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510(k) Data Aggregation
(79 days)
Soadco, S.L.
KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices.
KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Dynamic air removal steam sterilization - Exposure at 134 °C for 4 minutes and 16 minutes dry time.
KLOCKNER KITS are intended for sterilization of non-porous loads.
KLOCKNER KITS are recommended not to be stacked during sterilization.
The combined weight of the KIT WT SNIPER and the associated instruments is 820 grams.
The weight of the empty KIT WT SNIPER is 620 grams.
The KIT WT SNIPER is exclusively indicated to assist in the installation of implants of the VEGA® and ESSENTIAL® CONE 1.5 families and is not compatible with other lines and systems of other manufacturers.
Indications for Use for the KIT WT SNIPER JSI
KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices.
KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Dynamic air removal steam sterilization - Exposure at 134 °C for 4 minutes and 16 minutes dry time.
KLOCKNER KITS are intended for sterilization of non-porous loads.
KLOCKNER KITS are recommended not to be stacked during sterilization.
The combined weight of the KIT WT SNIPER JSI and the associated instruments is 920 grams.
The weight of the empty KIT WT SNIPER JSI is 620 grams.
The KIT WT SNIPER JSI is exclusively indicated to assist in the installation of implants of the VEGA® and ESSENTIAL® CONE 1.5 families and is not compatible with other lines and systems of other manufacturers.
Indications for Use for the KIT WT INTERNA
KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices.
KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Dynamic ar removal steam sterilization - Exposure at 134 °C for 4 minutes and 16 minutes dry time.
KLOCKNER KITS are intended for sterilization of non-porous loads.
KLOCKNER KITS are recommended not to be stacked during sterilization.
The combined weight of the KIT WT INTERNA and the associated instruments is 840 grams.
The KIT WT INTERNA is exclusively indicated to assist in the installation of implants of both the VEGA® and ESSENTIAL® CONE families and is not compatible with other lines and systems of other manufacturers.
Indications for Use for the KIT WT VEGA
KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices.
KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Dynamic ar removal steam sterilization - Exposure at 134 °C for 4 minutes and 16 minutes dry time.
KLOCKNER KITS are intended for sterilization of non-porous loads.
KLOCKNER KITS are recommended not to be stacked during sterilization.
The combined weight of the KIT WT VEGA and the associated instruments is 820 grams.
The weight of the empty KIT WT VEGA is 620 grams.
The KIT WT VEGA is exclusively indicated to assist in the installation of the VEGA® family and is not compatible with other lines and systems of other manufacturers.
Indications for Use for the KIT WT ESSENTIAL
KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices.
KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.
The kits are to be enclosed in a sterlization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Dynamic ar removal steam sterilization - Exposure at 134 ℃ for 4 minutes and 16 minutes dry time.
KLOCKNER KITS are intended for sterilization of non-porous loads.
KLOCKNER KITS are recommended not to be stacked during sterilization.
The combined weight of the KIT WT ESSENTIAL and the associated instruments is 800 grams.
The weight of the empty KIT WT ESSENTIAL is 620 grams.
The KIT WT ESSENTIAL is exclusively indicated to assist in the installation of implants of the ESSENTIAL® CONE family and is not compatible with other lines and systems of other manufacturers.
Indications for Use for the KIT MEDGUIDE®
KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices.
KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Dynamic ar removal steam sterilization - Exposure at 134 °C for 4 minutes and 16 minutes dry time.
KLOCKNER KITS are intended for sterilization of non-porous loads.
KLOCKNER KITS are recommended not to be stacked during sterilization.
The combined weight of the KIT MEDGUIDE® and the associated instruments is 240 grams.
The weight of the empty KIT MEDGUIDE® is 160 grams.
The KIT MEDGUIDE® is exclusively indicated to assist in the installation of implants of the VEGA® and ESSENTIAL® CONE families and is not compatible with other lines and systems of other manufacturers.
The subject device trays are designed to hold various dental surgical drills and tools to organize and protect the instruments that are sterilized in the tray by the healthcare provider . The base, inner trav, and lid components are designed to be integrated into a single unit (the complete trav) which contains and protects the interior components during sterilization. The lid latches to the base to secure the tray into a single unit. The base, inner tray, and lid components are perforated to allow for penetration of the sterilant, are to be used with moist heat (steam) sterilization and require the use of an FDA cleared wrap to maintain sterility. The subject device components are manufactured from injection molded polysulfone and AISI 316L stainless steel. Holders of various geometries to position instruments in the kits are manufactured from silicone. The subject device trays are summarized in the following table Summary of Tray Dimensions and Contents.
