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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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