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The implant for dental purposes, used to replace missing dental organs (teeth). The implant is self-tapping (threads) and is screwed into a pilot bore formed in the jawbone. Upon healing, the implant receives a post, which has a stem, and is adapted to carry dental supra-structures (false teeth).

The modification is to be able to use stronger titanium because of situations in which this could be beneficial. Since B.A.S.I.C. Dental has been approved as a system using CP Titanium, which is the weakest of the standard titanium available, we would like to be able to use stronger titanium to increase the overall strength of the implant. By using stronger titanium there should be no need for further testing, however the following tests were performed to compile with design controls. The testing revealed as expected that implants produced with stronger titanium had better shear/lateral forces, with no lateral constraints.

I'm sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) summary for a dental implant modification, focusing on material changes and substantial equivalence to a predicate device. It discusses:

• Device Identification and Modification: B.A.S.I.C. Dental Implant System, modified to use stronger titanium.
• Intended Use: Identical to the predicate device, for replacing missing teeth.
• Comparison to Predicate Device: Argues substantial equivalence based on identical dimensional characteristics and indications for use. Mentions other predicate devices with similar dimensions and titanium alloy materials.
• Testing: States that "the following tests were performed to compile with design controls. The testing revealed as expected that implants produced with stronger titanium had better shear/lateral forces, with no lateral constraints."
• Sterilization and Biocompatibility: Confirms the sterilization process remains the same and references ISO standards.
• Conclusion: Reaffirms substantial equivalence.
• FDA Letter and Indications for Use: The official FDA clearance letter and the stated indications for use.

Crucially, it does not provide details about acceptance criteria, specific study designs, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness with human readers (MRMC studies). The mention of "testing revealed... better shear/lateral forces" is too high-level to infer specific acceptance criteria or detailed study methodologies.

Therefore, I cannot populate the requested table or answer the specific questions about the study design, ground truth, or expert involvement based on the provided text.

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The implant for dental purposes, used to replace missing dental organs (teeth). The implant is self-tapping (threads) and is screwed into a pilot bore formed in the jawbone. Upon healing, the implant receives a post, which has a stem, and is adapted to carry dental suprastructures (false teeth).

The B.A.S.I.C. Dental Implant is an endosseous dental implant. The implant, healing cap and healing screws will now be provided in a sterilized medical grade Tyvek® pouches in accordance with ISO 11137 (SAL 10to). In addition, implants are now provided in diameter of 6.0 mm and lengths of 8.0 mm and 9.0 mm to provide a wider range of options for the dental professional.

The provided text is a 510(k) summary for the B.A.S.I.C. Dental Implant System. It describes modifications to an existing device rather than a new device that requires a comprehensive clinical study with acceptance criteria and a detailed study report. Therefore, much of the requested information regarding acceptance criteria, study details, and performance metrics is not explicitly available in this document.

However, based on the context of a 510(k) submission, the "acceptance criteria" are implied to be substantial equivalence to a predicate device, meaning the modified device performs as safely and effectively as a legally marketed device and does not raise new questions of safety or effectiveness. The "study" proving this is primarily a comparison to predicate devices and adherence to relevant standards, rather than a clinical trial with performance targets.

Here's an attempt to answer the questions based on the provided text, recognizing the limitations of a 510(k) summary for device modification:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for device modifications aiming for substantial equivalence rather than a new device with specific performance claims from a clinical trial, the "acceptance criteria" are primarily met through comparison to predicate devices and adherence to standards.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated as a traditional clinical "test set" in the document. The "samples" referenced for sterilization and device integrity validation are "produced under routine manufacturing conditions," but the quantity is not specified.
• Data Provenance: Not applicable in the context of a clinical study. The data provenance relates to internal testing (sterilization validation, FMEA, in-house requirements) and comparison to existing market data (other cleared devices). This is retrospective in the sense of looking at existing cleared devices and standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Number of Experts: Not applicable. Ground truth in this context is established by adherence to recognized standards (ISO 11137, FDA Guidance) and comparison to legally marketed predicate devices, rather than expert consensus on a specific test set.
• Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There was no clinical PIVOTAL trial of read performance to adjudicate.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, an MRMC comparative effectiveness study was not done or required for this 510(k) submission. This type of study is typically associated with new diagnostic devices or AI algorithms where human reader performance is a key outcome.
• Effect Size: N/A.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

• Standalone Study: No, this is not an AI/algorithm-based device. No standalone performance study in that sense was conducted or described.

