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510(k) Data Aggregation
(186 days)
The Omnibut is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.
The Omnibut™ is a transmucosal abutment used to support screw-retained prostheses on four or more implants. The subject device has a premanufactured connection for the platforms listed in Table 1 Compatible Implant Systems.
The system involves a ball abutment attached to an implant. A retention attachment allows for angle corrections of up to 30° off the implant axis. The ball abutment is inserted into the attachment is adjusted to the desired angle using an orientation screw. The abutment supports prostheses that connect via titanium cylinders, which are incorporated into resin or ceramic prostheses. Finally, the prostheses are retained to the abutment by prosthetic screws.
The subject device abutments and system components are manufactured from Ti-6Al-4V alloy conforming to ASTM F136. The subject device is a single use device is provided nonsterile and intended to be sterilized by the user prior to placement in the patient.
Here's a breakdown of the acceptance criteria and study information for the Omni-Directional Multi-unit Abutment System (Omnibut™), based on the provided FDA 510(k) summary:
Description of the Device
The Omnibut™ is a pre-manufactured prosthetic component directly connected to endosseous dental implants. It is intended for use as an aid in prosthetic rehabilitation, specifically for supporting screw-retained prostheses on four or more implants. The system includes a ball abutment attached to an implant, with a retention attachment allowing for angle corrections of up to 30° off the implant axis. It supports prostheses that connect via titanium cylinders, which are incorporated into resin or ceramic prostheses. The device is made from Ti-6Al-4V alloy and is provided non-sterile, requiring user sterilization.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Test) | Description of Test | Reported Device Performance (Results) |
|---|---|---|
| Biological Evaluation | ||
| ISO 10993-1:2018; FDA Guidance on the Use of ISO 10993-1, 2023 | Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process | PASS – All biological endpoint testing performed on the device, along with the analysis on the physical and chemical information, returned passing results. All biological endpoint testing suggests that the Omnibut is biocompatible and does not present a foreseen biological risk to those patient populations it is intended for. |
| ISO 10993-5 (2009) | Biological Evaluation of Medical Devices – Part 5: Tests for in vitro cytotoxicity | PASS – The test article showed no evidence of causing cell lysis or toxicity. The test article met the requirements of the test since the grade was grade 0 (no reactivity). |
| Sterilization Validation | ||
| AAMI TIR12:2020; ANSI/AAMI/ISO 17665-1:2026/(R)2013; ANSI/AAMI ST79:2017 | Designing, Testing, And Labeling Medical Devices Intended For Processing By Health Care Facilities: A Guide For Device Manufacturers, Overkill method according to Section 5.7 | PASS – Results from testing have demonstrated that the Omnibut was able to achieve a 10-6 SAL when using the recommended parameters in the Instructions for Use (IFU). |
| Mechanical Performance | ||
| ISO 14801:2016; FDA Guidance Document, "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" (May 12, 2004) Section 8 | Dentistry — Implants — Dynamic loading test for endosseous dental implants | PASS – The results conclude that when evaluated in a manner consistent with ISO 14801:2016, the Omnibut met all predetermined acceptance criteria. |
| No specific standard (Compatibility) | Reverse engineering dimensional analysis of OEM implant bodies, OEM abutments, and OEM abutment screws were performed to demonstrate that the Omnibut abutments are compatible with the noted implant systems. Compatibility must be demonstrated to ensure proper device functionality. | PASS – The engineering and dimensional analysis concluded that each Omnibut design is compatible with the applicable implant connection. PASS - Omnibut prosthetic side components were demonstrated to be compatible. |
| No specific standard (Retention Force Testing) | The Omnibut has a retention attachment. Retention Force testing was performed via tensile push-out to ensure that the attachment will not detach during clinical use. | PASS – The Omnibut retention attachment did not detach at a predetermined acceptable force. |
| No specific standard (Simulated-Use Testing) | Simulated Use of four Omnibuts with components connected to a Titanium Bar under a clinically relevant cyclic load. | PASS – The Omnibut and components did not yield, deform, or fracture after fatigue testing. |
| No specific standard (Simulated Cleaning Testing) | Simulated cleaning of Omnibuts in a fixture with a clinically worst case cleansibility construction. | PASS – All parts of the Omnibuts were clean of soil indicators after six soilage and cleaning cycles. |
| MR Safety | ||
| FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" (May 2021) | Non-clinical analysis to evaluate the subject device in the MR environment using scientific rationale and published literature (TO Woods, JG Delfino, and S Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices," Journal of Testing and Evaluation, Volume 49, No. 2, 2021, pp. 783-795). | The analysis addressed parameters per the FDA guidance, including magnetically induced displacement force and torque. The document does not explicitly state the results (e.g., "MR Safe" or "MR Compatible"), but implies that the analysis was sufficient to support safety in the MR environment based on the scientific rationale and literature used. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the exact sample sizes for each individual non-clinical test (e.g., number of abutments tested for dynamic fatigue, retention force, simulated use, or cleaning). It refers to the testing as "non-clinical" bench testing.
- Test Set Provenance: The data is generated from bench testing (laboratory studies), not from clinical data involving human patients. Therefore, information like "country of origin of the data" or "retrospective/prospective" is not applicable in the typical sense of clinical trials. The testing was performed in vitro.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the studies are non-clinical bench tests. The "ground truth" for these tests is based on established engineering standards (e.g., ISO 14801), biological evaluation standards (ISO 10993), and internal company protocols for mechanical and cleaning validation, not on expert clinical interpretation of patient data.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not applicable as the studies are non-clinical bench tests. Adjudication methods are typically employed in studies involving human interpretation or clinical endpoints to resolve discrepancies in assessment.
