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510(k) Data Aggregation
(121 days)
The Guided Surgery Kit is designed to hold various dental surgical drills and instruments to organize, steam sterilize, and transport between uses. The guided surgical drills are intended to cut into maxilla or mandible to create an osteotomy for endosseous dental implant placement.
The kit is to be enclosed in a FDA cleared steam sterilizable wrap (maximum thickness KC300) and sterilized in a FDA cleared sterilizer for one of the following cycles:
(1) Prevacuum Steam – At 132°C for 4 minutes with a 20 minute dry time.
(2) Gravity Steam At 132°C for 15 minutes with a 30 minute dry time.
· The kit is intended for sterilization of non-porous loads.
· Do not stack kits during sterilization.
· Implant Direct Sybron Manufacturing LLC does not make any lumen claims for the Sterilizable Guided kit.
The Guided Surgery Kit is offered in 2 complete kit variations for 3 implant systems: Legacy, Simply lconic, and InterActive as a reusable perforated tray for purposes of transport, steam sterilization and storage of dental instruments, similar to the reference device Standard Sterilizable Tray (K202524). The kit is sold non-sterile and contains site preparation instruments, dental driving tools, prosthetic driving tools and ratchet tool which can be used for implant placement. The proposed Guided Surgical Drills are reusable surgical instruments designed to prepare an osteotomy for a dental implant procedure. The features remain unchanged from the predicate Surgical Drills (K200265) except for the addition of a Guide Body and Shoulder Stop. The addition of a Guide Body allows the proposed drills to function with guide sleeves which can be integrated into an existing surgical quide template to assist in the drilling sequence and placement of dental implants.
The provided document, an FDA 510(k) clearance letter for a "Guided Surgery Kit," does not describe a study involving an AI/Artificial Intelligence device that requires the detailed information requested in the prompt.
The device in question, a "Guided Surgery Kit," is a collection of dental surgical drills and instruments to organize, steam sterilize, and transport between uses, including drills intended to cut into maxilla or mandible for dental implant placement. The document focuses on demonstrating substantial equivalence to predicate devices through comparisons of indications for use, technological characteristics, and performance data, primarily regarding biocompatibility, cleaning, and sterilization validation.
Therefore, many of the requested categories related to AI/ML device performance studies, such as "acceptance criteria for device performance," "sample sizes for test set," "number of experts for ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for training set," and "ground truth for training set," are not applicable to the content of this regulatory submission.
The document explicitly states: "Clinical performance data is not required to establish substantial equivalence for the subject device." This further indicates that no human-in-the-loop or AI-specific performance study was conducted or reported in this submission for this particular device.
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(149 days)
The Standard Sterilizable Tray is designed to hold various dental surgical and prosthetic instruments in order to organize, steam sterilize, and transport the instruments between uses. The tray is to be enclosed in an FDA cleared sterilizable wrap (maximum thickness KC300) and sterilized in an FDA cleared sterilizer for one of the following cycles:
(1) Prevacuum Steam - At 132°C for 4 minutes with a 20 minutes dry time.
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(2) Gravity Steam At 132°C for 15 minutes with a 30 minutes dry time.
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The tray is intended for sterilization of non-porous loads.
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Do not stack trays during sterilization.
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The tested Tray represents the worst case validated load of 667.52 grams.
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Implant Direct Sybron Manufacturing LLC does not make any lumen claims for the Standard Sterilizable Tray.
The Standard Sterilizable Tray is a reusable perforated instrument cassette system to hold dental instruments in place during transport, steam sterilization, and storage. The tray is designed to hold various dental surgical and prosthetic instruments in order to organize, steam sterilize, and transport the instruments between uses.
The Standard Sterilizable Tray is a container composed of three main components: a lid, a trav base and a variable inner trav, all made of polyphenylsulfone (Radel R5000). The inner tray has silicone rubber that is co-molded in the plastic of the inner tray as well as silicone grommets. In addition, accessory stainless-steel pan may be included in the tray.
The Standard Sterilizable Tray is available in one size with outer dimensions of 7.3 inch x 5.5 inch x 2.4 inch and offered in 2 inner tray configurations with varied instrument loads.