The provided text is a 510(k) summary for the KLOCKNER KITS, a medical device intended to enclose other medical devices for sterilization. The information provided focuses on the non-clinical testing performed to demonstrate the device meets acceptance criteria and is substantially equivalent to predicate devices. It does not contain information about a study proving a device (like AI/ML software) meets acceptance criteria for a diagnostic aid, which would involve concepts like sensitivity, specificity, human reader performance, expert ground truth, and training data.
Therefore, many of the requested elements for describing the acceptance criteria and a study proving device performance (especially those related to AI/ML or diagnostic performance) cannot be extracted from this document. This document describes a physical medical device (sterilization kits) and its validation through standard engineering and sterility testing, not an AI/ML diagnostic software.
However, I can extract the available information as best as possible, interpreting "device performance" in the context of this specific regulatory submission for the KLOCKNER KITS.
Device: KLOCKNER KITS (Sterilization Trays)
Purpose of the Study: To demonstrate that the KLOCKNER KITS are safe, effective, and perform as well as or better than legally marketed predicate devices, specifically regarding their ability to be cleaned, sterilized, and maintain integrity over multiple uses. This is a non-clinical validation study, not a clinical trial or a diagnostic AI performance study.
1. A table of acceptance criteria and the reported device performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance/Results |
|---|---|---|---|
| Manual Cleaning Validation | 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. | Cleaning instructions were validated and demonstrated that the subject devices could be visually and quantifiably cleaned. | Pass |
| Sterilization Validation (incl. sterilant penetration & dry time validation) | 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 4 configurations of trays demonstrate complete inactivation of all biologic indicators; A minimum SAL (Sterility Assurance Level) of 10-6 is achieved if the Instructions for Use are followed. | Pass |
| Dry time Validation | To validate that the sterilization instructions listed in the Instructions for Use appropriately dry the wrapped tray for storage. | Using pre-cycle and post-cycle weights, the weight gain after drying will be |
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(101 days)
Soadco, S.L.
Klockner Abutments are intended for use in dental implants to provide a support structure so that the edentulous or partially edentulous patients will regain their masticatory and aesthetic functions.
All digitally designed abutments for use with Klockner TiBase Abutments are intended to be sent to a SOADCO S.L. validated milling center for manufacture.
The abutments consist of healing abutments, temporary abutments, straight abutments, and an overdenture attachment system that consists of abutments, denture housings, and retention inserts, and TiBase abutments with screws.
This is a medical device 510(k) premarket notification for Klockner Abutments which are endosseous dental implant abutments. The submission aims to demonstrate substantial equivalence to previously cleared devices.
Here's the breakdown of the acceptance criteria and supporting studies, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in terms of specific performance targets (e.g., "must achieve X% accuracy"). Instead, it lists various non-clinical tests conducted to demonstrate substantial equivalence to predicate devices. The "reported device performance" is essentially that the device passed these tests in comparison to the predicate devices.
| Acceptance Criteria (Implied by tests performed) | Reported Device Performance (as stated in the document) |
|---|---|
| Sterilization validation (according to ISO 17665-1 and 17665-2) | Leveraged from previously cleared submissions K151194 and K170022. (Implies compliance with these ISO standards) |
| Biocompatibility (for TiBase, straight, healing, temporary, denture housing) | Leveraged from K170022 and K151194. (Implies compliance with biocompatibility standards for these components) |
| Biocompatibility for TiCN and ZrN coated abutments (according to ISO 10993-5, 10993-10, 10993-12) | Passed tests for in vitro cytotoxicity, skin sensitization for irritation and sensitization, and sample preparation/reference materials. (Implies compliance with these ISO standards for the coated abutments) |
| Mechanical testing (according to ISO 14801 Dentistry Implants Dynamic loading test) | Conducted. (Implies the device meets mechanical performance requirements for dynamic loading of endosseous dental implants) |
| Retention testing | Conducted to ensure retention is maintained throughout expected use. (Implies the device meets retention performance requirements) |
| Coating characterization (according to FDA Guidance Class II Special Controls Guidance Document) | Conducted using methods outlined in the FDA Guidance. (Implies the coating properties were characterized and meet relevant guidance) |
| MRI compatibility/safety | Non-clinical worst-case MRI review to evaluate metallic devices in the MRI environment using scientific rationale and published literature. Rationale addressed parameters per FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque. (Implies MRI safety has been addressed) |
| Materials | Titanium alloy conforming to ASTM F136; Zirconia (for copings) conforming to ISO 13356. Same materials as previously cleared products. |
| Manufacturing Process | Identical manufacturing processes as used for SOADCO S.L. products cleared previously in K151194 and K170022. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state a "sample size" in terms of number of patients or clinical cases for a test set, nor does it specify data provenance (country of origin, retrospective/prospective).
