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510(k) Data Aggregation
(263 days)
The UF(II) Anatomic abutment is intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. The abutment can be used in single tooth replacements and multiple tooth restorations.
The UF(II) Anatomic abutment is intended to be used with the root-form endosseous dental implant to aid in prosthetic rehabilitation. The anatomic abutment has scalloped margins to follow the gingival contour to provide better esthetic results with the final prosthesis. It consist of straight abutment and angled of 5°, 18°, and are made from titanium alloy conforming to ASTM F136. The anatomic abutments are pre-manufactured (stock) abutments is provided non-sterile, this should be user steam sterilized before use.
The provided text describes the 510(k) summary for the UF(II) Anatomic abutment, focusing on establishing substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a study design for device performance. Medical devices like this, classified as Class II, typically undergo performance testing to ensure safety and effectiveness.
Based on the information provided, here's a breakdown of the acceptance criteria and the studies conducted:
1. A table of acceptance criteria and the reported device performance
The document mentions several tests performed according to specific ISO standards and FDA guidance. The "acceptance criteria" are implied by adherence to these standards and demonstration of "substantial equivalence." The "reported device performance" is framed as successful completion of these tests, indicating the device meets the requirements of the standards.
| Acceptance Criteria (Implied) | Reported Device Performance (as described in document) |
|---|---|
| Sterilization Validation: Achieve a Sterility Assurance Level (SAL) of 10^-6 for steam sterilization, per ISO 17665-1 and ISO 17665-2, and FDA Guidance. | "Test results have demonstrated that the SAL of 10-6 was achieved and all testing requirements were met. Sterilization was conducted in accordance with FDA Guidance 'Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling'." |
| Fatigue Test: Meet the dynamic fatigue resistance requirements for endosseous dental implants, considering worst-case scenarios, as per ISO 14801:2007 and FDA Guidance. | "The fatigue test was performed on the subject device in accordance with ISO 14801:2007 Dentistry-Implants-Dynamic fatigue test for Endosseous Dental Implants. The worst case scenario was chosen based on the FDA guidance... The subject device was tested to evaluate its substantial equivalence..." |
| Biocompatibility: Demonstrate biocompatibility based on material composition and contact with the body, following ISO 10993-1 and FDA Guidance. | "The Biocompatibility Test are leveraged from previous submission (K122519). Biocompatibility test conducted in accordance with FDA Guidance Document Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process'." "No new issues of biocompatibility are raised for the subject devices. Therefore, no additional biocompatibility testing was required." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for the non-clinical tests (sterilization, fatigue). It refers to standard testing protocols outlined in the cited ISO standards and FDA guidance documents. These standards typically specify the number of samples required for robust testing.
- Sterilization Validation: Sample size not specified, but implied to be sufficient for achieving SAL of 10^-6 according to ISO 17665-1 and ISO 17665-2.
- Fatigue Test: Sample size not specified, but implied to be sufficient for testing according to ISO 14801:2007, often involving multiple samples tested to failure or a specified number of cycles. The test was conducted on "the subject device."
- Biocompatibility: No new samples were tested for biocompatibility; it was leveraged from a previous submission (K122519).
Data Provenance: The document does not specify the country of origin of the data for the non-clinical tests, nor whether the studies were retrospective or prospective. These are lab-based tests, not clinical studies involving human patients. The submitter is DIO Corporation, located in the Republic of Korea, so the testing was likely conducted in that region or by a contract lab.
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)
This question is not applicable in the context of this 510(k) submission. The "ground truth" for non-clinical performance tests like sterilization and fatigue are objective measurements against established engineering and biological standards (e.g., microbial kill rate, force sustained before failure). These tests do not typically involve human expert interpretation or consensus for establishing "ground truth" in the way a clinical diagnostic accuracy study would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods are used in clinical studies where human interpretation or a "gold standard" reference is subject to variability or requires reconciliation among multiple experts. The non-clinical tests described are objective, laboratory-based physical and biological assessments.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This question is not applicable. The device described, the UF(II) Anatomic abutment, is a dental implant component (an abutment). It is a passive mechanical device and not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study or AI assistance is not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable, as the device is mechanical and not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As discussed in point 3, the concept of "ground truth" derived from expert consensus, pathology, or outcomes data is not directly applicable to the non-clinical performance tests mentioned in the document.
