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The Fiber-Metal Post is indicated for use as a root canal post. The post is cemented into the prepared root canal of a tooth to support a permanent restoration.

The Fiber-Metal Post consists of central core wires twisted around polymer bristles that extend radially from the core. The post will be available is several sizes (length and OD as measured over the fibers) and configurations based on bristle arrangement (straight or tapered).

The provided text describes a 510(k) Premarket Notification for the Foremost Fiber-Metal Post, a root canal post. It does not pertain to an AI/ML powered medical device, therefore, many of the requested categories are not applicable.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The document mentions "Performance testing for the Fiber-Metal Posts consisted of a cyclic loading test on teeth restored using the post. Both occlusal and lateral loading was evaluated." It also states, "Unrestored, caries-free endodontically-treated teeth served as the control." However, the exact number of teeth or posts tested is not provided.
• Data Provenance: Not specified, but generally, such performance testing for dental devices is conducted in a laboratory setting or on extracted human or animal teeth. The document does not specify country of origin or whether it was retrospective or prospective in the context of human subjects.

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

Not applicable. This device is a physical root canal post, not an AI/ML system that requires expert ground truth for image interpretation or diagnosis. The "ground truth" here is the physical performance of the device under mechanical stress.

4. Adjudication Method for the Test Set

Not applicable. This is not an AI/ML or diagnostic device requiring adjudication of interpretations. The performance is measured mechanistically.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This is a physical dental device, not a diagnostic or AI system evaluated for reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. This is a physical dental device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the physical performance under cyclic loading, compared to a control group of "Unrestored, caries-free endodontically-treated teeth."

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML system that requires a training set.

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

Not applicable. This device is not an AI/ML system that requires a training set.

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Intended for use by dentists to give retention for reconstruction of endontically treated teeth.

Not Found

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for a dental device (FRC Postec Plus) and primarily focuses on regulatory approval based on substantial equivalence to a predicate device. It does not detail specific performance acceptance criteria or the study design and results as requested in your prompt.

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Intended for use as a fiber reinforced root canal post

everStick™ POST is a semi-manufactured product made of glass fibers and polymer/resin matrix. The glass fiber in everStick™ POST is unidirectional which increases the strength and stiffness of the final product perpendicular to the direction of the fibers.

This submission pertains to the everStick™ POST, a glass fiber root canal reinforcement device. The 510(k) summary provided does not contain the detailed performance study information typically found in a clinical study report for evaluating acceptance criteria and device performance in the context of an AI/ML medical device.

The document is a traditional 510(k) premarket notification for a medical device (a physical product) and therefore does not include the elements you've requested that are specific to AI/ML device studies.

Here's why the requested information cannot be extracted from the provided text:

• Acceptance Criteria & Reported Performance: The document states that the device is substantially equivalent to a predicate device (everStick™ K011788) with the same composition and technological characteristics, save for a slight difference in fiber/matrix ratio. It also states that the second predicate device (Ribbond K913040) has the same intended use but different technological characteristics that "do not raise new questions of safety and effectiveness." This implies that the acceptance criteria are primarily related to safety and effectiveness demonstrated through substantial equivalence to existing, legally marketed devices, rather than specific performance metrics from a comparative study. No specific numerical performance metrics are provided.
• Sample Size (Test Set) and Data Provenance: Not applicable, as this is not a study involving a test dataset for an AI/ML model.
• Number of Experts & Qualifications (Ground Truth): Not applicable. The ground truth for this type of device is established through material science testing and clinical experience with similar products, not expert consensus on image interpretation.
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable.
• Standalone (Algorithm Only) Performance: Not applicable, as this is a physical medical device, not an algorithm.
• Type of Ground Truth: For this device, the "ground truth" would be established through material property testing (e.g., strength, stiffness, biocompatibility) and clinical data/experience with the predicate devices. The document explicitly mentions comparing ingredients to "existing data available from dental polymerizable material" to state it "does not expose the dentist or the patient to unacceptable risks."
• Sample Size for Training Set: Not applicable.
• How Ground Truth for Training Set was Established: Not applicable.

Summary based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance: Not applicable. This is not a study involving a test dataset in the context of AI/ML.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used: Implied "ground truth" is based on material science testing, compositional analysis compared to approved predicate devices, and existing clinical data/experience with similar dental polymerizable materials and fiber reinforcement products.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

In conclusion, the K030820 submission is a standard 510(k) for a physical dental device. The "study" referenced for meeting acceptance criteria is implicitly the demonstration of substantial equivalence to predicate devices through compositional comparison and existing safety/effectiveness data for those predicates and similar materials, rather than a clinical trial with specific performance metrics against a defined ground truth derived from expert consensus or pathology, as would be common for AI/ML devices.