The studies mentioned are primarily non-clinical bench testing (e.g., sterilization, biocompatibility, mechanical testing, retention testing, coating characterization, MRI review). For these types of tests, "sample size" would refer to the number of devices or components tested, which is not detailed in this summary.
The "leveraged" data refers to studies performed on previously cleared predicate devices (K151194, K170022) and is therefore retrospective in relation to this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is typically relevant for studies involving human assessment or interpretation (e.g., imaging studies, clinical trials with expert review). Since the provided text describes primarily non-clinical bench testing, there is no mention of experts establishing ground truth in this context. The "truth" for these tests is based on objective measurements and compliance with recognized standards.
4. Adjudication Method for the Test Set
Again, this is applicable to studies with subjective assessments. As the studies are non-clinical bench tests, there is no adjudication method mentioned or applicable. Compliance is determined by objective measurements against established 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
No MRMC study was mentioned. This submission focuses on the substantial equivalence of a physical dental device (abutments) through non-clinical performance testing against established standards and predicates, not on AI-assisted diagnostic or interpretive tasks.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
No standalone algorithm performance study was mentioned. The device is a physical dental implant component, not a software algorithm.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" is defined by:
- Established standards: e.g., ISO 17665-1, ISO 17665-2, ISO 10993-5, ISO 10993-10, ISO 10993-12, ISO 14801, ASTM F136, ISO 13356.
- FDA Guidance: e.g., "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments," and "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment."
- Performance of predicate devices: The subject device's performance is compared to that of previously cleared predicate devices (K151194, K170022, K222288, K191123, K220612) to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
There is no mention of a training set as this is not an AI/machine learning device. The studies described are non-clinical laboratory tests.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set mentioned, this question is not applicable.
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(312 days)
Soadco, S.L.
Klockner Surgical Box is a set of sterilization cassettes (thirteen different models between injection molding and machining sterilization cassettes). They all are designed to hold various dental surgical drills, instruments and/or tools in order to organize, steam sterilize and transport the instruments between uses. Their use and handling are intended for physicians and dental professionals in health care or equivalent facilities. The sterilization cassettes have to be enclosed in an FDAcleared steam sterilizable wrap and sterilized in an FDA-cleared sterilizer according to the following cycle:
- o Pre-vacuum Steam at 134℃ for 4 minutes with 15 minutes drying time.
The trays are intended for sterilization of metal and thermoplastic loads.
Klockner Surgical Box is a reusable rigid sterilization cassette or organizing tray intended for the purpose of containing reusable (and in some cases, non-reusable) devices for sterliization. It is composed of multiple pieces, designed to be integrated into a single unit which contains and protects the interior components during sterilization.
Under the device trade name "Klockner Surgical Box", two different sets of sterliization surgical boxes are presented: (Both sets differ in the way the plastic is molded).
- Injection molding sterilization cassettes ●
- Machined sterilization cassettes ●
The provided text describes the Klockner Surgical Box, a set of sterilization cassettes, and its regulatory clearance (K173642). It focuses on non-clinical data to demonstrate substantial equivalence to predicate devices, rather than clinical data or AI algorithm performance.
Therefore, the requested information regarding AI algorithm performance metrics (e.g., sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, effect size of human readers with AI assistance) is not applicable to this document. This document pertains to the physical and functional performance of a medical device (sterilization cassettes) and not an AI-powered diagnostic or assistive tool.
However, I can extract information related to the acceptance criteria and the study that proves the device meets those criteria, based on the provided non-clinical performance testing.
1. Table of acceptance criteria and the reported device performance:
The document describes performance tests in "Table 5.1 Brief description of non-clinical performance testing" on page 11. The "Results" column essentially serves as the reported device performance, and the context of the "Standard(s) used" implies the acceptance criteria defined by those standards.
