 6)

8. The sample size for the training set

• Not applicable. This document describes the clearance of a physical medical device (aligners), not an AI/ML model for which training data would be specifically referenced in this context. The "software" mentioned is CAD/CAM software for design and manufacturing, not a machine learning model that undergoes a training phase in the traditional AI sense.

9. How the ground truth for the training set was established

• Not applicable. (See point 8).

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