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The product is used for indirect pulp capping, direct pulp capping, root end filling and Repair of perforation.

ENDOCEM MTA PREMIXED REGULAR is a root canal filling material conforming to ISO 6876, in a pre-loaded syringe that does not require any pre-mixing and is set by absorbing moisture from the root canal environment.

The provided text is a 510(k) summary for the medical device "ENDOCEM MTA PREMIXED REGULAR," which is a root canal filling material. This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing. It does not contain information about a study involving AI, human readers, or a test set with ground truth established by experts, as typically seen in submissions for AI-powered diagnostic devices.

Therefore, many of the requested items (2, 3, 4, 5, 6, 7, 8, 9) are not applicable to the content provided. I can, however, extract information regarding the acceptance criteria for the device itself and the tests performed to meet them.

Here's the information based on the provided text:

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

The document states that "All the test results met the preset test criteria." However, it does not explicitly list the specific acceptance criteria (e.g., "setting time must be between X and Y minutes") or the exact numerical results obtained for each test. It only lists the tests performed and implies that the performance was satisfactory.

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

This information is not provided in the document. The type of testing performed (bench and biocompatibility) generally does not involve "test sets" in the context of clinical or AI studies, but rather samples of the material for physical, chemical, and biological evaluation.

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)

This information is not applicable to the provided document, as it describes the testing of a medical material, not a diagnostic device requiring expert interpretation of results for ground truth.

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

This information is not applicable to the provided document.

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

There is no mention of an MRMC study or AI in the provided document.

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

This information is not applicable to the provided document. The device is a root canal filling material, not an algorithm.

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

This information is not applicable in the traditional sense for this type of device submission. For the physical and chemical tests, "ground truth" would be established by the adherence to specified standards (e.g., ISO 6876) and validated testing methodologies. For biocompatibility, "ground truth" is determined by established biological safety endpoints and accepted testing protocols (e.g., ISO 10993).

8. The sample size for the training set

This information is not applicable as this is not an AI/machine learning device with a training set.

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

This information is not applicable as this is not an AI/machine learning device with a training set.

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Permanent root canal obturation

White ENDOSEAL MTA is a root canal sealer conforming to ISO 6876, in a pre-loaded syringe that does not require any pre-mixing and is set by absorbing moisture from the root canal environment. The sealer can be used either alone or in combination with gutta-percha obturating cones, injected gutta-percha material or core-carriers, master cones.

The provided text is a 510(k) summary for a medical device (White ENDOSEAL MTA), which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This document does NOT contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of an AI/ML medical device.

The document discusses:

• Device Description: A root canal sealer for permanent root canal obturation.
• Performance Testing (Non-Clinical): This section outlines physical and chemical tests (e.g., setting time, flow, radiopacity, solubility, cytotoxicity) conducted according to ISO standards.
• Substantial Equivalence: The primary purpose of a 510(k) is to show that a new device is as safe and effective as a legally marketed predicate device. This is done by comparing technological characteristics and performance data.

The document does NOT contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets acceptance criteria using human readers, ground truth, or AI performance metrics.

Specifically, the following information is NOT present in the provided text:

• Acceptance Criteria Table and Device Performance for specific clinical or AI metrics: The "performance testing" section refers to ISO standards for material properties, not clinical or AI performance.
• Sample size for a test set (clinical or AI): No clinical study with a test set is described.
• Data provenance (country of origin, retrospective/prospective): Not mentioned.
• Number of experts and their qualifications for ground truth: No expert review for ground truth is described.
• Adjudication method for a test set: Not mentioned.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not conducted or reported.
• Effect size of human reader improvement with AI assistance: Not applicable as it's not an AI device.
• Standalone (algorithm only) performance: Not applicable as it's not an AI device.
• Type of ground truth (expert consensus, pathology, outcomes data): No ground truth for clinical or AI performance is described.
• Sample size for the training set: Not applicable as it's not an AI device.
• How ground truth for the training set was established: Not applicable.

The document focuses on the physical and chemical properties of a dental material and its biocompatibility to demonstrate substantial equivalence to a predicate device, not on diagnostic performance or capabilities involving AI or human interpretation of images.

