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Sentinel Camera is a non-mydriatic medical digital camera that is intended to capture digital images of the human eye.

The Sentinel Camera is accompanied by the following accessories: a charging base, eye cup, and power cable. The Sentinel Camera is designed for use in a medical environment. Captured images are used for documentation and consultation. Sentinel Camera has internal memory where captured images are stored. The Sentinel Camera is designed for non-mydriatic retinal imaging. In non-mydriatic imaging no mydriasis is needed because infrared light is used for targeting the retina and white light is flashed when an image is taken. The pupil does not respond to the infrared light, so examination is convenient for the patient. With small pupils, it is recommended to use mydriatic drops. The Sentinel Camera has three internal fixation targets for the patient to fixate on during imaging. The middle fixation target provides a macula-centered image. The left and right fixation targets provide disc-centered images. The transfer of images to the AI Optics Server is carried out via Wi-Fi communication. The Sentinel Camera has a rechargeable Li-ion battery that is charged when the camera is placed on charging base, which is connected to the mains by the power cable.

The provided text describes a 510(k) summary for the "Sentinel Camera," an ophthalmic camera. However, it does not contain information about acceptance criteria or a study that proves the device meets those criteria, particularly in the context of an AI-powered diagnostic or assistive tool. The document focuses on comparing the Sentinel Camera to a predicate device (Optomed Aurora Camera) based on their technical characteristics and safety/performance standards.

The 510(k) summary explicitly states: "Performance data for the Sentinel Camera, including extensive testing against recognized standards, supports the substantial equivalence of the Sentinel Camera to the predicate device. Both devices underwent similar testing to external standards." It concludes that the device "meets the necessary safety and performance criteria, with no new questions of safety or effectiveness."

Crucially, there is no mention of any AI component within the Sentinel Camera's functionality in this document, nor any studies that would involve AI performance metrics (like sensitivity, specificity, or human-AI collaboration studies). The device is described as "a non-mydriatic medical digital camera that is intended to capture digital images of the human eye."

Therefore, based on the provided text, I cannot answer the questions regarding acceptance criteria and studies proving the device meets them in the context of AI performance. The document does not provide such information.

If this device were to incorporate AI functionality, the information requested (acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, etc.) would be crucial for its regulatory submission. However, this particular document does not detail any such AI-related performance studies.

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The system is intended for use in radiation therapy clinics together with diagnostic or treatment equipment and provides: · accurate and reproducible patient positioning. • a respiratory signal to be supplied to diagnostic imaging equipment (primarily CTs) for prospectively (aka 4DCT) gated imaging and reconstruction. The system cannot directly determine the intended treatment target, since only the patient external surface is detected. The actual target position must therefore, whenever deemed necessary by qualified personnel, be verified using other systems such as CBCT or EPID.

The Sentinel hardware consists of a single scanner unit containing the laser and camera, mounted in the ceiling in front of the CT. The scanner is connected to the PC running the c4D software. During patient surface acquisition, a laser line is swept along the patient while the camera records a number of images. From the data acquired, a complete 3D surface of the patient can be reconstructed using laser line triangulation. On this surface the user, a health care professional, virtually marks where on the patient the respiratory motion signal shall be measured and in the next step, when the 4DCT imaging starts, the signal is measured with a frequency of around 16Hz. In general, the system is capable of acquiring more than 50 contours per second. The acquired 3D surface can also be exported and used as a reference image in the treatment room. The Sentinel system for the CT room is used in radiation therapy clinics to perform prospective or retrospective gated imaging (4DCT) prior to treatment. The system provides information about a patient's respiratory motion during the localization of the tumour in CT imaging. The system shall only be used by hospital personnel, qualified to work in radiation therapy or diagnostics departments. The Sentinel platform is based on advanced laser technology with multipurpose software modules covering different tasks in the diagnostic procedure. The software is user friendly and requires a minimum of user interaction in the daily clinical workflow. The software is designed to integrate with existing CT systems at the clinic. The Sentinel system does not require any markers to be placed on the patient or the couch and doesn't subject the patient to any additional radiation. This also means that the personnel can stay in the CT room during the whole set up procedure. Sentinel for the CT room includes the cRespiration module for respiratory gating during diagnostic CT imaging, so called 4D CT studies.

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (a 510(k) summary) does not explicitly list quantitative acceptance criteria in a table format with specific performance metrics for the Sentinel system or its cRespiration module. It makes a general statement about safety and effectiveness.

