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510(k) Data Aggregation
(163 days)
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.
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(3 days)
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.
| Property | Acceptance Criteria (Implied from Predicates) | Splash!® Dental Impression Material Performance |
|---|---|---|
| Material Type (ISO 4823) | Type 0-3 (Consistent with Precision) or Type 1-3 (Aquasil, P2 Polyether) | Type 0-3 |
| Recovery from Deformation | >98.0% (Aquasil) or 97.5% - 99.6% (P2, Precision) | 99.2% - 99.5% |
| Shrinkage | <0.50% (Aquasil) or 0.40 - 0.50% (P2 Polyether) or <0.10% (Precision) | Max. <0.10% |
| Working Time | 45 - 120 seconds (Range of Predicates) | 55 - 65 seconds |
| Hardness (Shore A) | 44 - 69 (Range of Predicates) | 62 - 67 |
| Strain in Compression | 1 - 10% (Range of Predicates) | 2.3 - 2.5% |
| Storage Conditions | 59° - 80° F (15° - 25° C) (Range of Predicates) | 59° - 78° F (15° - 25° C) |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly state the sample sizes for the "in-house testing" conducted on the Splash!® Dental Impression Material. It only mentions "Evaluations and in-house testing."
- Sample Size: Not specified.
- Data Provenance: The testing was "in-house testing" by Discus Dental, Inc. This typically means the data was generated internally by the manufacturer. The country of origin is not explicitly stated for the testing, but Discus Dental, Inc. is a US-based company, suggesting the testing likely occurred in the US. The data is retrospective in the sense that it's presented to support an existing product, but the tests themselves would have been conducted prospectively on samples of the material.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The testing described focuses on physical and chemical properties of the material, not on interpretations or diagnoses that would require expert consensus for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable/provided. The testing is for physical properties, not for diagnostic outcomes requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable/provided. The device is a dental impression material, not an AI-assisted diagnostic tool or system that would involve human readers interpreting images or data with and without AI assistance.
6. Standalone Performance Study (Algorithm Only)
This information is not applicable/provided. The device is a physical material, not an algorithm. Therefore, "standalone algorithm performance" is not relevant.
7. Type of Ground Truth Used
The "ground truth" for the performance evaluation of the Splash!® Dental Impression Material is based on standardized test methods for physical and chemical properties of dental impression materials. These methods define objective measurements for properties like recovery from deformation, shrinkage, working time, hardness, and strain in compression. The "truth" is established by the results of these standardized tests.
8. Sample Size for the Training Set
This information is not applicable/provided. As a physical material, there isn't a "training set" in the sense of machine learning algorithms. The material's formulation and manufacturing processes are likely developed through research and development, but this is distinct from an algorithmic training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided for the reasons stated above (not an AI/algorithmic device). The development of the material's properties would be guided by material science principles and performance targets, often benchmarked against existing successful products (like the predicates mentioned).
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(12 days)
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.
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(73 days)
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:
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.
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(97 days)
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.
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