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The DailyMate Orthodontic Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition. The aligner system repositions teeth by way of continuous gentle force.

The DailyMate® Orthodontic Aligner System is a series of dental aligners fabricated of clear, plastic removable aligners are designed and custom-made by dental professionals. The aligners are made of aesthetic and medical grade materials. Corrective force to straighten the teeth is delivered via minor changes into a modified position in each subsequent aligner.

Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them, specifically for the DailyMate Orthodontic Aligner System (K212803).

Based on the document, it's clear this is a premarket notification (510(k)) submission for an orthodontic aligner system. The review focuses on substantial equivalence to predicate devices rather than proving specific device performance criteria through clinical studies or AI algorithm validation in the way one might for a diagnostic AI device.

Therefore, the requested information about "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in terms of performance metrics for an AI algorithm is largely not applicable in the context of this 510(k) submission. This document describes a medical device, but not an AI/ML powered device that would have the specific types of performance studies (e.g., MRMC, standalone algorithm performance, ground truth establishment by experts) commonly associated with AI/ML medical devices.

The acceptance criteria here are for demonstrating substantial equivalence primarily through comparison of design, materials, indications for use, and a limited set of non-clinical (bench) tests.

Despite the non-applicability to AI/ML device validation, I will extract and present the relevant information that is available in the document, framed within the lens of substantial equivalence.

Overview of "Acceptance Criteria" for K212803 (DailyMate Orthodontic Aligner System)

The "acceptance criteria" for this 510(k) submission are not defined as specific performance metrics of an AI algorithm, but rather as meeting the requirements for substantial equivalence to predicate devices. This is achieved by demonstrating comparable:

• Indications for Use
• Mechanism of Action
• Method of Use
• Method of Manufacture
• Raw Material (Biocompatibility)
• Software Use (for aligner design)
• Sterilization (or lack thereof)
• And performing specific non-clinical (bench) tests to show material equivalence.

The "study that proves the device meets the acceptance criteria" refers to the entire 510(k) submission package, which includes a comparative analysis table and results from non-clinical bench testing.

Details as per the requested format:

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

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

• Test Set Sample Size: Not applicable in the context of an AI/ML test set. The "testing" referred to is biocompatibility testing (material samples) and non-clinical bench testing (device material samples). No human patient "test set" was used for performance evaluation.
• Data Provenance: The document does not specify the country of origin for the non-clinical testing data. The biocompatibility and bench testing data would be from laboratory experiments rather than patient data. The manufacturer is 3D Global Biotech Inc. from Taiwan. The correspondent contact is in California, USA.
• Retrospective/Prospective: Not applicable, as no clinical study on patient data was performed. The non-clinical tests are prospective laboratory studies.

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

• Not applicable. There was no AI/ML test set requiring expert-established ground truth. The "ground truth" equivalent for this device is the established safety and efficacy profiles of the predicate devices and the physical/chemical properties of the materials and device.

4. Adjudication method for the test set

• Not applicable. No expert adjudication was relevant or required for this type of submission.

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

• No. An MRMC study was not performed, as this is not an AI/ML assistance device for human readers.

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

• No. This is not a standalone AI algorithm device. The device itself is the physical aligner system. The software mentioned (3Shape Ortho System) is separate, already 510(k) cleared software used in the design process of the aligners and is human-in-the-loop (dental practitioner reviews and approves).

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

• For biocompatibility and material equivalence, the "ground truth" is established laboratory testing standards (e.g., ISO 10993) and the known properties/performance of the predicate device materials. There is no "truth" in the diagnostic sense (like pathology or outcomes data).

8. The sample size for the training set

• Not applicable. This device does not involve a training set for an AI/ML algorithm.

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

• Not applicable. As there is no AI/ML training set, no ground truth needed to be established for it.

Summary regarding AI/ML related criteria:

The provided document describes a 510(k) submission for a physical medical device (orthodontic aligners). While software (3Shape Ortho System) is used in the design and manufacturing process of the aligners, the submission emphasizes that this software is already 510(k) cleared (K152086) and is used by a human dental practitioner who reviews and approves the treatment plan. Therefore, the DailyMate Orthodontic Aligner System itself is not an AI/ML-powered diagnostic or therapeutic device requiring validation studies typical for AI/ML products (e.g., MRMC, standalone algorithm performance, specialized ground truth establishment). The "acceptance criteria" and "proof" in this context are solely related to demonstrating substantial equivalence to predicate devices through design comparison, material testing, and adherence to manufacturing standards.

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The Smylio Invisible Clear Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion.

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.

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.

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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The Invisalign System is indicated for the orthodontic treatment of malocclusion.

The Proposed Device is a minor change to the currently marketed Invisalign System (K143630) (hereafter referred to as "Predicate Device") to support repositioning of the mandible.

Invisalign System with Mandibular Advancement Feature consists of a series of doctor prescribed, customized, thin, clear plastic, removable orthodontic appliances (aligners) and proprietary ClinCheck 3-D software. The aligners gently move the patient's teeth in small increments and position the mandible forward from their original state to a more optimal, treated state. The Proposed Device treats patients with Class 1 and Class 2 malocclusion as well as patients with severe open bite, severe overiet, deep bite, skeletally narrow jaw, dental prostheses/implants. and/or those who require surgical correction. The Proposed Device includes two mandibular advancement features, also known as "precision wings", on each upper and lower aligner that function as mandibular repositioners, maintaining the lower jaw in the forward position.

The Proposed Device is made from the same material and utilizes the same manufacturing processes as the Predicate Device, Invisalign System (K143630). The software level of concern for the Predicate Device is moderate. Minor updates have been made to the proprietary ClinCheck 3-D software to enable placement of the mandibular advancement features on the aligners during the MA Phase of treatment. The software level of concern for the Proposed Device is determined to be the same as the Predicate Device: moderate.

I am sorry, but the provided text does not contain the specific information required to complete your request for acceptance criteria and the study details. The document is an FDA 510(k) summary for the Invisalign System with Mandibular Advancement Feature, which focuses on demonstrating substantial equivalence to a predicate device.

While it mentions performance testing and a clinical study, crucial details such as:

• A table of acceptance criteria and reported device performance
• Sample size used for the test set and data provenance
• Number of experts used to establish ground truth and their qualifications
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study (effect size with and without AI)
• Standalone algorithm-only performance
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• Sample size for the training set
• How ground truth for the training set was established

are not present within the provided text. The document refers generally to "internal design specification and with the applicable performance standards" and states that "Test results obtained verified the safety and effectiveness of the Proposed Device per design specifications and applicable standards," but does not explicitly enumerate these criteria or their fulfillment in a detailed manner.

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