• Acceptance Criteria (Implied): The device Sentinel, in particular its cRespiration module, should:

  • Provide "accurate and reproducible patient positioning."
  • Deliver "a respiratory signal to be supplied to diagnostic imaging equipment (primarily CTs) for prospectively and retrospectively (aka 4DCT) gated imaging and reconstruction."
  • Be substantially equivalent to its predicate device (Sentinel K120668) in terms of technological characteristics, safety, and efficacy.
  • Not introduce new issues of safety or efficacy due to software update (64-bit architecture) and rephrasing of intended use.

• Reported Device Performance:

  • "The system is capable of acquiring more than 50 contours per second."
  • Respiratory signal measured with a frequency of around 16Hz.
  • Allows for two detection points for thoracic and abdominal breathing motions.
  • Functionality of the software with respect to 64-bit support is unchanged.
  • "Performance data has been submitted to show that Sentinel achieves its intended use and that the software update and rephrasing of intended use raise no new issues of safety or efficacy." (This is a general statement, not specific quantitative performance data in the document itself).

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

The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that "re-verification has been performed to verify that the design outputs meets the design inputs after the change from 32-bit to 64-bit support."

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not provide details on the number of experts, their qualifications, or how they were used to establish ground truth for testing. It states that "the actual target position must therefore, whenever deemed necessary by qualified personnel, be verified using other systems such as CBCT or EPID," implying that qualified personnel are involved in clinical use and verification but not necessarily for structured testing with ground truth establishment.

4. Adjudication Method

The document does not mention any adjudication methods (e.g., 2+1, 3+1) for establishing ground truth in a test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide any information on the effect size of human readers improving with AI vs. without AI assistance. The device in question is a positioning and respiratory gating system, not an AI-based diagnostic tool for interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The document focuses on the system's capabilities (acquiring contours, measuring respiratory signals) and its integration into the clinical workflow, which inherently involves human interaction. It does not present data relevant to a standalone algorithm-only performance study. The system provides signals and positioning information to human professionals and other diagnostic equipment.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for testing. For its intended use of patient positioning and respiratory signal provision, ground truth would likely involve highly accurate measurements from other, established systems (e.g., precise physical measurements, data from other high-accuracy imaging modalities or motion tracking systems) against which the Sentinel system's output is compared.

8. Sample Size for the Training Set

The document does not provide the sample size for the training set. Given that this is a premarket notification for a predicate device with a software update and rephrased intended use, it's possible that extensive de novo training data for a machine learning model, as would be required for a distinctly AI device, was not the primary focus of this submission. The "re-verification" mentioned suggests testing against design inputs rather than extensive new machine learning model training.

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

The document does not provide information on how ground truth was established for any training set.

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The Sentinel Cerebral Protection System is indicated for use as an embolic protection device to capture and remove thrombus/debris while performing transcatheter aortic valve replacement procedures. The diameters of the arteries at the site of filter placement should be between 9 - 15 mm for the brachiocephalic and 6.5 - 10 mm in the left common carotid.

The Sentinel™ Cerebral Protection System (Sentinel CPS) is a 6 French, 95 cm working length, single use, temporary, percutaneously delivered embolic protection device, inserted into the radial or brachial artery. The system is designed to capture and remove debris dislodged during transcatheter aortic valve replacement (TAVR) procedures. The Sentinel CPS utilizes an embolic filter delivered to the brachiocephalic artery (Proximal Filter) and a second embolic filter delivered to the left common carotid artery (Distal Filter). At the completion of the procedure, the filters and debris are recaptured into the catheter and removed from the patient. The device is provided sterile and is single-use only.

The Sentinel CPS is available with a Proximal Filter size of 15 mm (target vessel size of 9 - 15 mm) and a Distal Filter size of 10 mm (target vessel size of 6.5 - 10 mm).

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not specify the exact sample sizes used for the non-clinical performance and biocompatibility tests. It broadly mentions "testing" and "verification and validation activities."

• Data Provenance: The studies are non-clinical (laboratory/in-vitro/animal) and therefore do not involve patient data or geographical provenance in the typical sense of clinical trials. The testing was conducted to assess modifications to a previously cleared device.

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

This information is not applicable to the type of study described. The study is a non-clinical assessment of material and functional changes to a medical device. Ground truth, in the context of expert consensus, pathology, or outcomes data, typically refers to clinical trials or diagnostic accuracy studies involving human interpretation or clinical outcomes. Here, the "ground truth" is defined by the technical specifications and performance requirements of the device, assessed through direct measurement and laboratory tests.

4. Adjudication Method for the Test Set

This is not applicable as there are no human interpretations or clinical decisions being made that would require adjudication. The evaluation is based on objective measurements and established test methodologies.

