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510(k) Data Aggregation
(78 days)
TREFOIL System
The TREFOIL System is used to restore chewing function in fully edentulous mandibles.
The three implants of the TREFOIL System are placed between the mental foramina in fully edentulous mandibles in a 1-stage surgical technique combined with an immediate function loading protocol, provided sufficient primary stability for the selected technique is achieved. In cases where sufficient primary stability for two implants or more is not reached, the implants along with the Framework may also be used with an early or delayed loading protocol.
The following prerequisites must be fulfilled:
- Adequate quantity of bone (minimum height of 13 mm for 11.5 mm implant and 14.5 mm for 13.0 implant and minimum width of 6-7 mm).
- Adequate mouth opening (minimum 40 mm) to accommodate the guided surgery instruments.
- Implant-supported prosthetics seated directly on dedicated implants
The TREFOIL System is a method of placing three dental implants in predetermined positions (between the mental foramina) and using a pre-designed prosthetic bar to act as a screw-retained framework seated on the implants. The TREFOIL System restores chewing function and esthetics in the mandible in completely edentulous patients.
The TREFOIL System consists of dental implants, surgical components necessary to place the implants in predetermined positions, and prosthetic components that are included in the prosthetic bar or are used in the dental lab during the creation of the prosthetic bar.
The Trefoil Implants are made of CP4 titanium. The implants are parallel walled and have an internal conical abutment connection. The implants have a 13.0 mm threaded portion and are available with both a 4.5 and 6.0 mm collar height. The apex of the implants have cutting chambers allowing for self-tapping. The implant bone interface has the TiUnite implant surface treatment.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets those criteria, specifically concerning an AI/algorithm-based diagnostic device. The document is a 510(k) premarket notification for a dental implant system (TREFOIL System) and discusses its substantial equivalence to previously marketed predicate devices.
The text does not include details about:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, or training sets for an AI/algorithm.
- Number or qualifications of experts, or ground truth adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used (e.g., pathology, outcomes data).
- How ground truth for any training set was established.
The document primarily focuses on:
- Device Description: The TREFOIL System is a dental implant system consisting of implants, surgical components, and prosthetic components for restoring chewing function in fully edentulous mandibles.
- Predicate Devices: It compares the subject device to two predicate TREFOIL Systems (K152836 and K170135).
- Technological Characteristics Comparison: The key difference noted is a change in implant length from 11.5 mm to 13.0 mm, which is already present in a reference predicate. All other technological characteristics (design, material, surface modification) are stated to be the same as the predicate devices.
- Non-Clinical Testing Summary: The document explicitly states that "No clinical data was used to support the decision of safety and effectiveness." Instead, the manufacturer leveraged data from the predicate devices because the subject device "does not represent a new worst case" for aspects like sterilization, packaging, shelf life, biocompatibility, and fatigue testing.
Therefore, I cannot fulfill your request for information about acceptance criteria and an AI/algorithm study based on the provided text.
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(114 days)
TREFOIL System
The Trefoil system is used to restore chewing function in fully edentulous mandibles.
The three implants of the Trefoil system are placed between the mental foramina in fully edentulous mandibles in a 1-stage surgical technique combined with an immediate function loading protocol, provided sufficient primary stability for the selected technique is achieved. In cases where sufficient primary stability of one or more implants is not reached, the implants along with the bar may also be used with an early or delayed loading protocol.
The following prerequisites must be fulfilled:
- Adequate quantity of bone (minimum width of 7mm; and minimum heights of 13mm for 11.5 mm implant and 14.5mm for 13.0 mm implant).
- Adequate mouth opening (minimum 40 mm) to accommodate the guided surgery instruments.
- Implant-supported prosthetics seated directly on dedicated implants.
The TREFOIL System is a method of placing three dental implants in predetermined positions (between the mental foramina) and using a pre-designed prosthetic bar to act as a screw-retained framework seated on the implants. The TREFOIL System restores chewing function and esthetics in the mandible in completely edentulous patients.
The TREFOIL System consists of dental implants, surgical components necessary to place the implants in predetermined positions, and prosthetic components that are included in the prosthetic bar or are used in the dental lab during the creation of the prosthetic bar.
