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The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.

BruxZir Shaded 16 PLUS blanks are used for the production of full-contour zirconia and zirconia-based substructures for crowns and bridges (restorations). Multiple thicknesses and shades (A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4, BL1, BL3, and White) are available for milling into BruxZir restorations. The manufactured restorations are made utilizing the CAD/CAM system for design and manufacturing. The designed and manufactured restorations are then sintered and glazed. BruxZir Shaded 16 PLUS restorations are designed to match the body shade in the glazed state; however, precolor and stain should be applied if polychromatic (gingival to incisal) blending or other esthetic effects are desired. The sintered material exhibits maximum strength, color, and translucency similar to natural dentition.

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The Paragonix BAROguard is intended to be used for the static hypothermic preservation of lungs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the lungs.

The intended organ storage time for BAROguard is up to 8 hours.

Donor lungs exceeding clinically accepted static hypothermic preservation times should be evaluated by the transplant surgeon to determine transplantability in accordance with accepted clinical guidelines and in the best medical interest of the intended recipient.

Note: Partial lungs can be transported via BAROguard by packaging lungs per institutional protocol and UNOS guidelines.

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The Boston PICO is indicated for surgical and cosmetic use in dermatology department, general surgery department and plastic surgery department, details are as follows:

1064 nm wavelength:

• Remove tattoos of all skin types (Fitzpatrick skin type I-VI) in the following colors: black, brown, green, blue and purple.
• Treat benign pigmented skin lesions of Fitzpatrick I-IV types.

532 nm wavelength:

• Remove tattoos of Fitzpatrick skin type I-III in the following colors: red, yellow and orange.
• Treat benign pigmented skin lesions of Fitzpatrick I-IV types.

Microbeam handpieces (1064nm and 532nm) are used for the treatment of wrinkles for skin types I-IV.

The Boston PICO is a multi-wavelength, pulsed laser system, and a solid-state laser capable of delivering energy at wavelengths of 1064nm, 532nm at extremely short duration in 250ps(± 20%). The combination of wavelength, pulse duration and energy fluence are disrupting the tattoo dye or pigment particles under the skin without harming the surrounding tissue. The fragmented dye or pigment particles eventually surface and fade as the epidermal layer of the skin is renewed. The 1064 nm wavelength can be frequency-doubled to 532nm as desired. The outputs of the two lasers are designed to be co-linear on the laser rail so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either the 532 nm or 1064 nm wavelengths. All these energies are delivered through an articulated arm and corresponding handpiece.

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BriefCase-Triage is a radiological computer aided triage and notification software indicated for use in the analysis of contrast-enhanced CT images that include the brain, in adults or transitional adolescents aged 18 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive cases of Brain Aneurysm (BA) findings that are 3.0 mm or larger.

BriefCase-Triage uses an artificial intelligence algorithm to analyze images and flag suspect cases in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for suspect cases. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device.

The results of BriefCase-Triage are intended to be used in conjunction with other patient information and based on professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.

BriefCase-Triage is a radiological computer-assisted triage and notification software device.

The software is based on an algorithm programmed component and is intended to run on a linux-based server in a cloud environment.

The BriefCase-Triage receives filtered DICOM Images, and processes them chronologically by running the algorithms on each series to detect suspected cases. Following the AI processing, the output of the algorithm analysis is transferred to an image review software (desktop application). When a suspected case is detected, the user receives a pop-up notification and is presented with a compressed, low-quality, grayscale image that is captioned "not for diagnostic use, for prioritization only" which is displayed as a preview function. This preview is meant for informational purposes only, does not contain any marking of the findings, and is not intended for primary diagnosis beyond notification.

Here's a breakdown of the acceptance criteria and study details for the BriefCase-Triage device, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Reported Device Performance

Note on Additional Operating Points (AOPs): The device also met performance goals (80% sensitivity and specificity) for three additional operating points (AOP1, AOP2, AOP3) with slightly varying sensitivity/specificity trade-offs (e.g., AOP3: Sensitivity 86.2%, Specificity 93.6%).

