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Softens dental calculus, tartar, and/or plaque to facilitate easier removal; Reduces scaling time; May be used in hand and ultrasonic scaling procedures.

EDS Calculus Softener (TURBO-CR™) is a professional use only product to be used by a dental hygienist to aid in the cleaning and removal of dental plaque, mineralized calculus and/or tartar from subgingival root surfaces and supragingival areas of teeth. The composition helps remove the etiological factors which have been implicated in fostering periodontal disease. The device contains chelating agents and detergents which reduce the hardness of mineralized plaque, calculus, and/or tartar. It consists of two component pastes that are combined in a dual barrel syringe for ease of dispensing and consistent dosage. The device contains an alkaline paste which effervescences or foams upon mixing through a mixing tip. This effervescence helps drive the activated composition into the "hard to reach" interproximal spaces between teeth as into the subgingival regions where tartar/plaque and or dental calculus can accumulate.

It is packaged in the familiar double-barrel syringe configuration used by numerous other dental materials. The double barrel syringe is placed into a manual cartridge gun (commonly available at the dental clinic) and the composition is dispensed into a dental tray which is then placed over the patient's dental arch for cleaning. The steps required to properly express the calculus softening composition are: remove cap, attach mixer, place into manual cartridge gun, express the material into a dental tray, and then place into the patient's mouth over the dental arch to be cleaned/debrided for 60 seconds. The patient is then instructed to rinse and the dental scaling can commence by the dental hygienist. After use, the mixer/dispensing tip and dental tray should be discarded and the cap replaced. The device is provided non-sterile and does not contain fluoride or any whitening agents.

The provided text is a 510(k) premarket notification for the EDS Calculus Softener (TURBO-CR™). It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with a defined test set, ground truth, and expert adjudication as one might see for a novel AI/imaging device.

Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth establishment, adjudication methods, MRMC studies, or effect size of human reader improvement with AI assistance, are not applicable to this type of submission. This document describes a new medical device and demonstrates its equivalence to existing, legally marketed devices, primarily through bench testing and comparison of characteristics, rather than a clinical trial demonstrating a novel performance claim that would require an AI-style evaluation.

Here's an attempt to answer the questions based on the provided text, highlighting where information is N/A or not relevant to this submission type:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in numerical targets (e.g., "softening of calculus by X%"). Instead, the performance objective is to demonstrate that the device is substantially equivalent to the predicate device in its ability to soften simulated dental calculus and meets relevant safety standards.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable in the context of human data or a specific "test set" for a novel algorithm. The testing described (bench and biocompatibility) is for the physical and chemical properties of the device itself. For example, for ASTM E384-22 (Microindentation Hardness), a sample of the material would be tested, not patient data. The document does not specify the number of material samples used for these bench tests.
• Data Provenance: Not applicable for device material testing. There is no patient data involved in the described equivalence testing.

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

• Number of Experts: Not applicable. Ground truth in this context is established through standardized laboratory tests (e.g., pH meter readings, viscometer measurements, hardness measurements) and adherence to international ISO and ASTM standards for biocompatibility and material properties. It does not involve human expert interpretation of images or clinical outcomes.
• Qualifications of Experts: N/A for human experts establishing ground truth. The testing is performed by laboratory personnel following established protocols.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. As there are no human expert interpretations requiring consensus or adjudication, this step is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

• MRMC Study: No. This type of study is typically performed for AI-assisted diagnostic tools where human reader performance is being evaluated with and without AI. This submission is for a physical/chemical dental product used by a hygienist, not an AI diagnostic tool.

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

• Standalone Performance: Not applicable. This is not an AI algorithm. The performance testing is for the physical and chemical properties of the gel.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for performance is established by objective measurements following standardized laboratory protocols (e.g., ASTM E384-22 for microindentation hardness, ISO 11609:2017 for pH, ISO 3219-2:2021 for viscosity) and biocompatibility testing against ISO standards (e.g., ISO 10993 series for cytotoxicity, irritation/sensitization). The foundational "ground truth" for the device's safety and effectiveness relies on the long history of safe clinical use of the predicate devices and the generally recognized as safe (GRAS) status of many of its components.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set" for an algorithm.

