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ENA TEMP/ ENAMEL PLUS TEMP is a system of liquid and powder resin available in different colours, for aesthetic temporary crown and bridge. It can be used both in laboratory (by indirect method: diagnostic waxing up or vacuum forming matrix) and in dental practice (by direct method in the mouth: silicone impression or preformed crown).

ENA TEMP/ ENAMEL PLUS TEMP is a system of liquid and powder resin available in different colours, for aesthetic temporary crown and bridge. It can be used both in laboratory (by indirect method: diagnostic waxing up or vacuum forming matrix) and in dental practice (by direct method in the mouth: silicone impression or preformed crown). Please note that the resin is absolutely the same, but they will be sold with two different brand names for commercial reasons. So, in order to simplify, from here on they will be denoted as "Temp"

This document describes a 510(k) premarket notification for a dental device, specifically a temporary crown and bridge resin. It focuses on establishing substantial equivalence to a predicate device rather than detailing extensive clinical trials with specific acceptance criteria and outcome measurements usually found in PMAs or clinical studies for novel devices.

Therefore, the requested information about acceptance criteria, study design, sample sizes for test and training sets, ground truth establishment, expert qualifications, and MRMC studies is largely not present in the provided text. The submission focuses on compliance with performance standards and comparison to a predicate device.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not mentioned. No specific "test set" in the context of a clinical performance study is described. The evaluation appears to be based on bench testing (compliance with ISO standards) and comparison to existing products.
• Data Provenance: Not applicable, as detailed patient data or clinical study data is not presented. The submission is from Micerium SpA, Italy.

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

• Number of Experts: Not mentioned.
• Qualifications: Not mentioned.

This type of information would be relevant for clinical studies where expert review is used to establish ground truth for a diagnostic or AI-driven device. This submission is for a material used in dentistry, and its performance evaluation likely relies on material science testing rather than expert-adjudicated clinical outcomes.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No clinical test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance

• MRMC Study: No, an MRMC study was not done. This device is a dental material, not an AI-driven diagnostic tool or a system involving human readers interpreting outputs.
• Effect Size of AI: Not applicable.

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

• Standalone Performance: Not applicable. This is not an algorithmic device.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this device's performance would primarily be established through material property testing against ISO standards (ISO 20795 for denture materials and ISO 10477 for crowns and bridges) and comparison to the identified predicate device (K000894) based on specifications and intended use. There is no mention of pathology, outcomes data from patients, or expert consensus in the clinical sense for establishing ground truth for this particular submission.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This is not an AI/ML device that requires a training set. The device is a resin for temporary crowns and bridges.

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

• Ground Truth Establishment: Not applicable, as there is no training set for an AI/ML model.

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Adhesive for luting ceramic and metal orthodontic brackets

Adhesive system, light curable both with halogen and LED Light, for brackets cementation. The accessories contact tissue for less than 1 hour and therefore are exempt from 510(k) requirements and are described only generally.

The provided document (K072978) is a 510(k) summary for a dental adhesive system (Tender Ortho Bond - Ena Bond - Ena Etch). This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through performance testing that adheres to recognized standards. It does not contain details of a clinical study or AI performance evaluation as requested in the prompt.

Therefore, many of the requested sections about acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment, specifically in the context of an AI device and clinical study, cannot be extracted from this document.

However, I can provide information based on what is available in the document regarding the device's performance evaluation against a standard.

1. Table of Acceptance Criteria and Reported Device Performance

The document references "ISO 4049:2000 Dentistry - Polymer - Based Filling, Restorative and Luting materials" as the standard followed for evaluating the device. While the exact acceptance criteria from ISO 4049:2000 are not explicitly detailed in the provided text, the submission states that the standard was followed. The implied "reported device performance" is that the device met the requirements of this standard for its intended use, otherwise, substantial equivalence would not have been granted.

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

This document does not describe a "test set" in the context of a clinical study or AI evaluation. The performance evaluation would have been conducted on laboratory samples according to the specifications of ISO 4049:2000. No information on sample sizes for these lab tests or data provenance (country of origin, retrospective/prospective) is provided in the publicly available summary.

