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The LightForce Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances.

The LightForce Orthodontic System (LFO System) is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances. The LFO System consists of patient-specific ceramic brackets, patient-specific placement jigs, and TPS that allows the orthodontist to view, measure, and diagnose cases.

The patient-specific brackets are available with slot sizes to orthodontic wires up to 0.022" in height and come in a variety of hook options colors and shades. The patient-specific placement jig is an optional-use lab device to aid orthodontists in bracket placement and bonding and is composed of an FDA cleared, class 1 certification material. The LFO system does not contain commercially available or patient-specific shaped arch wires, ligatures, or adhesives that affix the brackets to the teeth. The LFO system packaging consists of a single product offering box with indirect bonding trays (IDB trays) loaded with brackets as well as a secondary set of individual brackets and, where applicable IDB trays and/or bite turbo indirect bonding travs. The LFO system may also include non-patient-specific brackets for temporary use with predetermined torque, tip, offset and base contour, packaged and labeled separately.

The inclusion of an optional self ligating metal clip is to ligate a wire to the bracket by encapsulating the wire in the slot of the bracket.

This document is a 510(k) summary for the LightForce Orthodontic System (LFO System). The purpose of this summary is to demonstrate substantial equivalence to legally marketed predicate devices. It primarily focuses on the addition of an optional self-ligating nitinol clip to the existing LFO System.

Here's an analysis of the provided information concerning acceptance criteria and the study proving the device meets them, organized as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics for the overall device. Instead, it describes performance testing conducted to assess the differences introduced by the new self-ligating clip.

The key performance characteristics evaluated and their qualitative "performance" against the predicate are:

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

• Sample Size for Test Set: The document does not specify the sample sizes (e.g., number of brackets, number of tests) used for the non-clinical performance testing (tie-wing fracture, wire friction, wire escapement).
• Data Provenance: The data is from "Non-clinical Performance Testing" and "Biocompatibility," implying lab-based, retrospective testing performed by the manufacturer to support the 510(k) submission. There is no mention of country of origin of the data, but presumably it was conducted in the US or under standards accepted by the US FDA.

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

This section is not applicable as the testing described is non-clinical performance testing of physical characteristics and biocompatibility, not a clinical study involving human patients or expert interpretation of medical images/diagnoses. The "ground truth" here is established by the results of the physical and chemical tests based on established engineering and materials science principles and standards.

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as point 3. Adjudication methods are typically used in clinical studies or studies involving human judgment to establish a consensus "ground truth."

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 MRMC study was done. The document explicitly states: "No clinical performance testing was conducted on LFO System brackets."
• No AI component that would involve human readers. This device is a physical orthodontic system (brackets and treatment planning software) for correcting malocclusions, not an AI-powered diagnostic imaging tool that would assist human readers in interpreting images.

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

• No standalone algorithm performance study was done in the context of an AI/ML algorithm. The "LFO System" includes "TPS [treatment planning software] that allows the orthodontist to view, measure, and diagnose cases." However, the 510(k) summary focuses on the mechanical and material changes to the brackets (specifically the addition of the self-ligating clip) and does not describe performance testing related to the software's diagnostic or planning capabilities as a standalone algorithm. The software is part of the system that "allows the orthodontist to view, measure, and diagnose cases," implying a human-in-the-loop for diagnosis, not a standalone automated diagnosis.

7. The Type of Ground Truth Used

• For non-clinical performance testing (tie-wing fracture strength, wire friction, wire escapement): The ground truth is defined by the physical measurements obtained from mechanical testing rigs, compared against predefined engineering specifications or performance of the predicate device.
• For biocompatibility: The ground truth is established by the results of standardized biological assays and chemical characterization, evaluated against the requirements of international standards (ISO 10993-1:2018) and US FDA guidance.

8. The Sample Size for the Training Set

This section is not applicable. The device is an orthodontic appliance system, not an AI/ML device that requires a training set for model development. The "training" in this context refers to manufacturing processes, material selection, and design validation, not machine learning model training.

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

This section is not applicable for the same reasons as point 8.

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The LightForce Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances.

The LightForce Orthodontic System (LFO System) is a treatment planning software (TPS) and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances. The orthodontist uses the TPS (K200148) to select and order the patient-specific orthodontic brackets. The TPS allows the orthodontist to diagnose the patient, plan treatment, and position the orthodontic brackets based on a digital impression of the patient - the outcome of the TPS is a prescription for the patient-specific orthodontic brackets. The LFO System consists of patient-specific ceramic brackets, patient-specific bracket placement jigs, arch wire templates, and a TPS for viewing, measuring, and modifying cases. LightForce Orthodontics' (LFO) operators and the orthodontists use the TPS to generate a prescription of their choosing. LFO then manufactures the patient-specific brackets and placement jigs using proprietary additive manufacturing techniques. The orthodontist then bonds the brackets to the teeth using the optional placement jig and ligates wires to enable tooth movement. The LFO System does not contain commercially-available or patient-specific shaped arch wires, ligatures, or adhesives that affixes the brackets to the teeth.

The provided text describes the LightForce Orthodontic System and its claim of substantial equivalence to a predicate device, the Signature Orthodontic System (K181271). However, it does not contain information related to software performance evaluation or clinical studies involving human readers or AI assistance. The document focuses solely on the physical properties and material equivalence of the orthodontic brackets.

Here's an analysis based on the information provided, specifically addressing the questions where applicable:

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

The document does not explicitly state "acceptance criteria" with numerical thresholds for performance. Instead, it describes performance testing where the LightForce Orthodontic System (LFO System) brackets were compared to the predicate device, the Signature Orthodontic System. The reported performance is consistently framed as "equivalent to or better than" the predicate device.

