Search Results

Ask a specific question about this device

Relief ACP Oral Care Gel is indicated for relief of discomfort from dentin sensitivity. The product works by forming a layer of calcium phosphate and potassium nitrate on teeth.

Relief ACP Oral Care Gel

I am sorry, but I lack the ability to provide you with an answer to your request. The document does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. The document is an FDA 510(k) clearance letter for a dental product, primarily focusing on its regulatory status and intended use.

Ask a specific question about this device

Splash!® Dental Impression Material is intended for use with all crowns, bridges, occlusal and dental implant impression techniques to reproduce the structure of a patient's teeth and gums.

Splash!® Dental Impression Material is an addition-reaction base/catalyst polyvinylsiloxane dental impression material. It is available in Regular set or fast-setting Half-time varieties. Both are available in a heavy viscosity and in wild berry flavor, as well as unflavored.

Here's an analysis of the provided information regarding the Splash!® Dental Impression Material, focusing on acceptance criteria and the supporting study details:

Device: Splash!® Dental Impression Material

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Splash!® Dental Impression Material are primarily based on demonstrating substantial equivalence to predicate devices across various physical and chemical properties relevant to dental impression materials. The "acceptance criteria" are implied by the ranges and values observed in the predicate devices which the new device aims to meet or perform comparably to.

Ask a specific question about this device

Protégé Ultrasonic Inserts, both 25KHz and 30KHz models, are intended to be used in the handpieces of any magnetostrictive ultrasonic scaler for dental cleaning and the removal of tenacious calculus deposits by application of an ultrasonic vibrating tip to the teeth.

Protégé Ultrasonic Insert Devices

The provided document is a 510(k) premarket notification letter from the FDA for dental ultrasonic inserts. This type of document declares substantial equivalence to a predicate device and does not contain the detailed study information regarding acceptance criteria, sample sizes, expert qualifications, or ground truth that would typically be found in a clinical study report or a more comprehensive technical document.

Therefore, I cannot extract the requested information from this document. The document primarily focuses on regulatory approval and does not provide specifics on device performance beyond stating its intended use.

Ask a specific question about this device

To be used for cleaning and polishing procedures as part of a professionally administered prophylaxis treatment.

The ProActive Carem is a premium Prophylaxis Paste with fluoride that gently removes dental plaque and staining. It is a unique blend of polishing and cleaning agents designed for professional application during standard dental practice hygiene procedures.

This document is a 510(k) premarket notification for a dental device, specifically a "ProActive Care™ Prophylaxis Paste with Fluoride."

The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics as the predicate, or if it has different technological characteristics, that the new device does not raise different questions of safety and effectiveness.

Crucially, a 510(k) submission typically does not include new clinical studies proving device efficacy or meeting specific acceptance criteria in the way a pharmaceutical drug or a high-risk medical device might. Instead, substantial equivalence is often established through non-clinical performance testing, comparisons to predicate devices, and sometimes existing clinical literature.

Therefore, many of the requested items regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert adjudication, and MRMC studies are not applicable to this type of regulatory submission for this specific device.

Based on the provided document, here's what can be extracted and what cannot:

Acceptance Criteria and Device Performance:

The document does not specify quantitative acceptance criteria or a study that "proves the device meets the acceptance criteria" in the way one might expect for a novel device undergoing extensive clinical trials. Instead, the device's acceptability is based on its substantial equivalence to predicate devices already on the market.

Substantial Equivalence Determination (Section 8):
The ProActive Care™ Prophylaxis Paste is claimed to be substantially equivalent to the following products:

• Nupro® T Prophylaxis Paste with Fluoride and Triclosan (K000169)
• ProClude® (K002989)
• 3M™ Clinpro™ Prophy Paste (K990482)

The implication is that because these predicate devices are considered safe and effective for their intended use, and ProActive Care™ is substantially equivalent, it too is considered safe and effective. The criteria for demonstrating substantial equivalence would primarily involve comparing material composition, intended use, and non-clinical performance (e.g., abrasiveness, fluoride release, stability) to the predicate devices. However, the details of these comparisons are not present in this summary.

Detailed Breakdown of Requested Information:

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

   • Not Applicable / Not Provided in this document. The document does not contain a table of explicit, quantitative acceptance criteria or reported performance data in the context of a dedicated clinical study for this device. The "performance" is implicitly deemed acceptable by its substantial equivalence to predicate devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not Applicable / Not Provided in this document. This document does not describe a clinical study with a test set of human subjects or data. The submission relies on demonstrating similarity to existing, approved devices.

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 / Not Provided in this document. There is no "ground truth" establishment in the context of a diagnostic or predictive device. The regulatory body (FDA) reviews the submission and makes a determination of substantial equivalence.

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

   • Not Applicable / Not Provided in this document. No test set or adjudication process for diagnostic outcomes is mentioned.

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 / Not Provided in this document. This device is a prophylaxis paste, not an AI-powered diagnostic or assistive tool.

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

   • Not Applicable / Not Provided in this document. This is not an algorithmic device.

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

   • Not Applicable / Not Provided in this document. No ground truth for diagnostic validation is relevant here. The "ground truth" for the device's acceptability is its demonstrated substantial equivalence to predicate devices based on regulatory review of non-clinical data (e.g., chemical composition, physical properties) and intended use.

8. The sample size for the training set:

   • Not Applicable / Not Provided in this document. This is not a machine learning or AI device that would require a training set.

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

   • Not Applicable / Not Provided in this document. Not an AI device.

