(30 days)
The Signature Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances.
The Signature Orthodontic System (SO System) is a treatment planning software (TPS) and orthodontic appliance system used to correct malocclusions in orthodontic patientmatched orthodontic appliances. The SO System consists of patient-specific ceramic brackets, patient-specific bracket placement jigs, arch wire templates, and a TPS for viewing, and modifying cases. Signature Orthodontics' (SO) operators and the orthodontists use the TPS to generate a prescription of their choosing. SO 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 SO System does not contain commercially-available or patient-specific shaped arch wires, ligatures, or adhesives that affixes the brackets to the teeth.
The document provided focuses on the substantial equivalence of the "Signature Orthodontic System" to predicate devices, primarily through non-clinical performance testing. It does not contain information about a study proving the device meets acceptance criteria in the way this request is typically framed for AI/algorithm performance (e.g., sensitivity, specificity, or reader study metrics).
Instead, the provided text describes bench testing to demonstrate performance equivalence of orthodontic brackets, which is a different type of "acceptance criteria" and "study."
Here's an analysis based on the provided text, addressing the points where information is available or noting where it is not:
Acceptance Criteria and Device Performance (Based on Non-Clinical Bench Testing)
| Acceptance Criteria (Measured Performance Aspect) | Reported Device Performance (Signature Orthodontic System) | Related Predicate Device Performance | Conclusion (Signature Orthodontic System vs. Predicate) |
|---|---|---|---|
| Shear Bond Strength | Higher average value | Lower average value | Equivalent to or better than predicate |
| Torque Strength | Slightly higher average value | Slightly lower average value | Equivalent to predicate (no statistically significant difference) |
| Friction (Wire Drag) Force | Slightly lower average value | Slightly higher average value | Equivalent to predicate (no statistically significant difference) |
| Tensile Bond Strength | Higher average value | Lower average value | Equivalent to or better than predicate |
| Tie-wing Tensile Fracture Strength | Slightly lower average value | Slightly higher average value | Equivalent to predicate (no statistically significant difference) |
| ISO 27020 Compliance | Evaluated for compliance | N/A | Compliant |
| Biocompatibility (ISO 10993-1) | Evaluated for biocompatibility | N/A | Biocompatible (based on risk assessment and specific tests: genotoxicity, cytotoxicity (agarose and elution), sensitization, oral toxicity, irritation, chemical characterization) |
Note: The above criteria are for the physical properties and biocompatibility of the orthodontic brackets, not for the performance of a software algorithm in terms of diagnostic accuracy or reader improvement.
Additional Information based on the provided text:
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for each bench test. The text mentions "average value" and "statistically significant differences," implying multiple units were tested in each category.
- Data Provenance: Not applicable in the context of bench testing for physical devices. The testing was non-clinical.
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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. The ground truth for bench tests is the physical measurement based on standardized testing procedures, not expert consensus interpreting data.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as this refers to human review of diagnostic data.
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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 study was done. The document explicitly states: "No clinical performance testing was conducted on SO System brackets." The "Signature Orthodontic System" includes "treatment planning software," but the performance testing described only relates to the physical brackets.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not described as such. The "treatment planning software" is mentioned as part of the system, but its standalone performance (e.g., accuracy of treatment planning suggestions) is not detailed or evaluated in the provided performance data. The performance section focuses exclusively on the physical brackets.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Bench Test Measurements: The "ground truth" for the physical bracket tests would be the direct measurements obtained using calibrated instrumentation according to standardized test methods (e.g., for shear bond strength, torque strength, tensile strength, friction, and fracture strength). For biocompatibility, it's compliance with ISO 10993-1.
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The sample size for the training set
- Not applicable. This device is a physical orthodontic system and associated software, not an AI model requiring a training set in the typical sense of machine learning. The software aids in treatment planning but is not described as a learning algorithm that undergoes "training."
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How the ground truth for the training set was established
- Not applicable, as there is no "training set" for an AI algorithm described in this context.
§ 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.