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The ASI 'Advanced Endodontic System - Designer Series (Models 2133E, 2134E, 2115E, 2125E)' is a self-contained dental treatment unit that contains a built in air compressor, vacuum system and water supply. It is designed to provide air, water, vacuum and electricity to operate various dental handpieces, accessories and attachments and to serve as a base for other dental devices and accessories.

The device is intended for use to provide general dental restorative care and hygiene procedures in both traditional dental office settings and/or mobile applications by or under the supervision of a licensed dentist or a hygienist if permitted by applicable law

The ASI 'Advanced Endodontic System - Designer Series (Models 2133E, 2134E, 2115E, 2125E)' is a self-contained dental treatment unit that contains a built in air compressor, vacuum system and water supply. It is designed to provide air, water, vacuum and electricity to operate various dental handpieces, accessories and attachments and to serve as a base for other dental devices and accessories.

I'm sorry, but this document does not contain the information required to fulfill your request. This appears to be an FDA 510(k) clearance letter for a dental treatment unit, not a study report or a document detailing acceptance criteria and device performance evaluation. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Information on sample sizes, data provenance, or details about test sets.
• The number or qualifications of experts used to establish ground truth.
• Adjudication methods.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes.
• Standalone algorithm performance.
• Details about the type of ground truth used (pathology, outcomes data, etc.).
• Sample size for a training set or how ground truth for a training set was established.

This document is a formal notification of market clearance based on substantial equivalence, not a detailed technical report of device validation.

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The ASI Triton Mobile Dental System (Models 2025 and 2025M) is a self-contained dental treatment unit that contains a built in air compressor, vacuum system and water supply. It is designed to provide air, water, vacuum and electricity to operate various dental handpieces, accessories and attachments and to serve as a base for other dental devices and accessories.

The device is intended for use to provide general dental restorative care and hygiene procedures in both traditional dental office settings and/or mobile applications by or under the supervision of a licensed dentist or a hygienist if permitted by applicable law.

The ASI Triton Mobile Dental System (Models 2025 and 2025M) is a self-contained dental treatment unit that contains a built in air compressor, vacuum system and water supply. It is designed to provide air, water, vacuum and electricity to operate various dental handpieces, accessories and attachments and to serve as a base for other dental devices and accessories.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets any such criteria.

The document is a 510(k) premarket notification letter from the FDA regarding the "Triton Self Contained Dental System." It states that the FDA has reviewed the notification and determined the device is substantially equivalent to legally marketed predicate devices for its stated indications for use.

The document does not contain:

1. A table of acceptance criteria or reported device performance.
2. Information about sample sizes for a test set, data provenance, or training set.
3. Details on the number or qualifications of experts used for ground truth.
4. Adjudication methods.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
6. A standalone algorithm performance study.
7. The type of ground truth used.
8. How ground truth for a training set was established.

This type of FDA letter primarily confirms the substantial equivalence of a new device to existing ones, rather than detailing specific performance studies against acceptance criteria in the format requested.

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The Micadent is used to perform intra-oral air abrasion procedures including etching and preparing surfaces for composite restorations.

The AirPrep System incorporates the Micadent air abrasion system mounted inside the unit housing along with a membrane air dryer. The Micadent handpiece is mounted in a holder along the outside of the housing.

This document is a 510(k) premarket notification approval letter for the "Airprep System - Model 9001" and does not contain the detailed study information, acceptance criteria, or performance data typically included in a clinical study report. The letter indicates that the device has been determined to be substantially equivalent to previously marketed devices.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval rather than a scientific study report.

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The SEAC Advanced Dents System is a self-contained dental delivery system with a built-in air compressor, vacuum system and water supply. It is designed operate dental handpiece attachments and suction instruments. The SEAC Advanced Dental System can also be upgraded to include a Micadent air abrasion system mounted inside the unit with the handpiece mounted in a holder along side the other handvises connections. The Micadent is used to perform intra-oral air abrasion procedures including etching and preparing surfaces for composite restoration,

The SEAC Advanced Dents System is a self-contained dental delivery system with a built-in air compressor, vacuum system and water supply. It is designed operate dental handpiece attachments and suction instruments. The SEAC Advanced Dental System can also be upgraded to include a Micadent air abrasion system mounted inside the unit with the handpiece mounted in a holder along side the other handvises connections. The Micadent is used to perform intra-oral air abrasion procedures including etching and preparing surfaces for composite restoration,

I apologize, but the provided text from the FDA 510(k) letter does not contain the information required to describe the acceptance criteria and the study that proves the device meets them.

The document is a clearance letter for a "Seac Advanced Dental System" (Model 2001 or 2020), indicating that the device has been found substantially equivalent to a predicate device. It confirms that the device can be marketed.

However, it does not include:

1. A table of acceptance criteria and reported device performance: This type of information would be found in the premarket submission itself, detailing the performance standards the manufacturer set for their device and the results of their testing.
2. Sample size used for the test set and data provenance: Again, this data is part of the studies submitted, not typically in the clearance letter.
3. Number of experts and their qualifications for ground truth: This would be part of the study design and methodology.
4. Adjudication method: Similar to the above, this is a detail of the study design.
5. Multi-reader multi-case (MRMC) comparative effectiveness study details: This type of study is not mentioned or described in the provided text.
6. Standalone (algorithm only) performance: This device is a physical dental system, not an algorithm, so this criterion is not applicable.
7. Type of ground truth used: Not explicitly stated.
8. Training set sample size and ground truth establishment for training set: Not applicable as it's a physical device and not an AI/ML algorithm that requires training data in the same way.

The document primarily focuses on the regulatory clearance process and the determination of substantial equivalence, based on the device's design, function, and indications for use, rather than detailed performance study results.

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