The provided document is a 510(k) Summary for a medical device called the "Standard Sterilizable Tray." It outlines the device's characteristics, indications for use, comparison to a predicate device, and the non-clinical testing performed to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Important Note: The document describes non-clinical testing for a sterilization tray, which is a physical device, not an AI/ML algorithm. Therefore, many of the typical acceptance criteria and study aspects for AI/ML device performance (like "human readers improve with AI," "standalone algorithm performance," "number of experts for ground truth," "adjudication method," and "training set details") are not applicable to this submission. The information provided focuses on the physical and functional performance of the sterilization tray.
1. A table of acceptance criteria and the reported device performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ISO 10993-5: Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity | Observe the cytotoxicity potential of the device extract. | Morphological Grade 2 (mild) or better | Pass |
| ISO 17664: Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices | Verify the continued performance of the device during its useful life. | No visual degradation, silicone retention performance | Pass |
| TIR30 & TIR 12: Compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices; Designing, testing and labeling reusable medical devices for reprocessing in health care facilities | Verify the effectiveness of the recommended cleaning process. | < 12 µg/cm² of TOC recovered from devices; < 6.4 µg/cm² of protein recovered from devices. | Pass |
| ISO 17665-1: Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices | Verify the ability of the sterilization process to adequately sterilize the load. | 6 log reduction at half-cycle | Pass |
| ASTM D4169-16: Standard Practice for Performance Testing of Shipping Containers and Systems | Verify the durability of the device during transportation. | No damage | Pass |
2. Sample size used for the test set and the data provenance
The document specifies the types of tests conducted (e.g., biocompatibility, cleaning validation, sterilization validation, transport simulation) but does not provide specific sample sizes (e.g., number of units tested) for each test.
- Data Provenance: The tests are described as non-clinical laboratory tests performed by the manufacturer (Implant Direct Sybron Manufacturing, LLC) to demonstrate the device's performance. The document does not specify the country of origin of the data beyond being associated with this manufacturer's testing, nor does it classify the data as "retrospective" or "prospective" in the typical sense for clinical studies; these are laboratory validation studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this type of device and study. The "ground truth" for a sterilization tray's performance is established by objective measurements and standardized test methods (e.g., chemical analysis for cleanliness, biological indicators for sterilization efficacy, visual inspection for degradation/damage, etc.), not by expert interpretation of images or clinical outcomes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic imaging, where multiple human experts interpret data to create a consensus ground truth. For the physical and functional testing of a sterilization tray, results are typically determined by objective measurements and adherence to pass/fail criteria.
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. An MRMC study is designed for evaluating the impact of AI on human reader performance in diagnostic tasks. This submission concerns a physical medical device (sterilization tray) and its non-clinical performance characteristics, not an AI/ML algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This submission is for a physical medical device, not an AI/ML algorithm. There is no "algorithm only" performance to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by adherence to recognized international and industry standards (ISO, ASTM, TIR) and specific measurable criteria outlined within those standards for:
- Biocompatibility (cytotoxicity)
- Durability and continued performance over useful life (reprocessing cycles)
- Cleaning efficacy (residual protein and TOC)
- Sterilization efficacy (6-log reduction of biological indicators)
- Transportation durability (no damage)
These are objective, quantifiable measures derived from standardized laboratory tests, not subjective interpretations or clinical outcomes data.
8. The sample size for the training set
This question is not applicable. This is a submission for a physical medical device, not an AI/ML algorithm. There is no "training set."
9. How the ground truth for the training set was established
This question is not applicable for the same reasons as #8.
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(226 days)
Simply Iconic™ dental implants are two-piece implants for one-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
• Narrow (3.2mmD) implants: Indicated for single-tooth replacement (mandibular central and lateral incisors; maxillary lateral incisors), multiple-tooth replacements or denture stabilization.
· Short (6mm) 3.7mmD implants: Indicated for single-tooth (mandibular and maxillary central and lateral incisors), multiple tooth replacements or denture stabilization.
The Simply Iconic™ implants are two-piece dental implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
The top one-third (coronal part) of the Simply Iconic™ implant body is straight, with quadruple-lead micro-threads on the coronal aspect, and the lower two-thirds is tapered with dual-lead progressively deeper buttress threads. This design is intended for increased bone-to-implant contact (BIC). Three cutting flutes extend over the tapered portion of the implant body to make bone tapping unnecessary for implant insertion.
