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510(k) Data Aggregation
(206 days)
Biotech Dental, SAS
Kontact™ Dental Implant System is indicated for use in partially or fully edentulous patients to support maxillary or mandibular single unit, multiple-unit, or overdenture dental restorations. Kontact™ Dental Implant System is indicated for immediate loading when good primary stability is achieved and the occlusal loading is appropriate. Kontact™ Dental Implant System 3 mm diameter implants and prosthetics components are indicated for use in surgical and restorative applications in the maxillary lateral incisor or mandibular incisor regions.
All digitally designed Kontact™ Dental Implant System CAD/CAM abutments are intended to be sent to a Biotech Dental validated milling center for manufacture.
The purpose of this submission is to expand the marketing clearance for Kontact™ Dental Implant System which comprises endosseous root-form dental implants and prosthetic components for single-unit, multi-unit, and overdenture restorations to include two additional implant body designs, new Narrow Conical and Conical abutments, hand-milled FitPost abutments, inserts for the previously cleared UniPost abutments and CAD/CAM Titanium base and Titanium Blank, dental implant abutments.
The Kontact™ Dental Implant System Subject device include two implant designs: Kontact S+. The Kontact S and compatible Kontact implants are provided in five body diameters: 3.0 mm, 4.2 mm, 4.8 mm, and 5.4 mm. The body diameter for each implant is equal to the implant platform diameter. The 3.0 mm body implants have a smaller diameter and unique restorative interface. The 3.6 mm, 4.8 mm, and 5.4 mm implants share the same restorative interface. The Kontact S implants are provided in lengths ranging from 8 mm to 16 mm.
The Kontact S+ implants are provided in four body diameters: 4.0 mm, 4.5 mm, 5.0 mm, and 5.5 mm. The 4.0 mm body diameter implants have an implant platform diameter of 3.6 mm and 5.5 mm body diameter implants have an implant platform diameter of 4.2 mm diameter implants are available in both 3.6 mm and 4.2 mm implant platform diameters. All Kontact S+ implants share restorative interface as the 3.6 mm and larger diameter Kontact S implants. The Kontact S+ implants are provided in lengths ranging from 8 mm to 12 mm.
The implants have a recessed internal section for abutment indexing, and an internal threaded section for mating to the corresponding subject device cover screw, or abutment screw. Kontact S and Kontact S+ implants are manufactured from Commercially Pure (CP) – Grade 4 titanium conforming to ASTM F67 and ISO 5832-2. The endosseous threaded surface of the Kontact S+ implants are gritblasted with resorbable beta-tricalcium phosphate (β-ΤCP) particles.
Grit-blasting of the Kontact S+ implants create a roughened surface which provides an increase in total contact area of the implant surface to facilitate osseointegration.
The Subject device prosthetic components include seven implant abutment designs: Straight Conical, 30° Angulated Conical (indexed and non-indexed), Titanium Base, Titanium Blank and FitPost. The abutments designs are compatible with the Kontact, Kontact S+ implants. All Subject device abutments are manufactured titanium alloy conforming to ASTM F136 and ISO 5832-3.
The provided document describes the K213997 Kontact Dental Implant System. This premarket notification primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and literature review, rather than establishing performance criteria against specific clinical endpoints with a device that provides diagnostic information. Therefore, the typical structure for acceptance criteria and a study proving a device meets these criteria for an AI/ML diagnostic or prognostic device is not directly applicable.
However, I can extract the relevant information from the document to describe how the manufacturer demonstrated that their device met the safety and performance requirements for a dental implant system.
Here's the information organized based on your request, with adaptations for a non-diagnostic medical device:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (dental implant system), "acceptance criteria" are generally derived from recognized standards for biocompatibility and mechanical performance, and "reported device performance" refers to the results of non-clinical testing against these standards, as well as a review of clinical outcomes from a published study on similar implants.
