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510(k) Data Aggregation
(379 days)
SGS® Dental Implants System is intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. SGS® Dental Implants System may be immediate loading when good primary stability is achieved and with appropriate occlusal loading. Narrow diameter implants (3.2) are intended for maxillary lateral incisors and mandibular lateral and central incisors.
SGS® Dental Implants System is consist of endosseous form dental implants, internal hex implants, tapered design; cover screws, healing caps and abutment systems; Dental Implants:
P7N Narrow Conical Implant, Internal Hex available as follow:
Diameter 3.2 mm Length 8 mm
P1D Conical Groovy Double Connection Implant, Internal hex Conical Connection available as follow:
Diameter 3.5, 3.75, 4.2, 5, 6 mm Length 8, 10, 11.5, 13, 16.
P5D Conical Groovy Double Connection Implant, Internal hex Conical Connection available as follow:
Diameter 3.5, 3.75, 4.2, 4.5, 5, 6 mm Length 8, 10, 11.5, 13, 16.
P7D Conical Groovy Double Connection Implant, Internal hex Conical Connection available as follow:
Diameter 3.5, 3.75, 4.2, 4.5, 5, 6 mm Length 8, 10, 11.5, 13, 16.
Dental Abutments consist of:
Healing Abutments, Anatomic Straight Abutments, Straight Abutments, Straight Abutments Narrow/Wide, PEEK Temporary Abutments for bars, Angular Anatomic Abutments Ti, Angular Abutments Slim/Narrow, Multi-Base Angular Abutment, Anqular Ball Attachment, S-lock Straight/Anqular Abutment, Easy-Fix Angular Abutment, Straight/One-piece angular Multi-unit Abutment, Ball Attachments, Abutment for temporary restoration, Easy Fix Abutments Straight/Angular, Smart Lock abutments Straight/Angular, Flat connection abutments for casting, overdenture attachments. Titanium abutments are CNC machined with no anodized surface.
The provided document is a 510(k) summary for the SGS® Dental Implants System, used for dental implants and abutments. It details the device's characteristics and its equivalence to previously cleared devices. However, this document does not describe a study involving an AI/Machine Learning device, human readers, or image analysis for diagnosis.
Therefore, I cannot provide a table of acceptance criteria and reported device performance related to AI or a study proving an AI device meets those criteria, as the document pertains to mechanical dental implants and abutments, not a software or AI-based medical device.
The document discusses performance in terms of:
- Biocompatibility: Demonstrated as equivalent to the primary predicate based on the material (Ti6Al4V ELI) and leveraging prior biocompatibility testing per ISO 10993-1.
- Sterilization: Validated per ISO 11137 and ISO 17665, achieving a Sterility Assurance Level (SAL) of 10^-6.
- Shelf Life: Validated per ASTM F-1980 for 5 years.
- Mechanical Integrity (Fatigue Testing): Performed per ISO 14801 to verify the strength of the implant/abutment connection. Results are stated to have "demonstrated the performance" but no specific numerical acceptance criteria or detailed results are provided in this summary.
In summary, based on the provided document, I cannot answer the specific questions related to AI/ML device performance, human reader studies, or image analysis, as the device is a physical medical device (dental implants and abutments) and not an AI/ML diagnostic tool.
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(311 days)
A.B. DENTAL DEVICES® Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. A.B. DENTAL DEVICES® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
A.B. DENTAL DEVICES® Dental Implants System consists of narrow (XXX-3 model number) and standard (XXX-3.75 model number) platform internal hex implants that are used with screw retained, cement retained, or overdenture abutments. This submission adds the following abutments:
- Expansion of the P4 angled abutments to include: .
- Narrow platform abutments (standard and long lengths, 15 and 25 degrees) o
- Narrow platform, anatomic abutments (15 degrees) o
- o Additional standard platform abutments (15 and 25 degrees)
- Additional standard platform, anatomic abutments (15 and 25 degrees) O
- . Expansion of the P5 ball attachments to include narrow platform, 20 degree abutments
- Expansion of the P14 multiunit, angled abutments to include:
- Additional sleeve materials (Delrin and CoCr) O
- Narrow platform abutments (17 and 30 degrees) O
- P25 AB LOC for angular adaptor O
- Addition of P64 multiunit, straight and angled product line (narrow and standard platform, 17 ● and 30 degrees, with Delrin and Ti alloy sleeves), including its healing cap.
