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510(k) Data Aggregation
(1 days)
3M Unitek Orthodontic Products
3M Transbond Orthodontic Adhesive is indicated for the following uses:
- · Creating attachments for orthodontic tray aliqners.
- · Bonding orthodontic brackets to teeth.
3M Transbond Orthodontic Adhesive is a thixotropic, visible-light activated, radiopaque orthodontic adhesive. The product is stored in a multi-use syringe which is used with single-use dispensing tips.
3M Transbond Orthodontic Adhesive contains bisGMA, TEGDMA and Procrylat resins. The fillers are a combination of ytterbium trifluoride filler with a range of particles sizes from 0.1 to 5.0 microns, a non-agglomerated/non-aggregated surface modified 20 nm silica filler, a non-agglomerated/non-aggregated surface modified 75 nm silica filler, and a surface modified aggregated zirconia/silica cluster filler (comprised of 20 nm silica and 4 to 11 nm zirconia particles). The aggregate has an average cluster particle size of 0.6 to 10 microns. The inorganic filler loading is approximately 65% by weight (46% by volume).
This document is a 510(k) Premarket Notification for a dental adhesive, not an AI/ML medical device. Therefore, the requested information regarding acceptance criteria and study designs typically associated with AI/ML device performance (e.g., sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone performance) is not available in the provided text.
The document discusses the substantial equivalence of the 3M™ Transbond™ Orthodontic Adhesive to legally marketed predicate devices. The acceptance criteria and testing described pertain to the physical and chemical properties of the adhesive.
Here's a breakdown of the relevant information provided:
1. A table of acceptance criteria and the reported device performance:
The document mentions the following performance parameters were tested:
| Performance Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Shear Bond Strength (adhesion) | Not explicitly stated, but implied to be comparable to or better than predicate/reference devices. | "The performance bench studies and biocompatibility assessment show that the subject device is as safe, as effective, and performs as well as or better than the predicate and/or reference device." (Specific values are not provided in this summary.) |
| Depth of Cure (ISO 4049) | Not explicitly stated, but implied to be comparable to or better than predicate/reference devices. | "The performance bench studies and biocompatibility assessment show that the subject device is as safe, as effective, and performs as well as or better than the predicate and/or reference device." (Specific values are not provided in this summary.) |
| Three-Body Wear Resistance | Not explicitly stated, but implied to be comparable to or better than predicate/reference devices. | "The performance bench studies and biocompatibility assessment show that the subject device is as safe, as effective, and performs as well as or better than the predicate and/or reference device." (Specific values are not provided in this summary.) |
| Rheology | Not explicitly stated, but implied to be comparable to or better than predicate/reference devices. | "The performance bench studies and biocompatibility assessment show that the subject device is as safe, as effective, and performs as well as or better than the predicate and/or reference device." (Specific values are not provided in this summary.) |
| Biocompatibility Assessment | Successful completion according to relevant standards. | "The performance bench studies and biocompatibility assessment show that the subject device is as safe, as effective, and performs as well as or better than the predicate and/or reference device." |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in this 510(k) summary. These details would typically be found in the full test reports, which are not included in this document.
- Data Provenance: Not specified. These are bench studies, not patient data studies, so geographical origin or retrospective/prospective nature isn't typically relevant in the same way it would be for clinical AI/ML studies.
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 is a material science and engineering evaluation, not an AI/ML medical imaging device requiring human expert consensus for ground truth. The "ground truth" for these tests are objective measurements based on established dental material testing standards (e.g., ISO 4049).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not an AI/ML device requiring human adjudication of results.
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 dental adhesive, not an AI-assisted diagnostic tool.
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. The "performance" is inherent to the material itself, measured in laboratory settings without human interpretation assistance in the way an AI would be.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the performance tests (Shear Bond Strength, Depth of Cure, Three-Body Wear Resistance, Rheology) would be the objective measurements derived from standardized laboratory testing methods against established mechanical and chemical benchmarks for dental adhesives. This is not subjective expert consensus or patient outcomes data.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. There is no training set for this type of device.
