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The Embrace is a prescription only device that is indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods of rest. The device is worn on the wrist and senses Electrodermal Activity (EDA) and motion data to detect patterns that may be associated with generalized tonic clonic seizures in patients with epilepsy or at risk of having epilepsy. When a seizure event is detected, Embrace sends a command to a paired wireless device that is programmed to initiate an alert to a designated caregiver. The System records and stores data from Accelerometer, EDA, and Temperature sensors for subsequent review by a trained healthcare professional.

The Embrace is a wearable biosensor device that can capture, store, and wirelessly transmit sensor data via Bluetooth to a paired remote device. Embrace runs an on-board algorithm to continuously process sensor data and make a decision about whether the data might indicate a generalized tonic clonic seizure (GTCS). The algorithm has been validated on data, labeled using the gold-standard video-Electroencephalogram (EEG) methodology designed by a group of epileptologists at a top level 6 epilepsy centers, from epilepsy patients experiencing GTCSs in hospital Epilepsy Monitoring Units. When a likely GTCS is detected, the Embrace sends a message to the Alert smartphone application, which initiates calls and texts to summon the attention of designated caregivers. The device also enables patients to manually record seizure events, and provides contextual information related to activity and sleep.

The provided document describes the FDA 510(k) clearance for the Empatica Embrace device, a non-EEG physiological signal-based seizure monitoring system. The information below is extracted and organized to answer your request.

1. Table of Acceptance Criteria and Reported Device Performance

While the document doesn't explicitly state "acceptance criteria" in a separate section with specific numerical thresholds for clearance, the performance results presented indicate the observed efficacy. The implicit acceptance criteria would be for the device to perform well enough to demonstrate substantial equivalence to the predicate device and ensure safety and effectiveness.

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

• Sample Size: 141 patients diagnosed with epilepsy.
  • 80 pediatric patients (ages 6-21 years, median: 13 years)
  • 61 adult patients (ages 22-63 years, median: 39 years)
• Data Provenance: The study was conducted in a hospital Epilepsy Monitoring Unit (EMU) setting. While the document doesn't explicitly state the country of origin, the listed submitter address is in Milan, Italy. The data is prospective as patients were enrolled and monitored during their EMU stay for the purpose of this study.
• Observed GTCS: 31 EMU patients experienced a total of 54 generalized tonic-clonic seizures (GTCSs). 110 EMU patients did not experience any seizure.
• Recorded Data: 141 patients provided overall 409 days (9,806 hours) of ACM (accelerometer) and EDA (electrodermal activity) measurements, with a median of 49.2 hours of data per patient.

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

• Number of Experts: A "panel of three readers" was used.
• Qualifications of Experts: The ground truth was established using "the gold-standard video-Electroencephalogram (EEG) methodology designed by a group of epileptologists at a top level 6 epilepsy centers." This implies the "readers" were highly qualified medical professionals experienced in epilepsy diagnosis and seizure classification, likely epileptologists, given the standard of care in EMUs. Specific years of experience are not mentioned.

4. Adjudication Method for the Test Set

The document states "relative to a panel of three readers." While it doesn't explicitly detail the adjudication method (e.g., majority vote, independent assessment with reconciliation), the phrase "panel of three readers" suggests a consensus or majority agreement approach was used to establish the ground truth from the video-EEG data. It is not explicitly stated as 2+1 or 3+1, but rather that the ground truth was derived from the consensus of these three readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• No MRMC comparative effectiveness study was described where human readers' performance with and without AI assistance was evaluated. This study focused on the standalone performance of the device's algorithm in detecting GTCS.

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

• Yes, a standalone performance study was done. The reported PPA and FAR metrics represent the performance of the Embrace device's algorithm in detecting GTCS events based on its internal processing of EDA and motion data, without direct human intervention in the detection process. The device sends an alert when a likely GTCS is detected, which then initiates actions by caregivers. The study evaluates the accuracy of these automated detections.