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

Not applicable. This document does not describe a study involving expert-established ground truth for a test set. The validation is based on adherence to an engineering standard (ISO 4049:2000).

4. Adjudication Method for the Test Set

Not applicable. No clinical test set or expert adjudication is described.

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

No. This document does not mention an MRMC study or any comparison of human readers with or without AI assistance. The device is a dental adhesive, not an AI diagnostic tool.

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

No. The device is a dental adhesive. This concept is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for this medical device submission is compliance with the ISO 4049:2000 standard for "Dentistry - Polymer-Based Filling, Restorative and Luting materials." This standard dictates the methods and criteria for evaluating the physical, chemical, and biological properties of such materials. The specific tests (e.g., bond strength, cytotoxicity) described within the standard would serve as the "ground truth" for performance.

8. The Sample Size for the Training Set

Not applicable. This is not an AI device, so there is no training set in that context. The "training set" for the device's development would refer to the materials and formulations developed and refined prior to final testing, but no specific sample sizes for this are provided in the regulatory summary.

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

Not applicable for an AI training set. For the development of the adhesive material, the "ground truth" would have been established through iterative laboratory testing and material science principles, aiming to meet desired performance characteristics and ultimately comply with ISO 4049:2000. These details are not part of the 510(k) summary.

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Tender fiber is a semi-manufactured product made of fibers used to reinforce composite and acrylic prosthodontic appliances and to repair or reinforce denture and rethodontic appliances. It can be use as well to immobilize teeth for periodontic or orthodontic treatments.

Tender Fiber are silanized glass fibers, impregnated with light curing resin used to reinforce prosthodontic appliances and to repair or reinforce denture and orthodontic appliances.

This 510(k) summary provides information for a dental device, "Tender Fiber," and relies on substantial equivalence to predicate devices rather than a direct study demonstrating its performance against specific acceptance criteria. Therefore, much of the requested information regarding specific study details and statistical analysis is not available in this document.

However, I can extract the relevant information and explicitly state what is not provided.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not explicitly stated for performance testing. The document refers to "Cytotoxicity tests" and "Test results," but no details on sample size for these tests are provided.
• Data Provenance: Not specified for any specific test. However, the manufacturer is Micerium SpA, located in Italy, suggesting the tests would have been performed there or commissioned by them.

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

• Not applicable. This document describes a medical device undergoing premarket notification based on substantial equivalence, not a study evaluating human reader performance against ground truth established by experts.

4. Adjudication method (e.g., 2+1, 3+1, none) 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. This is not a study involving AI or human reader comparison. It's a submission for a physical dental device.

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

• Not applicable. This is not an algorithmic device.

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

• Not applicable/Not explicitly defined in the context of this submission. The "ground truth" here would relate to the performance standards and biocompatibility tests. For biocompatibility, the chemical and biological reactions serve as the "ground truth" against the ISO standards. For physical properties, the measured values compared against the ISO 4049 standard represent the ground truth.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI 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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EnaCem is a dual curing radiopaque fluorescent luting composite, available in several dentine colours, for cementation of posts, ceramic and composite inlay, onlay veneers and crowns. It can be used also for core build-up and as a liner.

The ENA CEM is a luting material available in a flowable consistency (Ena Cem) and also in a high viscous version (Ena Cem HF) that is available in different colours. Both can be used for cementing prosthesis appliances made in laboratory to the tooth. They can be used also for post-cementation. Ena Cem HF can also be used for core build-up and as a liner. The accessories and try-in materials contact tissue for less than 1 hour and therefore are exempt from 510(k) requirements and are described only generally.

The provided text is a 510(k) summary for a dental cement (ENA CEM) and does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving the device meets such criteria. It primarily focuses on the classification, description, and substantial equivalence of the dental cement to existing products.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving their fulfillment based on the provided text. The document is about regulatory approval of a dental cement, not the performance evaluation of an AI/software device.

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This device is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only on adults over the age of 12.