| Acceptance Criteria (Relevant Standards/Benchmarks) | Reported Device Performance |
|---|---|
| Biocompatibility: In accordance with ISO 10993-1, including Cytotoxicity (ISO 10993-5:2009) and Endotoxins (ANSI/AAMI ST72:2019). | Cytotoxicity: Performed and results were satisfactory. |
| Endotoxins: Performed and results were satisfactory. | |
| Overall Biocompatibility: Evaluated through published literature, internal routine monitoring data, and post-market surveillance data on implants made from the same material and surface treatment, indicating "failure rates below industry levels." | |
| Mechanical Performance: Static compression and compression fatigue testing according to ISO 14801 (worst-case constructs). | ISO 14801 Testing: Performed on worst-case constructs of the Subject device (covering implant platform, gingival height, and post correction angles combinations). Results demonstrated suitability for intended use, mitigating minor differences in designs, dimensions, or sizes compared to predicate/reference devices. |
| Sterilization: Steam Sterilization according to ISO 17665-1 and ISO TS 17665-2. | Steam Sterilization: Protocols leveraged from the prior K210220 Primary Predicate device clearance, indicating compliance. |
| MRI Safety Assessment: Parameters per FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" (magnetically induced displacement force and torque). | MRI Safety Assessment: Non-clinical worst-case MRI review performed using scientific rationale and published literature (e.g., Woods et al., 2019). The rationale addressed parameters for the entire system (all compatible implant bodies, abutments, and fixation screws) and material composition, demonstrating adequate safety in the MR environment. |
| Clinical Performance (Indirect): Acceptable bone-level changes and implant survival rates in a clinical context (benchmarked against industry standards). | Published Retrospective Study: Evaluated bone levels of 326 implants, showing decreases less than 1 mm ("well within accepted levels") through 50 months post-implantation, with an overall implant survival rate of 98% at 1 year. (This study was not performed by the submitter for this clearance but was leveraged as part of the biological evaluation and demonstration of clinical performance of similar implants). |
2. Sample Size Used for the Test Set and Data Provenance
For the non-clinical tests:
- Biocompatibility: The specific sample sizes for cytotoxicity and endotoxin tests are not individually stated but are implied to be sufficient per the referenced ISO and ANSI/AAMI standards.
- Mechanical Performance (ISO 14801): The sample size refers to "worst-case constructs," implying a selection of implant and abutment combinations designed to represent the most challenging scenarios for mechanical failure. The exact number is not explicitly stated.
- Data Provenance: The mechanical performance and sterilization data are from non-clinical bench testing conducted by the manufacturer. The biocompatibility evaluation also involved internal routine monitoring data.
For the leveraged clinical performance:
- Sample Size: 326 implants were evaluated in a published multi-center retrospective study.
- Data Provenance: This was a retrospective study. The country of origin is not specified, but it was a "multi-center" study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not directly applicable as this submission is not for an AI/ML diagnostic device requiring expert-established ground truth for a test set. The "ground truth" for this dental implant system is primarily established by:
- Compliance with recognized international standards (ISO, ANSI/AAMI): These standards define acceptable material properties and mechanical performance.
- Observation of physical outcomes in non-clinical bench tests: Mechanical integrity, sterilization efficacy, and MRI compatibility are directly measured.
- Leveraged Clinical Literature: The multi-center retrospective study (not conducted by the submitter) provides clinical outcome data (bone level changes, survival rate) for similar implants. The experts involved in that study (e.g., dentists, surgeons, researchers) would have established the "ground truth" of patient outcomes, though no specific number or qualifications are provided in this submission for that study.
4. Adjudication Method for the Test Set
Not applicable in the context of an AI/ML diagnostic or prognostic device with human adjudication. The "adjudication" for this device involves applying the results of the non-clinical tests (e.g., pass/fail for mechanical loads, conformity to biocompatibility limits) against the requirements of the referenced standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a dental implant system, not a diagnostic imaging device with AI assistance for 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 (dental implant system), not an algorithm.
7. The Type of Ground Truth Used
- Non-clinical Testing: The ground truth for mechanical performance, sterility, and MRI safety is established by direct measurement and observation against predefined criteria in recognized scientific and engineering standards (e.g., force limits, microbial kill rates, magnetic susceptibility properties).
- Biocompatibility: Established by adherence to ISO 10993 standards for various biological endpoints, alongside review of existing data.