The dental implant body are available in several diameter sizes (ranging from 3.2mmD - 7.0mmD), platform diameters (3.0, 3.4mmD) and lengths (ranging from 6 - 16 mm).
The Simply Iconic™ dental implants utilize the same implant abutment interface as the Implant Direct InterActive implants and are compatible with corresponding 3.0 and 3.4 mm platform InterActive abutments.
The Simply Iconic™ dental implants are composed of titanium 6AI4V ELI metal, anodized titanium 6Al4V ELI colors (magenta or gold). Soluble Blast Media (SBM) surface treatments with Hydroxyapatite (HA) blast media. SBM implant surfaces have a micro texture created on defined areas of the implant. The Simply Iconic™ dental implants are packaged sterile supplied with a cover screw and a 5mm healing collar.
The provided text is a 510(k) Summary for a dental implant device. It primarily details the comparison of the new device (Simply Iconic™ Implants) to predicate devices to establish substantial equivalence. It does not describe an AI/ML powered device, nor does it include information about acceptance criteria or studies related to AI/ML performance.
Therefore, I cannot fulfill the request as the document does not contain the required information for an AI/ML powered device, such as acceptance criteria tables, sample sizes for test/training sets, expert ground truth details, adjudication methods, or MRMC studies.
The document focuses on non-clinical testing for substantial equivalence of a physical dental implant, covering aspects like biocompatibility, fatigue, surface area analysis, pullout testing, insertion torque, sterilization, and shelf life.
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(127 days)
The Mini Sterilizable Tray is designed to hold various dental surgical and prosthetic instruments in order to organize, steam sterilize, and transport the instruments between uses. The tray is to be enclosed in an FDA cleared steam sterilizable wrap and sterilized in an FDA cleared sterilizer for one of the following cycles:
Pre-vacuum Steam – At 132°C for 4 minutes with a 20 minutes dry time. Gravity Steam - At 132°C for 15 minutes with a 30 minutes dry time.
- The tray is intended for sterilization of non-porous loads.
- Do not stack trays during sterilization.
- The tested Tray represents the worst case validated load of 354.10 grams.
- Implant Direct Sybron Manufacturing LLC does not make any lumen claims for the Mini Sterilizable Tray.
The Mini Sterilizable Tray is a reusable perforated instrument cassette system to hold dental instruments in place during transport, steam sterilization, and storage. The tray is designed to hold various dental surgical and prosthetic instruments in order to organize, steam sterilize, and transport the instruments between uses.
The Mini Sterilizable Tray is a container composed of three main components: a lid, a cassette base and a variable inner tray, all made of polyphenylsulfone (Radel R5000). The inner tray has silicone rubber that is co-molded in the plastic of the inner tray as well as silicone grommets. In addition, accessory stainless-steel components such as a pan and a bracket may be included in the tray.
The Mini Sterilizable Tray is available in one size with outer dimensions of 5.5 inch x 4.0 inch x 2.25 inch and offered in 5 inner tray configurations with varied instrument loads.
The provided document describes the FDA 510(k) clearance for a medical device called the "Mini Sterilizable Tray." This is a Class II device (Sterilization Wrap, Product Code: KCT). The document details the device's indications for use, its description, and a comparison to a predicate device, along with summary information on the non-clinical performance data used to demonstrate substantial equivalence.
However, the provided text does not contain information about an AI/ML powered device or a study involving human readers or expert consensus for ground truth establishment. Instead, it focuses on the physical and biological safety and effectiveness of a medical device used for organizing, steam sterilizing, and transporting dental instruments. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the engineering and biocompatibility testing required for medical devices, rather than the performance of an AI algorithm on a dataset.
Therefore, many of the requested fields related to AI/ML study design (such as sample size for test/training sets, data provenance, number/qualification of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types related to AI/ML) are not applicable to this document.
Below, I will extract the relevant information regarding the device's acceptance criteria and the studies performed, interpreting "acceptance criteria" as the performance standards the device must meet to be considered safe and effective for its intended use, and "study" as the non-clinical testing performed.