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The FIBIOCORE composite posts are intented for use by dentists to give retention for reconstruction of non-vital teeth. The device is intended to be cemented into the root canal of a tooth to stabilize and support a restoration.

Glass Fiber composite root canal post

The provided text describes a 510(k) premarket notification for the FIBIOCORE Glass Fiber Composite Posts. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than on detailed performance criteria typically associated with software or AI-based devices. Therefore, much of the information requested in your prompt (e.g., acceptance criteria tables, sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) is not applicable or available in this document.

Here's an analysis of the available information:

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

• Acceptance Criteria: The primary "acceptance criteria" for this 510(k) submission are based on demonstrating substantial equivalence to legally marketed predicate devices. This is achieved by showing the new device has similar:
  • Quality of mechanical characteristics
  • Mechanical safety
  • Materials
  • Design
  • Performance
  • Indications for use
• Reported Device Performance:
  • Biocompatibility: Standard ISO 10993-5 "Biological evaluation of medical devices - Tests for Cytotoxicity : in vitro methods" was conducted, showing "no evidence of a cytotoxic response."
  • Mechanical Strength: Mechanical tests were conducted in conformance with ISO 3597-2 (Three-point Bending Standards). The results "showed the material to be suitable for root canal posts." Other unspecified mechanical tests were also conducted to characterize the material.

2. Sample sized 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 in the document as it is not typically required for a 510(k) submission for a Class I dental device. The "test set" in this context refers to samples of the physical device used for mechanical and biological testing, not a dataset for an algorithm.

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. This device is a physical dental post, not an AI or imaging device requiring expert interpretation for ground truth. Technical experts would have conducted the ISO standard tests.

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

• Not applicable. This refers to adjudication of expert interpretations for AI/imaging studies, which is not relevant here.

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 not an AI-assisted device, so MRMC studies are not applicable.

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

• No. This is not an algorithm, so standalone performance is not applicable.

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

• The "ground truth" for this device's performance is established by conformance to international standards (ISO 10993-5 for biocompatibility and ISO 3597-2 for mechanical strength) and by demonstrating similar physical and mechanical properties to predicate devices.

8. The sample size for the training set

• Not applicable. This device does not use a "training set" in the context of machine learning.

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

• Not applicable. There is no training set for this device.

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The Carbon Post is a root canal post for use with composite resin cement in a prepared root canal in a non-vital tooth to stabilize and support a restoration.

Not Found

The provided text is a 510(k) premarket notification FDA letter for a device called "Carbon Post." This document is a regulatory approval letter and does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested information based on the input text. The letter confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed, but it does not detail the scientific studies or performance data that would typically be associated with such a submission.

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FRC Postec is intended for use by dentists to give retention for reconstruction of endontically treated teeth

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to Ivoclar Vivadent, Incorporated for their device, FRC POSTEC. This document is related to the regulatory approval of a medical device, specifically a root canal post, and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter explicitly states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This type of regulatory submission (510(k)) focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies that define and meet specific acceptance criteria in the manner expected for new, novel devices or those undergoing a PMA (Premarket Approval) process.

Therefore, I cannot provide the requested information from the given text. The document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. Information about MRMC comparative effectiveness studies.
6. Details of standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is a regulatory approval letter based on substantial equivalence, not a detailed technical report or study protocol.

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The Glass Post is a root canal post for use with composite resin cement in a prepared root canal in a non-vital tooth to stabilize and support a restoration.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter for a dental device (Glass Post) and does not contain information about acceptance criteria or a study proving device performance using AI. The document confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not detail any performance studies, acceptance criteria, or AI-related evaluations. It is a regulatory approval, not a technical performance report.

Therefore, I cannot provide the requested information based on the input text.

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Snowpost & Snowlight posts are indicated for use wherever root canal posts are required Showpost & Showingin posts are mellor and/or where known metal allergies are of concern.

Not Found

The provided 510(k) summary (K012354) for the Snowpost & Snowlight devices describes acceptance criteria and a study to demonstrate substantial equivalence to predicate devices, but does not describe an AI/ML device or its performance criteria. The device in question is a physical dental product (glass fiber composite root canal post).

Therefore, I cannot fulfill the request to describe the acceptance criteria and study that proves an AI device meets acceptance criteria based on this document. The information requested regarding AI/ML device performance, sample sizes for training/test sets, ground truth establishment, expert adjudication, MRMC studies, and standalone performance is not applicable to this 510(k) submission.

However, I can extract the information relevant to the actual device described in the 510(k):

1. Table of Acceptance Criteria and Reported Device Performance:

Regarding the other points requested (which are for AI/ML devices):

• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, this is a physical medical 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): Not applicable.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here is the performance against ISO standards.
• 8. The sample size for the training set: Not applicable. There is no AI model.
• 9. How the ground truth for the training set was established: Not applicable.

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