Search Results

The Chlorine Sentinel II is intended for use by hemodialysis professionals as a secondary chlorine device to provide continuous monitoring of Combined Chlorine. It is not intended to replace the primary method of monitoring chlorine as part of the hemodialysis water treatment system. It functions completely independent of the water treatment system does not come into direct contact with feed water used to prepare dialysate.

Chlorine Sentinel II is a complete system that attaches to the drain of a hemodialysis water treatment system sample port. It detects dissolved combined chlorine in concentrations at or above 10 PPB by primary detection technology. It self-monitors for maintenance-required conditions and loss of electrical power.

The Chlorine Sentinel II is self-testing. It uses chlorinated city water to automatically test the chlorine detecting functionality of the device once a day and records if the test passed, failed to detect chlorine, or didn't rinse out after detecting chlorine.

The device is designed to use as little water as possible. The sampling water is only used for the length of time that it takes for the chlorine test to be completed. The customer determines how frequently the test needs to be taken from every 5 minutes to every 20 minutes. The user also sets the start time and end time for each day of the week.

The Chlorine Sentinel II has two combined chlorine concentration set points. The user can set a warning set-point at a value of 0.01 PPM to 0.09 PPM. Once the chlorine concentration exceeds this value, the device will alarm at 2-HZ to warn the user of chlorine present at that set-point. The second set-point is factory set at 0.10 PPM.

A chlorine concentration equal to or above the 0.10 PPM set-point will activate the buzzers and the red chlorine alarm indicators at 5 HZ for as long as the condition exists. The buzzers can only be muted for 3 minutes (then automatically reset) for as long as the condition exists. The alarms can be by-passed. When by-passed the pulsing lights will turn solid and the buzzer will double click over 15 minutes.

The front cover of the device has two screens. The screen of the chlorine monitor indicates the presence of combined chlorine when the value is not 0.000. The touch screen is used to enter user data and show the statuses of the device.

This FDA 510(k) clearance letter for the Chlorine Sentinel II provides limited specific details on acceptance criteria and study methodologies, particularly concerning clinical performance. The focus is on demonstrating substantial equivalence to a predicate device through technological comparison and bench testing.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for clinical performance that can be directly compared to reported device performance metrics like sensitivity, specificity, or accuracy. Instead, the substantial equivalence is drawn based on similar intended use, technological characteristics, and performance verified through bench testing.

Based on the "Detailed Comparison of the Subject and Predicate Devices" (Page 8-10) and "Testing" (Page 14), here's a synthesis of what can be inferred about performance:

Note: The document primarily focuses on technological equivalence and adherence to safety/testing standards rather than presenting quantitative performance metrics against specific clinical acceptance criteria for sensitivity, specificity, or accuracy in a diagnostic context. This device is a water purification system component, not a diagnostic tool.

2. Sample Size for Test Set and Data Provenance

The document describes "Performance – Bench" testing but does not specify a "test set" in the context of clinical data, nor does it provide a sample size in terms of number of cases or data provenance (country, retrospective/prospective). The studies are bench-level evaluations of the device's technical specifications and linearity.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth for a test set. The validation appears to be against established analytical standards (CLSI EP06-A, EP17-A2) for linearity and detection limits, and engineering standards for safety and electromagnetic compatibility.

4. Adjudication Method

As there is no mention of human expert review or a "test set" in a clinical sense, there is no adjudication method described.

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

No MRMC study was done, as this device is a water purification system component and not a diagnostic device involving human interpretation of medical images or data. Therefore, there is no effect size reported for human readers improving with AI assistance.

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

The device operates standalone in its function of monitoring chlorine. The "Performance – Bench" testing described would fall under a standalone performance evaluation, but not in the sense of a medical AI algorithm. It's a measurement device whose performance is assessed against technical specifications and analytical standards.

