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The PS System is intended for the delivery and evacuation of endodontic irrigation solutions during root canal procedures.

The PS System presents a clinically effective way to irrigate the entire canal space during root canal treatments. The PS System is a closed system negative pressure irrigation apparatus that draws fluid through the individually placed cannula toward the coronal chamber by way of evacuation that is controlled independently through the dental chair vacuum system, eliminating the risk of apical irrigant extrusion during root canal procedures. The PS System creates a closed system by establishing an air tight seal between the tooth and stage via a lightcurable barrier. The PS System is designed to accommodate the full range of tooth and root canal anatomy and is offered in three specific procedural kits based on the type of tooth to be treated: anterior, premolar, and molar.

The provided document is a 510(k) summary for the PS System, a dental device used for endodontic irrigation. It describes the device's function, comparison to a predicate device, and non-clinical and clinical performance data.

Based on the document, here's an analysis of the acceptance criteria and study information, addressing your points:

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

The document does not present a formal table of acceptance criteria with corresponding performance metrics. Instead, it lists the types of performance tests conducted and then concludes based on the results. The key "acceptance criteria" appear to be:

• Ability to deliver and evacuate endodontic irrigation solutions.
• Performance akin to the predicate device (EndoVac System K140685).
• Reduction of apical extrusion risk compared to conventional positive pressure syringe irrigation.
• Safety and effectiveness equivalent to the predicate.

Reported Device Performance (based on the "Non-Clinical Performance Testing and Compliance" section):

The document states that the following performance tests were conducted as part of design verification:

• Suction Flow Rate Performance
• Critical Dimensions for Clinical Performance Analysis
• Corrosion Testing
• Simulated Canal Performance Testing
• Shelf Life Verification
• Biocompatibility Analysis
• Transit Testing
• Additive Manufacturing Summary Document

The conclusion states that based on "extensive comparative analysis and testing," the PS System is substantially equivalent to the predicate, and that differences "do not raise any new questions of safety and effectiveness." This implies the tests successfully demonstrated comparable performance and met the underlying safety and effectiveness expectations for such a device. However, specific quantitative performance metrics or pass/fail thresholds for these tests are NOT provided in this summary document.

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

The document is a 510(k) summary, which typically provides an overview rather than detailed study protocols. As such, the sample sizes for the non-clinical tests are not specified.

Data Provenance: The studies are described as "Non-Clinical Performance Testing." The document is submitted by Inter-Med, Inc. from Racine, WI, USA, suggesting the testing was likely conducted in the US or by a US-affiliated entity. The document doesn't specify if the data is retrospective or prospective, but as it's for design verification, it would inherently be prospective testing.

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

This information is not provided in the document. The tests performed are primarily engineering and material performance tests (e.g., suction flow rate, corrosion, biocompatibility, dimensions). These types of tests typically rely on established standards and laboratory measurements rather than expert human interpretation for "ground truth." Therefore, experts in establishing "ground truth" would not be relevant in the same way they would be for, say, an AI-based diagnostic device.

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

Adjudication methods (like 2+1, 3+1 for consensus readings) are typically used in clinical studies or studies involving human readers/interpreters, especially for AI or diagnostic devices where subjective interpretation is involved. Since this document focuses on non-clinical performance testing of a physical medical device, adjudication methods are not applicable and thus not 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

No. The PS System is a dental handpiece/irrigation system, not an AI or diagnostic imaging device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

No. This is not an algorithm or AI device. It is a physical medical device for irrigation. Therefore, a standalone algorithm performance study is not applicable and was not performed.

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

For the non-clinical performance tests mentioned (Suction Flow Rate, Critical Dimensions, Corrosion, Simulated Canal Performance, Shelf Life, Biocompatibility, Transit), the "ground truth" would be established by:

• Reference standards and measurements: For dimensions, flow rates, and physical properties.
• Standardized testing protocols: For corrosion, shelf life stability, and transit resilience.
• ISO standards and established biological assays: For biocompatibility (e.g., ISO 7405, ISO 10993-1).