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
An MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices involving human readers/interpreters, which is not the case for this dental implant abutment. The device is a physical component, not a diagnostic AI tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
A standalone performance study was not done in the context of an algorithm. This question is relevant for AI/software devices; this device is a physical medical device. The "standalone" performance here refers to the device's mechanical and biological performance on its own, which is what the bench tests evaluate.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical performance evaluations relies on:
- Established engineering and biological standards: e.g., ISO 14801:2016 for dynamic fatigue, ISO 10993 for biocompatibility, ANSI/AAMI/ISO for sterilization.
- Predetermined acceptance criteria: For retention force, simulated use, and cleaning efficacy, the "ground truth" is defined by specific pass/fail criteria established during the test design based on expected clinical performance and safety.
- Dimensional accuracy and compatibility models: For compatibility testing, the "ground truth" is established by the dimensions and specifications of OEM implant bodies and abutments.
8. The Sample Size for the Training Set
This information is not applicable because the device is a physical medical component, not a machine learning model or AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reason as above (not a machine learning model).
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(139 days)
CEREC Cercon 4D™ Abutment System is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations.
The system comprises three parts:
- CEREC Cercon 4D™ Abutment Block
- TiBase
- CAD/CAM system
The CEREC Cercon 4D™ ceramic structure cemented to the TiBase is recommended for two-piece hybrid abutments for single tooth restorations and hybrid abutment crowns, used in conjunction with endosseous dental implants.
The CEREC Cercon 4D Abutment Blocks, which are used for fabrication of a ceramic structure, two-piece hybrid abutments (meso-structure and crown) and abutment crowns, that are cemented to a TiBase (titanium base) used with dental implant systems. The CEREC Cercon 4D Abutment Blocks are not provided as the finished, fully assembled dental implant medical devices. The abutment blocks are materials supplied to dental professionals that must be further processed/manufactured using CAD/CAM technology and they are not intended to be reused as in the context of direct patient-applied devices and materials.
CEREC Cercon 4D™ Abutment Block are Yttria-doped zirconia blocks suitable for chairside and lab side use in fabrication of single cement-retained restorations. CEREC Ceron 4D™ Abutment Block are designed with a pre-drilled screw access channel and anti-rotation feature. The design allows for fabrication of a ceramic structure, two-piece hybrid abutments (mesostructure and crown) and abutment crowns, that are cemented to theBase (Titanium base) used with dental implant systems.
The provided document describes the substantial equivalence of the CEREC Cercon 4D™ Abutment Blocks and System, primarily focusing on non-clinical performance and material characteristics, rather than an AI/ML-based device. Therefore, many of the requested elements pertaining to AI/ML device studies (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this document.
However, I can extract information related to the acceptance criteria and study that proves the device meets those criteria from the perspective of a medical device (specifically, a dental abutment system), even without AI elements.
Here's the information based on the provided text, with Not Applicable (N/A) for fields that relate to AI/ML studies and are not covered in this document.
Acceptance Criteria and Device Performance for CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System
The device under review is primarily a dental abutment system, and its performance is evaluated based on material properties, mechanical strength, and software integration, not on diagnostic accuracy or AI assistance.
1. Table of Acceptance Criteria and the Reported Device Performance
| Test Performed | Test Method/Applicable Standards | Acceptance Criteria | Reported Performance (Results) |
|---|---|---|---|
| Flexural Strength | ISO 6872:2015 Amd 1. 2018 Dentistry-Ceramic Materials | >1,100 MPa | Pass |
| Fatigue Testing | ISO 14801:2016 Dentistry-Implants-Dynamic loading test for endosseous dental implants | (Implied: Meets requirements) | Pass |
| Sterilization Validation | ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices | Achieve a Sterility Assurance Level (SAL) of 10⁻⁶ | Validated |
| Biocompatibility | ISO 10993 standard series (specifically ISO 10993-5, -10, -23) | Meets ISO 10993 requirements | Meets requirements |
| Software Validation (Angulation) | Internal software integration requirements for the addition of the proposed device | Max angulation of 20° (User cannot proceed if outside) | Meets requirements |
| Software Validation (Wall Thickness) | Internal software integration requirements for the addition of the proposed device | Minimal wall thickness of 0.5 mm (User cannot proceed if outside) | Meets requirements |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set:
- For Flexural Strength (Table 8.1): Not explicitly stated, but typically involves a certain number of samples to ensure statistical significance as per ISO 6872.
- For Fatigue Testing (Table 8.2): "New fatigue testing was conducted on the worst-case combinations relating to the greatest angulation, the platform size and the gingival height for the proposed Dentsply Sirona TiBase/Dentsply Sirona Implant Systems and Third Party TiBase/Third Party Implant Systems (Camlog) combinations." The exact number of samples per test condition is not specified in the document, but standardized tests like ISO 14801 would stipulate a minimum.
- For Sterilization Validation, Biocompatibility, and Software Validation: Not explicitly specified in terms of sample count in this summary.
- Data Provenance: The document does not specify the country of origin of the data. The tests are described as "non-clinical tests" and "performance bench testing," indicating laboratory-based studies. The document does not mention if the data is retrospective or prospective, as this distinction is more relevant for clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is not an AI/ML diagnostic tool requiring expert ground truth for image interpretation or similar. The "ground truth" (or more accurately, established performance standards) for this device is based on mechanical properties and ISO standards, which are objective and do not require expert human interpretation in the way an AI diagnostic system would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no human expert interpretation or consensus review is involved in the performance testing of this device (e.g., physical strength, material composition).