7. Type of Ground Truth Used

The ground truth used for performance validation appears to be:

• Analytical Standards: CLSI standard EP06-A for linearity and CLSI standard EP17-A2 for limit of blank, limit of quantitation, and limit of detection.
• Functional Specifications: The device's ability to detect chlorine at specified concentrations (e.g., 0.10 PPM alarm, 0.01 PPM warning) and perform self-tests.
• Engineering Standards: IEC 61010-1 for electrical safety and IEC 60601-1-2:2020 for electromagnetic compatibility.

This is not "expert consensus, pathology, or outcomes data" as typically seen in diagnostic device clearances.

8. Sample Size for the Training Set

The document does not mention a "training set" as it would be understood for machine learning or AI algorithms. The device's operation is based on a polarographic sensor and PLC control, not a learned model from a dataset.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set in the context of machine learning or AI for this device.

Ask a specific question about this device

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.

Ask a specific question about this device

The dS Sentinelle Breast 16ch 3T Coil are intended to be used in conjunction with Philips 3.0T Magnetic Resonance Scanners to produce diagnostic images of the breast anatomy that can be interpreted by a trained physician. When used with a disposable biopsy grid, the device permits access to breast anatomy for biopsy and localization procedures.

The dS Sentinelle Breast 16 Ch 3.0T MR Coils is a receive only coil to be used on a 70cm bore Philips Ingenia 3.0T MR System. The coil arrays are designed to correspond with the scanner strength.

The dS Sentinelle Breast 16Ch 3T coil is a phased array design consisting of patient support with three different coil configurations (2, 10 or 16 channels):

1. 16Ch for diagnostic imaging: performed in 16Ch configuration that consists of two dS Sentinelle Lateral 4Ch coils and the dS Sentinelle Medial 8Ch coil.

2. 10Ch for bilateral interventional procedures requiring lateral access: performed in 10Ch configuration that consists of the dS Sentinelle Medical 8Ch coil and two dS Sentinelle Lateral 1Ch coils (right and left).

3. 2Ch for unilateral interventional procedures allowing both lateral and medial access: performed in 2Ch configuration that consists of two dS Sentinelle Lateral 1Ch coils (right and left).

The coils receive magnetic resonance signals generated in hydrogen nuclei (protons) in the Breast while blocking the high-frequency magnetic field applied by the MRI scanner at specified timings.

The coil arrays include 4Ch right and left lateral coils, a medial coil and 1Ch right and left lateral biopsy coils.

Images are typically generated as axial, sagittal, coronal and oblique slices and include full coverage of the breast anatomy.

The dS Sentinelle Breast 16Ch 3T Coil is tuned to receive RF frequency corresponding to the proton precession in a 3.0 tesla magnetic field (respectively), which is governed by the Larmor equation.

The Variable Coil Geometry design of the dS Sentinelle Breast 16Ch 3T Coil allows each imaging element to be independently positioned and configured for each patient. Patients can then be positioned quickly and effectively as the imaging elements can be positioned as close to the breast as possible optimizing the signal-to-noise ratio for each individual patient. For clinical imaging, coil housings are placed next to the tissue to help minimize motion artifacts due to patient motion during scanning.

The subject dS Sentinelle Breast Coil system also includes a tabletop compression system which facilitates immobilization of the breast for imaging and interventional procedures and serves to hold the individual imaging coils in proximity to the breast(s). The intent of this is to reduce motion artifacts and ensure the imaging elements are positioned as close to the breast(s) as possible to optimize signal-to-noise ratio and image quality.

Based on the provided text, the device in question is the dS Sentinelle Breast 16ch 3.0T Coil, which is a receive-only MR coil. The acceptance criteria and the study proving the device meets them are described in the "Summary of Non-Clinical and Clinical Performance Data" section.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

The document references "FDA guidance Magnetic Resonance (MR) Receive-only Coil – Performance Criteria for Safety and Performance Based Pathway, issued December 11, 2020" for the acceptance criteria. While the specific numerical thresholds for these criteria are not explicitly detailed in the provided text, the document states that these requirements were met. It lists the types of performance tests conducted.