- . Modification to the P4a-S screw to improve its performance characteristics
The provided document is a 510(k) summary for the A.B. DENTAL DEVICES® Dental Implants System. It describes the device, its indications for use, and a comparison to predicate devices, focusing on the expansion of existing abutment lines and the addition of new ones. The document details the performance testing conducted to demonstrate substantial equivalence, primarily bench testing for mechanical properties and rationale for other characteristics.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance values in the manner typically seen for algorithmic performance. Instead, it describes various tests and states that the differences in the subject device do not raise new issues or are addressed through testing to establish substantial equivalence to predicate devices. The "acceptance criteria" here are implicitly meeting the performance of the predicate devices or demonstrating that the modifications do not create a new worst-case scenario.
| Aspect of Performance | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Mechanical Strength | - Subject device does not create a new mechanical worst-case compared to predicate (e.g., shorter moment arm, more material). | - Engineering analysis confirmed that new components do not constitute a new mechanical worst-case. |
| - Meets or exceeds performance of predicate devices when tested per ISO 14801. | - Dynamic testing per ISO 14801 was performed on worst-case constructs, demonstrating substantial equivalence (e.g., narrow platform constructs demonstrated substantial equivalence to Straumann Crossfit SLA 3.3 mm (K111357), P64-3.75 shown equivalent to standard platform P14 abutment). | |
| - Modified screw (P4a-S) meets static torque to failure requirements and dynamic testing per ISO 14801. | - Static torque to failure testing conducted for modified P4a-S screw. Static and dynamic testing per ISO 14801 performed in the same construct. The results imply successful performance to support equivalence, though specific values are not provided. | |
| Biocompatibility | Materials (Ti-6Al-4V ELI, Delrin, CoCr) are biocompatible and identical to those used in predicate devices. | - Application of ISO 10993-1, with a scientific rationale that biocompatibility testing was not needed as materials and manufacturing methods are identical to the sponsor's own predicate devices. |
| Cleaning/Sterility | Modifications do not create a new worst-case for cleaning or sterility. Sterilization process is validated per ISO 17665. | - Scientific rationale used to determine that additional components do not constitute a new cleaning or sterility worst-case. Sterilization validated per ISO 17665. The same color anodization (gold) has been cleared on other abutments in K162482, suggesting no new sterility issues related to this aesthetic change. |
2. Sample Size Used for the Test Set and the Data Provenance
The document states that "worst-case construct(s)" were used for mechanical testing per ISO 14801. However, it does not specify the sample size (number of units) for these tests. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective) as the tests are bench-based engineering tests rather than clinical studies with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this type of device and study. The "ground truth" here is based on engineering principles, material properties, and established test standards (like ISO 14801), not on expert consensus for clinical interpretations or diagnoses.
4. Adjudication Method for the Test Set
This information is not applicable as the tests are objective engineering measurements and evaluations against established standards, not subjective assessments requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This is not applicable. The device is a dental implant system (hardware), not an AI or software as a medical device (SaMD) that involves human readers or clinical image interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This is not applicable as the device is a dental implant system, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on:
- Engineering principles and rationale: Used to determine if components constitute a "new worst-case" mechanically or for cleaning/sterility.
- Standardized bench testing: Specifically mentioned ISO 14801 for mechanical fatigue testing and static torque to failure.
- Biocompatibility standards: Application of ISO 10993-1.
- Sterilization standards: Validation per ISO 17665.
- Comparison to predicate devices: The established performance and characteristics of the legally marketed predicate devices serve as a benchmark for demonstrating substantial equivalence.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of this device submission, which involves physical implants and abutments rather than machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no training set mentioned or implied for this type of device.
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(446 days)
Alpha Dent Implants Dental Implants System is intended for surgical placement in the maxillary and/or mandbular arch, to support crowns, bridges, or over dentures, in edentulous patients. It is intended to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. The System is intended to be used in either single tooth or multiple teeth applications. The prostheses can be screw or cement retained to the abutment. The Alpha Dent Implants Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The Alpha Dent Implants Dental Implants System consists of one or two stage endosseous form dental implants, internal hexagonal and one piece implants system. Abutments are used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation. The implantation procedure can be accomplished in a one-stage surgical operation for all implants type beside the INTEGRAL which is for one stage only. The system includes two-piece implant families: Active, Active Plus, and Classic, and a one-piece implant family: Integral. The system also includes prosthetic components such as healing caps, straight and angular abutments, titanium esthetic abutments, multi-unit abutments, ball attachments, and accessories.
