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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 Cleo bracket line is intended to operate together with other orthodontic devices to apply forces to teeth. Under the supervision of a trained dental professional or orthodontist, this may result in changes to the position of teeth.

The Cleo bracket line is indicated for orthodontic treatment of malocclusions and craniofacial abnormalities as diagnosed by a trained dental professional or orthodontist.

The Cleo bracket line of products are single-use ceramic orthodontic brackets intended to be bonded to a tooth to hold an orthodontic archwire used to apply pressure to the tooth in order to alter the position of the tooth.

The Cleo bracket line of products are made of 99.9% alumina through the process of ceramic injection molding.

Visual placement aids (VPAs) are placed in the Cleo bracket line to help provide visual contrast at the arch wire slot and intertwin areas of the bracket. The VPA is removed from the bracket before orthodontic treatment begins; VPAs do not serve a function during the orthodontic treatment. The presence of the VPA within the bracket prior to treatment will not impact the safety and performance of the bracket during the device's intended use.

The VPAs are made of polyurethane raw material through the process of injection molding.

The provided text is a 510(k) summary for the "Cleo" orthodontic bracket. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for a new AI/software device.

Therefore, the information required to answer the requested questions about acceptance criteria, study design (sample size, data provenance, ground truth, expert adjudication, MRMC, standalone performance, training set details) is not present in the provided document.

This document describes a physical medical device (orthodontic brackets) and its comparison to existing similar devices based on material, design parameters, and intended use, rather than a software or AI-based device that would typically undergo the type of performance evaluation outlined in your questions.

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A-Line Advanced orthodontic ceramic bracket is intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.

This orthodontic bracket is made of polycrystalline ceramic and is used for the treatment of malocclusion. It is designed to be attached to the surface of patients' teeth and be connected to the orthodontic wire in order to apply physical pressure on the tooth movement. Each model differs in size and dimension, color identification as they are attached to the tooth surface corresponding to 20 of the 28 permanent teeth.

The provided text is a 510(k) summary for a medical device called "A-Line Advanced" (an orthodontic ceramic bracket). It does not describe a study involving an algorithm, AI, or human readers, so many of the requested items are not applicable.

Here's the information that can be extracted and a note for those that are not present:

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

The document provides the following performance characteristics and specifications, which serve as acceptance criteria for the device:

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

The document does not specify the exact sample sizes for each test mentioned (e.g., how many brackets were tested for corrosion, how many teeth for adhesion, etc.). The provenance of the data is from non-clinical laboratory testing performed by "KTR (Korea Testing & Research Institute)" and "Seoul National University Dental Hospital Dental Material & Device Evaluation Center." These are non-clinical (bench) tests, not human data.

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

Not applicable. This is a non-clinical device that does not involve expert image interpretation or ground truth establishment in the context of the requested AI/human reader study format. A "biological evaluation written by an expert [Seoul National University Dental Hospital Dental Material & Device Evaluation Center]" was used to justify not conducting certain biocompatibility tests. No specific number or individual qualifications are listed beyond "expert."

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

Not applicable. There is no human reading or adjudication process 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. This is a physical medical device (orthodontic bracket), not an AI-powered diagnostic or assistive tool.

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

Not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for this device would be defined by established engineering and biocompatibility standards (e.g., ISO standards) and the physical properties and performance characteristics of the device when subjected to these standardized tests. It does not involve expert consensus on medical images or pathology.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model requiring a training set.

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

Not applicable. This is a physical device, not an AI model.

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DynaFlex ® Clear Bracket & Buttons is indicated for alignment of teeth during orthodontic treatment.

DynaFlex ® Clear Brackets & Buttons is a series of clear, lightweight, ceramic brackets, and buttons. DynaFlex ® Clear Brackets & Buttons are used in the alignment of teeth through orthodontic treatment of misalignment and malocclusion in patients by moving teeth progressively to a final, treated state.

DynaFlex ® Clear Brackets & Buttons are designed to move teeth to improve their alignment. Ceramic brackets are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred position. Ceramic brackets are intended for use in affixed to a tooth so that pressure can be exerted on the teeth. Bonding supplies are used to bond the bracket on to a tooth. Ceramic brackets are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred position.

DynaFlex ® Clear Brackets & Buttons may be adjusted by the dentist. The appliance is provided as a non-sterile device and is single use. DynaFlex® Clear Bracket & Buttons is for prescription only.

The provided text does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML device performance study. The document is a 510(k) summary for DynaFlex Clear Brackets & Buttons, which are orthodontic physical devices, not an AI/ML software.

The document discusses performance characteristics based on bench testing for bond strength and other non-clinical performance tests for overall design, biocompatibility, and manufacturing process validation. It then establishes substantial equivalence to a predicate device (Carriere SLX 3D Clear) based on similar design, materials, manufacturing methods, intended use, and similar technological characteristics.

Therefore, many of the requested elements pertaining to AI/ML device performance studies (such as sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI) are not applicable or available in this document.

However, I can extract the relevant information regarding the performance characteristics and the non-clinical testing performed to establish substantial equivalence for this specific medical device.