- Clinical Outcomes Data (leveraged): For the indirect clinical performance evaluation, the ground truth was based on clinical outcomes (bone-level changes, implant survival rates) derived from a published multi-center retrospective study.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set. The design and manufacturing processes are informed by engineering principles, material science, and prior predicate device data, rather than machine learning on a "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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(129 days)
Biotech Dental, SAS
Drill Stop Kit is intended to be used to enclose drill stops that are to be sterlized by a health care provider. Drill Stop Kit is intended to allow sterilization of the enclosed medical devices. Drill Stop Kit requires the use of a double pouch to maintain the sterility of the enclosed devices (pouch must be FDA cleared in the U.S.)
Drill Stop Kit is to be enclosed in a sterilization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:
In the U.S. only, dynamic air removal (pre-vacuum)- Exposure at 132 °C for 4 minutes and 20 minutes dry time. Drill Stop Kit is intended for sterilization of non-porous loads.
Drill Stop Kit is recommended not to be stacked during sterilization.
The combined weight of the Drill Stop Kit and the associated devices is 199.8 grams.
The weight of the empty Drill Stop Kit is 192.6 grams.
Prosthetic Kit is intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Prosthetic Kit is intended to allow sterilization of the enclosed medical devices.
Prosthetic Kit requires the use of a double pouch to maintain the sterility of the enclosed devices (pouch must be FDA cleared in the U.S.)
Prosthetic Kit is to be enclosed in a sterlization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:
In the U.S. only, dynamic air removal (pre-vacuum) – Exposure at 132 °C for 4 minutes and 20 minutes dry time. Prosthetic Kit is intended for sterilization of non-porous loads.
Prosthetic Kit is recommended not to be stacked during sterilization.
The combined weight of the Prosthetic Kit and the associated instruments is 178.8 grams.
The weight of the empty Prosthetic Kit is 141.8 grams
Healing Screws Kit is intended to be used to enclose healing screws that are to be sterilized by a health care provider. Healing Screws Kit is intended to allow sterilization of the enclosed medical devices. Healing Screws Kit requires the use of a double pouch to maintain the sterility of the enclosed devices (pouch must be FDA cleared in the U.S.).
Healing Screws Kit is to be enclosed in a sterilization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:
In the U.S. only, dynamic air removal (pre-vacuum) - Exposure at 132 °C for 4 minutes and 20 minutes dry time.
Healing Screws Kit is intended for sterilization of non-porous loads.
Healing Screws Kit is recommended not to be stacked during sterilization.
The combined weight of the Healing Screws Kit and the associated instruments is 203.1 grams.
The weight of the empty kit Healing Screws Kit is 168.9 grams.
Kit for Healing Screws Kontat Perio Level is intended to be used to enclose healing screws that are to be sterilized by a health care provider. Kit for Healing Screws Kontat Perio Level is intended to allow sterilization of the enclosed medical devices. Healing Screws Kit, Perio Level requires the use of a double pouch to maintain the sterility of the enclosed devices (pouch must be FDA cleared in the U.S.).
Kit for Healing Screws Kontat Perio Level in a sterilization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:
In the U.S. only, dynamic air removal (pre-vacuum) – Exposure at 132 °C for 4 minutes dry time. Kit for Healing Screws Kontat Perio Level is intended for sterilization of non-porous loads.
Kit for Healing Screws Kontat Perio Level is recommended not to be stacked during sterilization.
The combined weight of the Kit for Healing Screws Kontat Perio Level and the associated instruments is 200.0 grams. The weight of the empty Kit for Healing Screws Kontat Perio Level is 169.0 grams.
Scanbodies Kit is intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Scanbodies Kit is intended to allow sterilization of the enclosed medical devices.
Scanbodies Kit requires the use of a double pouch to maintain the sterility of the enclosed devices (pouch must be FDA cleared in the U.S.)
Scanbodies Kit is to be enclosed in a sterilization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:
In the U.S. only, dynamic air removal (pre-vacum) – Exposure at 132 °C for 4 minutes and 20 minutes dry time. Scanbodies Kit is intended for sterilization of non-porous loads.
Scanbodies Kit is recommended not to be stacked during sterilization.
The combined weight of the Scanbodies Kit and the associated instruments is 259.7 grams.
The weight of the empty Scanbodies Kit is 233.9 grams.
Pick-up Impression Coping Cica Kit is intended to be used to enclose pick-up impression copings that are to be sterilized by a health care provider. Pick-up Impression Coping Cica Kit is intended to allow sterilization of the enclosed medical devices. Pick-up Impression Coping Cica Kit requires the use of a double pouch to maintain the sterility of the enclosed devices (pouch must be FDA cleared in the U.S.)