There is no mention of expert consensus, pathology, or outcomes data being used for ground truth in this context, as they are not relevant to the types of tests described.

8. The sample size for the training set

The device is a physical medical device, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

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

As there is no "training set" (see point 8), this question is not applicable.

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armor LC™ is a resin-based, light-cured protective barrier material recommended to protect dental materials or tissues.

armor LC™ is a light-cured resin dam designed to seal around and protect the gingival tissue during professional dental procedures. It consists of a viscous urethane dimethacrylate (UDMA)based resin foam supplied in a black 1 mL syringe. armor LC™ is only for prescription use and is a single-use, non-sterile, product. Using an applicator tip, the uncured product is applied over the gingival margin where it flows to form a seal at the base of the teeth. It is then rapidly light cured in situ to form a flexible material barrier. After the dental procedure it is readily removable with simple dental instruments.

The provided FDA 510(k) summary for the Mavrik Dental Systems Ltd.'s armor LC™ device does not include the detailed acceptance criteria or the study data proving the device meets those criteria for the specific performance tests listed. The document generally states that the device "functioned as intended and met the pre-defined acceptance criteria" for each test.

Therefore, many of the requested details cannot be extracted from this document. However, based on the information provided, here's what can be stated:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified for any of the performance tests.
• Data Provenance: The studies were "Mavrik Dental Systems conducted several performance tests," implying they were conducted by the manufacturer. The document does not specify the country of origin, but the applicant's address is Israel. The tests are "Non-Clinical Performance Data" and "Bench Performance Testing," indicating they are likely laboratory-based studies rather than retrospective or prospective clinical studies involving human patients.

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

• Not applicable as this is a non-clinical bench testing and biocompatibility study, not a study requiring expert readers for ground truth establishment.

4. Adjudication method for the test set:

• Not applicable as this is a non-clinical bench testing and biocompatibility study.

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 not an AI-assisted device, nor does the document describe an MRMC study.

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

• Not applicable. This is not an AI algorithm. The performance described is for the device itself (a light-cured resin dam).

7. The type of ground truth used:

• For Bench Performance Testing: The "ground truth" would be the pre-defined acceptance criteria based on engineering specifications and comparison to predicate devices, but these specific criteria are not detailed in the document.
• For Biocompatibility: The "ground truth" or standard for acceptance was compliance with specific international consensus standards (ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 7405).

8. The sample size for the training set:

• Not applicable. This device does not involve machine learning or AI that would require a training set.

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

• Not applicable as there is no training set for this device.

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Triumph Resin Dam is a resin-based, light-cured protective barrier material recommended to protect dental materials or tissues. For Use only by a Licensed Dentist. Rx Use Only.

Triumph Resin Dam is a light-cured, resin dam material recommended to block out or protect dental materials or tissues. Triumph contains polymerizable monomers that when light-cured form a protective barrier. When set the resin has a low strength allowing its removal from the protected surfaces.

This document is a 510(k) summary for a medical device called "Triumph Resin Dam," which is a resin-based, light-cured protective barrier material for dental use. The summary focuses on demonstrating substantial equivalence to a predicate device ("OpalDam") rather than presenting a study proving performance against acceptance criteria in the typical sense of a clinical trial for diagnostic AI.

However, I can extract the relevant information from the document to construct an answer aligned with your request, interpreting "acceptance criteria" as the criteria for demonstrating substantial equivalence and "study" as the comparison tests performed.

Here's a breakdown of the requested information based on the provided text:

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

For this type of device (a Class I dental resin dam), the "acceptance criteria" are essentially the characteristics and performance deemed equivalent to a legally marketed predicate device. The document primarily focuses on demonstrating substantial equivalence to the Opal Dam (K971284) and referencing BriteSmile (K010935) for hardness comparison.

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The intended use of the FixaFloss is to be placed between teeth for the fixation of rubber dams.

The FixaFloss is a waxed dental floss with a silicone conical clamping element intended to be placed between teeth for rubber dam fixation.

