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Tomas-pins are temporary, enossal anchorage point for attachment of orthodontic appliances.
To provide a fixed anchorage point for attachments of orthodontic appliances.

tomas-pin micro screws (orthodontic micro implant) are anchorage elements made of grade 5 titanium (3.7165), according to ASTM (American Society for Testing and Materials). They are inserted into the bone and serve as a temporary anchor for various orthodontic tooth movements. The tomaspin is constructed as follows: The screw features hex type slots. Rectangular wires are inserted to accommodate orthodontic elements, such as arches, elastic bands and brackets. Preferably, the wire should be fixed on the tomas-pin with light cured adhesive should completely/fully enclose the wire and retention head. The retention channel below the slots serves to securely anchor the adhesive to the tomas-on. This also protects the soft tissue (cheek, lips, tongue) against irritation that could result from the screw head.

The thread of the tomas-pin SD is self-drilling. The tomas-pin SD is inserted and screwed into the bone by either manual or mechanical method.

The shoulder connection between the thread and soft tissue sleeve serves as a stop to prevent the tomas-pin from sinking into the soft tissue. The soft tissue sleeve between the thread and retention head helps to prevent irritation between the gingiva and the tomas-pin, therefore.

The provided document is a 510(k) premarket notification summary for the Dentaurum tomas-pin (Temporary Orthodontic Micro Anchorage System). This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a performance study with detailed acceptance criteria and supporting data for a new device.

Therefore, the document does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a device performance study.

Instead, it relies on a comparison of the tomas-pin device to predicate devices based on:

• Intended Use: The tomas-pin has the same intended use as the predicate devices: "To provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed."
• Material: The tomas-pin is made of Titanium Grade 5 (ASTM), which is similar to the Titanium and Titanium Alloy (ASTM F 136-98) used in the predicate devices.
• Design and Characteristics: The submission states that the tomas-pin has similar dimensions and characteristics to the predicate devices.
• Potential Adverse Effects: These are identified as identical to those of the predicate devices.

The conclusion drawn is that the tomas-pin is "substantially equivalent in design, material, intended use and function" to the listed predicate devices. There is no performance study described in this document to assess specific acceptance criteria for a new device's efficacy or accuracy.

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To provide a fixed anchorage point for attachment of orthodontic appliances.

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This document is a 510(k) clearance letter from the FDA for a dental implant, not a study describing acceptance criteria and device performance. Therefore, I cannot extract the requested information. The letter confirms that the TOMAS Pin 6mm device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It does not contain details about a study with acceptance criteria, sample sizes, ground truth establishment, or expert involvement.

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Tomas-pins are temporary, enossal anchorage elements for the treatment of tooth abnormalities in orthodontics and pre-prosthetics.
To provide a fixed anchorage point for attachments of orthodontic appliances.
Temporary Orthodontic Micro Anchorage

tomas-pin micro screws (orthodontic micro implant) are precisely manufactired, anchorage elements made or grade 5 thankin (orrroo), according to ASTM (American Society for Testing and Materials). They are insorted into the best as follows: The head of the screw features hex type slots. movements. The tonias pill is constructions or thoughtic elements, such as arches, elastic bands and Reclaigular Wires are misetted to accomments on the tomas-pin with light cured adhesive. The adhesive should blackers. I relevably, the wire and retention head. The retention channel below the slots serves to securely anchor the adhesive to the tomas-pin. This also protects the soft tissue (cheek, lips, tongue) against irritation that could result from the screw head.

The thread of the tomas-pin is self-tapping but not self-drilling, which means that pre-drilling according to the I he tiread of the tomas-pin is ser tapping our it accommodate the tomas-pin. The tomas-pin is inserted and screwed into the bone by either manual or mechanical method.

The shoulder connection between the thread and soft tissue sleeve serves as a stop to prevent the tomas-pin I he silouius. Conficenon between the and seeve between the thread and retention head helps to prevent irritation between the borgiva and the tomas-pin, therefore, ensuring optimal hygiene.

The tomas-pins are delivered in glass sterile ampoules. The package contains labels that can be inserted into the patient's file for future reference and tracking.

The tomas-pins are available in the following sizes:

Tomas-pin 08 (Order No. 302-008-00)
Length of screw body: 8mm
Diameter: 1.2mm

Tomas-pin 10 (Order No. 302-010-00)
Length of screw body: 10mm
Diameter: 1.2mm

The provided document is a 510(k) Premarket Notification from 2005 for the TOMAS pin (Temporary Orthodontic Micro Anchorage System). It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a dedicated study report, especially as would be expected for a newly developed device with performance claims.

Therefore, the information required to fully answer your request for a study that proves the device meets acceptance criteria is not present in the provided text. The document is essentially a regulatory submission for market clearance based on equivalence.

However, I can extract and infer some information based on the document's content and the typical structure of such submissions.

Here's an analysis of what can be found or reasonably inferred:

1. Table of Acceptance Criteria and Reported Device Performance

This table is not available in the provided text in the form of specific acceptance criteria and detailed performance metrics. The submission focuses on comparing the TOMAS pin to predicate devices across several attributes.

Explanation: The document's purpose is to argue that the TOMAS-pin is "substantially equivalent" to existing, legally marketed predicate devices. Therefore, the "acceptance criteria" are intrinsically linked to matching or having similar characteristics to these predicates. The "reported device performance" is essentially a description of the TOMAS-pin's design, material, and intended use as compared to the predicates. There are no quantitative performance metrics (e.g., strength, stability, biocompatibility test results) explicitly stated or provided against specific numerical acceptance criteria within this document. The assumption is that if it's equivalent in material and design to devices already deemed safe and effective, it will also be safe and effective.