For:
- Sterilization Validation: The "ground truth" is an objective measurement of microbial reduction (e.g., spore log reduction) or sterility against a defined standard.
- Fatigue Test: The "ground truth" is the objective mechanical performance (e.g., cycles to failure, maximum load sustained) measured by engineering equipment against the requirements of ISO 14801.
- Biocompatibility: The "ground truth" is derived from established biological responses to materials as per ISO 10993-1 (e.g., cytotoxicity, sensitization, irritation).
8. The sample size for the training set
This question is not applicable, as this is a mechanical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8.
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(184 days)
Straumann® BLX Implants are suitable for endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially edentulous patients. BLX Implants can be placed with immediate function on singletooth, bar and bridges applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations are connected to the implants through the corresponding abutment components.
Straumann® BLX SRAs and Antomic Abutments: Prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. Temporary components can be used prior to the final components to maintain, stabilize and shape the soft tissue during the healing phase; they may not be placed into occlusion. Final abutments may be placed into occlusion when the implant is fully osseointegrated. BLX Temporary Abutments have a maximum duration of usage of 180 days.
The Straumann BLX Implants are fully tapered implants manufactured utilizing the Roxolid material and are finished with SLActive® surface. The connection is identified as conical fitting with Torx style engaging feature. There are two available prosthetic platforms identified as RB (Regular Base) and WB (Wide Base). The subject devices have a RB platform (a "small top/head") with a Torx-style internal connection, which is identical for all the implant lengths. They are provided sterile by gamma radiation and are available in various sizes.
Straumann® BLX SRAs are manufactured from TAN and are intended to be placed on BLX Straumann dental implants to provide support for permanent screw-retained single or multi-unit restorations. They are provided sterile by gamma radiation and are available in various sizes and angulations.
Straumann® BLX Anatomic Abutments are manufactured from TAN and are intended to be placed on BLX Straumann dental implants to provide support for permanent cement-retained single or multi-unit restorations. They are provided non-sterile and are available in various sizes and angulations. They are delivered with the corresponding basal screw. Anatomic Abutments are provided with pre-defined mucosa margins and with a size that allows for further modification by the customer via hand grinding tools.
The provided text describes a 510(k) premarket notification for the Straumann® BLX Line Extension - Implants, SRAs and Anatomic Abutments. This submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than performing a de novo study to establish new acceptance criteria. Therefore, the information requested in your prompt (Acceptance Criteria and study design for proving it) is not explicitly present in the provided document in the way one might find it for a novel device undergoing clinical trials.
However, based on the performance testing section, we can infer some aspects that act as "acceptance criteria" for demonstrating substantial equivalence to the predicate devices. The study conducted is primarily a series of bench tests and validation studies rather than a clinical trial or a study designed to prove new acceptance criteria.
Here's an attempt to structure the answer based on the provided text, highlighting what is implicitly or explicitly stated about "acceptance" in the context of a 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission demonstrating substantial equivalence to predicate devices, explicit "acceptance criteria" as pass/fail thresholds for a novel claim are not presented. Instead, the performance tests aimed to show that the subject device performs equivalently to the predicate devices and meets relevant industry standards. The "performance" column here reflects the outcome of those equivalence demonstrations.
| Acceptance Criterion (Inferred from Equivalence Testing) | Reported Device Performance |
|---|---|
| Sterilization Validation: Sterility Assurance Level (SAL) of 10-6 in accordance with ISO 11137-1:2006. | Validated to SAL of 10-6 using the over kill bioburden method in accordance with ISO 11137-2:2013 for BLX implants and SRAs. |
| Shelf Life: Packaging and materials prevent adverse effects over time. | Shelf life of 5 years demonstrated as packaging is equivalent to predicate/reference devices, and materials are not adversely affected by time. |
| End-User Sterilization (Anatomic Abutments): Validation according to ISO 17665-1 and ISO 17665-2. | Recommended sterilization method has been validated for BLX Anatomic Abutments. |
| Pyrogenicity: Meets pyrogen limit specifications (e.g., LAL Endotoxin Analysis with testing limit of 20 EU/device). | Device meets pyrogen limit specifications as determined by LAL Endotoxin Analysis with a testing limit of 20 EU/device (for blood contacting and implanted devices). |
| Biocompatibility: Equivalent to predicate/reference devices per ISO 10993-1:2009 and FDA Guidance. | Biological assessment shows the subject devices have equivalent body contact, duration, material formulation, and sterilization methods compared to predicate/reference devices. No new testing performed due to equivalence. |
| Dynamic Fatigue & Static Strength: Equivalent to predicate/reference devices as per FDA guidance for root-form endosseous dental implants. | Dynamic fatigue and static strength tests were performed on both RB and WB platforms (worst-case considerations) and shown to be equivalent to the reference devices. |
| Insertion Torque: Allows for suitable implant insertion torques. | Insertion torque tests were conducted on worst-case BLX implants (Ø3.75 mm) and demonstrated that the implants and related cutting instruments allow reaching suitable implant insertion torques. |
2. Sample size used for the test set and the data provenance
- Sterilization Validation: The document states that the validation was in accordance with ISO 11137-1:2006 and ISO 11137-2:2013, specifically mentioning the "over kill bioburden method." These standards outline protocols for sample size determination, but the exact sample sizes used for the sterilization validation are not specified in this document.