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

No, an MRMC comparative effectiveness study was not done. This study focuses on the technical performance and biocompatibility of a modified device, not on assessing human reader performance with or without AI assistance.

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

No, a standalone algorithm-only performance study was not done. The device (Sentinel Cerebral Protection System) is a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this study is based on pre-established acceptance criteria derived from engineering specifications, regulatory guidelines (e.g., FDA Guidance, ISO 10993-1), and the performance of the predicate device. These criteria define what constitutes acceptable performance for each test (e.g., specific force ranges, pore sizes, biological response limits).

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here. This is a non-clinical verification and validation study for a physical medical device, not a machine learning model.

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

As the concept of a training set is not applicable, this question is not relevant.

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The Sentinel® Cerebral Protection System is indicated for use as an embolic protection device to capture and remove thrombus/debris while performing transcatheter aortic valve replacement procedures. The diameters of the arteries at the site of filter placement should be between 9 - 15 mm for the brachiocephalic and 6.5 - 10 mm in the left common carotid.

The Sentinel® Cerebral Protection System (Figure 1) is a 6 French, 95 cm working length, single use, temporary, percutaneously-delivered embolic protection catheter inserted into the right radial or brachial artery. The system is designed to capture and remove embolic material (thrombus/debris) during transcatheter aortic valve replacement (TAVR) procedures. The Sentinel System employs two embolic filters, one delivered to the brachiocephalic artery (Proximal Filter), and one to the left common carotid artery (Distal Filter). The nominal filter diameters are 15 mm (Proximal Filter) and 10 mm (Distal Filter).

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

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Study Details

The primary study referenced for demonstrating acceptance criteria is "Cerebral Protection in Transcatheter Aortic Valve Replacement – The SENTINEL Study."

2. Sample Size and Data Provenance

• Test Set (Clinical Study):
  • Randomized Cohort: 363 patients (123 in Safety Arm, 121 in Test Arm, 119 in Control Arm).
  • Roll-in Patients: 65 additional non-randomized patients.
  • Data Provenance: Prospective, multi-center, randomized study conducted at 19 centers in the United States and Germany.

3. Number and Qualifications of Experts for Ground Truth (Test Set)

• Clinical Events Committee (CEC): Remained blinded throughout the trial and adjudicated all Major Adverse Cardiac and Cerebrovascular Events (MACCE) endpoints. The qualifications of these experts are not explicitly detailed beyond being a "Clinical Events Committee."
• Independent Blinded MRI Core Lab: Analyzed all MRI endpoint data. Qualifications are not explicitly detailed.
• Independent Blinded Neurocognitive Core Lab: Analyzed all neurocognitive endpoint data. Qualifications are not explicitly detailed.

4. Adjudication Method (Test Set)

• Clinical Events Committee (CEC): The text states that the CEC "adjudicated all Major Adverse Cardiac and Cerebrovascular Events (MACCE) endpoints." This implies an expert review and final decision on these events. The specific method (e.g., 2+1, 3+1) is not explicitly stated, but it was a blinded process.

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

• No, an MRMC comparative effectiveness study was not done in the context of comparing human readers with and without AI assistance. The SENTINEL study was a clinical trial comparing a device intervention (Sentinel System) to standard of care (TAVR only), not an AI efficacy study.
• Therefore, no effect size for human readers improving with vs. without AI assistance is reported.

6. Standalone (Algorithm Only) Performance

• The Sentinel® Cerebral Protection System does not contain software and is a physical medical device. Therefore, a standalone (algorithm only) performance study was not applicable and not performed.

7. Type of Ground Truth Used (Clinical Study)

• Clinical Endpoints: MACCE (death, stroke, Class 3 AKI) were adjudicated by a blinded Clinical Events Committee. This represents expert consensus based on clinical data.
• Imaging Endpoints: DW-MRI lesion volumes were analyzed by an independent blinded MRI core lab. This also relies on expert interpretation of imaging data.
• Neurocognitive Endpoints: Neurocognitive evaluations were analyzed by an independent blinded neurocognitive core lab. This relies on expert assessment of neurocognitive test battery results.
• Captured Debris Histopathology: For the Test Arm, captured debris underwent histopathology. This is pathology ground truth for the presence and nature of embolic material.

8. Sample Size for the Training Set

• The Sentinel system is a physical device and does not involve a "training set" in the context of machine learning. The "training" for the device would be the rigorous bench, animal, and early human use (roll-in patients) studies.
• The roll-in patients (65 subjects) could be considered a form of early clinical "training" or experience-building for the sites and procedures, but they were explicitly non-randomized and separate from the primary effectiveness analysis.

