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Nightwear Aligners are indicated for the alignment of permanent teeth during orthodontic treatment of malocclusion.

The Smylio Nightwear 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 at least 9 to 12 hours a day and are to be removed for eating and for cleaning.

Smylio Nightwear 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 aligners are shipped to the treating clinician's office where they are then distributed to the patient in sequential stages. The patients' dental health professional then monitors their treatment of the first aligner to the delivery of the final aligner.

Nightwear Aligners are a sequence of transparent aligners created from a digital orthodontic treatment plan. The Nightwear Aligners are fabricated of a transparent thermoformed polyurethane plastic. Each aligner delivers 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 Nightwear Aligners incorporate 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 the Smylio Nightwear Aligners and its substantial equivalence to a predicate device (iSMILE Aligners K200908). However, it does not contain acceptance criteria or a study designed to explicitly prove the device meets specific performance acceptance criteria in terms of diagnostic accuracy or a quantitative measure of treatment effectiveness with a defined threshold.

Instead, the document focuses on demonstrating substantial equivalence for regulatory clearance based on:

• Similarities in Indications for Use: Both devices are indicated for the alignment of permanent teeth during orthodontic treatment of malocclusion.
• Similarities in Technological Characteristics: The device description, materials, manufacturing method, and mode of action are compared and found to be "Same" as the predicate device.
• Non-clinical performance testing: Durability testing, material property testing (ASTM D638, ASTM D790), and biocompatibility testing (ISO 10993 standards) were performed to ensure the material and manufacturing process are suitable.
• Clinical performance testing: An internal clinical study was conducted to demonstrate that tooth alignment may occur with the specified wear time for mild malocclusions. This is a descriptive finding rather than a performance metric against a predefined acceptance criterion.

Therefore, many of the requested items (acceptance criteria table, ground truth establishment, MRMC study, effect size) are not explicitly present or detailed in the provided text because the regulatory submission's goal was substantial equivalence, not necessarily a performance claim against specific quantitative targets.

However, I can extract the information that is present and note where the information is absent according to your request.

Description of Acceptance Criteria and Proving Study (Based on Provided Text)

The provided text focuses on establishing substantial equivalence to a predicate device (iSMILE Aligners, K200908) for regulatory purposes, rather than proving the device meets specific quantitative performance acceptance criteria in terms of treatment efficacy or diagnostic accuracy against a predefined threshold. The "acceptance criteria" can be inferred as successful demonstration of similar indications for use, technological characteristics, and safety and basic functional performance, which collectively support substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Clinical): 20 patients
• Data Provenance: The study was conducted internally under an FDA cleared IDE application (G200298). The country of origin is not specified but it is an internal clinical performance test. The study is prospective in nature as it is a "clinical performance testing" that "was conducted".

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

• Number of Experts: Not specified.
• Qualifications of Experts: The clinical performance was determined "as determined by the treating dentist." No further specific qualifications (e.g., years of experience, specialization) are provided for these dentists.

4. Adjudication method for the test set

• Adjudication Method: Not specified. The outcome was "as determined by the treating dentist," implying a single determination, not a consensus or adjudicated process among multiple experts.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not performed. This device is an orthodontic aligner, not an AI-powered diagnostic tool, so such a study would not be applicable. The text does not mention AI assistance.

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

• Standalone Performance: Not applicable. This device is a physical orthodontic aligner, not an algorithm or AI system.

7. The type of ground truth used

• Type of Ground Truth: The "ground truth" for the clinical performance was the observation that "tooth alignment may occur for patients with mild malocclusions as determined by the treating dentist." This appears to be a clinical assessment/outcome, not pathology, imaging, or universally accepted objective ground truth.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This refers to a physical medical device, not a machine learning algorithm that requires a training set. The "design" (digital models) is approved by the treating physician, but this is not a training set in the context of AI.

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

• Ground Truth for Training Set: Not applicable (as above, no training set for an algorithm). The device design process involves digital scans and sequential dental models designed and approved by the treating physician, which would be the "input" for manufacturing, not a training set with established ground truth for an algorithm.

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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 Smylio Invisible Clear Aligners is indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion.

The Smylio Invisible Clear Aligners are intraoral thermoformed plastic aligners that are worn 20 to 22 hours per day and are designed to be used in a sequence, each aligner providing a gentle continuous force, to allow for the movement of teeth to the final desired position. The aligners are to be removed for eating and for cleaning.

Smylio Invisible Clear Aligners are fabricated using a three-step process.

The first step is to obtain the dimensions and details of the patient's baseline dentition. This is generally done using an oral scan data or a physical impression. This scanned data (digital CAD/CAM models or patient models) are imported into specialized dental software for treatment planning.

The second step is the printing of 3D models of the treatment plan for use in step 3 (thermoforming). In the second step, the doctor utilizes a software application to plan the treatment by creating a series of sequential models that gradually position the teeth into their final desired position. A 3D printer is used to create the molds needed for each treatment step to provide the surface around which the aligner is thermoformed.

The final step is the thermoforming of a plastic sheet material to each of the sequential treatment steps. This process is done using a standard thermoforming equipment and the appropriate material as outlined in this submission.

Here's an analysis of the provided text regarding the Smylio Invisible Clear Aligners' acceptance criteria and the study conducted:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided text describes a "manufacturing validation" study. While it states that "three critical aspects of the manufacturing process were assessed," it does not explicitly state the sample size (e.g., number of aligners, number of 3D models tested).

The data provenance is not specified regarding country of origin, nor whether it was retrospective or prospective. Given it's a manufacturing validation, it's inherently prospective in the sense of testing newly manufactured prototypes.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of experts to establish ground truth for the manufacturing validation. The ground truth was established by "target input values" or "predefined tolerance of the manufacturing process." An "independent 3rd party software and digital calipers" were used for measurements.

4. Adjudication Method for the Test Set

No adjudication method is mentioned as experts were not used to establish ground truth. Measurements were taken using instrumentation and compared against predefined tolerances.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical performance testing was not conducted."

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

The manufacturing validation study appears to be a standalone performance assessment of the manufacturing process and resulting product (aligners). While software (3Shape®) is involved in the design and planning, the validation focuses on the physical accuracy of the manufactured components (digital models, 3D printed molds, thermoformed aligners) against their intended values, not on the performance of the software as a standalone diagnostic or treatment planning tool in comparison to a human. The independent 3rd party software and digital calipers act as the measurement tools, not as the AI algorithm itself being evaluated.

7. The Type of Ground Truth Used

The ground truth used for the manufacturing validation was based on pre-defined target input values for translational and rotational measurements. These targets represent the intended or desired dimensions and angles planned during the treatment design.

8. The Sample Size for the Training Set

No training set is mentioned or applicable here. The study described is a manufacturing validation, not an AI algorithm development study that would involve training data.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there was no training set.

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