Study Details

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

• Sample Size: 544 cases
• Data Provenance: Retrospective, blinded, multicenter study from 6 US-based clinical sites. The cases were distinct in time or center from those used for algorithm training.

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

• Number of Experts: Three (3) senior board-certified radiologists.
• Qualifications: "Senior board-certified radiologists." (Specific number of years of experience not detailed in the provided text).

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

• The text states the ground truth was "determined by three senior board-certified radiologists." It doesn't explicitly describe an adjudication method like "2+1" or "3+1." This implies a consensus approach where all three radiologists agreed, or a majority rule, but the exact mechanism for resolving discrepancies (if any) is not specified.

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

• No, an MRMC comparative effectiveness study was NOT done. The study's primary objective was to evaluate the standalone performance of the BriefCase-Triage software. The secondary endpoint compared the device's time-to-notification to that of the predicate device, but not its impact on human reader performance.

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

• Yes, a standalone performance study was done. The primary endpoints (sensitivity and specificity) measure the algorithm's performance in identifying Brain Aneurysm (BA) findings.

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

• Expert Consensus: The ground truth was "determined by three senior board-certified radiologists."

7. The sample size for the training set:

• Not explicitly stated. The document mentions the algorithm was "trained during software development on images of the pathology" and that "critical findings were tagged in all CTs in the training data set." However, the specific sample size for this training data is not provided.

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

• Manually labeled ("tagged") images: The text states, "As is customary in the field of machine learning, deep learning algorithm development consisted of training on manually labeled ('tagged') images. In that process, critical findings were tagged in all CTs in the training data set." It does not specify who performed the tagging or their qualifications, nor the method of consensus if multiple taggers were involved.

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The BodyGuardian™ Remote Monitoring System detects and monitors cardiac arrhythmias in ambulatory patients, when prescribed by a physician or other qualified healthcare professional.

The BodyGuardian Remote Monitoring System is intended for use with adult and pediatric patients who are at least 29 days old in clinical and non-clinical settings to collect and transmit electrocardiogram (ECG) and other health parameters to healthcare professionals for monitoring and evaluation. Health parameters, such as heart rate and ECG data, are collected from external devices such as ECG sensors.

The BodyGuardian Remote Monitoring System does not provide any diagnosis.

The BodyGuardian Remote Monitoring System (BGRMS) is a system for recording and analyzing ECG data for cardiac arrhythmias to assist healthcare professionals, including ECG technicians at 24/7 attended analysis centers in evaluating a patient's cardiac health. Reports are generated for clinician review, that provide analysis and summary of the ECG data collected during a patient's monitoring study. Both the predicate and proposed devices, feature a modular design inclusive of outpatient cardiac telemetry (commonly called mobile cardiac telemetry (MCT)), cardiac event monitor and connected/non-connected Holter modalities. Components in the system external to the software include ECG monitors, electrodes, mobile phones and apps.

The BGRMS System includes the following main components:

• ECG monitor – a patient worn device for ECG waveform data collection and transmission, utilized with compatible electrodes
• Mobile App – applications that execute on an off-the-shelf (OTS) smartphone to communicate with the ECG monitor and the PatientCare Server for collection and transmission of data
• PatientCare – server software responsible for receiving, storing, analyzing, and displaying and reporting data gathered from the ECG monitors; includes the ECG analysis algorithm BeatLogic™
• AI-Based Device Software Functionality (AI-DSF) – Automated classification of continuous
  ECG based on the proprietary BeatLogic™ AI algorithm. BeatLogic consists of an ensemble of deep neural networks (DNNs), trained on real-world patient data and post-processing logic that combines the DNN output to produce individual beat, rhythm, and waveform classifications. This output is intended to be reviewed and confirmed by healthcare professionals to assist in diagnosis.

The provided FDA 510(k) clearance letter and summary for the BodyGuardian Remote Monitoring System (BGRMS v3.0) contains information on the device's acceptance criteria and study to prove it.

Acceptance Criteria and Reported Device Performance

The clinical validation results met all predefined acceptance criteria, though the specific criteria are not explicitly detailed in the provided document beyond "substantially equivalent performance for BeatLogic." The performance was assessed by evaluating the Sensitivity and Positive Predictive Value (PPV) for key rhythms. While specific numerical values for the acceptance criteria are not given, the reported device performance is stated as meeting these unspecified criteria.

