Search Results

Whip Mix Preppies Plus ® is a device used as part of a professionally administered prophylaxis treatment. It is used on the tooth surface prior to;

• . Restoration cementation.
• Acid etching procedures: .
  • o Sealants
  • Orthodontic brackets o
  • 0 Composite restorations

Whip Mix Preppies Plus is an innovative blend of polishing and cleaning agents including 2% Chlorhexidine Gluconate (CHG) relative to liquid component and is in a paste form. Each cup provides enough flour of pumice paste for a single use. Preppies Plus has no fluoride, oils, or added flavoring agents.

The provided text is a 510(k) summary for a dental abrasive polishing agent, Preppies Plus®. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria through quantitative metrics.

The document primarily focuses on demonstrating substantial equivalence to predicate devices, particularly regarding safety and intended use, rather than presenting a performance study with specific acceptance criteria and outcome metrics.

Here's a breakdown of what can be extracted from the text in relation to your request, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

• Cannot be provided: The document does not define specific quantitative acceptance criteria (e.g., minimum abrasive effectiveness, maximum sensitivity reduction, etc.) or report detailed performance metrics against such criteria. The "Substantial Equivalence" table compares device characteristics and intended uses, but not performance against pre-defined success/acceptance criteria.

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

• Cannot be provided: There is no mention of a "test set" in the context of a performance study. The document refers to "non-clinical tests for bio-compatibility performed," but no details on sample size, methodology, or data provenance (country of origin, retrospective/prospective) are given for these tests.

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

• Cannot be provided: Since no performance study utilizing a "test set" with ground truth is described, information about experts or their qualifications is absent.

4. Adjudication Method for the Test Set:

• Cannot be provided: As no performance study with a test set is detailed, there's no mention of an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No: The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it refer to AI assistance or human reader improvement with AI. This is a medical device, not an AI/software device in the context of diagnostic imaging.

6. Standalone (Algorithm Only) Performance Study:

• No: This is a physical dental product, not an algorithm. Therefore, a standalone algorithm-only performance study is not applicable and not mentioned.

7. Type of Ground Truth Used:

• Cannot be provided: No performance study establishing ground truth (e.g., pathology, outcomes data, expert consensus) is described for this device. The closest concept is the "known risks associated with chlorhexidine in the FDA database," used as input for a risk management process, but this is not establishing ground truth for device performance.

8. Sample Size for the Training Set:

• Not Applicable/Cannot be provided: This is a physical dental product, not a machine learning model, so there is no "training set" in that context.

9. How the Ground Truth for the Training Set was Established:

• Not Applicable/Cannot be provided: As there's no training set, there's no method for establishing its ground truth.

Summary of Device Safety and Effectiveness provided in the document:

The document states that the safety and effectiveness are established through:

• The established use of chlorhexidine in medical device applications since the 1970s and in many dental applications.
• A thorough search of the FDA database for known risks associated with chlorhexidine, which informed their risk management process.
• Adherence to ISO 14971 for risk management, identifying and mitigating known hazards to an acceptable level.
• Comparison to their existing 510(k) exempt device (Preppies Flour of Pumice), with the only difference being the addition of 2% Chlorhexidine Gluconate (CHG).
• "Acceptable results of the non-clinical tests for bio-compatibility performed." (No details on what these tests were, their methodology, or results are provided).
• The conclusion that the new device "introduces no new risks and is considered substantially equivalent" to predicate devices.

In essence, this 510(k) summary primarily asserts substantial equivalence based on material composition (addition of CHG), intended use, and a risk management process, rather than presenting a detailed performance study with quantitative acceptance criteria.

Ask a specific question about this device

The Vericore Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely endentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

The abutment is placed over the implant and is mounted on to the implant with an abutment screw.

This device is compatible with the following manufacturers' implant systems: Nobel Biocare, Southern Hexed, 3i, 3i Certain, Zimmer, Endopore, Nobel Replace, Southern Trilobe, Astra and Straumann.

This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.

Angled abutments and narrow diameter implants are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.

The Devices covered in this submission are abutments which are placed on the dental implant to provide support for a prosthetic restoration.

Vericore Abutments are made from Titanium grade Ti-6Al-4V. The abutment screws and are made from Titanium grade Ti-6A1-4V. The abutment is made to be placed over the implant and is mounted on to the implant with an abutment screw. The abutments are compatible with the following implant systems: Zimmer - Narrow, Regular, Wide Nobel Biocare - Narrow, Regular, Wide 3i - Regular Hexed 3i Certain - Narrow, Regular, Wide Southern Hexed - Narrow, Regular, Wide Endopore -- Narrow, Regular and 5mm Nobel Replace- Narrow, Regular, Wide and 6mm Southern Trilock - Narrow, Regular and Wide Astra - Narrow and Regular Straumann - Narrow, Regular and Wide

Here's a breakdown of the acceptance criteria and study information for the Vericore Custom Abutment in Titanium, based on the provided text:

Acceptance Criteria and Device Performance

Study Information

The provided document describes a premarket notification (510(k)) for a medical device, which primarily relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo clinical study with specific acceptance criteria in the way a new drug or novel medical device might. Therefore, some of the requested categories are not directly applicable in the traditional sense of a clinical trial or AI performance study.

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

• Sample Size: Not specified for the fatigue testing. It refers to "the worst case scenario for each connection platform style." This implies a selection of representative abutment designs for testing, but not a large statistical sample of patient data.
• Data Provenance: Not specified. The testing was described as "conducted according to ISO 14801," an international standard, suggesting it was laboratory-based testing rather than data from human patients.

