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510(k) Data Aggregation
(64 days)
Medimecca Co., Ltd.
Honorst Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Honorst Implant System is for single stage and two stage surgical procedures. This system is intended for delayed loading.
Honorst Implant System are devices made of titanium intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices such as artificial teeth, and to restore the patients chewing function. Honorst Implant System consists of fixtures, abutments, and screws. Its material, structure and intended use are substantial equivalent to the predicate devices in the market. Honorst Implant System offers two different implants in SLA treatment and also offers two different onebody implants in SLA treatment. The Milling Abutment is only to be hand milled and not undergo CAD/CAM fabrication.
This is a 510(k) premarket notification for a medical device called "Honorst Implant System," a dental implant system. The document focuses on demonstrating substantial equivalence to predicate devices. It does not contain information about the performance criteria of a device or a study proving that it meets them in the way described in your request.
The document is a submission to the FDA for market clearance, arguing that the new device is as safe and effective as devices already on the market. It describes the Honorst Implant System's features and compares them to predicate devices, particularly the "CHAORUM Implant System (K160536)" by the same manufacturer.
Here's why the requested information cannot be extracted from this document:
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Acceptance Criteria and Reported Device Performance: This document does not list explicit performance acceptance criteria (e.g., specific thresholds for accuracy, sensitivity, specificity, etc.) for the Honorst Implant System. Instead, it argues that the device is "substantially equivalent" to existing devices based on similar design, materials, and intended use. The "Performance Data" section (page 6) states that "The verification/validation testing activities were conducted on the subject device for the modifications made" and that a "worst-case analysis demonstrated that the primary predicate remains the worst-case scenario with respect to fatigue testing." It also explicitly states that "Sterilization, shelf life, endotoxin, and biocompatibility testing were not conducted since the materials, surface treatments, packaging, and sterilization have not changed from the primary predicate device (K160536) and the device modifications do not raise a concern for the worst case for these tests." This means the performance data is primarily focused on mechanical aspects and demonstrating that changes did not negatively impact the existing safety/effectiveness profile, rather than establishing new performance metrics.
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Sample Size for Test Set and Data Provenance: Not applicable. There is no clinical trial or performance study detailed with a "test set" in the context of AI/diagnostic device performance. The testing mentioned is engineering/materials-based.
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Number of Experts and Qualifications: Not applicable. There are no experts establishing ground truth in the context of diagnostic performance for this type of device submission.
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Adjudication Method: Not applicable.
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Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not applicable. This is a physical dental implant system, not an AI-assisted diagnostic tool.
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Standalone Performance (Algorithm only): Not applicable. This is a physical device.
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Type of Ground Truth Used: Not applicable in the context of AI/diagnostic performance. The "ground truth" here is implied by the established safety and effectiveness of the existing predicate devices through their long-standing use and prior FDA clearances. The applicant validates the new device's engineering and material properties against industry standards and comparisons to these predicate devices.
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Sample Size for Training Set: Not applicable. There is no AI component or training set in this submission.
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How Ground Truth for Training Set Was Established: Not applicable.
In summary, this document is a regulatory submission for market clearance based on substantial equivalence, not a performance study that measures and reports against acceptance criteria for a diagnostic/AI device.
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(314 days)
MEDIMECCA CO., LTD.
Chaorum Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Chaorum Implant System is for single stage and two stage surgical procedures. This system is intended for delayed loading.
Chaorum Implant System are devices made of titanium intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices such as artificial teeth, and to restore the patients chewing function. Chaorum Implant System consists of fixtures, abutments, and screws. Its material, structure and intended use are substantially equivalent to the predicate devices. It offers three different implants in RBM treatment and SLA treatment.
The provided text describes a 510(k) submission for the "Chaorum Implant System," which is an endosseous dental implant system. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific performance acceptance criteria for an AI/ML algorithm.
Therefore, many of the requested categories about acceptance criteria, study design for AI/ML performance, sample sizes for AI/ML test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance are not applicable to this document. This submission pertains to a physical medical device (dental implants), not a software or AI/ML-driven device.
However, I can extract information regarding the non-clinical testing performed to validate the safety and substantial equivalence of the physical device.