The FixaFloss is a waxed dental floss assembled with 1 size and 1 color silicone conical resilient clamping element packaged as a one string product containing 20 resilient connes in a hygienic dispenser with an integrated cutting blade.

The provided text is a 510(k) summary for the FixaFloss device, a waxed dental floss with a silicone conical clamping element intended for rubber dam fixation. However, it does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving the device meets those criteria.

This document is a regulatory submission focused on demonstrating substantial equivalence to a legally marketed predicate device (The Hygenic Corp., Wedjets). It describes the device, its intended use, and claims substantial equivalence, but it does not present:

• A table of acceptance criteria.
• Reported device performance against specific criteria.
• Details of any study (sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth).
• Information on training sets.

Therefore, I cannot fulfill your request based on the provided text. The document's purpose is to clear the device for market by showing it is similar to an existing product, not to publish detailed performance study results against specific criteria.

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Bari-Kad™ is a device intended to protect soft tissue and isolate a tooth or a series of teeth from paste in the mouth during dental procedures, such as teeth whitening.

Bari-Kad™ Packing Device

The provided document is an FDA 510(k) clearance letter for the BioEnvelop Agro, Incorporated's "Bari-Kad™ Packing Device". This device is a dental product (rubber dam and accessories) intended to "protect soft tissue and isolate a tooth or a series of teeth from paste in the mouth during dental procedures, such as teeth whitening."

Based on the content of this regulatory letter, it is not a study report or clinical trial documentation. It primarily states:

• The FDA has reviewed the 510(k) premarket notification.
• The device is found substantially equivalent to legally marketed predicate devices.
• It outlines regulatory compliance requirements.
• It includes an "Indications for Use Statement."

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the document does not provide any of the following information:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets, data provenance.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results (human readers improvement with/without AI).
6. Standalone (algorithm-only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This is a regulatory clearance notice, not a scientific study report. To find the information you're looking for, you would typically need to consult the original 510(k) submission summary or any clinical studies referenced within it (if any were required, which is less common for Class I devices like this one).

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This product is light-cured composite resin indicated to protect soft tissue during in-office bleaching.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to GC America, Incorporated, regarding the device "GC TiON GINGIVAL PROTECTOR." This document approves the device for market based on substantial equivalence to a predicate device, but it does not contain any information about acceptance criteria or a study proving that the device meets those criteria.

The letter focuses on the regulatory classification and general provisions for marketing the device. The "Indications for Use" section simply states the intended purpose of the device: "This product is light-cured composite resin indicated to protect soft tissue during in-office bleaching."

Therefore, I cannot provide the requested information based on the input text. There is no mention of:

• A table of acceptance criteria or reported device performance.
• Sample sizes, data provenance, or ground truth establishment for any test or training set.
• Expert involvement or adjudication methods.
• MRMC comparative effectiveness studies or standalone algorithm performance.

To fulfill your request, you would need to provide a document that describes the performance testing and associated results for the GC TiON GINGIVAL PROTECTOR.

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The BriteSmile Masking Cream is intended to be used as an accessory to the BriteSmile Barrier Material to protect soft tissues during teeth-whitening procedures.

The BriteSmile Masking Cream protects the lips and mucosal areas farther away from the teeth that will not come into contact with the teeth whitening gel but which may be exposed to heat from the BriteSmile lamp used to activate the bleaching gel during the teeth whitening procedure. The BriteSmile Masking Cream is a white cream with a pH of 6.5 to 7.0.

The provided 510(k) summary for BriteSmile Masking Cream focuses on establishing substantial equivalence to a predicate device through various tests rather than setting specific acceptance criteria with performance metrics. Therefore, explicit "acceptance criteria" in the format of a performance table are not available in the document.

The document highlights the types of studies conducted to demonstrate safety and performance but does not provide quantitative results or detailed methodologies that would typically be associated with performance acceptance criteria for a medical device that produces a measurable output (e.g., diagnostic accuracy, sensitivity, specificity).

