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HERMES Medical Imaging suite that provides software applications used to process, display, analyze and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.

The base product design of Hermes Medical Imaging Suite v5.7 is the same as for the Hermes Medical Imaging Suite v5.6 (K153056). The following modules have been added in this applicatio to Hybrid Viewer NM Processing: Colonic Transit, Remnant Liver, Parathyroid, Dosimetry, Classic DMSA, Oesophageal Transit/Reflux, HIDA, Salivary Gland, Bone3Phase Analysis and Uniformity.

Here's an analysis of the provided text regarding the acceptance criteria and study details for the Hermes Medical Imaging Suite v5.7:

Understanding the Device:

The device, HERMES Medical Imaging Suite v5.7, is a software application suite for processing, displaying, analyzing, and managing nuclear medicine and other medical imaging data. It has added several new modules compared to its predecessor (v5.6).

Challenges in Extracting Information:

The provided text is a 510(k) summary, which is a regulatory document focused on demonstrating substantial equivalence to a predicate device. It doesn't present a traditional "acceptance criteria" table or a single, comprehensive study report with detailed methodologies. Instead, it describes a series of comparative tests against predicate devices and manual calculations. Therefore, the "acceptance criteria" are implied by the comparisons and the statement that "the testing results supports that all the software specifications have met the acceptance criteria." The reported performance is the outcome of these comparisons.

1. Table of Acceptance Criteria and Reported Device Performance

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HERMES Medical Imaging Suite that provides software applications used to process, display, and manage nuclear medicine and other medical imaging data transferred from other workstation or acquistion stations.

The Hermes Medical Imaging Suite provides software applications used to process, display, and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.

This submission for the Hermes Medical Imaging Suite v5.6 does not contain the information requested in your prompt.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It explicitly states that "The tests for verification and validation followed Hermes Medical Solutions AB design controlled procedures. The risk analysis concluded that all the software specifications have met the acceptance criteria." However, it does not provide any specific acceptance criteria, reported performance, or details about clinical studies (e.g., sample sizes, ground truth establishment, expert involvement, MRMC studies, or standalone performance).

The document primarily focuses on:

• Identifying the device and its intended use.
• Listing predicate devices (e.g., Hermes Medical Imaging Suite v5.5, v5.3, and Xeleris 3.1).
• Stating that the new version (v5.6) has the "same technological characteristics as the original device and the same indication for use."
• Mentioning that modifications include "transfer of BRASS DatScan support and Thyroid Analysis from the Old Hermes workstation (Oracle® SUN Solaris, see K130541) to the new platforms with Microsoft® Windows."

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, and performance measures based on the provided text.

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HERMES Medical Imaging suite that provides software applications used to process, display, and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.

The base product design of Hermes Medical Imaging Suite v5.5 is the same as for the Hermes Medical Imaging Suite v5.4 (K140269). A modification has been made in the reconstruction software Hybrid Recon™ where a new feature is added to enable quantitative reconstruction. The Hermes Medical Imaging Suite provides software applications used to process, display, analyze and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.

The provided text is a 510(k) summary for the Hermes Medical Imaging Suite v5.5. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical performance studies for a novel AI device. Therefore, much of the requested information regarding AI-specific criteria (e.g., MRMC studies, training set details, expert ground truth adjudication) is not present. However, I can extract information related to the bench testing performed.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size: The text mentions "bench testing using both Jaszczak phantom and IEC phantom." Phantoms are physical objects with known properties used for controlled testing, not human patient data. Therefore, there is no "sample size" in the conventional sense of patient cases, nor is there data provenance in terms of country of origin or retrospective/prospective status.
• Data Provenance: N/A (phantom data)

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

• N/A. Ground truth for phantom studies is established by the known physical properties and activity concentrations set up by the engineers/researchers conducting the test, not by expert medical review.

4. Adjudication Method for the Test Set

• N/A. Adjudication is not applicable to phantom studies where ground truth is known inherently.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, a TRMC study was not done. The document describes bench testing with phantoms, not human reader studies.