Summary of what the document does provide:

• Device Name: ProActive Care™ Prophylaxis Paste with Fluoride
• Intended Use: "To be used for cleaning and polishing procedures as part of a professionally administered prophylaxis treatment." (Page 1 and Page 4)
• Classification Name: Oral cavity abrasive polishing agent
• Regulatory Class: I
• Predicate Devices: Nupro® T Prophylaxis Paste with Fluoride and Triclosan (K000169), ProClude® (K002989), 3M™ Clinpro™ Prophy Paste (K990482) (Page 2)
• Decision: The FDA determined the device is "substantially equivalent" to legally marketed predicate devices. (Page 3)

Ask a specific question about this device

Precision VPS Impression Material is intended for use with all crowns, bridges, occlusal and dental impression techniques to reproduce the structure of a patient's teeth and gums.

Precision VPS Impression Material is an addition-reaction base/catalyst polyvinylsiloxane dental impression material available in three different viscosities intended for use with all crowns, bridges, occlusal and dental implant impression procedures.

This document is a 510(k) premarket notification for a dental impression material, which typically involves demonstrating substantial equivalence to a predicate device rather than presenting a full clinical study with acceptance criteria and a test set and experts in the way machine learning algorithms are evaluated. Therefore, most of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment is not applicable or not provided in the context of this type of regulatory submission.

However, based on the information provided, here's what can be extracted and what cannot:

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

This document does not specify formal "acceptance criteria" or provide "reported device performance" in the quantitative manner typically associated with clinical trials for new medical devices or software. The submission focuses on demonstrating substantial equivalence to legally marketed predicate devices based on the same intended use and basic technological characteristics of a dental impression material.

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. This is a 510(k) submission for a dental impression material, not a study involving a test set of data in the context of a machine learning or diagnostic device study. The "test set" in this context would implicitly be the physical testing of the material's properties (e.g., set time, accuracy, tear strength), which are not detailed in this summary.

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. There is no mention of experts establishing a ground truth for a test set in the provided summary.

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

Not applicable. No adjudication method is mentioned as there is no "test set" in the context of human interpretation.

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. This device is a dental impression material, not an AI-assisted diagnostic tool or system that would involve human readers or MRMC studies.

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

Not applicable. This device is a physical material, not an algorithm.

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

Not applicable. The "ground truth" for a dental impression material would likely refer to its physical and chemical properties meeting established standards for accuracy, stability, etc., which are usually validated through bench testing rather than clinical "ground truth" as in diagnostic studies. This summary does not provide details on such testing.

8. The sample size for the training set

Not applicable. The concept of a "training set" is not relevant for a physical dental impression material.

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

Not applicable. The concept of a "training set" and its "ground truth" is not relevant for a physical dental impression material.

Summary of Device and Regulatory Context (Based on provided text):

• Device Name: Precision VPS Impression Material
• Applicant: Discus Dental, Inc.
• Application Type: 510(k) Premarket Notification
• Date of Summary: January 8, 2004
• Intended Use: For use with all crowns, bridges, occlusal, and dental implant impression procedures to reproduce the structure of a patient's teeth and gums.
• Device Description: An addition-reaction base/catalyst polyvinylsiloxane dental impression material available in three viscosities.
• Regulatory Classification: Class II, Product Code ELW, Regulation Number 872.3660 (Impression Material)
• Basis for Substantial Equivalence: Precision VPS Impression Material is claimed to be substantially equivalent to:
  • Aquasil Ultra Smart Wetting Impression Material (Dentsply, Intl., K021416)
  • P2 Polyether (Heraeus Kulzer GmbH, K030318)

The FDA's letter (dated March 25, 2004) confirms that they reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use, allowing it to be marketed. This determination implies that the device has met the necessary regulatory requirements for substantial equivalence, which for this type of device typically involves demonstrating similar technological characteristics and performance (e.g., mechanical properties, biocompatibility) to the predicate devices, rather than a clinical study with primary endpoints and statistical analysis of a test set.

Ask a specific question about this device

The DisChem™ Chemical Proportioning & Dispensing System, Aquarius model, for use exclusively with Cetlycide-G concentrate and diluent packaged specifically for the DisChem™ system, is intended for dispensing the Cetylcide-G use solution.

Not Found

This document is a FDA 510(k) clearance letter for the DisChem™ Chemical Proportioning and Dispensing System. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter is a regulatory document confirming that the FDA has reviewed the manufacturer's premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It states that the device can be marketed subject to general controls and other applicable regulations.

Therefore, I cannot provide the requested information based on the provided input. The prompt specifically asks about performance studies and acceptance criteria, none of which are detailed in this regulatory clearance letter.

Ask a specific question about this device

Mega Bite is designed for making accurate occlusal records.

Not Found

This document is a 510(k) clearance letter from the FDA for a dental impression material called "Mega Bite Registration." It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The letter is primarily a regulatory communication stating that the device can be marketed. It does not detail the technical performance or the studies conducted to establish substantial equivalence.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

Ask a specific question about this device

Source of illumination for curing photo-activated, visible light cured dental restorative materials.

Not Found

This document is a 510(k) clearance letter from the FDA for a dental curing light, not a study report or a document detailing acceptance criteria and performance data for a device.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device, and does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for a test set or data provenance.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. Information about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
6. Results of a standalone algorithm performance study.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for a training set.
9. How ground truth for a training set was established.

This document is a formal communication from the FDA granting market clearance, not a technical report or clinical study summary.

Ask a specific question about this device

Ask a specific question about this device