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

• Ground Truth for Training Set: Not applicable, as there is no training set.

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• Final cementation of ceramic, composite, or metal inlays, onlays, crowns, bridges, posts, and screws.
• Final cementation of ceramic, composite, or metal restorations on implant abutments.
• Permament cementation of ceramic or composite veneers.

EDS Universal Cement is an automix, dual-curing, self-adhesive resin cement. This multi-purpose device can be used to affix a variety of ceramic, composite, or metal restorations without the aid of an etchant or bonding agent. The device is comprised of two pastes (base and catalyst) that contain dimethacrylate resins, inorqanic filler particles (60% by wt), and a photoinitiator system. The mixing ratio is roughly 1 part base to 1 part catalyst. The device is packaged in a 5 mL dualbarreled syringe and comes in three shades: translucent (white), opaque (white), and A2 (tooth colored). EDS Universal Cement provides a bond between tooth surfaces (dentin and enamel) and ceramic, composite, and metal restorations. The device provides radiopacity and is resistant to mechanical stress and water damage. EDS Universal Cement is provided non-sterile and has a shelf-life of two years.

The provided document is a 510(k) premarket notification for a dental cement (EDS Universal Cement). It does not describe an AI/ML powered device, nor does it contain information about acceptance criteria or a study proving the device meets said criteria in the context of AI/ML performance metrics.

However, based on the document, I can extract information related to product testing and equivalence to predicate devices, which serves a similar purpose to acceptance criteria and studies in regulatory submissions for traditional medical devices.

Here's an interpretation of the request using the available information for a non-AI/ML device:

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

The document does not explicitly state "acceptance criteria" with numerical thresholds for performance. Instead, it relies on demonstrating equivalence to a legally marketed predicate device (Unicem HM). The performance is reported through a series of tests against this predicate.

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

The document does not specify the exact sample sizes for the individual tests (e.g., number of samples for shear bond strength, number of animals for in vivo tests). It generally refers to "samples of the subject and predicate devices."

The data provenance is not explicitly stated in terms of country of origin. The study types (biocompatibility, physical properties, adhesion) are all non-clinical in vitro or in vivo (animal) studies, not human clinical studies. Therefore, it is retrospective if the tests were performed on pre-existing batches or prospective if the tests were designed specifically for this submission. The summary does not provide this detail.

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

This concept is not applicable here as these are laboratory-based non-clinical tests for a dental cement, not diagnostic or AI performance evaluation studies requiring expert ground truth. The "ground truth" for these tests would be the established scientific methods and measurements.

4. Adjudication method for the test set

Not applicable for non-clinical laboratory tests. The results are typically objectively measured according to standardized protocols (e.g., ISO standards for biocompatibility, universal testing machine for shear bond strength).

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 dental cement, not an AI-powered diagnostic device.

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

Not applicable. This is a dental cement, not an AI-powered device.

7. The type of ground truth used

For biocompatibility tests, the ground truth is established by ISO (International Organization for Standardization) standards (e.g., ISO 10993 series), which define acceptable biological responses.

For physical properties and adhesion tests, the "ground truth" is measured physical and material properties derived from standardized laboratory testing methods (e.g., shear bond strength in MPa). The comparison is against the predicate device's performance under similar testing conditions.

8. The sample size for the training set

Not applicable. This is a traditional medical device, not an AI/ML system requiring a training set.

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

Not applicable. This is a traditional medical device, not an AI/ML system.

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EDS Combo-Rinse is intended to cleanse root canal systems by irrigating root canals.

EDS Combo-Rinse is an aqueous solution for use during the irrigation phase of endodontic root canal preparation procedures. The device has a dual purpose of flushing out any loosened debris and removing the smear layer produced from root canal instrumentation.

