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The LightForce Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances.
The LightForce Orthodontic System (LFO System) is a treatment planning software (TPS) and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances. The orthodontist uses the TPS (K200148) to select and order the patient-specific orthodontic brackets. The TPS allows the orthodontist to diagnose the patient, plan treatment, and position the orthodontic brackets based on a digital impression of the patient - the outcome of the TPS is a prescription for the patient-specific orthodontic brackets. The LFO System consists of patient-specific ceramic brackets, patient-specific bracket placement jigs, arch wire templates, and a TPS for viewing, measuring, and modifying cases. LightForce Orthodontics' (LFO) operators and the orthodontists use the TPS to generate a prescription of their choosing. LFO then manufactures the patient-specific brackets and placement jigs using proprietary additive manufacturing techniques. The orthodontist then bonds the brackets to the teeth using the optional placement jig and ligates wires to enable tooth movement. The LFO System does not contain commercially-available or patient-specific shaped arch wires, ligatures, or adhesives that affixes the brackets to the teeth.
The provided text describes the LightForce Orthodontic System and its claim of substantial equivalence to a predicate device, the Signature Orthodontic System (K181271). However, it does not contain information related to software performance evaluation or clinical studies involving human readers or AI assistance. The document focuses solely on the physical properties and material equivalence of the orthodontic brackets.
Here's an analysis based on the information provided, specifically addressing the questions where applicable:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" with numerical thresholds for performance. Instead, it describes performance testing where the LightForce Orthodontic System (LFO System) brackets were compared to the predicate device, the Signature Orthodontic System. The reported performance is consistently framed as "equivalent to or better than" the predicate device.
| Test Type | Acceptance Criteria (Not Explicitly Stated, Implied Comparison) | Reported Device Performance (LightForce Orthodontic System) |
|---|---|---|
| Shear Bond Strength | Equivalent to or better than predicate device | Equivalent to or better than the predicate device |
| Torque Strength | Equivalent to or better than predicate device | Equivalent to or better than the predicate device |
| Friction (wire drag) Force | Equivalent to predicate device | Equivalent to the predicate device |
| Tensile Bond Strength | Equivalent to predicate device | Equivalent to the predicate device |
| Tie-wing Tensile Fracture Strength | Equivalent to predicate device | Equivalent to the predicate device |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for the bench tests.
The data provenance is not specified (e.g., country of origin, retrospective or prospective). These were bench tests, so "provenance" might refer to the lab where they were conducted, which is not mentioned.
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)
This question is not applicable as the evaluation involved bench testing of physical properties of orthodontic brackets, not interpretation of data by human experts to establish "ground truth." There was no "test set" in the context of human interpretation or AI performance assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable for the same reason as point 3. There was no human interpretation or adjudication involved.
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
The document explicitly states: "No clinical performance testing was conducted on LFO System brackets." Therefore, no MRMC study was performed, and there is no information on human reader improvement with or without AI assistance. The focus of this submission is on the physical properties of the brackets, not on the AI capabilities of the treatment planning software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
While the LightForce Orthodontic System includes "treatment planning software (TPS)", the document focuses on the orthodontic appliance system (the brackets). The non-clinical performance testing described is for the brackets themselves, not the standalone performance of the algorithm within the TPS. The document does not provide details on standalone algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench tests of the brackets, "ground truth" implicitly refers to the measured physical properties and mechanical performance of the predicate device (Signature Orthodontic Brackets), against which the LFO System brackets were compared. This is a property-based or measurement-based ground truth, not expert consensus or pathology.
8. The sample size for the training set
This question is not applicable as the document describes bench testing of physical orthopedic devices and does not mention any training set for an AI model.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8.
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.