| Acceptance Criteria (Implied by Standard/Test) | Reported Device Performance (Results) |
|---|---|
| Cleaning Validation | Cleaning instructions were validated and demonstrated that the subject device could be visually and quantifiably cleaned. |
| Standards: AAMI TIR30:2011, ISO/DIS 19277 / AFNOR-NF S94-091, ISO 11737-1:2006, ISO 9377-2:2000, European Pharmacopoeia ("Method D" from 2.6.14 chapter) | |
| Steam Sterilization Validation | No growth at half cycle (Half cycle validation: 2' at 134°C). |
| Standards: ISO 17665-1:2006, ISO 17665-2:2009, AAMI TIR12:2010, ISO 11737-2:2009 | |
| Limits of Reuse | The kits were challenged with 101 reprocessing cycles. Both types of sterilization boxes met inspection and performance criteria after 101 reuses. (Biocompatibility included). |
| Standards: FDA Guideline: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (2011), AAMI TIR12:2010, AAMI TIR30:2011, ISO 10993 | |
| Drying Time | Worst-case loads were determined to be visually and quantifiably dry after exposure to the sterilization cycle and claimed dry time. |
| Standards: Validated in Drying Time Validation Report (ISO 17665; AAMI TIR12) |
2. Sample sized used for the test set and the data provenance:
The document states that "Surgical Box Kit Klockner and Bone Space Maintainers Box Kit are the containers that represent worst cases" for the validation tests. This implies that these specific models were used as representatives for the entire Klockner Surgical Box line. The exact number of units of these "worst-case" models used for testing is not explicitly stated, but it refers to "the kits" for the limits of reuse test.
- Test Set Sample Size: Represented by "Surgical Box Kit Klockner" and "Bone Space Maintainers Box Kit" as worst-case containers. The precise number of these kits tested is not provided, other than "the kits" for reuse.
- Data Provenance: The tests were carried out to demonstrate compliance for the device manufactured by Soadco, S.L. in Andorra, implying the tests were conducted for this device and potentially at their facility or a contracted lab. The document does not specify if the data is retrospective or prospective, but given it's for premarket notification, it would be data collected specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The study is a non-clinical performance evaluation of a physical sterilization device, not an AI model that requires expert ground truth for image interpretation or diagnosis. The "ground truth" for these tests would be defined by the rigorous standardized methods of the cited regulatory standards (e.g., absence of microbial growth, visual cleanliness, material integrity after cycles).
4. Adjudication method for the test set:
Not applicable, as it pertains to expert consensus for AI model evaluation, which is not relevant here. The evaluation methods for the device performance tests would follow the protocols of the cited 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:
Not applicable. This is a non-clinical study for a physical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a non-clinical study for a physical device, not an AI algorithm.
7. The type of ground truth used:
The "ground truth" for the non-clinical tests is based on objective, quantifiable measures and methodologies prescribed by recognized international and national standards:
- Cleaning validation: Visual inspection and quantifiable cleaning measures (e.g., residual soil detection).
- Steam sterilization validation: Absence of microbial growth in biological indicators after sterilization.
- Limits of reuse: Meeting inspection and performance criteria (e.g., material integrity, functionality) after a specified number of reprocessing cycles.
- Drying time: Visual and quantifiable dryness.
8. The sample size for the training set:
Not applicable. There is no AI model or training set involved.
9. How the ground truth for the training set was established:
Not applicable. There is no AI model or training set involved.
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(317 days)
SOADCO S.L.
The Klockner Vega TiBase for CEREC® abutments are titanium alloy abutments placed onto Klockner Vega Implants to provide support for customized prosthetic restorations. The Klockner Vega TiBase for CEREC® abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Klockner Vega TiBase for CEREC® abutments are to be designed and milled using Sirona CEREC Premium SW 4.2 software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.
Klockner Vega TiBase for CEREC® abutments are two-piece abutment (composed of the ti-base component and a ceramic mesostructure or coping) fabricated by using the Sirona Dental CAD/CAM System and are to be used with Klockner Vega Dental Implant Systems, with conical and hexagonal internal connection, platforms MV, NV, RV. The Klockner Vega TiBase for CEREC® are Ti-base abutments, made of titanium alloy. The coronal portion is designed to interface with the pre-machined mounting hole in the milling blanks compatible with the Sirona CEREC® systems, and the base portion is available in three models to fit three Klockner® dental implant platforms.
The provided text is a 510(k) summary for the Klockner Vega TiBase for CEREC®. This document is primarily concerned with establishing substantial equivalence to existing legally marketed predicate devices, rather than proving the device meets specific acceptance criteria through a clinical study or a detailed performance study where "acceptance criteria" refers to the thresholds of performance for an AI/CADe device.
Therefore, the provided document does not contain the information requested for acceptance criteria and a study proving device meets those criteria, particularly in the context of an AI/CADe device. The Klockner Vega TiBase for CEREC® is a physical dental implant abutment, and its approval process focuses on bench testing (dimensional verification, dynamic fatigue, bending assays) and biocompatibility, as well as demonstrating equivalence to predicate devices, rather than statistical performance metrics like sensitivity, specificity, or reader improvement seen with AI/CADe devices.
The "bench testing" mentioned in the document is for mechanical properties and fit, not for statistical performance metrics against a ground truth as would be the case for an AI/CADe system.