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

• As the device does not employ machine learning, there is no "training set" ground truth in that sense.
• For the non-clinical and animal studies which demonstrate the device's fundamental performance (analogous to foundational data for a conventional device), the "ground truth" was established through:
  • Bench Testing: Engineering specifications and direct measurements against those specifications.
  • Animal Studies: Direct observation of device performance in in vivo conditions, gross pathology, and histopathology. These informed design improvements and verified safety and fundamental function before the pivotal human clinical trial.

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The Sentinel BreastScan II System is intended for viewing and recording heat patterns generated by the human body in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities or in an environment where patient care is provided by qualified healthcare personnel. The patient populations include adult. The device is for adjunctive diagnostic screening for detection of breast cancer and diseases affecting blood perfusion or reperfusion of tissue or organs. This device is intended for use by qualified healthcare personnel trained in its use.

The Sentinel BreastScan II System consists of a portable device that captures and records thermal infrared energy (heat) emitting from a person's body. There is no compression of the breast or patient contact with the device and the test emits no radiation to the patient. The device consists of a thermal camera, a metal enclosure to secure and protect components, a motor and electronics to raise and lower the tester to adjust the camera for various sized patients, a chair with attached armrests, adjustable special heat reflecting mirrors, a computer with a touchscreen monitor, data storage, software, and Wi-Fi communication. The tester includes an air cooling unit that blows cool air during part of the test cycle.

The provided text describes the Sentinel BreastScan II System, which is a telethermographic system for adjunctive diagnostic screening for breast cancer. However, the document primarily focuses on demonstrating substantial equivalence to a predicate device (Infrared Sciences Corp., BreastScan IR) based on technological characteristics and adherence to safety standards.

Crucially, the provided text DOES NOT contain information regarding a study that proves the device meets specific performance-based acceptance criteria for its diagnostic claims (e.g., sensitivity, specificity, accuracy for breast cancer detection).

The "Performance Data" section only mentions compliance with electrical safety standards (ANSI/AAMI ES60601-1, IEC 60601-1-2) and claims that the device "meets all Sentinel BreastScan II requirements and specifications as provided in the verification and validation testing results reports." It does not provide any specific quantitative performance metrics related to diagnostic accuracy, nor does it detail any clinical studies (such as MRMC or standalone performance studies) that would typically be used to demonstrate such performance.

Therefore, I cannot fulfill the request to provide:

• A table of acceptance criteria and reported device performance specific to diagnostic accuracy, as this data is not present.
• Sample size and data provenance for a diagnostic test set.
• Number of experts and their qualifications for establishing ground truth, adjudication methods, MRMC study details, or standalone performance study details, as these studies are not described.
• Type of ground truth used for diagnostic claims.
• Sample size for the training set or how ground truth was established for it.

The document indicates that the device's 510(k) clearance was based on demonstrating "substantial equivalence" to a predicate device, which often relies on demonstrating similar technological characteristics and adherence to general safety standards rather than new clinical performance studies for diagnostic accuracy, especially for Class I or II devices where a predicate exists with established performance.

In summary, the provided document does not contain the information requested about a study proving the device meets performance-based acceptance criteria for its diagnostic function.

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Sentinella 102 (models Sentinella 102 and Sentinella 102 Horus) is a mobile gamma camera system which is intended for imaging the distribution of radionuclides in the human body by means of photon detection. The images are intended to be interpreted by qualified personnel.

Sentinella 102 (models Sentinella 102 and Sentinella 102 Horus) may be used intraoperatively if a protective sheath is used.

Sentinella 102 (models Sentinella 102 and Sentinella 102 Horus) may be used at the patient's bedside, or in Emergency Room or Intensive Care Unit.

Sentinella 102 is a currently marketed portable gamma camera system which includes a small gamma camera designed to obtain images from small organs and structures labeled using radionuclides emitting gamma-rays.

The Sentinella system also includes analysis and display equipment, a cart and ergonomic arm, which facilitates the equipment portability and positioning, and accessories.

Due to the difficulty which may involve indentifying the physical location in the body of the patient of the structures observed in the gammagraphy, the model Sentinella 102 Horus incorporates an optical camera that registers the same area that it is being observed by the gamma camera. Both images are coregistered and shown in real time. During this process, the gammagraphy is not reprocessed or modified in any way, so remains unaltered at the end of the process.

This FDA 510(k) summary (K162052) primarily addresses a modification to an existing device, the Sentinella 102 (models Sentinella 102 and Sentinella 102 Horus), specifically the introduction of a new collimator model. The document explicitly states that no new clinical testing has been carried out because there are no new indications for use. Therefore, a comprehensive study proving acceptance criteria for a new device or algorithm is not present in this document.

