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Bosworth AEGIS Liner & Restorative Material is used as a light-cured radio-opaque cavity liner and pulp capping material, and, with the addition of tooth shades, as a class V restorative material.

AEGIS Liner & Restorative Material w/ACP

The provided text is a Section 510(k) premarket notification determination letter from the FDA for a dental device, "AEGIS Liner & Restorative Material w/ACP."

This document does not contain any information regarding acceptance criteria or a study proving that the device meets those criteria.

The letter's purpose is to inform the manufacturer that the FDA has reviewed their submission and determined the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on the information provided by the manufacturer in their original 510(k) submission, which would have included performance data, but that data is not present in this FDA letter.

Therefore, I cannot answer any of the specific questions about acceptance criteria or study details as they are not described in the provided text.

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The Bosworth Air Polisher is a dental handpiece used for cleaning and polishing teeth. It projects a spray of water, air, and powder onto the tooth surface. The Bosworth air Polisher is designed to be used by a Dental Professional.It is a prescription device The packaging contains the following statement. "Caution: Federal law restricts this device to sale by or on the order of a Dentist. "

The Air Polisher is a hand-held device that contains air and water lines, a capped chamber for the cleaning powder, and a nozzle. This device connects to a standard turbine tube that supplies air and water. When the Air Polisher is connected and activated, a stream comprised of powder, air, and water spray is generated. This spray can be directed on the tooth surface to clean and polish the tooth.

The provided text describes a 510(k) submission for a dental device, the "Bosworth Air Polisher." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with specific performance metrics and acceptance criteria in the same way a novel device might.

Therefore, many of the requested sections (sample size, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission in the provided document. The "study" here is primarily a comparison to a predicate device and limited performance testing to support basic functionality.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria for a 510(k) are typically based on demonstrating equivalent performance or safety to a predicate device, as opposed to establishing specific numerical thresholds for clinical outcomes. The "performance" described here relates to functional tests rather than clinical efficacy.

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

• Sample Size: Not specified in terms of human subjects or teeth. The tests described are functional engineering tests.
• Data Provenance: The tests were conducted internally by the manufacturer, Harry J. Bosworth Company. The document does not specify country of origin for any "data" beyond the company's location in Skokie, Illinois, USA. The testing is retrospective to the submission date.

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

• Not Applicable. The "ground truth" for the tests described are engineering specifications and functional outcomes (e.g., connection remaining intact, completing 130 treatments). These are not clinical outcomes requiring expert adjudication in the same way as, for example, image interpretation.

4. Adjudication Method for the Test Set

• Not Applicable. As the tests are functional/engineering in nature, formal adjudication by multiple experts for a "test set" is not relevant or described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC comparative effectiveness study was not performed or described. This type of study is typically conducted for diagnostic devices or AI-assisted interpretation, which is not the nature of this dental hand-held device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not Applicable. This is a mechanical dental handpiece, not an algorithm or AI system. Therefore, standalone performance (without human-in-the-loop) is not a relevant concept for this device. The device is the "algorithm" in that its mechanical function is its performance.

7. The Type of Ground Truth Used

• Engineering Specifications and Functional Outcomes: The "ground truth" for the performance testing cited (reuse life, connection integrity) refers to successful completion of engineered stress tests against predefined functional criteria.

8. The Sample Size for the Training Set

• Not Applicable. This device does not involve a "training set" in the context of machine learning or algorithms. Its design and performance are based on mechanical engineering principles, comparison to a predicate, and specified functional tests.

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

• Not Applicable. As there is no training set, there is no ground truth established for one. The "ground truth" for the device's design is the established performance and safety record of the predicate device and relevant engineering standards.

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The Bosworth Dentin Resin is used with either an acid etchant or a self-etch bond to provide a light-cure bond for bonding dental resin composites, resin luting cements, orthodontic adhesives and resin sealalnts to tooth structures - tooth enamel and dentin. It is indicated for use with light-cure, self-cure (autopolymerizable) and dual-cure (light-cure and/or self-cure combination) resin based materials.