The Alpha Dent Implants Dental Implants System has been assessed for acceptance criteria through a series of non-clinical tests.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Material Biocompatibility | Biocompatibility cytotoxicity testing per ISO 10993-5 was performed and results were successful. The implants and prosthetic components are manufactured from Titanium alloy (Ti 6Al 4V ELI) complying with standard ASTM F 136. |
| Surface Morphology and Cleanliness | SEM and Surface analysis (EDS) after the anodize process demonstrated typical features of an anodized surface structure, and the morphology and cleanliness of the final product. The surface morphology and coating characterization are substantially equivalent to the predicate device K050705. |
| Sterilization Validation | Radiation Sterilization validation tests were conducted in compliance with ANSI/AAMI/ISO 11137-1:06 and EN ISO 11137-2:12. Test results demonstrated that a Sterility Assurance Level (SAL) of 10^-6 was achieved and all testing requirements were met. |
| Pyrogenicity | Pyrogenicity testing was performed according to USP using the LAL method on the sterile implants and met the acceptance criteria as required by USP and . |
| Shelf Life (Packaging Integrity) | Accelerated aging per ASTM-F-1980:07 was applied to the final sterile packaged product. Shelf life studies were completed by an independent testing laboratory in accordance with ISO 11607-1. Test results were successful and supported a 5-year shelf life for the sterilized products. Real-time shelf life studies are completed. |
| Dynamic Fatigue (Mechanical Performance) | Static and dynamic compression performance testing was conducted per ISO 14801:07 - Dentistry - Implants - Dynamic fatigue test for Endosseous Dental implants. The worst-case scenario (highest abutment angulation and lowest diameter implant) was tested. The test articles were able to withstand 5,000,000 cycles without failure at a substantially equivalent load to the cited predicate device. Comparative fatigue testing was conducted against a predicate device of similar intended use, size, and design. The results indicate substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify exact sample sizes for each of the non-clinical tests (biocompatibility, surface analysis, sterilization validation, pyrogenicity, shelf life, and fatigue testing). It generally refers to "test articles" being used. The data provenance is derived from non-clinical laboratory studies conducted by the manufacturer and an independent testing laboratory. The country of origin of the data is not explicitly stated, but the standards cited are international (ISO, ASTM, ANSI/AAMI).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the acceptance criteria and study detailed are based on objective non-clinical performance data and adherence to specified international standards, rather than expert judgment or interpretation of medical images or patient outcomes.
4. Adjudication Method for the Test Set
This section is not applicable as the acceptance criteria are based on objective measurements and adherence to pre-defined technical standards, not on subjective assessment or adjudication by multiple evaluators.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This is a non-clinical evaluation focusing on the physical and mechanical properties of the dental implant system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This section is not applicable as the device is a dental implant system, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests was established through:
- International Standards: Adherence to specific requirements outlined in standards like ASTM F 136 (material), ISO 10993-5 (biocompatibility), ANSI/AAMI/ISO 11137-1, EN ISO 11137-2 (sterilization), USP , (pyrogenicity), ASTM-F-1980, ISO 11607-1 (shelf life), and ISO 14801:07 (fatigue testing).
- Predicate Device Equivalence: Performance was compared to legally marketed predicate devices, demonstrating "substantial equivalence" in terms of design, materials, and performance characteristics.
- Objective Measurements: Laboratory measurements such as microscopy for surface morphology (SEM), elemental analysis (EDS), and force/cycle counts for fatigue testing.
8. The Sample Size for the Training Set
This section is not applicable as the device is a dental implant system, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reason as above.
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(183 days)
A.B. DENTAL DEVICES® Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. A.B. DENTAL DEVICES® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
A.B. DENTAL DEVICES® Dental Implants System consists of one and two stage endosseous form dental implants, internal hexagonal and one piece implants systems. Narrow platform implants are to be used with straight abutments only. The following components are being added:
- . P0-3 narrow platform healing caps, 4 and 7 mm length
- PON-3.75 standard platform, narrow healing caps, 4 and 7 mm length .
- P3-5 standard platform, straight abutment, 5 mm diameter, 5 mm length ●
- P3S-3 narrow platform, anatomic, straight abutment, 1, 2, 3 mm shoulder lengths
- . P3SW-3.75 standard platform, anatomic, straight abutment, wide diameter, 1, 2, 3 mm shoulder lengths
- P3W-3 narrow platform, straight abutment, wide diameter, 9 mm length
- P5-3 narrow platform, ball attachment, 4, 5, 6 mm height
- P5-3.75-20 standard platform, 20º ball attachment, 4 and 6 mm height ●
- P9HG-3.75 standard platform, composed abutment, gold alloy
- P9R and P9HR -3.75 standard platform, composed abutment, CoCr alloy
- . P25-3 narrow platform, A.B. LOC abutments, 0, 1, 2, 3, 4 5 mm height
- . P25-3.75 standard platform. A.B. LOC abutments. 0. 1. 2 mm height
- . P64-3.75 standard platform, straight adaptor abutment, 1, 2, 3, 4, 5 mm heights
- P64 plastic and Ti alloy sleeve
- P64 healing cap ●
- PK standard platform, anatomic anti-rotation abutment, 1, 2, 3, 4 mm height
- PK plastic sleeve
- . PK healing cap
This document is a 510(k) premarket notification for the A.B. Dental Devices® Dental Implants System. It describes the device, its indications for use, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria in a typical medical device AI context.