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

• Yes, the bench testing using phantoms represents a standalone evaluation of the algorithm's performance in quantitative reconstruction, as it compares the device's output to a known ground truth without human intervention in the interpretation loop.

7. The Type of Ground Truth Used

• Phantom Gold Standard: The ground truth was established by the known "true activity" and "reconstructed activity" within different Regions of Interest (ROIs) of the Jaszczak and IEC phantoms. This is a controlled, objective ground truth based on the physical setup of the phantom experiment.

8. The Sample Size for the Training Set

• The document does not provide any information regarding a training set size. This information is typically relevant for machine learning or AI models, which are not explicitly detailed here beyond the mention of "quantitative reconstruction" capabilities.

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

• This information is not provided in the document.

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HERMES Medical Imaging suite that provides software applications used to process, display, analyze and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.

The base product design of Hermes Medical Imaging Suite v5.4 is the same as for the Hermes Medical Imaging Suite v5.3 (K131233). A modification has been made of the product where the imaging processing application BRASS™ has been transferred from the Oracle® Solaris environment to the Microsoft® Windows environment. BRASS™ has also been updated with improved support for management and analysis of amyloid PET imaging as described in the 510(k) submission. The Hermes Medical Imaging Suite provides software applications used to process, display, analyze and manage nuclear medical imaging data transferred from other workstation or acquisition stations.

The provided text is a 510(k) summary for the HERMES Medical Imaging Suite v5.4. It describes the device, its intended use, and substantial equivalence to predicate devices. However, it does not contain specific details about acceptance criteria, device performance metrics, or a study design with sample sizes, ground truth establishment, or expert involvement as requested.

The summary states: "The testing results supports that all the software specifications have met the acceptance criteria." but does not elaborate on what those criteria were or how performance was measured against them. It focuses on the substantial equivalence based on technological characteristics and indication for use with predicate devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information for most of the numbered points, as that information is not present in the provided document.

Here's a breakdown of what can and cannot be extracted from the provided text based on your request:

Acceptance Criteria and Device Performance Study (Information Not Provided in Document)

The document states that "The testing results supports that all the software specifications have met the acceptance criteria." However, it does not provide:

• A table of acceptance criteria.
• Reported device performance metrics.
• Details of the study that proves the device meets the acceptance criteria.

Therefore, the following points cannot be addressed from the given text:

1. A table of acceptance criteria and the reported device performance
* Not provided in the document. The document only states that acceptance criteria were met.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
* Not provided in the 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)
* Not provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
* Not provided in the 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
* Not provided in the document. The document describes a comparison to predicate devices, focusing on technological equivalence, not a comparative effectiveness study with human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
* Not provided in the document.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
* Not provided in the document.

8. The sample size for the training set
* Not provided in the document. This document focuses on a 510(k) submission for a software update and comparison to predicate devices, not on the deep learning aspects of an AI model's training.

9. How the ground truth for the training set was established
* Not provided in the document.

What the document does state:

• Device Description: The HERMES Medical Imaging Suite v5.4 is an update to v5.3 (K131233). The primary change is the transfer of the BRASS™ imaging processing application from Oracle® Solaris to Microsoft® Windows environment, with improved support for management and analysis of amyloid PET imaging.
• Intended Use: To process, display, analyze, and manage nuclear medicine and other medical imaging data transferred from other workstations or acquisition stations.
• Testing: "The tests for verification and validation followed Hermes Medical Solutions AB design controlled procedures. The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results supports that all the software specifications have met the acceptance criteria."
• Substantial Equivalence: The device is deemed substantially equivalent to predicate devices (HERMES Medical Imaging Suite v5.3 (K131233), HERMES HDAQ Acquisition Station and Hermes Workstation (K021656), Xeleris 3.1 processing and review workstation (K130884), and Scenium 3.0 (K123528)) based on similar technology, fundamental concepts, and operation, with the specific modification for BRASS™ noted. The "results showed a good compliance."