- Bench Testing (Dynamic Fatigue, Static Strength, Insertion Torque): The document mentions that "worst-case considerations" were used for testing various platforms (RB and WB) and implant sizes (e.g., Ø3.75 mm for insertion torque). Specific sample sizes for these bench tests are not provided.
- Data Provenance: All data appears to be prospective bench testing and validation studies conducted by or for the manufacturer (Institut Straumann AG / Straumann USA, LLC). No country of origin for the data is specified beyond it being conducted by the applicant's entity.
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 and not provided in the document. The studies described are engineering and materials science tests (sterilization, biocompatibility, mechanical strength), not studies involving human interpretation or clinical outcomes that would require "experts to establish ground truth." The ground truth for these tests is based on established scientific and engineering principles, international standards (ISO), and FDA guidance documents.
4. Adjudication method for the test set
This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are relevant for studies that involve human interpretation and potential disagreements, such as image reading studies. The described studies are objective engineering tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable and not provided. The device is an endosseous dental implant system, not an AI-powered diagnostic tool or image analysis software. Therefore, an MRMC study or evaluation of AI assistance is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. As stated above, this is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used
The "ground truth" for the various tests described is derived from:
- International Standards: e.g., ISO 11137-1, ISO 11137-2, ISO 17665-1, ISO 17665-2, ISO 10993-1.
- FDA Guidance Documents: Such as "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile."
- Engineering Principles: For mechanical testing like fatigue, strength, and torque.
- Predicate Device Performance: The underlying "ground truth" for a 510(k) submission is that the new device is "substantially equivalent" to predicate devices, meaning it performs as safely and effectively without raising new questions of safety or effectiveness.
8. The sample size for the training set
This information is not applicable and not provided. There is no "training set" as this is not a machine learning or AI-driven device.
9. How the ground truth for the training set was established
This information is not applicable and not provided. There is no "training set" for this device.
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(122 days)
The UV Active Implant System is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic attachment to restore a patient's chewing function.
The narrow (Ø3.0, Ø3.3) implant is limited to the replacement of maxillary lateral incisors and mandibular incisors. It is intended for delayed loading.
The Regular (Ø3.8 ~ Ø5.5) implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability is achieved with appropriate occlusal loading.
The Wide (Ø5.9 ~ Ø6.4) implants can be placed with a conventional two stage surgical process with an option for transmucosal healing and are indicated for the molar region with delayed loading.
The UV Active Implant System includes UV Active Fixture, Abutments (Multi- unit abutment, Cemented abutment, Angled abutment, Solid abutment and Mill abutment), Cylinders (Temporary cylinder, Cemented cylinder, CCM Cylinder) and screws (Abutment screw, Cylinder screw). The UV Active Implant System is specially designed for using in dental implant surgery. A successfully osseointegrated fixtures will achieve a firm implant when the fixture is operated under the controlled conditions per well-known clinical studies. There are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations.
The UV Active Fixture is made of pure titanium grade 4(ASTM F67) and surface treatment is done with SLA (Sand-blasted, Large grit, Acid-atched). The fixtures have the diameter (3.06.4mm) and length (7.013.0mm).
The multi-unit abutment have the diameter of 4.8mm and the angle has straight, 20° and 30°. It is made from titanium alloy conforming to ASTM F136.