Pick-up Impression Coping Cica Kit is to be enclosed in a sterilization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:
In the U.S. only, dynamic air removal (pre-vacuum) – Exposure at 132 °C for 4 minutes and 20 minutes dry time. Pick-up Impression Coping Cica Kit is intended for sterilization of non-porous loads.
Pick-up Impression Coping Cica Kit is recommended not to be stacked during sterilization.
The combined weight of the Pick-up Impression Coping Cica Kit and the associated instruments is 338.0 grams.
The weight of the empty tray Pick-up Impression Coping Cica Kit is 291.4 grams.
Pop-up Impression Coping Cica Kit is intended to be used to enclose pop-up impression copings that are to be sterilized by a health care provider. Pop-up Impression Coping Cica Kit is intended to allow sterilization of the enclosed medical devices. Pop-up Impression Coping Cica Kit requires the use of a double pouch to maintain the sterility of the enclosed devices (pouch must be FDA cleared in the U.S.)
Pop-up Impression Coping Cica Kit is to be enclosed in a sterilization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:
In the U.S. only, dynamic air removal (pre-vacuum) = Exposure at 132 °C for 4 minutes and 20 minutes dry time. Pop-up Impression Coping Cica Kit is intended for sterilization of non-porous loads.
Pop-up Impression Coping Cica Kit is recommended not to be stacked during sterilization.
The combined weight of the Pop-up Impression Coping Cica Kit and the associated instruments is 317.1 grams.
The weight of the empty kit Pop-up Impression Coping Cica Kit is 270.9 grams.
Multi Kontact Surgical Kit is intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Multi Kontact Surgical is intended to allow sterilization of the enclosed medical devices. Multi Kontact Surgical requires the use of a double pouch to maintain the sterility of the enclosed devices (pouch must be FDA cleared in the U.S.) Multi Kontact Surgical is to be enclosed in a sterlization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:
In the U.S. only, dynamic air removal (pre-vacuum) – Exposure at 132 °C for 4 minutes dry time.
Multi Kontact Surgical is intended for sterilization of non-porous loads.
Multi Kontact Surgical is recommended not to be stacked during sterilization.
The combined weight of the Multi Kontact Surgical and the associated instruments is 580.7 grams.
The weight of the empty Multi Kontact Surgical is 449.6 grams.
Try-in Abutment Kit is intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Try-in Abutment Kit is intended to allow sterilization of the enclosed medical devices. Try-in Abutment Kit requires the use of a double pouch to maintain the sterlity of the enclosed devices (pouch must be FDA cleared in the U.S.). Try-in Abutment Kit is to be enclosed in a sterilization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:
In the U.S. only, dynamic air removal (pre-vacuum) – Exposure at 132 °C for 4 minutes dry time.
Trv-in Abutment Kit is intended for sterilization of non-porous loads.
Try-in Abutment Kit is recommended not to be stacked during sterilization.
The combined weight of the Try-in Abutment Kit and the associated devices is 469.5 grams.
The weight of the empty Try-in Abutment Kit is 463.8 grams
AtlaSurgery Guided Surgery Kit is intended to be used to enclose other medical devices that are to be sterilized by a health care provider. AtlaSurgery Guided Surgery Kit is intended to allow sterilization of the enclosed medical devices. AtlaSurgery Guided Surgery Kit requires the use of a double pouch to maintain the sterility of the enclosed devices (pouch must be FDA cleared in the U.S.).
AtlaSurgery Guided Surgery Kit is to be enclosed in a sterilization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:
In the U.S. only, dynamic air removal (pre-vacuum) = Exposure at 132 °C for 4 minutes and 20 minutes dry time.
AtlaSurqery Guided Surgery Kit is intended for sterilization of non-porous loads.
AtlaSurgery Guided Surgery Kit is recommended not to be stacked during sterilization.
The combined weight of the AtlaSurgery Guided Surgery Kit and the associated instruments is 689.2 grams.
The weight of the empty AtlaSurgery Guided Surgery Kit is 476.0 grams.
