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The Ormco™ Spark™ Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e., all second molars). The Ormco™ Spark™ Aligner System positions teeth by way of continuous gentle force.

The Ormco™ Spark™ Aligner System consists of a series of doctor-prescribed, custom manufactured, clear plastic removable orthodontic appliances (aligners) that incrementally move the patient's teeth from an original state to a treated state. Treatment planning, aligner design and aligner manufacture are supported by a proprietary software system. The Ormco™ SparkTM Aligner system consists of multiple interfacing software modules; Web, Design, Approver and Fabrication. The Spark Aligner Web software module is an online portal, where clinicians can create new patient profiles, plan treatments, manage patients and submit prescriptions, photos, images and digital scans to Ormco. Ormco technicians use a reference Anatomy software and the Ormco™ Spark™ Aligner Design software to create a 3D model of the patient's teeth from dental scans and to generate a 3D image of a final, treated state, as well as 3D aligner transitional treatment stage models, and submits them to the clinician. The clinician uses the Approver Software to review and approve the models, then Ormco uses the Fabrication software to produce resin molds for thermoforming the aligners.

The clinician receives the aligners and provides them, in sequential "stages", to the patient, confirming fit and monitoring treatment from the placement of the first aligner to the removal of the final aligner. The trays are held in place by pressure and can be removed by the patient at any time.

Several treatment options may be integrated into the Ormco Spark/Kappa aligner. Attachments or "buttons" may be prescribed by the dental practitioner to facilitate tooth movement and aligner anchorage. The dental practitioner may choose a standard dental composite and adhesive to bond the attachments to the dentition. The aligners are individually identified and dispensed to patients and are to be worn in a specific, prescribed sequence. Hooks may be designed into the aligner, then connected by an elastic to a toothbonded button on the opposite arch. to apply additional forces. Bite ramps are step features built into the lingual surfaces of the upper aligner arch that used by the clinician to prevent movement of the teeth during overbite correction treatment. Pontics are cavity spaces (that may or may not be "tooth-shaped") built into the aligner per clinician's request to address voids of missing teeth or other gaps during treatment.

The provided text describes the Ormco™ Spark™ Aligner System and its substantial equivalence to a predicate device, the Invisalign System (K143630). However, it does not contain a study that establishes acceptance criteria and then proves the device meets those criteria through specific performance metrics. Instead, the submission relies on demonstrating substantial equivalence to a legally marketed predicate device based on technological characteristics, performance testing, and a literature review.

Therefore, the requested information elements related to the acceptance criteria and a study proving the device meets them cannot be fully extracted as they are not explicitly present in the provided text.

Here's a breakdown of what can be extracted or inferred based on the supplied document, addressing the prompt's points where possible:

1. Table of acceptance criteria and the reported device performance

The document does not provide a table of explicit acceptance criteria with numerical targets and reported performance values for those targets. Instead, it discusses "performance testing" to demonstrate substantial equivalence to the predicate device.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified for any of the performance tests. The document only mentions "all tested samples" for material property tests (translucency, staining, shelf life, shipping) and "specified cycles" for aligner features.
• Data Provenance: The document does not explicitly state the country of origin or whether the data is retrospective or prospective. The performance testing appears to be bench testing conducted by the manufacturer ("Ormco").

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

• This information is not provided. The document mentions "orthodontic specialists" conducted a "comprehensive scientific literature review and analysis" to support substantial equivalence, but not for establishing ground truth for a test set of the proposed device.

4. Adjudication method for the test set

• This information is not provided. There is no mention of an independent adjudication method for performance tests.

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 MRMC comparative effectiveness study was done or mentioned. The device described (Ormco™ Spark™ Aligner System) is a physical orthodontic appliance system, not an AI-assisted diagnostic or treatment planning tool that would typically involve human "readers" or "AI assistance" in the sense of image interpretation. The software components described are for treatment planning, design, and manufacturing workflow, not for AI-driven interpretation or assisted reading by human experts.

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

• This question is not directly applicable. The "algorithm" here refers to the software that assists in designing and manufacturing the aligners. The overall device is a system involving both software and physical aligners, prescribed and managed by a dental professional. The performance tests evaluate the physical properties of the aligners and the accuracy of certain features, not the standalone diagnostic performance of an algorithm.

7. The type of ground truth used

• For the physical and material performance tests (stress relaxation, flexural/tensile strength, translucency, staining, shelf life, shipping, attachment accuracy, etc.), the ground truth would implicitly be measured physical and chemical properties against established industry standards or comparable predicate device properties.
• For biocompatibility, the ground truth was adherence to ISO 10993-1 standards.
• For the overall claim of substantial equivalence, the "ground truth" for efficacy and safety relies heavily on the established performance and safety record of the predicate device (Invisalign System) and general scientific literature on clear aligners, as no clinical performance testing was done on the proposed device.

8. The sample size for the training set

• This information is not provided. The document describes a "proprietary software system" with "multiple interfacing software modules" for treatment planning, aligner design, and manufacture. If these modules involve machine learning, no details about training set size are given. Given the nature of the device (orthodontic aligners), "training set" may refer to data used for software development and design rather than a clinical AI model training.

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

• This information is not provided. As with point 8, if there's an AI/ML component implying a "training set," the document does not elaborate on how ground truth for such a set would be established. For traditional software development, "ground truth" might align with engineering specifications and clinical requirements documented by the developers and dental professionals.

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