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510(k) Data Aggregation
(142 days)
Vapor® Ceramic Brackets are intended for orthodontic movement of natural teeth.
Ceramic orthodontic brackets are small devices that are intended to teeth, upon which an orthodontic wire is placed to move the teeth to desired positions. They are indicated for orthodontic treatment in patients of all ages when prescribed by an orthodontist. Ceramic orthodontic brackets are primarily offered as an aesthetic alternative to metal orthodontic brackets. They are close to natural tooth coloring, and blend in well enough that they are not as visible as metal brackets. This aesthetic look is popular with many patients, and especially older patients. Ceramic orthodontic brackets have been in use throughout the orthodontic industry for approximately thirty years.
Like its predicate, Vapor® ceramic brackets are manufactured from polycrystalline alumina (ceramic) material, and have bases that are designed to provide maximum adhesion to the tooth while still allowing for easy and complete removal when necessary. The brackets incorporate a water soluble color placement dot as an indicator for correct selection of brackets for each tooth.
Like its predicate, Vapor® ceramic brackets do not incorporate medicinal substances, tissues, or blood products. They do not include software or accessories, and are delivered non-sterile to the end user. Ceramic brackets are intended to be used only once by a single patient. Product labels contain appropriate "do not reuse" symbols. Orthodontic ceramic brackets are used for the duration of orthodontic treatment, which can last more than 30 months. During this time, the devices remain in direct contact with the patient's oral cavity. Because the intended purpose of the device is clearly understood by licensed orthodontists, instructions for use are not provided.
With the exception of the materials from which they are constructed, the form, fit, and function of orthodontic ceramic brackets are identical to those of traditional metal orthodontic brackets. Orthodontic ceramic brackets, like metal brackets achieve their intended purpose (to move teeth into a desired position) through industry standard "prescriptions" that are pre-programmed into the design of the brackets. That is, specific torques, angulations, and distal offset dimensions are designed into each bracket, along with archwire slots that are designed to accommodate the correct size archwire (typically .018" or .022" thick).
Ceramic brackets are designed with tie wing undercut spaces for orthodontic ligatures. They have a molded ceramic bracket body with rounded corners and edges, and rounded hooks on the distal-qingival tie wings to accommodate ligation during orthodontic treatment. These design characteristics allow a tensioned ligating wire to move the brackets, which are securely bonded to the teeth, along a pre-determined path until the desired tooth position is reached. Elastic ligatures may be used on the tie wings and hooks to further facilitate tooth movement, and to secure the orthodontic wire into the bracket's archwire slot.
The provided 510(k) summary for the Vapor® Ceramic Brackets (K132368) describes performance testing to demonstrate substantial equivalence to a predicate device. However, it does not provide information typically found in studies for AI/ML-based devices regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance. The device is a physical orthodontic bracket, not an AI/ML-based diagnostic or assistive system.
Therefore, many of the requested details are not applicable or not available in this document. I will extract the information that is present concerning acceptance criteria and the "study" (nonclinical performance testing) that demonstrates the device meets these criteria.