7. The Type of Ground Truth Used

• The ground truth used was expert consensus based on gold-standard video-Electroencephalogram (EEG) methodology. This is considered a high-fidelity ground truth for seizure detection in an Epilepsy Monitoring Unit (EMU) setting. Every recorded seizure was classified as epileptic.

8. The Sample Size for the Training Set

The document states: "Embrace runs an on-board algorithm to continuously process sensor data and make a decision about whether the data might indicate a generalized tonic clonic seizure (GTCS). The algorithm has been validated on data, labeled using the gold-standard video-Electroencephalogram (EEG) methodology designed by a group of epileptologists at a top level 6 epilepsy centers, from epilepsy patients experiencing GTCSs in hospital Epilepsy Monitoring Units."

• The document describes the validation of the algorithm on data from specific sources but does not explicitly state the sample size used for the training set. The 141 patient dataset is specifically described as the "clinical testing" dataset, suggesting it was used for evaluation, not necessarily for training. It's common for validation data to be distinct from training data.

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

• Similar to the validation set, the description implies that the data used for training (or at least development and refinement) of the algorithm was "labeled using the gold-standard video-Electroencephalogram (EEG) methodology designed by a group of epileptologists at a top level 6 epilepsy centers, from epilepsy patients experiencing GTCSs in hospital Epilepsy Monitoring Units." This indicates a high-quality, expert-driven ground truth establishment process for the data used to develop and refine the algorithm.

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The Embrace is a prescription only device that is indicated for use as an adjunct to seizure monitoring of adults in home or healthcare facilities during periods of rest. The device is worn on the wrist, and senses Electrodermal Activity (EDA) and motion data to detect patterns that may be associated with generalized tonic seizures in patients with epilepsy or at risk of having epilepsy. When a seizure event is detected, Embrace sends a command to a paired wireless device that is programmed to initiate an alert to a designated caregiver. The System records and stores data from Accelerometers, EDA, and Temperature for subsequent review by a trained healthcare professional.

The Embrace is a wearable biosensor device that can capture, store, and wirelessly transmit sensor data via Bluetooth to a paired remote device. Embrace runs an on-board algorithm to continuously process sensor data and make a decision about whether the data might indicate a generalized tonic clonic seizure (GTC). The algorithm has been validated on data, labeled using the gold-standard video-Electroencephalogram (EEG) methodology designed by a group of epileptologists at a top level 4 epilepsy center, from epilepsy patients experiencing GTCs in hospital Epilepsy Monitoring Units. When a likely GTC is detected, the Embrace sends a message to the Alert smartphone application, which initiates calls and texts to summon the attention of designated caregivers.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

Note on Acceptance Criteria: The document does not explicitly state numerical acceptance criteria for PPA and FAR. Instead, it reports the device's performance metrics and implicitly suggests that these values are deemed acceptable for marketing the device as "substantially equivalent" to a predicate device. The FDA typically relies on a comparison to predicate devices and clinical justification for novel devices.

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

• Sample Size for Test Set:
  • 135 patients diagnosed with epilepsy were enrolled.
  • Out of these, 22 patients experienced a total of 40 generalized tonic clonic seizures (GTCSs).
  • 113 patients did not experience any seizures during the study.
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the study was conducted within an "Epilepsy Monitoring Unit (EMU)" in a "top level 4 epilepsy center," suggesting a clinical setting in a developed healthcare system (likely the US, given the FDA submission).
  • Retrospective or Prospective: The study enrolled patients and observed them for seizure events within the EMU, implying a prospective collection of data for the purpose of validating the device.

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

• Number of Experts: Three readers.
• Qualifications of Experts: They are referred to as a "panel of three readers." Although their specific qualifications (e.g., neurologists, epileptologists, years of experience) are not explicitly detailed in this document, the context of an "Epilepsy Monitoring Unit" and "gold-standard video-Electroencephalogram (EEG) methodology designed by a group of epileptologists" strongly suggests they were highly qualified medical professionals specializing in epilepsy and EEG interpretation.