Here's the relevant information that can be extracted, acknowledging that it does not fit the typical format for AI/ML algorithm evaluation:
1. A table of Acceptance Criteria and the Reported Device Performance:
The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner for each test, nor does it report specific performance values against those criteria. Instead, it lists the types of non-clinical tests conducted to validate the device's safety and substantial equivalence. The conclusion states that "Based on the similarities and the test results of the validation activities, we conclude that the Chaorum Dental Implant System is substantially equivalent to the predicate device." This implies that the device met the unstated acceptance criteria for each test to support the substantial equivalence claim.
Therefore, for AI/ML-specific criteria, this section is N/A as this is not an AI/ML device.
For the physical device, a table summarizing the types of non-clinical tests performed is provided in the document:
| No | Test Title | Test Standard | Implied Acceptance |
|---|---|---|---|
| 1 | Physical tests (visual, packaging, packaging seal efficacy, dimension, sterility - direct transfer method) | Not explicitly listed for each, but general quality control and sterility standards apply. | The device's physical attributes, packaging integrity, and sterility were confirmed to meet established standards. For sterility, the direct transfer method was used, implying successful sterilization according to protocol. Dimensions and visual inspection would have ensured conformance to design specifications. |
| 2 | RBM/SLA Surface treatment tests (roughness average, developed surface area ratio, surface characteristics (SEM), surface composition analysis (EDX)) | Not explicitly listed for each, but general material and surface characterization standards apply. | The RBM and SLA surface treatments were characterized and confirmed to be consistent with the intended design and expected properties for dental implants, ensuring appropriate surface characteristics for osseointegration. |
| 3 | TiN coating tests (surface roughness and abrasion testing) | Not explicitly listed, but material and coating standards apply. | The TiN coating was evaluated for its roughness and abrasion resistance, confirming its suitability for the device's function and durability. |
| 4 | Mechanical properties test (adaptation accuracy (Implant to abutment compatibility), 35° compressive loads, torsional breaking force, removal torque force, fatigue test) | Not explicitly listed, but industry standards for dental implant mechanical testing apply. | The mechanical integrity and performance of the implant system (fixtures, abutments, screws) were confirmed through various tests, demonstrating appropriate strength, compatibility, and durability under simulated physiological loads to ensure device functionality and patient safety. This would include ensuring the device can withstand chewing forces without failure and maintain a stable connection between components. |
| 5 | Sterilization validation and shelf-life tests | Not explicitly listed, but ISO 11137 series and ISO 11607 series are common standards. | Sterilization processes (gamma irradiation) were validated to ensure the device is sterile at the point of use, and shelf-life testing confirmed that the sterility and integrity of the device are maintained over its intended storage period. |
| 6 | Biocompatibility tests (Cytotoxicity, Acute Systemic Toxicity, Intracutaneous Reactivity, Pyrogen Test, Local Lymph Node Assay (LLNA), Bone Implantation Test) | ISO10993 series (specific parts listed in the document) | The device materials and design were proven to be biocompatible, meaning they do not cause adverse biological reactions (e.g., cell toxicity, irritation, sensitization, systemic toxicity, fever, or undesirable tissue reactions) when in contact with human tissue or implanted in bone. The bone implantation test would demonstrate appropriate osteointegration or tissue response in a living model. |
2. Sample size used for the test set and the data provenance:
N/A. This does not refer to an AI/ML algorithm's test set. The non-clinical tests described involve physical devices and material samples. The document does not specify the number of units or samples used for each physical or biocompatibility test, nor the provenance in the context of "data" (e.g., country of origin, retrospective/prospective). These are laboratory tests on manufactured articles.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
N/A. This is not an AI/ML device that requires human experts to establish ground truth for image interpretation or diagnosis. The "ground truth" for the non-clinical tests would be the accepted standards and specifications for material science, mechanical engineering, and biocompatibility, as evaluated by engineers and scientists in accredited labs.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
N/A. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers in a diagnostic or interpretive task (often in AI/ML performance evaluation). This is not relevant to the non-clinical physical and biological testing of a dental implant.
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:
N/A. MRMC studies are used to evaluate diagnostic systems, often with AI components assisting human readers. This document describes a physical medical device, not a diagnostic system with an AI component.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
N/A. This is not an AI/ML algorithm; it is a physical dental implant system.
7. The type of ground truth used:
For the non-clinical tests, the "ground truth" is defined by:
- Engineering specifications and design requirements: For dimensional accuracy, mechanical properties, and compatibility.
- Material standards: ASTM F136, ASTM F67 for titanium alloys.
- International standards: ISO10993 series for biocompatibility.
- Sterilization validation protocols: For sterility and shelf-life.
