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The Storm Mini Screw is a threaded titanium dental implant screw intended to provide a fixed anchorage point for the attachment of orthodontic appliances and facilitate the orthodontic movement of teeth. It is used temporarily and must be removed after orthodontic treatment has been completed. The Storm Mini Screw is provided sterile and is intended for single use only.

The Storm Mini screw is a self-tapping and self-drilling screw constructed of grade 5 titanium (Ti6Al4V) and anodized for the ease of identification through color. After bone insertion, the Storm Mini Screw is designed to be immediately used as an anchorage for orthodontic devices. The Storm mini-screw head is designed to facilitate placement of orthodontic appliances such as wires, springs, and elastic ligatures. The Storm Mini Screw is intended for single use only and used temporarily and must be removed after orthodontic treatment has been completed. The Storm Mini Screw is a threaded titanium dental implant screw intended to provide a fixed anchorage point for the attachment of orthodontic appliances and facilitate the orthodontic movement of teeth. It is used temporarily and must be removed after orthodontic treatment has been completed. The Storm Mini Screw is provided sterile and is intended for single use only.

This 510(k) premarket notification describes the Storm Mini Screw, an orthodontic mini screw. The submission primarily focuses on establishing substantial equivalence to predicate devices based on material, intended use, and mechanical characteristics rather than presenting performance metrics against specific acceptance criteria for a novel device. Therefore, many of the requested sections regarding detailed study design, sample sizes, and ground truth establishment are not applicable or not provided in the document.

Here's a breakdown of the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in the typical sense (e.g., a specific tensile strength value that must be met). Instead, the performance is demonstrated through comparison to predicate devices and general statements about meeting requirements for intended use.

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "tests for sterilization validation" and "test certifications performed after sterilization and accelerated ageing," but specific sample sizes for these tests are not provided.
• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) for a physical device, these tests are typically conducted in a laboratory setting.

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

This section is not applicable as the device is a physical orthodontic screw, and its performance is evaluated through mechanical and sterilization testing, not through expert interpretation of data or images.

4. Adjudication Method for the Test Set

This section is not applicable as the device is a physical orthodontic screw and its performance is evaluated through objective physical and chemical tests, not through subjective assessment requiring adjudication.

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 section is not applicable. The Storm Mini Screw is a physical medical device, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant to this submission.

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

This section is not applicable. The Storm Mini Screw is a physical medical device, not an algorithm, so standalone AI performance is not relevant.

7. The Type of Ground Truth Used

For the specific tests mentioned:

• Mechanical Strength: The "ground truth" would be established by the physical properties of the materials and the design, measured against engineering standards and comparison to predicate devices. It's a direct measurement of physical properties.
• Sterilization Validation: The "ground truth" is achieved when the sterilization process (VD Max25 dosage) effectively renders the device sterile, typically verified through biological indicator testing.
• Sterile Shelf Life: The "ground truth" is established by accelerated aging studies simulating the effects of time on sterility and packaging integrity.

8. The Sample Size for the Training Set

This section is not applicable. The Storm Mini Screw is a physical medical device, not an AI model, and therefore does not have a "training set."

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

This section is not applicable for the same reason as above.

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Blugoo HD is used to reproduce the structure of a patient's teeth and gums.

Blugoo HD is a three part product (Part A, Part B, and Part C). Part A and B are a two part resin based impression mix. Blugoo HD Part C Yellow Wash is a two part resin based impression material. It can be used in conjunction with Blugoo HD for high definition impressions.

This 510(k) premarket notification describes a dental impression material named Blugoo HD. The submission focuses on demonstrating substantial equivalence to a predicate device, Extrude, rather than providing a performance study with specific acceptance criteria and reported device performance metrics in the way a diagnostic AI device would.

Therefore, many of the requested sections (e.g., acceptance criteria table, sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, ground truth type, training set size, training set ground truth) are not applicable to this type of submission for a dental impression material. The submission aims to show that the new material performs similarly to an already approved material for its intended use.

Here's an overview based on the provided document:

1. Table of acceptance criteria and the reported device performance

Not applicable. For a dental impression material, acceptance criteria would typically involve physical and chemical properties matching or performing equivalently to a predicate device, as opposed to diagnostic performance metrics like sensitivity or specificity. This document lists attributes for comparison but does not provide specific numerical acceptance criteria or reported performance values.

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. The submission does not describe a clinical performance study with a 'test set' in the context of diagnostic performance. The comparison is based on technological characteristics and material properties.

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. Ground truth as typically understood in AI/diagnostic studies is not relevant here.