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

The document mentions "relative to a panel of three readers" for PPA calculation. This implies that the ground truth was established by consensus (or agreement) among these three readers. The specific adjudication method (e.g., if at least 2 out of 3 had to agree, or if all 3 had to agree, or if a tie-breaking fourth expert was used) is not explicitly stated. However, the use of a "panel" suggests a structured review process.

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

• Was an MRMC comparative effectiveness study done? No. The study described focuses on the standalone performance of the Embrace device (i.e., the algorithm's ability to detect seizures) against a human-established ground truth. It does not evaluate how human readers' performance might change with or without the device's assistance.

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

• Yes, a standalone performance study was done. The performance metrics (PPA and FAR) directly reflect the algorithm's ability to detect GTC seizures based on sensor data. The device "runs an on-board algorithm to continuously process sensor data and make a decision about whether the data might indicate a generalized tonic clonic seizure (GTC)."

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

• Ground Truth Type: Expert consensus based on "gold-standard video-Electroencephalogram (EEG) methodology." This is a strong form of ground truth for epilepsy, as video-EEG is the primary method for diagnosing and classifying seizures in clinical practice. The data was "labeled using the gold-standard video-Electroencephalogram (EEG) methodology designed by a group of epileptologists."

8. The sample size for the training set

The document states, "The algorithm has been validated on data, labeled using the gold-standard video-Electroencephalogram (EEG) methodology designed by a group of epileptologists at a top level 4 epilepsy center, from epilepsy patients experiencing GTCs in hospital Epilepsy Monitoring Units."

However, it does not explicitly state the sample size of the training set. It only describes the validation set (the 135 patients). It's common for regulatory submissions to omit detailed training set information, focusing instead on the independent validation (test) set.

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

• The ground truth for the training set (implied, as the exact set is not detailed) was established using the "gold-standard video-Electroencephalogram (EEG) methodology designed by a group of epileptologists at a top level 4 epilepsy center." This indicates that the training data was meticulously labeled by highly qualified experts using the most reliable method for seizure detection.

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The Embrace Neonatal MRI System is indicated for use as a magnetic resonance imaging device for producing axial, sagittal, coronal and oblique images that displays the internal structure of neonatal head with circumference of up to 38 cm and weight between 1Kg and 4.5 Kg. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

The Embrace Neonatal MRI System is a 1Tesla Permanent MRI system producing MR images of Neonatal head. During MRI scan, body parts to be imaged are held within a uniform static magnetic field, and are subject to sequences of RF pulses and gradient magnetic fields. The signal from the precession of the magnetization created by these fields is sampled and processed to produce image data.

The provided document is a 510(k) Premarket Notification for the Embrace Neonatal MRI System. It details the device's indications for use, comparison to a predicate device, and the non-clinical testing performed. However, it explicitly states that no clinical studies were conducted to establish substantial equivalence for this device. Therefore, it does not contain the acceptance criteria or study details regarding device performance from a clinical perspective.

Here's the information that can be extracted or inferred:

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

Based on the document, direct clinical acceptance criteria and reported device performance from a clinical study are not available. The document focuses on non-clinical testing and comparison to a predicate device for substantial equivalence.

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

• Test set for clinical performance: Not applicable, as no clinical studies were performed.
• Test set for non-clinical performance (phantom images, V&V): Not specified in the document. The provenance of this data is from Aspect Imaging Ltd., likely internally generated during device development.

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

Not applicable, as no clinical studies with expert-established ground truth were performed. The document mentions "When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis," but this refers to the intended use of the device, not a performance study.

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

Not applicable, as no clinical studies with adjudication were performed.

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. The device is an MRI system, not an AI diagnostic tool designed to assist human readers. Moreover, no clinical studies were performed.

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

Not applicable. This is an MRI system, not a standalone algorithm. Its performance is evaluated on its ability to produce diagnostic quality images, which are then interpreted by a human physician.

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

Not applicable for a clinical study. For the non-clinical phantom images, the "ground truth" would be the known properties and geometry of the phantoms themselves, used to assess image quality, resolution, and artifact levels.

8. The sample size for the training set:

Not applicable. This is an MRI system, not an AI model that requires a specific training set in the conventional sense. The "training" of the system would involve engineering and calibration using test data and phantoms.