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. The "ground truth" here is based on engineering and materials science principles and international standards (ISO 14801) for mechanical performance, not expert human interpretation of medical data.

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

• Not applicable. This type of adjudication is relevant for human-interpreted medical image or diagnostic studies, not for the mechanical testing described.

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 is a medical device (dental implant abutment) and the submission details mechanical performance testing, not an AI-assisted diagnostic or interpretation tool.

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

• Not applicable. This device is a physical medical implant component, not an algorithm.

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

• The "ground truth" for the performance evaluation derives from established engineering principles, materials science specifications (Titanium grade Ti-6Al-4V), and an international standard for mechanical testing (ISO 14801). Compliance with these standards and comparison to a predicate device's measured performance serves as the basis for evaluation.

8. The sample size for the training set

• Not applicable. There is no concept of a "training set" in the context of this type of medical device submission.

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

• Not applicable. As there's no training set, this question is not relevant.

Ask a specific question about this device

The Vericore Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely endentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

The abutment is placed over the implant and is mounted on to the implant with an abutment screw.

This device is compatible with the following manufacturers' implant systems: Branemark, Southern Hexed, 3i, 3i Certain, Zimmer and Endopore.

This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Also highly angled abutments (i.e. 15 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.

Zimmer - Narrow, Regular, Wide Nobel Biocare - Narrow, Regular, Wide 3i -Micro Mini, Regular Hexed, 5mm 3i Certain - Narrow, Regular, Wide Southern Hexed - Narrow, Regular, Wide Endopore - Narrow, Regular and 5mm Astra - Narrow and Regular Straumann - Narrow, Regular, Wide

The Devices covered in this submission are abutments which are placed on the dental implant to provide support for a prosthetic restoration.

Vericore Abutments are made from biocompatible yttria-stablized zirconia blocks. The abutment screws are made from Titanium grade Ti-6A1-4V The abutment is placed over the implant and is mounted on to the implant with an abutment screw The abutments are compatible with the following implant systems:

Zimmer - Narrow, Regular, Wide Nobel Biocare - Narrow, Regular, Wide 3i -Micro Mini, Regular Hexed, 5mm 3i Certain - Narrow, Regular, Wide Southern Hexed - Narrow, Regular, Wide Endopore - Narrow, Regular and 5mm Astra - Narrow and Regular Straumann - Narrow, Regular, Wide

This is a medical device 510(k) premarket notification for a dental abutment, not an AI/ML device. Therefore, the requested information (acceptance criteria for AI/ML performance, study details for AI/ML validation, sample sizes for training/test sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and standalone performance) is not applicable and cannot be extracted from the provided text.

The document discusses the substantial equivalence of the "Vericore™ Abutment" to previously marketed dental abutments, based on its materials, intended use, and compatibility with various implant systems. It's a traditional medical device submission, not involving AI or machine learning.

Ask a specific question about this device

The Vericore Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. In is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

The abutment is placed over the implant and is mounted on to the implant with an abutment screw; an abutment adaptor will be added between the implant and the abutment. The abutment adaptor is intended to interface between the abutment and the implant allowing the abutment to meet with and be sealed to the parts of the implan that can not be milled into the abutment.

This device is compatible with the following manufacturers' implant systems: Nobel Biocare, Southern Trilock.

This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.

Also highly angled abutments (i.e. 28 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended foor the posterior region due to limited strength of the implant.

Replace- Narrow (3.5mm), Regular (4.3mm), Wide (5.0mm) and 6mm Southern Trilock - Narrow (3.5mm), Regular (4.3mm) and Wide (5.0mm)

The Devices covered in this submission are abutments which are placed on the dental implant to provide support for a prosthetic restoration.

Vericore Abutments are made from biocompatible yttria-stablized zirconia blocks. The abutment screws and adaptors are made from Titanium grade Ti-6A1-4V for the screws and Grade 4 for the adaptors. The abutment is placed over the implant and is mounted on to the implant with an abutment screw; an abutment adaptor will be added between the implant and the abutment. The abutment adaptor is intended to interface between the abutment and the implant allowing the abutment to meet with and be sealed to the parts of the implant that can not be milled into the abutment. The abutments are compatible with the following implant systems:

Replace- Narrow (3.5mm), Regular (4.3mm), Wide (5.0mm) and 6mm Southern Trilock - Natrow (3.5mm), Regular (4.3mm) and Wide (5.0mm)

The provided text is a 510(k) summary for the Vericore™ Abutment, a dental implant abutment. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert qualifications that would typically be found in a study demonstrating device performance.

Therefore, I cannot provide the requested table and study details.

The document primarily focuses on:

• Device Description: What the Vericore Abutment is made of and how it functions.
• Intended Use: The clinical purpose of the abutment.
• Predicate Device: The legally marketed device (Atlantis Zirconia Abutments) to which equivalence is claimed.
• Regulatory Information: FDA’s determination of substantial equivalence and general controls applicable to the device.

There is no mention of any performance studies, clinical trials, or bench tests with specific acceptance criteria or results. The FDA's 510(k) clearance process for devices like this often relies on demonstrating substantial equivalence to a predicate device, sometimes through physical and mechanical testing, but the details of such testing (if performed and submitted) are not present in this summary.

Ask a specific question about this device