The Cemented abutment, Angled abutment, Solid abutment and Mill abutment has same diameter when comparing to each primary predicate device. The subject device and the predicate device are the same except for surface treatment change from machined surface to TiN Coated surface. The Cemented abutment, Solid abutment and Mill abutment made from titanium alloy confirming to ASTM F67. The Abutment screw and Cylinder screw are made of titanium alloy confirming to ASTM F136 and no surface treatment for these components.
The Fixtures are supplied gamma sterilization. The abutments, screws and cylinders are provided nonsterile, these should be user steam sterilized before use.
The provided text describes a 510(k) submission for the UV Active Implant System, which is an endosseous dental implant system. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study design for acceptance criteria based on performance metrics such as sensitivity, specificity, and AUC. The "acceptance criteria" discussed are related to meeting standards for medical devices and demonstrating substantial equivalence.
Based on the provided information, I can extract the following:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not in the format of sensitivity/specificity/AUC, but rather conformance to established medical device standards and demonstrated substantial equivalence to predicate devices.
| Acceptance Criteria Category | Specific Acceptance Criteria (Standards Met) | Device Performance/Outcome |
|---|---|---|
| Sterilization Validation | ISO 11137-1, 11137-2, 11137-3 (Gamma) | Achieved SAL of 10^-6 |
| ISO 17665-2 (Steam) | All testing requirements met | |
| Shelf Life Testing | ASTM F1980 (Accelerated aging) | Accelerated aging results supported; real-time testing ongoing |
| ASTM F88 (Seal peeling) | Met | |
| ASTM F1140 (Burst test) | Met | |
| ASTM F1929 (Dye penetration) | Met | |
| ASTM F2096 (Bubble test) | Met | |
| Sterility test | Met | |
| Appearance | Met | |
| Dimension Test | Met | |
| Fatigue Test | ISO 14801:2007 | Met criteria ("worst case scenario chosen") |
| Biocompatibility | ISO 10993-1 (Biological evaluation) | No new issues of biocompatibility raised |
| ISO 10993-5 (Cytotoxicity in vitro) | Met | |
| ISO 10993-12 (Sample preparation) | Met | |
| Substantial Equivalence | Comparison to predicate devices (K122519, K173975, K170608, K161987, K062129, K071357, K150199, K161416, K141457, K161689) across various characteristics (materials, design, dimensions, indications for use, surface treatment, etc.) | Found to be substantially equivalent. Differences in packaging were validated not to affect safety/efficiency. Differences in diameter and Indications For Use are mitigated by reference predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of a clinical performance study with human subjects, nor does it refer to data provenance in terms of country of origin or retrospective/prospective collection for an AI/CAD-like device. The testing described is non-clinical testing on the device itself (e.g., sterilization, fatigue, biocompatibility). Therefore, there is no mention of sample size for human subjects or data provenance.
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/CAD system evaluated by experts for ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable.
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 AI/CAD functionality is described in this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. No AI/CAD functionality is described in this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is the fulfillment of established engineering, material, and biological standards through laboratory testing. For example:
- Sterilization: Measured sterility assurance level (SAL).
- Fatigue: Measured force resistance and cycles to failure against ISO 14801:2007.
- Biocompatibility: In vitro cytotoxicity assays and general biological evaluation against ISO 10993 series.
- Dimensional/Material: Conformance to specified dimensions and material properties (e.g., CP Ti Gr4 (ASTM F67), Ti-6Al-4V ELI (ASTM F136)).
8. The Sample size for the Training Set
Not applicable. There is no training set mentioned, as this is not an AI/CAD device.
9. How the ground truth for the training set was established
Not applicable.
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(90 days)
The Zimmer Zfx Titanium Abutment for Straumann Bone Level Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with Straumann Bone Level implants with a Narrow CrossFit Connection (NC) Ø3.3mm or Regular Crossfit Connection (RC) Ø4.1mm or Ø4.8mm.
The Zimmer Zfx Titanium Abutment for the Straumann Bone Level implant system is designed for use with Straumann Bone Level implants to support single or multi tooth restorations. The abutment/implant interface is a conical connection with 4 grooves for insertion guidance.