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

Not applicable. No test set or adjudication method is described.

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. Blugoo HD is a dental impression material, not an AI or diagnostic tool.

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

Not applicable. Blugoo HD is a physical material, not an algorithm.

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

Not applicable. Ground truth in the diagnostic sense is not relevant here. The "ground truth" for this type of submission is the performance of the legally marketed predicate device against which the new device is compared. This comparison is based on established industry standards and material science, not clinical diagnostic outcomes.

8. The sample size for the training set

Not applicable. There is no AI model or training set involved.

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

Not applicable. There is no AI model or training set involved.

Summary of the Study / Equivalence Claim:

The study described is not a performance study in the diagnostic sense, but rather a substantial equivalence claim based on a comparison of technological characteristics between the new device (Blugoo HD) and a legally marketed predicate device (Extrude, manufactured by Sybron Dental Specialties, Inc., K012405).

The submission asserts that Blugoo HD has similar technological characteristics to the predicate device in the following areas:

• Anatomical sites
• Design
• Formulation
• Type
• Intended use
• Mixing time
• Working time
• Minimum removal time from start of mix
• Linear dimensional change
• Elastic recovery
• Strain in compression
• Impression longevity
• Storage conditions
• Detail reproduction
• Compatibility with gypsum

The evidence presented is this list of comparative characteristics. The regulatory body (FDA) reviewed this claim and determined that the device is substantially equivalent to the predicate device for its stated indications for use: "Blugoo HD is used to reproduce the structure of a patient's teeth and gums."

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This device is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is intended for use in patients where orthodontic treatment has been completed. Screws are intended for single use only.

The O.A.S.I. System consists of self tapering titanium grade 5 (Ti6A14V) screws,

This document is a 510(k) premarket notification for the "O.A.S.I. System" (Mini Screws) by Lancer Orthodontics. It seeks to establish substantial equivalence to a predicate device, the "Dual Top Anchor Systems Screws" by Jeil Medical Corporation (K033767).

Based on the provided text, a formal study demonstrating the device meets specific acceptance criteria is not included. The document's purpose is to show substantial equivalence to an existing legally marketed device, not to present a new clinical or performance study with defined acceptance criteria.

Therefore, many of the requested items cannot be extracted directly from this document because they pertain to a type of study that was not performed or detailed here. This submission relies on a comparison of technological characteristics to a predicate device rather than presenting novel performance testing data against specific acceptance criteria.

However, I can extract information related to the comparison of technological characteristics used to establish substantial equivalence.

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

As no specific performance study with acceptance criteria is detailed in this 510(k) submission, a table of acceptance criteria and reported device performance cannot be generated. The submission's "performance" is based on its similarity to the predicate device in the following areas:

Note: The "reported device performance" in this context refers to the technological characteristics being "similar and therefore equivalent" to the predicate device, which is the basis for 510(k) clearance.

The remaining requested items (2-9) are typically associated with a performance study designed to demonstrate a device meets specific clinical or analytical endpoints. Since this document is a 510(k) submission focused on substantial equivalence through comparison of technological characteristics, most of these details are not present.

Summary of what is not present in the provided document:

• 2. Sample size used for the test set and data provenance: No test set is described.
• 3. Number of experts used to establish the ground truth for the test set and qualifications: No test set or ground truth establishment is described.
• 4. Adjudication method for the test set: No test set or adjudication process is described.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No such study is mentioned.
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
• 7. The type of ground truth used: No specific ground truth is referenced for performance testing, as the equivalence is based on technological characteristics.
• 8. The sample size for the training set: Not applicable; there is no "training set" for this type of device submission.
• 9. How the ground truth for the training set was established: Not applicable.

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paragon, a dental amalgam alloy, a device that consists of a metallic substance intended to be mixed with mercury to form a filling material for treatment of dental caries.

a dental amalgam alloy, a device that consists of a metallic substance intended to be mixed with mercury to form a filling material for treatment of dental caries.

This document is a 510(k) premarket notification decision letter from the FDA for a dental amalgam alloy called "Paragon™". It does not describe a study that proves the device meets acceptance criteria, nor does it provide specific acceptance criteria or device performance data.

The letter explicitly states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices, meaning it allows the device to be marketed. Substantial equivalence is the basis for clearance for this type of device, rather than a direct demonstration of meeting pre-defined acceptance criteria through a specific study as would be required for higher-risk devices or novel technologies.

Therefore, I cannot provide the requested information from this document. The document primarily focuses on regulatory approval based on substantial equivalence to existing devices, not on the results of a performance study with acceptance criteria.

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