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510(k) Data Aggregation
(225 days)
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":
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance (Orthometric Ceramic Brackets) |
|---|---|---|
| Dimensional Characteristics | Demonstrate similarity to predicate | Data demonstrates similarity when compared to predicate. |
| Adhesion Strength | Demonstrate similar behavior to predicate | Similar behavior to predicate in external force for detachment and shear stress. |
| Friction Resistance | Demonstrate similarity to predicate | Demonstrated similarity in the friction resistance test compared to predicate. |
| Biocompatibility | Meet applicable requirement of ISO 10993 | Meets the applicable requirement of ISO 10993. |
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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(422 days)
Ceramic Bracket is indicated for orthodontic movement of natural teeth.
Ceramic bracket are designed to move teeth to improve their alignment. Ceramic bracket are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred position. Ceramic bracket are intended for use in affixed to a tooth so that pressure can be exerted on the teeth. Use bonding supplies to bond the bracket on to a tooth. Use bonding supplies to bond the bracket on to a tooth. Ceramic bracket are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred position.
This is a 510(k) premarket notification for a medical device called "Ceramic Bracket." The document describes the device, its intended use, and argues for its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a numerical or pass/fail threshold manner, as might be seen for diagnostic device performance. Instead, it relies on demonstrating compliance with relevant ISO standards and comparability to the predicate device. The device is a physical orthodontic bracket, not a diagnostic algorithm.
Therefore, I will present the performance tests conducted and the general conclusion for device acceptance.
| Acceptance Criteria (Implied by Standards) | Reported Device Performance |
|---|---|
| Compliance with ISO 27020 (General Orthodontic Brackets) | Device meets performance specifications of ISO 27020:2010 |
| Biocompatibility | Evaluated and tested according to ISO 10993 standards: |
- ISO 10993-3 (Genotoxicity, Carcinogenicity, Reproductive toxicity)
- ISO 10993-5 (In vitro cytotoxicity)
- ISO 10993-10 (Irritation and skin sensitization)
- ISO 10993-11 (Systemic toxicity)
- ISO 10993-12 (Sample preparation and reference materials) |
| Mechanical Function (Shear Bond Strength) | Tested, results compared to ISO 6872:2015, ISO 29022:2013, ISO 27020:2010, ISO 6474-2:2012, and clinical literature data. |
| Mechanical Function (Torque Strength) | Tested, results compared to ISO 6872:2015, ISO 29022:2013, ISO 27020:2010, ISO 6474-2:2012, and clinical literature data. |
| Structural Integrity | Tested, results compared to ISO 6872:2015, ISO 29022:2013, ISO 27020:2010, ISO 6474-2:2012, and clinical literature data. |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the exact sample sizes used for each mechanical or biocompatibility test. It indicates that "Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intend use" and lists the types of tests.
- Data Provenance: Not specified in terms of country of origin. The testing was conducted to comply with international ISO standards, suggesting tests were performed in accordance with these globally recognized methodologies. The testing appears to be based on physical device samples rather than clinical data sets. It is a retrospective evaluation against established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device and study. The "ground truth" for a physical device like an orthodontic bracket is its physical and biological performance as measured against engineering and biocompatibility standards, not an expert-annotated dataset. The standards themselves are developed by expert consensus in the relevant fields (dentistry, materials science, biocompatibility).
4. Adjudication method for the test set
Not applicable. The "test set" here refers to physical samples of the device being evaluated through standardized laboratory tests, not a dataset requiring human 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 an orthodontic bracket, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed or required.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an orthodontic bracket, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance evaluation is established by:
- International Standards: Specific ISO standards (e.g., ISO 27020, ISO 6872, ISO 29022, ISO 6474-2 for mechanical properties; ISO 10993 series for biocompatibility).
- Clinical Literature Data: Used as a reference for comparison in mechanical testing.
Essentially, the device's characteristics are measured and compared against predefined thresholds and benchmarks set by these standards and literature, rather than against a human expert's "ground truth" for a case.
8. The sample size for the training set
Not applicable. Since this is a physical medical device and not an AI/algorithm, 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 this type of device.