The "Performance Data" section lists several types of engineering analysis and biocompatibility/sterilization/fatigue testing, but these are for the physical dental implant system itself, not for an AI/algorithm-based diagnostic or assistive device. There is no mention of a "device performance" in terms of clinical metrics like sensitivity, specificity, accuracy, or an effect size for human readers.
Therefore, for the specific questions asked about acceptance criteria and a study proving device performance (especially questions related to AI/algorithm performance), the provided text does not contain the requested information.
Here's why and what's missing:
-
A table of acceptance criteria and the reported device performance: Not present. The document focuses on comparing the new components (healing caps, abutments) to previously cleared predicate devices based on material, diameter, platform, length, design, and sterility. There are no performance metrics or acceptance criteria for a diagnostic/assistive function.
-
Sample size used for the test set and the data provenance: Not applicable as there is no "test set" for an AI algorithm. The performance data mentioned relates to physical testing (e.g., fatigue testing), but not clinical trials or data for an algorithm.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth established for an AI algorithm.
-
Adjudication method for the test set: Not applicable.
-
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 document is not for an AI-assisted device.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI algorithm.
-
The type of ground truth used: Not applicable.
-
The sample size for the training set: Not applicable.
-
How the ground truth for the training set was established: Not applicable.
In summary, this document is a 510(k) submission for conventional dental implant components, not an AI-powered medical device. As such, it does not contain the information requested about acceptance criteria and studies proving the performance of an AI/algorithm-based device.
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(270 days)
OsteoReady® Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. RidgeReady® 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible.
OsteoReady® Dental Implant System is consist of endosseous form dental implants, internal hex implants, tapered design; cover screws, healing caps and abutment systems;
Dental Implants:
Performance implants are available as follow: Diameters 3.85, 4.2, 5.0 and 6.0mm with lengths, 7 ( 7mm only to 5&6 dmm), 8, 10, 11.5, 13, & 15 (15mm not for 6.0 dm);
Performance Hybrid Implants are available as follow: Diameter 3.85mm with lengths of 10, 11.5, 13 and 15mm;
RidgeReady Implants are available as follow: Diameter 3.0mm with lengths of 8.0, 10, 12, and 14mm;
Dental Abutments:
Healing Caps, Temporary Abutment, Anatomic Angulated Abutment 15, Anti-Rotation Abutment Slim / Standard, Anatomic Abutment, Angulated Abutment 15, Anti-Rotation Abutment with Collar, Ball Attachments, PEEK Temporary Abutment, O-Ring Abutments, Direct Clip Abutments, attachments for ball.
The provided document is a 510(k) Premarket Notification summary for the OsteoReady® Dental Implant System. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study to prove the device meets specific acceptance criteria for a novel AI/ML-driven medical device.
Therefore, many of the requested details regarding acceptance criteria, performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment for AI/ML performance are not present in this document.
The document details the device's technical specifications, materials, and intended use, and then compares them to predicate devices to argue for substantial equivalence. The "performance" mentioned in the document refers to non-clinical bench testing (e.g., sterilization, shelf life, fatigue, biocompatibility) rather than clinical performance metrics typically associated with AI/ML device validation.
Here's an attempt to answer the questions based only on the provided text, highlighting what is not available:
1. A table of acceptance criteria and the reported device performance
The document does not define explicit quantitative acceptance criteria for clinical performance that would typically be seen for an AI/ML device, nor does it report clinical performance metrics. Instead, the "performance" discussed relates to non-clinical bench testing.
| Acceptance Criteria (Not explicitly stated for clinical performance, but implied for non-clinical) | Reported Device Performance (from non-clinical tests) |
|---|---|
| Sterilization (SAL of 10^-6 achieved per ISO 11137) | Test results demonstrated SAL of 10^-6 was achieved and all testing requirements met. |
| LAL/Endotoxin (Met criteria per USP 161 and USP 85) | Test results met the criteria. |
| Shelf Life (5 years per ASTM F-1980) | Test results demonstrated 5 years shelf life. |
| Packaging Validation (Safety during transportation per ASTM D4169) | Test results met the criteria. |
| Biocompatibility (Cytotoxicity, Irritation, Sensitization per ISO 10993-5, 10993-10) | All test results met the criteria. Manufacturing process did not change biocompatibility. |
| Fatigue (Mechanical connection strength per ISO 14801) | Results demonstrated high performance of implant/abutment mechanical connection. |
| Surface Cleanliness | Surface results met OsteoReady requirements. |
| Risk Assessment (No new safety/effectiveness issues per ISO 14971) | Demonstrated no new safety and/or effectiveness issues. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided as the submission focuses on substantial equivalence based on material properties, design, and non-clinical bench testing, not clinical studies with test sets of patient data for an AI/ML device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided. Ground truth for an AI/ML device performance study would typically involve expert annotations or pathology reports, which are not relevant to this type of 510(k) submission for a dental implant system.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided as no clinical test set for performance evaluation of an AI/ML device was conducted or reported.