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

Not applicable. As described in point 8, this is an MRI system, not an AI model with a training set. If considering the calibration and engineering process, the "ground truth" would be established through physical measurements, known phantom compositions, and established MRI physics principles.

In summary, the provided FDA 510(k) letter and summary explicitly state that no clinical studies were conducted to support substantial equivalence for the Embrace Neonatal MRI System. The device was cleared based on non-clinical testing, including phantom images, to demonstrate its ability to provide diagnostic quality images, and comparison to a legally marketed predicate device (Wrist 3 MRI System). The rationale given for not performing clinical studies was the "vulnerable patient population" (neonates) and that the "benefits of sample clinical images did not outweigh the risks associated with acquisition of those images."

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Embrace Thermoplastic from Bionix Development Corporation is intended to be used for the external support and immobilization of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases.

Silhouette Thermoplastic from Bionix Development Corporation is intended to be used for the external support and immobilization of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases. It is intended to be used by or under the direction of a licensed physician.

Embrace Thermoplastic from Bionix Development Corporation is a moldable lowtemperature thermoplastic comprised of polycaprolactone, a biodegradable thermoplastic polymer that has been approved by the Food and Drug Administration for other medical device applications.

Embrace Thermoplastic becomes pliable and moldable by hand at temperatures of about 160 to 170 degrees Fahrenheit. This heating is most often done by immersion in hot water. To improve the ease of handling the polycaprolactone material in its heated, softened state, the Embrace Thermoplastic sheets will be bonded to a non-low temperature rigid thermoplastic frame. These frames also serve as convenient points to affix the Embrace Thermoplastic to an underlying patient support device.

Embrace Thermoplastic will be supplied in a variety of configurations and sizes, depending on the size and location of the body part to be immobilized, and to enable compatibility with other radiation therapy immobilization devices already in use. The Embrace Thermoplastic sheets may be perforated to enhance an even stretch over anatomical protuberances such as the nose and chin. This improves the conformity and rigidity of the resulting mask by preventing over-stretching and thinning in these areas. Perforation patterns may be uniform (as in a sheet intended to be used over a limb) or variable (such as in a sheet intended to be used with the head), all designed to enhance the even stretch of the material and the rigidity of the resultant mask.

The typical application of Embrace Thermoplastic is to create a conformal "mask" of an anatomical body part, such as the head, by stretching the pliable heated polycaprolactone sheet over the body part and allowing it to cool and become rigid. The resulting conformal "mask" can then be used to position and reposition a patient undergoing a course of external beam radiation therapy with a high degree of accuracy and reproducibility.

Here's a breakdown of the acceptance criteria and study information for the Embrace Thermoplastic, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The device is marketed as substantially equivalent to predicate devices, meaning its performance is considered acceptable if it is comparable to these devices. The acceptance criteria are implicitly defined by the performance characteristics of the predicate devices.

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

• Test Set Sample Size: The document does not specify a distinct "test set" in the context of typical machine learning or diagnostic device studies. Instead, samples of each thermoplastic material (Embrace, Klarity, Aquaplast) were used for bench testing. The exact number of individual samples tested for each attribute (e.g., number of rigidity measurements) is not provided, but it implies a sufficient number for representative physical and radiation attenuation measurements.
• Data Provenance: The data is generated from bench testing of the actual materials. No mention of geographical origin or retrospective/prospective nature is applicable as it's not human subject data.

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

Not applicable. The ground truth for physical properties (rigidity, shrinkage, melting point, etc.) and radiation attenuation for this type of medical device is established through instrumental measurements and standardized testing methods, not expert consensus.

4. Adjudication Method for the Test Set

Not applicable, as the "ground truth" is derived from direct instrumental measurements, not human interpretation requiring adjudication.

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

No. This study is focused on the physical and radiation-attenuation properties of a thermoplastic material used for patient immobilization. It does not involve human readers interpreting medical images or making diagnoses, thus an MRMC study is not relevant.

