Search Results

The BLUEDIAMOND IMPLANT is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols:

• Delaved loading
• Immediate loading when good primary stability is achieved and with appropriate occlusal loading.
  For the BLUEDIAMOND IMPLANTS with a Thread Length of 5mm,
  It is indicated for fixed or removable reconstruction in situations of moderate to severely atrophic jawbone and with adequate bone quality that allows primary stability after implant insertion, where a longer implant cannot be placed due to limited vertical bone height. The recommended healing time before loading is between 10 to 12 weeks.
  It is specifically recommended for:
• Fixed partial dentures/splinted units (one implant per unit)
• Pontic cases in combination with at least one longer implant
• Fully edentulous cases with at least one 5 mm Short Implant in combination with 2 longer implants in the anterior region and at least four total implants

The BLUEDIAMOND IMPLANT is a dental implant body system made of CP Ti Grade 4 with the surface treated by SLA method. It is intended to be placed in the maxillary or mandibular areas to restore masticatory function.
It has different thread lengths depending on the diameter and length. The Implanted length of the device is the length that is implanted into the bone, including the length from the thread to the shoulder, which is the non-threaded part.
The Gingival (Cuff) area of the device has grooves; the bottom of the grooves indicate the implantable length.
The BLUEDIAMOND IMPLANT is consisted of the following components.
BLUEDIAMOND IMPLANT Cuff Type: The BLUEDIAMOND IMPLANT is a dental implant body system made of CP Ti Grade 4 with the surface treated by SLA method. It is intended to be placed in the maxillary or mandibular areas to restore masticatory function.
Material: CP Ti Grade 4 of ASTM F67
Dimension (mm):

• Normal Thread Ø 4.0 x 9.0, 11.0, 13.0, 15.0 (7.0, 9.0); Ø 4.4 x 7.0, 9.0, 11.0, 13.0, 15.0 (5.0, 7.0, 9.0); Ø 4.7 x 7.0, 9.0, 11.0, 13.0, 15.0 (5.0, 7.0, 9.0)
• Deep Thread Ø 4.4 x 9.0, 11.0, 13.0, 15.0 (5.0, 7.0, 9.0); Ø 4.8 x 7.0, 9.0, 11.0, 13.0, 15.0 (5.0, 7.0, 9.0); Ø 5.1 x 7.0, 9.0, 11.0, 13.0, 15.0 (5.0, 7.0, 9.0)
  Diameter X Total Length (Thread Length):
• Normal Thread Ø 4.0: 8.0, 9.0, 10.0, 11.0 (1.0, 2.0); Ø 4.4: 7.0, 8.0, 9.0, 10.0, 11.0 (1.0, 2.0); Ø 4.7: 7.0, 8.0, 9.0, 10.0, 11.0 (1.0, 2.0)
• Deep Thread Ø 4.4: 8.0, 9.0, 10.0, 11.0 (1.0, 2.0); Ø 4.8: 7.0, 8.0, 9.0, 10.0, 11.0 (1.0, 2.0); Ø 5.1: 7.0, 8.0, 9.0, 10.0, 11.0 (1.0, 2.0)
  Implanted Length (Thread to Shoulder Height): 2.0, 3.0, 4.0
  Gingival (Cuff) Height: Not Found

The BLUEDIAMOND IMPLANTs are compatible to abutments of The BLUEDIAMOND IMPLANT System from K182448, K192614, K210161, K203808, K233450.

The provided text is an FDA 510(k) summary for a dental implant device (BLUEDIAMOND IMPLANT). It focuses on demonstrating substantial equivalence to predicate devices, rather than an AI/ML medical device. Therefore, it does NOT contain the specific information required to answer your prompt, such as:

• Acceptance Criteria for AI/ML Performance: The document does not describe performance metrics like sensitivity, specificity, AUC, or other measures typically used for AI/ML models. Instead, it focuses on physical and material properties, and mechanical performance (fatigue, pull-out).
• Study Proving Device Meets Acceptance Criteria for AI/ML: No AI model training, validation, or testing is described. The "performance test" section refers to fatigue tests and pull-out tests, which are engineering tests for the physical implant, not for an AI algorithm.
• Sample Sizes for Test Set (AI/ML): Not applicable, as there's no AI/ML test set.
• Data Provenance (AI/ML): Not applicable.
• Number of Experts/Qualifications (AI/ML Ground Truth): Not applicable.
• Adjudication Method (AI/ML Ground Truth): Not applicable.
• MRMC Study (AI/ML): Not applicable.
• Standalone Performance (AI/ML): Not applicable.
• Type of Ground Truth (AI/ML): Not applicable.
• Sample Size for Training Set (AI/ML): Not applicable.
• How Ground Truth for Training Set was Established (AI/ML): Not applicable.

The document primarily discusses:

• Device Description: Material (CP Ti Grade 4), surface treatment (S.L.A), dimensions, components.
• Indications for Use: Placement in maxillary/mandibular molar areas for prosthetic support, delayed and immediate loading protocols, specific recommendations for 5mm thread length implants.
• Substantial Equivalence: Comparison of the BLUEDIAMOND IMPLANT to a primary predicate device (ARi ExCon Implant System) and several reference devices based on design, dimensions, material, surface treatment, sterilization, shelf life, and features.
• Non-Clinical Testing: Biocompatibility, pyrogen/endotoxin testing, sterilization validation, shelf life, modified surface treatment evaluation, and performance test (fatigue test in accordance with ISO 14801, and pull-out testing), and MR compatibility.

In summary, the provided text describes a physical dental implant device and its regulatory submission to the FDA, not an AI/ML-driven medical device. Therefore, it does not contain the information requested about AI acceptance criteria, performance studies, or ground truth establishment.

Ask a specific question about this device

The Ni2 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 smaller Ni2 dental implants (Ø3.6, 4.0, 5.0 mm) 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 larger Ni2 Implants (Ø6.0, 7.0 mm) 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 Ni2 Implant System is comprised of dental implants, superstructures, instruments for prosthetics and surgical instruments. The Ni2 Implant System is specially designed for use in dental implant surgery. A successfully osseointegrated implant will achieve a firm implant when surgically implanted under controlled conditions. They are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations.

The Ni2 Implant System, fixtures are made of commercial pure titanium, grade 4 (ASTM F67) which have a S.L.A (Sand blasted large grit acid etched) treated surface and supplied sterile (gamma radiation). These fixtures can be used one stage surgery method or two stage surgery method. And that are surgically inserted into the upper and/or lower jawbone. The fixtures replace tooth root as providing a stable foundation for restorations.

Geometrically, the implant is screw type. An abutment is connected to the implant through a tapered joint. The Ni2 fixtures are compatible with the abutments which have been previously cleared in K221866.

The non-threaded section of the implant body is also SLA surface treated.

Here's an analysis of the provided text regarding the acceptance criteria and study proving a device meets them.

Based on the provided document (K221847 for the Ni2 Implant System), there is NO information about AI/ML device performance or associated studies.

The document is a 510(k) premarket notification for a dental implant system, and it focuses on demonstrating "substantial equivalence" to existing predicate devices through non-clinical testing. It explicitly states: "No clinical studies are submitted."

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/ML device, as the provided text pertains to a traditional medical device (dental implant).

To answer your request, if this were an AI/ML device, I would need a document that describes studies related to the AI/ML algorithm's performance.

However, I can extract information relevant to the dental implant system's equivalence, which might be mistaken for "acceptance criteria" in a broader sense within the context of a 510(k) submission.

If we interpret "acceptance criteria" as the parameters used to demonstrate substantial equivalence for this traditional dental implant device:

Here's how the document addresses the device's characteristics and how its equivalence is proven:

1. A table of acceptance criteria and the reported device performance

The document doesn't present a formal table of "acceptance criteria" and "reported device performance" in the way one would for an AI/ML algorithm (e.g., sensitivity, specificity thresholds). Instead, it demonstrates substantial equivalence by comparing the characteristics of the Ni2 Implant System to predicate and reference devices. The "performance" is implicitly deemed acceptable if it is substantially equivalent to legally marketed devices.