The provided text describes a 510(k) summary for the EDS Combo-Rinse device, which is an aqueous solution for use during root canal preparation. The submission focuses on demonstrating substantial equivalence to a predicate device (QMix™ 2in1 Endodontic Irrigating Solution). Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed in terms of equivalence to the predicate device, rather than independent performance metrics defined specifically for EDS Combo-Rinse.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state sample sizes for the biocompatibility or smear layer removal testing.
Regarding data provenance:

• The tests were conducted to determine equivalence to the predicate device.
• The document implies these were non-clinical tests.
• Country of origin is not specified but is assumed to be part of the manufacturer's testing process.
• The studies were retrospective in the sense that they compared the new device to existing predicate devices, but the testing itself would have been prospective for the EDS Combo-Rinse samples.

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

Not applicable. The "ground truth" here is the established safety and performance profile of the predicate device and the accepted standards (ISO 10993). There is no mention of human experts establishing ground truth for a test set in the context of device performance. The assessment is based on laboratory test results against established benchmarks.

4. Adjudication Method for the Test Set

Not applicable. There was no explicit adjudication method for a test set described, as the evaluation was based on objective, standardized tests (biocompatibility according to ISO 10993, and smear layer removal testing).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study is not relevant for a root canal irrigating solution and was not performed. The device is a physical/chemical irrigant, not an imaging or diagnostic AI tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense. The biocompatibility and smear layer removal tests are standalone evaluations of the device's physical and chemical properties and performance, without human intervention in the device's function during testing. This is a "device only" performance assessment.

7. The Type of Ground Truth Used

The ground truth used for comparison was:

• Established performance of the predicate device: QMix™ 2in1 Endodontic Irrigating Solution, particularly its biocompatibility and smear layer removal capabilities.
• International standards: ISO 10993 for biocompatibility testing.
• Regulatory precedence: The fact that components have been "used in legally marketed devices and were found safe for dental use."

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The term "training set" is not relevant to this type of device submission.

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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EDS Ultrasonic Tips are intended for use by dental professionals for the removal of soft and hard tissue during endodontic root canal preparation procedures. They can also aid in the removal of endodontic posts and other intra-canal blockages.

EDS Ultrasonic Tips are an accessory to a piezoelectric ultrasonic handpiece and scaler unit. These powered components are not included as part of the device submitted for application with the 510(k) submission. EDS Ultrasonic Tips are stainless steel and will be available in M3x0.5 and #5-40 thread with 6 different tip designs. 1 tip design is devised for post removal; the remaining 5 tips are designed for negotiating the various angles and directions of root canals.

The provided text describes the acceptance criteria and the study conducted for the EDS Ultrasonic Tips.

Here's the breakdown of the information requested:

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

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

• Sample size: Not explicitly stated in the provided text. The document mentions "Mechanical testing was conducted in the form of breakage resistance testing," but does not specify the number of tips tested.
• Data provenance: Not explicitly stated. Given that the testing was conducted to support a 510(k) submission, it would typically be prospective testing conducted by the manufacturer, Essential Dental Systems.

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

• Not applicable. The study involved mechanical testing, not expert-based ground truth establishment for a diagnostic or similar device.

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

• Not applicable. The study involved mechanical testing, not a method requiring adjudication of expert opinions.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is an ultrasonic tip used in endodontic procedures, not an AI-powered diagnostic tool requiring human reader studies.
• The document explicitly states: "Discussion of Clinical Tests Performed: Not Applicable."

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

• Not applicable. The device is a physical instrument, not an algorithm.

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

• For the breakage resistance testing, the "ground truth" would be established by engineering standards or specifications for material integrity and performance, likely measured through mechanical stress tests to determine the point of failure or acceptable loads. This is not categorized as expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

• Not applicable. The device is a physical instrument, not an algorithm that requires a training set.

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

• Not applicable. As above, there is no training set for this type of device.

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Endo-Express® Handpiece is indicated for the removal of dentin, shaping and obturation of the root canal. This application area extends to endodontic procedures using NiTi or stainless steel endodontic instruments intended by the manufacturer for use in the mechanical preparation of root canals.

Endo-Express® Handpiece is a reciprocating handpiece for use with NiTi or stainless steel instruments during endodontic procedures. The handpiece is driven by an air motor. The steps required to properly operate the handpiece are: push button to open chuck, insert instrument handle into chuck, release button to close chuck, run handpiece. After use, the handpiece should be lubricated and autoclaved. The contents of the kit are 1 Endo-Express® Handpiece, 1 Lubricant bottle, 1 nozzle attachment.