This device is an endosseous dental implant consisting of the major component, of root-form, screw type, and the accessories, designed to facilitate placing and using the implant in orthodontic procedures. The accessories contact tissue for less than 1 hour and therefore are exempt from 510(k) requirements and are described only generally. The smoothly curved head has a groove in the middle for the attachment of elastics, chains, or coil springs commonly used in orthodontics. The head (groove) has a aperture where a wire or auxiliary can be attached. The rounded head of the implant has an internal hexagon for insertion of the screw driver. The MAS implant is made from Group V titanium.

This 510(k) summary describes a dental implant device called the Miniscrews Anchoring System (MASᵀᴹ System). However, it does not contain details about acceptance criteria or a study proving the device meets specific performance metrics.

The document focuses on establishing substantial equivalence to existing predicate devices based on:

• Intended Use: Providing a fixed anchorage point for orthodontic appliances.
• Technological Characteristics: Screw-type endosseous dental implants made of Grade V titanium with similar design concepts (e.g., rounded head with a groove for attachments, self-tapping, roughened screw area, smoothly machined transmucosal neck).
• Materials: Group V titanium, which is a well-established material in the industry.

Therefore, I cannot provide the requested information for the following points as they are not present in the provided text:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs without AI assistance.
• If a standalone performance study was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• The sample size for the training set.
• How the ground truth for the training set was established.

This submission is a traditional 510(k) that relies on demonstrating substantial equivalence to already cleared devices, rather than presenting novel performance data against specific acceptance criteria. The FDA's letter confirms that the device is substantially equivalent to legally marketed predicate devices, allowing its market entry based on this comparison.

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ENA HFO is a composite system for direct and indirect aesthetic restorations in anterior and posterior sectors.

ENA HFO is a system for direct and indirect aesthetic restorations in anterior and posterior sectors, composed by a light curing radiopaque composite, available in different colors, with accessories for application and polishing. The accessories contact tissue for less than 1 hour and therefore are exempt from 510(k) requirements and are described only generally.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the K062906 device:

It is important to note that the provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It does not contain detailed information about specific acceptance criteria, performance studies with sample sizes, expert involvement, or statistical analyses typically found in a full study report or technical documentation. The summary primarily lists the device's properties and claims similarity to existing products.

Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly list quantitative acceptance criteria for device performance. Instead, it states that the device has "similar technological characteristics" and "similar physical data" to predicate devices. The "Risk to Health" section implicitly defines areas where the device should not fail, which could be interpreted as a form of acceptance criteria in terms of safety.

Study Information

Based on the provided 510(k) summary, the following study information is available:

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

   • Sample Size: Not specified in the provided summary.
   • Data Provenance: Not specified. The summary mentions "cytotoxicity tests" (in Appendix V, which is not provided), but no details on the data origin (e.g., country) or whether it was retrospective or prospective.

2. 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 510(k) summary. The summary does not describe a clinical study or a study involving expert assessment to establish ground truth for performance metrics.

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

   • This information is not provided as there is no mention of a test set with human adjudication in the summary.

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:

   • No MRMC study was conducted or reported. This device is a dental composite material, not an AI-assisted diagnostic tool, so such a study would not be applicable.

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

   • This device is a physical material, not an algorithm. Therefore, a standalone algorithm performance study is not applicable and was not performed.

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

   • The summary implies that performance (e.g., cytotoxicity, physical data) was assessed against standard laboratory tests and material specifications, likely comparing to predicate devices or industry standards like ISO 4049:2000. It does not refer to clinical outcomes, expert consensus, or pathology for establishing ground truth of inherent device performance.

7. The sample size for the training set:

   • Not applicable/Not provided. The summary refers to a manufactured product and its testing, not a machine learning model requiring a training set.

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

   • Not applicable/Not provided, as there is no training set for a machine learning model.

In summary, the provided K062906 510(k) summary is a regulatory document focused on demonstrating substantial equivalence. It highlights the device's intended use, composition, and similarity to existing products, along with general safety considerations (like cytotoxicity tests). It does not offer the detailed efficacy study data, expert involvement, or statistical results that would typically answer many of the questions asked.

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