The Bosworth Dentin Resin can also be used with the same light-curable, selfcurable and dual-curable resin based materials to bond to ceramic and metal surfaces including dental amalgam.

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I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a product called "Bosworth Dentin Resin," dated September 1, 2006.

It states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices for the specified indications for use. This letter is an official notification of market clearance based on substantial equivalence, not a detailed report of performance testing against specific acceptance criteria.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for the test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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Bosworth Seal is a light-activated dental sealant for sealing pits and fissures of anterior and posterior teeth. The Bosworth Seal is a surface glaze and is used for denture and orthodontic retention systems.

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This document is a 510(k) clearance letter from the FDA for a dental pit and fissure sealant called "Bosworth Seal." It does not contain information about acceptance criteria, device performance, or any studies. The letter is a regulatory approval, not a scientific report detailing clinical trials or performance evaluations.

Therefore, I cannot provide the requested information based on the given text.

To answer your request, I would need a document that describes the clinical performance evaluation of the "Bosworth Seal" device, detailing its testing and results against specified performance metrics.

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Bosworth Bond is an all-in-one 2-component etch and prime material. Bosworth Bond is used for etching and giving a initial bond coat in one step prior to enamel bonding resin cements and orthodontic adhesives. It changes color on mixing. When the material has cured on the tooth, color disappears, leaving a clear bond.

Dye-free 1- or 2-component versions are available. They do not change color. If a dry tooth enamel bonding surface is present, the 2-component Bosworth Bond is employed. looki onamel surface is kept moist to slightly wet, then only the Part B component needs to be used.

Bosworth Bond is an all-in-one 2-component etch and prime material. Bosworth Bond is used for etching and giving a initial bond coat in one step prior to enamel bonding resin cements and orthodontic adhesives. It changes color on mixing. When the material has cured on the tooth, color disappears, leaving a clear bond.

Dye-free 1- or 2-component versions are available. They do not change color. If a dry tooth enamel bonding surface is present, the 2-component Bosworth Bond is employed. looki onamel surface is kept moist to slightly wet, then only the Part B component needs to be used.

I am sorry, but the provided text content does not contain information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) premarket notification letter from the FDA regarding a dental bonding agent called "Bosworth Bond" (K043170). It discusses the device's substantial equivalence to predicate devices and outlines regulatory requirements. It does not include:

• A table of acceptance criteria and device performance.
• Details about sample sizes, data provenance, or the number/qualifications of experts.
• Adjudication methods, MRMC studies, or standalone algorithm performance.
• Information on ground truth types, training set sizes, or how training set ground truth was established.

Therefore, I cannot fulfill your request based on the provided text.

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The orthodontic adhesive is used to bond dental orthodontic brackets onto a tooth or teeth where a filled, light-cure (light-activated) resin-adhesive is indicated. This type of cure is used when sufficient light exposure is possible due to the low opacity of the bracket or through excessive use of adhesive the adhesive can be directly exposed to light.

The orthodontic adhesive can also be used to bond orthodonticbands in place where a filled light-cure resin-adhesive is indicated (sufficient light exposure is possible to cure/harden/polymerize the adhesive).

The adhesive can also be used to bond or cement a non-opaque dental restoration (crown, bridge, vencer, inlay,only, etc.) to the tooth when the material of the restoration permits sufficient light through it to cure/harden/polymerize the adhesive. It is not indicated when radiopacity is needed in the adlesive.

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The provided document is a 510(k) clearance letter from the FDA for the "Aegis® ORTHO Light-Cured Orthodontic Adhesive." This type of document declares "substantial equivalence" to a predicate device, which means the new device is as safe and effective as a legally marketed device that does not require premarket approval.

It is important to understand that this document does NOT contain a detailed description of acceptance criteria or a study proving the device meets those criteria in the way you've outlined for a typical AI/software medical device submission.

This document is for a physical dental adhesive, not an AI or software device. Therefore, the specific questions you've asked regarding AI device performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth definitions are not applicable to the content of this 510(k) letter.