In summary, this 510(k) primarily focuses on demonstrating that a software update to an existing device, which includes transferring a feature to a new operating system and enhancing support for amyloid PET imaging, maintains substantial equivalence without introducing new safety or effectiveness concerns requiring detailed clinical performance studies to the extent of proving specific acceptance criteria with quantifiable metrics.

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HERMES Medical Imaging suite that provides software application used to process, display, analyze and manage nuclear medical imaging data transferred from other workstation or acquisition stations.

The Hermes Medical Imaging Suite provides software applications used to process, display, analyze and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.

The provided text describes a 510(k) submission for the Hermes Medical Imaging Suite v5.3. It focuses on the substantial equivalence of the new version to previously marketed predicate devices, primarily due to a change in the software's operating environment from Oracle® Solaris to Microsoft® Windows.

Although the document mentions "acceptance criteria" and "testing results supports that all the software specifications have met the acceptance criteria," it does not provide specific details on what these acceptance criteria were, what the reported device performance against those criteria was, or any clinical study details.

Therefore, many of the requested items cannot be extracted from this document.

Here's a breakdown of what can be inferred and what is explicitly missing:

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

Explanation: The document states, "The testing results supports that all the software specifications have met the acceptance criteria." However, it does not define what those specifications or acceptance criteria were, nor does it provide any quantitative performance metrics. The testing was primarily focused on demonstrating that the transfer of NM-processing applications to a new operating environment maintained the same technological characteristics and intended use as the predicate devices.

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

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified.

Explanation: The document focuses on technical verification and validation of software functionality after an operating environment change. It does not describe a clinical study involving a test set of patient data.

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)

• Number of Experts: Not applicable, as no clinical test set for ground truth establishment is described.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: 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

• MRMC Study: No. This document describes a software update for an image processing system, not an AI-assisted diagnostic tool or a comparative effectiveness study involving human readers.
• Effect Size: Not applicable.

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

• Standalone Study: The document does not describe a standalone performance study in the context of an algorithm's diagnostic accuracy. The "testing" mentioned refers to verification and validation of software specifications, ensuring the functionality remained consistent after the platform migration.

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

• Type of Ground Truth: Not applicable, as the document does not describe a clinical study requiring ground truth for diagnostic accuracy. The testing was against design specifications and predicate device performance, not clinical ground truth.

8. The sample size for the training set

• Sample Size (Training Set): Not applicable. This device is not described as an AI/ML device that requires a training set.

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

• Ground Truth Establishment (Training Set): Not applicable.

Summary of the Study described:

The study described in the 510(k) summary is a technical verification and validation study to demonstrate that the Hermes Medical Imaging Suite v5.3, with its NM-processing applications transferred from Oracle® Solaris to Microsoft® Windows, maintains the same technological characteristics and intended use as its predicate devices. The "testing" ensured that "all the software specifications have met the acceptance criteria," and "comparisons were made between HERMES Medical Imaging Suite v5.3 and HERMES Medical Imaging Workstation (K121278), HERMES HDAQ Acquisition Station and Hermes Workstation (K021656), HERMES HDAQ Acquisition Station and Hermes Workstation (K002782) and Xeleris 2 processing and review workstation (K051673). The results showed a good compliance."

This is a regulatory submission focused on demonstrating substantial equivalence for a software update rather than a clinical performance study with specific diagnostic accuracy metrics.

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HERMES Medical Imaging suite that provides software applications used to process, display, analyze and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.

The Hermes Medical Imaging Suite provides software applications used to process, display, analyze and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.

The provided text describes the 510(k) summary for the HERMES Medical Imaging Suite v5.2, but it does not contain the specific details required to complete all sections of your request regarding acceptance criteria and the study proving the device meets them.