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(30 days)
3M Unitek Corporation
The 3MM Clear Tray Aligner system is a series of clear, lightweight, plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e., all second molars). Utilizing a series of incremental tooth movements, it sequentially positions teeth by way of continuous gentle force.
The 3M Clear Tray Aligner System is a series of clear plastic aligners that offer a solution for patients who want an aesthetic orthodontic treatment by utilizing a set of removable aligners to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology.
A dental health professional (e.g. orthodontist or dentist), using a standard personal computer prescribes the 3M Clear Tray Aligner system based on an assessment of the patient's teeth, determines a course of treatment with the system, takes molds of the patient's teeth and completes a prescription form using a standard dental software used for tooth alignment, 3M then designs a series of plastic travs intended to gradually realign the patient's teeth in accordance with the physician's prescription using a standard dental software used for tooth alignment. The prescribing physician reviews and approves the model scheme before the molds are produced. Once approved, 3M produces trays, which are formed of clear, thin, thermoformed plastic. The trays are sent back to the dental health care professional who then provides them to the patient, confirming fit and design. Over a period, additional trays are provided sequentially to the patient by the dental health professional to gradually move the target teeth to the designed position. The dental care professional monitors treatment from the moment the first aligner is delivered to when the final aligner is delivered. The trays are held in place by pressure and can be removed by the patient at any time.
The provided text describes the 3M™ Clear Tray Aligner and its substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical trial report or performance study for a diagnostic or AI-driven device.
The document is a 510(k) summary for a medical device, focusing on demonstrating substantial equivalence to already marketed predicate devices (Invisalign® System and ClearCorrect System) rather than presenting a performance study with detailed acceptance criteria for a novel AI or diagnostic algorithm.
Here's a breakdown of why this information is not present in the provided text, and what is available:
1. A table of acceptance criteria and the reported device performance:
- Not Available: The document does not provide a table of acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for device performance in the context of an AI or diagnostic tool.
- What is available: The document focuses on demonstrating that the 3M™ Clear Tray Aligner is "as safe, as effective, and is substantially equivalent" to predicate devices based on:
- Shared indications for use.
- Similar technological characteristics (thermoplastic material, incremental tooth movement principle).
- Similar mechanism of action.
- Bench testing for material properties (translucency, shelf life, life expectancy) which showed "acceptable" properties.
- Biocompatibility testing (cytotoxicity, sensitization, irritation) which "met the requirements of the study protocols" and found the material "non-cytotoxic, non-sensitizing and is not an intracutaneous irritant."
- Software verification and validation for the ordering and processing software, which was considered "moderate" level of concern.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not Available: There is no mention of a "test set" in the context of evaluating an AI or diagnostic algorithm's performance. The document describes testing of the physical material and software, not an algorithm's diagnostic accuracy on a dataset.
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 Available: Not applicable, as there's no mention of a test set requiring expert-established ground truth for an AI or diagnostic assessment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Available: Not applicable for the same reason as above.
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 Available: The device is a physical orthodontic aligner system, not an AI or diagnostic tool that assists human readers. Therefore, an MRMC study is not relevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Available: The device is a physical product. While it uses software for ordering and design, the submission does not perform a standalone performance evaluation of a diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Available: Ground truth, in the context of AI/diagnostic evaluation, is not mentioned. The "ground truth" for the material and software testing would be established by the specifications of those tests (e.g., chemical composition standards for biocompatibility, functional requirements for software).
8. The sample size for the training set:
- Not Available: Not applicable, as there is no AI model or algorithm being "trained" in the sense of machine learning for diagnostic purposes. The software mentioned facilitates ordering and processing, but it's not described as an AI algorithm that learns from a training set.
9. How the ground truth for the training set was established:
- Not Available: Not applicable for the same reason as above.
In summary: The provided document is a 510(k) premarket notification for a physical medical device (orthodontic aligners). Its purpose is to demonstrate substantial equivalence to existing devices through comparisons of indications for use, technology, materials, and limited bench and biocompatibility testing. It does not describe an AI or diagnostic algorithm, nor does it present a study with performance-based acceptance criteria typical for such technologies.