Pilot Drills Kit for Guided Surgery is intended to be used to group other medical devices that are to be sterilized by a health care provider. Pilot Drills Kit for Guided Surgery is intended to allow sterlization of the group medical devices. Pilot Drills Kit for Guided Surgery requires the use of a double pouch to maintain the sterility of the enclosed devices (pouch must be FDA cleared in the U.S.).
Pilot Drills Kit for Guided Surgery is to be enclosed in a sterilization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:
In the U.S. only, dynamic air removal (pre-vacuum) – Exposure at 132 °C for 4 minutes dry time.
Pilot Drills Kit for Guided Surgery is intended for sterilization of non-porous loads.
Pilot Drills Kit for Guided Surgerv is recommended not to be stacked during sterilization.
The combined weight of the Pilot Kit for Guided Surgery and the associated instruments is 39.4 grams.
The weight of the empty Pilot Drills Kit for Guided Surgery is 36.8 grams.
The subject device trays are reusable rigid containers, comprising a base (bottom), a removable inner trav (if applicable), and a lid (cover). The subject device trays are to be used to organize and protect the dental healing screws, try-in abutments, instruments, and accessories that are sterilized in the trays by the healthcare provider. The base, inner tray, and lid components are designed to be integrated into a single unit which contains and protects the interior contents during sterilization. The trays are perforated to allow for penetration of the sterilant, are to be used with moist heat (steam), and require the use of an FDA cleared pouch to maintain sterility.
The subject device includes a total of 10 sizes (same lid and base and enclosed volumes), and a total of 11 tray configurations. The subject device has seven (7) trays that are 2-piece plastic trays manufactured from Polyphenylsulfone (Radel® R-5000) for the lid and Polypropylene (PPHS) or Polysulfone for the base. The subject device has three (3) trays that are 3-piece plastic trays manufactured from Polyphenylsulfone (Radel R-5000) with silicone grommets. The subject device has one (1) tray that is a 2-piece metal tray manufactured from stainless steel.
This document is a 510(k) Premarket Notification for Biotech Dental Kits, which are instrument sterilization trays. It details the device's indications for use, technological characteristics, and non-clinical testing performed to demonstrate substantial equivalence to predicate devices.
Acceptance Criteria and Device Performance Study for Biotech Dental Kits
The review focuses on the "Summary of Non-Clinical Testing" section, specifically the table and the text indicating how the device meets acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Automated Cleaning Validation (FDA Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued March 2015) | To validate that the cleaning instructions provided in the Instructions for Use appropriately clean the tray, and to ensure the sterilization cycle will be effective. | Protein assay: less than 6.4 µg/cm² (Assay quantitation limits: 5.0 µg/mL) | |
| TOC assay: less than 2.010 mg/L (Assay quantitation limits: 2.010 mg/L) | Pass | ||
| Sterilization Validation (including sterilant penetration and dry time validation) (ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO 17665-2) | To validate that the sterilization instructions listed in the Instructions for Use appropriately sterilize the tray and contents. | 3 consecutive half-cycles performed for each of the two sizes of trays will demonstrate complete inactivation of all biologic indicators; A minimum SAL of 10⁻⁶ is achieved if the Instructions for Use are followed | Pass |
| Dry time | To validate that the sterilization instructions listed in the Instructions for Use appropriately dry the pouched tray for storage. | Using pre-cycle and post-cycle weights, the weight gain after drying will not exceed ± 3% | Pass |
| Life Cycle / Simulated Use Life Validation (FDA Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued March 2015) | To validate the service life of the trays as stated in the Instructions for Use. | Visual inspection, component dimensional fit verification, functional closure/latch verification for 100 use cycles | Pass |
| Biocompatibility of Subject Device (by cytotoxicity testing) (ANSI/AAMI/ISO 10993-5, ANSI/AAMI/ISO 10993-12) | To evaluate the cytotoxicity potential of the test article using an in vitro cell culture assay. | Non-cytotoxic if ≤ 30% reduction of NRU cell viability after exposure to extract of the device | Pass |
2. Sample size used for the test set and data provenance:
The document describes non-clinical performance testing.
- Cleaning Validation: The sample size isn't explicitly stated as a numerical count of individual units tested, but it refers to the cleaning validation of "the tray." The number of cycles performed for the cleaning validation is not specified in the summary.