Specifically, the document states:
- No clinical data are included in this submission. This immediately indicates that no study involving human subjects or real-world patient outcomes (which would be necessary for ground truth establishment and performance metrics) was conducted or provided.
- The discussions are centered on substantial equivalence to predicate devices based on indications for use, materials, design features, and manufacturing workflow, not on a new performance evaluation against defined acceptance criteria for an AI/CADe.
- Bench testing is mentioned for dimensional verification and dynamic fatigue/bending assays, which are engineering tests for a physical device, not performance studies for an AI algorithm.
In summary, none of the requested information regarding acceptance criteria, study design for AI/CADe performance, sample sizes for test/training sets, expert readers, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/CADe device is present in this document.
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(165 days)
SOADCO, S.L.
The KLOCKNER® VEGA® dental implant system is indicated to replace missing teeth in single and multiple unit applications within the mandible or maxilla. Implants can be for immediate placement and function in extraction sites and partially or completely healed alveolar ridge situations, when good primary stability is achieved and with appropriate occlusal loading. Different loading protocols (immediate, early or delayed) can be applied in partially or totally edentulous patients. The prosthetic restorations can be single-unit or multiple-unit restorations.
The Ø 3.0 mm implants should only be used for unit restorations for maxillary lateral incisors and mandibular lateral and central incisors.
Not Found
This document is a 510(k) clearance letter for the Klockner Vega Dental Implant System and does not contain the requested information about acceptance criteria and a study proving device performance.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory requirements, such as registration, labeling, and good manufacturing practices, but does not include any performance data or details of a study.
Therefore, I cannot provide the specific information requested regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
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(270 days)
SOADCO, S.L.
The Klockner Dental Implant Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges. The Klockner Dental Implant Abutments include protective cap, temporary abutment, angled abutments, straight abutments, cast abutments are intended to be used with the Klockner Dental Implant Systems, models: Essential EC, Essential EC 1.5.
Klockner Dental Implant Abutments (II) consist of a group of prosthetic components to be used with dental implants as an aid in prosthetic rehabilitation. According to their function, they are classified in:
- Protective cap, made of titanium alloy, intended to be provisionally connected to dental abutment as a protection when choosing direct oral impression on the abutment.
- Temporary abutment, made of titanium alloy, intended to be provisionally connected to dental abutment to retain a provisional screw-retained multiple-unit restoration.
- Angled abutments, made of titanium alloy, intended to be definitively connected to dental implant to enable screw-retained multiple-unit restorations. These abutments, used when it is necessary to correct prosthesis axis with respect to implant axis, are available with different angulation and different transmucosal height, enabling the anatomic characterization of the gum margin and facilitating the prosthetic fitting.
- Straight abutments, made of titanium alloy, intended to be definitively connected to dental implant to enable screw-retained multiple-unit restorations, with not correction of implant angulation. These abutments are available with different transmucosal height, enabling the anatomic characterization of the qum margin and facilitating the prosthetic fitting.
- Cast abutments, made of gold alloy and Co-Cr-Mo alloy, intended for cement-retained single- unit and multiple-unit restorations and for screw-retained single-unit restorations on dental implants using the casting technique.
All these abutments are designed for Klockner Dental Implant Systems, models Essential EC (K080224) and Essential EC 1.5 (K082200), with internal octagonal cone connection.
The document is a 510(k) premarket notification for the Klockner Dental Implant Abutments (II). Based on the provided text, the following information can be extracted regarding the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a clear, summarized format. Instead, it states that "Fatigue testing, conducted according to ISO 14801 and the Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, has been performed considering worst-case conditions." It then reports that "Results obtained show that devices performance is acceptable as per their intended use."
To infer the acceptance criteria and reported performance, we can deduce them from the referenced standard, ISO 14801, which outlines specific fatigue test methods for dental implants. The acceptance criterion for fatigue testing according to ISO 14801 typically involves surviving a certain number of load cycles (e.g., 5 million cycles) at a specified load without fracture or permanent deformation beyond acceptable limits. The reported performance is a general statement that the device met these implicit criteria.
