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The AUTOLIGN is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options (Export of Models, Indirect Bonding Transfer Media) based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives. The use of the AUTOLIGN requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.

The AUTOLIGN is stand-alone software which utilizes images of the patient's intraoral anatomy from intraoral cameras and/or desktop laboratory scanners to create a 3D virtual dental model that can be used in the same manner as a traditional physical dental model. AUTOLIGN facilitates the segmentation and editing of the 3D virtual digital model as well as analysis which can be used in secondary orthodontic treatment planning. The software allows for measurement- including Bolton analyses. The models and analysis produced by the proposed Software can be exported to an orthodontic laboratory or directly to orthodontic appliance manufacturers for use in orthodontic treatment planning and design of orthodontic appliances. The material used for vacuum pressing (thermoforming) the final device appliances of sequential aligners on the production cast is DURAN®, but those which satisfy all the requirements specified on the Autoling User Manual can also be used.

The provided text describes the AUTOLIGN device and its comparison to predicate devices, but it does not contain specific acceptance criteria, a detailed study proving the device meets those criteria, or the requested information about sample sizes, ground truth establishment, or clinical study details.

The document is a 510(k) summary for the AUTOLIGN device, which is a software tool for orthodontic treatment planning and design. Its purpose is to demonstrate substantial equivalence to legally marketed predicate devices, not to present a detailed clinical validation study with specific performance metrics.

Here's what can be extracted and what is missing based on your request:

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

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device itself (e.g., accuracy, sensitivity, specificity for specific measurements or analyses). The "acceptance" is implicitly that the software functions as intended and is as safe and effective as the predicate device.
• Reported Device Performance: The document only states that "The software passed the testing and performed per its intended use." No specific performance metrics or quantitative results are provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not mentioned.
• Data Provenance: Not mentioned.

3. 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)

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.
• Ground Truth Establishment: Not mentioned.

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

• Not mentioned.

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

• An MRMC study is not mentioned. The study described is a non-clinical software verification and validation, along with a comparison to predicate devices. There is no mention of human readers or AI assistance in a comparative effectiveness context.

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

• The document implies standalone testing as it states "The AUTOLIGN underwent software, hardware, integration, verification and validation testing... The software passed the testing and performed per its intended use." However, specific standalone performance metrics (e.g., algorithm accuracy for segmenting teeth, or measuring arch length) are not provided. The device itself is described as "stand-alone software."

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

• Not mentioned.

8. The sample size for the training set

• Not mentioned, as there is no specific mention of a machine learning model or training set in the context of the device's validation.

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

• Not mentioned (for the same reason as point 8).

Summary of what is available from the text:

• Device Name: AUTOLIGN
• Regulatory Status: Class II medical device (K192847)
• Intended Use: Front-end device for managing orthodontic models, systematic inspection, detailed analysis, treatment simulation, and virtual appliance design based on 3D models of patient dentition.
• Non-clinical Tests: Software, hardware, integration, verification, and validation testing were performed according to FDA guidance.
• Result of Non-clinical Tests: "The software passed the testing and performed per its intended use."
• Predicate Device Comparison: The report extensively compares the AUTOLIGN's indications for use and technological characteristics to three predicate devices (Ortho System™, Orchestrate 3D, CEREC Ortho Software) to establish substantial equivalence.

In conclusion, the provided text focuses on regulatory approval through substantial equivalence to predicate devices and general software validation, rather than a detailed clinical study with quantitative acceptance criteria and performance metrics for the AUTOLIGN itself.

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The UniSmile Clear Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition. The UniSmile Clear Aligner System positions teeth by way of continuous gentle force.

The UniSmile Clear Aligner System is fabricated of clear thin thermoformed plastics in a sequential series to progressively reposition the teeth. Corrective force to reposition the teeth is delivered via minor changes into a position in each subsequent aligner.