6. Standalone (i.e. algorithm only without human-in-the loop performance) Study

Not applicable. This device is a physical product (a thermoplastic), not an algorithm or software. Therefore, there is no standalone algorithm performance to evaluate.

7. Type of Ground Truth Used

The ground truth used in this study is based on direct physical measurements and instrumental radiation attenuation measurements. These are objective, quantifiable properties of the material itself.

8. Sample Size for the Training Set

Not applicable. This device is a physical product and the study involves bench testing of its properties. There is no machine learning model being trained, and therefore no "training set."

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

Not applicable, as there is no training set.

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Embrace Pit and Fissure Sealant, Low Fill is a professional dental material, designed with no Bisphenol A, that contains fluoride releasing, light cured, glass-filled acrylate resins and is less than 10% filled. Embrace Pit and Fissure Sealant, Low Fill is available in two shades (tooth-colored and off-white) and is used to seal the pits and fissures in teeth.

Embrace Pit and Fissure Sealant, Low Fill is a fluoride releasing, light-cured acrylate resin, with no Bisphenol A, that is less than 10% filled and is available in two shades, tooth-colored and off-white.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "Embrace™ WetBond™ Pit and Fissure Sealant, Low Fill" device:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document describes performance testing (bench testing) for the device. It does not explicitly state "acceptance criteria" in a pass/fail sense, but rather lists measured performance characteristics which are presumably considered acceptable given the conclusion of substantial equivalence.

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

The document describes bench testing. It does not specify the sample sizes used for each of the performance metrics. The data provenance is from bench laboratory testing conducted by PULPDENT CORPORATION. It is not clinical data, so terms like "retrospective" or "prospective" for human subjects do not apply here.

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

This information is not applicable as the study described is bench testing of physical/chemical properties, not a study involving human subjects or expert assessment for ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable as the study described is bench testing of physical/chemical properties.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in the provided document. The study focuses on bench testing of material properties.

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

No, a standalone study in the context of an algorithm's performance was not conducted or described. This device is a dental material, not an AI or software device.

7. The Type of Ground Truth Used:

The "ground truth" for the bench tests would have been established by standard scientific measurement techniques and established protocols for each material property (e.g., using a universal testing machine for compressive strength, a light meter for cure time, etc.). It's based on objective physical and chemical measurements, not expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set:

This information is not applicable. There is no "training set" as this is a physical product undergoing bench testing, not a machine learning model.

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

This information is not applicable as there is no training set.

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emBRACE is intended to provide padding for patient comfort and aid in positioning during radiologic visualization of the breast using x-ray technology.

emBRACE is a radiolucent foam cushion used during radiologic visualization of the breast. emBRACE is non-sterile and is a single use device.

emBRACE will be offered in the following configurations for ease of use dependent o the radiological system used:

• Product Number 00283-001 for use on an 18x24cm bucky. .
• Product Number 00283-100 for use on a 25x29cm bucky. .
• Product Number 00283-200 for use on a 29x30cm bucky. .

The provided text describes the regulatory clearance for the "emBRACE" device, a radiolucent foam cushion used for patient comfort and positioning during mammography. However, it does not include the details typically found in a study proving a device meets acceptance criteria related to AI/ML or diagnostic performance.

The document is a 510(k) summary for a Class II medical device (IZH) and Class I (IYX) that received clearance based on substantial equivalence to a predicate device (MammoPad® Radiolucent Cushion). This type of submission generally focuses on demonstrating that the new device has the same intended use, principles of operation, and overall technological characteristics, and raises no new questions of safety and effectiveness compared to the predicate device. It typically does not involve clinical performance studies with specific acceptance criteria as would be expected for a diagnostic or AI-based device's accuracy or efficacy.

Therefore, many of the requested fields cannot be filled from the provided text as the information is not present.

Here's what can be extracted and what cannot:

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

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

• Not applicable/Not provided. This type of information would be relevant for a clinical performance study, which is not described as being conducted for this 510(k) submission.

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

• Not applicable/Not provided. No clinical performance study requiring expert ground truth is described.

