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510(k) Data Aggregation
(1 days)
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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(161 days)
S-Line™ 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
S-Line™ orthodontic ceramic bracket is used to treat malocclusion, the abnormal occlusion of the upper and the lower teeth. It is intended to be applied on the surface of teeth to restore dental esthetics and functionality and it is designed to be used jointly with orthodontic wire.
The applicant, BIO CETEC CO., LTD., submitted a 510(k) premarket notification for their device, S-Line™ Orthodontic Ceramic Bracket, claiming substantial equivalence to the C-Line™ Orthodontic Ceramic Bracket (K163467) as the primary predicate device and DAMON 4Clear (K081415) as a reference device. Transbond™ XT (K073697) was also used as a bonding agent for performance testing.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state formal "acceptance criteria" with numerical thresholds for performance. Instead, it describes performance tests conducted to demonstrate substantial equivalence by comparing the S-Line™ device to the reference device (DAMON 4Clear) and the primary predicate device (C-Line™). The reported "performance" is that the S-Line™ device's test results demonstrate substantial equivalence.
| Performance Test | Objective | Comparison Against | Reported Performance of S-Line™ |
|---|---|---|---|
| Wire Slot Torque test | Demonstrate stability to withstand torque force from wire. | Reference device (DAMON 4Clear) (implicit from context) | Substantially equivalent |
| Shear Bonding test | Demonstrate bond strength of brackets. | Reference device (DAMON 4Clear) (implicit from context) | Substantially equivalent |
| Bracket Removal Test | Demonstrate stability of brackets' de-bonding performance from the enamel surface with a plier. | Reference device (DAMON 4Clear) (implicit from context) | Substantially equivalent |
| Wire Drag Test | Measure friction between wire and bracket slot. | Reference device (DAMON 4Clear) (implicit from context) | Substantially equivalent |
| Door Pull-Out Test | Measure tensile force at the moment of fracture from the orthodontic wire. | Reference device (DAMON 4Clear) (implicit from context) | Substantially equivalent |
| Adhesive Strength Bonding Test | Study bonding of an adhesive to tooth structure or a bracket. | Not explicitly stated what it was compared against, likely also reference device. | Substantially equivalent |
| Biocompatibility Tests | ISO 10993-1, 10993-5, 10993-10 standards | ||
| Cytotoxicity | Assess for toxic effects on cells. | ISO 10993-5 | Non-cytotoxic |
| Mucosal Irritation | Assess for irritation to mucosal membranes. | ISO 10993-10 | None Irritation |
| Skin Sensitization | Assess for hypersensitivity reactions. | ISO 10993-10 | Do not show any hypersensitivity |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for the non-clinical performance tests. It also does not specify the data provenance (e.g., country of origin, retrospective/prospective). The tests were conducted internally by the manufacturer or a contracted lab to meet ISO standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable as the study is a non-clinical performance study of a device (orthodontic bracket) and does not involve human subjects or expert assessment for ground truth in the context of clinical outcomes or imaging interpretation. Ground truth for these tests would be derived from the physical properties and measurements according to ISO standards.
4. Adjudication Method for the Test Set:
This information is not applicable for non-clinical performance testing. Adjudication methods are typically employed in clinical studies involving human readers/investigators.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC comparative effectiveness study was not done. The study described is a non-clinical performance study of a medical device, not a study evaluating human reader performance with or without AI assistance.
6. Standalone Performance:
Standalone performance was done in the context of the device's physical and mechanical properties. The non-clinical performance tests (wire slot torque, shear bond, bracket removal, wire drag, door pull-out, adhesive strength, and biocompatibility) evaluate the device itself without human-in-the-loop interaction.
7. Type of Ground Truth Used:
The ground truth for the non-clinical performance tests was based on physical and mechanical measurements according to specified ISO standards. For example, bond strength would be a measured force, and biocompatibility would be assessed against the criteria of ISO 10993.
8. Sample Size for the Training Set:
This information is not applicable. The S-Line™ Orthodontic Ceramic Bracket is a physical medical device, not an AI/machine learning algorithm, and therefore does not have a "training set."
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as above.
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(184 days)
C-LineTM 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
C-Line ™ orthodontic ceramic brackets are intended to be bonded to a tooth to apply pressure to a tooth to alter its position. C-Line ™ orthodontic ceramic brackets consist of a translucent alumina body and a bonding base. The bracket's color marking and cords indicates the bracket positioning and facilitate bracket identification.
Here's an analysis of the provided text regarding the acceptance criteria and study details for the C-Line Orthodontic Ceramic Bracket, structured to answer your specific questions.
Important Note: The provided document is a 510(k) summary for a medical device (orthodontic ceramic bracket). It establishes substantial equivalence by comparing the new device to a predicate device, rather than proving a specific clinical performance. Therefore, sections related to AI performance, human reader improvement, and distinct ground truth for training/test sets are not applicable as this is not an AI/ML medical device.