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Permanent root canal obturation

This product is the root canal sealer conforming to ISO 6876. This is a pre-loaded syringe type that does not require mixing and set by absorbing the moisture around the root canal.

The provided document describes a 510(k) premarket notification for a medical device called "White ENDOSEAL MTA," which is a root canal filling material. This submission focuses on non-clinical performance testing and does not involve a study proving the device meets acceptance criteria related to AI/ML or human-in-the-loop performance.

Therefore, most of the requested information regarding AI/ML-specific study design (such as sample sizes for test and training sets, expert adjudication, MRMC studies, standalone algorithm performance, and ground truth establishment) cannot be found in this document.

However, I can extract information related to the performance testing (non-clinical) performed for this device based on the provided text.

Here's the breakdown of the information that can be extracted, and an explanation of why other requested information is not applicable:

Information available from the document:

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

The document lists performance testing against ISO 6876 standards, which implicitly defines acceptance criteria. The reported performance for the proposed device (White ENDOSEAL MTA) is compared to the predicate device.

Note: The document states "All the test results met the preset test criteria," indicating compliance with the referenced standards (ISO 6876, ISO 10993 series) for the White ENDOSEAL MTA.

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

• Sample Size: Not specified for the non-clinical tests. Non-clinical bench testing often uses small, controlled samples, but the exact number isn't in this summary.
• Data Provenance: The testing was conducted by "MARUCHI" (the manufacturer) or by testing institutions following specific ISO standards. The location is the Republic of Korea (manufacturer's address). The data is from non-clinical bench testing, not patient data.

Information NOT available or NOT applicable to this document:

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)

• This document describes non-clinical laboratory testing (e.g., material properties, biocompatibility), not clinical studies involving expert interpretation of medical images or patient outcomes. Therefore, there is no concept of "ground truth" established by medical experts in this context.

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

• Not applicable. This is for clinical study ground truth establishment, not non-clinical bench testing.

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 document is about a root canal filling material, not an AI/ML device for image interpretation or diagnosis. No human reader studies were mentioned.

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

• Not applicable. This is not an AI/ML device.

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

• For the non-clinical tests described, the "ground truth" is defined by the objective measurement parameters and specifications set forth by the international standards (ISO 6876, ISO 10993 series) and internal testing methods. There is no clinical "ground truth" derived from patients or expert consensus.

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. As above, there is no AI/ML component or training set.

Summary:

This 510(k) submission for "White ENDOSEAL MTA" focuses on demonstrating substantial equivalence to a predicate device through non-clinical (bench and biocompatibility) testing, confirming it meets established international standards for root canal filling materials. It does not involve AI/ML technology, clinical performance studies, or the types of expert-driven data collection and analysis that would require answering questions 3, 4, 5, 6, 8, and 9.

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CleaniCal is a Calcium Hydroxide paste that has a creamy consistency and is suitable for several indications including:

• Temporary disinfectant dressings in the obturation of root canals;
• Indirect pulp capping or management of deep caries lesions; or
• Direct pulp capping.

CleaniCal is a type of pre-filled syringe to Calcium Hydroxide Paste with a pH 12.3.

This document describes the premarket notification (510(k)) for CleaniCal, a Calcium Hydroxide Cavity Liner. The information provided is primarily focused on demonstrating substantial equivalence to predicate devices through non-clinical performance testing and comparison of characteristics, rather than a clinical study evaluating diagnostic accuracy or reader performance of an AI-powered device.

Therefore, many of the typical elements used to describe the acceptance criteria and the study proving an AI-powered device meets those criteria are not directly applicable or available in this type of submission. This premarket notification is for a dental material (calcium hydroxide paste), not an AI device.

Let's break down what can be extracted and what cannot, based on the provided text, in the context of your request for an AI device.

Observation: The provided document describes a medical device (a dental calcium hydroxide paste called "CleaniCal"), not an AI-powered device. Therefore, many of the questions related to AI-specific study designs (e.g., MRMC studies, standalone algorithm performance, AI assistance effect size) will not be addressed in this document.

However, I will interpret the request as best as possible using the available information, mapping it to your bullet points where applicable, and highlighting where information is not present for this type of device.