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 provided. This type of study is specifically relevant to AI/ML devices that assist human readers, which is not the nature of the OsteoReady® Dental Implant System.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. This refers to AI/ML algorithm performance, which is not applicable to a physical dental implant system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is the conformity to established engineering and material standards through non-clinical testing (e.g., ISO, ASTM, USP standards). There is no "ground truth" derived from clinical patient data or expert consensus in the sense of an AI/ML device.
8. The sample size for the training set
This information is not provided. There is no "training set" in the context of this 510(k) submission for a physical medical device.
9. How the ground truth for the training set was established
This information is not provided as there is no training set mentioned or relevant to this type of device.
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(154 days)
UNIQA® Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. UNIQA® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
UNIQA Conical Connection Implants: #UCI & #UC7 are to be used only with straight abutments.
Conical Mini implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.
UNIQA® Dental Implant System is consist of endosseous form dental implants, internal hex implants, tapered design; cover screws, healing caps and abutment systems; The Dental Implants provided in two types of design:(a) Conical Hex; (b) Internal Hex; Each implant design is available in two options of surface treatment (1) Pure & Porous, P&P which consists of Hydroxyapatite and Calcium Phosphates; or (2) SBA - which consists of sand blast large particles with acid etched;
The provided text describes UNIQA® Dental Implants System and its comparison to predicate devices, but it does not contain information about acceptance criteria for a study or the study details to prove the device meets acceptance criteria related to a diagnostic or AI-assisted product.
The document is a 510(k) premarket notification for a medical device (dental implants and abutments). It focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through comparison of:
- Intended Use and Indications for Use: The UNIQA® system has the same general indications as its primary predicate, with some specific details for certain implant types (e.g., mini implants for specific jaw regions, use with straight abutments) matching reference devices.
- Technological Characteristics: This includes thread design, measurements (diameter/length), connection type, material (Titanium Alloy Ti6Al4V ELI), surface treatment (Pure & Porous, P&P or SBA), self-tapping feature, sterilization method (Gamma Ray), and packaging (Double packaging).
- Performance Testing: Bench tests like fatigue testing (ISO 14801), sterilization validation (ISO 11137, ISO 17665), shelf life (ASTM F-1980), biocompatibility (ISO 10993-5), and surface cleanliness are mentioned. These tests are performed to ensure the device's safety and effectiveness in relation to its physical and material properties, rather than its diagnostic performance.
Therefore, I cannot provide the requested information about acceptance criteria and study details for a diagnostic or AI-assisted device, as this information is not present in the provided text.
The document explicitly states: "Clinical Testing - No clinical data is included in this submission." This confirms that no studies involving human subjects were conducted or reported for this submission to establish a clinical performance metric.
To reiterate, the provided text does not contain:
- A table of acceptance criteria for diagnostic performance metrics (e.g., sensitivity, specificity, accuracy).
- Reported device performance values for diagnostic tasks.
- Sample size used for a test set in a diagnostic study.
- Data provenance for a diagnostic study.
- Number of experts or their qualifications for establishing ground truth in a diagnostic study.
- Adjudication methods for ground truth in a diagnostic study.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
- Standalone performance (algorithm only without human-in-the-loop performance) for a diagnostic algorithm.
- Type of ground truth used for a diagnostic study (expert consensus, pathology, etc.).
- Sample size for a training set of a diagnostic algorithm.
- How ground truth for a training set of a diagnostic algorithm was established.
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(374 days)
A.B. DENTAL DEVICES® Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. A.B. DENTAL DEVICES® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Two Stage Implants: I22, I5, I55, I10.
P4 and P14 angled abutments are to be used only with standard platform implants 3.5 mm in diameter or larger.
