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For orthodontic splinting

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

This document is a 510(k) summary and FDA letter regarding the everStick® A&O device. It does not contain information about acceptance criteria or a study proving device performance in the context of typical AI/diagnostic device evaluation (e.g., sensitivity, specificity thresholds, sample sizes for test sets, expert consensus, MRMC studies).

The document is a premarket notification for a medical device (glass fiber for orthodontic splinting) that is being evaluated for substantial equivalence to a predicate device, not for performance against specific diagnostic metrics.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on regulatory approval based on material composition and clinical use comparison to existing devices, not on quantitative performance metrics typically associated with AI or diagnostic studies.

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For anterior and limited posterior restorations and sealings in dentistry
A flowable light cure microhybrid composite for tooth filling, sealing and cementing.

Stick™ Flow is a flowable composite with excellent color stability. It is flowable, aesthetic, abrasion resistant, strongly radiopaque and high gloss polish able.

The provided text {0} only mentions a 510(k) summary, device description, and intended use as part of a premarket notification for a dental composite material. It then states that the device is "substantially equivalent" to a previously approved device (Aeliteflo™, K955292). The subsequent text {1, 2, 3} consists of an FDA letter approving the 510(k) notification, confirming substantial equivalence, and specifying the indications for use.

Crucially, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, as these are typically not included in the brief type of 510(k) summary provided here.

Therefore, I cannot fulfill the request to build the table and answer the questions based on the given input, as the necessary information is absent. The document focuses on regulatory approval based on substantial equivalence, not on detailed performance study results.

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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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For periodontal splinting

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

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets those criteria. The document is a 510(k) summary for a product called "everStick™ PERIO", detailing its description, intended use, and substantial equivalence to a predicate device, but it does not include performance data, study designs, or ground truth information.

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As orthodontic retainer

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

The provided text is a 510(k) summary for the everStick™ ORTHO device, a glass fiber orthodontic retainer. It primarily focuses on demonstrating substantial equivalence to a predicate device (everStick™ K011788) rather than detailing a specific clinical study with acceptance criteria and performance metrics in the way a diagnostic AI device submission would.

Therefore, many of the requested fields cannot be directly extracted from this document as the information does not exist within the provided text. This device is a material, not an AI or diagnostic device that would typically have the kind of performance metrics you are asking for.

Here's an attempt to address the request based on the available information, noting where information is absent:

1. Table of acceptance criteria and the reported device performance

Based on the provided K021126 summary, there are no explicit acceptance criteria or reported device performance metrics in terms of sensitivity, specificity, accuracy, or similar measures typically associated with diagnostic or AI devices. The submission focuses on substantial equivalence to a predicate device (everStick™ K011788) based on material composition and intended use.

The key "performance" mentioned is that its composition is "equal with its predicate device, everStick™," with only "the ratio of glass fibers and polymer matrices are slightly different." It states that "everStick ORTHO does not expose the dentist nor the patient to unacceptable risks," which is a safety assertion rather than a performance metric.

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 available in the provided 510(k) summary. A "test set" in the context of diagnostic device validation (especially AI) is not applicable here as this is a material rather than a diagnostic algorithm. The declaration of substantial equivalence often relies on existing data or literature for the predicate device, not new clinical studies with test sets in the same manner as AI.

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 available. No "ground truth" establishment by experts for a test set is mentioned, as this is a material device submission.

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

This information is not applicable and not available. No adjudication method is mentioned for a test set.

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 available. This device is a material product, not an AI system. Therefore, no MRMC study, human reader improvement with AI, or effect size is relevant or mentioned.

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

This information is not applicable and not available. This device is a material product, not an algorithm.

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

This information is not applicable and not available. The concept of "ground truth" in the context of diagnostic accuracy is not relevant for this material device submission. The "truth" here relates to material properties and safety, which are typically assessed through laboratory testing or existing literature on similar materials.

8. The sample size for the training set

This information is not applicable and not available. As this is not an AI/diagnostic device, there is no "training set."

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

This information is not applicable and not available. As there is no "training set," there is no ground truth established for it.

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As reinforcement in manufacturing and/or repairing full or partial dentures as well as overdentures and orthodontic appliances. As reinforcement for temporary and/or permanent plastic/composite inlays, onlays and bridges. As reinforcement for customized splints used to immobilize teeth which may be required for post-trauma, post-operative, or for orthodontic therapy.

everStick™ is a semi-manufactured product made of glass fibers and polymer/resin matrix for reinforcing dental acrylic polymers. everStick™ is made of unidirectional fibers which increase the strength and stiffness of the final product perpendicular to the direction of the fibers.

This submission describes the "everStick™" device, a glass fiber reinforcement material for dental applications. However, the provided text does not contain a study that establishes acceptance criteria and then proves the device meets those criteria with specific performance metrics.

Instead, the submission is a 510(k) premarket notification for substantial equivalence, where the new device (everStick™) is compared to a predicate device (fibreStick™, K003333). The core of this type of submission is to demonstrate that the new device is as safe and effective as a legally marketed predecessor, not necessarily to set and meet new performance benchmarks through a dedicated clinical study.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not present in this type of regulatory document.