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

The document does not specify the sample sizes used for the bench tests.
The data provenance is not specified (e.g., country of origin, retrospective or prospective). These were bench tests, so "provenance" might refer to the lab where they were conducted, which is 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)

This question is not applicable as the evaluation involved bench testing of physical properties of orthodontic brackets, not interpretation of data by human experts to establish "ground truth." There was no "test set" in the context of human interpretation or AI performance assessment.

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

This question is not applicable for the same reason as point 3. There was no human interpretation or adjudication involved.

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

The document explicitly states: "No clinical performance testing was conducted on LFO System brackets." Therefore, no MRMC study was performed, and there is no information on human reader improvement with or without AI assistance. The focus of this submission is on the physical properties of the brackets, not on the AI capabilities of the treatment planning software.

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

While the LightForce Orthodontic System includes "treatment planning software (TPS)", the document focuses on the orthodontic appliance system (the brackets). The non-clinical performance testing described is for the brackets themselves, not the standalone performance of the algorithm within the TPS. The document does not provide details on standalone algorithm performance.

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

For the bench tests of the brackets, "ground truth" implicitly refers to the measured physical properties and mechanical performance of the predicate device (Signature Orthodontic Brackets), against which the LFO System brackets were compared. This is a property-based or measurement-based ground truth, not expert consensus or pathology.

8. The sample size for the training set

This question is not applicable as the document describes bench testing of physical orthopedic devices and does not mention any training set for an AI model.

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

This question is not applicable for the same reason as point 8.

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The LightForce Orthodontic System is a treatment planning software (TPS) and Orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances.

The LightForce Orthodontic System (LFO System) is a treatment planning software (TPS) and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances. The LFO System consists of patient-specific ceramic brackets, patient-specific bracket placement jigs, arch wire templates, and a TPS for viewing, measuring,modifying cases and submitting orders. LightForce Orthodontics' (LFO) operators and the orthodontists use the TPS to generate a prescription of their choosing. LFO then manufactures the patient-specific brackets and placement jigs using proprietary additive manufacturing techniques. The orthodontist then bonds the brackets to the teeth using the optional placement jig and ligates wires to enable tooth movement. The LFO System does not contain commercially-available or patient-specific shaped arch wires, ligatures, or adhesives that affixes the brackets to the teeth.

The change is to upgrade LFO System's Treatment Planning Software (TPS) from version 3.1 to version 4.0. TPS version 3.1 was originally cleared in K183542 and the LFO System was originally cleared in K181271. TPS version 4.0 provides improved software architecture, updated hosting infrastructure and improvements to the user interface to better match the intended use of the product based on customer feedback and validation input.

A comparison of TPS 3.1 and TPS 4.0 shows that both software provide the same features and functional workflows is evidence of substantial equivalence. The replacement software is identical in performance and function to the previously used software.

The LightForce Orthodontic System (LFO System) is a treatment planning software (TPS) and orthodontic appliance system designed to correct malocclusions using patient-matched orthodontic appliances. The current submission (K200148) focuses on an upgrade to the Treatment Planning Software (TPS) from version 3.1 to version 4.0.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The submission does not explicitly define quantitative "acceptance criteria" with specific thresholds that the device must meet for performance metrics. Instead, the study aims to demonstrate equivalence between the new TPS version 4.0 and the previously cleared TPS version 3.1. The performance criteria are functional aspects of the software, and the reported performance is simply "Equivalent (Test Report)".

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

The document does not explicitly state the specific "sample size" for the test set used to validate TPS 4.0. The validation activities are described as "Validation testing of the TPS was performed in accordance with LFO's design control activities for software and to the software's Test Plan."

The data provenance (country of origin, retrospective/prospective) is not mentioned. Given it's a software upgrade validation, it's likely internal testing rather than clinical study data from patients.

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

The document does not specify the number of experts or their qualifications used to establish ground truth for the software validation. The testing seems to be internal validation against a "Test Plan" and comparison to functionality of the previous software version.

4. Adjudication method for the test set

The document does not describe an adjudication method for the test set results. The determination of "equivalence" likely relied on direct comparison of functionalities and outputs against predefined test cases within the "Test Plan."

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 multi-reader multi-case (MRMC) comparative effectiveness study was done or reported in this submission. The submission is focused on a software upgrade for a treatment planning system and does not involve AI assistance for human readers in a diagnostic capacity.

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

A standalone performance evaluation of the algorithm (TPS 4.0) against its predecessor (TPS 3.1) was performed. "Validation testing of the TPS was performed in accordance with LFO's design control activities for software and to the software's Test Plan." The results in Table 6-1 compare the performance of TPS 4.0 directly to TPS 3.1 across various functional areas. This is essentially a standalone comparison of the software versions.

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

The "ground truth" for the software validation appears to be the expected functional behavior and outputs as defined by the "Test Plan" for the software, and by direct comparison to the performance of the legally marketed predicate software (TPS 3.1). For example, the software's ability to "view patient's digital impression," "move patient's teeth," or "deliver case securely" would be verified against predetermined correct outcomes or the established behavior of the prior version. It is not based on expert consensus on clinical cases, pathological findings, or patient outcomes data.

8. The sample size for the training set

This submission pertains to the validation of a software upgrade (TPS 4.0 to TPS 3.1). It is not a submission for a de novo AI/ML algorithm that requires a training set in the traditional sense. The software's development would have involved internal testing and refinement, but a specific "training set" for an AI model is not applicable here as the primary claim is functional equivalence and improvement of an existing treatment planning software.

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

As noted above, this submission does not involve a "training set" for an AI/ML algorithm in the context of establishing ground truth for training. The software's capabilities are based on its design and implementation for treatment planning, not on learning from a labeled dataset.

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