The dental implants are threaded endosseous implants made of CP4 titanium. The implant is parallel walled and has an internal connection. The implant is available in three diameters 4.3, 5.0, and 5.5 mm. All three diameters are available in lengths of 11.5 and 13mm and have a 4.5 mm tissue collar that has a smooth machined surface without threads. The apex of the implants has cutting chambers allowing for self-tapping. The implant bone interface has the TiUnite implant surface treatment. The TREFOIL System bar is made of titanium vanadium alloy. The TREFOIL System surgical tooling is made of stainless steel.
The provided document is a 510(k) premarket notification for a medical device called the "TREFOIL System," an endosseous dental implant. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove acceptance criteria for a new AI/software device.
Therefore, many of the requested categories for AI/software acceptance criteria and study details are not directly applicable to this document. The document describes mechanical and material testing for the dental implant system.
Below is an attempt to extract relevant information and note where the requested details are not present in this type of submission.
This document describes the TREFOIL System, an endosseous dental implant system, and its substantial equivalence to a predicate device, K152836 (also TREFOIL System). The performance data presented refers to fatigue testing and biocompatibility testing to demonstrate the device meets its design requirements and is safe for use.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Acceptance Criteria (Implicit from testing) | Reported Device Performance |
|---|---|---|
| Fatigue Strength | Withstand foreseeable mastication forces (per ISO 14801) | Significantly higher fatigue strength than the predicate TREFOIL System (K152836) |
| Biocompatibility | Meet standards for biological safety (per CEN EN ISO 10993-5, CEN EN ISO 10993-12, CEN EN ISO 10993-18) | Compliant with standards (testing performed) |
| Sterilization | Validated per ANSI/AAMI/ISO 11137 | Validated (same as predicate) |
| Packaging | Adequate for maintaining sterility and integrity | Same as predicate (plastic vial/thermoform tray) |
| Shelf Life | Maintain integrity and functionality for specified duration | 5 years for implants, 3 years for drills/screw taps (real-time aging) |
| Material Equivalence | Same material as predicate, same manufacturing, intended use, and patient contact | Same CP titanium for implants, stainless steel for tooling, titanium vanadium alloy for bar |
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: The document does not specify the exact number of samples used for the fatigue testing or biocompatibility testing. It generally refers to "testing performed."
- Data Provenance: Not specified, but generally refers to laboratory testing performed by the manufacturer. These are bench tests, not human 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)
- This question is not applicable to this type of device submission. There is no human "ground truth" to establish for mechanical and material testing of an implanted medical device. The "ground truth" here is the adherence to established engineering and material science standards (e.g., ISO 14801).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable. Adjudication methods like 2+1 are used in clinical studies, typically for diagnostic or screening devices where human interpretation is involved. For a mechanical implant device, performance is measured against objective physical standards.
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
- This question is not applicable. This document is for a physical medical device (dental implant system), not an AI or software device involving human readers or interpretation of medical images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is objective measurements against international standards (e.g., ISO 14801 for fatigue testing, CEN EN ISO 10993 for biocompatibility) and comparison to the performance of the legally marketed predicate device. It is based on engineering principles and material science.
8. The sample size for the training set
- This question is not applicable. This is not an AI/machine learning device that would require training data.
9. How the ground truth for the training set was established
- This question is not applicable. This is not an AI/machine learning device.
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(195 days)
TREFOIL System
The TREFOIL System is used to restore chewing function in fully edentulous mandibles.
The three implants of the TREFOIL System are placed between the mental foramina in fully edentulous mandibles in a 1-stage surgical technique combined with an immediate function loading protocol, provided sufficient primary stability for the selected technique is achieved. In cases where sufficient primary stability for two implants or more is not reached, the implants along with the Framework may also be used with an early or delayed loading protocol.
The following prerequisites must be fulfilled:
- Adequate quantity of bone (minimum height of 13 mm and minimum width of 6-7 mm).
- Adequate mouth opening (minimum 40 mm) to accommodate the guided surgery instruments.
- Implant-supported prosthetics seated directly on dedicated implants
The TREFOIL System is a method of placing three dental implants in predetermined positions (between the mental foramina) and using a pre-designed prosthetic bar to act as a screw-retained framework seated on the implants. The TREFOIL System restores chewing function and esthetics in the mandible in completely edentulous patients.
The TREFOIL System consists of dental implants, surgical components necessary to place the implants in predetermined positions, and prosthetic components that are included in the prosthetic bar or are used in the dental lab during the creation of the prosthetic bar.
