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V-Mix is used for debridement, removing the smear layer, and cleansing the root canal system.

V-Mix is a two-part, dual-action root canal cleanser. V-Mix A is an aqueous solution that contains carboxylic acid chelating agents and surfactants. V-Mix B is an aqueous solution that contains sodium hypochlorite. Once the two solutions are mixed, the mixed solution cleanses and debrides the root canal system by removing the organic and inorganic debris during and after endodontic instrumentation.

The provided document is a 510(k) K193357 Premarket Notification for the V-Mix device. It includes a general statement that "Clinical performance is not deemed necessary" and states that non-clinical tests were conducted to evaluate functionality, performance, safety, and substantial equivalence.

Therefore, the document does not report on acceptance criteria or a study proving the device meets acceptance criteria in a clinical setting.

It lists several non-clinical tests that were performed, but no details of these tests (such as specific methods, results, or acceptance criteria) are provided.

Hence, I cannot extract the requested information as it is not present in the provided text.

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Vista Rinse and Vista Rinse Plus are endodontic irrigating solutions that cleanse the root canal system by removing the smear layer after endodontic instrumentation.

Vista Rinse and Vista Rinse Plus are endodontic irrigating solutions that cleanse the root canal system by removing the smear layer after endodontic instrumentation. Both medical devices are packaged in bottles. Clinical use of the medical devices requires the irrigant to be expelled from syringes through irrigation tips, which are class I medical devices per EIC product code (syringe, periodontic, endodontic, irrigating) and CFR regulation number 872.4565 and are 510(k) exempt.

The provided document is a 510(k) summary for the Vista Rinse and Vista Rinse Plus endodontic irrigating solutions. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria as one might find for a novel medical device. Therefore, much of the requested information regarding a study proving acceptance criteria and specific performance metrics in a clinical context is not explicitly available in this document.

However, I can extract information related to the non-clinical performance testing which served as the basis for demonstrating substantial equivalence.

Here's the breakdown based on the provided text:

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

The document does not define explicit "acceptance criteria" in a quantitative sense as might be found in a clinical trial protocol. Instead, it relies on demonstrating comparable performance to predicate devices through non-clinical testing. The reported device performance is presented as being "commensurate with" or "identical to or better than" the predicate devices.

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes (e.g., number of test specimens, number of wells for cytotoxicity) used for the non-clinical tests.

• Cytotoxicity Testing: No specific sample size is mentioned.
• SEM Evaluation & Calcium Chelation Testing: No specific sample size is mentioned for the SEM evaluations or calcium chelation.
• Data Provenance: The testing was conducted by Inter-Med/Vista Dental Products, the submitter, as part of their 510(k) submission. The exact country of origin or whether the data was retrospective or prospective (for non-clinical lab studies) is not detailed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable. For non-clinical performance testing like cytotoxicity and smear layer removal, the "ground truth" is established by scientific methodologies and laboratory measurements, not by expert consensus. There were no human experts adjudicating test results in this context.

4. Adjudication method for the test set

Not applicable, as there was no human expert adjudication of test results for these laboratory studies.

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 an endodontic irrigating solution, not an AI-assisted diagnostic or therapeutic device 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 medical solution, not a software algorithm.

7. The type of ground truth used

The "ground truth" for the non-clinical performance testing was based on:

• Laboratory measurements and analytical chemistry: For composition verification (analytical testing), pH, and chelation characteristics.
• Standardized biological assays: For cytotoxicity testing (ISO 10993-5:2009).
• Microscopic imaging and qualitative assessment: For smear layer removal (SEM evaluation). The effectiveness was compared to the known performance of predicate devices, which utilize 17% EDTA, considered the "gold standard."

8. The sample size for the training set

Not applicable. This document describes a traditional medical device (chemical solution), not a machine learning or AI-driven device that requires a training set.

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

Not applicable, as no training set was used.

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A visual aid for the identification of carious dentin.

Vista Dyes are colored agents that when applied to the suspected carious areas of the tooth stains the carious dentin. The method of operation and placement of Vista Dyes are similar to that of the primary predicate and reference device, Caries Finder (K955445) and Pulpdent Snoop (K964430), respectively. A drop of the dye is applied to the carious dentine, rinsed with water and air dispersed. The stained carious tissue is then removed with a low speed rotary bur. The process may be repeated until there are no more stainable tissues in the carious cavity.