Acceptance Criteria and Reported Device Performance for Vapor® Ceramic Brackets (K132368)
The "study" supporting the Vapor® Ceramic Brackets meeting acceptance criteria is a series of nonclinical performance tests designed to compare the device's physical properties and performance against its predicate device (FastBraces® Ceramic Brackets, K130446). The acceptance criteria are implicitly defined by performing "comparably" to or "exceeding" the performance of the predicate device or a minimum performance requirement.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test | Acceptance Criteria (Implicit) | Reported Device Performance (Vapor® Ceramic Brackets) |
|---|---|---|
| Shear Strength Test | Implicit Acceptance Criteria: Equivalent to predicate device K130446, exceeding the minimum test performance requirement, and comparable average value to the predicate device. Additionally, it must "exceed the minimum bond strength required to affix the bracket to the tooth." | The average value was comparable to the predicate device, and the Vapor® bracket exceeded the minimum test performance requirement. The bond strength of Vapor® Ceramic Brackets are comparable to the predicate, and exceed the minimum bond strength required to affix the bracket to the tooth. |
| Wire Torque Test | Implicit Acceptance Criteria: Equivalent to predicate device K130446, average breaking value exceeding the minimum test performance requirement of 2400 gm Force, and exceeding the breaking value of the predicate device. | The average breaking value of the Vapor® test samples (3,806 gm Force) exceeded the minimum test performance requirement of 2400 gm Force, as well as the breaking value of the predicate device (3,473 gm Force before breakage occurred). |
| Wire Drag Test | Implicit Acceptance Criteria: Comparable to predicate device K130446, with average drag force within an acceptable range, indicating similar sliding mechanics. | The average drag force of a ligated wire on the Vapor® test samples was slightly higher than the Predicate device, but still within an acceptable range, indicating similar sliding mechanics during treatment. |
| Bracket Removal Test | Implicit Acceptance Criteria: Equivalent or better than predicate device K130446, showing less fragmentation than the predicate device upon removal. | The Vapor® bracket samples showed less fragmentation than the Predicate device upon removal from the substrates using the specified adhesive. The Vapor® bracket removal test resulted in less bracket fracturing as compared to the predicate device when removing the bracket from a substrate using pliers. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the numerical sample size (n) for each test set. It refers to "test samples" for Vapor® and "the predicate device" implying that multiple units were tested for each scenario.
- Data Provenance: The tests are nonclinical (laboratory) performance tests conducted to evaluate the physical properties of the ceramic brackets. The origin is implicitly the manufacturer's testing facility or a certified lab, not patient data from a specific country. This is retrospective in the sense that the device has been manufactured, and its properties are being measured.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not Applicable. For nonclinical performance tests of a physical device like an orthodontic bracket, "ground truth" is established by direct physical measurement according to established test methodologies and engineering standards, rather than expert consensus on interpretive data (like imaging). There are no experts establishing ground truth in the way described for AI/ML devices.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in human interpretations, often in clinical studies or expert labeling of data for AI/ML. For these nonclinical performance tests, results are derived from physical measurements.
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/ML-based diagnostic or assistive system. There are no "human readers" or "AI assistance" involved in its intended use or the testing described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- For these nonclinical performance tests, the "ground truth" is established by physical measurement against engineering specifications and the performance of a legally marketed predicate device. For instance, the sheer strength is a direct measurement of force; resistance to breakage is a direct measurement of force applied before failure.
8. The Sample Size for the Training Set
- Not Applicable. This is a physical device, not an AI/ML system that requires a "training set." The ceramic brackets are manufactured, and their performance is then tested.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set, this question is not relevant.
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(106 days)
FastBraces® Ceramic Brackets are intended for orthodontic movement of natural teeth.
Ceramic orthodontic brackets are small devices that are intended to teeth, upon which an orthodontic wire is placed to move the teeth to desired positions. They are indicated for orthodontic treatment in patients of all ages when prescribed by an orthodontist. Ceramic orthodontic brackets are primarily offered as an aesthetic alternative to metal orthodontic brackets. They are close to natural tooth coloring, and blend in well enough that they are not as visible as metal brackets. This aesthetic look is popular with many patients, and especially older patients. Ceramic orthodontic brackets have been in use throughout the orthodontic industry for approximately thirty years.
Like its predicate, FastBraces® ceramic brackets are manufactured from polycrystalline alumina (ceramic) material, and have bases that are designed to provide maximum adhesion to the tooth while still allowing for easy and complete removal when necessary. The brackets incorporate a water soluble color placement dot as an indicator for correct selection of brackets for each tooth.
Like its predicate. FastBraces® ceramic brackets do not incorporate medicinal substances, tissues, or blood products. They do not include software or accessories, and are delivered non-sterile to the end user. Ceramic brackets are intended to be used only once by a single patient. Product labels contain appropriate "do not reuse" symbols. Orthodontic ceramic brackets are used for the duration of orthodontic treatment, which can last more than 30 months. During this time, the devices remain in direct contact with the patient's oral cavity. Because the intended purpose of the device is clearly understood by licensed orthodontists, instructions for use are not provided.