Acceptance Criteria and Study for the Mini Sterilizable Tray
This submission is for a physical medical device (sterilization tray), not an AI/ML-powered device. Therefore, the "acceptance criteria" relate to the physical and biological performance of the device, and the "study" refers to non-clinical laboratory testing. The concept of "ground truth" here is based on established scientific and regulatory standards for sterilization, biocompatibility, and physical integrity.
1. A table of acceptance criteria and the reported device performance
For a physical medical device like this, the acceptance criteria are typically defined by recognized standards (e.g., ISO, AAMI, ASTM) and internal specifications. The "reported device performance" is a statement that the device successfully met these standards.
| Acceptance Criteria Category | Specific Criteria (Implicitly based on standards) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1 and ISO 10993-5 (absence of cytotoxicity). | "The Mini Sterilizable Trays were successfully tested for biocompatibility testing in accordance with ISO 10993-1 and ISO 10993-5. The results of a cytotoxicity tests demonstrated that extracts of the device did not elicit a cytotoxic response in the test system." (Page 9) |
| Device Performance & Wear | Maintain functionality after simulated use cycles. | "Non-clinical performance and wear testing of the Mini Sterilizable Tray through simulated use testing. The Sterilizable Mini Tray and its co-packaged components were subjected to 120 simulated uses cycles. Simulated use testing demonstrated that the co-packaged components worked as designed after the simulated use." (Page 9) |
| Cleaning Validation | Effective cleaning; residuals within acceptable limits (TOC, protein). | "Cleaning efficiency was successfully conducted in accordance with AAMI TIR30 and AAMI TIR12. The study used a clinically-relevant, simulated soil, extended drying time between soiling and processing, and minimal processing parameters for the cleaning process. Extracts of proposed devices were analyzed for total organic carbon (TOC) and protein as residual soil markers." (Page 9) |
| Sterilization | Achieve a Sterility Assurance Level (SAL) of 10⁻⁶. | "Sterilization validation was successfully conducted in accordance with ISO 17665-1. The overkill approach as per ISO 17665-1 was used to demonstrate an SAL of 10⁻⁶." (Page 9) (Note: The document states "10°" which appears to be a typographical error, and given the context of SAL for sterilization, it should be 10⁻⁶ for medical devices to achieve terminal sterility). The specific sterilization cycles validated are: - Pre-vacuum Steam: 132°C for 4 minutes with a 20 minutes dry time. - Gravity Steam: 132°C for 15 minutes with a 30 minutes dry time. (Page 5) |
| Transportation Simulation | Maintain physical integrity and component retention during transit. | "Transportation simulation testing validates the packaging and distribution of the Mini Sterilizable Tray and co-packaged instruments. The tests performed included Handling, Stacking, Loose-Load Vibration, Vehicle Vibration, Concentrated Impact, and an additional Handling test per ASTM D4169-16 DC-13, Assurance Level I, Schedules: A, C, F, E, J, A. The transportation testing demonstrates that the Mini Sterilizable Trays and co-packed components were not damaged and remained in their designated location." (Page 9) |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify exact numerical sample sizes for each test (e.g., how many trays were tested for biocompatibility or cleaning). It mentions "120 simulated uses cycles" for performance and wear testing (Page 9). Regulatory standards for these types of tests typically specify minimum sample sizes, but these are not enumerated in the summary.
- Data Provenance: Not explicitly stated regarding country of origin for the testing data. The testing is non-clinical (laboratory-based), not human clinical. All tests appear to be prospective as they are conducted specifically to demonstrate the performance of the new device for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This pertains to a physical medical device. "Ground truth" for biocompatibility, sterilization, and physical performance is established through adherence to international and national standards (e.g., ISO, AAMI, ASTM) and scientific principles, not through expert consensus on labeled image data.
4. Adjudication method for the test set
- Not applicable. This pertains to a physical medical device. Decisions about test success are based on whether the device meets pre-defined quantitative or qualitative acceptance criteria per the relevant standards, not on adjudication of subjective interpretations.
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 sterilization tray, not an AI/ML diagnostic or assistive tool. No human readers or AI assistance are involved in its primary function or testing for this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used
- Type of Ground Truth: The "ground truth" for this device's performance is based on established scientific principles and consensus standards for medical device safety and effectiveness.