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-assisted diagnostic device; therefore, MRMC studies are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device. Its "system" aspect refers to the combination of the abutment block, TiBase, and CAD/CAM system for fabrication, not an AI algorithm. The performance described is of the physical components and the software's ability to constrain design parameters.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by international consensus standards (e.g., ISO 6872, ISO 14801, ISO 10993, ISO 17665-1) for dental materials and implants, along with internal software integration requirements. These are objective, quantitative measures rather than subjective human interpretations or clinical outcomes data in the context of diagnostic accuracy.
8. The sample size for the training set
Not applicable. This device does not have a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. This device does not have a "training set" in the context of machine learning.
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(560 days)
Medentika abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
Medentika abutments for the Dentsply Sirona Astra Tech OsseoSpeed EV 3.0mm and TX 3.0mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.
Medentika TiBase CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. Medentika TiBase is intended for use with the Straumann® CARES® System. All digitally designed copings and/or crowns are intended to be sent to Straumann for manufacture at a validated milling center.
Medentika abutments for the Nobel Biocare Nobel Active®* 3.0mm, Dentsply Sirona Astra Tech OsseoSpeed EV®* 3.0mm and TX®* 3.0mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.
Medentika PreFace CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
Medentika Preface is intended for use with the Straumann® CARES® System. All digitally designed abutments for use with Medentika CAD/CAM Abutments are intended to be manufactured at a Straumann® CARES® validated milling center. The final patient matched form is a MedentiCAD abutment.
Medentika abutments for the Dentsply Sirona Astra Tech OsseoSpeed EV 3.0mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.
Multi-unit abutments are indicated for use with dental implants as a support for multi-unit screw retained bridges and bars in the maxilla or mandible of a partially or fully edentulous patient.
The Medentika abutments include abutments, abutment screws, caps, and bases which are labelled under a specific Medentika series and are compatible with a specified dental implant system. The abutments include sinqle-unit abutments intended for use with dental implants as a support for single or multiple tooth protheses in the maxilla or mandible of a partially or fully edentulous patient. The abutments also include multi-unit abutments indicated for use with dental implants as a support for multi-unit screw retained bridges and bars in the maxilla or mandible of a partially or fully edentulous patient.
The purpose of this premarket notification is to add additional abutments. The subject abutments include abutments compatible with additional dental implant systems forming a new Medentika series (the OT series). The subject abutments also include abutments compatible with new implant diameters in existing Medentika series (E, EV, F, and S). Lastly, the subject abutments include new abutment designs compatible with existing implant diameters in existing Medentika series (R).
This looks like a 510(k) Summary for a medical device (dental abutments), which means the document is about proving "substantial equivalence" to a predicate device, not about proving clinical effectiveness or performance against pre-defined acceptance criteria in the way one might for a novel AI/software medical device.
Therefore, the information requested in your bullet points (e.g., acceptance criteria table, sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) is not applicable to this type of regulatory submission because the device is a mechanical one, not an AI/software device. The data presented here is focused on demonstrating physical and mechanical compatibility and equivalence to previously cleared devices.
Here's why each point is not applicable and what information is provided:
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A table of acceptance criteria and the reported device performance: This document doesn't provide a typical "acceptance criteria" table as would be seen for an AI/software device measuring diagnostic performance (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating that the new abutments perform similarly to existing, cleared abutments through "dynamic fatigue testing" and "dimensional analysis and reverse engineering." The performance is implicitly "accepted" if these tests show equivalence to the predicate.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No "test set" in the context of diagnostic performance is mentioned. The "testing" refers to non-clinical, physical testing (fatigue, dimensional analysis). There is no patient data involved in this type of submission for a mechanical device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth, in the AI/software sense, is not established for this device. The "truth" is based on engineered specifications and physical testing.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No human adjudication of diagnostic output is relevant here.
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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-assisted device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" is engineering specifications and physical measurements.
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The sample size for the training set: Not applicable. There is no AI/machine learning component to "train."
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How the ground truth for the training set was established: Not applicable for the same reason as above.
What the document does provide regarding device performance and testing:
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Type of Testing:
- Dynamic fatigue testing according to FDA guidance and ISO 14801 (Dentistry - implants dynamic loading test for endosseous dental implants).
- Dimensional analysis and reverse engineering of the implant-to-abutment connection platform.
- Sterilization validation (steam and gamma irradiation) referenced from K191123, ISO 17665-1, ISO/TS 17665-2, ISO 11137-1, ISO 11137-2.
- Sterile packaging validation referenced from K191123, ISO 11607-1, ISO 11607-2.
- Biocompatibility evaluations referenced from K142167, K170838, K191123, K150203, K061804 in accordance with ISO 10993-1.
- MR testing referenced from K180564 in accordance with ASTM F2052-15, ASTM F2213-06 (2011), ASTM F2182-11a, and ASTM F2119-13.
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Conclusion: The tests demonstrated "implant to abutment compatibility" and "established substantial equivalency of the proposed device with predicate devices." This is the "proof" that the device meets the (implicit) acceptance of being substantially equivalent to existing, legally marketed devices.
In summary, this document is for a traditional mechanical medical device, and the regulatory pathway does not involve performance studies in the way you've outlined for AI/software-based devices.
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(400 days)
Bonafix TiBase abutments are intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient.
The Bonafix TiBase abutment is composed of two-piece abutment that is a titanium base at the bottom and a zirconia superstructure (CAD/CAM patient specific superstructure) at the top. The dental restoration and mesostructure are fabricated using a CAD/CAM process. The subject device abutment platform diameters range from 3.0 mm to 5.7 mm, and the corresponding compatible implant body diameters also range from 3.3 mm to 7.0 mm. The apical end is prefabricated to match the compatible implant platform and is available with implant connections for crowns (engaging) or bridges (non-engaging). Each abutment is provided with a screw designed to match the compatible implant.