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

• Not applicable/Not provided. No clinical performance study requiring adjudication 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

• No, this was not done. The device is a physical cushion, not an AI or diagnostic software.

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

• No, this was not done. The device is a physical cushion, not an algorithm.

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

• Not applicable/Not provided. No ground truth establishment was necessary for this type of device and submission. The "ground truth" for a 510(k) of this nature is typically the established safety and effectiveness of the predicate device.

8. The sample size for the training set

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

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

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

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Embrace Gel is intended for use as an ultrasound coupling media for use with the Embrace™ 3D Ultrasound Tomography System K070477.

Embrace™ Gel Pad is en expandable polymer used to provide a coupling medium between breast tissue and the Embrace™ 3D Ultrasound Tomography System K070477. The gel is prepared just prior to scanning by placing the gel pad in the dome and adding hydrating fluid. The gel pad expands and fills the voids between the probe and breast tissue. After the ultrasound scan is completed, the gel is removed from the dome in one piece.

This document is a 510(k) summary for the Embrace Gel, an ultrasound coupling media. It explicitly states that its function and performance are similar to a predicate device (Aquasonic 100 Ultrasound Trans Gel K802146) and that it is "substantially equivalent".

The document does not contain information about acceptance criteria, a specific study proving the device meets those criteria, or any of the detailed aspects of a study typically associated with AI/software device evaluation (e.g., sample sizes, expert qualifications, ground truth, MRMC studies, standalone performance).

The FDA's review in this case determined that the device is substantially equivalent to a legally marketed predicate device, allowing it to proceed to market. This type of submission for a physical medical device (like an ultrasound gel) typically focuses on material safety, physical properties, intended use, and comparison to existing, already-approved devices, rather than a clinical performance study with statistical endpoints as would be required for a diagnostic AI algorithm.

Therefore, I cannot provide the requested information from the given text as it is not present.

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Embrace™ Dual Cure Composite Materials are multi-purpose, hydrophilic, fluoride-releasing, resin-based materials that contain no Bisphenol A and bond tightly to dentition.

Embrace™ Dual Cure Composite Materials are used to permanently cement dental posts, porcelain crowns, inlays, onlays, bridges, porcelain/laminate veneers and periodontal splints, to repair porcelain crowns intra-orally and as a build-up and repair material.

Embrace™ Dual Cure Composite Materials are multi-purpose, hydrophilic, fluoride-releasing, resin-based materials that contain no Bisphenol A and bond tightly to dentition.

The provided text is a 510(k) premarket notification for a dental material (PULPDENT EMBRACE™ DUAL CURE COMPOSITE MATERIALS). This type of submission focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than conducting a de novo study with acceptance criteria and performance data in the way an AI/ML device would.

Therefore, the document does not contain the information requested in your numbered list, such as:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets, data provenance, or details on training sets.
3. Number of experts, their qualifications, or adjudication methods for ground truth.
4. Multi-reader multi-case comparative effectiveness studies.
5. Standalone algorithm performance.
6. Specific ground truth types.

Instead, the document states:

• "PULPDENT DUAL CURE COMPOSITE MATERIALS are substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above."
• It refers to predicate devices that have "been found substantially equivalent under the 510(k) Premarket Notification process as Class II Dental Devices."
• It cites a general statement from an NIH Technology Assessment Conference regarding the high benefit-to-risk ratio and safety of dental restorative materials over time.

In summary, this document describes a regulatory pathway based on substantial equivalence to predicate devices for a dental material, not a de novo study with performance metrics as typically seen for AI/ML device evaluations.

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Embrace™ WetBond™ Clear Sealant is a hydrophilic, light-cured material recommended for use as a pit and fissure sealant. Embrace™ WetBond™ Clear Sealant may be used to seal small defects such as buccal pits, lingual grooves or facial surface defects. Embrace™ WetBond™ Clear Sealant may also be used as an orthodontic bracket coating. Embrace™ WetBond™ Clear Sealant hardens/cures such that the material is clear.