Details of the Study Proving Device Meets Acceptance Criteria

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

• Sample Size: Not explicitly stated, but described as "real-world, randomly selected ECG records" with a demographic breakdown of 48.6% Female, 39.2% Male, 12.2% unknown gender, 50.1% < 65 years of age, 49.8% ≥ 65 years of age, and 0.1% unknown age.
• Data Provenance: "Real-world patient data" with representation across "US geographic region," indicating data from the United States. The data is retrospective as it was used to train and validate the algorithm, selected to reflect various algorithm outputs, compatible ECG device configurations, accessory types, and demographic factors.

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

This information is not provided in the document. The document states that the BeatLogic™ AI algorithm's "output is intended to be reviewed and confirmed by healthcare professionals to assist in diagnosis," but it does not specify how the ground truth for the test set was established or the number/qualifications of experts involved in this process.

3. Adjudication Method for the Test Set

This information is not provided in the document.

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

• Was it done?: No, an MRMC comparative effectiveness study is not explicitly mentioned. The study focuses on the standalone performance of the AI algorithm (BeatLogic™).
• Effect size of human readers improvement: Not applicable, as an MRMC study was not described.

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

• Was it done?: Yes. The performance measurement of the BeatLogic™ algorithm involved evaluating Sensitivity and PPV, which are metrics typically used for standalone algorithm performance against a ground truth. The document explicitly states, "Performance of the algorithm was assessed by evaluating the Sensitivity and Positive Predictive value (PPV) for key rhythms across different patient subgroups." Furthermore, it mentions that the algorithm's "output is intended to be reviewed and confirmed by healthcare professionals to assist in diagnosis," implying that the performance reported is that of the algorithm prior to human review.

6. The Type of Ground Truth Used

The ground truth annotations were established based on "ground truth annotations on real-world ECG data." The method of establishing these annotations (e.g., expert consensus, pathology, outcomes data) is not explicitly stated. However, the context of cardiac arrhythmia detection strongly suggests ground truth would be established by qualified cardiologists or electrophysiologists.

7. The Sample Size for the Training Set

• Sample Size: Not explicitly stated, but described as "real-world, randomly selected ECG records" that ensured "representation across algorithm outputs, compatible ECG device configurations and accessory types and demographic factors encompassing patient age, gender, geographic location, and indication for monitoring."

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

The document states that the BeatLogic™ AI algorithm consists of "deep neural networks (DNNs), trained on real-world patient data." However, the specific method for establishing the ground truth for this training data is not explicitly provided. It is implied that this involved annotations on "real-world patient data," but the process for generating these annotations (e.g., expert review, automated processes) is not detailed.

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The Boston Pico755 is indicated for the removal of tattoos and benign pigmented lesions, including but not limited to Ota nevus, Hori spots (Hori nevus), and melasma. The Boston Pico755 with the 2 mm and 6 mm handpieces and the handpieces with Focus Array are indicated for the treatment of acne scars and wrinkles in Skin Types I-IV.

The Boston Pico755 is a medical solid-state laser equipment which is indicated for the removal of tattoos and benign pigmented lesions, including but not to limited to: Ota nevus, Hori spots (Hori nevus) and melasma. It has handpieces for the treatment of acne scars and wrinkles in skin types I-IV. The device is intended to be used in professional healthcare facilities by trained physicians only.

The subject device Boston Pico755 consists of main unit (including power module, laser module, control system and cooling system), a light guide articulated arm, a footswitch, a handpiece and protective Glasses. It is connected to supply mains directly through undetachable power cord and plug. There are 8 types of replaceable handpieces - Zoom S, Zoom X, M, M6, M8, M10, 755x, 755s, and operators can choose the appropriate handpiece according to treatment needs.

When the system automatically detects the model of the installed handpiece, it will display the corresponding treatment interface specific to that handpiece. Users can view or adjust relevant parameters such as wavelength, fluence, energy, spot size, and repetition rate directly from the interface.

