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CT VScore+ is a software application intended for non-invasive evaluation of calcified lesions of the coronary arteries based on ECG-gated, non-contrast cardiac CT images for patients aged 30 years or older. The device automatically generates calcium scores for the coronary arteries (combined LM+LAD, RCA, LCX) and highlights the segmented calcium on the original CT image. The device also offers the option for the user to display the calcium scores in the context of reference data from the MESA and Hoff-Kondos databases.

The segmented arteries include combined LM+LAD, RCA, and LCX. To obtain separate LM and LAD results, the user must perform manual segmentation. The segmentation map of calcifications is intended for informational use only and is not intended for detection or diagnostic purposes. The 3D Calcium View output is provided strictly as an informational and supplementary output and should never be used alone as the method of reviewing the calcium segmentation.

CT VScore+ is a software application intended for non-invasive evaluation of calcified lesions of the coronary arteries based on ECG-gated, non-contrast cardiac CT images for patients aged 30 years or older. The application runs on the Vitrea platform.

The device automatically generates Agatston and volume calcium scores for each of the coronary arteries (combined LM+LAD, RCA, LCX) based on the volume and density of the calcium deposits and highlights the Segmented calcium on the original CT image. The device also offers the option for the user to display the calcium scores in the context of reference data from the MESA and Hoff-Kondos databases.

The software uses deep learning-based segmentation methods. Users can edit the automated segmentation, including manually assigning calcifications to anatomical structures.

The device automatically outputs a combined LM+LAD score as the final automated output. To obtain separate LM and LAD results, the user must perform manual segmentation using the provided editing tools.

The device is Software as a Medical Device (SaMD) that operates on ECG-gated, non-contrast cardiac CT DICOM images.

The device does not interact directly with the patient. The device is a software application that runs on the Vitrea platform and processes ECG-gated non-contrast cardiac CT DICOM images. The device automatically generates Agatston and volume calcium scores for each of the coronary arteries (LAD+LM, RCA, LCX) based on the volume and density of the calcium deposits and highlights the segmented calcium on the original CT image. Results can be exported to image management, archival, or reporting systems that support DICOM standards for further review and interpretation.

Results can also be saved in DICOM Structured Reports (DICOM SR) format.

The CT VScore+ device is a software application for non-invasive evaluation of calcified lesions of the coronary arteries from ECG-gated, non-contrast cardiac CT images. The study presented demonstrates the analytical validity and performance of the device against predefined acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): 236 independent cases.
• Data Provenance: The pivotal validation dataset was sourced from diverse U.S. sites and scanner vendors. The development dataset, from which the test set was independent, included data from four institutions (two US sites and two Japanese sites). The 236 cases for validation were "independent" at both the patient level and the site level from the development dataset. It is retrospective data.

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

• Number of Experts: Three.
• Qualifications of Experts: U.S. board-certified radiologists/cardiologists. (Specific years of experience are not mentioned).

4. Adjudication Method for the Test Set

• Adjudication Method: A "2+1 consensus process" was used. This typically means that if two experts agree, their consensus defines the ground truth. If there's a disagreement between two, the third expert acts as a tie-breaker or adjudicator.

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

• The provided document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study to assess the effect size of human readers improving with AI vs. without AI assistance. The study focuses on the standalone performance of the AI algorithm against a consensus ground truth.

6. Standalone Performance Study (Algorithm Only)

• Yes, a standalone performance study was conducted. The metrics listed in the table (ICC, Kappa, Dice Score) directly assess the performance of the CT VScore+ algorithm in isolation against the established ground truth.

7. Type of Ground Truth Used

• Type of Ground Truth: Expert consensus. Specifically, the reference standard ground truth was established by consensus manual scoring on an FDA-cleared device (Vitrea CT VScore, K243240) and a 2+1 consensus process by three U.S. board-certified radiologists/cardiologists.

8. Sample Size for the Training Set

• Sample Size (Training Set): 94 cases (part of the 210 cases used for development).

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

• The document implies that the ground truth for the training set (part of the development dataset) was established similarly to the validation set's ground truth, i.e., "by consensus manual scoring on an FDA-cleared device (Vitrea CT VScore, K243240)" by experts, given that the development process involved ensuring "robust and unbiased performance." However, the exact details of ground truth establishment specifically for the training set are not explicitly broken out as they are for the pivotal validation dataset. It's reasonable to infer a similar rigorous process if the data was used for deep learning model development.