The device described is "Vista Dyes", a caries detection device. Based on the provided text, there is no detailed study provided that presents specific acceptance criteria and device performance metrics in a quantitative manner. The submission primarily relies on demonstrating substantial equivalence to predicate devices (Caries Finder and Pulpdent Snoop) based on identical indications for use, technological characteristics, and methods of application, rather than presenting a performance study with specific acceptance criteria.

The document states: "Clinical performance is not deemed necessary to support the substantial equivalence of the proposed device." Therefore, there is no information about acceptance criteria, reported device performance, sample size, ground truth establishment, or expert involvement for a performance study.

However, based on the information provided, we can infer some aspects of what would typically be considered "acceptance criteria" through the comparative analysis with predicate devices.

Here's an analysis of the provided information in response to your questions:

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

No explicit quantitative acceptance criteria or reported device performance (e.g., sensitivity, specificity) were provided in the document. The substantial equivalence argument serves as the "acceptance criteria" here, meaning that the device's characteristics must be sufficiently similar to the predicate devices to not raise new questions of safety or effectiveness.

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. No clinical or performance test set was described.

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. No clinical or performance test set requiring expert ground truth was described.

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

Not applicable. No clinical or performance test set was 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 device is a dye, not an AI-assisted device, and no MRMC study was performed.

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

Not applicable. This device is a dye, not an algorithm.

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

Not applicable. No performance study requiring ground truth was conducted or described. The safety and effectiveness are established by substantial equivalence to legally marketed predicate devices, implying that the known performance characteristics of the predicate devices implicitly serve as a "ground truth" for what is acceptable.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable. This is not an AI/ML device, so there is no training set or associated ground truth establishment.

Summary of Acceptance Criteria and Performance (Inferred from Substantial Equivalence):

• Blue Dye: 99% distilled water, 1% methylene blue dye. Differs from primary predicate (which uses propylene glycol) but is equivalent to reference device (Pulpdent Snoop). |
  | Physical Properties | Colored aqueous liquid. Identical to predicate. |
  | Chemical Properties | 1% dye concentration. Identical to predicate. |
  | Intended Use | Same target population and anatomical site. Identical to predicate. |
  | Packaging Configuration | - Dropper bottles: Identical to predicate.
• Prefilled 1.2mL syringes: Additional configuration, deemed not to raise new concerns as it simplifies application and is common in dentistry. |
  | Sterility | Non-sterile. Identical to predicate. |
  | Shelf-Life | 3 years. Based on accelerated testing and ongoing real-time aging. Identical to predicate. |
  | Prescription/OTC Use | Prescription use only. Identical to predicate. |
  | Biocompatibility | Confirmed via literature review, LD50 analysis of constituents, existing FDA data, and longstanding use of predicate without significant adverse events (MAUDE database). |
  | Safety and Effectiveness | Demonstrated through substantial equivalence to legally marketed predicate devices, with no new questions of safety or effectiveness raised by minor differences. |

In essence, the "study" for Vista Dyes was a substantial equivalence comparison demonstrating that its characteristics are similar enough to existing, legally marketed devices that it does not require new clinical performance data.

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Vista Clear is intended for sulcus retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry used with gingival retraction cord. Vista Clear facilitates the insertion of the cord into the sulcus.

Vista Clear is used to facilitate sulcus retraction prior to taking a dental impression of a tooth. This entails placement of the device into the sulcus which provides physical displacement of the gingival tissue from the tooth. If using a gingival retraction cord, the subject device facilitates the insertion of the cord into the sulcus while also creating a physical barrier to prevent gingival bleeding and oozing from affecting restorative and tissue management procedures.

The provided text describes a 510(k) premarket notification for a medical device called "Vista Clear." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing extensive clinical trials or performance testing against specific acceptance criteria for efficacy in the same way a novel device might.

Therefore, the document does not contain information on "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of clinical performance or diagnostic accuracy. Instead, the "device performance" described relates to non-clinical testing demonstrating equivalence to a predicate device.