Instead, the document asserts substantial equivalence based on the fact that the new collimator does not change the indications for use, biocompatibility, electrical safety, electromagnetic compatibility, software, or overall performance specifications compared to the previously cleared predicate device (K143156).

Here's an attempt to answer the questions based on the provided text, acknowledging that a full "study" as requested isn't detailed for this specific submission:

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

The document does not provide a table with specific acceptance criteria and reported device performance for this submission. It states that the device has the same performance specifications as the previous models already certified by the FDA (predicates). It mentions that "no new NEMA performance tests were necessary for the present submission" and that "The previous NEMA test report was carried out using the NEMA NU-1:2007."

To create such a table, one would need to refer to the K143156 submission for the specific performance criteria and results based on NEMA NU-1:2007. Without that previous document, the exact metrics are unavailable here.

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

Not applicable. No new clinical or performance test set was used for this 510(k) submission, as it relies on the performance of the predicate device (K143156).

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. No new test set requiring expert ground truth establishment was used for this submission. The interpretation of images is generally intended to be by "qualified personnel" as stated in the Indications for Use, but this refers to clinical use, not a specific study methodology outlined here.

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

Not applicable. No new test set requiring adjudication was used for this submission.

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 gamma camera system, not an AI-powered diagnostic or assistive tool. No MRMC study or AI-related effectiveness study was performed or mentioned in this document.

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

Not applicable. This device is a gamma camera system and not an algorithm. Therefore, "standalone" algorithm performance is not relevant to this submission.

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

Not applicable for this specific 510(k) due to the nature of the submission (modification of an existing device without new clinical testing). For the original predicate device (K143156), performance testing would likely have involved phantom studies and possibly clinical validation leading to NEMA NU-1:2007 compliance, which uses established physical and technical metrics rather than clinical "ground truth" like pathology for image interpretation.

8. The sample size for the training set

Not applicable. As a physical medical imaging device, it does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. As a physical medical imaging device, it does not involve a "training set" in the context of machine learning or AI.

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The Sentinel Cardiology Information Management System is intended to connect to supported medical devices and analyzers in order to download, store, access and manage cardiovascular information and facility information.

The Sentinel Cardiology Information Management System provides download and storage of data from supported Holter recorders and feeds this data to separate and optional Holter analyzers. The completed reports are stored back in Sentinel.

The Sentinel Cardiology Information Management System facilitates presenting, analyzing, reviewing cardiovascular information, including automatic interpretation of 12 lead ECG and stores the finished reports. The automatic interpretation of 12-lead ECG is not suitable for neonates.

Sentinel supports importing reports from external systems and provides an HL7 interface to external systems. The Sentinel Cardiology Information Management System is intended to be used by a trained user and as an aid to a medical professional in hospital or primary care environment.

The Sentinel Cardiology Information Management System is not intended for patient monitoring.

The Spacelabs Healthcare Ltd. (Spacelabs) Sentinel Cardiology Information Management System (Spacelabs) is a stand-alone software product which can capture, store, access and manage electrocardiograph (ECG), ambulatory blood pressure (ABP), stress test, ergospirometry, spirometry, event and plethysmography data with Holter analyses and reports, together with the corresponding patient information. Sentinel can be used as a single stand-alone installation, or as part of a multi-user network. Sentinel may be used for recording and reviewing of ECG of adults and pediatrics in a clinical environment inside and outside of hospitals.

The provided document does not contain detailed acceptance criteria or a study proving the device meets specific performance criteria in the format requested. The document focuses on regulatory submission (510(k)) for the Spacelabs Sentinel Cardiology Information Management System, asserting substantial equivalence to predicate devices, and referencing general quality and safety standards for software and medical electrical equipment.

It states:

• "Test results indicated that Spacelabs Sentinel complies with predetermined specifications and the applicable standard." (Page 6)
• "Verification results indicated that Spacelabs Sentinel complies with the applicable requirements of the standard." (Page 6)
• "Test results indicated that Spacelabs Sentinel complies with predetermined specifications and the applicable standards." (Page 7)
• "The results of these activities demonstrate that Spacelabs Sentinel is as safe, as effective, and performs as well as or better than the predicate device." (Page 7)

However, it does not explicitly list what those "predetermined specifications" or "applicable standards" are in terms of performance metrics (e.g., sensitivity, specificity, accuracy for interpretations), nor does it describe specific studies with sample sizes, ground truth establishment, or expert involvement for these performance metrics.

