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The Smylio Invisible Clear Aligners are thermoformed plastic aligners designed to be worn in sequence to facilitate the movement to the final desired position. The sequential aligners introduce incremental movements that move teeth by way of gentle continuous force. The aligners are to be worn 20 to 22 hours a day and are to be removed for eating and for cleaning.

Smylio Invisible Clear Aligners are designed from digital scans of a patient's dentition submitted by a dental health professional (e.g. dentist or orthodontist). Using the scan, sequential dental models are designed and approved by the treating physician prior to manufacturing.

Once the treatment plan is reviewed and approved by a dental health professional, each 3D model from the treatment plan is manufactured. The aligner trays are then manufactured by thermoforming a dental thermoplastic sheet over each model. The aligner trays are then delivered to the patients' dental health professional then monitors their treatment of the first aligner to the delivery of the final aligner.

AI/ML Overview

The provided text is a 510(k) Premarket Notification summary for Smylio Invisible Clear Aligners. It focuses on demonstrating substantial equivalence to predicate devices based on indications for use, technological characteristics, and non-clinical performance testing. Crucially, the document explicitly states that "Clinical performance testing was not conducted for this 510(k) Notification." Therefore, there is no study described that proves the device meets acceptance criteria through clinical performance.

The "acceptance criteria" discussed in this document pertain to demonstrating substantial equivalence to existing legally marketed devices, rather than a direct evaluation of clinical efficacy or safety against performance metrics. The proof of meeting these "acceptance criteria" comes from the comparisons made in the tables and the statement that non-clinical testing was sufficient.

Here's an analysis based on the information provided, specifically addressing the questions you raised, while acknowledging the absence of a clinical study:

1. A table of acceptance criteria and the reported device performance:

Since no clinical performance study was conducted, there aren't "acceptance criteria" in the traditional sense of clinical endpoints (e.g., bone density improvement, disease detection accuracy). Instead, the "acceptance criteria" for this 510(k) submission are implied by the comparison to predicate devices, demonstrating equivalence in various specifications, materials, and non-clinical testing.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (Comparison to Predicates)
Regulation Number: Same regulation number as predicate (21 CFR 872.5470)	Same (21 CFR 872.5470)
Classification Name: Same classification name as predicate (Orthodontic Plastic Bracket)	Same (Orthodontic Plastic Bracket)
Product Code: Same product code as predicate (NXC)	Same (NXC)
Classification: Same classification as predicate (Class II)	Same (Class II)
OTC or Rx: Same prescription status as predicate (Rx)	Same (Rx)
Material: Same as predicate (Thermoplastic polyurethane-polyester composite resin) or similar acceptable material.	Same as primary predicate; material for reference predicate is Co-polyester or co-polymer, but stated "Same as predicate" due to the subject device matching the primary predicate.
Material Properties: Acceptable for use as an aligner.	Acceptable materials properties established for use as an aligner (same as predicates).
Material Testing: Compliance with ASTM D790-10 for flexural properties.	ASTM D790-10 testing conducted and found compliant (same as predicates).
Biocompatibility: Biocompatible according to ISO 10993-1.	Biocompatible according to ISO 10993-1 (same as predicates). Additional cytotoxicity testing per ISO 10993-5:2009 performed on final product.
Sterility: Matching predicate status (Non-sterile).	Non-sterile (same as predicates).
Device Description: Sequential thermoformed plastic aligners.	Sequential thermoformed plastic aligners (same as predicates).
Patient Removable: Yes.	Yes (same as predicates).
Indication for Use: Indicated for alignment of teeth during orthodontic treatment of malocclusion (same as predicate).	Same as primary predicate. Differences from reference predicate ("alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion") do not raise substantial equivalence questions.
Intended Use: Orthodontic tooth movement.	Same (same as predicates).
Mode of Action: Continuous gentle force applied to teeth.	Same (same as predicates).
Durability Testing: Simulate real-world use to ensure suitability for prescribed period of use.	Durability testing was conducted, and the aligner material and manufacturing process produced suitable aligners.
Manufacturing Validation: Robustness of the process from 3D printing through thermoforming.	Internal manufacturing validation performed and robustness demonstrated.

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

Test Set (Clinical): Not applicable. No clinical performance test set was used, as explicitly stated: "Clinical performance testing was not conducted for this 510(k) Notification."
Non-Clinical Testing: The document refers to "durability testing" and "material characterization" (ASTM D790-10, ISO 10993-1, ISO 10993-5) but does not provide specific sample sizes for these tests. Data provenance for non-clinical tests is internal to Smylio, Inc.

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

Not applicable. Since no clinical test set was used, there were no experts establishing ground truth for evaluating clinical performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No clinical test set.

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. This device is a physical aligner, not an AI-assisted diagnostic or treatment planning tool for human readers. No MRMC study was conducted.

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

Not applicable. This device is a physical aligner. Performance is demonstrated through material properties and design, not an algorithm's standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For demonstrating substantial equivalence: The "ground truth" used are the established characteristics and performance metrics of the legally marketed predicate devices (Spark Clear Aligner System K203737 and Smylio Invisible Clear Aligners K173784).
For non-clinical testing: The "ground truth" is based on industry standards (ASTM D790-10, ISO 10993-1, ISO 10993-5) for material properties and biocompatibility, as well as internal validation procedures for manufacturing robustness.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set. The "design" is based on established orthodontic principles and the design of predicate devices. Patient-specific aligners are manufactured based on individual patient digital scans.

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

Not applicable. (See point 8).

In summary, the provided document describes a 510(k) submission where substantial equivalence for a physical medical device (clear aligners) is demonstrated through a comparison of design, materials, indications for use, and non-clinical testing to legally marketed predicate devices. No clinical performance study was conducted or deemed necessary for this submission.

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