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The Carriere® Motion Pro® Clear Bite Corrector is intended to provide orthodontic movement and alignment of teeth during orthodontic treatment for Class II and Class III cases with symmetrical and asymmetrical malocclusions and Class I cases with mesially positioned maxillary molars or mandibular crowding. The appliance is indicated for use by dental and orthodontic professionals and is applicable to any patient demographic undergoing orthodontic treatment.

The Carriere Motion Pro Clear Bite Corrector is a single-use, direct bond, esthetic orthodontic appliance made of 17-4 stainless steel and polyethersulfone. It attaches the maxillary or mandibular canine or 1st premolar to the molar to provide a treatment solution for patients with malocclusions of primary, permanent, or mixed dentition. The Carriere Motion Pro Clear Bite Corrector is intended to provide orthodontic movement and alignment of teeth during orthodontic treatment for Class II and Class III cases with symmetrical and asymmetrical malocclusions and Class I cases with mesially positioned maxillary molars or mandibular crowding. The appliance is indicated for use by dental and orthodontic professionals and is applicable to any patient demographic undergoing orthodontic treatment. An optional drop-in hook, manufactured from 304 stainless steel, is included and is intended to work in conjunction with the Carriere Motion Pro Clear appliance to facilitate attachment of various orthodontic auxiliaries, such as elastomeric chain, nitinol springs, ligature wire, and elastics.

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CEREC Tessera Abutment System is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations.

For BH 3.0 S, NC Variobase C 3.3, Camlog 3.3 S and S BL 3.3 L titanium bases, the indication is restricted to the replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible.

The system comprises three parts:

• CEREC Tessera Abutment Block
• TiBase
• CAD/CAM system

The CEREC Tessera ceramic structure cemented to the TiBase is recommended for two-piece hybrid abutments for single tooth restorations and hybrid abutment crowns, used in conjunction with endosseous dental implants.

The compatible Implant systems, titanium bases and CAD/CAM systems are shown below:

Implant Systems:

• Dentsply Sirona: Astra Tech OsseoSpeed TX, Ankylos
• BioHorizons: Internal connection
• Nobel Biocare: Replace, Replace Select, Nobel Active, NobelReplace Concial Connection, Branemark, NobelSpeedy Groovy
• Straumann: Tissue Level, Bone Level
• Thommen Medical: Element, Contact
• Osstem/Hiossen: Osstem TS, (USA:Hiossen ET)
• Zimmer/Biomet: External hex, Certain, Tapered Screw-Vent
• MIS: C1 Conical connection, V3 Conical connection, SEVEN internal hex, M4 internal hex
• Altatec - Camlog
• MIS: C1 Conical connection (NP and WP), V3 Conical connection, SEVEN internal hex, M4 internal hex

CAD/CAM Systems:

• Sirona Dental CAD/CAM System

Titanium Bases:

Implant: AstraTech Osseospeed TX

• Platform: 3.5/4.0; TiBase AT TX 3.5/4.0 GH1 L; Reference 6598093; Size L
• Platform: 4.5/5.0; TiBase AT TX 4.5/5.0 GH1 L; Reference 6598101; Size L
• Platform: 3.5/4.0; TiBase AT OS 3.5/4.0 GH1 L; Reference 6282532; Size L
• Platform: 4.5/5.0; TiBase ATOS 4.5/5.0 GH1 L; Reference 6282540; Size L

Implant: Ankylos

• Platform: C/X; TiBase ANK C/ GH 1 S; Reference 6586528; Size: S

• Platform: C/X; TiBase ANK C/ GH 2 S; Reference 6586536; Size: S

• Platform: C/X; TiBase ANK /X GH 1 S; Reference 6586544; Size: S

• Platform: C/X; TiBase ANK /X GH 2 S; Reference 6586551; Size: S

Manufacturer: M.I.S. Implants

Implant: C1 Conical Connection

• Platform: NP; CN-TB001 C1 NP GH 0.5; Reference CN-TB001; Size: L
• Platform: NP; CN-B015 C1 NP GH 1.5; Reference CN-TB015; Size: L

Implant: V3 Conical Connection

• Platform: NP; VN-TB001 V3 NP GH 0.5; Reference VN-TB001; Size: L
• Platform: NP; VN-TB015 V3 NP GH 1.5; Reference VN-TB015; Size: L