After turning on the device, set the Wavelength, Fluence, Frequency, Spot Size, etc. to be used then press the Footswitch in the READY state, the laser will be energized and transferred through the Articulated Arm and handpiece. The cooling system controls the heating caused by the laser output.

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The Baylis Connector Cable is intended to connect Baylis Radiofrequency (RF) Puncture generators to separately cleared compatible RF devices.

The Baylis Connector Cable is a sterile, single-use device designed to connect Baylis-approved Radiofrequency (RF) generators (including the PrecisePath RF Puncture Generator and RFP-100A Generator) to separately cleared compatible RF devices (e.g., RF guidewires).

The Baylis Connector Cable is 10 feet long with a multi-pin positive locking Generator Connector at one end and a spring-loaded wire connection connector at the other end which allows connection to the RF delivery device. Between the connector ends is a single insulated conductor cable.
Principle of Operation: Enables RF power transfer from generator to RF puncture device; no changes from predicate device.

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Magnetic Resonance Imaging (MRI) is a noninvasive technique used for diagnostic imaging. MRI with its soft tissue contrast capability enables the healthcare professional to differentiate between various soft tissues, for example, fat, water, and muscle, but can also visualize bone structures.

Depending on the region of interest, contrast agents may be used.

The MR system may also be used for imaging during interventional procedures and radiation therapy planning.

The PET images and measures the distribution of PET radiopharmaceuticals in humans to aid the physician in determining various metabolic (molecular) and physiologic functions within the human body for evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders, and cancer.

The integrated system utilizes the MRI for radiation-free attenuation correction maps for PET studies. The integrated system provides inherent anatomical reference for the fused MR and PET images due to precisely aligned MR and PET image coordinate systems.

BIOGRAPH One with software Syngo MR XB10 includes new and modified hardware and software compared to the predicate device, Biograph mMR with software syngo MR E11P-AP01. A high level summary of the new and modified hardware and software is provided below:

Hardware

New Hardware

• Gantry offset phantom
• SDB (Smart Distribution Box)

New Coils

• BM Contour XL Coil
• BM Head/Neck Pro PET-MR Coil
• BM Spine Pro PET-MR Coil
• Transfer of up-to-date RF coils from the reference device MAGNETOM Vida.

Modified Hardware

• Main components such as:
  • Detector cassettes / DEA
  • Phantom holder
  • Gantry tube
  • Backplane
  • Magnet and cabling
  • Gradient coil
  • MaRS (measurement and reconstruction system)
  • MI MARS
  • PET electronics
  • RF transmitter TBX3 3T (TX Box 3)
• Other components such as:
  • Cover
  • Filter plate
  • Patient table
  • RFCEL_TEMP

Modified Coils

• Body coil
• Transfer of up-to-date RF coils from the reference device MAGNETOM Vida with some improvements.

Software

New Features and Applications

• Fast Whole-Body workflows
• Fast Head workflow
• myExam PET-MR Assist
• CS-Vibe
• myExam Implant Suite
• DANTE blood suppression
• SMS Averaging for TSE
• SMS Averaging for TSE_DIXON
• SMS without diffusion function
• BioMatrix Motion Sensor
• RF pulse optimization with VERSE
• Deep Resolve Boost for FL3D_VIBE and SPACE
• Deep Resolve Sharp for FL3D_VIBE and SPACE
• Preview functionality for Deep Resolve Boost
• EP2D_FID_PHS
• EP_SEG_FID_PHS
• ASNR recommended protocols for imaging of ARIA
• Open Workflow
• Ultra HD-PET
• "MTC Mode"
• OpenRecon 2.0
• Deep Resolve Boost for TSE
• GRE_PC
• The following functions have been migrated for the subject device without modifications from MAGNETOM Skyra Fit and MAGNETOM Sola Fit:
  • 3D Whole Heart
• Ghost reduction (Dual polarity Grappa (DPG))
• Fleet Reference Scan
• AutoMate Cardiac (Cardiac AI Scan Companion)
• Complex Averaging
• SPACE Improvement: high bandwidth IR pulse
• SPACE Improvement: increase gradient spoiling
• The following function has been migrated for the subject device without modifications from MAGNETOM Free.Max:
  • myExam Autopilot Spine
• The following functions have been migrated for the subject device without modifications from MAGNETOM Sola:
  • myExam Autopilot Brain
  • myExam Autopilot Knee
• Transfer of further up-to-date SW functions from the reference devices.