This FDA 510(k) summary for the UniSmile Clear Aligner System does not contain details of an acceptance criteria study, nor a study proving the device meets specific performance criteria through clinical data or statistical analysis.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (ClearCorrect System, K113618) and a reference device (Orchestrate 3D, K181112) primarily through a comparison of:

• Intended Use/Indications for Use: The UniSmile system is indicated for "treatment of tooth malocclusion in patients with permanent dentition" to "position teeth by way of continuous gentle force," which is stated to be "Same" as the predicate.
• Technological Characteristics, Design, and Device Features: This includes comparisons of regulation number, common name, product code, device description, mode of action, anatomy location, size/dimension, method of manufacturing, material, material hardness, material tensile modulus, material tensile strength, and biocompatibility.

Here's a breakdown of the specific information requested, based on the provided document:

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

The document does not provide a table of acceptance criteria in terms of clinical outcomes (e.g., specific tooth movement percentages, treatment success rates, patient satisfaction scores) or quantitative engineering performance thresholds (beyond material properties).

Instead, the "acceptance criteria" appear to be implicit in the demonstration of substantial equivalence, where the UniSmile system's characteristics are deemed "Same" or "Similar" to the predicate device.

However, the document does provide information on material properties which can be considered "reported device performance" in a technical sense:

Note: The "acceptance criteria" for tensile modulus and strength are vaguely stated as "acceptable for as an orthodontic base material," rather than specific numerical thresholds.

Regarding the study that proves the device meets acceptance criteria:

The document does not describe a specific clinical study or an engineering performance study designed to prove the device meets pre-defined acceptance criteria for efficacy or overall clinical performance (e.g., ability to correct malocclusion in a patient population).

Instead, it relies on:

• Material Testing: "Performance properties have been tested and approved for clear aligner applications." (pg 3)
• Biocompatibility Testing: "Biocompatibility testing has been provided according to ISO-10993." (pg 3) This is further detailed in the comparison table (pg 5) as "Passed ISO 10993-1 assessment" including cytotoxicity, intracutaneous intradermal reactivity, and sensitivity.

These tests demonstrate the mechanical and biological safety of the materials used, but not the overall clinical effectiveness of the system in treating malocclusion.

Additional requested information (based on the provided text):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided. The document does not describe a clinical "test set" in the context of human patients or clinical outcomes for the UniSmile system. The "test set" for material and biocompatibility testing is not specified in terms of sample size or provenance.

3. 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/Not provided. No clinical "test set" requiring expert ground truth establishment for performance evaluation is described. The "ground truth" for material properties and biocompatibility would be based on validated laboratory standards and measurements, not expert consensus on clinical cases.

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

• Not applicable/Not provided. No clinical "test set" requiring adjudication or consensus among experts is described.

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/Not provided. This document describes a physical medical device (clear aligners) and a software (Orchestrate 3D) used for treatment planning, not an AI-assisted diagnostic or interpretative system where human reader performance would be a relevant metric. The software is used to design treatment plans, not to interpret cases or assist human readers in a diagnostic capacity.

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

• Not applicable/Not provided. The UniSmile Clear Aligner System involves a series of physical clear aligners and a software for treatment planning. The aligners are worn by patients, and the treatment plan is designed by software but approved by a dental practitioner (human-in-the-loop). There is no "standalone algorithm" performance assessed in the context of interpretation or diagnosis in this document.

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

• For material performance and biocompatibility, the "ground truth" is based on established ISO standards and laboratory testing protocols.
• For the software (Orchestrate 3D), the "ground truth" for its function (treatment plan design) is implicitly tied to its equivalence to the predicate software and its established regulatory clearance (K181112), and ultimately the practitioner's approval. No independent "ground truth" for treatment plan accuracy from clinical outcomes is mentioned for this 510(k).

8. The sample size for the training set

• Not applicable/Not provided. The document does not describe a "training set" in the context of machine learning or AI algorithm development for the UniSmile system or its associated software.

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

• Not applicable/Not provided. As no training set is mentioned, the method for establishing its ground truth is not relevant here.

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