Implant: V3 Conical Connection / C1 Conical Connection

• Platform: SP; CS-TB001 SP GH 0.5; Reference CS-TB001; Size: L
• Platform: SP; CS-TB015 SP GH 1.5; Reference CS-TB015; Size: L
• Platform: SP; CS-TB030 SP GH 3; Reference CS-TB030; Size: L

Implant: C1 Conical Connection

• Platform: WP; CW-TB001 C1 WP GH 0.5; Reference CW-TB001; Size: L
• Platform: WP; CW-TB015 C1 WP GH 1.5; Reference CW-TB015; Size: L
• Platform: WP; CW-TB030 C1 WP GH 3; Reference CW-TB030; Size: L

Implant: SEVEN internal hex, M4 internal hex

• Platform: NP; MN-TB001 INT HEX NP GH 0.5; Reference MN-TB001; Size: L
• Platform: NP; MN-TBC15 INT HEX NP GH 1.5; Reference MN-TBC15; Size: L
• Platform: SP; MD-TB001 INT HEX SP GH 0.5; Reference MD-TB001; Size: L
• Platform: SP; MD-TBC15 INT HEX SP GH 1.5; Reference MD-TBC15; Size: L
• Platform: SP; MD-TBC30 INT HEX SP GH 3; Reference MD-TBC30; Size: L
• Platform: WP; MW-TB001 INT HEX WP GH 0.5; Reference MW-TB001; Size: L
• Platform: WP; MW-TBC15 INT HEX WP GH 1.5; Reference: MW-TBC15; Size: L
• Platform: WP; MW-TBC30 INT HEX WP GH 3; Reference: MW-TBC30; Size: L

Manufacturer: BioHorizons

Implant: Internal Connection

• Platform: 3.0; TiBase BH 3.0 GH 1 S; Reference 6532779; Size: S
• Platform: 3.5; TiBase BH 3.5 GH 1 L; Reference 6532894; Size: L
• Platform: 4.5; TiBase BH 4.5 GH 1 L; Reference 6532951; Size: L
• Platform: 5.7; TiBase BH 5.7 GH 1 L; Reference 6536242; Size: L

Manufacturer: Nobel Biocare

Implant: Replace, Replace Select

• Platform: NP; TiBase NB RS 3.5 GH 1 L; Reference 6282474; Size: L
• Platform: RP; TiBase NB RS 4.3 GH 1 L; Reference 6282482; Size: L
• Platform: WP; TiBase NB RS 5.0 GH 1 L; Reference 6282490; Size: L
• Platform: 6.0; TiBase NB RS 6.0 GH 1 L; Reference 6282508; Size: L

Implant: Nobel Active, Nobel Replace Conical Connection

• Platform: NP; TiBase NB A 4.5 GH 1 L; Reference 6308188; Size: L
• Platform: RP; TiBase NB A 5.0 GH 1 L; Reference 6308253; Size: L

Implant: Branemark

• Platform: NP; TiBase NB B 3.4 GH 1 L; Reference 6282516; Size: L

Implant: NobelSpeedy Groovy

• Platform: RP; TiBase NB B 4.1 GH 1 L; Reference 6282524; Size: L

Manufacturer: Straumann

Implant: Tissue Level

• Platform: RN (4.8 mm); TiBase SSO 4.8 GH 1 L; Reference 6284249; Size: L
• Platform: WN (6.5 mm); TiBase SSO 6.5 GH 1 L; Reference 6284256; Size: L

Implant: Bone Level

• Platform: NC (3.3 mm); TiBase S BL 3.3 GH 1 L; Reference 6308154; Size: L
• Platform: RC (4.1 mm/ 4.8 mm); TiBase S BL C 4.1 GH 1 L; Reference 6308337; Size: L

Manufacturer: Thommen Medical

Implant: Element, Contact

• Platform: 3.5; TiBase TM 3.5 GH 1 S; Reference 6531854; Size: S
• Platform: 4; TiBase TM 4 GH 1 S; Reference 6532829; Size: S
• Platform: 4.5; TiBase TM 4.5 GH 1 S; Reference 6532837; Size: S
• Platform: 5; TiBase TM 5 GH 1 S; Reference 6544360; Size: S
• Platform: 6; TiBase TM 6 GH 1 S; Reference 6544378; Size: S

Manufacturer: Osstem / Hiossen

Implant: Osstem TS (US Hiossen ET)

• Platform: Mini; TiBase O TS 3.5 GH 1 L; Reference 6527035; Size: L
• Platform: Regular; TiBase O TS 4.0 GH 1 L; Reference 6527043; Size: L