New Software / Platform

• PET-Compatible Coil Setup
• Select&GO
• PET-MR components communication

Modified Features and Applications

• HASTE_CT
• FL3D_VIBE_AC
• PET Reconstruction
• Transfer of further up-to-date SW functions from the reference devices with some improvements.

Modified Software / Platform

• Several software functions have been improved. Which are:
  • PET Group
  • PET Viewing
  • PET RetroRecon
  • PET Status and Tune-up/QA

Other Modifications and / or Minor Changes

• Indications for use
• Contraindications
• SAR parameter
• Off-Center Planning Support
• Flip Angle Optimization (Lock TR and FA)
• Inline Image Filter
• Marketing bundle "myExam Companion"
• ID Gain
• Automatic System Shutdown (ASS) sensor (Smoke Detector)
• Patient data display (PDD)

The FDA 510(k) Clearance Letter for BIOGRAPH One refers to several AI/Deep Learning features. However, the provided document does not contain explicit acceptance criteria for these AI features in a table format, nor does it detail a comparative effectiveness study (MRMC study) for human readers. It primarily focuses on demonstrating non-inferiority to the predicate device through various non-clinical tests.

Below is an attempt to extract and synthesize the information based on the provided text, while acknowledging gaps in the information regarding specific acceptance criteria metrics and clinical studies.

Acceptance Criteria and Study Details for BIOGRAPH One AI Features

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a dedicated table format. Instead, it describes performance in terms of achieving "convergence of the training" and "improvements compared to conventional parallel imaging," or confirming "very similar metrics" to the predicate. The "acceptance criteria" are implied by these statements and the successful completion of the described tests.

2. Sample Sizes Used for Test Set and Data Provenance

The document primarily describes a validation dataset which serves as the "test set" for the AI models during development, and an additional "test dataset" for specific evaluations.

• Deep Resolve Boost for FL3D_VIBE and SPACE:

  • Test Set Description: The "collaboration partners (testing)" data is mentioned as the source for testing, implying an external, independent test set. No specific number for this test set is provided beyond the 1265 measurements for training/validation.
  • Sample Size (Validation/Training): 27,679 3D patches from 1265 measurements.
  • Data Provenance: "in-house measurements (training and validation) and collaboration partners (testing)." The country of origin is not specified but is likely Germany (Siemens Healthineers AG) and/or China (Siemens Shenzhen Magnetic Resonance LTD.) where the manufacturing is listed.
  • Retrospective/Prospective: "Input data was retrospectively created from the ground truth by data manipulation and augmentation." This indicates retrospective data use.

• Deep Resolve Sharp for FL3D_VIBE and SPACE:

  • Test Set Description: The document states, "The high-resolution datasets were split to 70% training and 30% validation datasets before training to ensure independence of them." This implies the 30% validation dataset is used as the test set.
  • Sample Size (Validation/Training): 27,679 3D patches from 1265 measurements (split into 70% training and 30% validation).
  • Data Provenance: "in-house measurements (training and validation) and collaboration partners (testing)."
  • Retrospective/Prospective: "Input data was retrospectively created from the ground truth by data manipulation." This indicates retrospective data use.

• Deep Resolve Boost for TSE (First Mention - General Performance):

  • Test Set Description: The "evaluation on the test dataset" is mentioned. The validation set is 30% of the 500 measurements.
  • Sample Size (Validation/Training): Approximately 13,000 high resolution 3D patches from 500 measurements (split into 70% training and 30% validation).
  • Data Provenance: "in-house measurements."
  • Retrospective/Prospective: "Input data was retrospectively created from the ground truth by data manipulation." This indicates retrospective data use.