Acceptance Criteria and Device Performance for CleaniCal (a Dental Material)

The acceptance criteria for "CleaniCal" are primarily defined by its ability to meet established ISO standards for dental root canal filling materials and its biocompatibility. The study proving the device meets these criteria is a series of non-clinical (bench and biocompatibility) tests.

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

The document states: "All the test results met the preset test criteria." The "preset test criteria" are the specific requirements within the referenced ISO standards. The table below summarizes the types of tests performed and the general outcome as stated in the document. Specific numerical acceptance values or reported performance metrics for each test (e.g., exact flow rate, specific radio-opacity value) are not provided in this 510(k) summary, only that the device "met" them.

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

• Sample Size for Test Set: Not explicitly stated in the document. For non-clinical bench testing, sample sizes are typically determined by relevant ISO standards or internal quality procedures.
• Data Provenance: The testing institution is MARUCHI itself (the manufacturer) or external labs contracted by MARUCHI, as implied by "Testing institution's method." The country of origin for the testing would likely be Republic of Korea as that is where MARUCHI is located. These are non-clinical, pre-market tests, so the retrospective/prospective distinction for clinical data doesn't apply here.

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

• Not Applicable. For this type of dental material, "ground truth" is established by adherence to specified physical, chemical, and biological properties as defined by international standards (e.g., ISO 6876, ISO 10993). This does not involve clinical "experts" in the sense of radiologists reading images to establish ground truth for diagnostic AI. The tests are laboratory-based measurements.

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

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic accuracy assessments where human readers interpret data that AI might also interpret. The tests performed for CleaniCal are objective laboratory measurements, not subjective evaluations requiring adjudication.

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-powered device. Therefore, no MRMC study, AI assistance comparison, or effect size calculation with human readers was performed or is relevant.

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

• Not Applicable. This is not an AI-powered device.

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

• For CleaniCal, the "ground truth" is based on objective measurements of material properties and biological responses as defined by international standards (ISO 6876, ISO 10993 series). This includes properties like pH, flow, radio-opacity, and results of various biocompatibility tests (cytotoxicity, systemic toxicity, genotoxicity, implantation). It is not clinical ground truth derived from expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

• Not Applicable. This is not an AI-powered device. There is no "training set" in the context of machine learning.

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

• Not Applicable. This is not an AI-powered device. There is no "training set" or "ground truth establishment" for a training set.

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• Permanent obturation of the root canal following vital pulp-extirpation
• Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings.

ENDOSEAL MTA is an endodontic sealer based on MTA, providing a biocompatible and effective root canal filling. It is premixed and pre-loaded in a syringe, which allows a complete filling of the entire root canal including accessory and lateral canals. The product is eugenol-free and will not impede adhesion inside the root canal.

Below is a summary of the acceptance criteria and study information for the Endoseal MTA device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The provided text does not specify the sample sizes used for the test set in any of the performance or biocompatibility tests.
The data provenance is from non-clinical testing conducted by MARUCHI, as presented in the 510(k) submission. The country of origin of data is implicitly the Republic of Korea, where MARUCHI is located. The studies are retrospective in the sense that they are summary test results, not prospective trials.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable to this type of device submission. The "ground truth" for this medical device (a root canal filling resin) is established by adherence to recognized international standards (ISO) for material properties and biocompatibility, as well as by comparison to legally marketed predicate devices. The performance is assessed through laboratory testing, not through expert consensus on diagnostic images or patient outcomes in the same way an AI diagnostic device would be.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving expert review of data (e.g., imaging) where there might be disagreement in interpretations. For performance and biocompatibility testing of a material, the results are typically quantitative or qualitative based on established standard methods, and adjudication is not usually applied in this context.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted for this device. This type of study is relevant for diagnostic or AI-assisted devices where human readers interpret medical images or data. The Endoseal MTA is a material used in a dental procedure.

6. Standalone Performance Study

Yes, a standalone performance study was done in the sense that the device was subjected to a series of bench and biocompatibility tests without human intervention or interpretation of the material's properties by human operators with respect to its performance against the set standards. The tests were performed on the device itself to verify its physical, chemical, and biological properties.