Manufacturer: Zimmer / Biomet

Implant: External hex

• Platform: 3.4; TiBase BO 3.4 GH 1 L; Reference 6282557; Size: L
• Platform: 4.1; TiBase BO 4.1 GH 1 L; Reference 6282565; Size: L
• Platform: 5.0; TiBase BO 5.0 GH 1 L; Reference 6282573; Size: L

Implant: Certain

• Platform: 3.4; TiBase B C 3.4 GH 1 S; Reference 6308048; Size: S
• Platform: 4.1; TiBase BC 4.1 GH 1 L; Reference 6308097; Size: L
• Platform: 5.0; TiBase BC 5.0 GH 1 L; Reference 6308121; Size: L

Implant: Tapered Screw-Vent

• Platform: 3.5; TiBase Z TSV 3.5 GH 1 L; Reference 6282581; Size: L
• Platform: 4.5; TiBase Z TSV 4.5 GH 1 L; Reference 6282599; Size: L
• Platform: 5.7; TiBase Z TSV 5.7 GH 1 L; Reference 6282607; Size: L

Manufacturer: Straumann

Implant: Bone Level

• Platform: NC (3.3 mm); TiBase NC Variobase C 3.3 GH 1; Reference 220.043; Size: S
• Platform: RC (4.1 mm/ 4.8 mm); TiBase RC Variobase C 4.1 GH 1; Reference 220.044; Size: L

Manufacturer: Altatec GmbH-Camlog

Implant: Camlog

• Platform: 3.3; CAMLOG Titanium Base CAD/CAM, for Ø 3.3 mm GH 0.4; Reference K2244.3348; Size S
• Platform: 3.8; CAMLOG Titanium Base CAD/CAM, for Ø 3.8 mm GH 0.3; Reference K2244.3848; Size: S
• Platform: 4.3; CAMLOG Titanium Base CAD/CAM, for Ø 4.3 mm GH 0.3; Reference K2244.4348; Size: S
• Platform: 5.0; CAMLOG Titanium Base CAD/CAM, for Ø 5.0 mm GH 0.3; Reference K2244.5048; Size: L
• Platform: 6.0; CAMLOG Titanium Base CAD/CAM, for Ø 6.0 mm GH 0.3; Reference K2244.6048; Size: L

The proposed CEREC Tessera Abutment System is a modification of the previously cleared CEREC Tessera Abutment Block (K221402). The proposed CEREC Tessera Abutment Blocks are intended for fabrication of single cement-retained restorations. The proposed CEREC Tessera Abutment System (with the additional TiBase and Implant System compatibilities and change in wall thickness) is comprised of the CEREC Tessera Abutment Block, applicable TiBase, and CAD/CAM systems in both chairside (CEREC chairside software) and labside (inLab labside software) use. The CEREC Tessera Abutment Blocks are not provided as the finished, fully assembled dental implant medical device. The CEREC Tessera Abutment Blocks are materials supplied to dental professionals that must be further processed/manufactured using CAD/CAM technology and they are not intended to be reused as in the context of direct patient-applied devices and materials.

The CEREC Tessera Abutment Blocks are designed with a pre-drilled screw access channel and anti-rotation feature. The design allows for fabrication of a ceramic structure used to create 2-piece hybrid abutments and hybrid abutment crowns cemented to a TiBase used with dental implant systems. The patient-specific ceramic structure is then cemented to a TiBase to create the two-piece abutment which constitutes the final finished medical device. The following patient-specific ranges for CAD/CAM fabrication of the abutments are:

• Maximum angulation of 20°
• Minimal wall thickness of 0.5 mm
• Gingival height ranges from 0.5 mm -3.0 mm
• Minimum abutment post height (i.e. length above the gingival height) of >4 mm

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The iCardio.ai CardioVision™ AI is an automated machine learning–based decision support system, indicated as a diagnostic aid for patients undergoing an echocardiographic exam consisting of a single PLAX view in an outpatient environment, such as a primary care setting.

When utilized by an interpreting clinician, this device provides information that may be useful in detecting moderate or severe aortic stenosis. iCardio.ai CardioVision™ AI is indicated in adult populations over 21 years of age. Patient management decisions should not be made solely on the results of the iCardio.ai CardioVision™ AI analysis. iCardio.ai CardioVision™ AI analyzes a single cine-loop DICOM of the parasternal long axis (PLAX).