Here's a summary of the comparative characteristics:

Study to prove device meets the acceptance criteria (Substantial Equivalence):

The "study" refers to the non-clinical tests performed to demonstrate that the Ni2 Implant System performs as safely and effectively as, or is substantially equivalent to, legally marketed predicate devices.

2. Sample sized used for the test set and the data provenance

• Sample size: Not explicitly stated in terms of number of physical implants tested for each mechanical or material property. The document refers to "non-clinical test data" validating substantial equivalence.
• Data provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This would typically be a laboratory/bench-test setting.
• Retrospective or prospective: The tests appear to be prospective, performed specifically for this 510(k) submission or leveraged from prior submissions (e.g., K221866).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This question is not applicable as there is no "test set" in the context of human expert review for an AI/ML algorithm. The "ground truth" for a traditional dental implant device is established through engineering specifications, material standards (ASTM, ISO), and validated test methods (e.g., fatigue testing, biocompatibility testing).

4. Adjudication method for the test set

• Not applicable as there is no "test set" requiring human adjudication in the context of an AI/ML algorithm.

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

• No. This is explicitly stated: "No clinical studies are submitted." An MRMC study is relevant for AI/ML diagnostic devices, not traditional dental implants.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. This is not an AI/ML algorithm.

7. The type of ground truth used

• For this traditional device, the "ground truth" is established by:
  • Engineering specifications and design parameters: Dimensions, tolerances, connection types.
  • Material standards: ASTM F67 (for CP Ti Grade 4).
  • Biocompatibility standards: ISO 10993-1.
  • Sterilization standards: ISO 11137-1, 2, 3.
  • Sterile barrier shelf-life standards: ASTM F1980.
  • Imaging analysis techniques: SEM (Scanning electron microscopy) and EDS (Energy Dispersive X-ray Spectroscopy) for surface characteristics.
  • Mechanical/Fatigue testing: Although specific results are not detailed, these are implied by the broad statement "non-clinical test data submitted for the Ni2 implant system validates its substantial equivalence."

8. The sample size for the training set

• Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established

• Not applicable. This is not an AI/ML device.

In conclusion, the provided document clearly indicates that the Ni2 Implant System is a traditional medical device (dental implant). The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical bench testing and adherence to recognized standards, not through AI/ML algorithm performance studies or clinical trials involving human readers/interpreters.

Ask a specific question about this device

The ARi ExCon Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols:

• Delayed loading

• Immediate loading when good primary stability is achieved and with appropriate occlusal loading.

For TiGEN Abutment and ZrGEN Abutment, all digitally designed abutments for use with TiGEN Abutment and ZrGEN Abutment are intended to be sent to a MegaGen-validated milling center for manufacture.

The ARi ExCon Implant is a substructure of a dental implant system made of CP Ti Grade 4 with the surface treated by SLA method. It is intended to be placed in the maxillary or mandibular areas to restore masticatory function.
The Abutments are prosthetic components directly or indirectly connected to the endosseous dental implant and are intended for use as an aid in prosthetic rehabilitation, allows single & multiple prosthetic restorations.

The provided text is an FDA 510(k) premarket notification summary for the "ARi ExCon Implant System." It details various components of the dental implant system (implants, cover screws, healing abutments, etc.) and compares them to predicate and reference devices to demonstrate substantial equivalence.

However, the document does not contain information about a study that proves the device meets specific acceptance criteria in the context of an AI/human-in-the-loop performance study, such as an MRMC study. The "Performance test" section on page 25-26 only mentions fatigue testing according to ISO 14801 and "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment" to evaluate the performance of subject devices (implant components), and that test results met pre-set criteria. This is a mechanical performance test, not a clinical or human-reader study.

Therefore, I cannot fulfill the request for information regarding:

1. A table of acceptance criteria and reported device performance (in the context of AI/human performance).
2. Sample size for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results or effect size.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used (clinical/AI performance).
8. Training set sample size.
9. How training set ground truth was established.

The document primarily focuses on demonstrating substantial equivalence of the dental implant components through material comparisons and mechanical bench testing to predicate and reference devices, not on the performance of a medical AI device or human-in-the-loop performance with AI assistance.

Ask a specific question about this device