The FDA's review for this type of device primarily relies on:

• Comparison to a predicate device: Showing that the new device has the same intended use, technological characteristics, and performs as well as a device already on the market.
• Performance testing: This would involve bench testing (e.g., bond strength, wear, solubility, biocompatibility) to demonstrate that the device meets an accepted standard or performs comparably to the predicate. Details of these tests are not included in this summary letter.

Therefore, I cannot populate your requested table and information points based on the provided text. The document does not contain the information requested.

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The orthodontic adhesive is used to bond dental orthodontic brackets onto a tooth or teeth where a filled, two component, dual-cure (light-activated with a post-cure chemical-cure) resin-adhesive is indicated. The adhesive is also indicated when a self-cure or chemical-cure only adhesive is needed to bond orthodontic brackets to teeth. This latter type of cure is used when sufficient light exposure is not possible due to the opacity of the bracket.

The orthodontic adhesive can also be used to bond orthodonticbands in place where a filled, two component, dual-cure resin-adhesive is indicated. The adhesive is also indicated when a self-cure or chemical-cure only adhesive is needed to bond orthodontic bands.

The adhesive can also be used to cement dental restorations (crowns, bridges, veneers, inlays, onlys, etc.) where a filled, two component, dual-cure resin is indicated. The adhesive is also indicated when a self-cure or chemical-cure only adhesive is needed to bond or cement a dental restoration.

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The provided text is a 510(k) premarket notification letter from the FDA regarding a dental adhesive device, Aegis® ORTHO Dual-Cured Orthodontic Adhesive. It does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of an AI/ML medical device.

The document primarily addresses the substantial equivalence of the device to existing predicate devices under the FDA's 510(k) pathway. This pathway is for medical devices that are substantially equivalent to a legally marketed predicate device and does not typically involve the detailed performance studies, acceptance criteria, or ground truth establishment that would be associated with AI/ML devices.

Therefore, for your request, I cannot provide the information as it relates to an AI/ML device study because:

• No acceptance criteria are mentioned for an AI/ML device. The document discusses regulatory compliance for a physical dental adhesive.
• No study proving device performance in the context of AI/ML is detailed. The letter acknowledges the device's substantial equivalence to predicate devices, but this is a regulatory determination, not a performance study for an AI/ML algorithm.
• None of the requested specific categories (sample size, data provenance, expert qualifications, adjudication, MRMC, standalone performance, ground truth types, training set details) are present in the document. These are relevant to AI/ML device evaluation, not a physical dental adhesive.

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Aegis Pit & Fissure Sealant with ACP is a light-activated dental sealant for sealing pits and fissures in primary or permanent posterior teeth.

The Aegis Pit & Fissure Sealant with ACP is available in opaque and tinted shades, when different shades are indicated for use.

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The provided text is a 510(k) premarket notification letter from the FDA regarding the "Aegis® Pit & Fissure Sealant." This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML or diagnostic devices.

The letter is a regulatory document stating that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It discusses regulatory compliance and general controls but does not include technical study details.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details based on the provided text. The requested information types (e.g., test set sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are characteristic of performance evaluations for diagnostic or AI/ML-driven devices, which are not described in this regulatory clearance letter for a dental sealant.

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Alginate Impression Material III (Fast & Regular Set) with water is used as dental impression material.

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This document is a 510(k) premarket notification from the FDA for an Alginate Impression Material III (Fast & Regular). It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria.

Therefore, I cannot fulfill your request with the provided input. The document is a regulatory approval letter, not a technical report or study summary.

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Pit & Fissure Sealant with Fluoride is a light-activated dental sealant for sealing pits and fissures in primary or permanent posterior teeth.

The Pit & Fissure Sealant with Fluoride is available in clear, opaque and linted shades, when differen! shades are indicated for use.

Pit & Fissure Sealant with Fluoride is a light-activated dental sealant for sealing pits and fissures in primary or permanent posterior teeth. The Pit & Fissure Sealant with Fluoride is available in clear, opaque and linted shades.

This is a 510(k) clearance letter from the FDA for a dental sealant. This document does not contain information about acceptance criteria or a study proving device performance against such criteria. Instead, it states that the device is "substantially equivalent" to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the provided text.

Ask a specific question about this device