The titanium base abutment and screw are manufacturated from titanium alloy conforming to ASTM F136. The superstructure is to be manufactured from zirconia conforming to ISO 13356. The subject devices are provided non-sterile to the end user. All digitally designed superstructures, and/or hybrid crowns for use with Bonafix TiBase abutments are to be sent to a Zentek validated Milling center for manufacture. The zirconia superstructure in straight only and is not to be designed to provide an angle or divergence correction.
The provided text is related to a 510(k) premarket notification for a dental device called "Bonafix TiBase." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific performance acceptance criteria for a new clinical claim.
Therefore, the input document does not contain the information requested regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth establishment.
- Adjudication method for a test set.
- Information on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
- Information on a standalone algorithm performance study.
- The type of ground truth used (beyond what might be inferred from the "Non-Clinical Testing Summary" referring to standards compliance).
- Sample size for the training set.
- How ground truth for the training set was established.
The document primarily focuses on non-clinical testing for biocompatibility, sterilization, and engineering/dimensional analysis to support substantial equivalence.
The "Non-Clinical Testing Summary" mentions an "Engineering and dimensional analysis... for determination of compatibility" and compliance with ISO 10993-5 (cytotoxicity) and ANSI/AAMI/ISO 17665-1 (sterilization). It also refers to an MRI review based on scientific rationale and published literature. However, these are evaluations of the device's characteristics against standards and existing knowledge, not a study proving a specific performance metric against a defined acceptance criterion in the way an AI/ML device might be evaluated for diagnostic accuracy.
The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence of the Bonafix TiBase to its predicate device." This further confirms that the type of study you're asking about (e.g., related to diagnostic accuracy, clinical outcomes for a new claim, or AI performance) was not conducted or deemed necessary for this 510(k) submission.
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(482 days)
The PiezoImplant System is intended for use in dental implant applications for oral rehabilitation of edentulous and partially dentate adult patients over the age of 21 in the maxilla and mandible. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures. The prosthetic components are connected to the implants by the corresponding abutments. The PiezoImplant System is intended for delayed loading.
The Piezolmplant System consists of endosseous dental implants, surgical instruments and restorative components in a variety of dimensions to accommodate differing patient anatomy. The Rex TL endosseous implants are blade-form having a wedge shape and an endosseous resorbable blast media (RBM) surface. The REX TL 1.8 implant series has a buccolingual thickness of 1.8mm, a mesiodistal width of 5mm and an external hex connection platform. The REX TL 2.9 implant series has a buccolingual thickness of 2.9mm, a mesiodistal width of 5mm and an internal hex connection platform. The endosseous lengths for both implant series range from 9mm to 15mm and all lengths are offered for both series. Cover screws provide protection to the threads of the abutment connection during endosseous and gingival healing. Retention screws fasten the implant and abutment. A variety of Piezolmplant abutments are offered including Healing, Angled, Straight, Provisional Cylinders and Multi-unit. Restorations can be screw and/or cement-retained to the abutments.
The provided text describes a 510(k) premarket notification for the Rex Implants, Inc. PiezoImplant System. This submission is for a dental implant system, and most of the document focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and mechanical testing. The document also includes information about two clinical studies to support the special controls for blade-form endosseous dental implants.
It's important to note that this is NOT a study that "proves the device meets the acceptance criteria" in the typical sense of a clinical trial proving efficacy against pre-defined endpoints for a drug or novel device. Instead, it's a demonstration of substantial equivalence, where the device needs to show similar performance to legally marketed predicate devices, especially regarding safety and effectiveness, to gain market clearance. The acceptance criteria in this context are for substantial equivalence, often demonstrated through comparison to predicates and meeting special controls, which include mechanical testing and, in this case, clinical experience.
Here's a breakdown of the requested information based on the provided text, focusing on the clinical data section which is most relevant to "device performance" in a functional sense:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not explicitly state "acceptance criteria" for the clinical performance in a structured table. Instead, it refers to fulfilling "special controls" and showing "equivalent performance" to the predicate. The "acceptance criteria" presented below are derived from industry standards and the performance metrics mentioned in the clinical studies.
| Acceptance Criterion (Derived from Special Controls & Clinical Practice) | Reported Device Performance (PiezoImplant System) |
|---|---|
| Study 1: Case Series (Retrospective) | |
| Implant Success Rate (accord. to ICOI Health Scale) at ≥ 1 year post-loading | 88.6% (70/79 implants) deemed a success (optimum health). |
| Bone Loss Criteria (≤1mm at year one + 0.2 mm/year thereafter) | Mean (SD) bone level change following implantation (34 to 106 months): -0.68 (±1.05) mm (for 37 implants across 20 patients). |
| Mean (SD) bone level change post-loading (1.3 to 79 months): -0.05 (± 0.55) mm (for 37 implants across 20 patients). | |
| Implants meeting bone loss criteria: 35/37 (All but two implants met the criteria). | |
| Study 2: Prospective Cohort Study | |
| Intraoperative Discomfort (VRS) | 42 of 44 patients reported discomfort as none, slight, or mild. |
| 2 patients reported discomfort as severe. | |
| Postoperative Pain (VAS) | Mean (SD) VAS on day after surgery: 24 ± 15 (max 100-point scale). Reduced to near zero by postoperative day six. |
| Marginal Bone Loss (Implantation to Loading) | 0.38 (± 0.48) mm (mean SD). |
| Marginal Bone Loss (Loading to 12 months post-loading) | 0.20 (± 0.19) mm (mean SD). |
| Implant Satisfaction at 1 year post-loading | All 58 implants (from 43 patients) were satisfactory at one year post-loading. |
2. Sample Size Used for the Test Set and the Data Provenance
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Study 1 (Case Series Review):
- Initial Patient Sample: 56 patients (20 male, 35 female, ages 24 to 81, mean age 59.7 years).