- For biocompatibility: Absence of cytotoxic response (measured in lab assays against scientific benchmarks).
- For sterilization: Achieving a defined Sterility Assurance Level (SAL), typically 10⁻⁶, based on validated microbiological methods.
- For cleaning: Residuals (TOC, protein) below recognized safe limits.
- For performance/wear: Functional integrity after simulated use cycles.
- For transportation: Physical integrity after simulated shipping stresses.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device relying on a training set of data.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device relying on a training set of data.
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(148 days)
The Surgical Drills are intended to cut into maxilla or mandible to create an osteotomy for endosseous dental implant placement.
The proposed Surgical Drills are reusable invasive surgical instruments designed to prepare an osteotomy for a dental implant procedure. The base material of the drill is made of surgical grade stainless steel. The bone cutting portion of the drill may be coated with diamond like coating (DLC) or laser marked to indicate the depth marks. The Surgical Drills consist of straight drills, and cortical drills. Straight drills are available in diameters 3.2 to 5.1 mm. Step drills are available in diameters 2.3/2.0 to 5.4/4.8 mm. Cortical drills are available in diameters 3.2 to 7.0 mm. The straight and step drills have osteotomy depth indicators and are intended to make osteotomies for Implant Direct endosseous dental implants.
The provided document is a 510(k) summary for a medical device called "Surgical Drills." It is a regulatory submission to the FDA for market clearance, demonstrating substantial equivalence to a predicate device, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria, ground truth, experts, and training/test sets are not applicable here.
However, I can extract and present the acceptance criteria and the studies performed to demonstrate the device's conformance, as detailed in the document.
Acceptance Criteria and Device Performance for Surgical Drills (Non-AI/ML Device)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Biocompatibility | Tested in accordance with ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-11. | Successfully tested against the specified ISO standards for biocompatibility. |
| Performance Testing (Drilling) | No significant changes in axial drilling thrust forces after repeated use. | Results indicate no significant changes in axial drilling thrust forces in all three groups (subject device and predicate device) after repeated use and processing. |
| Visual Assessment (Cutting Surfaces) | Cutting surfaces assessed visually using SEM images. | (Implicitly, the visual assessment supported the performance, as no negative findings were reported, and the device was deemed substantially equivalent.) |
| Corrosion Testing | No sign of corrosion after processing according to Instructions for Use (ASTM F1089). | All tested Surgical Drills showed no sign of corrosion without magnification after being boiled for 30 minutes and allowed to cool and air dry. |
| Cleaning Validation | Cleaning efficiency demonstrated in accordance with AAMI TIR30 and AAMI TIR12, meeting acceptable levels for residual soil markers (TOC and protein). | Cleaning efficiency successfully conducted. Extracts analyzed for total organic carbon (TOC) and protein as residual soil markers, implying acceptable levels were achieved. |
| Sterilization Validation | Sterilization demonstrated with a Sterility Assurance Level (SAL) of 10^-6 in accordance with ISO 17665-1 (overkill approach). | Sterilization validation successfully conducted to demonstrate an SAL of 10^-6 using the overkill approach as per ISO 17665-1. |
| Distribution Testing | Passed QA inspection before and after simulated shipping (ASTM D4169-16) with no impact on the device. | All drills subjected to the distribution testing passed the QA inspection prior to and after the distribution simulation, indicating no impact from distribution. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state numerical sample sizes for each test in the way you would typically see for an AI/ML study. Instead, it refers to "worst-case drills" for corrosion and distribution testing, and "all three groups" for performance testing (referring to the subject device and predicate device, likely with multiple samples per group).
- Provenance: This is a regulatory submission for a medical device. The data provenance is from the manufacturing company, Implant Direct Sybron Manufacturing, LLC, specifically from their non-clinical testing performed to support the 510(k) submission. These are prospective tests conducted by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a physical medical device (surgical drills), not an AI/ML system that requires expert-established ground truth for classification or prediction. The "ground truth" for these tests is based on objective measurements and established industry standards (e.g., ISO, ASTM, AAMI).