• Deep Resolve Boost for TSE (Second Mention - Banding Artifacts):

  • Test Set Description: "Additional test dataset for banding artifact reduction: more than 2000 slices." This dataset was acquired after the release of the predicate network.
  • Sample Size: More than 2000 slices.
  • Data Provenance: "in-house measurements and collaboration partners."
  • Retrospective/Prospective: Not explicitly stated for this specific additional dataset, but the training/validation data for the predicate was retrospective.

3. Number of Experts and Qualifications for Ground Truth

• Radiologist Evaluation for Deep Resolve Boost for TSE (Second Mention): The document mentions "the radiologist evaluation revealed no difference in suitability for clinical diagnostics."

  • Number of Experts: Not specified (singular "radiologist" used, but typically multiple are implied for such evaluations).
  • Qualifications: "Radiologist." No specific years of experience or subspecialty are mentioned.

• Other features: For Deep Resolve Boost/Sharp for FL3D_VIBE and SPACE, and Deep Resolve Boost for TSE (first mention), the ground truth is derived directly from acquired image data (see section 7). No independent human expert ground truth establishment for these.

4. Adjudication Method (for Test Set)

• Radiologist Evaluation for Deep Resolve Boost for TSE (Second Mention): The adjudication method is not specified in the document (e.g., 2+1, 3+1). It only states "the radiologist evaluation."

• Other features: Adjudication methods are not applicable as human experts were not establishing ground truth for objective metrics.

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

• Was an MRMC study done? No, the document does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance is compared. The evaluation for Deep Resolve Boost for TSE mentions "radiologist evaluation" but not in a comparative MRMC study context.
• Effect Size: Not applicable, as no MRMC study was performed.

6. Standalone (Algorithm Only) Performance

• Was standalone performance done? Yes, the performance testing for all Deep Resolve features (Boost and Sharp for FL3D_VIBE, SPACE, and TSE) was conducted "algorithm only" by evaluating metrics like PSNR, SSIM, MSE, and LPIPS, and then visual inspection/radiologist evaluation. These refer to the algorithm's direct output performance.

7. Type of Ground Truth Used

• Deep Resolve Boost for FL3D_VIBE and SPACE: "The acquired datasets (as described above) represent the ground truth for the training and validation."
• Deep Resolve Sharp for FL3D_VIBE and SPACE: "The acquired datasets represent the ground truth for the training and validation." Input data was manipulated (cropped k-space) to create low-resolution input and high-resolution output/ground truth from the same dataset.
• Deep Resolve Boost for TSE (First Mention): "The acquired datasets represent the ground truth for the training and validation." Input data was manipulated (cropped k-space) to create low-resolution input and high-resolution output/ground truth from the same dataset.
• Deep Resolve Boost for TSE (Second Mention): "The acquired training/validation datasets... represent the ground truth for the training and validation." Input data was manipulated by undersampling k-space, adding noise, and mirroring k-space.
• Summary: The ground truth for all AI features was derived from acquired, high-resolution original image data (retrospectively manipulated to simulate inputs). For Deep Resolve Boost for TSE (second mention), there was also an implicit "expert consensus" or "expert reading" component for the "radiologist evaluation" regarding clinical suitability.

8. Sample Size for the Training Set

• Deep Resolve Boost for FL3D_VIBE and SPACE: 81% of 1265 measurements (for 27,679 3D patches).
• Deep Resolve Sharp for FL3D_VIBE and SPACE: 70% of 1265 measurements (for 27,679 3D patches).
• Deep Resolve Boost for TSE (First Mention): 70% of 500 measurements (for approx. 13,000 high resolution 3D patches).
• Deep Resolve Boost for TSE (Second Mention): More than 23,250 slices (93% of the combined training/validation dataset from K213693).