Here's an analysis based on the information provided, highlighting what is present and what is absent:

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

• Acceptance Criteria: Not explicitly stated as quantifiable performance targets. The acceptance criterion for this 510(k) submission is "substantial equivalence" to the predicate device.

• Reported Device Performance:

  • "Testing which has been performed on everStick™ indicates that the device has the same intended use but somewhat different technological characteristics."
  • "everStick™ is a polymer/resin impregnated unidirectional continuous glass fiber whereas fibreStick™ is a polymer pre-impregnated unidirectional continuous glass fiber."
  • "The different technological characteristics of everStick™ does not raise new questions of safety and effectiveness and demonstrates that the device is as safe and effective as the predicate device."
  • "Test results indicate that there are no hazards presented with the use of everStick™ as compared with the predicate device."

  Note: While tests were performed, the specific results (e.g., tensile strength, bond strength, flexural modulus, etc.) and their comparison to specific numerical acceptance criteria are not provided in this summary. The "performance" is primarily described in terms of its equivalence to the predicate and the absence of new safety concerns.

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

• Sample Size: Not specified. This document only mentions "testing" and "test results" without detailing the number of samples or specimens used in any specific test.
• Data Provenance: Not specified. The country of origin of the testing data is not mentioned. Given the applicant is from Finland, it's possible testing occurred there. The nature (retrospective/prospective) of the data collection is also not specified, though typically engineering or bench testing is prospective for a new 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. This type of information is generally relevant for studies involving human interpretation or clinical endpoints that require expert assessment to establish ground truth (e.g., image-based diagnostic devices). This submission is for a material used in dentistry, and the evaluation relies on physical/mechanical testing, not expert consensus on diagnostic interpretations.

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

• Not Applicable. As above, adjudication methods are for resolving discrepancies in expert interpretations, which is not relevant for the type of testing implied for this dental material.

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 dental material, not an AI-assisted diagnostic device. Therefore, MRMC studies and AI improvement effect sizes are not relevant.

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

• Not Applicable. This is not an algorithm or AI device.

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

• Ground Truth: The "ground truth" in this context would likely be established through standard engineering and materials science methods. For example, a universal testing machine would measure material properties (e.g., flexural strength, modulus) which are considered objective physical properties, not subject to expert interpretation for ground truth. Comparison would be made to the predicate device's known properties or established industry standards for dental materials.

8. The sample size for the training set

• Not Applicable. This is not a machine learning or AI device that requires a "training set."

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

• Not Applicable. As above, no training set for AI.

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As reinforcement in manufacturing and/or repairing full or partial dentures as well as overdentures and orthodontic appliances. As reinforcement for temporary and/or permanent plastic/composite partial and full crowns and bridges. As reinforcement for customized splints used to immobilize teeth which may be required for post-trauma, post-operative, or orthodontic therapy.

everStickNet™ is a semi-manufactured product made of glass fibers and polymer/resin matrix for reinforcing dental acrylic polymers. everStickNet™ is made of a thin fiberglass fabric, which increase the strength and stiffness of the final product in all directions.

The provided text is a 510(k) summary for the everStickNet™ device, which is a glass fiber reinforcement material. The document focuses on establishing substantial equivalence to a predicate device (fibreNet™) rather than presenting a study with specific acceptance criteria and performance metrics for the everStickNet™ itself.

Therefore, many of the requested details, such as a table of acceptance criteria, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details, are not available in this document.

The core information presented is a comparison to a predicate device and a statement regarding the safety and effectiveness based on that comparison.

Here's a breakdown of what can be extracted based on the provided text:

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

This information is not provided in the document. The filing focuses on substantial equivalence to a predicate device, stating that "Test results indicate that there are no hazards presented with the use of everStickNet™ as compared with the predicate device." It does not define specific performance acceptance criteria for the everStickNet™ in terms of quantifiable metrics.

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. The document mentions "Testing which has been performed on everStickNet™" but does not detail the nature of this testing, including sample size or data provenance.

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. The assessment appears to be based on technical characteristics and comparison to a predicate device, not on diagnostic or interpretative tasks requiring expert ground truth.

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

This information is 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 provided. The device is a material for dental reinforcement, not an AI-assisted diagnostic tool.

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

This information is not applicable. The device is a physical material, not an algorithm.

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

This information is not explicitly stated. The "test results" mentioned likely refer to material property testing (e.g., strength, stiffness) rather than a ground truth for diagnostic accuracy or outcomes. The basis for safety and effectiveness is stated as being "as safe and effective as the predicate device" based on "different technological characteristics" that "does not raise new questions of safety and effectiveness."

8. The sample size for the training set:

This information is not applicable/not provided. The device is a material, not a machine learning model that requires a training set.

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

This information is not applicable/not provided.

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Ask a specific question about this device

Ask a specific question about this device