4. Adjudication Method for the Test Set
Not applicable, as this is not an AI/ML study requiring expert adjudication of results. The results are based on objective physical and chemical testing.
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, and therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical surgical tool, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests is based on:
- International Standards: e.g., ISO 10993 series for biocompatibility, ISO 17665-1 for sterilization.
- Industry Standards: e.g., ASTM F1089 for corrosion testing, AAMI TIR30 and TIR12 for cleaning validation, ASTM D4169-16 for distribution testing.
- Objective Measurements: e.g., axial drilling force measurements, visual/SEM assessment for performance, TOC and protein levels for cleaning, absence of visible corrosion.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for a physical surgical device.
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(315 days)
Legacy2, simplyLegacy2, Legacy3, simplyLegacy3, and Legacy4 dental implants are two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
- . Narrow (3.2mmD) implants: Indicated for single-tooth replacement (mandibular central and lateral incisors; maxillary lateral incisors), multiple-tooth replacements or denture stabilization.
- Short (<10mm) 3.7mm implants: Indicated for single-tooth (mandibular and maxillary central and lateral incisors), multiple tooth replacements or denture stabilization.
The Legacy 2, Legacy3, and Legacy4 fixture-mounts are intended for use with the corresponding dental implants (Legacy2, Legacy3, and Legacy4, respectively). The fixture-mounts can function as an abutment. As an abutment, fixture-mounts are intended for use with dental implants in the maxillary and/or mandibular arches to provide support for crowns or bridges for edentulous or partially edentulous patients.
- . Fixture-mounts as an abutment for narrow (3.2mmD) Implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.
- Fixture-mounts as an abutment for short (8mm) 3.7mmD implants: Indicated for tooth . replacement of mandibular and maxillary central and lateral incisors.
Legacy2, simplyLegacy2, Legacy3, simplyLegacy3, and Legacy4 implants are compatible with the following abutments.
| Manufacturer | Abutment Line | Platform Diameter |
|---|---|---|
| Implant Direct | Legacy | 3.0mm, 3.5mm, 4.5mm, 5.7mm |
The Legacy2, Legacy4, and simplyLegacy2 implants have implant body and are supplied in similar dimensions. This 510(k) notice includes the Legacy3 dimensions previously cleared in K090234 and K131097; the Legacy3 (7.0mmD) is the same as the previously cleared Legacy3, but in a wider diameter.
The top approximate one-third of the implant body is straight, and the lower approximate two-thirds is tapered with progressively deeper buttress-threads. The Legacy3 implant body also features progressively deeper buttress threads, with quadruple-lead micro-threads at the coronal aspect; this implant body is evenly tapered. Each implant features a color-coded internal hex with a lead-in bevel. The simplyLegacy2 and simplyLegacy3 implants are identical to the Legacy3 implants, respectively, except that they are supplied without the corresponding fixturemount/abutment.
The table below outlines the body diameters, platform diameters, and lengths in which each Legacy implant model is available.
The provided document is a 510(k) premarket notification from the FDA for dental implants. It details the device description, indications for use, comparison to predicate devices, and performance data. However, it does not contain information about a study proving that the device meets acceptance criteria related to an AI/ML-driven medical device, as implied by the detailed questions about ground truth, expert adjudication, MRMC studies, and training/test set sample sizes.
The performance data presented in the document solely pertains to physical and biological properties of the dental implants, such as fatigue testing, biocompatibility, surface area and bone-to-implant contact analysis, pull-out testing, insertion torque testing, sterilization validation, endotoxin testing, shelf-life validation, and distribution validation.
Therefore, I cannot answer the questions about acceptance criteria for an AI/ML device, ground truth establishment, sample sizes for AI/ML training/test sets, expert adjudication, or MRMC studies, as these concepts are not applicable to the content of this regulatory submission for traditional dental implants.
The document explicitly states on page 7: "No animal or clinical studies were performed in support of this 510(k) notice." This further confirms the absence of the type of studies implied by your questions, which are typically found in submissions for diagnostic or AI-powered devices.
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(306 days)
Implant Direct Custom Bars are patient specific devices indicated for attachment to dental implants in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function.
Custom bars are compatible at the implant level with InterActive (3.4mm Platform) & SwishActive (3.4 Platform) System implants.