- Implants: 111 implants.
- Patients meeting ≥12 months post-loading criterion: 37 patients (79 implants).
- Patients with follow-up radiographs: 23 patients (43 implants).
- Patients with time of implantation radiographs: 20 patients (37 implants) for bone level measurements.
- Data Provenance: The text states "Clinical data from five OUS clinical centers was acquired," indicating data from Outside the U.S. and is retrospective.
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Study 2 (Prospective Cohort Study):
- Initial Patient Sample: 44 patients (15 male, 29 female, mean age 59.5 ± 12 years, age range 35 to 88 years).
- Implants: 59 REX TL implants implanted. One implant was lost, leaving 58 implants (from 43 patients) for analysis.
- Data Provenance: "44 patients... were prospectively enrolled in an International Piezosurgery Academy Study at six OUS clinical centers," indicating data from Outside the U.S. and is prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not specify the number of experts used to establish ground truth or their qualifications for either clinical study.
- For Study 1, it mentions "Bone level measurements were made on each radiographic image using ImageJ." It doesn't state who performed these measurements or if multiple experts were involved in defining the baseline or changes.
- For Study 2, clinical outcomes like discomfort, pain, and marginal bone loss were recorded, but the involvement of independent experts for ground truth establishment beyond the reporting clinicians is not detailed.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the clinical outcomes or ground truth establishment in either study. The results appear to be reported based on direct collection and measurement.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a MRMC comparative effectiveness study was not done. The studies described are clinical outcome studies for the device itself, not studies comparing human reader performance with and without AI assistance for interpretation. The device itself is a physical implant, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical dental implant system, not a software algorithm. Therefore, "standalone algorithm performance" is not relevant to this device. The clinical studies assess the physical implant's performance in human patients.
7. The Type of Ground Truth Used
- Study 1 (Case Series):
- Implant Success: Based on the ICOI Health Scale. While this is a clinical scale, it's applied to the clinical observations and outcomes of the implants.
- Bone Level Changes: Radiographic measurements using ImageJ, with the implant shoulder as a reference. This is a form of radiological ground truth based on quantifiable measurements.
- Study 2 (Prospective Cohort):
- Intraoperative Discomfort: Patient-reported (via VRS - likely Verbal Rating Scale). This is patient-reported outcome data.
- Postoperative Pain: Patient-reported (via VAS - Visual Analog Scale). This is patient-reported outcome data.
- Marginal Bone Loss: Radiographic measurements. This is a form of radiological ground truth.
- Implant Satisfaction: Clinical assessment based on the study protocol, leading to the conclusion that "All of the 58 implants were satisfactory." This is likely clinical outcome data based on defined criteria.
8. The Sample Size for the Training Set
Not applicable. The PiezoImplant System is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The "training set" for the development of such a device would involve engineering design, material science research, and mechanical testing, not a dataset in the AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As explained above, there is no "training set" for this physical device in the AI sense. Ground truth for the development of the device would involve established scientific and engineering principles, material standards (e.g., ASTM F136 for titanium alloy), and mechanical testing methodologies (e.g., ISO 14801). The "ground truth" for the clinical studies mentioned above is established through clinical observation, patient reports, and radiographic measurements as detailed in point 7.
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(47 days)
The TSV™ BellaTek® Encode® Healing Abutments are intended for use as an accessory to endosseous dental implants during endosseous and gingival healing to prepare gingival tissue for acceptance of a final abutment and restoration.
The purpose of this submission is to obtain 510(k) premarket clearance for the TSVIM BellaTek® Encode® Healing Abutments compatible with Tapered Screw-Vent® and Trabecular Metal implant systems. Abutments sizing is based on implant platform diameter.
TSV™ BellaTek® Encode® Healing Abutments are designed to aid in soft tissue contouring during the healing period after implant placement, creating an emergence profile for the final prosthesis. They have the added design feature of machined markings for identification when taking an abutment level impression or an intraoral scan/digital impression. The occlusal surface of the device include markings that provide information about the mating implant's position and orientation.
The principal of operation and Encode "Coding Scheme of the same as the primary predicate device. The pattern of the markings for the subject device is specific to the Tapered Screw-Vent", and Trabecular Metal implant lines.
The provided text does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria. Instead, it is a 510(k) summary for a medical device (TSV™ BellaTek® Encode® Healing Abutments) demonstrating substantial equivalence to a predicate device.
The document explicitly states: "No clinical data were included in this submission." and relies on non-clinical testing data and equivalence to a predicate device.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth, expert opinions, or MRMC studies, as this information is not present in the provided text.
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(247 days)
The LOCATOR® F-Tx Attachment System is designed to support fixed, partial or full arch restorations on endosseous dental implants in the mandible or maxilla for the purpose of restory function. It is used in fixed hybrid restorations that can be attached with a snap-in system.