Here's the information derived from the provided text, focusing on the available details:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Bond Strength Testing: "all samples tested" (specific number not provided).
• Other Non-Clinical Testing: Not specified.
• Data Provenance: Not specified, but generally, bench test data is generated in-house by the manufacturer.

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

• Not applicable as this is not an AI/ML device performance study requiring expert ground truth for image/data interpretation. Performance is based on physical property measurements and adherence to standards.

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

• Not applicable. Performance is based on direct measurement against defined physical or material standards, not interpretive human judgments.

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 as this is not an AI/ML device.

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

• Not applicable as this is not an AI/ML device.

7. The type of ground truth used

• For bond strength: Quantitative measurement of physical breaking point against a specified minimum.
• For other properties (In/Out, Torque, Angulation, Rotation): Quantitative measurement of dimensions and angles against a specified range (derived from the predicate device).
• For biocompatibility: Compliance with ISO 10993 series through laboratory testing.
• For manufacturing process: Adherence to internal technical specifications and standards.

8. The sample size for the training set

• Not applicable as this is not an AI/ML device.

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

• Not applicable as this is not an AI/ML device.

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Ceramic Brackets Orthometric are intended for use in orthodontic treatment. The brackets are affixed to teeth so that pressure can be exerted on the teeth.

The Orthometric's Ceramic Brackets are composed of different designs of brackets that are made of Aluminum Oxide. The ceramic brackets are ICERAM, ICERAM-P, and ICE CLEAR.

The provided document is a 510(k) premarket notification for "Ceramic Brackets Orthometric". It focuses on demonstrating substantial equivalence to a predicate device, rather than defining and proving acceptance criteria for a new AI/ML device. Therefore, the requested information elements related to AI/ML device performance, such as sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and how ground truth was established, are not applicable or available in this document.

However, I can extract information related to the performance tests conducted to demonstrate equivalence for this non-AI medical device.

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

The document does not explicitly state numerical acceptance criteria in a table format. Instead, it describes performance tests carried out to prove the technical equivalence to the predicate device. The comparison table (Table 5.1) focuses on equivalence of characteristics rather than specific performance metrics and acceptance thresholds.

Based on the text: "Performance tests were carried out to prove the technical equivalence between the Orthometric's Ceramic Brackets and the predicate Clarity Advanced Ceramic Brackets (K102803)."

And the findings:

• "The data demonstrates the similarity of the dimensional characteristics when compared."
• "The results of adhesion strength tests demonstrate that both products had similar behavior, showing equivalence, both in the measurement of the external force necessary for detachment and in the shear stress."
• "The Orthometric's Ceramic Brackets demonstrated similarity in the friction resistance test."

A summary table for performance could be constructed as follows, with the understanding that "acceptance criteria" here is implicitly "demonstrate similarity/equivalence to the predicate":

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

The document does not specify the exact sample sizes used for the performance tests (dimensional characteristics, adhesion strength, friction resistance). It also does not mention data provenance (country of origin, retrospective/prospective) for these non-clinical engineering tests.

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

Not applicable. This is not an AI/ML device requiring expert-established ground truth for a test set. This document describes material and mechanical property equivalence.

4. Adjudication method for the test set

Not applicable. This is not an AI/ML device requiring adjudication.

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 is not an AI/ML medical device.

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

Not applicable. This is not an AI/ML medical device.

7. The type of ground truth used

Not applicable in the context of expert-derived ground truth for an AI/ML device. For this device, "ground truth" would refer to established physical and material properties (e.g., actual dimensions measured by instruments, measured forces, biological reactions to materials as per ISO standards).

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device.

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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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Vatech Clismile is indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.

This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocclusion of the upper and lower teeth.

It is used to correct teeth by transmitting physical force to each tooth, and is a selfligation bracket using a ceramic body and a metal cap made of a metal material. Shelf-life is not applicable because of the low likelihood of time-dependent product degradation.

The provided text describes a 510(k) premarket notification for a medical device called "Vatech Clismile," which is an orthodontic bracket. The document focuses on demonstrating substantial equivalence to a predicate device, "In-Ovation C." The information does not present a study with detailed acceptance criteria and performance reports in the context of an AI/ML powered device. Instead, it focuses on the equivalence of physical and materials characteristics.

Therefore, many of the requested fields cannot be filled as they pertain to the evaluation of an AI-powered medical device through clinical or performance studies with ground truth establishment, which is not the subject of this document.

However, I can extract the relevant information regarding the technical characteristics and the performance testing mentioned to demonstrate equivalence.

Here's the information based on the provided text, with many fields marked as "Not applicable" due to the nature of the document.

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

The document does not explicitly state "acceptance criteria" in a quantitative sense as might be expected for software or AI performance, but rather focuses on equivalence of physical/material properties and adherence to relevant standards.