The "Summary of Performance Testing" section primarily lists compliance with general software development standards (FDA guidance documents, IEC 62304) and electrical safety/usability standards (IEC 60601-1, IEC 60601-1-6, IEC 60601-2-25, IEC 80601-2-30, IEC 62366). While these are important for device safety and functionality, they are not performance criteria related to the diagnostic accuracy of features like "automatic interpretation of 12-lead ECG."

Therefore, based only on the provided text, I cannot complete the table or answer all the requested questions. The document mentions "automatic interpretation of 12-lead ECG" as a feature but does not provide the performance data or details of a study to validate this interpretation.

If more detailed performance study information were available in an accompanying document, it would be needed to answer your request fully.

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Sentinella 102 (Models Sentinella 102 Horus) is a mobile gamma camera system which is intended for imaging the distribution of radionuclides in the human body by means of photon detection. The images are intended to be interpreted by qualified personnel.

Sentinella 102 (Models Sentinella 102 Horus) may be used intraoperatively, if a protective sterile sheath is used.

Sentinella 102 (Models Sentinella 102 Horus) may be used at the patient's bedside, or in Emergency Room or Intensive Care Unit.

Sentinella 102 (Models Sentinella 102 Horus) is a mobile gamma camera system which is intended for imaging the distribution of radionuclides in the human body by means of photon detection.

The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device, the "Sentinella 102 and 102 Horus" gamma camera system. This document grants market clearance based on substantial equivalence to a predicate device.

Crucially, this document does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the context of clinical performance metrics like sensitivity, specificity, accuracy, or reader improvement with AI.

The letter confirms the device's regulatory classification, its intended use (imaging the distribution of radionuclides in the human body), and outlines the general controls and regulations it must comply with. It does not include the results of performance studies that would typically define acceptance criteria for diagnostic efficacy.

Therefore, I cannot provide the requested information about acceptance criteria or a study proving the device meets them from this document. The document primarily addresses regulatory clearance, not clinical performance metrics or studies using AI.

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The system is intended for use in radiation therapy clinics together with diagnostic or treatment equipment and provides:

• accurate and reproducible patient positioning. .
• patient motion supervision with an audible and/or visual alarm whenever . the patient motion during treatment is outside of the specified tolerance values, while still allowing for normal breathing motion without triggering the alarm.
• a respiratory signal to be supplied to diagnostic imaging equipment . (primarily CTs) for prospectively and retrospectively (aka 4DCT) gated imaging and reconstruction.

The system cannot directly determine the location of the intended treatment target, since only the patient external surface is detected. The actual target position must therefore, whenever deemed necessary by qualified personnel, be verified using other systems such as CBCT or EPID.

The Sentinel system is intended for use in radiation therapy clinics to accurately position patients in a reproducible way, prior to treatment and to monitor the patient continuously during treatment. The system provides information about a patient's position and the adjustments required in order to position the patient as close as possible to a reference setup. During monitoring, the system reports deviations in the patient's position during treatment.

The system shall only be used by hospital personnel, qualified to work in radiation therapy or diagnostics departments.

The Sentinel platform is based on advanced laser technology with multipurpose software modules covering different tasks in the treatment procedure. The c4D multi-application software supports all modes of operation in one integrated package. The software is user friendly and requires a minimum of user interaction in the daily clinical workflow, while providing the advanced user with sophisticated data management, analysis and reporting functionalities. The software is designed to integrate with existing systems at the clinic, such as CT, linacs and R&V systems, and with motorized couch tops.

The Sentinel system does not require any markers to be placed on the patient or the couch, and doesn't subject the patient to any additional radiation. This also means that the personnel can stay in the treatment room during the whole set up procedure.

Sentinel includes three application modules, cPosition for fast and accuracy patient positioning, cMotion for motion detection during the treatment delivery procedure and cRespiration for respiratory gating diagnostic CT imaging, so called 4D CT studies. Patient positioning before the actual treatment begins, together with subsequent motion detection, ensures that the patient's position is correct both before and during the whole treatment delivery.

The Sentinel hardware consists of a single scanner unit containing the laser and camera, mounted in the ceiling in front of the gantry. The scanner is connected to the PC running the c4D software.

During patient surface acquisition, a laser line is swept along the patient while the camera records a number of images. From the data acquired, a complete 3D surface of the patient can be reconstructed using laser line triangulation. For patient positioning, the acquired surface is captured in a few seconds and can contain several hundred contours. For motion detection the number of contours are typically lowered so that the desired frame rate is achieved. The system is capable of acquiring more than 50 contours per second.