Embrace™ WetBond™ Clear Sealant is a hydrophilic, light-cured material recommended for use as a pit and fissure sealant. Embrace™ WetBond™ Clear Sealant may be used small defects such as puch pins, lingual grooves or facial sufface defects. Embrace™ WetBond™ Clear Sealant may also be used as an orthodontic bracket coating. Embrace™ WetBond™ Clear Sealant hardens/cures such that the material is clear.

The provided text describes a 510(k) premarket notification for the Embrace™ WetBond™ Clear Sealant. This notification asserts substantial equivalence to existing predicate devices based on design, composition, and intended use, rather than presenting a study to define and meet specific acceptance criteria in the way that would typically be done for a novel AI/software device.

Therefore, many of the requested categories for AI/software device studies are not applicable to this submission. The submission relies on existing knowledge about the safety and effectiveness of the chemical components and predicate devices, supported by laboratory testing on physical/mechanical properties and post-market surveillance of similar products.

Here's an attempt to address the requested information based on the provided text, indicating where information is not applicable (N/A) due to the nature of the device and submission:

1. Table of Acceptance Criteria and Reported Device Performance

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 for test set: Not explicitly stated for specific tests directly of the Embrace™ WetBond™ Clear Sealant within this summary. The "four studies" were conducted on "similar products with the same Embrace™ WetBond™ resin base." One clinical study is mentioned ("Clinical performance of Embrace™ WetBond™ Pit and Fissure Sealant. Dr. JP O'Donnell. 2005."), but the sample size and provenance details are not provided in this submission summary.
• Data provenance:
  • "Penetration depth and marginal leakage..." - Professor Michael DeGrange, Biomaterials Innovations Research Development Laboratory, Paris, France. (2001, 2002)
  • "Microleakage of surface sealants in Class V restorations after thermal cycling." - Pulpdent Corporation.
  • "In vitro study on toothpaste / toothbrush abrasion resistance of a new dental material: Seal-n-Shine." - Pulpdent Corporation.
  • "Clinical performance of Embrace™ WetBond™ Pit and Fissure Sealant." - Dr. JP O'Donnell. (2005)
  • The studies mentioned appear to be a mix of in-vitro (laboratory) and potentially in-vivo (clinical) based on their titles. The submission doesn't explicitly state if the clinical study was prospective or retrospective here.

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

• N/A. For direct testing of the Embrace™ WetBond™ Clear Sealant, the submission relies on laboratory testing and reference to prior studies, not on expert consensus to establish ground truth in the context of diagnostic performance. For the referenced studies, the experts are listed as "Professor Michael DeGrange" and "Dr. JP O'Donnell," implying their scientific and clinical expertise, respectively, but no panel or number of experts for "ground truth" establishment is detailed.

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

• N/A. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials involving human interpretation of diagnostic results. This submission focuses on material properties and clinical performance of a sealant, not diagnostic interpretation.

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

• N/A. This device is a pit and fissure sealant, not an AI or diagnostic imaging device. Therefore, MRMC studies and AI assistance are not relevant.

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

• N/A. This device is a material, not an algorithm.

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

• For the laboratory studies, the "ground truth" would be established by the physical and mechanical measurement standards and protocols relevant to dental materials (e.g., measuring penetration depth, leakage, abrasion resistance).
• For the clinical study, "outcomes data" related to sealant performance (e.g., retention, caries prevention) would be the ground truth.
• For substantial equivalence, the "ground truth" is defined by the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

• N/A. This is a material device, not a machine learning model. There is no "training set."

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

• N/A. As there is no training set for a machine learning model, this question is not applicable.

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Embrace ™ WetBond ™ Restoration & PFM Repair Kit is a convenience kit used by the dentists to repair restorations. The components were designed for bonding to all restorative, metal and ceramic restorations. The components were designed for bonding to all restorative, metal and ceramic surfaces, including precious and non-precious metals, porcelain and enamel. The Kit provides materials to prepare, prime, protect, opaque, and restore materials.