- Sterilization Validation: "3 consecutive half-cycles performed for each of the two sizes of trays." This implies a total of 6 cycles across two representative sizes (one representing the most challenging to sterilize).
- Dry Time: Not explicitly stated, but performed in conjunction with sterilization validation.
- Life Cycle / Simulated Use Life Validation: "100 use cycles" are performed for this validation.
- Biocompatibility: The acceptance criteria reference "extract of the device," implying testing on material samples representative of the device.
The data provenance is not explicitly stated as country of origin, nor is it categorized as retrospective or prospective. However, given that these are non-clinical performance tests (e.g., cleaning, sterilization efficacy, material compatibility, and durability) conducted as part of a premarket submission, they are inherently prospective tests performed in a controlled laboratory environment to evaluate the device's design and manufacturing parameters.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document states that no clinical data were included in this submission. Therefore, no human experts (e.g., radiologists) were used to establish ground truth in the context of clinical interpretation or diagnosis. The ground truth for these non-clinical tests is based on established scientific and engineering principles, and validated laboratory methodologies and standards (e.g., ISO, AAMI, FDA guidance). The "experts" involved would be the engineers, microbiologists, and other technical personnel who perform these tests and interpret the results against the defined acceptance criteria. Their qualifications are implicit in the adherence to the referenced standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
No adjudication method is relevant or described as these are non-clinical, objective performance tests against established quantitative and qualitative criteria (e.g., protein residue levels, sterility assurance level, weight gain, visual inspection for integrity). There is no subjective human reading or interpretation of "cases" that would require 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 MRMC comparative effectiveness study was done. This device is a medical instrument sterilization tray, not an AI-powered diagnostic or assistive technology for human readers. The submission explicitly states, "No clinical data were included in this submission."
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 sterilization tray, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
As these are non-clinical tests, the "ground truth" is defined by:
- Established industry standards: ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO 17665-2, ANSI/AAMI/ISO 10993-5, ANSI/AAMI/ISO 10993-12.
- FDA guidance documents: "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (issued March 2015)."
- Validated laboratory methodologies: Protein assays (Micro BCA Protein Assay), TOC assays, biologic indicator inactivation, weight measurements, visual inspections.
The ground truth is therefore based on meeting specific, measurable, and objective physical, chemical, and microbiological endpoints defined by regulatory and consensus standards.
8. The sample size for the training set:
Not applicable. This device is a physical product and does not involve machine learning or a "training set."
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this device.
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(142 days)
BIOTECH DENTAL, SAS
Kontact™ Dental Implant System is indicated for use in partially or fully edentulous patients to support maxillary or mandibular single unit, multiple-unit, or overdenture dental restorations. Kontact Dental Implant System is indicated for immediate loading when good primary stability is achieved and the occlusal loading is appropriate. Kontact 3 mm diameter implants and prosthetics components are indicated for use in surgical and restorative applications in the maxillary lateral incisor or mandibular incisor regions.
The Kontact™ Dental Implant System comprises endosseous root-form dental implants, abutments, abutment screws, and other associated components for single-unit, multi-unit, and overdenture restorations. Kontact dental implants are provided in five body diameters: 3.0 mm, 3.6 mm, 4.2 mm, 4.8 mm, and 5.4 mm. The platform diameter for each size is the same as the (maximum) body diameter. The implants are provided in lengths ranging from 8 mm to 16 mm. The implants have a recessed internal section for abutment indexing, and an internal threaded section for mating to the corresponding subject device cover screw, or abutment screw. All implants are manufactured from titanium alloy conforming to ASTM F136 and ISO 5832-3. The endosseous threaded surface of the subject device implants is grit-blasted with non-resorbable aluminum oxide (Al2O3) particles. Kontact conventional and prosthetic components include cover screws, abutment screws, temporary abutments, straight abutments, angled abutments, prepable abutments, multi-unit abutments, healing caps, and overdenture abutments. Most device screws and all subject device abutments are manufactured from titanium alloy conforming to ASTM F136 and ISO 5832-3. Select subject device abutments and screws manufactured from titanium alloy are anodized using standard electrolytic passivation processing to impart a distinctive surface color. The subject device abutment screw intended for 3 mm diameter implants and the prosthesis screw intended for conical abutments are manufactured from cobalt alloy, conforming to ASTM F1058 and ISO 5832-7. The abutment screw is coated with titanium nitride (TiN); the prosthesis screw is coated with chromium nitride (CrN). Subject device healing caps intended for use with UniPost abutments, and IsoPost abutments are manufactured from polyetheretherketone (PEEK). Subject device healing caps intended for NanoPost abutments and IsoPost abutments are manufactured from polymethyl methacrylate (PMMA).