7. Type of Ground Truth Used

The ground truth used for this device is based on established international standards (ISO 6876, ISO 10993 series) for the physical, chemical, and biological properties of root canal filling materials. The device's performance is measured against the criteria defined by these standards, and its safety and effectiveness are supported by demonstrating substantial equivalence to legally marketed predicate devices that also comply with these standards.

8. Sample Size for the Training Set

This information is not applicable. This device is a medical material, not an AI or machine learning algorithm that requires a training set. The "training set" concept is not relevant for evaluating the performance of a physical material.

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

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

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• A root-end filling material
• For the repair of root canals as an apical plug during apexification
• For repair of root perforations during root canal therapy
• As a consequence of internal resorption
• As a pulp capping material
• For the filling of pulpotomy of deciduous tooth

The raw materials of the ENDOCEM Zr are Natural Pure Cement and Zirconium dioxide, and it has been showing good sealing ability and biocompatibility. It is prepared as a mixture of powder and water, and is used in a putty form which gradually hardens in the oral environment.

The acceptance criteria for the ENDOCEM Zr device and the study that proves it meets these criteria are described below.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not specify the sample sizes used for the non-clinical performance tests. The data provenance is also not explicitly stated beyond the tests being conducted based on ISO standards. Since these are bench tests on materials, it's implied to be laboratory-generated data, not human patient data, and therefore does not have a country of origin in the typical sense for clinical trials.

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

This information is not applicable to the data provided. The performance data presented are for non-clinical bench tests (e.g., physical and biocompatibility properties) of a dental material, not for an AI/CADe device or a study involving expert interpretation of patient data. Therefore, there is no "ground truth" established by human experts in the context of image interpretation or diagnosis.

4. Adjudication Method for the Test Set

This information is not applicable as the study involved non-clinical bench testing of material properties, not a clinical study requiring adjudication of interpretations.

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 information is not applicable. The submission describes the premarket notification for a dental material (ENDOCEM Zr), not an AI-assisted device. Therefore, no MRMC study or AI assistance effect size is discussed.

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

This information is not applicable as the submission is for a dental material, not an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance data is based on the objective measurements and assessments defined by the referenced ISO standards (e.g., ISO 6876 for physical properties, ISO 7405 for cytotoxicity). The criteria for "passing" or "meeting" the standard are inherent to the standard methods themselves.

8. The Sample Size for the Training Set

This information is not applicable. The device is a dental material, not a machine learning model, so there is no training set in the context of AI.

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

This information is not applicable as there is no training set for a machine learning model.

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• Repair of perforation
• Root canal filling

The raw materials of the ENDOSEAL are Natural Pure Cement, Zirconium dioxide, and Citric acid anhydrous, and the device has been showing good sealing ability and biocompatibility. It is prepared as a mixture of powder and water, and it is used in a putty form which gradually hardens in the oral environment.

The provided text describes the submission of a 510(k) premarket notification for a medical device called ENDOSEAL, a root canal filling resin. The document focuses on demonstrating substantial equivalence to a predicate device (ENDOCEM MTA) rather than proving the device meets specific performance criteria through a clinical study.

Here's an analysis of the provided information concerning acceptance criteria and studies:

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

Note: The document explicitly states: "All the test results met the preset test criteria." It does not provide the specific numerical acceptance criteria for each test or the specific numerical results obtained for the ENDOSEAL device. It relies on a general statement of compliance.

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

The document does not describe any human-subject study or "test set" in the context of clinical performance. The "tests" mentioned are non-clinical bench and biocompatibility tests. Therefore, sample sizes for a test set, data provenance, and related information are not applicable to the studies described.

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

Not applicable, as no human-subject clinical test set is described.

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

Not applicable, as no human-subject clinical test set is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a submission for a root canal filling material, and the studies described are non-clinical bench and biocompatibility tests. There is no mention of AI or human readers.

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

Not applicable. This is a medical device (root canal filling material), not an algorithm or AI system.

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

For the non-clinical tests described, the "ground truth" would be the established methods and criteria within the referenced ISO standards (ISO 6876, ISO 7405, ISO 10993-10, ISO 10993-11) and standard bench testing protocols for capacity and pH. These standards define the acceptable range or outcome for the specific properties being tested.

8. The sample size for the training set

Not applicable. No training set for an algorithm is described.

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

Not applicable. No training set for an algorithm is described.