A hypothetical table based on common ISO 14801 requirements would look like this:
| Acceptance Criteria (Implied by ISO 14801) | Reported Device Performance |
|---|---|
| Fatigue Strength: Device must withstand 5 million cycles at a specified load (stress) without fracture or permanent deformation. | "Devices performance is acceptable as per their intended use." (This implies the devices met the fatigue strength requirements of ISO 14801) |
| Corrosion Resistance: (For Co-Cr cast abutments) Confirm high corrosion resistance. | "Test results confirm the high corrosion resistance of Co-Cr-Mo alloy" |
| Galvanic Corrosion: (For Co-Cr cast abutments) Show insignificant galvanic corrosion with unalloyed titanium (Ti c.p.) and titanium alloy (Ti-6Al-4V). | "show an insignificant galvanic corrosion of this material with respect to unalloyed titanium (Ti c.p.) and titanium alloy (Ti-6Al-4V)." |
| Biocompatibility: All materials used in the manufacture must be biocompatible according to ISO 10993-1:2009 and ISO 7405:2008. | "All materials used... have been subject to biological evaluation... according to the requirements of applicable recognized standards ISO 10993-1:2009 and ISO 7405:2008." (Additional biocompatibility testing was not considered necessary as materials are identical to previously cleared devices). |
| Sterilization: Bioburden and sterility testing accordance with ISO 11737-1 and ISO 11737-2. Steam sterilization validation according to ISO 17665-1. | "Klockner Dental Implant Abutments (II) have been subject to bioburden and sterility testing... Steam sterilization validation according to ISO 17665-1 has been carried out." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact sample size for the bench testing (fatigue testing, corrosion tests, etc.). It mentions "worst-case conditions" but no specific number of units tested.
- Data Provenance: The studies are non-clinical (bench testing) performed by SOADCO, S.L., the manufacturer, which is based in Andorra. The data is prospective in the sense that the tests were conducted specifically for this submission, but it's not clinical patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This is not applicable as the studies are non-clinical bench tests. "Ground truth" in this context refers to standardized measurements and material properties according to recognized standards (e.g., ISO 14801, ISO 10993, ASTM standards). The "truth" is established by the test protocols and the physical properties of the materials and device design, not by expert consensus on observable phenomena.
4. Adjudication Method (for the test set)
Not applicable. This concept typically refers to clinical studies where independent experts review and agree upon diagnoses or outcomes. For bench testing, the results are objectively measured against established scientific and engineering standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical data are included in this submission." This type of study is for clinical evaluations involving human readers and interpretations of medical cases, which is not relevant to this device's non-clinical submission.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This refers to the performance of AI algorithms. The Klockner Dental Implant Abutments (II) are physical medical devices, not software or AI-based diagnostic tools.
7. The Type of Ground Truth Used
For the non-clinical studies:
- Fatigue Testing: The ground truth is derived from engineering standards and physical principles. Specifically, the ISO 14801 standard provides the methodology and criteria for evaluating the fatigue life of dental implants and abutments.
- Biocompatibility: The ground truth is established by recognized biocompatibility standards (ISO 10993-1:2009 and ISO 7405:2008) and the known properties of the materials used.
- Corrosion Resistance: The ground truth is based on material science and engineering standards (ISO 10993-15, ASTM F746, ASTM G71) for evaluating corrosion and galvanic corrosion.
- Sterilization: The ground truth is based on microbiological testing standards (ISO 11737-1, ISO 11737-2, ISO 17665-1) to ensure the device can be effectively sterilized.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
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(296 days)
SOADCO, S.L.
The Klockner Dental Implant Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges or overdentures. The Klockner Dental Implant Abutments include healing caps, temporary abutments, angled abutments, straight abutments, and overdentures. All abulments are intended to be used with the Klockner Dental Implant Systems, models: Essential EC, Essential ECK, Essential ECK, Essential EC 1.5, SK2 and NK2.
Klockner Dental Implant Abutments consist of a group of prosthetic components placed into dental implants to aid in prosthetic rehabilitation. According to their function, they are classified in:
- Healing caps, are manufactured in Titanium Alloy, intended to assist in healing or modification of the adjacent tissues for internal octagonal connection system.
- Protective caps, manufactured in PMMA and Titanium Alloy intended to protect abutments when choosing direct oral impression for internal octagonal connection system.
- Temporary abutments, manufactured in Titanium cp, Titanium Alloy and Titanium cp + -PMMA, intended to support provisional prosthetic restorations for internal octagonal connection system.
- Angled abutments, manufactured in Titanium cp and Titanium Alloy, intended to retain definitive dental prosthesis. Used when it is necessary to correct the implant axis, for internal octagonal connection system and external hexagonal connection system.
- Straight abutments, manufactured in Titanium Alloy and Titanium cp, intended to retain definitive dental prosthesis for internal octagonal connection system. Includes Titanium Octacone Scan abutment, a Titanium Base for CAD/CAM. This base is suitable for precision fit custom abutments or crown and bridge restorations fabricated with CAD/CAM technology provided separately by 3M ESPE as the Lava System.
- Overdenture abutments, manufactured in Titanium Alloy and POM C, intended to retain removable dental prosthesis for internal octagonal connection system and external hexagonal connection system.