The LOCATOR® F-Tx Attachment System is compatible with the following implants: Implant Manufacturer Connection Type / Platform
| Astra Tech | OsseoSpeed Plus EV: 3.6, 4.2, 4.8 mm |
|---|---|
| BioHorizons | Internal Hex: 3.0, 3.5, 4.5, 5.7 mm |
| Biomet 3i | Osseotite ® Certain ® : 3.4, 4.1, 5.0, 6.0 mm |
| Camlog | Camlog, Conelog: 3.3, 3.8, 4.3, 5.0 mm |
| iSy: 3.8, 4.4, 5.0 mm | |
| Dentsply | Ankylos ® : 3.5, 4.5, 5.5, 7.0 mm |
| MIS Implants | Internal Hex: 3.75, 4.5 mm |
| Nobel Biocare | NobelActive ™ : 3.0, 3.5, 3.9 mm |
| Replace ™ Select: 3.5, 4.3, 5.0, 6.0 mm | |
| Brånemark: 3.5, 4.1, 5.1 mm | |
| Straumann | Bone Level: 3.3, 4.1, 4.8 mm |
| Standard: 4.8, 6.5 mm | |
| Zimmer | Tapered Screw-Vent ® : 3.5, 4.5, 5.7 mm |
The LOCATOR® F-Tx Attachment System is for rigid connection of fixed, partial and full arch restorations on endosseous dental implants using a snap-in or screw-retained attachment system. The system includes abutments and healing caps. LOCATOR F-Tx abutments are compatible with the implant systems, connection types, and platform sizes listed above, and are provided in various gingival cuff heights ranging from 1 to 6 mm. LOCATOR F-Tx System abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). LOCATOR F-Tx abutments may be provided with an optional coating of either TiCN (titanium carbon nitride) or TiN (titanium nitride). LOCATOR F-Tx System Healing Caps are made of PEEK.
The provided text describes a 510(k) premarket notification for a medical device, the LOCATOR® F-Tx Attachment System. It focuses on demonstrating substantial equivalence to pre-existing predicate devices, rather than presenting a study design with specific acceptance criteria and detailed performance data often seen for novel AI/ML devices. As such, many of the requested points regarding acceptance criteria, study types (MRMC, standalone), sample sizes for test/training sets, expert qualifications, and ground truth establishment are not applicable or cannot be extracted from this document, as it is not a performance study report for an AI/ML device.
This document outlines the device's intended use, design, materials, and provides a comparison to legally marketed predicate devices to establish substantial equivalence. The "Performance Data" section primarily details the non-clinical testing performed to meet various ISO standards related to sterilization, biocompatibility, and mechanical testing, which are typical for dental implant components.
Here's an attempt to address the request based only on the available information, noting where information is absent:
Acceptance Criteria and Device Performance for LOCATOR® F-Tx Attachment System
Based on the provided 510(k) summary, the "acceptance criteria" are primarily demonstrated through substantial equivalence to predicate devices and adherence to relevant non-clinical performance standards. The performance data presented focuses on material properties, sterilization, biocompatibility, and mechanical retention, rather than performance metrics for an AI/ML system.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence: | |
| - Similar Indications for Use | -"The LOCATOR® F-Tx Attachment System is designed to support fixed, partial or full arch restorations on endosseous dental implants in the mandible or maxilla for the purpose of restoring masticatory function. It is used in fixed hybrid restorations that can be attached with a snap-in system." |
- "Substantial equivalence in indications and design principles to legally marketed predicate devices." Comparing language: "The subject device and primary predicate have slightly different Indications for Use language. However, the difference in language does not change the intended use of abutments." |
| - Similar Design Principles | - "LOCATOR F-Tx and Locator (K072878) are each provided with varving cuff heights. The abutment/implant interfaces of all LOCATOR F-Tx abutments are identical to those of the corresponding Locator (K072878) abutments." |
| - Similar Materials | - Abutment: Ti-6Al-4V ELI (same as predicate). - Abutment Coating: TiN (same as predicate), TiCN (same as reference predicate K150295).
- Prosthetic Retention Component: PEEK (predicate uses Nylon). This difference is noted but deemed acceptable. |
| Material Biocompatibility (ISO 10993-1, -5, -12) | - "Characterization and biocompatibility testing of the TiCN coating," - "Biocompatibility testing of the PEEK Healing Caps."
- (Specific results not detailed, but testing was performed and deemed acceptable for submission). |
| Sterilization (ISO 17665-1, -2) | - "Sterilization testing." - (Specific results not detailed, but testing was performed and deemed acceptable for submission). |
| Mechanical Performance (Specifically Retention Strength) | - "The mechanical testing demonstrated the retention strength of the LOCATOR F-Tx Attachment System when using the High Retention Balls was statistically greater than the tensile force created when masticating worst case sticky food (p
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(267 days)
Medentika TiBase CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
Medentika PreFace CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
The subject device includes two CAD/CAM abutment designs, the Medentika TiBase and the Medentika PreFace. The TiBase is a two-piece abutment used as a base when fabricating a zirconia superstructure and the PreFace is an abutment used in fabricating a full patient-specific abutment in titanium alloy. Both abutment designs are provided non-sterile and are intended to be sterilized by the clinician. Medentika Preface Abutment is available in diameters 3.0 mm to 7.0 mm. Medentika TiBase Abutment is available in diameters 3.25 mm to 7.0 mm. The specific diameters for each Series coordinate with the compatible implant systems and sizes listed below.
TiBase is available in two post designs. TiBase Generation 1 has a conically shaped post that is 4.0 mm high and TiBase Generation 2 has a parallel walled post shape that is 5.5 mm high. PreFace is available in one cylinder height of 20 mm. The maximum angle for abutments fabricated using TiBase or PreFace is 30°, the maximum gingival height is 6 mm and the minimum post height is 4 mm.