The provided document is a 510(k) summary for the Endo-Express® Handpiece, stating its substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a dedicated study with the specific components you requested (such as sample sizes, expert qualifications, and MRMC studies).

Here's a breakdown of why this information isn't present in the provided text:

• Nature of the Document: This is a premarket notification (510(k)) seeking clearance based on substantial equivalence. For Class I and many Class II devices, clinical trials with formal acceptance criteria, statistical analyses, and ground truth establishment are often not required if substantial equivalence to a legally marketed predicate device can be demonstrated through performance testing, comparison of technological characteristics, and intended use.
• "Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows: Not Applicable" (Section 7): This explicitly states that specific non-clinical tests were not performed in a way that would require detailed reporting of acceptance criteria and results in this summary. It implies that the demonstration of substantial equivalence relied on other factors, primarily comparison of intended use and technological characteristics to the predicate.
• "Discussion of Clinical Tests Performed: Not Applicable" (Section 8): This confirms that no clinical studies were performed for the purpose of this 510(k) submission. Therefore, there would be no data on sample sizes, expert-established ground truth, MRMC studies, or standalone algorithm performance.

Based on the provided document, the following information is available for your request:

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

(Note: The document implies the "acceptance" is based on the device having similar characteristics and intended use to the predicate. There are no numerical performance metrics or thresholds explicitly defined as acceptance criteria for this specific submission.)

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

• Sample Size for Test Set: Not applicable. No test set for performance comparison was described as part of a new study in this submission.
• Data Provenance: Not applicable.

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

• Not applicable. No ground truth establishment by experts for a test set was described in this submission.

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

• Not applicable.

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. No MRMC study was performed or described. This device is a mechanical dental handpiece, 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 mechanical dental handpiece, not an algorithm.

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

• Not applicable.

8. The sample size for the training set:

• Not applicable.

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

• Not applicable.

Summary of the study that proves the device meets the acceptance criteria:

The document states, "Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows: Not Applicable" and "Discussion of Clinical Tests Performed: Not Applicable."

Instead of a specific performance study, the substantial equivalence was demonstrated by:

• Comparison of Intended Use: The Endo-Express® Handpiece has the same intended use as the predicate device (TEP E4R).
• Comparison of Technological Characteristics: The device has similar technological characteristics to the predicate, with the main differences being cosmetic appearance and maximum allowable motor speed. The key functional characteristics (latch type, file type, motor connection, reduction ratio) are identical to the predicate.

The "study" proving the device meets the implicit acceptance criteria (i.e., being substantially equivalent to a legally marketed predicate) is primarily a direct comparison of specifications and intended use outlined in Section 6, rather than a clinical or detailed non-clinical performance study with explicit acceptance criteria and results.

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Ti-Core® Flow+ is indicated for vital or non-vital tooth core build-up (replacement of existing restorations and/or lost tooth structure), as a base prior to fabricating an indirect restoration, and as a post cement. Ti-Core® Flow+ is also indicated for cementing of endodontic posts, crowns, bridges, inlays, onlays, and for core build-ups.

Ti-Core® Flow+ is a dual-cure resin cement that can be used as a luting agent and core material. It is packaged in the familiar double-barrel syringe and our materials with the puttless other dental materials. The steps required to oroperly express the cement are: remove cap, attach mixer, attach dispensing tip, press plunger. After use, the mixer/dispensing tip should be discarded and the cap replaced.

The contents of the kit are
2 - Dual chambered syringes each containing 9 am resin cement

• 20 Mixers
  10 - Thin dispensing tips
  10 - Thick dispensing tips

The provided document describes the acceptance criteria and the study conducted for the Ti-Core® Flow+ dental resin cement.