The product, Kontact™ Dental Implant System, has not reported any clinical studies. The only data provided is non-clinical performance data.
Here's the breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Evaluation Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Conformance to ISO 10993-5 and ISO 10993-12 | Device demonstrates biocompatibility according to ISO 10993-5 (tests for in vitro cytotoxicity) and ISO 10993-12 (sample preparation and reference materials). Specific results are not detailed but compliance with these standards indicates meeting requirements for biological safety. |
| Gamma Sterilization | Conformance to ISO 11137-1 and ISO 11137-2 | Validation performed for subject device implants and cover screws. Specific Sterility Assurance Levels (SAL) are not stated, but conformance to these standards implies achieving a validated sterile state (e.g., SAL of 10^-6). |
| Bacterial Endotoxin Testing (BET) | ≤ 20 EU/device | Limulus amebocyte lysate (LAL) test performed according to ANSI/AAMI ST72 and USP 43-NF38:2020 . Ongoing monitoring and control ensure BET levels meet or are below ≤ 20 EU/device. This indicates the devices are free from pyrogenic contamination within accepted limits. |
| Shelf Life Validation | Conformance to ASTM F1980 and ISO 11607-1 | Packaging stability validated. Conformance to ASTM F1980 (standard guide for accelerated aging of sterile medical device packages) and ISO 11607-1 (packaging for terminally sterilized medical devices) indicates the device maintains its integrity and sterility over its claimed shelf life. Specific shelf life duration is not provided. |
| Moist Heat Sterilization (End-user) | Conformance to ISO 17665-1 and ISO TS 17665-2 | Instructions and validation for end-user moist heat sterilization provided. Conformance to ISO 17665-1 (sterilization of health care products - moist heat - requirements for the development, validation and routine control of a sterilization process for medical devices) and ISO TS 17665-2 (guidance on the application of ISO 17665-1) ensures proper sterilization by the end-user. Specific parameters are not detailed. |
| Static Compression & Compression Fatigue Testing | Conformance to ISO 14801 | Mechanical performance testing performed on the subject device according to ISO 14801 (dentistry - implants - dynamic fatigue test for endosseous dental implants). The fatigue limit data for abutments compatible with 3.0 mm diameter implants was supported by reference device K183518, and "constructs of all other subject device abutments in combination with all other subject device implants have sufficient strength for their intended use." This indicates the devices meet mechanical strength requirements for their intended application. The specific criteria for "sufficient strength" are not explicitly quantified (e.g., number of cycles survived, load at failure) but implied by conformance to the standard. |
| Endosseous Surface Characterization | Demonstrated by SEM and EDS | The grit-blasted surface (with non-resorbable aluminum oxide) was validated by scanning electron microscope (SEM) and energy dispersive X-ray spectroscopy (EDS) characterization. This confirms the presence and composition of the surface modification intended to facilitate osseointegration. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for any of the non-clinical tests.
- Data Provenance: All data is non-clinical and derived from laboratory testing of the device and its components, primarily referencing international and industry standards (ISO, ASTM, ANSI/AAMI, USP). Information on the country of origin of the test data is not provided, but the manufacturer is Biotech Dental, SAS, based in France. The data is retrospective in the sense that it's generated as part of a premarket submission, not from a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This device relies on pre-defined engineering and sterility standards, not expert-established ground truth from clinical cases. There were no clinical studies.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
- Not applicable. There was no test set for clinical performance 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. No clinical studies were conducted, and this product does not involve AI or human reader interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This product is a physical dental implant system, not a software algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)
- Not applicable. Ground truth, in the clinical sense, was not used as there were no clinical studies. The "ground truth" for non-clinical testing is adherence to established international and industrial standards (e.g., ISO, ASTM) for material properties, mechanical performance, and sterility.
8. The Sample Size for the Training Set
- Not applicable. There was no training set, as this is a physical medical device and not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There was no training set.
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