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information: The document does not specify quantitative acceptance criteria (e.g., "biocompatibility shall meet ISO 10993 cytotoxicity limits") nor does it provide quantitative performance results (e.g., "cytotoxicity score of X"). It only states that testing was completed to validate safety and performance.

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

The document does not specify the sample sizes used for any of the tests (biocompatibility, functionality, shelf life, antimicrobial). It also does not explicitly state the data provenance (e.g., country of origin, retrospective/prospective). Dental product studies often involve human subject testing or in vitro/ex vivo testing, but no details are provided here.

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

This information is not applicable and not provided. The product is a masking cream, and its performance is evaluated through technical and biological tests rather than interpretation or diagnosis by experts.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. The nature of the studies (biocompatibility, functionality, etc.) does not typically involve adjudication like in diagnostic imaging studies.

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

No MRMC study was conducted or mentioned. This type of study is relevant for diagnostic devices where human readers interpret results, which is not the case for a masking cream.

6. Standalone (Algorithm Only) Performance Study:

No standalone performance study in the context of an algorithm or AI was conducted or mentioned. The device is a physical product (masking cream), not an algorithm.

7. Type of Ground Truth Used:

The "ground truth" for the tests mentioned (biocompatibility, functionality, shelf life, antimicrobial) would be established by:

• Biocompatibility: Adherence to established biocompatibility standards (e.g., ISO 10993 series) and specific test results (e.g., non-cytotoxic, non-irritating).
• Functionality: Demonstrating the ability to reduce heat transmission and protect soft tissue as intended. This might involve thermal measurements or clinical observations.
• Shelf Life: Stability testing to ensure the product maintains its properties over its declared shelf life.
• Antimicrobial: Standard microbiological testing to evaluate antimicrobial efficacy or resistance to microbial growth.

The document does not detail the specific methodology for establishing these "ground truths."

8. Sample Size for the Training Set:

This information is not applicable and not provided. The device is not an AI/ML algorithm that requires a training set.

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

This information is not applicable and not provided, as there is no training set for this type of device.

Summary of Available Information:

The 510(k) summary for BriteSmile Masking Cream emphasizes that safety and performance were validated through standard design control procedures, including biocompatibility, functionality, shelf life, and antimicrobial testing. However, it does not provide specific quantitative acceptance criteria or detailed results of these tests. The nature of the device (a masking cream) means that many of the requested categories related to expert interpretation, AI, or diagnostic performance are not applicable.

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PULPDENT PUTTY DAM is a light-cured resin used by the dental professional during bleaching, air abrasion and etching procedures. PULPDENT PUTTY DAM protects soft tissue by creating a physical barrier.

PULPDENT PUTTY DAM is a light-cured resin used by the dental professional during bleaching, air abrasion and etching procedures. PULPDENT PUTTY DAM protects soft tissue by creating a physical barrier.

The provided text is a 510(k) Premarket Notification for a dental device called "Pulpdent Putty Dam." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed acceptance criteria and a study proving the device meets those criteria in the way a clinical trial for an AI/ML medical device would.

Therefore, many of the requested categories are not applicable to this document. I will fill in the available information and explain why other sections are not present.

Acceptance Criteria and Device Performance Study for Pulpdent Putty Dam

This 510(k) Premarket Notification for Pulpdent Putty Dam primarily establishes substantial equivalence to predicate devices, rather than presenting a performance study against specific, quantified acceptance criteria. The claim of safety and effectiveness rests on the general usage history of similar materials and regulatory approvals of predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. This submission does not describe a test set or a study with a specific sample size. The safety and effectiveness claims are based on:

• General usage history of similar materials (predicate devices) over approximately 10 years.
• The fact that predicate products have received 510(k) Premarket approval.

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

Not applicable. There was no specific test set requiring ground truth established by experts. The document mentions "The safety and effectiveness of these resins is supported by the editors of Reality. 2002." While "Reality" is a dental product review publication, this is not a formal ground truth establishment process for a specific test set.

4. Adjudication Method for the Test Set

Not applicable, as no test set requiring adjudication was described.