Acceptance Criteria and Device Performance

Study Information

1. Sample size used for the test set and the data provenance:
   The document does not specify a distinct "test set" in the traditional sense for a clinical study. The performance evaluation was based on non-clinical tests conducted according to ISO standard 4049. The sample size for these non-clinical tests (e.g., number of specimens for film thickness, flexural strength) is not provided. The provenance of these non-clinical test materials (e.g., origin of the raw materials, specific lab where tests were conducted) is also not explicitly stated, though it's implied the testing was done by Essential Dental Systems or a contracted lab.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable. This was a non-clinical, in-vitro study based on ISO standard specifications, not a study requiring expert clinical ground truth assessment on human data.

3. Adjudication method for the test set:
   Not applicable. This was a non-clinical, in-vitro study.

4. 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 document pertains to a dental resin cement, not an AI-powered diagnostic device, and no human reader studies are described.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. This is not an algorithm or AI device.

6. The type of ground truth used:
   The "ground truth" for evaluating the device's performance against its acceptance criteria was the ISO standard 4049 specification limits for various physical and chemical properties of dental resin cements.

7. The sample size for the training set:
   Not applicable. This is not a machine learning or AI device that requires a training set.

8. How the ground truth for the training set was established:
   Not applicable. There is no training set for this device.

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EDTA Plus is a root canal cleanser designed to facilitate removal of dentinal debris from the walls of root canals prior to obturation

EDTA Plus is a root canal cleanser for use in endodontic procedures. During/After endodontic instrumentation, the product should be used to clean the canal space and remove the smear layer before placement of the endodontic filling. The material can be delivered into the canal using a side-vented, closed tip irrigation needle.

The device consists of a 16 oz. bottie of EDTA Plus, a peach-colored aqueous solution.

The provided document is a 510(k) summary for a medical device called "EDTA Plus," a root canal cleanser. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.

The document primarily focuses on:

• Identification of the submitter and device.
• Comparison to predicate devices (SmearClear® and Moyco-EDTA) for the purpose of demonstrating substantial equivalence.
• Device description (16 oz. bottle of peach-colored aqueous solution).
• Intended Use (root canal cleanser to facilitate removal of dentinal debris before obturation).
• The FDA's decision letter granting substantial equivalence (K072555).

In summary, the provided text does not contain the information requested for a detailed description of acceptance criteria and the study proving device performance as it pertains to AI or diagnostic device performance metrics. This type of submission (510(k) for a cleanser) typically relies on demonstrating equivalence to existing products based on composition and known mechanisms of action, rather than clinical performance studies with specific statistical endpoints and ground truth comparisons.

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Endo-CHXTM is intended to irrigate and cleanse root canal systems.
ENDO-CHX™ is intended to irrigate and cleanse root canal systems.

Endo-CHX™ is a root canal cleanser for use in endodontic procedures. After endodontic instrumentation, the product should be used to cleanse the canal space before placement of the endodontic filling. The material should be delivered into the canal using an irrigating neede. A side-vented, closed tip irrigation needle is most preferred.

The provided document is a 510(k) summary for a root canal cleanser called Endo-CHX™. As such, it primarily focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study demonstrating performance against those criteria in the way that might be expected for an AI-powered diagnostic device.

Here's an analysis based on the information provided, while noting the limitations due to the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not applicable in the traditional sense for this type of device and submission. For a root canal cleanser, "acceptance criteria" would typically relate to its chemical properties, biocompatibility, and efficacy in cleaning the root canal system, often demonstrated through in vitro or ex vivo studies. The 510(k) summary focuses on substantial equivalence to predicate devices rather than setting and meeting specific quantitative performance metrics like sensitivity or specificity.

The "device performance" is implicitly established by demonstrating that it functions similarly to legally marketed predicate devices and is considered safe and effective.

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

There is no test set in the context of an AI/diagnostic device performance study. The 510(k) relates to a chemical solution.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable. Ground truth, expert consensus, or clinical adjudication as would be relevant for an AI/diagnostic device is not part of this submission type.

4. Adjudication Method

This information is not applicable.

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

This information is not applicable. This is not an AI-powered diagnostic device.

6. Standalone Performance Study

The submission mentions "Non-Clinical Testing: The performance and biocompatibility documentation provided the submission support the safety and effectiveness of the Endo-CHX root canal cleanser for the indicated uses." This suggests standalone testing was performed, but the details (e.g., specific tests, outcomes, quantitative measures) are not provided in this summary exhibit. It just states that such documentation exists and supports safety and effectiveness.