Summary of the Study:

The study described is a non-clinical evaluation of the ENDOSEAL device, focusing on bench testing and biocompatibility assessments to demonstrate substantial equivalence to a predicate device (ENDOCEM MTA).

• Objective: To show that ENDOSEAL has similar physical and biocompatible properties and comparable performance specifications to ENDOCEM MTA. The primary goal is to address whether adding Zirconium dioxide and Citric acid anhydrous and removing Bismuth Trioxide from the formulation raises new questions of safety and effectiveness.
• Methodology: The device underwent a series of tests based on international standards:
  • ISO 6876: Visual inspection, packaging integrity, setting time, solubility, and radiopacity.
  • ISO 7405: Cytotoxicity.
  • ISO 10993-10: Skin sensitization (Local Lymph Node Assay, LLNA).
  • ISO 10993-11: Acute systemic toxicity.
  • Other bench testing: Capacity and pH (Saline Extracts).
• Results: The submission states, "All the test results met the preset test criteria."
• Conclusion: Based on these non-clinical tests, the manufacturer concluded that ENDOSEAL is substantially equivalent in safety and effectiveness to the predicate device.

Key takeaway: This 510(k) summary primarily demonstrates that the new device's material composition changes do not negatively impact its performance or biocompatibility compared to a legally marketed predicate device, as evidenced by non-clinical testing. It does not involve human-subject clinical trials or AI performance evaluations.

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• A root-end filling material
• For the repair of root canals as an apical plug during apexification
• For repair of root perforations during root canal therapy
• As a consequence of internal resorption
• As a pulp capping material
• For the filling of pulpotomy of deciduous tooth

This product is designed for vital pulp therapies like direct pulp capping treatment. It effectively prevents secondary infection as well as pulp irritation.

The provided text describes a 510(k) summary for the medical device ENDOCEM MTA (Mineral Trioxide Aggregate). The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria for device performance in a clinical setting.

Therefore, many of the requested sections below are not applicable because the submission relies on demonstrating comparable physical and biocompatible properties to a predicate device, not on proving clinical efficacy against specific acceptance criteria in a study.

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The submission does not define specific "acceptance criteria" in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) for the device. Instead, the acceptance criteria for the device evaluation were based on meeting ISO 6876 standards for physical properties and demonstrating similar physical and biocompatible properties to the predicate device.

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

Not applicable. This submission does not describe a clinical "test set" in the context of an effectiveness study. The evaluation focused on bench testing (physical characteristics) and biocompatibility, comparing the new device to a predicate device. Information on sample sizes for these tests (e.g., number of samples for setting time measurement) is not provided in the summary.

The data provenance is from bench and biocompatibility testing performed by the manufacturer, MARUCHI, located in South Korea. The study is not a retrospective or prospective clinical study on human subjects.

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

Not applicable. No clinical "test set" requiring ground truth established by experts is described in this submission. The evaluation was based on standardized physical property tests (ISO 6876) and biocompatibility assessments, not on interpretation of clinical data by experts.

4. Adjudication Method for the Test Set

Not applicable. As there is no clinical "test set" requiring ground truth established by experts, no adjudication method was used.

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

No. A MRMC comparative effectiveness study was not done. The submission is a 510(k) for substantial equivalence based on physical and biocompatibility properties, not a clinical efficacy study involving human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a dental material (root filling material), not a software algorithm or an AI-powered system that would have "standalone performance" in the context of an algorithm's output without human intervention.

7. The Type of Ground Truth Used

The "ground truth" for the device evaluation was based on:

• ISO 6876 standards: For physical properties like setting time, solubility, dimensional change, and radiopacity. The values defined by this international standard serve as the reference.
• Predicate device properties: The submission states that the new device has "similar physical and biocompatible properties" and "comparable performance specifications" to the predicate device (MTA MATERIAL, K981620). The properties of the predicate device, demonstrated to be safe and effective, represent an implicit "ground truth" for equivalence.

8. The Sample Size for the Training Set

Not applicable. This submission describes a new medical device, not an AI or machine learning algorithm that requires a "training set."

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

Not applicable. As there is no training set for an algorithm, the concept of establishing ground truth for a training set does not apply.

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