The provided text does not contain detailed information about the acceptance criteria and a specific study that definitively proves the device meets those criteria in the format requested.

The document is a 510(k) Summary for the Sentinel device, primarily focused on demonstrating substantial equivalence to a predicate device. It briefly mentions "Verification and validation has been carried out according to the C-RAD quality management system" and refers to a "V&V report," but the details of this report, including specific acceptance criteria and study results, are not provided in this summary.

It does state: "For the functionality of sending data to the CT for gated imaging and/or reconstruction, non-clinical (phantom) tests have been performed in collaboration with three hospitals in Europe: Uppsala (Sweden), Malmö (Sweden), and Lisbon (Portugal)." However, the details of these phantom tests (e.g., specific metrics, acceptance thresholds, sample sizes, a table comparing expected vs. observed performance) are not included.

Therefore, I cannot directly extract the full requested information from the provided text.

Here's a breakdown of what can be inferred or what is missing based on the prompt's requirements:

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

• Acceptance Criteria: Not explicitly stated in a quantifiable, tabular format. The general intent is that the device provides "accurate and reproducible patient positioning" and "patient motion supervision with an audible and/or visual alarm whenever the patient motion during treatment is outside of the specified tolerance values, while still allowing for normal breathing motion without triggering the alarm" and provides "a respiratory signal to be supplied to diagnostic imaging equipment (primarily CTs) for prospectively and retrospectively (aka 4DCT) gated imaging and reconstruction." Specific numerical thresholds for accuracy, reproducibility, or alarm triggers are not provided.
• Reported Device Performance: Not presented in a quantifiable, tabular format. The document states that "non-clinical (phantom) tests have been performed" and concludes that "the non clinical tests demonstrates that the device is safe, as effective, and performs as well as the legally marketed device Sentinel (K082582)." No specific performance metrics or results from these tests are given.

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

• Sample Size (Test Set): Not specified. The "non-clinical (phantom) tests" were performed, implying inanimate objects were used, not human patients. The number of phantom tests or data points is not mentioned.
• Data Provenance: "non-clinical (phantom) tests have been performed in collaboration with three hospitals in Europe: Uppsala (Sweden), Malmö (Sweden), and Lisbon (Portugal)." This indicates a prospective testing approach on phantoms.

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 as the tests were "non-clinical (phantom) tests." Ground truth for phantom tests would typically involve precisely known physical properties or measurements rather than expert human interpretation of medical images.

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

• Not applicable/Not mentioned. Given it was non-clinical phantom testing, adjudication methods for human interpretation of medical data are not relevant.

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 MRMC comparative effectiveness study was done. This device is a positioning and monitoring system, not an AI-assisted diagnostic tool that requires human reader improvement studies. The document focuses on the device's ability to position and monitor, not interpret.

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

• The non-clinical phantom tests likely represent a standalone performance evaluation of the system's accuracy and functionality in controlling and monitoring without direct human intervention in the positioning process itself (though humans would set up the tests). The document doesn't explicitly describe these tests as "standalone" in the context of an AI-only performance evaluation, but rather as demonstrating the device's technical capabilities.

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

• For the non-clinical phantom tests, the ground truth would inherently be based on the known, precisely engineered properties of the phantoms and/or reference measurements established through highly accurate measurement tools. It's not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

• Not applicable/Not mentioned. The document describes the system as "based on advanced laser technology with multipurpose software modules." It does not indicate the use of a machine learning model that would require a "training set" in the conventional sense. The software functions based on "advanced surface registration algorithms" and laser line triangulation.

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

• Not applicable, as no training set for a machine learning model is indicated.

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The Sentinelle Breast MRI tabletop with 16 Channel Coil Array for Siemens 1.5T/3T MRI Systems is designed to provide magnetic resonance images of breast anatomy when used in conjunction with a Magnetic Resonance Scanner. These images are interpreted by a trained physician. When used with a disposable sterile plate (biopsy grid), the device permits access to breast anatomy for biopsy and localization procedures.