There is no "expert consensus" or "pathology" in the sense of clinical diagnostic ground truth for these types of tests, other than expert evaluation within the relevant engineering and scientific fields to ensure compliance with standards.
8. The sample size for the training set:
N/A. This is not an AI/ML algorithm. There is no concept of a "training set" for the physical device.
9. How the ground truth for the training set was established:
N/A. As above, no training set is involved.
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(178 days)
MEDIMECCA CO., LTD.
UD Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. UD Implant System is for single stage and two stage surgical procedures. This system is intended for delayed loading.
UD Implant System is a dental implant system made of titanium (Fixture: ASTM F136 / Prosthetic Abutment: ASTM F136, ASTM F67 Gr 4) intend to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. This device may be used to replace one or more missing teeth. Its material, structure and intended use are substantial equivalence with the predicate device.
The provided text describes a 510(k) summary for the "UD Implant System," a dental implant device. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a study proving a device meets specific acceptance criteria based on performance metrics.
Therefore, many of the requested sections about clinical study details (sample size, ground truth, expert adjudication, MRMC studies, standalone performance, training set) cannot be answered. The provided text outlines non-clinical testing conducted to validate safety, but not performance-based acceptance criteria against clinical outcomes.
Here's a breakdown of what can be extracted and what cannot, based on your request:
1. A table of acceptance criteria and the reported device performance
This information is not explicitly provided in terms of performance metrics or acceptance criteria for clinical efficacy. The summary focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and intended use, and provides a list of non-clinical tests for safety and physical characteristics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No clinical test set or data provenance is mentioned as this is a 510(k) submission focusing on substantial equivalence through non-clinical testing and comparison to a predicate device.
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. No clinical test set or ground truth established by experts is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set or adjudication method is mentioned.
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 dental implant, not an AI-assisted diagnostic tool, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a dental implant, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable for clinical performance. The "ground truth" or basis for acceptance in this submission relates to the adherence to standards for materials, mechanical properties, and biocompatibility in non-clinical testing, and the substantial equivalence to a predicate device.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable.
Summary of Device and Evidence Presented (based on available information):
Device: UD Implant System (Endosseous Dental Implant)
Purpose of Submission: Demonstrate substantial equivalence to a predicate device (Hero II and IS Dental Implant System by KJ Meditech Co., Ltd. K121047) to market the device.
Evidence for Substantial Equivalence:
- Intended Use: Identical to the predicate device.
- Operating Principle: Same.
- Basic Design: Same.
- Material: Titanium (ASTM F136 / ASTM F67 Gr 4) - similar to the predicate's Titanium 6Al 4V ELI Alloy.
- Surface Treatment: R.B.M. (Same as predicate).
- Structure: Internal Hexagon connection, self-taping cutting edge threads (Same as predicate).
- Dimensions: Similar range of diameters and lengths for fixtures and abutments.
- Surgery Type: One stage, Two stages (Same as predicate).
- Sterilization: Gamma radiation (Same as predicate).
- Shelf-life: 5 years (Same as predicate).
Non-clinical Testing Conducted (for safety, not performance against clinical acceptance criteria):
- Physical tests: visual, packaging, packaging seal efficacy, dimension, sterility (direct transfer method).
- Surface treatment tests: roughness average, developed surface area ration, surface characteristics (SEM), surface composition analysis (EDX).
- Mechanical properties tests: adaptation accuracy (Implant to abutment comparability), 35° compressive loads, torsional breaking force, removal torque force, fatigue test.
- Sterilization validation and shelf life tests.
- Biocompatibility tests (in accordance with ISO10993 series).
The 510(k) summary concludes that the UD Implant System is substantially equivalent to the predicate device based on these comparisons and non-clinical tests. It does not contain information about clinical performance studies with specific acceptance criteria that would typically be associated with AI/software medical devices or new device types requiring de novo clinical validation.
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(51 days)
MEDIMECCA CO., LTD.
The Hero II Dental Implant System and the UI Dental Implant System are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The Hero II Dental Implant System and the UI Dental Implant System are for single and two stage surgical procedures. These systems are intended for delayed loading.
The Hero II Dental Implant System and the UI Dental Implant System are dental implant systems made of Titanium 6AL 4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. The systems are similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of these systems have been treated with R.B.M (Resorbable Blast Media) for fixtures and TiN coating for abutments.