Medentika CAD/CAM Abutments are compatible with eleven dental implant systems. Each Medentika abutment series has a precision implant/abutment interface corresponding to the implant system predicate for that series.
The provided document is a 510(k) premarket notification for Medentika CAD/CAM Abutments, asserting substantial equivalence to legally marketed predicate devices. It does not describe a study involving an AI/ML powered device, nor does it detail acceptance criteria related to such a device's performance. Instead, it focuses on non-clinical testing to demonstrate safety and effectiveness for a dental abutment. Therefore, I cannot extract the requested information regarding acceptance criteria, study design for AI/ML performance, ground truth establishment, or human-in-the-loop studies from this document.
The "Performance Data" section (Page 6/7) explicitly states the types of non-clinical testing conducted:
- Engineering analysis and dimensional analysis: To determine compatibility with original manufacturers' components.
- Static and dynamic compression-bending testing: According to ISO 14801 (Dentistry – Implants – Dynamic fatigue test for endosseous dental implants).
- Sterilization testing: According to ISO 17665-1 and ISO 17665-2 to demonstrate an SAL of 10^-6.
- Biocompatibility testing: For cytotoxicity according to ISO 10993-5.
The acceptance criteria would be the successful completion of these tests in accordance with the specified ISO standards and demonstrating compatibility and performance comparable to the predicate devices. However, the document does not list the quantitative acceptance criteria or the specific numerical results obtained for each test (e.g., specific fatigue life, or precise dimensional tolerances met).
In summary, the document does not contain the information required to answer the prompt as it pertains to AI/ML device performance. The device is a physical medical device (dental abutments), and the review is for substantial equivalence based on physical and mechanical properties, not an AI/ML algorithm.
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(450 days)
The CORE 3D abutment system for digital prosthetic solutions are dental abutments placed into a dental implant to provide support for dental prosthetic restorations. The abutments include:
- Titanium Bases to be attached to the underlying implant and upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abulment;
- Titanium Abutment Blanks with a pre-machined implant connection where the upper portion may be custom-milled in accordance with a patient-specific design using CAD/CAM techniques;
- Abutment Screws to permanently fix the abutments to the Implant.
Core 3D abutments are intended for use to support single-tooth (unit) and multiple-tooth (bridges and bars) prostheses, in the mandible or maxilla for functional and aesthetic restorations.
Core 3D abutments designed using CAD/CAM techniques must fulfill the Core 3D allowable range of design specifications and be provided as straight abutments only.
Core 3D abutments and are compatible for use with the following dental implants: - Nobel Biocare Branemark System (K022562, K934825)
- Zimmer Tapered Screwvent (K013227, K061410, K072589)
The proposed devices are dental implant abutments intended to be placed into dental implants and to provide support for dental prosthetic restorations.
The system is composed of the following principal components:
- Titanium Bases to be attached to the underlying implant and upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abutment;
- Titanium Abutment Blanks with a pre-machined implant connection where the upper portion may be custom-milled in accordance with a patient-specific design using CAD/CAM techniques
- Abutment Screws: to fix abutments to the underlying dental implant.
The final form of the device including superstructures to titanium bases and patientspecific designs for abutment blanks may be designed using CAD CAM techniques under Core3D design specifications and limitations using the following system: - CAD/CAM Software: 3Shape Dental System including 3Shape Dental Designer
- Scanner: 3Shape D810 model
- Milling machine: SAUER HSC-20 DMG.
Mechanical resistance of the implant-abutment connection is essential to ensure correct long-term functional performance of the complete dental restoration. Dimensional compatibility and mechanical performance of bases and screws together with the underlying implant are of primary importance. These concepts are the basis upon which the system design characteristics and functional performance are established.
The proposed Titanium Bases and Titanium Abutment Blanks are available with either an internal conical connection or external connection, depending on the underlying dental implant. The internal conical types are available in diameters of 3.4, 4.5, and 5.7mm for bases and in diameters of 3.5, 4.5 and 5.7mm for blanks. The external connection types are available in diameters of 3.5, 4.1 and 5.1mm.
Here's an analysis of the provided text regarding the acceptance criteria and study for the CORE 3D Abutment System for Digital Prosthetic Solutions:
Important Note: The provided document is a 510(k) Premarket Notification, which focuses on demonstrating substantial equivalence to predicate devices rather than establishing entirely new safety and efficacy data through clinical trials. As such, the information you've requested regarding detailed acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, and MRMC studies might not be explicitly present in the way it would be for a novel device. The document primarily highlights bench testing results proving compatibility and mechanical performance.
Acceptance Criteria and Device Performance
The document does not explicitly present a table of numerical acceptance criteria alongside reported device performance in the format of a clinical study. Instead, it states that bench testing was performed to determine conformance to performance specifications and requirements.
Table of Acceptance Criteria (Inferred) and Reported Device Performance:
| Acceptance Criteria Category (Inferred from document) | Description / Acceptance Standard (Inferred) | Reported Device Performance |
|---|---|---|
| Mating Characteristics Compatibility | Abutment-implant mating must be compatible. | "all testing showed correct operation of the device as per its intended use, specifically including dimensional compatibility" |
| Mechanical Compression Testing | Must meet specified mechanical strength requirements for compression. | "all testing showed correct operation of the device as per its intended use...mechanical performance testing" |
| Fatigue Testing | Must withstand specified cyclic loading without failure for long-term functional performance. | "all testing showed correct operation of the device as per its intended use...mechanical performance testing" |
| Software Validation (CAD/CAM) | Software must correctly prevent the milling of abutments that do not fulfill Core3D design criteria. | "software validation testing of the software system used to ensure that incorporated design limitations correctly prevent the user from milling abutments that do not fulfill the Core3D design criteria" |
| Compatibility with Implants | Must be compatible with specified dental implants (e.g., Nobel Biocare, Zimmer Tapered Screwvent). | Explicitly states compatibility with these implants. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the sample size used for the bench tests (e.g., number of abutments tested for mechanical properties).