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

This information is not provided. The document does not describe a clinical or performance study with a distinct "test set" in the sense of a population of patients or experimental samples for evaluating performance against criteria. The submission is a comparison to predicates, relying on the established record of those devices for safety and effectiveness.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided. As there's no described "test set" and outcome evaluation, there's no mention of experts establishing a ground truth.

4. Adjudication Method for the Test Set

This information is not provided. No adjudication method is mentioned as there's no specific test set or study requiring it described.

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

This information is not provided. The document makes no mention of an MRMC study and, given the nature of the device (a temporary micro-implant for orthodontic anchorage), such a study would be highly unlikely and irrelevant to this 510(k) submission.

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

This is not applicable. The TOMAS pin is a physical medical device, not an algorithm or AI software. Therefore, a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used

This information is not provided in the context of a performance study for the TOMAS pin itself. The "ground truth" for this 510(k) submission implicitly relies on the established safety and effectiveness of the identified predicate devices. The TOMAS pin is argued to be equivalent in design, material, and intended use to these already approved devices.

8. Sample Size for the Training Set

This information is not provided. There is no "training set" in the context of this 510(k) submission for a physical medical device. This term typically applies to machine learning models.

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

This information is not provided and is not applicable for the same reasons as point 8.

Summary of Missing Information and Why:

The provided document is a 510(k) Premarket Notification, which is a regulatory pathway primarily focused on demonstrating "substantial equivalence" of a new device to an already legally marketed "predicate" device. It is not a detailed report of a new clinical or performance study with specific acceptance criteria and performance data for the new device.

Therefore, the document does not contain:

• Specific numerical acceptance criteria for the TOMAS pin's performance.
• Data from a performance study proving the TOMAS pin meets such criteria.
• Details on test set sample sizes, data provenance, expert panels for ground truth, or adjudication methods, as these are typically part of a dedicated clinical or non-clinical performance study report.
• Information related to AI/algorithm performance (MRMC, standalone algorithm, training sets), as the device is a physical implant.

The "proof" of the device meeting acceptance criteria in the context of this 510(k) is the assertion of substantial equivalence to previously cleared devices that implicitly met the FDA's safety and effectiveness standards.

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ConTec: Duo, ConTec LC, ConTec LCR are adhesive compounds that are used to fix orthodontic appliance to teeth.

ConTec Duo, ConTec LC, Contec LCR are adhesive compounds

The provided text is a 510(k) clearance letter from the FDA for dental adhesive devices (ConTec Duo, ConTec LC, ConTec LCR). It confirms that the devices are substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information regarding acceptance criteria, study data, device performance metrics, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone).

Therefore, I cannot answer the request with the information provided. The typical 510(k) clearance letter focuses on regulatory approval based on substantial equivalence, not detailed study results as would be found in a clinical trial report or a scientific publication.

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Dentaurum GlasTec Dental Orthodontic Cement is a dental glass ionomer cement used to cement orthodontic bands to tooth surfaces.

Dentaurum GlasTec Dental Orthodontic Cement

Considering the provided text, which is an FDA 510(k) clearance letter for a dental orthodontic cement, it's important to understand that this type of document does not contain the information requested in your prompt regarding acceptance criteria, study details, and data provenance for a medical device's performance evaluation.

The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, not necessarily on presenting detailed clinical study results or performance against specific acceptance criteria in the format you've outlined. The letter confirms that the device is substantially equivalent for its stated indications for use.

Therefore, I cannot extract the requested information from the provided text. The document is an administrative clearance, not a technical report or study summary.

To answer your prompt, I would expect to see a safety and effectiveness summary, clinical study report, or similar technical documentation that describes the device's performance characteristics and how they were evaluated.

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Dentaurum NO-MIX One Step Bracket Adhesive is a self-cure orthodontic bracket adhesive used with a liquid primer and an enamel etching gel (37.4% phosphoric acid gel) to adhere orthodontic brackets to tooth surfaces.

Not Found

This document is an FDA 510(k) clearance letter for the "Dentaurum NO-MIX One-Step Bracket Adhesive." It is not a study report or a technical document detailing acceptance criteria and performance data from a specific study.

Therefore, the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth definitions cannot be extracted from the provided text.

The letter merely states that the device has been found "substantially equivalent" to legally marketed predicate devices, meaning it does not require a new premarket approval application based on its similarity to existing, approved devices. The FDA performs its own review to determine substantial equivalence based on information submitted by the manufacturer, but this letter does not contain those details.

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Dentaurum MIX Two-paste Bracket Adhesive is a self-cure orthodontic bracket adhesive used with a liquid primer and an enamel etching gel (37.4% phosphoric acid gel) to adhere orthodontic brackets to tooth surfaces.

Dentaurum MIX Two-paste Bracket Adhesive

This document is a 510(k) clearance letter from the FDA for a dental adhesive. It does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, or study methodologies that you've requested.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document primarily focuses on regulatory approval based on "substantial equivalence" to a predicate device, rather than detailed performance study results.

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ConTec Light is used to set resinous dental adhesive material by transmission of visible light.

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This request cannot be fulfilled. The document provided is an FDA 510(k) clearance letter for a dental light curing device called "ConTec Light". It confirms substantial equivalence to a predicate device and allows the manufacturer to market it.

However, the document does NOT contain any information regarding:

• Acceptance criteria table or reported device performance metrics (e.g., accuracy, sensitivity, specificity).
• Any details about a study that proves the device meets specific performance criteria.
• Sample sizes, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, types of ground truth, or training set details.

The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive performance studies with detailed statistical analyses as might be found in a PMA (Premarket Approval) submission for a novel, high-risk device, or a publication describing a clinical trial for an AI-powered diagnostic.

Therefore, I cannot extract the requested information from the provided text.

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Ask a specific question about this device

Ask a specific question about this device