The document states that "The testing results supports that all the software specifications have met the acceptance criteria," and "Comparisons were made between Hybrid Display and e.cam computer / e.soft workstation (K023190), and between Hybrid Recon™ and Xeleris 2 processing and review workstation (K051673). The results showed a good compliance." However, it does not provide the quantitative acceptance criteria, reported device performance, or detailed information about the studies.

Therefore, I will fill in the table and other sections with what can be inferred from the text, and clearly state where information is Not Provided (NP).

Description of the Acceptance Criteria and the Study

The HERMES Medical Imaging Suite v5.2 underwent verification and validation testing following Hermes Medical Solutions AB design controlled procedures. The testing aimed to demonstrate that all software specifications met the defined acceptance criteria and that the device was substantially equivalent to its predicate devices. The primary focus of the comparison appears to be on the equivalence in processing, display, analysis, and management of nuclear medicine and other medical imaging data. Specific comparisons were made for the "Hybrid Display" and "Hybrid Recon™" features against existing, legally marketed workstations to show "good compliance," implying that their performance matched or was equivalent to the predicate devices.

1. Table of Acceptance Criteria and the Reported Device Performance

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

• Sample Size: Not Provided (NP). The document mentions "testing" and "comparisons" but does not specify the number of cases, images, or data points used in these assessments.
• Data Provenance: Not Provided (NP). The document does not specify the country of origin of the data or whether the data was retrospective or prospective.

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

• Number of Experts: Not Provided (NP).
• Qualifications of Experts: Not Provided (NP).

4. Adjudication method for the test set

• Adjudication Method: Not Provided (NP).

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 Done: No. The provided text refers to comparisons between software applications, not studies involving human readers or AI assistance.
• Effect Size of Human Readers Improvement with AI: Not Applicable (NA), as no MRMC study with AI assistance for human readers was mentioned.

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

• Standalone Performance Study: Yes, implied. The "good compliance" results for "Hybrid Display" and "Hybrid Recon™" against predicate devices suggest an evaluation of the device's processing and display capabilities independent of human interpretation or intervention, focusing on its functional equivalence to existing validated software.

7. The type of ground truth used

• Type of Ground Truth: Implied to be comparison against the performance and output of previously cleared, legally marketed predicate devices (e.g., e.cam computer / e.soft workstation, Xeleris 2 processing and review workstation). This is a form of predicate device equivalence, where the "ground truth" is established by the accepted performance of the predicate.

8. The sample size for the training set

• Sample Size for Training Set: Not Provided (NP). The document does not mention any machine learning or AI components that would require a distinct "training set."

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

• Ground Truth Establishment for Training Set: Not Applicable (NA), as no training set for machine learning was mentioned.

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Bonding between dentin/enamel and 3M ESPE silorane (or oxirane) based composites

Hermes Bond 3 is classified as Resin Tooth Bonding Agent (21 C.F.R. § 872.3200) because it is a device intended to be painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials. Hermes Bond 3 offers the advantages of a simplified bonding procedure, eliminating the need for a separate etching step. Thus it reduces both possible errors during application and post-operative sensitivity. Additionally, it saves the dentist valuable chair time. Hermes Bond 3 is intended to provide bonding between dentin/enamel and silorane (or oxirane) based composites. This is ensured by the formulation of Hermes Bond 3 which has especially been optimized for this purpose. Hermes Bond 3 will be available in a two-vial version, one containing the Hermes Bond 3 Primer and one containing the Hermes Bond 3 Link (Bond).

The provided text describes a 510(k) premarket notification for a dental adhesive named "Hermes Bond 3." It is a regulatory document focused on establishing substantial equivalence to predicate devices, rather than a detailed study report on device performance based on acceptance criteria. Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not present in the provided text.

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

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. It makes a qualitative statement about meeting safety and effectiveness requirements. The "performance" described is in the context of the device's function and advantages.