The dental implants are threaded endosseous implants made of CP4 titanium. The implant is parallel walled and has an internal conical abutment connection. The implant is available in 11.5 mm length with two available collar lengths (4.5, 6.0 mm). The apex of the implants have cutting chamber allowing for self-tapping. The implant bone interface has the TiUnite implant surface treatment. The TREFOIL System bar is made of titanium vanadium alloy. The TREFOIL System surgical tooling is made of stainless steel.
The provided text describes a 510(k) premarket notification for the TREFOIL System, an endosseous dental implant system. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.
Therefore, much of the requested information about acceptance criteria, detailed study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not explicitly available in the provided text.
However, I can extract the information related to the performance data presented and what it aimed to establish.
Here's a summary based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria in a table format, nor does it provide numerical performance results against such criteria. Instead, it describes types of testing performed and their general conclusions.
| Acceptance Criterion (Inferred from testing) | Reported Device Performance |
|---|---|
| Surgical Accuracy (Angular and Translational) | Established the angular and translational accuracy errors generated by the surgical procedure, indicating the system's ability to maintain precision during implant placement. |
| Framework Compensation Mechanism (Passive Fit) | The ability of the Trefoil framework compensation mechanism to adapt to expected angular and translational accuracy errors was established through 3D modeling. The modeling confirmed that the compensation mechanism ensures a passive fit of the framework bar on the implants. |
| Fatigue Strength (Withstand Mastication Forces) | Fatigue testing was performed to establish that the TREFOIL System will withstand foreseeable mastication forces. The results demonstrated a higher fatigue strength than the predicate Branemark Novum (K000018). |
| Sterilization Efficacy | For sterile devices, the sterilization method (Gamma radiation) is the same as the predicate and was validated in accordance with ANSI/AAMI/ISO 11137. For non-sterile devices (for end-user sterilization), pre-vacuum and gravity moist heat sterilization were validated in accordance with ANSI/AAMI/ISO ISO 17665-1. No additional testing was required. |
| Packaging Integrity | The packaging for the subject device is the same as the predicate (titanium cylinder in plastic vial with PVC shrink-wrap and tamper-resistant strip). No additional testing was required. |
| Shelf Life | The packaging for the subject device is the same as the predicate and has a 5-year expiration date, determined by real-time aging. No additional testing was required. |
| Biocompatibility | The device is manufactured from the same material using the same method as the predicate, has the same intended use, and patient contact type/duration. No additional testing was required. |
| Surface Treatment Qualification | The Trefoil implants use the same TiUnite surface treatment as the predicate NobelActive implants. This treatment was qualified through Auger analysis, IR spectrum analysis, and cytotoxicity testing. No additional testing was required. |
2. Sample Size for the test set and data provenance:
- Surgical Accuracy Test: Implants were placed "into bone models." The specific number of models or implants is not stated.
- Data Provenance: The nature of the studies suggests these were retrospective (laboratory-based) tests conducted by the manufacturer, rather than prospective clinical trials with patient data. The country of origin for the data is not specified but is presumably where Nobel Biocare AB conducts its research.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
This information is not provided in the document. The tests described (surgical accuracy in bone models, 3D modeling for passive fit, fatigue testing) are physical or computational tests, not human-interpretation-based tests that would require expert ground truth.
4. Adjudication method for the test set:
This information is not applicable/not provided. The assessment of these non-clinical tests would have been based on measurement and engineering analysis, not expert adjudication of subjective findings.
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:
This is not applicable. The device is an endosseous dental implant system, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical medical device (dental implant system), not an algorithm or software.
7. The type of ground truth used:
- Surgical Accuracy Test: Ground truth would have been based on physical measurements and engineering specifications of the implant placement within the bone models (e.g., deviation from planned position and angle).
- Framework Compensation Mechanism: Ground truth was established through three-dimensional modeling and simulation, confirming the design's ability to achieve a "passive fit" based on engineering principles.
- Fatigue Testing: Ground truth was based on material science and engineering standards (ISO 14801) and the device's ability to withstand a specified number of cycles at a given load.
- Other tests (Sterilization, Packaging, Shelf Life, Biocompatibility, Surface Treatment): Ground truth was established through adherence to recognized industry standards (e.g., ISO, ANSI/AAMI), analytical chemistry (Auger analysis, IR spectrum), and established biological testing methodologies (cytotoxicity).
8. The sample size for the training set:
This information is not applicable/not provided. The device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable/not provided, as there is no training set for this type of device.
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