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

• Deep Resolve Boost for FL3D_VIBE and SPACE: The "acquired datasets" represent the ground truth. "Input data was retrospectively created from the ground truth by data manipulation and augmentation. This process includes further undersampling of the data by discarding k-space lines as well as creating sub-volumes of the acquired data."
• Deep Resolve Sharp for FL3D_VIBE and SPACE: The "acquired datasets represent the ground truth." "Input data was retrospectively created from the ground truth by data manipulation. k-space data has been cropped such that only the center part of the data was used as input. With this method corresponding low-resolution data as input and high-resolution data as output / ground truth were created for training and validation."
• Deep Resolve Boost for TSE (First Mention): Similar to Deep Resolve Sharp for FL3D_VIBE and SPACE: "The acquired datasets represent the ground truth for the training and validation. Input data was retrospectively created from the ground truth by data manipulation. k-space data has been cropped such that only the center part of the data was used as input. With this method corresponding low-resolution data as input and high-resolution data as output / ground truth were created for training and validation."
• Deep Resolve Boost for TSE (Second Mention): "The acquired training/validation datasets... represent the ground truth for the training and validation. Input data was retrospectively created from the ground truth by data manipulation and augmentation. This process includes further undersampling of the data by discarding k-space lines, lowering of the SNR level by addition of noise and mirroring of k-space data."

In summary, for all AI features, the ground truth for training was established by using high-quality, originally acquired MRI data that was then retrospectively manipulated (e.g., undersampled, cropped, noise added) to create synthetic "lower quality" input data for the AI model to learn from, with the original high-quality data serving as the target output or ground truth.

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Cardiopulmonary Bypass (CPB):
Bio-Medicus Life Support catheters are peripheral-access catheters used to perfuse vessels or organs in conjunction with extracorporeal cardiopulmonary bypass (CPB) procedures. The catheter introducer is intended to facilitate proper insertion and placement of the appropriately sized catheter within the vessel. Catheter models with tip lengths of 18 cm (7.09 in), 50 cm (19.7 in), or 55 cm (21.7 in) and without additional side holes may be used as either drainage or reinfusion catheters. This product is intended for use in adult and pediatric patients for up to 6 hours.

Extracorporeal Membrane Oxygenation (ECMO) and Extracorporeal Life Support (ECLS):
The Bio-Medicus Life Support catheters and introducers are single-lumen drainage or reinfusion peripheral-access catheters to be used in ECMO or ECLS with an extracorporeal circuit intended for use in adult and pediatric patients with acute respiratory or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.

The Bio-Medicus Life Support catheter is a single-lumen catheter used to drain or reinfuse blood. The introducer facilitates proper insertion and placement of the appropriately sized catheter over a guidewire within the vessel. These devices are intended to perfuse vessels or organs in conjunction with extracorporeal support, including cardiopulmonary bypass (CPB), Extracorporeal Membrane Oxygenation (ECMO) and Extracorporeal Life Support (ECLS). Catheter models with tip lengths of 18 cm (7.09 in), 50 cm (19.7 in), or 55 cm (21.7 in), with and without additional side holes may be used as either drainage or reinfusion catheters.

These devices are sterile, nonpyrogenic, disposable, intended for single use only. Do not store the product above 25°C (77°F).

Extracorporeal membrane oxygenation (ECMO): Bench studies were performed after device preconditioning including exposure (21 days) to simulated in vivo use conditions to demonstrate safety and reliability.

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The BEAR® (Bridge-Enhanced ACL Restoration) Implant is a bovine extracellular matrix collagen-based implant for treatment of anterior cruciate ligament (ACL) injuries. The BEAR® Implant is indicated for adults, adolescents and children with a complete or partial rupture of the ACL, as confirmed by MRI. Patients must have an ACL stump attached to the tibia to construct the repair. Children with open physes must have sufficient bone in the femoral and tibial epiphyses on either side of the intended tunnel locations to avoid disruption of the growth plates.

The BEAR® Implant (nominal 22 mm in diameter and 44 mm in length) is cylindrical in shape and comprised of collagen and extracellular matrix derived from bovine connective tissue, which has been cleaned, disinfected and processed by a proprietary manufacturing method. The implant has been terminally sterilized by electron-beam irradiation and is intended to be used with up to 10 ml of autologous blood drawn during the surgical implantation procedure. The BEAR® Implant stabilizes the blood in the gap between the torn ligament ends. The BEAR® Implant is resorbed within 8 weeks and replaced with a fibrovascular repair tissue.

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