7. Type of Ground Truth Used

• Ground Truth: For this device modification, the "ground truth" is established by:
  • Regulatory Standards: Compliance with ISO 11137 for sterilization, and internal requirements for device integrity and functionality.
  • Predicate Device Equivalence: The existence and safety/effectiveness of previously cleared devices (both the unmodified B.A.S.I.C. Dental Implant System and other manufacturers' devices) with similar dimensions and characteristics serve as the de facto "ground truth" for the new design's safety and effectiveness.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable.

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The BASIC Dental Implant System Post & Core - Thin Attachment is indicated for attaching artificial teeth to a dental implant.

The Post and Core - Thin Attachment is a one-piece attachment. The base is cemented into a dental implant. Artificial teeth are then attached to the Post and Core - Thin using conventional techniques.

The provided document is a 510(k) summary for the BASIC Dental Implant System Post and Core - Thin Attachment, submitted to the FDA in 2002. This summary states that no performance data or results of clinical studies were provided for this device. Instead, the submission concluded that the device is "substantially equivalent to other existing Post and Core attachments in commercial distribution."

Therefore, based solely on the provided information, it is not possible to describe acceptance criteria or a study proving the device meets those criteria, as none were included in this 510(k) summary.

In such a scenario for a 510(k) submission, the FDA's determination of substantial equivalence often relies on:

• Comparison to a Legally Marketed Predicate Device: The current device (Post and Core - Thin Attachment) is compared to a predicate device (BASIC Dental Implant System Post and Core Attachment, K960868). The assumption is that if the new device has the same intended use, similar technological characteristics, and raises no new questions of safety and effectiveness, then the performance data of the predicate device (or lack thereof, if also cleared through substantial equivalence without new performance data) is deemed sufficient.
• Existing Standards: While not explicitly mentioned here, for certain device types, compliance with recognized industry standards might be cited in lieu of novel performance studies.

To answer your specific questions based on the provided text, the response would be as follows:

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

   • Acceptance Criteria: Not specified in the document. The basis for clearance was substantial equivalence to a predicate device, not meeting predefined performance criteria from a new study.
   • Reported Device Performance: No performance data was reported or provided in this 510(k) summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not applicable as no performance studies were conducted or provided for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not applicable as no performance studies were conducted or provided for this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable as no performance studies were conducted or provided for this submission.

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 device is a mechanical dental implant accessory, not an AI-assisted 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 mechanical dental implant accessory, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

   • Not applicable as no performance studies were conducted or provided for this submission.

8. The sample size for the training set

   • Not applicable as no computational or AI-based device was involved. No training set was used.

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

   • Not applicable as no computational or AI-based device was involved. No training set was used.

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The Implant for dental purposes, used to replace missing dental organs (teeth). The Implant is self-tapping (threads) and is screwed into a pilot bore formed in the jawbone. Upon healing, the Implant receives a post, which has a stem, and is adapted to carry dental suprastructures (false teeth).

The BASIC Dental Implant is an endosseous dental implant.

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria.

Specifically:

1. Acceptance Criteria and Reported Device Performance: The document explicitly states "Performance Data: None" and "Results of Clinical Study: None." Therefore, no table can be created.
2. Sample Size and Data Provenance (Test Set): Not applicable, as no study results are reported.
3. Number and Qualifications of Experts (Ground Truth - Test Set): Not applicable.
4. Adjudication Method (Test Set): Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable, as no study is detailed.
6. Standalone Performance Study: Not applicable.
7. Type of Ground Truth Used: Not applicable.
8. Sample Size for Training Set: Not applicable.
9. How Ground Truth for Training Set was Established: Not applicable.

The document is a 510(k) summary for the BASIC Dental Implant System Implant. It focuses on demonstrating substantial equivalence to a legally marketed predicate device (BASIC Dental Implant System, K960868), which allowed it to be marketed without new clinical performance data. The FDA letter confirms the substantial equivalence determination.

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The BASIC Dental Implant System Straight 2-Piece Post and Core Attachment is indicated for attaching artificial teeth to a dental implant.

The Straight Post and Core II Attachment is a three-piece attachment. The top is attached to the base with a hex screw. The base is cemented into a dental implant. Artificial teeth are then attached to the Straight Post and Core II using conventional techniques.

The provided document is a 510(k) summary for the BASIC Dental Implant System Straight Post and Core II Attachment, which is an accessory to a dental implant. It states that no performance data or clinical studies were conducted for this device, as it was deemed substantially equivalent to an existing device (BASIC Dental Implant System 2-Piece Post and Core Attachment K number K001259).

Therefore, it is not possible to provide the requested information regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, or ground truth types, as these are typically derived from formal performance studies which were not performed for this 510(k) submission.

The document indicates that the determination of substantial equivalence was based on a comparison to a predicate device already on the market, implying that the new device shares similar technological characteristics and intended use, and therefore is presumed to meet the same safety and effectiveness standards without requiring new performance studies.

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