- Data Provenance: The study was non-clinical bench testing. The document does not specify the country of origin for the data itself, but the submitter is based in Spain. It is retrospective in the sense that the testing was completed before the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: This information is not provided in the document. For non-clinical bench testing, "ground truth" is typically established by engineering specifications and standards, not by human experts adjudicating clinical outcomes.
- Qualifications of Experts: Not applicable in the context of this type of non-clinical testing.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable for non-clinical bench testing. The results are typically compared directly against engineering specifications and industry 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
- MRMC Study: No, an MRMC comparative effectiveness study was not conducted.
- Effect Size: Not applicable. This device is a dental implant abutment, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: The document does not describe a standalone performance study in the way it might for an AI algorithm. However, standalone bench testing of the physical abutments and an evaluation of the CAD/CAM software (which operates without human intervention in determining design limits once programmed) effectively represent the "algorithm only" performance for the relevant aspects of this device. The software validation aimed to ensure the software's inherent design limitations correctly prevent non-compliant abutment milling.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the mechanical and dimensional aspects of the abutments and their mating, the ground truth was based on engineering specifications, industry standards, and perhaps predicate device performance data. For the CAD/CAM software, the ground truth for software validation was the Core3D design specifications and limitations.
8. The Sample Size for the Training Set
- Sample Size for Training Set: This information is not provided and is generally not applicable in a traditional sense for a physical medical device. The CAD/CAM software is likely developed based on engineering rules and algorithms, not "trained" on a data set in the machine learning sense.
9. How the Ground Truth for the Training Set was Established
- How Ground Truth for Training Set was Established: Not applicable in the context of this device. The "ground truth" for the software's design rules would have been established by engineering design principles, material properties, and regulatory requirements specific to dental abutments.
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(140 days)
The Tapered Screw-Vent® X Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. The 4.1mmD Tapered Screw Vent X Implants should be splinted to additional implants when used in the posterior region.
The Tapered Screw-Vent®X Implant is an endosseous dental implant. The implant is composed of titanium alloy and Trabecular metal. The implant section is designed for ease of implantation and with greater surface area for osseointegration. The implant section surface is treated to facilitate osseointegration. In addition, the implant section is tapered with triple-lead threads. The Tapered Screw-Vent X implants will be offered in two different texturing configurations: full texture to the top of the implant and texture to 0.5mm from the top of the implant. In addition, both texturing configurations of the implant will have coronal grooves on the collar to within 0.64mm of the top of the implant similar to the predicate Tapered Screw-Vent P Dental implant. The implant/abutment interface platform diameter will be offered in sizes of 3.5mm, 4.5mm, or 5.7mm depending on the outside implant thread diameter. The new device will feature MTX surface equivalent to existing Zimmer Dental implants. The MTX surface is used on the titanium body and is exposed on surfaces apical and coronal to the Trabecular Metal.
The provided text describes a dental implant device, the Tapered Screw-Vent® X Implant, and outlines its characteristics, comparison to predicate devices, and testing performed. However, it does not contain information regarding acceptance criteria or a study that specifically proves the device meets those criteria in the context of an AI/ML algorithm or software.
The document is a 510(k) summary for a medical device (endosseous dental implant) and focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing (mechanical performance) and some clinical data on safety and basic performance.
Therefore, for the requested information related to acceptance criteria and an AI/ML study, the answer is: Not applicable / Not provided in the document.
Here’s a breakdown based on the document's content, highlighting why the requested information for AI/ML performance is not available:
1. A table of acceptance criteria and the reported device performance:
- Not applicable for AI/ML performance. The document does not mention any AI/ML components or software.
- The "Non-clinical Testing" section states: "Testing was performed following 'Guidance for Industry and FDA Staff -Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments.' Performance testing demonstrated that the device performs appropriately for the proposed indications for use." This general statement refers to mechanical and material performance, not AI/ML metrics.
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 for AI/ML test sets. The document refers to clinical studies for human subjects, not a dataset for software testing.
- Clinical Study Sample Size (for device performance): Not explicitly stated in terms of number of patients for the studies, only that a "controlled population" and "normal patients and subjects with elevated risk factors" were included.
- Data Provenance (for clinical studies): Not specified (e.g., country of origin).
- Study Type: "A prospective clinical study" and "A second, longitudinal data collection study" were conducted.
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 for AI/ML ground truth. The document describes clinical studies evaluating implant performance in patients, where "ground truth" would likely be clinical outcomes observed by treating clinicians, not expert consensus on an image or data set for an AI algorithm. No information is provided about expert panels or their qualifications for establishing ground truth as requested for AI/ML evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No adjudication method for an AI/ML test set 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. No MRMC study is mentioned, as this device is a physical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. No AI algorithm is part of this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the AI/ML context. For the clinical studies mentioned, the "ground truth" would be related to clinical outcomes such as implant loading success, osseointegration, absence of adverse events, etc. The document states: "No device related adverse events were reported in either study to date." This implies observed clinical outcomes.
8. The sample size for the training set:
- Not applicable. No AI training set is mentioned.
9. How the ground truth for the training set was established:
- Not applicable. No AI training set is mentioned.
In summary: The provided document is for a physical medical device (dental implant) and does not contain any information related to AI/ML algorithms, their acceptance criteria, performance studies, or associated ground truth establishment.
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