Custom bars are compatible at the abutment level with InterActive (3.4mm Platform) & SwishActive (3.4 Platform) system straight multi-unit abutments.
Implant Direct Custom Bars are computer-aided design/computer-aided manufacturing, individually designed prosthetic devices for partially or fully edentulous restorations. The bars and fixation screws are made from Wrought Titanium Alloy conforming to an FDA recognized consensus standard ASTM F136. The Custom Bars consist of two device types: fixed-detachable frameworks and overdenture bars. The bar systems consists of the bars as well as fixation screws to facilitate the attachment to the dental implants.
Implant Direct Custom Bars are attached directly to an implant to provide support for the fabricated denture. The implant specific interfaces on the Custom Bars are designed and manufactured with precise mating features in order to the mating surfaces of the implants or abutments.
The Implant Direct Custom Bars are designed and produced at Implant Direct under the direction of clinical professionals. The patient requirements and implant locations are obtained conventionally or digitally and a bar is designed, using CAD software, according to established customization parameters. Once the design is finished, the bar design is sent to the clinician for approval before manufacture. After bar design approval is received, the bar design is milled using a precise CAM system, inspected, cleaned, packaged non-sterile, and shipped to the customer where it is finished into the final restoration.
This document describes the premarket notification for "Custom Bars" (K162633), which are patient-specific dental devices. The device is a physical product, not an AI/ML powered medical device. Therefore, the questions related to AI/ML device performance, such as sample sizes for test and training sets, expert ground truth establishment, MRMC studies, standalone performance, and data provenance, are not applicable.
However, I can extract information related to the performance data and the study conducted for this non-AI/ML device:
1. Table of Acceptance Criteria and Reported Device Performance:
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Testing | ||
| - Fatigue Testing (ISO 14801) | Bar interface successfully completes endurance testing and is equivalent to the predicate device. | Results indicated that the bar interface successfully completed endurance testing and was equivalent to the predicate device. |
| - Bending Strength (modified ASTM F382) | Device is equivalent to the predicate device. | Results indicated that the subject device is equivalent to the predicate device. |
| Biocompatibility Testing | Device meets all biocompatibility requirements for its intended use (ISO 10993-1 and ISO 10993-5). | Cytotoxicity testing and comprehensive biocompatibility evaluation was conducted. Results indicate that the device met all biocompatibility requirements for its intended use. The material conforms to FDA recognized consensus standard ASTM F136 and is equivalent to the reference predicate. |
| Steam Sterilization Validation | Acceptance criteria are met, and devices can be sterilized per Gravity Displacement and Pre-vacuum cycle parameters (ISO 17665-1 and ISO 17665-2). | Results indicated the acceptance criteria was met and the devices can be sterilized per Gravity Displacement and Pre-vacuum cycle parameters. (Performed on worst-case sample) |
Regarding the other requested information, since this is not an AI/ML medical device, the following points are not applicable or not provided in the document:
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of mechanical and biocompatibility testing. The testing was performed on "worst-case configurations" and "worst-case sample" as described.
- 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. "Ground truth" in the context of expert consensus, pathology, or outcomes data is typically for diagnostic/screening devices, not for physical dental prosthetics.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for physical device performance testing against laboratory standards.
- 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, as this is not an AI/ML device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this physical device, the "ground truth" or standard for acceptance is adherence to recognized international standards (ISO 14801, ASTM F382, ISO 10993-1, ISO 10993-5, ISO 17665-1, ISO 17665-2) and equivalence to predicate devices, as demonstrated through non-clinical laboratory testing.
- The sample size for the training set: Not applicable, as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.
Additional Information from the document:
- Study Type: Non-clinical testing (mechanical, biocompatibility, and cleaning/sterilization validation). Clinical performance testing was not performed and was deemed not required to support substantial equivalence.
- Predicate Device for Comparison: Dentsply International ISUS Implant Suprastructures (K122424) was the primary predicate. Nobel Biocare NobelProcera Overdenture Bar (K132749) and Biomet 3i CAM StructSURE Overdenture Bars (K101582) were used as references.
- Conclusion: The studies concluded that the Custom Bars are substantially equivalent to the legally marketed predicate devices based on the non-clinical testing performed.
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