Embrace™ WetBond™ Restoration & PFM Repair Kit is a convenience kit used by the dentist to repair restorations. The components were designed for bonding to all restorative, metal and ceramic restorations. The components include for preparing, priming, opaquing and protecting surfaces, and for sealing, finishing and polishing the final repair or restoration.

The provided text is a 510(k) Premarket Notification for the Embrace™ WetBond™ Restoration & PFM Repair Kit. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a study with defined metrics.

Therefore, many of the requested sections (e.g., acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study, standalone performance, training set details) are not applicable or cannot be extracted from this type of regulatory submission.

The document primarily states that the device is "substantially equivalent" to legally marketed predicate devices and that its chemical ingredients are "used in the established dental materials." It mentions "laboratory testing [of] mechanical properties to the predicate products" but does not provide details about this testing, including specific acceptance criteria or results.

Here's a breakdown of what can be extracted or inferred based on the provided text:

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

• Not applicable / Cannot be extracted. The document states: "Though there is no ISO or ANS/ADA standard applicable to Embrace™ WetBond™ Restoration & PFM Repair Kit, laboratory testing [of] mechanical properties to the predicate products." This indicates that direct performance against established standards with specific acceptance criteria is not presented. Instead, a comparison of mechanical properties to predicate devices was performed, but the criteria and results are not detailed.

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

• Cannot be extracted. The document mentions "laboratory testing mechanical properties," but does not provide any details about the sample size, test set, or data provenance.

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 / Cannot be extracted. The submission is for a dental restoration kit, not an AI/diagnostic device that typically requires expert-established ground truth for performance evaluation.

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

• Not applicable / Cannot be extracted. This type of adjudication is relevant for diagnostic studies, not for the evaluation of a dental material kit.

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 device is a dental material kit, 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 dental material kit, not an algorithm.

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

• Not applicable / Cannot be extracted. The ground truth in the context of a dental restoration kit would typically relate to mechanical properties, biocompatibility, and clinical outcomes. The document vaguely refers to "laboratory testing mechanical properties," but doesn't specify the "ground truth" or reference methods used for these evaluations. The primary "truth" here is its substantial equivalence to previously cleared devices.

8. The sample size for the training set

• Not applicable. This device is a dental material kit, not a machine learning model that requires a training set.

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

• Not applicable. This device is a dental material kit, not a machine learning model that requires a training set.

Summary of Safety and Effectiveness Data from K032953:

The core of the safety and effectiveness data for the Embrace™ WetBond™ Restoration & PFM Repair Kit, as presented in this 510(k) submission, relies on:

• Substantial Equivalence: The primary argument is that the device is "substantially equivalent in design, composition, performance, intended use, safety and effectiveness" to three legally marketed predicate devices:
  • Kuraray Clearfil Porcelain Repair Kit
  • Ultradent Porcelain Repair Kit
  • Ivoclar Vivadent Ceramic Repair Kit
    These predicates were previously cleared under the 510(k) process as Class II Dental Devices (CFR 872.3200).
• Component Material Equivalence: The individual components of the Embrace™ WetBond™ Restoration & PFM Repair Kit were also found to be substantially equivalent to existing materials in the market.
• Chemical Ingredients: The chemical ingredients used "are used in the established dental materials."
• Laboratory Testing (Mechanical Properties): The document states that "laboratory testing [of] mechanical properties to the predicate products" was conducted. However, no specific details about the tests, methods, results, or acceptance criteria are provided in this summary.
• General Clinical Experience with Dental Adhesives: The submission cites the NIH Technology Assessment Conference on Effects and Side-Effects of Dental Adhesives, which states, "General usage of these materials over about 20 years indicates a high benefit-to-risk ratio. There is no evidence of short-term or long-term risk. There is no suspicion of any problems after virtually billions of procedures in the United States." This statement is used to support the general safety profile of dental adhesive materials.

In essence, the "study" demonstrating the device meets "acceptance criteria" is an argument for substantial equivalence to already cleared devices, supported by the common use of its chemical constituents and a general reference to comparable mechanical property testing. Specific quantitative performance data or traditional study designs with explicit acceptance criteria are not detailed in this provided text.

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