Study Details (Missing Information)

The provided text is a 510(k) summary, which focuses on establishing substantial equivalence rather than detailing a specific clinical or performance study with the requested metrics. Therefore, the following information is not present:

• Sample size used for the test set and the data provenance: Not mentioned. The document refers to "biocompatibility testing" and "comparison for chemistry, performance data," but doesn't provide details on the test set for these comparisons.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• Adjudication method for the test set: Not mentioned.
• 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, as this is a dental adhesive, not an AI diagnostic device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a dental adhesive, not an AI algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated. For biocompatibility, it would typically be based on established biological tests and standards. For performance, it would likely be laboratory or in-vitro tests comparing bond strength, durability, etc., against predicate devices, but these details are not provided.
• The sample size for the training set: Not applicable, as this is a dental adhesive, not a machine learning model.
• How the ground truth for the training set was established: Not applicable, as this is a dental adhesive, not a machine learning model.

In summary: The document is a regulatory submission demonstrating substantial equivalence for a dental bonding agent. It confirms that biocompatibility testing was performed and that the device's chemistry, performance, and indications for use are comparable to legally marketed predicate devices, thereby meeting safety and effectiveness requirements. However, it does not provide the detailed study parameters, acceptance criteria, or performance data that would be typical for a clinical study report of a diagnostic device or AI algorithm.

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Bonding between dentin/enamel and silorane based composite filling materials

Bonding between dentin/enamel and methacrylate based composite filling materials

Bonding mediator for fissure sealing

Hermes Bond 2 is classified as Resin Tooth Bonding Agent (21 C.F.R. § 872.320(1) because it is a device intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restorative material.

Like Adper Prompt L-Pop, 3M ESPE's well-known and well-established resin bonding agent, Hermes Bond 2 offers the advantages of a simplified bonding procedure, eliminating the need for a separate etching step. Thus it reduces both possible errors during application and post-operative sensitivity. Additionally, it saves the dentist valuable chair time. Being based on methacrylate chemistry itself, Hermes Bond 2 is well suited for bonding methacrylate composites. The compatibility to silorane based composites is ensured by the formulation of Hermes Bond 2 which has especially becu optimized for this purpose. In fact, the bond strength obtained for Hermes/Hermes Bond 2 is comparable to that of Adper Prompt L-Pop with conventional methacrylate composites.

Hermes Bond 2 is also intended to be used as a bonding mediator for fissure sealing as is Adper Prompt L-Pop.

Like Adper Prompt L-Pop, Hermes Bond 2 will be available in single dose applicators and in a two-vial version.

The provided text is a 510(k) summary for a dental adhesive called Hermes Bond 2. It details the device's classification, comparison to predicate devices, and a statement on safety and effectiveness. However, it does not contain the specific information required to answer your request about acceptance criteria and the study proving the device meets those criteria.

The 510(k) summary makes a general statement that "The comparison for chemistry, performance data and indications for use shows that Hermes Bond 2 is substantially equivalent to the predicate devices" and "In summary, it can be concluded that safety and effectiveness requirements for Hermes Bond 2 are completely met." It also mentions that "biocompatibility testing was carried out. The results show that Hermes Bond 2 is a safe device."

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method.
• Information on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
• Information on a standalone (algorithm only) performance study.
• The type of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

The document focuses on demonstrating substantial equivalence to predicate devices (Adper Prompt L-Pop, RelyX Unicem, Protemp 3 Garant) based on chemistry, performance data (implied to be comparable bond strength), and indications for use, rather than presenting a detailed study with specific acceptance criteria and results. The "performance data" mentioned is likely referring to bond strength, with the statement that "the bond strength obtained for Hermes/Hermes Bond 2 is comparable to that of Adper Prompt L-Pop with conventional methacrylate composites," but no specific metrics or acceptance criteria are given.

