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510(k) Data Aggregation
(260 days)
iSMILE is indicated for the alignment of teeth during orthodontic treatment of malocclusion.
The i5MLE is indicated for use in alignment of teeth during orthodontic treatment of malocclusion.
The iSMILE is a sequence of transparent aligners created from a digital orthodontic treatment plan. The iSMILE aligner is fabricated of a transparent thermoformed polyurethane plastic. Each aligner delivery a unique combination of minor forces to create the planned tooth movement. The digital orthodontic treatment plan is created by a dental health professional. The iSMILE Aligner incorporates the use of attachments to create spaces and force points in order to cause minor tooth movement. These force points are located in specific areas and positioned in such a way that they provide a continuous force which slowly dissipates over time on the tooth to be moved for as long as the aligner is worn.
The provided text describes a 510(k) premarket notification for the iSMILE Dental Aligners, comparing it to a predicate device, the Invisalign System. The document focuses on demonstrating substantial equivalence rather than providing a detailed study report for novel performance claims.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The text indicates that the device underwent non-clinical performance tests to demonstrate substantial equivalence. These tests focused on material properties and process validation. Rather than specific quantitative acceptance criteria for each test, the document states generally that the device met "acceptable results" or "acceptance criteria."
| Test Category | Specific Test / Property | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Material Properties (Biocompatibility) | Cytotoxicity | Passed Biocompatibility testing per ISO 10993-1 | Passed |
| Sensitization | Passed Biocompatibility testing per ISO 10993-1 | Passed | |
| Irritation | Passed Biocompatibility testing per ISO 10993-1 | Passed | |
| Acute Systemic Toxicity | Passed Biocompatibility testing per ISO 10993-1 | Passed | |
| Mutagenicity | Passed Biocompatibility testing per ISO 10993-1 | Passed | |
| Subacute Toxicity | Passed Biocompatibility testing per ISO 10993-1 | Passed | |
| Material Properties (Mechanical) | Tensile Strength Yield | Acceptable results in comparison to samples tested (no defined specification or standard) | Produced acceptable results |
| Aligner Elongation (Break Point) | Acceptable results in comparison of break point (no defined specification or standard) | Showing acceptable results | |
| Tensile Stress at Break Point | Acceptable results (no defined specification or standard) | Produced acceptable results | |
| Modulus | Acceptable results between the samples tested (no defined specification or standard) | Showed acceptable results between the samples tested | |
| Load of Materials | Acceptable results (no defined specification or standard) | Found acceptable results | |
| Water Absorption | Acceptable results (no defined specification or standard) | Found acceptable results | |
| Process Validation | Process Flow Validation (Finished device matches software output specifications) | Not explicitly stated, but implies the finished device must match the software output specifications, meaning the aligners themselves must accurately reflect the digitally planned tooth movement and morphology. The text states: "The output and work model and aligner were tested and compared. Aligners met the acceptance criteria of this testing." This indicates the acceptance criteria was likely a measure of geometric accuracy or fit. | Aligners met the acceptance criteria. The iSMILE functioned as intended and observed as expected. The results of this performance testing are accepted according to acceptance criteria and do not raise any additional concerns. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size for the test set used for these non-clinical performance tests. For material tests (tensile strength, elongation, stress, modulus, load, water absorption), it refers to "a sample of base materials" or "samples tested." For biocompatibility, it states "the used thermoforming sheets," implying the specific material intended for the device. For Process Flow Validation, it mentions "the output and work model and aligner were tested and compared," but no numbers are provided.
The data provenance is internal, as 3D Diagnostix Inc. completed the tests to support their 510(k) submission. There is no information regarding country of origin for test data or whether it was retrospective or prospective, as these are non-clinical engineering and material tests, not clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable to the provided document. The tests performed are non-clinical, focusing on material and manufacturing process validation. There is no mention of a "ground truth" derived from expert consensus for clinical accuracy in the context of expert review.
4. Adjudication Method for the Test Set
This section is not applicable. The tests described are laboratory-based engineering and material performance tests, not clinical evaluations requiring adjudication of expert interpretations.
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
This section is not applicable. The device described is a physical dental aligner, not an AI diagnostic or assistive software. No MRMC study was conducted or mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This section is not applicable. The device is a physical product (dental aligners), not an algorithm or AI software. There's mention of "software output specifications" in relation to Process Flow Validation, meaning software designs the aligners, but the performance testing is for the physical aligner's manufacturing and material properties, not the diagnostic accuracy of the software itself.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For the non-clinical tests, the "ground truth" is based on established scientific and engineering principles, national/international standards (like ISO 10993-1 for biocompatibility), and internal specifications. For mechanical properties, where no external standards existed, internal comparisons of "acceptable results" were used. For Process Flow Validation, the "ground truth" was likely the digital design specifications derived from the software output. No pathology or outcomes data is mentioned as ground truth for these non-clinical tests.
8. The Sample Size for the Training Set
This section is not applicable. The document describes a physical medical device and its non-clinical performance tests for 510(k) clearance, not an AI algorithm that would require a training set.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons as #8.
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