Healing caps, protective caps and temporary abutments are used for a limited time, while angled abutments, straight abutments and overdenture abutments are intended for a definitive use.
This is a 510(k) premarket notification for KLOCKNER Dental Implant Abutments. This document primarily focuses on establishing substantial equivalence to predicate devices based on material, design, and intended use, rather than presenting a clinical study with detailed acceptance criteria and performance metrics for a novel AI/ML device.
Therefore, many of the requested points, particularly those related to AI/ML device performance, ground truth, expert adjudication, and sample sizes for training/test sets, cannot be extracted from this document because they are not applicable to the type of device and submission presented.
Here's an analysis of the provided text based on the questions, noting where information is not applicable or available:
1. A table of acceptance criteria and the reported device performance
This document does not present quantitative acceptance criteria or device performance metrics for a novel device in the way a clinical study for an AI/ML device would. The submission aims to establish "substantial equivalence" based on similar materials, design, and intended use to existing predicate devices.
The "acceptance criteria" for a 510(k) submission are typically related to demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is achieved through comparisons to predicate devices and bench testing.
- Bench Testing: The document states, "The results of bench testing confirm acceptable device performance as per its intended use." Specific performance values or acceptance criteria for these bench tests (e.g., torsion, fatigue testing according to ISO 14801) are not provided in this summary.
- Sterilization: "A sterilization according ISO 17665-1 was carried out to confirm the recommended sterilization."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) for dental implant abutments, not an AI/ML device requiring a test set for diagnostic performance evaluation. The "testing" referred to is bench testing on the physical device components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. There is no "ground truth" establishment in the context of an AI/ML device for this submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No test set for diagnostic performance evaluation is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. There is no "ground truth" in the context of an AI/ML device for this submission. The "truth" for substantial equivalence rests on comparison to predicate devices and standard engineering/material testing.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. As above, this pertains to an AI/ML device, which this is not.
Summary of available information:
- Device: KLOCKNER Dental Implant Abutments (healing caps, protective caps, temporary abutments, angled abutments, straight abutments, overdenture abutments).
- Intended Use: To be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges, or overdentures.
- Study Type: 510(k) premarket notification for substantial equivalence. The "study" involves comparison to predicate devices and bench testing.
- Acceptance Criteria & Performance:
- Demonstration of substantial equivalence to predicate devices (K080224, K082200, K010132, K062129, K071585, K033243, K071357, K050705, K992334, K060291, K072624, K092248, K101798, K083876, K102804, K072055). This involves comparing indications for use, basic design, operating principles, material, and packaging.
- Bench testing for torsion and fatigue (according to ISO 14801) under worst-case conditions.
- Bioburden and sterility testing (in accordance with ISO 11737-1 and ISO 17665-1).
- The document explicitly states: "No clinical data are presented in this submission."
- Data Provenance: The document does not discuss clinical data or patient data. The "data" are from non-clinical bench tests and comparisons to specifications of predicate devices.
- Conclusion: The submitter believes the device is substantially equivalent to predicate devices, and bench testing confirms acceptable performance for its intended use. The FDA concurred with this determination.
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(113 days)
SOADCO, S.L.
The Klockner Essential implant system is especially designed for surgical insertion into the bone to replace the root of the teeth, acting as the support for the dental implants formed by implant accessories.
The Essential Cone 1.5 implants are fitted with an internal octagonal conical connection. Immediate loading is appropriate for the Essential Cone 1.5 implants when good primary stability is achieved with appropriate occlusal loading.
8mm Implants are not indicated for use as single implants and for immediate load.
The Klockner Essential Cone 1.5 implant system consists of a implants to restore the mastication system. The different EC 1.5 are available in four different diameters: 3.5mm, 4.0mm, 4.5mm and 4.8mm and the range of lengths varies between 8mm and 16mm. They are internally connected.
I am sorry but the provided text describes a 510(k) premarket notification for a dental implant system (Klockner Essential Implant System Models Essential Cone 1.5). This type of document focuses on establishing substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance data often found in clinical trials or AI/software validation studies.
Therefore, I cannot extract the information required concerning acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
The document primarily states that the device is "substantially equivalent to the previously cleared Klockner Essential Cone (EC) dental implants system cleared in K080224 because the intended use, the composition and the endosseous surface treatment are identical to the Klockner Essential predicate devices. The design principles are the same as the Klockner Essential predicate devices." This means the product is considered safe and effective based on its similarity to an already approved device, not on a new, explicit performance study against defined acceptance criteria.
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(156 days)
SOADCO, S.L.
The Klockner Essential implant system is especially designed for surgical insertion into the bone using additional material to replace the root of the teeth, acting as the support for the dental implants formed by implant accessories.