With the exception of the materials from which they are constructed, the form, fit, and function of orthodontic ceramic brackets are identical to those of traditional metal orthodontic brackets. Orthodontic ceramic brackets, like metal brackets achieve their intended purpose (to move teeth into a desired position) through industry standard "prescriptions" that are programmed into the design of the brackets. Specific torques, angulations, and distal offset dimensions are designed into each bracket, along with archwire slots that are designed to accommodate the correct size archwire (typically .018" or .022" thick).
Ceramic brackets are designed with tie wing undercut spaces for orthodontic ligatures. They have a molded ceramic bracket body with rounded corners and edges, and rounded hooks on the distal-gingival tie wings to accommodate ligation during orthodontic treatment. These design characteristics allow a tensioned ligating wire to move the brackets, which are securely bonded to the teeth, along a pre-determined path until the desired tooth position is reached. Elastic ligatures may be used on the tie wings and hooks to further facilitate tooth movement, and to secure the orthodontic wire into the bracket's archwire slot.
The document describes the performance testing for FastBraces® Ceramic Brackets, an orthodontic device. The evaluation aims to demonstrate substantial equivalence to a predicate device (K922499, Reflections Ceramic Dental Bracket).
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implicit) | Reported Device Performance (FastBraces® Ceramic Brackets) | Reported Device Performance (Predicate Device) |
|---|---|---|---|
| Shear Test (Bond Strength) | Comparable to predicate and exceeds minimum bond strength required to affix the bracket to the tooth. | Comparable to predicate, exceeds minimum bond strength. | (Not explicitly stated, but FastBraces® performance is comparable) |
| Wire Torque Test (Bracket Strength) | Comparable bracket strength to predicate. | Averaging 3,473 gm Force before breakage. | Averaging 3,333 gm Force before breakage. |
| Wire Drag Test (Sliding Mechanics) | Comparable or superior sliding mechanics to predicate. | Lower forces required to drag a ligated stainless steel wire, indicating better sliding mechanics. | (Not explicitly stated, but required higher forces than FastBraces®) |
| Bracket Removal Test (Fracturing) | Comparable or superior performance in terms of less bracket fracturing during removal compared to predicate. | Less bracket fracturing during removal. | (Not explicitly stated, but experienced more fracturing than FastBraces®) |
Note: The document directly compares the new device to the predicate. The "acceptance criteria" are implied to be "comparable to or better than the predicate device" for each performance metric.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each nonclinical performance test (Shear Test, Wire Torque Test, Wire Drag Test, Bracket Removal Test). The data provenance is not specified beyond "nonclinical performance testing," but it can be inferred that these tests were conducted on new FastBraces® Ceramic Brackets and the predicate device, likely in a laboratory setting. No geographical origin is mentioned, and the data is retrospective as it was conducted prior to this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable. The study involves nonclinical performance testing (physical and mechanical tests) on orthodontic brackets, not analysis of medical images or patient data that would require expert interpretation for ground truth establishment.
4. Adjudication Method for the Test Set
This section is not applicable, as there is no human interpretation or subjective assessment involved in the nonclinical performance tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Improvement with vs. without AI Assistance
No. The document explicitly states: "No clinical performance testing was conducted on FastBraces® Ceramic Brackets." Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No. This device is a physical medical device (orthodontic brackets), not an AI-powered algorithm. Therefore, no standalone algorithm performance study was done.
7. The Type of Ground Truth Used
For the nonclinical performance tests, the "ground truth" is defined by the objective measurements obtained from standardized laboratory tests (e.g., measured force for shear strength, measured torque for bracket strength, measured force for wire drag, visual assessment for fracturing after removal). There is no "ground truth" in the sense of expert consensus, pathology, or outcomes data, as these are material and mechanical property tests.
8. The Sample Size for the Training Set
This section is not applicable. This device is a physical medical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This section is not applicable, as there is no training set for this device.
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