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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 Progressive Technology Inc. Chi Lites Orthodontic Sapphire Bracket is a line of single-use devices intended for orthodontic movement of teeth. The bracket is used temporarily and is removed upon completion of orthodontic treatment.

Progressive Technology Inc. is submitting this Premarket Notification for its Class II product, an orthodontic sapphire bracket. The device is intended for use in conjunction with comprehensive orthodontics to control the movement of individual teeth. The brackets are comprised of several geometries that vary from bracket to bracket, corresponding to the intended tooth. These geometries contribute to the fit of the bracket to the tooth and also impart the axial control of the energy from the archwire.

The provided text describes the 510(k) premarket notification for the "Chi Lites Orthodontic Sapphire Bracket." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study for a new, AI-powered medical device. Therefore, much of the requested information regarding acceptance criteria, AI performance metrics, and human reader studies is not applicable to this specific document.

However, I can extract information related to the device performance testing done to support the substantial equivalence claim.

Here's the breakdown based on the provided text, adapted to fit the requested format where possible, and noting where information is not available or outside the scope of this document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Fracture Testing: 20 brackets were tested (10 Chi Lites Orthodontic Sapphire bracket, 10 predicate bracket).
• Bond/Shear Strength: 40 brackets were tested (20 Chi Lites Orthodontic Sapphire bracket, 20 predicate bracket).
• Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective. Given the nature of a 510(k) submission for a physical device, these tests would typically be prospective, controlled laboratory tests performed 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. This is a physical device where ground truth is established through direct measurements of mechanical properties (force, shear strength) rather than expert interpretation of images or patient data.

4. Adjudication Method for the Test Set

• Not applicable. As above, ground truth is based on direct measurements, not subjective expert judgment requiring adjudication.

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

• No. This type of study is relevant for AI-powered diagnostics or image interpretation systems, not for a physical orthodontic bracket.

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

• The ground truth for the performance testing was established through direct physical measurement of mechanical properties (fracture force and bond/shear strength) in controlled laboratory settings. These are objective, quantitative measurements.

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.

Summary from the Document regarding Substantial Equivalence:

The document concludes that the "function and performance of Chi Lites Orthodontic Sapphire bracket is similar to the predicates. There are no changes in the intended use and fundamental scientific technology. All of the materials used in the device have been used in cleared orthodontics devices. Since the subject and predicate are similar in design, function and performance, they are substantially equivalent to the predicate device."

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Empower Clear brackets are intended for orthodontic movement of teeth as diagnosed by an orthodontist. It is used temporarily and is removed upon completion of orthodontic treatment. Empower Clear brackets are intended to be single use only.

The Empower Clear line of products is single-use devices intended for use in conjunction with comprehensive orthodontics to control the movement of individual teeth. The Ceramic Bracket combines the aesthetics of a ceramic bracket with the versatility and ease of self ligation. These brackets are comprised of several geometries that vary from bracket to bracket, corresponding to the intended tooth. These geometries contribute to the fit of the tooth and also impart the axial control of the energy from the archwire.

This document is a 510(k) premarket notification for the Empower Clear orthodontic bracket. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study with detailed performance metrics. Therefore, it does not contain the kind of information requested in the prompt regarding acceptance criteria, reported device performance, sample sizes, expert ground truth establishment, adjudication methods, or MRMC/standalone studies.

The document primarily provides:

• Device Description: Empower Clear line of single-use devices intended for use in comprehensive orthodontics to control tooth movement.
• Intended Use: Orthodontic movement of teeth as diagnosed by an orthodontist, used temporarily, removed upon completion of treatment, single use only.
• Technological Characteristics: Made of Alumina Oxide [Al2O3], same material as predicate devices (Radiance and In-Ovation C). Clip material for Empower Clear is the same as In-Ovation C.
• Biocompatibility Testing: States that biocompatibility testing was conducted and indicated the bracket material (Aluminum Oxide [Al2O3]) is safe for use, free of harmful extractables, and caused no oral mucosa irritation or skin sensitization. This is the closest approximation to a "study" mentioned, but it lacks specific quantitative acceptance criteria or detailed results suitable for the table requested.
• Substantial Equivalence Analysis: Compares Empower Clear to predicate devices (Radiance and In-Ovation C) based on material, intended use, single use, and non-sterile packaging, concluding they are "Equivalent." This is the core of the 510(k) submission.