The iCardio.ai CardioVision™ AI is a standalone image analysis software developed by iCardio.ai Corporation, designed to assist in the review of echocardiography images. It is intended for adjunctive use with other physical vital sign parameters and patient information, but it is not intended to independently direct therapy. The device facilitates determining whether an echocardiographic exam is consistent with aortic stenosis (AS), by providing classification results that support clinical decision-making.

The iCardio.ai CardioVision™ AI takes as input a DICOM-compliant, partial or full echocardiogram study, which must include at least one parasternal long-axis (PLAX) view of the heart and at least one full cardiac cycle. The device uses a set of convolutional neural networks (CNNs) to analyze the image data and estimate the likelihood of moderate or severe aortic stenosis. The output consists of a binary classification of "none/mild" or "moderate/severe," indicating whether the echocardiogram is consistent with moderate or severe aortic stenosis. In cases where the image quality is insufficient, the device may output an "indeterminate" result.

The CNNs and their thresholds are fixed prior to validation and do not continuously learn during standalone testing. These models are coupled with pre- and post-processing functionalities, allowing the device to integrate seamlessly with pre-existing medical imaging workflows, including PACS, DICOM viewers, and imaging worklists. The iCardio.ai CardioVision™ AI is intended to be used as an aid in diagnosing AS, with the final diagnosis always made by an interpreting clinician, who should consider the patient's presentation, medical history, and additional diagnostic tests.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) clearance letter for CardioVision™:

Acceptance Criteria and Reported Device Performance

Note: The document explicitly states that the levels of sensitivity and specificity exceed the predefined success criteria and those of the predicate device, supporting the claim of substantial equivalence. While exact numerical thresholds for the acceptance criteria aren't provided in terms of specific values, the narrative confirms they were met.

Study Details

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The Ceribell Infant Seizure Detection Software is intended to mark previously acquired sections of EEG recordings in newborns (defined as preterm or term neonates of 25-44 weeks postmenstrual age) and infants less than 1 year of age that may correspond to electrographic seizures in order to assist qualified clinical practitioners in the assessment of EEG traces. The Seizure Detection Software also provides notifications to the user when detected seizure prevalence is "Frequent", "Abundant", or "Continuous", per the definitions of the American Clinical Neurophysiology Society Guideline 14. Delays of up to several minutes can occur between the beginning of a seizure and when the Seizure Detection notifications will be shown to a user.

The Ceribell Infant Seizure Detection Software does not provide any diagnostic conclusion about the subject's condition and Seizure Detection notifications cannot be used as a substitute for real time monitoring of the underlying EEG by a trained expert.

The Ceribell Infant Seizure Detection Software is a software-only device that is intended to mark previously acquired sections of EEG recordings that may correspond to electrographic seizures in order to assist qualified clinical practitioners in the assessment of EEG traces.

Ceribell Infant Seizure Detection Software: Acceptance Criteria and Supporting Study

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 713 patients.
  • 25-36 weeks PMA: 155 patients
  • 37-44 weeks PMA: 321 patients

  • 44 weeks PMA: 237 patients

• Data Provenance: The EEG recordings were obtained from patients less than 1 year of age who received continuous EEG monitoring within the hospital environment. The study was retrospective. The country of origin is not explicitly stated in the provided text.

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

• Number of Experts: 3
• Qualifications of Experts: Expert pediatric neurologists who were fellowship-trained in epilepsy or clinical neurophysiology.

4. Adjudication Method for the Test Set

• Adjudication Method: A two-thirds majority agreement among the 3 expert pediatric neurologists was required to form a determination of seizures, establishing the reference standard for the test set.

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 explicitly described. The study focused on the standalone performance of the algorithm against an expert-adjudicated ground truth.

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

• Yes, a standalone performance study was done. The performance metrics (PPA and FP/hr) were evaluated for the Ceribell Infant Seizure Detection Software algorithm without human intervention in the detection process. The reviewing neurologists for ground truth establishment were explicitly blinded to the software's output.

7. The Type of Ground Truth Used

• Type of Ground Truth: Expert consensus (adjudication by a panel of 3 expert pediatric neurologists).

8. The Sample Size for the Training Set

• The sample size for the training set is not provided in the document. The document states, "Importantly, none of the data in the validation dataset were used for training of the Seizure Detection algorithm; the validation dataset is completely independent."

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

• The document does not explicitly state how the ground truth for the training set was established. It only mentions that the validation dataset was independent and not used for training.

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