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The Spark™ Clear Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.

The Spark™ Clear Aligner System consists of a series of doctor-prescribed, custom manufactured, thin, clear, plastic removable orthodontic appliances (aligners) that gently move the participant's teeth in small increments from their original state to a more optimal, treated state. Treatment planning, aligner design, and aligner manufacture are supported by a proprietary software system. 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 aligners are held in place by pressure and can be removed by the patient at any time. The aligners are individually identified and dispensed to patients and are to be worn in a specific prescribed sequence. Several treatment options may be integrated into the Spark Clear Aligners consisting of:

• Attachments: Attachments are small protuberances of tooth-colored dental bonding material and may be prescribed by the dental clinician to act as anchor points on the teeth to focus the forces of the aligner to help with teeth movement.

o Templates: Attachments are placed onto the teeth via Templates. The dental practitioner may choose a standard dental composite, to fill into the Template themselves, and adhesive to bond the attachments onto the dentition. The option for composite material to be prefilled into the Template during manufacturing is also available via Prefilled Attachment (PFA) Templates.

• Hooks & Cutouts: Hooks and Cutouts may be designed into the aligner to accommodate elastics for aiding in applying additional aligner forces. Integrated Hooks are an optional alternative to the traditional Hooks.

• Bite ramps: Bite ramps are step features built into the lingual surfaces of the upper and lower aligner arch that are used by the clinician to prop open the bite temporarily so that certain teeth have a clearer path for movement without interference.

• Pontics: Pontics are cavity spaces (that may or may not be "tooth-shaped") built into the aligner per clinician's request to fill voids of missing teeth or other gaps that the clinician may wish to retain during treatment.

· Posterior Bite Turbos: Posterior Bite Turbos (PBT) are designed to prevent complete closure of jaws.

The provided text is a 510(k) summary for the Spark™ Clear Aligner System. It describes the device and its intended use, and compares it to a legally marketed predicate device to establish substantial equivalence. However, this document does not contain the specific details about acceptance criteria, device performance, or a study designed to prove the device meets those criteria, as typically found in a clinical or performance study report.

The document states: "Non-Clinical performance bench testing to international standards and FDA recognized consensus standards for Aligner, Sequential Device has been conducted to determine conformance" and lists several ISO and ASTM standards. It also mentions biocompatibility testing. Crucially, it states: "Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on this product."

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because the provided text explicitly states that clinical testing was not conducted, and it does not detail the specific performance results or acceptance criteria from the non-clinical bench testing.

Here's a breakdown of why each specific point you asked for cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document mentions conformance to international standards (e.g., ASTM F 1980-21, ISO 14971, ISO 10993 series, ISO 7405, ANSI ADA Standard No. 41-2020) for non-clinical bench testing and biocompatibility. However, it does not detail specific acceptance criteria (e.g., a certain tensile strength or alignment accuracy) or quantify the device's performance against those criteria.
2. Sample size used for the test set and the data provenance: Not mentioned. Since no clinical testing was conducted and the details of non-clinical bench testing are not provided beyond listing standards, the sample size or data provenance (e.g., country of origin, retrospective/prospective) for any test set are not available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. Ground truth is typically established in clinical studies or human-in-the-loop evaluations, which were explicitly stated as not being conducted.
4. Adjudication method for the test set: Not mentioned. Adjudication is relevant for expert-based ground truth establishment, which did not occur according to the document.
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: Not applicable and not mentioned. MRMC studies are typically for diagnostic AI systems involving human readers interpreting images, which is not the nature of this physical aligner system. The device is a physical orthodontic appliance, not a diagnostic AI tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical appliance, not a standalone algorithm in the typical sense of AI and software. While it has proprietary software for treatment planning, the document does not discuss its standalone performance in a quantifiable manner against specific criteria.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned. As clinical testing was not performed by the applicant (for this submission), there's no ground truth established in that context. The "ground truth" for the non-clinical testing would refer to the validated methods and metrics within the specified international standards, but specific details are not provided.
8. The sample size for the training set: Not applicable. This is a physical device, not an AI model that undergoes "training" the way machine learning models do. While its proprietary software might use data, the document does not describe it in terms of AI model training.
9. How the ground truth for the training set was established: Not applicable, for the same reasons as point 8.

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SparkTM Clear Aligner System: The Spark™ Clear Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.

SparkTM Software System: The Spark™ Software System is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual design of a series of dental casts, which may be used for sequential aligner trays, retainers or bracket bonding templatesor based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.

The use of the Spark™ Clear Aligner System and Spark™ Software System requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well to have received a dedicated training in the use of the software.

The Ormco Spark™ Clear Aligner System consists of a series of doctor-prescribed, custom manufactured, thin, clear plastic removable orthodontic appliances (aligners) that gently move the participant's teeth in small increments from their original state to a more optimal, treated state.

Treatment planning, aligner design and aliqner manufacture are supported by a proprietary software system. The Spark™ Clear Aligner system consists of multiple interfacing software modules; Web, Design, Anatomy, 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. Trained technicians use the Ormco™ Spark™ Aligner Anatomy and 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.

The aligners are individually identified and dispensed to patients and are to be worn in a specific, prescribed sequence. Several treatment options may be integrated into the Ormco Spark aligner consisting of: Attachments, Hooks, Bite ramps, Pontics, Posterior Bite Turbos.

The provided document is a 510(k) summary for the Spark™ Clear Aligner System, seeking substantial equivalence to predicate devices. It primarily focuses on comparing the subject device to existing devices and outlining performance bench testing, rather than describing a study to prove acceptance criteria for an AI device.

Therefore, the document does not contain the requested information about acceptance criteria and a study proving an AI device meets them.

The document describes a medical device (Spark™ Clear Aligner System) which includes a "Spark™ Software System" intended for treatment simulation and virtual design of dental casts. However, it does not provide details on specific AI acceptance criteria or a study demonstrating the software's performance against such criteria. The "Non-Clinical Test Data" section mentions "Comparative performance testing of the functions of the Proposed device compared to the cleared stand-a-lone device," and lists several ISO and ASTM standards for biocompatibility, risk management, software life-cycle, usability engineering, and material properties, but does not offer concrete performance metrics or studies in the context of AI.

The document states that "Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on this product." This further confirms that a study to prove AI performance against acceptance criteria, as typically understood in the context of diagnostic or predictive AI, was not performed or reported here.

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