Acceptance Criteria and Study Overview
The C-Line Orthodontic Ceramic Bracket K163467 sought to demonstrate substantial equivalence to a predicate device (Clarity Advanced Ceramic Bracket, K102803) by showing similar performance in non-clinical (bench) tests and comparable design characteristics and intended use. The "acceptance criteria" here are implied by the comparison to the predicate device, meaning the new device should perform similarly or better than the predicate in engineering tests without raising new questions of safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a substantial equivalence determination based on non-clinical testing against a predicate, "acceptance criteria" are not explicitly defined as numerical thresholds. Instead, the performance of the applicant device (C-Line) is compared directly to the predicate device (Clarity Advanced) to demonstrate similarity.
| Performance Characteristic | Acceptance Criterion (Implied - Similar to Predicate) | Reported Device Performance (C-Line) |
|---|---|---|
| Mechanical Properties | "similar to the predicate device" | |
| Wire Slot Drag Test | Similar to predicate | Result of test data was similar for both brackets. |
| Wire Slot Torque Test | Similar to predicate | C-Line brackets had higher torque strength than Clarity Advanced brackets due to the higher in/out thickness of C-Line. (This difference was not flagged as raising new safety/effectiveness concerns). |
| Shear Test | Similar to predicate | Two brackets had a very similar shear strength. No fracture occurred during debonding. |
| Bracket Removal Test | Similar performance to predicate | C-Line brackets had a tendency to remain adhesive lower than Clarity Advanced because of the undercut pattern base, implying an acceptable debonding outcome. Most adhesive remained on enamel. |
| Biocompatibility | Compliance with ISO 10993 standards | All user directly contacting materials are compliance with ISO10993 requirements (Cytotoxicity, Sensitization, Oral Mucosal Irritation, Systemic Toxicity, Degradation Products from Ceramics). |
| Design Characteristics | Conforming to ISO 27020:2010 | Conforms to ISO 27020:2010. Slight differences in bracket in-out and torque angles were noted but deemed not to raise new safety/effectiveness questions. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample sizes for the "test set" for each individual bench test. It mentions "bench testing" was conducted on the C-Line device and the predicate device. The provenance is not specified, but the manufacturing company is based in the Republic of Korea, suggesting the testing was likely performed there or by a contract lab. The tests are "non-clinical," so "retrospective or prospective" data provenance is not applicable in the human data sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a non-clinical, bench testing study, not a study involving human expert interpretation for ground truth.
4. Adjudication Method for the Test Set
Not applicable. This is a non-clinical, bench testing study.
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 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 device.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests would be the established scientific and engineering principles and the performance of the legally marketed predicate device. For example:
- For mechanical properties (shear strength, torque strength), the "ground truth" is measured physical values and established material science expectations.
- For biocompatibility, the "ground truth" is established by adherence to recognized international standards (ISO 10993 series).
- For design characteristics, the "ground truth" is conforming to the referenced international standard (ISO 27020:2010).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so there is no training set in the context of an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device.
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(85 days)
Opal® Bond™ Flow is a light viscosity, light cure bonding adhesive used for bonding to etched enamel and is recommended for appliances, permanent retainers, bondable bite turbos/ramps or similar applications.
Opal® Bond™ Flow is a light cure adhesive designed for bonding brackets other bondable appliances to etched enamel.
The provided text describes a 510(k) submission for "Opal® Bond™ Flow," a light cure bracket adhesive. The submission aims to demonstrate substantial equivalence to predicate devices, focusing on performance characteristics through in-house testing and comparisons.
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
The text doesn't explicitly state "acceptance criteria" with numerical thresholds for each test. Instead, it describes desired outcomes relative to competitors for each functional test performed. The reported device performance is described as "as well or better than the predicate devices currently on the market."
| Function | Acceptance Criteria (Desired Outcome described) | Reported Device Performance |
|---|---|---|
| Shear Peel | Higher adhesion onto brackets compared to competitors (acceptable and preferred). | Performs as well or better than predicate devices. |
| Flexural Strength | Higher number than competitors (good). Modulus side comparable to most competitors. | Performs as well or better than predicate devices. |
| Hardness | Within competitors' range. | Performs as well or better than predicate devices. |
| Shear Bond (with bracket) | Highest value compared to competitors acceptable. | Performs as well or better than predicate devices. |
| Compressives | High numbers compared to competitors acceptable. | Performs as well or better than predicate devices. |
| Metal Shear | Both measures high or higher than competitors. | Performs as well or better than predicate devices. |
| Depth of Cure | At the high end of competitors. | Performs as well or better than predicate devices. |
| Tensile Pull | (No specific criteria described, only that it measures force to pull off a bracket.) | Performs as well or better than predicate devices. |
| Ambient Light Sensitivity | Low times for working and cure time. | Performs as well or better than predicate devices. |
| Sorption | Low readings. | Performs as well or better than predicate devices. |
| Stain Testing | Low score (1 being lowest, less staining). | Performs as well or better than predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify the exact sample sizes used for each of the bench tests (Shear Peel, Flexural Strength, etc.). It only states that these tests were "conducted during the R & D phase on Opal® Bond MV and compared to 3M Unitek's Transbond and Transbond LV (K073697) and Reliance's Flow-Tain LV (K083051)."