Due to the nature of this 510(k) document, I cannot fulfill your request for detailed acceptance criteria and study results as it would be inappropriate to invent or infer data not present in the provided text.

The document's purpose is to show equivalence to existing devices, not to present a de novo study with performance metrics against a defined set of acceptance criteria in the way a medical AI/software device might.

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The Pre-Cemented Orthodontic Bracket System Extension is indicated for use in bonding orthodontic appliances for orthodontic treatment.

The Pre-Cemented Orthodontic Bracket System Extension is comprised of pre-cemented ceramic and metal orthodontic brackets, transfer tray, and the adhesives described in K061252. Components of this system are used exactly as described in K061252 (Pre-cemented Orthodontic Bracket System) with the same fundamental technology and for the same intended use. This modification adds a second ceramic orthodontic bracket to the Pre-cemented Orthodontic Bracket System (K060837).

This 510(k) submission (K081291) describes a modification to an existing device, adding a second ceramic orthodontic bracket to an already cleared Pre-Cemented Orthodontic Bracket System (K061252), which itself includes components from K060837. This submission does not contain information about a study based on acceptance criteria in the traditional sense of a clinical performance study with defined endpoints like sensitivity, specificity, or inter-reader agreement.

The device, a Pre-Cemented Orthodontic Bracket System Extension, is a dental device intended for use in bonding orthodontic appliances. The core of this submission focuses on demonstrating that the new component maintains the same safety and effectiveness characteristics as the predicate devices.

Here's an breakdown of the information available in relation to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. There is no explicit "test set" in the context of a clinical performance study to evaluate diagnostic performance or similar metrics. The evaluation relies on established safety and performance data from predicate devices and component materials rather than a new clinical trial.
• Data Provenance: Not applicable. The submission refers to "previous biocompatibility data" and "performance date (data)" from the predicate devices (K060837 and K061252) and the prior use of components in legally marketed devices. This would be considered retrospective in the sense of leveraging existing data, but it's not a prospective study.

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

• Not applicable. There is no "test set" in the context of a clinical performance study requiring expert ground truth establishment.

4. Adjudication Method for the Test Set

• Not applicable. There is no "test set" requiring adjudication.

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

• No, an MRMC comparative effectiveness study was not done. This device is not an AI-based diagnostic tool, but rather a physical orthodontic bracket system. Therefore, the concept of human readers improving with or without AI assistance is not relevant.

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

• No, a standalone algorithm performance study was not done. This is not an AI algorithm.

7. The Type of Ground Truth Used

• The ground truth, in an indirect sense, is established by regulatory clearance and historical safety/effectiveness of the predicate devices and the individual components used. The biocompatibility data also serves as a ground truth for a specific safety aspect. It's not based on expert consensus for diagnostic accuracy, pathology, or outcomes data from a new study.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI-based device that requires a training set.

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

• Not applicable. No training set for an AI algorithm is involved.

Summary of the Study (or Lack Thereof) to Prove Acceptance Criteria:

The "study" in this context is a benchmarking and equivalency assessment against predicate devices and known material safety. The manufacturer did not conduct a new clinical study to establish acceptance criteria for performance; instead, they demonstrated that:

• The device components are already used in legally marketed devices.
• The device's materials have established biocompatibility, and since the formulation hasn't changed, no new biocompatibility testing was deemed necessary.
• The device maintains the same fundamental technology and intended use as its predicate.

The FDA's review concluded that the device is "substantially equivalent" to the predicate devices, thereby meeting the necessary regulatory acceptance for marketing. This type of submission relies heavily on a comparison to existing, cleared devices rather than new performance data generation for defined acceptance criteria.

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