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(94 days)
3M UNITEK CORPORATION
The intended use of APC™ Flash-Free Adhesive is as a light cure orthodontic adhesive that is designed to be used in bonding orthodontic appliances for orthodontic treatment.
APC™ Flash-Free Adhesive is indicated for use in bonding orthodontic appliances for orthodontic treatment.
It consists of a resin-saturated mat that is attached to the apprimated for Craceets, ceramic brackets, and bondable buccal tubes. The relatively low viscosity of the resin allows it to form a fillet at the edges of the bracket which reduces the need to remove excess adhesive, also known as flash.
The acceptance criteria and study proving the device meets them are described below:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bond Strength Test | Provide the minimum bond strength to hold a bracket to a tooth (comparable to predicate devices) | APC™ Flash-Free Adhesive performs comparably to the predicate devices (Adhesive Precoated Brackets and APC™ Plus Adhesive) and provides the minimum bond strength to hold a bracket to a tooth. |
| Primer Compatibility Test | Provide the minimum bond strength to hold a bracket to a tooth when used with specified primers (comparable to predicate device) | APC™ Flash-Free Adhesive performs comparably to APC™ Plus Adhesive and provides the minimum bond strength to hold a bracket to a tooth when used with Transbond MIP Primer and Transbond Plus SEP Primer. |
| Accelerated Aging (Thermocycling) | Provide the minimum bond strength to hold a bracket to a tooth following specified cycles (comparable to predicate device) | APC™ Flash-Free Adhesive performs comparably to APC™ Plus Adhesive and provides the minimum bond strength to hold a bracket to a tooth following a specified number of cycles between hot and cold environments. |
| Ambient Light Stability Test | Provide the minimum bond strength to hold a bracket to a tooth following ambient light exposure (comparable to predicate device) | APC™ Flash-Free Adhesive performs comparably to APC™ Plus Adhesive and provides the minimum bond strength to hold a bracket to a tooth following exposure to ambient light. |
2. Sample Size for Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each nonclinical performance test (bond strength, primer compatibility, accelerated aging, ambient light stability). However, these are bench tests, a common practice in dental material testing. The data provenance is from nonclinical, bench-top testing conducted by 3M Unitek Corporation. The country of origin for the data is not specified but implicitly assumed to be the United States, where the company is based and seeking FDA clearance. The data is prospective for the device being tested, in the sense that the tests were performed specifically to evaluate the performance of APC™ Flash-Free Adhesive.
3. Number of Experts and Qualifications for Ground Truth
No human experts were used to establish ground truth for the test set. All testing described is nonclinical bench testing to evaluate physical properties of the adhesive.
4. Adjudication Method for the Test Set
No adjudication method was used as the testing involved objective physical measurements (e.g., bond strength) rather than subjective human assessment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done, as this is a physical dental adhesive, not an imaging or diagnostic device requiring human interpretation of cases.
6. Standalone (Algorithm Only) Performance Study
No standalone (algorithm only) performance study was done, as this device is a physical product (an adhesive), not a software algorithm.
7. Type of Ground Truth Used
The ground truth used for these nonclinical tests was based on objective physical measurements (e.g., bond strength values) and comparison against the performance of legally marketed predicate devices, which are accepted as safe and effective.
8. Sample Size for the Training Set
This device is a physical product (adhesive), not an AI/ML algorithm requiring a training set. Therefore, there is no training set sample size.
9. How Ground Truth for Training Set Was Established
As there is no training set for a physical adhesive, this question is not applicable.
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(142 days)
3M UNITEK CORPORATION
Clarity™ Advanced Ceramic Brackets are intended for use in orthodontic treatment. The brackets are affixed to teeth so that pressure can be exerted on the teeth.
Clarity Advanced Ceramic Brackets are intended to teeth, upon which an orthodontic wire is used to move the teeth to new positions. Clarity Advanced Ceramic Brackets consist of a translucent alumina body and a glass-grit bonding base. The bracket is either uncoated or coated with a thin film of stabilized zirconia. The brackets incorporate a watersoluble color placement indicator system that marks archwire and vertical slots to aid in bracket positioning and color codes tie wing(s) to facilitate bracket identification.