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(104 days)
These devices are intended for the correction of orthodontic malocclusions as diagnosed by a dentist or orthodontist. They are used to transmit and provide axial directional control to the kinetic energy from an orthodontic archwire, for movement of individual teeth for treatment.
These ceramic brackets will be used for correction of malocclusions as diagnosed and overseen by trained practitioners of orthodontics. These brackets will be directly bonded to teeth; will have interface with the archwire to direct applied forces. These devices are intended for single use only and are not delivered in a sterile state.
The Ceramic Bracket line of products are single-use devices intended for use in conjunction with comprehensive orthodontics to control the movement of individual teeth.
These one-piece ceramic brackets are comprised of polycrystalline aluminum oxide. The general geometric composition of these devices is made of archwire slot, tie wings, and a pad (which provides a bonding surface). The archwire slot is a channel through the bracket used to engage the archwire. The tie wings are small hook shaped protrusion use as an anchor point for the ligatures work by tying the archwire into the archwire slot. The geometry of the pad is such that the bracket has a stable footprint. The pad is coated with aluminum oxide particles to facilitate bracket bonding with orthodontic adhesives.
These brackets are comprised of several geometries that vary from bracket to bracket, corresponding to the teeth they are intended for. 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 document pertains to a 510(k) premarket notification for "Ceramic Brackets" (K110335). This document is a regulatory submission for a medical device and thus does not include the type of detailed study information (sample size, ground truth, expert qualifications, etc.) that would be found in a clinical trial or performance study report for an AI/CAD system.
The document asserts substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a standalone study with detailed metrics. Therefore, many of the requested categories of information are not applicable or cannot be extracted from this type of regulatory submission.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document doesn't present "acceptance criteria" in the sense of predefined thresholds for sensitivity, specificity, F1-score, or similar performance metrics typically associated with AI/CAD systems. Instead, the "acceptance criteria" for this type of submission are based on demonstrating "substantial equivalence" to existing legally marketed predicate devices.
| Acceptance Criteria (based on substantial equivalence) | Reported Device Performance (as stated by Ortho Organizers Inc.) |
|---|---|
| Intended Use: Must be equivalent to predicate devices (for correction of orthodontic malocclusions). | "intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter the tooth's position" - Equivalent to predicate. |
| Bracket Body Material: Must be equivalent to predicate devices. | "99.9% Polycrystalline aluminum oxide" - Equivalent to predicate. |
| Pad Coating Material: Must be equivalent to predicate devices. | "Irregular Microcyrstalline Aluminum Oxide" - Equivalent to predicate. |
| Biocompatibility: Must be equivalent to predicate devices. | "Yes" - Equivalent to predicate. |
| Single Use: Must be equivalent to predicate devices. | "Yes" - Equivalent to predicate. |
| Non-Sterile packaging: Must be equivalent to predicate devices. | "Yes" - Equivalent to predicate. |
| Color-coded indicator for bracket identification: May have minor differences. | "Yes, optional" for Ortho Organizer vs. "Yes" for predicate. This minor difference does not raise new safety or effectiveness concerns (Equivalent). |
| No new types of safety and effectiveness questions raised. | "Descriptive and performance testing demonstrate substantial equivalence." (General statement, no specific safety/effectiveness metrics provided). |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This document does not describe a performance study with a "test set" in the context of AI/CAD system evaluation. The assessment is based on material properties, intended use, and design features compared to predicate devices.
- The "performance testing" mentioned is likely mechanical and material testing to ensure the bracket meets engineering specifications, not a clinical trial or diagnostic accuracy study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No "ground truth" establishment by experts is described for this type of medical device. The "truth" is established by the known performance and safety profiles of the predicate devices and the physical/chemical identicality or similarity of the new device.
4. Adjudication method for the test set:
- Not Applicable. No test set or adjudication method as described for AI/CAD systems.
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/CAD system or a diagnostic imaging tool that would involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. The "ground truth" for this submission method is effectively the established safety and efficacy of the predicate devices, against which the new device is compared in terms of its material, design, and intended use.
8. The sample size for the training set:
- Not Applicable. This document does not describe the development or training of an AI algorithm.
9. How the ground truth for the training set was established:
- Not Applicable. This document does not describe the development or training of an AI algorithm.
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