The Essential Solid implants are fitted with an internal octagonal conical connection combined with an external octagonal connection measuring 1.2 mm in height.
The Essential Cone implants are fitted with an internal octagonal conical connection.
The Essential ECK implants are fitted with a larger internal octagonal conical connection than that of the Essential Cone implants.
Immediate loading is appropriate for the Essential Cone and Essential Cone and Essential ECK implants when good primary stability is achieved with appropriate occlusal loading. Abutments can be used in single tooth replacements and multiple tooth restorations.
8mm Implants are not indicated for use as unitary implants and for immediate load.
The Klockner Essential implant system consists of a group of implants, implant accessories and additional material to restore the mastication system. The different EC, ES and ECK models are available in three different diameters: 3.5mm, 4.0mm and the range of lengths varies between 8mm and 16mm. They are internally connected.
This document (K080224) is a 510(k) premarket notification for the Klockner Essential Dental Implants System. It aims to demonstrate substantial equivalence to previously cleared devices. Based on the provided text, the submission focuses on asserting equivalence based on intended use, composition, endosseous surface treatment, and design principles, rather than presenting a study with acceptance criteria and performance data in the way a diagnostic AI device would.
Therefore, a table of acceptance criteria and device performance, as well as details about sample sizes, expert adjudication, MRMC studies, standalone performance, training data, and ground truth for a study proving the device meets acceptance criteria, cannot be extracted from this document. These types of studies are typically not required or presented for dental implant submissions that demonstrate substantial equivalence through comparison to predicate devices, especially concerning their physical and material properties.
The relevant sections of the document are primarily focused on:
- Device Identification: Name, manufacturer, contact.
- Device Description: Physical characteristics (diameters, lengths, connection types) of the Klockner Essential implant system (EC, ES, ECK models).
- Intended Use: Surgical insertion into bone to replace tooth roots, acting as support for dental implants, with specific indications for different diameters and bone types, and considerations for immediate loading.
- Predicate Devices: Listing of previously cleared Klockner dental implants and other manufacturers' implants used for comparison.
- Basis for Substantial Equivalence: Stating that "the intended use, the composition and the endosseous surface treatment are identical to the Klockner predicate devices. The design principles are the same as the Klockner predicate devices."
In summary, this document does not contain the information requested in your prompt regarding acceptance criteria and a study demonstrating performance against those criteria because it's a 510(k) submission based on substantial equivalence to predicate devices, not a performance study of a novel diagnostic or AI-based device.
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(126 days)
SOADCO, S.L.
S3M Klockner implants are a dental implant which consist of a small conical fixture (the root-form configuration). This implant enabling to be used as a support fitting when the gap to be replaced is not sufficient for a standard fitting (Ø 4.2 mm shoulder), or in areas of aesthetic concern, where the long-term preservation of the papilla is very important, such as the upper lateral incisors and lower incisors.
The S3M Klockner implant are an endosseous implant, are a device made of Grade 3 commercially pure titanium , which consist of a small conical fixture (the root-form configuration), perhans eigth to fourteen millimetres in length that have a shot peening process and a pasivated surface. Are available in diameter 3.1mm.
The provided document is a 510(k) premarket notification for a dental implant. It does not contain information about acceptance criteria or a study proving the device meets said criteria in the format requested.
Specifically, the document primarily focuses on establishing "substantial equivalence" of the KLOCKNER dental implants (S3M) to previously cleared predicate devices. This regulatory pathway does not typically involve the detailed performance studies with acceptance criteria, sample sizes, expert ground truth, and statistical analysis that would be present for a new device requiring a PMA or a more extensive de novo submission.
Here's why the requested information cannot be extracted from the provided text:
- No detailed performance study: The document mentions "Mechanical testing was done in accordance with the FDA guidance «Information for premarket notification submissions for screw type endosseous implants» issued on December 9, 1996. Results from an independent laboratory showed that the surface treatment to have sufficient osseointegration. Additional test reports include finite elements analysis." However, it does not provide the specific acceptance criteria for these tests, the actual results, or the methodology of the "independent laboratory study" beyond that.
- Focus on Substantial Equivalence: The primary assertion is that the device is "substantially equivalent" to predicate devices (S3 KLOCKNER DENTAL IMPLANTS and NARROW NECK ITI STRAUMANN). This generally means demonstrating similar materials, design, indications for use, and performance characteristics without necessarily conducting new, exhaustive clinical trials or performance studies against predefined acceptance criteria for novel claims.
Therefore, I cannot populate the table or answer the specific questions as the required data is not present in the provided text. The document is a regulatory submission demonstrating equivalence, not a detailed scientific study report with acceptance criteria and results.
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