The provided text describes the 510(k) summary for the Clarity™ Advanced Ceramic Brackets, focusing on substantial equivalence to predicate devices through non-clinical performance testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Performance Metric) | Reported Device Performance (Clarity™ Advanced) |
|---|---|
| Bond Strength (Shear-peel) | Comparable to Clarity™ SL and Clarity™ brackets; exceeds minimum bond strength to hold the bracket to the tooth. |
| Bracket Strength (Torsional force to break a bracket) | Comparable to Clarity™ Metal-Reinforced Ceramic Brackets and InVu® Aesthetic Braces; exceeds minimum requirements. |
| Material Friction (Surface frictional forces of wire against bracket) | Zirconia-coated aluminum oxide surface exhibited lower coefficients of friction as compared to the uncoated aluminum oxide surface (a positive outcome). |
| Debond Strength/Mechanism (Squeeze debond) | Squeeze debond moments are comparable to Clarity™ SL brackets and slightly lower for Clarity™ brackets. |
| Biocompatibility | Assessment developed using standard risk assessment techniques and consideration of FDA and internationally recognized guidelines; conclusion that the device is safe. |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes "nonclinical performance testing."
- Sample Size for Test Set: Not explicitly stated in the provided text. The text only mentions "The test results showed that..." for each test, implying a sample was used but not quantifying it.
- Data Provenance: The data is based on bench testing conducted by the manufacturer, 3M Unitek Corp, a US-based company. The data is prospective in the sense that it was generated specifically for this 510(k) submission to demonstrate performance. There is no indication of external data sources or retrospective analysis of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This question is not applicable to this type of submission. The "ground truth" for the non-clinical performance tests (bond strength, bracket strength, friction, debonding) is established by the physical and mechanical properties of the materials and device and measured through standardized engineering tests, not through expert human interpretation or consensus.
4. Adjudication Method for the Test Set:
Not applicable. As noted above, the "truth" for these physical performance tests is directly measured by instruments, not human review or 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 device is a physical orthodontic bracket, not an AI-powered diagnostic or treatment planning tool that involves human readers or interpretation of medical images. 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 algorithm or software device.
7. The Type of Ground Truth Used:
The "ground truth" for these non-clinical tests is based on objective, quantitative measurements of physical properties, such as force (bond strength, debond strength, bracket strength) and coefficients of friction, using standardized testing methodologies.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that requires a training set. The performance data is generated through physical bench testing.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set for an AI/ML algorithm, this question is irrelevant to the device described.
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(152 days)
3M UNITEK
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(46 days)
3M UNITEK
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(71 days)
3M UNITEK
Clarity Modified Ceramic Bracket is intended for use in orthodontic treatment.
Not Found
I am sorry, but the provided text does not contain any information regarding the acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a device named "Clarity™ Modified Ceramic Brackets," which primarily discusses regulatory aspects and substantial equivalence to legally marketed predicate devices. It does not include details about device performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot provide the requested information in the table format.
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(65 days)
3M UNITEK
3M™ Unitek™ APC™ Plus Adhesive is indicated for use in orthodontic appliance application and bonding for orthodontic treatment.
Not Found
I am sorry, but the provided text does not contain the necessary information to answer your request. The document is an FDA 510(k) clearance letter for a dental adhesive (3M™ Unitek™ APC™ Plus Adhesive). It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements. However, it does not include any details about acceptance criteria for performance, studies demonstrating performance, sample sizes, expert qualifications, adjudication methods, or ground truth establishment. These details are typically found in the 510(k) submission itself or in associated studies, not in the clearance letter.
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(73 days)
3M UNITEK
Unite Bonding Adhesive is indicated for bonding orthodontic appliances to teeth for orthodontic treatment.
Not Found
I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to a medical device manufacturer, 3M Unitek, regarding their "Unite Bonding Adhesive." This document primarily addresses the substantial equivalence determination of the device and regulatory compliance.
The document does not contain any information about:
- Acceptance criteria for device performance.
- The study that proves the device meets acceptance criteria (including details like sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details).
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided text. This type of information is typically found in the 510(k) summary or the full 510(k) submission, neither of which is present here.
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