A.B. DENTAL DEVICES® Dental Implants System consists of one and two stage endosseous form dental implants, internal hexagonal and one piece implants systems. Narrow platform implants are to be used with straight abutments only. The following components are being added:
| Implant | Platform | Diameter, mm | Length, mm |
|---|---|---|---|
| I22 | Standard | 3.75 | 8, 10, 11.5, 13, 16 |
| 4.2 | 8, 10, 11.5, 13, 16 | ||
| 4.5 | 8, 10, 11.5, 13, 16 | ||
| 5 | 8, 10, 11.5, 13, 16 | ||
| I5 | Narrow | 3.3 | 10, 11.5, 13, 16 |
| I55 | Narrow | 3.3 | 10, 11.5, 13, 16 |
| 3.5 | 8, 10, 11.5, 13, 16 | ||
| Standard | 3.75 | 8, 10, 11.5, 13, 16 | |
| 4.2 | 8, 10, 11.5, 13, 16 | ||
| 4.5 | 8, 10, 11.5, 13, 16 | ||
| 5 | 8, 10, 11.5, 13, 16 | ||
| 6 | 8, 10, 11.5, 13, 16 | ||
| I10 | Standard | 4.5 | 10, 11.5, 13, 16 |
Abutments:
- P0-14 Healing caps, 2.5 7 mm heights .
- P3-5 straight abutments, 5 mm diameter, 7 9 mm length ●
- P4 angled abutments, 15 - 25 degree angulation, standard platform, standard and long lengths
This is a 510(k) summary for a dental implant system. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive performance data against specific acceptance criteria for a novel AI/ML device. Therefore, much of the requested information regarding AI/ML device performance studies is not available in this document.
Here's an analysis of the provided text based on your request, highlighting what is present and what is not:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria in the typical sense for an AI/ML device, as it describes a dental implant system. The performance data presented are primarily related to mechanical and biological safety, not diagnostic accuracy or effectiveness against quantifiable metrics for an AI system.
However, we can infer some "performance data" or testing performed:
| Test Performed | Reported Device Performance |
|---|---|
| Fatigue testing per ISO 14801:2007 | Performed on worst-case implant and abutment combination for standard platform implants and abutments. Engineering analysis to determine novel worst-cases. (Implication: Device withstands fatigue as per standard) |
| Cytotoxicity testing per ISO 10993-5 | Performed. (Implication: Device is biocompatible) |
| Biological risk assessment | Performed. (Implication: Risks are assessed and managed) |
| Gamma sterilization validation per ISO 11137 | Validated. (Implication: Device is sterile) |
| Steam sterilization validation per ANSI/AAMI/ISO 17665-1:2006 | Validated. (Implication: Device is sterile) |
| Packaging validation and accelerated shelf-life testing | Performed. (Implication: Packaging maintains sterility, shelf life is established) |
| LAL testing | Performed. (Implication: Device is endotoxin-free) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The performance data listed (fatigue, cytotoxicity, sterilization, etc.) are standard engineering and biological tests for medical devices, not clinical studies with patient data.
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 information is not applicable and not provided. The "ground truth" for these tests relates to established standards and physical/chemical properties, not expert consensus on medical images or patient outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided.
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. This is a conventional dental implant, not an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the performance tests (fatigue, cytotoxicity, sterilization) would be the established international standards themselves (ISO 14801, ISO 10993-5, ISO 11137, ANSI/AAMI/ISO 17665-1) and their defined pass/fail criteria. For LAL testing, it would be the absence of endotoxins as per FDA guidance.
8. The sample size for the training set
This information is not applicable and not provided. This is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not applicable and not provided. This is not an AI/ML device.
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(160 days)
OsteoReady ® ZircoSeal® Dental Abutments are intended to be used with an endosseous implant to aid prosthetic rehabilitation in order to restore the patient's chewing function. OsteoReady® ZircoSeal® Abutments are compatible with DENTIN® Dental Implant System - Prestige Implant System diameters 3.75, 4.2, 5 & 6;
OsteoReady® ZircoSeal® Abutments are Straight Anti-Rotation Abutments made of titanium alloy. OsteoReady® ZircoSeal® Abutments are available in the following measurements:
Slim Anti-Rotation Titanium Abutment with ZircoSeal®: Length 5,7,9,11,13 mm with Diameter 3.75 mm.
Anti-Rotation Titanium Abutment with ZircoSeal®: Length 5,7,9,11,13 mm Diameter 4.5 mm.
Anti-Rotation Straight Titanium Abutment with ZircoSeal®: Shoulder Length 1,2,3,4 mm Diameter 4.5 mm.
OsteoReady® ZiroSeal® Abutments are straight only and are not intended to be modified chairside or by CAD/CAM to provide an angle correction.
The ZircoSeal surface treatment is the trade name of zirconium nitride.
The ZircoSeal® simply indicates the signature zirconium nitride surface treatment of the abutment. The trade name is unrelated to claims of "sealing" of implant/abutment connection platform.
This document is a 510(k) premarket notification for the OsteoReady® ZircoSeal® Abutments, asserting substantial equivalence to previously marketed devices. It does not describe a study to prove a device meets specific acceptance criteria in the way one might expect for a diagnostic or AI-powered device.