Here's an analysis based on the provided text, addressing your questions to the extent possible, and highlighting what's not present:

Key Takeaway: This 510(k) summary is for a device with a clear physical/chemical function (sulcus retraction, bleeding control) and claims substantial equivalence based on technological characteristics and non-clinical testing, not clinical performance or diagnostic accuracy with human interpretation.

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

The concept of "acceptance criteria" in this 510(k) largely revolves around demonstrating substantial equivalence to the predicate device and meeting relevant non-clinical performance standards. There are no explicit quantitative clinical performance acceptance criteria (e.g., sensitivity, specificity, AUC) stated in the document, as it's not a diagnostic device.

Reported Device Performance (from "Non-Clinical Performance Testing and Compliance"):

2. Sample size used for the test set and the data provenance

• Test Set (for non-clinical performance): The document does not specify a "test set" in the context of clinical or diagnostic performance data (e.g., number of patient cases, images). The testing refers to laboratory-based evaluations of the device's material properties, packaging, and stability.
  • Data Provenance: N/A. This is a submission for a new device, and the data provenance refers to materials/engineering tests, not patient data. No country of origin for patient data (as there isn't any provided in text) or retrospective/prospective study type is mentioned as no clinical studies were performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• N/A. This information is relevant for studies involving human interpretation or diagnostic accuracy. For this type of device and 510(k) submission, ground truth relates to the results of objective laboratory tests (e.g., is it cytotoxic?), not expert consensus on clinical findings.

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

• N/A. As no expert consensus or human interpretation of clinical cases was performed, no adjudication method is relevant or 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

• N/A. This device is a dental material, not an AI or diagnostic imaging device. Therefore, no MRMC study was conducted or is applicable.

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

• N/A. This is not an algorithm-based device.

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

• The "ground truth" for this device is based on objective laboratory test results (e.g., analytical chemistry, toxicology, microbiology, stability) that confirm the material properties, safety, and functionality of the device compared to established scientific principles and the predicate device's known characteristics. It's not clinical outcomes or expert labels.

8. The sample size for the training set

• N/A. This term is relevant for machine learning models. No training set is applicable for this type of medical device submission.

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

• N/A. As there is no training set, this question is not applicable.

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Vista FS and Vista FS Liquid are intended for sulcus retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry used with gingival retraction cord. Vista FS Liguid facilitate the insertion of the cord into the sulcus.

Vista FS and Vista FS Liquid are medical devices used to facilitate sulcus retraction prior to taking a dental impressions of a tooth. This entails placement of the sulcus which provides physical displacement of the gingival tissue from the tooth. If using a gingival retraction cord, the subject devices facilitate the insertion of the cord into the sulcus while also facilitating the creating of a physical barrier to prevent gingival bleeding and oozing from affecting restorative and tissue management procedures.

The provided text does not contain specific acceptance criteria for performance metrics (such as sensitivity, specificity, or F1 score) or detailed results from a clinical study that would allow a direct comparison to such criteria. Instead, the document focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics, intended use, and non-clinical performance testing.

Therefore, many of the requested fields cannot be directly extracted from the provided text. However, based on the information available, here's what can be provided:

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

The document does not explicitly state quantitative acceptance criteria in terms of clinical performance metrics. The evaluation is based on demonstrating substantial equivalence to predicate devices. The "reported device performance" in this context refers to the results of non-clinical testing confirming manufacturing, cytotoxicity, shelf-life, microbiological properties, and transit resilience.

2. Sample size used for the test set and the data provenance

The document describes non-clinical laboratory testing. It does not refer to a "test set" in the context of clinical data or a patient population. The samples for testing were likely materials from the manufactured devices themselves (e.g., aliquots for analytical testing, cell cultures for cytotoxicity). No information on the country of origin of data or whether it was retrospective or prospective is provided, as these are not relevant to the described non-clinical tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This information is relevant for studies relying on expert-derived ground truth, typically in image analysis or diagnostic scenarios. The provided document concerns non-clinical testing of a dental product.

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

Not applicable. Adjudication methods are used in studies involving human interpretation or subjective assessments, which are not described in this document for the evaluation of this dental product.

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 product (sulcus retraction material) and not an AI-assisted diagnostic tool.

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

Not applicable. This device is a dental product and not an algorithm.