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Direct anterior restorations including: Class III, IV, V and VI Veneers Incisal edge repair - Direct posterior restorations including: Class I or II or V Sandwich technique with glass ionomer resin material Cusp buildups - Core buildups - Splinting . - Indirect anterior and posterior restorations including: . Inlays Onlays Veneers

Hermes is a one component dental filling composite. Hermes uses different monomer chemistry and a different polymerization mechanism than most filling composites which are currently commercially available. Based on its particular chemistry, Hermes reveals considerably low shrinkage properties.

The provided document is a 510(k) Summary of Safety and Effectiveness for a dental device called "Hermes," a tooth shade resin material. It is a premarket notification for a Class II device. The document states that the device is substantially equivalent to predicate devices based on performance data and indications for use.

However, the document does not contain any information about acceptance criteria or a specific study proving the device meets acceptance criteria in the format of a clinical study assessing algorithm performance, which is what your query implies.

Instead, it's a regulatory submission demonstrating substantial equivalence to already approved predicate devices. It states that "Biocompatibility testing for Hermes provides evidence that the device is safe for its intended use." And "In summary, it can be concluded that safety and effectiveness requirements for Hermes are completely met."

Therefore, based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided in the context of an algorithm's performance. The document focuses on demonstrating substantial equivalence to predicate dental restorative materials, implying that "acceptance criteria" are met if it performs similarly or equivalently to established devices for its intended use.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of regulatory submission. There is no "test set" in the context of validating an algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. There is no ground truth established by experts for a test set in this document.

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. This document is about a dental restorative material, not an AI or imaging device with human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the context of an algorithm's performance. The "ground truth" for this device's performance is likely measured against established standards for dental materials (e.g., shrinkage, strength, wear resistance), usually through laboratory or in-vitro tests, and clinical performance as observed over time, but these details are not provided here.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

In conclusion, the provided 510(k) summary is for a dental restorative material and does not describe a study involving acceptance criteria and performance metrics for an AI/algorithm-based device as implied by your detailed request. It confirms that the device meets safety and effectiveness requirements, primarily through biocompatibility testing and comparison to predicate devices, rather than through an algorithm performance study.

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Bonding between dentin/enamel and silorane based composite filling materials Bonding between dentin/enamel and methacrylate based composite filling materials

Hermes Bond is classified as Resin Tooth Bonding Agent (21 C.F.R. § 872.3200) because it is a device intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restorative material. Like Adper Prompt L-Pop, 3M ESPF's well-known and well-established resin bonding agent, Hermes Bond offers the advantages of a simplified bonding procedure, eliminating the need for a separate etching step. Thus it reduces both possible crrors during application and post-operative sensitivity. Additionally, it saves the dentist valuable chair time. Being based on methacrylate chemistry itsclf, Hermes Bond is well suited for bonding methacrylate composites. The compatibility to silorane based composites is ensured by the formulation of Hermes Bond which has especially been optimized for this purpose. The acidic methacrylates provide efficient etching of the dental hard tissue and initiation of the polymerization of the siloranc-based composite (e.g. "Hermes")at the interface with the adhesive. The blend of co-monomers allows at the same time formation of a uniform adhesive film on dentin and enamel, and additional chemical crosslinking between OHfunctionalized methacrylates and siloranes.

The provided document is a 510(k) summary for a dental adhesive, "Hermes Bond." It discusses the device's characteristics, intended use, and substantial equivalence to predicate devices. However, it does not contain the information required to answer the specific questions about acceptance criteria and a study proving device performance as it pertains to AI/algorithm performance.

The document describes a traditional medical device (a dental bonding agent) and its regulatory clearance process, which focuses on demonstrating substantial equivalence to existing devices through chemistry, performance data (like bond strength), and indications for use. It does not mention any AI component, algorithms, or studies involving human readers, ground truth establishment, or training/test sets for AI models.

Therefore, I cannot extract the requested information from the provided text. The questions posed ("Acceptance criteria and the study that proves the device meets the acceptance criteria," including details like "Sample sized used for the test set," "Number of experts used," "Adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," and "sample size for the training set") are typically relevant for evaluating AI/machine learning medical devices, which this document does not describe.

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