- Data Provenance: The data is from "in-house testing" conducted during the R&D phase by Opal Orthodontics. It is retrospective for the purpose of this 510(k) submission, as it was performed prior to the submission. The country of origin of the data is implicitly the USA, where Opal Orthodontics is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There were no human experts used to establish "ground truth" for the performance tests. The "ground truth" for these physical and chemical property tests is derived directly from the laboratory measurements and comparisons to predicate devices, following established scientific and industrial standards for materials testing in dentistry.
4. Adjudication Method for the Test Set
Not applicable. The tests are objective measurements of material properties, not subjective assessments requiring expert 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 dental adhesive, not an imaging or diagnostic AI-assisted device. Therefore, no MRMC study involving human readers and AI assistance was conducted or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or software. It is a physical dental adhesive.
7. The Type of Ground Truth Used
For the bench tests, the "ground truth" is based on objective physical and chemical property measurements and comparative performance against legally marketed predicate devices, as well as adherence to established industry standards for testing such materials. There is no mention of pathology, outcomes data, or expert consensus in establishing the ground truth for these specific material performance tests.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product, not a machine learning model. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for a physical product.
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(85 days)
Opal® Bond MV is a light cure orthodontic adhesive designed for bonding brackets and other bondable appliances to etched enamel.
Opal® Bond MV is a light cure orthodontic adhesive.
The provided document is a 510(k) summary for a medical device (Opal® Bond MV, an orthodontic adhesive). It outlines the device's intended use and claims substantial equivalence to predicate devices based on various tests. However, it does not contain a table of acceptance criteria or specific performance metrics from a study that "proves the device meets the acceptance criteria" in the way one would expect for a more complex AI/software medical device.
The information provided describes the types of tests performed and states that a "detailed Clinical Summary" with supporting literature was included in the submission, but the details of this summary and specific performance results are not present in the excerpt.
Based on the provided text, here's what can be extracted and what information is missing:
1. Table of acceptance criteria and the reported device performance:
This information is not explicitly provided in the excerpt. The document lists several tests performed (Shear Peel, Flexural Strength, Hardness, Shear Bond with bracket, Compressive, Metal Shear, Depth of Cure, Tensile Pull, Ambient Light Sensitivity, Clinic, Lab) and states that these were "compared to 3M Unitek's Transbond (K073697)". However, it does not detail:
- Specific acceptance criteria (e.g., "Shear Bond strength must be greater than X MPa").
- The actual quantitative results of Opal® Bond MV for these tests.
- The quantitative results of 3M Unitek's Transbond for comparison.
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: Not specified in the provided text.
- Data provenance: Not specified in the provided text. It mentions "Clinical Summary" and "literature," implying some human data might be involved, but details are absent.
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 or Not specified. This device is an adhesive, and its performance would typically be measured through objective mechanical and chemical tests rather than expert interpretation of images or clinical outcomes in the same way an AI diagnostic device would. If a "Clinic" test involved human assessment, the details are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable or Not specified. This is a mechanical/chemical properties study, not a human reader study 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:
- No. This is not an AI device, so an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the technical tests (Shear Peel, Flexural Strength, etc.), the "ground truth" would be established by standardized laboratory testing procedures and universally accepted scientific definitions of these material properties, measured using instruments.
- For the "Clinic" test, if it involved a clinical trial, the "ground truth" would likely be based on clinical outcomes relevant to orthodontic bonding (e.g., bracket retention, adverse events) assessed by clinical experts, but this is not detailed.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set. The device's performance is based on its material properties, developed through R&D (which might involve iterative testing, but not "training data" in the AI sense).
9. How the ground truth for the training set was established:
- Not applicable. As above, this is not an AI/machine learning device.
In summary:
The provided document details a Traditional 510(k) submission for an orthodontic adhesive. The "study" referenced involves a series of mechanical and chemical tests comparing the new device (Opal® Bond MV) to an existing predicate device (3M Unitek's Transbond). However, the specific quantitative results of these tests and the defined acceptance criteria are not included in this excerpt. The document implicitly claims that the device meets acceptance criteria by stating "substantial equivalence" based on these tests and supporting literature, but the raw data or detailed performance tables are omitted from this summary.
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