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IS Multi Unit Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as bridges.

IS Multi Unit Abutments are premanufactured dental implant abutments directly connected to the endosseous dental implant with internal hex connections (multiple tooth). IS Multi Unit Abutment System is made of Titanium ELI according to ASTM F136.

IS Multi Unit Abutment System is composed of IS Multi Unit Abutment, IS Multi Unit Angled Abutment, Multi Unit Abutment Cylinder, Multi Unit Healing Cap, Multi Unit Temporary Cylinder, IS Multi Unit Angled Abutment Screw and Cylinder Screw.

All Multi-Unit Abutments (Straight/Angled) are intended only for multi-unit loaded restoration.

I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves a device meets them in the context of an AI/ML medical device.

The document is a 510(k) premarket notification for a dental implant abutment system (IS Multi Unit Abutment System) and focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway for traditional medical devices, not typically AI/ML-driven ones.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document primarily details device descriptions, indications for use, material specifications, and comparisons to predicate devices in terms of physical characteristics and intended use. It also mentions non-clinical testing data related to sterilization and fatigue testing for the physical dental device components.

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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.

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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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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