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 for Test Set: Specific sample sizes are not explicitly stated for all tests. For "Dimensional analysis," specific models "Clismile 12-1223" and "IN-OVATION C H100-132-81" (corresponding to the maximum canine) were used for comparative assessment. The document states "Bracket generally uses a one-kit product consisting of 20 brackets." and that "Clismile is also composed of the same number of sets" as the predicate.
• Data Provenance: Not specified, but the manufacturing company is Rayence Co., Ltd. from Gyeonggi-do, Korea. The tests are likely internal company evaluations or performed by accredited labs.
• Retrospective/Prospective: Not specified, but given the context of a 510(k) submission, these would be controlled tests performed for regulatory submission.

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. This document does not describe a study involving expert readers or establishment of ground truth in a clinical assessment context. The evaluations are primarily engineering and materials performance tests.

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

Not applicable. (No expert adjudication involved for this type of technical performance testing).

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 is not an AI-powered device and no MRMC study was conducted.

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

Not applicable. This is not an AI algorithm.

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

The "ground truth" for the tests performed is based on:

• Engineering specifications and measurements (e.g., dimensions, torque, angulation).
• Material composition analysis.
• Standardized test methods (e.g., ISO 27020 for brackets, ISO 10993 series for biocompatibility, ISO 22674 for metallic materials).
• Direct comparison to the predicate device's established characteristics.

8. The sample size for the training set

Not applicable. There is no AI/ML model for which a training set would be required.

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

Not applicable. There is no AI/ML model.

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This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single use only.

Orthodontic Ceramic bracket, VENUS and ROSE Bracket is an orthodontic bracket attached to teeth to recover aesthetics and function of malocclusion. Made with aluminum oxide, it is attached to teeth and straightens irregular teeth with orthodontic wire installed through the wire's elasticity. It is made with aluminum oxide and seeks smooth movement of orthodontic wire for straightening irreqular teeth and it requires additional rubber ring or ligating wire to fix Wire.

VENUS Bracket no hook type and ROSE bracket have consists of three parts: the first part is the slot for the orthodontic wire; the second part is a round groove that is to hold a wire with an elastic "O" ring; the third part is the base that adheres to the tooth surface. A colored marking on wing part of bracket indicates orientation for placement.

VENUS Bracket with hook type consist five parts: the slot for the slot for the orthodontic wire; the second part is a round groove that is to hold a wire with an elastic "O" ring; the third part is the base that adheres to the tooth surface; forth part is open guide part which serves as a path for movement of device used to open cap ligated to body; last part is different part from other type of models, it has self-ligating Clip to fix the teeth.

These devices are designed for orthodontic use only. The devices intended use for single use only.

The provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria in the context of an AI/ML medical device. Instead, it is a 510(k) summary for orthodontic brackets (VENUS Bracket and ROSE Bracket), establishing their substantial equivalence to a predicate device (ROSA Bracket).

The document details the device's description, indications for use, comparison with a predicate device, and non-clinical performance data (biocompatibility and mechanical properties) to support its safety and effectiveness. It explicitly states that "No clinical performance testing was performed on VENUS and ROSE brackets," which means there would be no study to prove acceptance criteria based on clinical outcomes.

Therefore, I cannot provide the requested table and information as it is not present in the provided text.

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This device is intended for the orthodonic movement of teeth. It is removed after orthodontic treatment has been completed. The devices are intended to be single use only

The proposed device, Luce Ceramic Bracket, consists of ceramic orthodontic brackets which are bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontics wire, to alter the tooth position. The ceramic bracket is produced using AI203, translucent polycrystalline aluminum oxide (99.99%). The brackets are bonded to the teeth with commercially available materials and linked together by "arch wire" that applies steady, gentle pressure to produce desired tooth movement.

The provided document is a 510(k) Summary for the Luce Ceramic Bracket, a Class II medical device. This document focuses on demonstrating the substantial equivalence of the new device to a legally marketed predicate device (Alpha Pure K163117), rather than proving that the device meets specific performance criteria through a study with a test set and ground truth.

Therefore, the document does not contain the information requested regarding acceptance criteria, study details (sample size, data provenance, number of experts, adjudication, MRMC study, standalone performance, type of ground truth, training set details). The concept of "acceptance criteria" in this context refers to the FDA's "substantial equivalence" determination, which is based on demonstrating that the new device is as safe and effective as a predicate device, primarily through comparison of technological characteristics and intended use, rather than through de novo performance studies with a well-defined ground truth in the way one might evaluate an AI/ML diagnostic algorithm.

Specifically, the document states:

• "Non-Clinical Study Performance: Biocompatibility testing were conducted on the predicate devices, Alpha Pure(K166117). Since the materials, manufacturing process, packaging materials and methods are identical between the subject and predicate devices, the test reports can be leveraged for the subject device. Subject device and the predicate(K16117) are Identical." This indicates that no new performance studies were conducted for the Luce Ceramic Bracket because it is deemed identical to its predicate for performance relevant to safety and effectiveness (e.g., biocompatibility).

The 510(k) pathway often relies on demonstrating similarity to existing devices, reducing the need for extensive new clinical or performance studies if substantial equivalence can be established through design, material, and manufacturing comparisons.

In summary, none of the requested information about acceptance criteria for a new performance study or details of such a study are present in this 510(k) summary. The document's purpose is to show substantial equivalence through direct comparison of features and leveraging prior testing on the predicate device.

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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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