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

The "ground truth" for the non-clinical tests described would be the established scientific standards and methods for analytical chemistry, cytotoxicity assessment, stability testing, and microbiological evaluation. For example, for cytotoxicity, the "ground truth" is typically determined by observing cell viability and growth inhibition according to standardized protocols (e.g., ISO 10993).

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this document describes non-clinical testing of a physical medical device, not a machine learning model.

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

Not applicable. As there is no training set for a machine learning model, this question is not relevant to the provided document.

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Source of illumination for curing photo-activated dental restorative materials and adhesives.

The Valiant Curing Light is a visible light activator for polymerization of dental materials and adhesives, such as dental resins and composites. The Valiant Curing Light is composed of a cordless handpiece, a charging base, disposable barrier sleeves, a light attenuating shield, and an instruction for use. The cordless handpiece is made of medical grade aluminum, electronic elements, glass lenses, and medical grade plastic elements. A plastic rotation switch provides an interface to switch between various modes of the cordless handpiece. Once a mode is selected, an ON/OFF button activates and executes the selected mode. The unit is battery operated and contains a removable and rechargeable Li ion battery. The charging base allows for placement and inductive charging of the handpiece when not in use. The light attenuating shield absorbs emitted light from the cordless handpiece to minimize ocular radiation to the patient and user. The Valiant Curing Light is provided non-sterile. Disposable barrier sleeves (510(k) number K132953, TIDI Shield, Model 21102, by TIDI Products) assist in mitigating patient contamination; additionally, the handpiece, charging base and light attenuating shield can withstand common surface disinfectants. Also included in the Valiant Curing Light is an instructions for use. The instructions for use details the function and four independently operable settings of the device: 1) standard curing mode, 2) ramp curing mode, 3) boost curing mode, and 4) white light mode (visualizing of dental anatomy). The white light mode can be used for intraoral illumination to aid in the visualization of dental anatomy (i.e. equivalent to a class I dental operating light, CFR 872.4630). The curing light modes 1-3 provide broad spectrum blue light (400 - 500mm, with peaks at 410nm and 475nm) to cure a variety of dental restorative materials and adhesives utilizing the most common photoinitiators (CQ and PPD). The white light mode 4 provides an aid for illuminating dental anatomy.

The document describes the Valiant Curing Light, a dental device for curing photo-activated dental restorative materials and adhesives. The submission aims to demonstrate substantial equivalence to a predicate device, the Valo Cordless (K110582).

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for performance in a table format with pass/fail thresholds. Instead, it demonstrates performance by comparing the Valiant Curing Light to its predicate device, the Valo Cordless, and asserting "statistically similar" or "equivalent" performance in various non-clinical tests.

However, based on the non-clinical performance testing sections, we can infer the implied acceptance criteria:

Study Details

The document relies solely on non-clinical (benchtop) performance testing to demonstrate substantial equivalence. No clinical studies were deemed necessary.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated for each test (e.g., number of composite pucks, number of light measurements). The descriptions refer to "testing concluded," "measurements obtained," or "comparison testing" without specifying the number of samples or repetitions beyond general terms.
• Data Provenance: The studies were non-clinical, likely conducted in a laboratory setting by Inter-Med / Vista Dental Products. There is no mention of country of origin of the data as it's not patient data, nor is it retrospective or prospective in the clinical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This question is not applicable as the studies were non-clinical benchtop tests comparing physical properties and performance against a predicate device and engineering design specifications. The ground truth would be established by scientific measurement and engineering validation, not expert consensus in a clinical context.

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

• This question is not applicable as there were no human readers or expert adjudications involved in establishing ground truth for these non-clinical tests.

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:

• This question is not applicable. This is a dental curing light, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

• This question is not applicable. This device is a physical tool (a curing light), not an algorithm. Therefore, "standalone" algorithm performance is not relevant.

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

• The "ground truth" for the non-clinical tests was established through objective physical measurements and engineering validation, comparing the device's performance against its own design specifications and against the measured performance of a legally marketed predicate device (Valo Cordless). For example, microhardness measurements would be taken using standardized laboratory techniques.

8. The sample size for the training set:

• This question is not applicable. The Valiant Curing Light is a physical device, not an AI algorithm that requires a training set.

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

• This question is not applicable as there is no training set for this device.

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