The Sentinelle Breast MRI Tabletop with 16 Channel Coil Array for Siemens 1.5/3T MRI Systems is a receive-only MRI imaging coil and interventional system for breast anatomy. The system consists of a tabletop which supports the patient and imaging coils which provide a means of enabling interventional device guidance. The tabletop, like other breast coils provides an aperture to admit the breasts and provides the physician access to the breast(s). This aperture enables the guidance of interventional devices (such as biopsy needles), when performing a biopsy. The tabletop's compression system facilitates immobilization of the breast for imaging and interventional procedures and serves to hold the individual imaging coils in proximity to the breast(s). Compression plates (also referred to as immobilization plates) provided with the system are held in frames, which may be positioned in the left-right and anteriorposterior directions and fixed in place to gently immobilize one or both breasts for interventional procedures. When performing a stereotactic interventional procedure (such as biopsy or wire localization), one or more compression plates may be interchanged for a sterile, single use, disposable fenestrated plate (also referred to as biopsy grid) cleared under FDA 510(k) Number: K060873. The biopsy grid contains apertures that permit the physician to access the breast for intervention, while minimizing tissue motion. When performing biopsy and/or imaging of a single breast, the system may be used with two compression plates immobilizing that breast. The contralateral breast support prevents the contralateral breast from interfering with medial-approach interventions. When imaging both breasts, a medial coil element is used between the breasts in conjunction with two lateral coils. The tabletop's receive-only coil system acts to passively collect RF emissions from the nuclei excited by the MRI. The Sentinelle phased array breast coil set consists of 2, 10 or 16 RF coil elements in a phased array design. The coil elements and electronics are enclosed in a rigid housing that is resistant to fluid ingress and is fire retardant. The coils are positioned close to the patient's breast during imaging. This receive-only coil is designed to give an improved signal-to-noise ratio, image resolution and image acquisition over that of a standard body coil.

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

Device: Sentinelle Breast MRI Tabletop with 16 Channel Coil Array for Siemens 1.5/3T MRI Systems

1. Table of Acceptance Criteria and Reported Device Performance

The provided document defines acceptance criteria primarily through a comparison to a predicate device and extensive verification and validation testing, ensuring safety and performance are substantially equivalent. The acceptance criteria are implicit in the comparison to the predicate and the successful completion of a comprehensive set of tests. The reported device performance is indicated by the successful completion of these tests and a finding of substantial equivalence.

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

The document does not explicitly state a numeric "sample size" in terms of patient cases for clinical studies for the "test set" in the traditional sense of AI/clinical trial studies. Instead, the testing involved:

• Phantoms: Used for various technical and performance evaluations (e.g., SNR, gMap, detuning, field distortions, noise).
• Volunteers: Used for "Volunteer Imaging" tests (VAR-02350 for 1.5T, VAR-02363 for 3T).

Data Provenance:

• The tests were conducted in-house by trained testing personnel.
• The use of contrast agent was not used in obtaining the images.
• The tests were performed on the proposed device.
• The nature of the testing (phantom and volunteer imaging for technical parameters) suggests this is prospective data collection specifically for device verification.
• Country of origin is not explicitly stated for individual tests but the manufacturer is based in Canada.

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

The document does not mention the use of experts to establish "ground truth" for the test set in the context of diagnostic accuracy, as this is a device for image acquisition, not for diagnostic interpretation. The "ground truth" here is implied by objective physical measurements (e.g., signal-to-noise ratios, field distortions) and the observed performance of the device against engineering specifications and NEMA standards.

The phrase "These images are interpreted by a trained physician" in the Indications for Use refers to the subsequent clinical use of the images, not the validation of the device itself.

4. Adjudication Method for the Test Set

Given that the testing focuses on technical performance parameters of an MRI coil rather than diagnostic interpretation, an adjudication method for a diagnostic test set is not applicable and therefore not mentioned. The tests are objective measurements (e.g., SNR values, signal measurements, scout image quality).

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 done. This type of study focuses on the diagnostic performance of human readers and is not relevant for the type of device (an MRI coil) described in this submission, which is about image acquisition and quality, not interpretation assistance.

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

The entire set of tests performed (Tables 4 and 5) can be considered a standalone study of the device's technical performance. These tests evaluate the coil directly, independent of a human interpreter's diagnostic ability. For example, "SNR Evaluation," "gMap," "Heating and Performance Output," "Passive Detuning Test," "Field Distortions Test," "RF Noise Test," etc., are all standalone performance metrics of the hardware.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's validation is based on:

• Engineering Specifications/Standards: Performance measured against NEMA standards and internal functional requirements.
• Physical Measurements: Quantifiable data from phantoms (e.g., SNR ratios, field distortion measurements).
• Visual Assessment: For aspects like "Body Scout" images and "Volunteer Imaging," the "ground truth" is the expected image quality and appearance generated by a properly functioning MRI coil.

No pathology or outcomes data is used as the device is for imaging and intervention guidance, not for diagnosis itself.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of an AI algorithm because the device is a hardware component (an MRI coil) and not an AI-powered diagnostic algorithm.

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

As there is no AI algorithm or training set discussed in the document, this question is not applicable.

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