Instead, the "acceptance criteria" here refer to meeting the requirements for demonstrating substantial equivalence to predicate devices, primarily through performance testing, biocompatibility testing, and comparison of device characteristics.
Here's an analysis based on the provided text, addressing your questions where applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of "acceptance criteria" paired with "reported device performance" in the context of clinical accuracy or performance metrics for an AI/diagnostic device. Instead, it lists the types of tests conducted and their successful outcomes as proof of equivalence and safety.
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sterilization Validation | Achieve a Safety Assurance Level (SAL) of 10⁻⁶ | Met all applicable criteria; SAL of 10⁻⁶ was achieved. |
| Biocompatibility Testing | Meet all applicable criteria as per ISO 10993-5 (cytotoxicity) | Met all applicable criteria. |
| Surface Treatment Eval. | (Implied) Consistency with predicate device characteristics | Chemical analysis and abrasion characteristics evaluated (details not provided beyond being "similar"). |
| Material Composition | (Implied) Same or equivalent to predicate devices (GR-5 Titanium) | GR-5 Titanium Ti-6Al-4V ELI (consistent with most predicates). |
| Design Characteristics | (Implied) Similar to predicate devices | Straight Anti-Rotation Abutments, various lengths/diameters, Internal Hex connection (similar to predicates). |
| Indications for Use | (Implied) Substantially equivalent to predicate devices | Minor verbiage differences, but determined not to change intended use. |
| Risk Assessment | Conducted in accordance with ISO 14971:2012 | Determined that differences raise no new safety or effectiveness issues. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a test set or data provenance in the context of a clinical performance study (e.g., for AI/diagnostic algorithms). The "tests" mentioned are non-clinical, such as sterilization, biocompatibility, and material characterization. Therefore, information about "sample size for a test set" or "data provenance" (country of origin, retrospective/prospective) is not applicable or provided.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This device is a dental abutment, not an AI or diagnostic device requiring expert interpretation for ground truth.
4. Adjudication Method
Not applicable. There is no clinical study involving human interpretation or ground truth adjudication in this submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document does not mention an MRMC study. The device is a physical dental abutment, not a diagnostic tool requiring human-AI comparative effectiveness evaluation.
6. Standalone Performance Study
Yes, in a non-clinical sense. The testing performed (sterilization, biocompatibility, surface treatment evaluation) assessed the standalone performance of the OsteoReady® ZircoSeal® Abutments against established standards (ISO, AAMI) and similarity to predicate devices. However, this is not a "standalone algorithm performance" study as would be relevant for an AI device.
7. Type of Ground Truth Used
The concept of "ground truth" as typically applied to diagnostic or AI studies is not directly relevant here. The "truth" in this context is established by:
- Standards compliance: E.g., ISO 10993-5 for biocompatibility, ISO 17665-1/2 and ANSI/AAMI ST79:2010 for sterilization.
- Material specifications: GR-5 Titanium Ti-6Al-4V ELI.
- Manufacturing specifications: Device design features (diameters, lengths, connection type).
- Chemical analysis: For surface treatment evaluation.
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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(137 days)
NOVA® Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. NOVA® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
NOVA® Dental Implants System consists of internal hex dental implants. cover screws and healing caps; abutments system and superstructures; impression copy system & surgical instruments.
Internal hex implants:-
PSI implants are provided in diameters: 3.3, 3.75, 4.2, 5 & 6 with lengths 8, 10, 11.5, 13, & 16 mm. (16 mm is not provided for 6 mm diameter).
PCI implants are provided in diameters: 3.3, 3.75, 4.2, 5 & 6 with lengths 8, 10, 11.5, 13, & 16 mm. (16 mm is not provided for 6 mm diameter).
NOVA Dental Abutments internal hex system provides:
Healing Caps:
HC Series - Narrow (3.75 mm) - Platform height 2,3,4,5,6,7
HC Series - Standard (4.7 mm) - Platform height 2.3.4.5.6.7
HCW Series - Wide (6.00 mm) - Platform height 3,4,5,6
PMI Series - Premium (3.75, 4.7, 6.0 mm) - Platform height 2,3,4,5,6,7
Straight Abutments (Long, straight, narrow, anatomic, curve):
ST Series: Length 8.5, 9.5, 11.5, 12.5 mm.
STA Series: With Shoulder profile height 1, Length 9 mm; profile height 2, Length 10; profile height 3, Length 11; profile height 4 Length 12.
STN: Narrow length 11 mm.
SLM Series: Anatomic Straight Abutment: profile height 1,2,3 length 9,10,11 mm.
SCM Series: Anatomic Straight Abutment: profile height 1.2.3 length 9.10.11 mm.
Angulated Abutments (standard, anatomic, curve):
Standard Angulated Abutment Length 7,9,11 Angulations 15°, 25°.