7. Type of Ground Truth Used

For non-clinical testing of a root canal cleanser, the "ground truth" would likely involve standardized in vitro models or ex vivo tooth specimens. The effectiveness would be measured by properties such as debris removal, antibacterial activity, or smear layer removal, often compared to controls or predicate devices. However, direct "ground truth" establishment in a clinical sense (like pathology for cancer) is not specified or generally applicable here.

8. Sample Size for the Training Set

There is no training set for this device as it is not an AI/machine learning product.

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

There is no training set for this device.

Summary of Relevant Information from the Provided Text:

• Acceptance Criteria & Performance: Not explicitly stated as quantitative metrics. Performance is inferred through "substantial equivalence" to predicate devices and general statements about non-clinical testing supporting safety and effectiveness.
• Study Type: Non-clinical (e.g., in vitro or ex vivo) testing was performed for performance and biocompatibility. No clinical trials were deemed necessary ("Clinical Testing: Not applicable").
• Predicate Devices: The device was compared to K061689 (Aquatine™ EC Endodontic Cleanser) and K053167 (BioPure™ MTAD™ Root Canal Cleanser). The comparison focuses on mechanism of action and composition.
• Conclusion: The device is considered "substantially equivalent to the predicates and raises no issues of safety and effectiveness."

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The EZ-Fill® Xpress Epoxy Root Canal Cement System is indicated for permanent sealing of root canals following established endodontic procedures.

The EZ-Fill® Xpress Epoxy Root Canal Cement System is an obturation system for filling straight and minimally curved canals. The bi-directional spiral (cement carrier that fully coats the canal, but prevents excess cement form exiting apically) and epoxy root canal cement, combined with a single point technique, creates a seal equivalent to lateral condensation and thermoplastic gutta percha. The contents of the kit are identical except that '2 - Dual Chambered Syringes containing 9.5 gm of root canal sealer' and '20 - Mixing Tips' replace the '7.5 gm - Epoxy Root Canal Cement Gel, 8.0 gm - Powder (Epoxy Root Canal Cement), and 1 Measuring Scoop.' The full list of contents is as follows: 4 - Color Coded to ISO Size 25 Bi-Directional Spirals (1 - 21mm length and 3 - 25 mm length), 2 - Dual Chambered Syringes containing 9.5 gm root canal sealer, 20 - Mixing Tips.

The provided document describes the EZ-Fill® Xpress Epoxy Root Canal Cement System and its substantial equivalence to predicate devices, but it does not contain a study that proves the device meets specific acceptance criteria in the format requested.

The document focuses on demonstrating substantial equivalence through:

• Comparison of device description, intended use, and technological characteristics to predicate devices.
• Bench testing to show compliance with international standards (ADA Specification No.57 and ISO 6876) for physical properties.
• Biocompatibility literature to show no new safety concerns compared to predicate devices.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth are Not Applicable (N/A) based on the provided text, as a direct study demonstrating achievement of criteria is not presented.

Here's a breakdown of the available information:

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. The document only mentions "Bench Testing performed" without detailing the number of samples or tests conducted.
• Data Provenance (country of origin, retrospective/prospective): Not specified.

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

• Not Applicable. Bench testing against pre-defined physical property standards does not typically involve expert ground truth establishment in the same way clinical or diagnostic studies do. The "ground truth" here is the standard itself.

4. Adjudication method for the test set

• Not Applicable. See point 3.

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 document explicitly states: "Discussion of Clinical Tests Performed: Not Applicable." This is a material testing for a root canal cement, not a diagnostic AI device.

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

• Not Applicable. This is not an AI/algorithm-based device.

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

• For physical properties, the ground truth is based on the requirements and methodologies outlined in ADA Specification No.57 and ISO 6876.
• For biocompatibility, the ground truth is established by biocompatibility literature and Material Safety Data Sheets, indicating that the materials do not raise new safety concerns compared to legally marketed predicate devices.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device that requires a training set.

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

• Not Applicable. See point 8.

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