The provided text describes a Special 510(k) submission (K130221) for the "Hero II Dental Implant System" and a renamed "UI Dental Implant System." This submission aims to add a new design fixture model and change a name, stating that the intended use and principal technology are unchanged from the unmodified device (K121047).
The document does not contain acceptance criteria or a study proving that the device meets those criteria, as typically understood for performance metrics like sensitivity, specificity, or reader agreement in AI/imaging devices. Instead, this 510(k) is a substantial equivalence determination based on comparison to a predicate device.
Here's an analysis based on the provided text, addressing the requested points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. The document does not define specific performance acceptance criteria (e.g., accuracy, precision) for the dental implant system itself, nor does it report performance metrics against such criteria in the context of a clinical study or statistical analysis. The "performance" mentioned refers to the device's characteristics and materials.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No "test set" in the context of evaluating performance metrics (like for an AI or diagnostic device) is mentioned. The submission is based on non-clinical testing and comparison to a predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. No "ground truth" establishment by experts for a test set is described.
4. Adjudication Method for the Test Set
Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not mention any MRMC study or any study comparing human readers with and without AI assistance. This device is a dental implant, not a diagnostic imaging device with an AI component in the described context.
6. Standalone (Algorithm Only) Performance Study
No. This is a physical medical device (dental implant), not an algorithm or AI system.
7. Type of Ground Truth Used
Not applicable. There is no mention of ground truth in the context of pathology, outcomes data, or expert consensus for assessing device performance. The "ground truth" in this submission relates to the device's physical and material characteristics being substantially equivalent to the predicate.
8. Sample Size for the Training Set
Not applicable. The device is a physical dental implant, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Summary of Device Acceptance and Study (Based on the Provided Text):
The acceptance of the "Hero II Dental Implant System" and "UI Dental Implant System" in this 510(k) submission is based on demonstrating substantial equivalence to a previously cleared predicate device (K121047). The study that proves this is a comparison of the subject device's characteristics to those of the predicate device, supported by non-clinical testing.
Acceptance Criteria (Implicitly based on Substantial Equivalence):
- Intended Use: Must be the same as the predicate device.
- Technological Characteristics: Must be the same or similar to the predicate device, with any differences not raising new questions of safety or effectiveness.
- Material Composition: Must be the same as the predicate device (Titanium 6AL 4V ELI alloy).
- Performance Characteristics (Non-Clinical): Must meet the same non-clinical performance standards as the predicate device (e.g., cleanness after surface treatment, shelf-life, sterilization validation).
Study Proving Acceptance (Substantial Equivalence Determination):
- Purpose of Submission: To add a new design fixture model and change a name to an unmodified device cleared under K121047. The intended use and principal technology of the subject device are stated to be the same as the unmodified device.
- Device Description: The subject devices (Hero II and UI Dental Implant System) are dental implant systems made of Titanium 6AL 4V ELI alloy. Their surfaces are treated with R.B.M (Resorbable Blast Media) for fixtures and TiN coating for abutments. Size information for various diameters and lengths is provided.
- Indications for Use: The indications for use are identical to those of the predicate device, covering use in partially or fully edentulous mandibles and maxillae, supporting single or multiple-unit restorations, and intended for single and two-stage surgical procedures with delayed loading.
- Non-clinical testing:
- Tests Conducted: Energy Disperse X-ray micro analyzer (EDX) and Scanning Electron Microscopy (SEM) Analysis to verify cleanness after surface treatment, shelf-life testing, and sterilization validation.
- Rationale: These tests were conducted on the unmodified device (K121047) and reviewed in that previous 510(k) submission. The document states that "These characteristics have not been changed on the modified device; therefore it is substantially equivalent to the unmodified device in these regards."
- Basis for Substantial Equivalence:
- Same intended use as predicate (K121047).
- Same fundamental scientific technology: threaded, root form implants made of titanium.
- Same internal hexagon abutment connection system with internal beveled interface.
- Both are bone-level implants with similar body shape design (straight walled neck and tapered body design).
- Difference: "minor thread design on the fixture." The submission implicitly argues this minor difference does not raise new questions of safety or effectiveness.
- Conclusion: The submission concludes that the subject devices are substantially equivalent to the predicate devices based on identical intended use, operating principle, basic design, and material.
In essence, the "study" is a technical and regulatory comparison against a predicate device, demonstrating that the new/modified dental implant systems do not introduce new safety or effectiveness concerns compared to already cleared devices.
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