Anatomic Angulated Abutments Platform height 1,2,3,4 Angulations 15°, 25°.
Anatomic Angulated Curve Platform height 1,2,3, Angulations 15°, 25° .
Ball Attachments Platform height 1.2.3.4.5.6 and related components covers and caps.
Material:
NOVA® Dental Implants System and Dental Abutments System is made of Titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136.
The provided document is a 510(k) premarket notification for the NOVA® Dental Implants System. It aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing new acceptance criteria or proving performance through a clinical study.
Therefore, many of the requested details about acceptance criteria and a study proving the device meets those criteria are not available in this document. This submission focuses on demonstrating that the new device is as safe and effective as existing, predicate devices by comparing their characteristics and performance through non-clinical testing.
Here's what can be extracted and inferred from the document:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, formal "acceptance criteria" for a new, standalone clinical study are not explicitly stated for individual performance metrics in the way you might find in an efficacy trial. Instead, the "acceptance" is based on the new device's performance being comparable to or meeting standards similar to the predicate devices, as demonstrated through various tests.
| Characteristic | Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (NOVA® Dental Implants System) |
|---|---|---|
| Biocompatibility | Conform to ISO 7405:2008 (Dentistry Evaluation of biocompatibility of medical devices used in dentistry) and demonstrate no evidence of causing cell lysis or toxicity, equivalent to predicate devices. | Test results demonstrated no evidence of causing cell lysis or toxicity and thus present equivalent performance as its predicate devices. |
| Dynamic Fatigue Strength | Comply with ISO 14801:2007 (Dentistry-Implants-Dynamic fatigue test for endosseous dental implants), demonstrating equivalent fatigue load strength to predicate devices. | Fatigue - Static & Cycling tests conducted comply with ISO 14801:2007. The results demonstrate that the subject devices are substantially equivalent to the predicate devices. |
| Sterilization | Achieve a Sterility Assurance Level (SAL) of 10-6 and meet all testing requirements. | Test results demonstrated that the SAL of 10-6 was achieved and all testing requirements were met. |
| Material Composition | Conform to ASTM F136 (Titanium alloy Ti-6Al-4V ELI) and be identical to predicate devices. | Made of Titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136. Shares the same raw material as its predicate devices (GR-5 Titanium Ti-6Al-4V ELI). |
| Primary Stability for Immediate Loading | (Implied to be achieved and maintained upon implantation, comparable to predicate devices stated for immediate loading with good primary stability and appropriate occlusal loading). | Indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading, similar to predicate devices. (No specific numerical data on primary stability is provided as this is a non-clinical submission). |
| Intended Use / Indication for Use | Equivalent to the predicate devices: surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices (artificial teeth) to restore chewing function. Also, for immediate loading when good primary stability is achieved and with appropriate occlusal loading. | Identical to the predicate devices. |
| Technological Characteristics (Design) | Similar to predicate devices: threaded, root form endosseous implants. Internal hex dental implants, cover screws, healing caps, abutments, superstructures, impression copy system, surgical instruments. Dimensions (diameters and lengths) comparable to predicate devices. Surface treatments (sand blast with acid etched, anodized) comparable to predicate devices. | Described as internal hex dental implants with various diameters (3.3, 3.75, 4.2, 5, 6 mm) and lengths (8, 10, 11.5, 13, 16 mm). Includes PCI (straight contour) and PSI (tapered contour) implants. Surface treatment includes sand blast with acid etched and anodized. Shares similarity with predicate devices in design and technological characteristics. |
| Risk Management | Conducted in accordance with ISO 14971:2007. | Risk management process was carried out with accordance to ISO 14971:2007. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This submission relies on engineering bench tests and comparisons to predicate devices, not patient-based test sets.
- Data Provenance: The document does not specify the country of origin for the data used in the biocompatibility, sterilization, or mechanical tests, nor does it refer to retrospective or prospective patient data. This is a non-clinical submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" in the context of expert consensus or pathology data is used for clinical studies diagnosing a condition. This document is for a dental implant system being cleared via substantial equivalence, which primarily involves engineering, material, and biocompatibility testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically for clinical performance evaluations, especially for diagnostic devices.
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 premarket notification for a physical medical device (dental implants), not an AI-powered diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical dental implant and abutment system, not an algorithm or software. No standalone algorithm performance was studied.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The compliance of the device with established international standards (ISO 7405, ISO 5832-3, ISO 14801, ISO 14971), and the direct comparison of its design, materials, and intended use against already cleared predicate devices, serves as the basis for "truth" in this regulatory context of substantial equivalence. This is primarily engineering and material science compliance with standards, and logical deduction for equivalence to predicate devices.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth established for one.
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