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

Not applicable. This type of study is typically performed for diagnostic devices where human readers interpret results, often with and without AI assistance. The Pulpdent Putty Dam is a physical barrier material, not an interpretative diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical dental material, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth," in the context of this 510(k), is implicitly based on the established safety record and performance of the predicate devices in clinical use over time. It relies on:

• Expert Consensus/Clinical Experience: "General usage of these materials over about 10 years indicates a high benefit-to-risk ratio."
• Regulatory Precedent: The predicate devices having received 510(k) approvals and being classified as Class I Dental Devices.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm requiring a training set.

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

Not applicable. This device is not an AI/ML algorithm requiring ground truth establishment for a training set.

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Prime-Dent Light Cure Soft Dental Dam is for soft tissue isolation and moisture prevention/barrier.

Not Found

This document is a 510(k) premarket notification letter from the FDA regarding the "Prime-Dent Light Cure Soft Dental Dam." It states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

However, this document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria. The letter is a regulatory approval, not a technical performance report.

Therefore, I cannot provide the requested information. The document focuses on regulatory compliance and substantial equivalence to a predicate device, not on presenting experimental data regarding the device's performance against defined acceptance criteria.

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The Niveous Liquid Dam resin is indicated to protect soft tissue during in-office bleaching.

Niveous Liquid Dam is a light-cured resin used for soft tissue isolation/protection during teeth whitening procedures. The material is dispensed from a syringe into the gingival crest just shy of the tooth structure. The resin is light-cured (polymerized) on the soft tissue by exposure for 20 seconds per section of material.

This submission is for a Class II medical device, Niveous Liquid Dam, intended to protect soft tissue during in-office bleaching. It is a 510(k) premarket notification, which means the device's acceptance criteria are centered on demonstrating substantial equivalence to a predicate device, rather than proving novel performance metrics through a clinical study with acceptance criteria.

Therefore, the requested information regarding detailed acceptance criteria, specific performance metrics, sample sizes, expert qualifications, and MRMC studies, as typically found in clinical trials for novel devices with performance claims, is not applicable in this 510(k) summary. The "study" for this device is the comparison of its characteristics to a legally marketed predicate device to establish substantial equivalence.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for substantial equivalence, formal quantitative acceptance criteria (e.g., sensitivity, specificity thresholds) and corresponding reported performance metrics (e.g., exact measured diagnostic accuracy) in a clinical study are not provided in this document. The "acceptance criteria" are based on demonstrating comparable characteristics and intended use to predicate devices. The "reported device performance" is implicitly that it performs equivalently to the predicate devices for its intended use.

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

• Sample Size for Test Set: Not applicable. No "test set" in the sense of a clinical trial dataset with patient samples was used for this 510(k) submission as it focuses on substantial equivalence based on material properties and intended use.
• Data Provenance: Not applicable for a traditional clinical "test set." The data provenance for the comparison is the existing regulatory files and market history of the predicate devices.

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

• Number of Experts: Not applicable. No external experts were used to establish ground truth for a clinical test set as part of this submission. The "ground truth" for substantial equivalence is based on the known characteristics and approved status of the predicate devices.

• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. No formal adjudication method for a clinical test set was employed as part of this 510(k) submission.

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

• MRMC Study: No. This device is a dental material, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant.

• Effect Size: Not applicable.

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

• Standalone Performance Study: No. This device is a physical dental material, not an algorithm.

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

• Type of Ground Truth: The "ground truth" for this 510(k) submission is the established safety and effectiveness profile, chemical composition, physical characteristics, and intended use of the legally marketed predicate devices (FastDam [K972775] and OpalDam [K971284]). The applicant demonstrated that Niveous Liquid Dam is sufficiently similar to these predicates.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device is a dental material, not an AI/machine learning algorithm, so there is no "training set" in that context. The development of the material would involve internal R&D and quality control, but not a "training set" as understood in AI studies.

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

• Ground Truth for Training Set Establishment: Not applicable. As there is no AI training set, this question is not relevant.

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