The Zimmer Zfx Titanium Abutment for Straumann Bone Level Implant System is a patient specific dental implant abutment with a competitor compatible interface. The purpose of a Patient-Specific abutment is to satisfy customer needs that are otherwise difficult to meet with off-the-shelf abutments. They can be manufactured in multiple sizes, shapes, and angles within the limits established in this submission. They frequently incorporate the modifications typically done at a dental laboratory or "chair-side" by a dentist. Traditional methodologies require the customer (dentist/laboratory technician) to begin with a "stock" abutment and use manual subtractive techniques to remove material from this original "stock" design. However, a Patient-Specific abutment will incorporate these same modifications desired by the customer (dentist/laboratory technician) at the time of fabrication at the manufacturing facility.
The engineering drawings list ranges in areas (attributes) of the abutment that may be modified depending upon patient-specific needs.
The abutment is composed of Titanium alloy (Ti6Al4V), and secured to the implant with a separate Titanium alloy screw for retention.
The new abutment will be offered in Narrow CrossFit (NC) Ø 3.3mm and Regular CrossFit (RC) Ø 4.1mm or Ø 4.8mm implant connection sizes.
The provided document is a 510(k) Pre-Market Notification for a dental abutment, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance criteria through a study with a test set of data. Therefore, many of the requested elements for AI/machine learning device studies are not applicable to this document.
However, I can extract information related to the non-clinical testing performed to support the substantial equivalence claim.
Here's the breakdown based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define acceptance criteria in a quantitative table format for performance metrics like accuracy, sensitivity, or specificity, as would be expected for an AI/ML device. Instead, "acceptance criteria" are implied by demonstrating compatibility and equivalent mechanical performance to a predicate device through non-clinical testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compatibility | • The Zimmer Zfx Titanium Abutment for Straumann Bone Level Implant System can be deemed compatible with the Straumann Bone Level implant interface. |
| • Achieved through reverse engineering of Straumann Bone Level implants, abutments, and retaining screws. | |
| • Dimensional specifications were developed based on reverse engineering results. | |
| • Tolerance analysis and rotational analysis conducted to illustrate the nature of fit between Zimmer parts and OEM implant. | |
| Mechanical Strength/Fatigue | • Fatigue testing completed on Zimmer fabricated abutments assembled to OEM implants, in accordance with FDA guidance "Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments." |
| • Results were "compared to fatigue testing data of the predicate #3 device" (Straumann Bone Level Anatomic Abutment). The direct quantitative results of this comparison are not provided, but the conclusion is that the device is substantially equivalent. | |
| Sterilization | • Sterilization procedures listed in the Instruction For Use were validated to provide a minimum sterility assurance level of 10⁻⁶. |
| MRI Safety | • Evaluated for interactions with magnetic fields during MRI in accordance with FDA Guidance: "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment." |
| • Determined that the presence of the abutment poses no additional restrictions on MRI beyond what would otherwise occur for the patient. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document does not specify a "test set" in the context of an AI/ML study, but for non-clinical testing:
- Reverse Engineering: Based on "actual measurements taken from Straumann Bone Level implants, abutments and retaining screws." The exact number of units measured is not specified.
- Fatigue Testing: The number of Zimmer fabricated abutments and OEM implants used for fatigue testing is not specified.
- Data Provenance: The data is internally generated from non-clinical laboratory testing performed by Zimmer Dental Inc. (USA) and references FDA guidance documents. This is prospective data collection for the purpose of regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/ML study involving human expert ground truth for classification or diagnosis. The "ground truth" for compatibility and mechanical performance was established through engineering analysis and physical testing against established standards and predicate device performance.
4. Adjudication method for the test set
Not applicable. No expert adjudication method was employed as it was not an AI/ML study requiring human interpretation or consensus for a "test set."
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 medical device submission for a physical dental abutment, not an AI/ML software. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical dental abutment, not an algorithm.
7. The type of ground truth used
For the non-clinical testing:
- Compatibility: "Ground truth" was established by reverse engineering measurements of existing, legally marketed Straumann Bone Level implant components and developing dimensional specifications, and by conducting tolerance and rotational analyses to ensure proper fit.
- Mechanical Fatigue: "Ground truth" was established by comparing the fatigue test results of the new device to the fatigue testing data of the predicate device (#3, Straumann Bone Level Anatomic Abutment), as well as adherence to FDA guidance standards for dental implant abutments.
- Sterilization: Validation against a minimum sterility assurance level (SAL) of 10⁻⁶, a recognized standard.
- MRI Safety: Adherence to FDA guidance for assessing passive implants in an MR environment.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for an AI/ML model.
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