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

• Test Set Sample Size: The document does not specify a numerical sample size for the clinical performance testing.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions that images were "Acquired." Given the context of FDA clearance for a medical device, it's generally expected to be prospective data collected for regulatory submission, but this is not explicitly stated.

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

• Number of Experts: The document states "a U.S. Board Certified radiologist." This implies only one expert was used for the clinical image quality assessment.
• Qualifications of Experts: The expert was a "U.S. Board Certified radiologist." No information about their years of experience is provided.

4. Adjudication Method for the Test Set

• Adjudication Method: There was no explicit adjudication method described. With only one radiologist assessing image quality, there's no need for an adjudication process.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not reported or conducted. The clinical performance testing focused on assessing image quality by a single radiologist, not on comparing reader performance with or without AI assistance. The device is an MRI coil, not an AI software.

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

• This question is not applicable to the device described. The dS Sentinelle Breast 16ch 3.0T Coil is a hardware device (an MR coil), not an AI algorithm. Therefore, "standalone" algorithm performance is not a relevant concept for this product. The testing focused on the image quality produced by the coil.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the clinical performance assessment was the subjective interpretation of "sufficient quality for diagnostic use" by a U.S. Board Certified radiologist. This is expert consensus (albeit from a single expert). It is not based on pathology, outcomes data, or a complex consensus process.

8. The Sample Size for the Training Set

• This question is not applicable to the device described. The dS Sentinelle Breast 16ch 3.0T Coil is a hardware device (an MR coil). Hardware devices typically do not have "training sets" in the context of machine learning or AI models. Their performance is validated through engineering tests and clinical image quality assessment.

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

• This question is not applicable for the same reason as point 8.

Ask a specific question about this device

The dS Sentinelle Breast 16ch 1.5T Coil is intended to be used in conjunction with Philips 1.5T Magnetic Resonance Scanners to produce diagnostic images of the breast anatomy that can be interpreted by a trained physician. When used with a disposable biopsy grid, the device permits access to breast anatomy for biopsy and localization procedures.

The dS Sentinelle Breast 16ch 1.5T Coil is a receive only coil to be used on a 70cm bore Philips Ingenia 1.5T MR System. The coil arrays are designed in a magnetic strength (1.5T) to correspond with the scanner strength. The dS Sentinelle Breast 16ch 1.5T Coil is a phased array design consisting of patient support with three different coil configurations (2, 10 or 16 channels): 1. 16Ch for diagnostic imaging: performed in 16ch configuration that consists of two dS Sentinelle Lateral 4Ch coils and the dS Sentinelle Medial 8Ch coil. 2. 10Ch for bilateral interventional procedures requiring lateral access: performed in 10Ch configuration that consists of the dS Sentinelle Medical 8ch coil and two dS Sentinelle Lateral 1ch coils (right and left). 3. 2Ch for unilateral interventional procedures allowing both lateral and medial access: performed in 2Ch configuration that consists of two dS Sentinelle Lateral 1Ch coils (right and left). The coils receive magnetic resonance signals generated in hydrogen nuclei (protons) in the Breast while blocking the high-frequency magnetic field applied by the MRI scanner at specified timings. The coil arrays include 4Ch right and left lateral coils, a medial coil and 1Ch right and left lateral biopsy coils. Images are typically generated as axial, sagittal, coronal and oblique slices and include full coverage of the breast anatomy. The dS Sentinelle Breast 16ch 1.5T Coil is tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation. The Variable Coil Geometry design of the dS Sentinelle Breast 16ch 1.5T Coil allows each imaging element to be independently positioned and configured for each patient. Patients can then be positioned quickly and effectively as the imaging elements can be positioned as close to the breast as possible optimizing the signal-to-noise ratio for each individual patient. For clinical imaging, coil housings are placed next to the tissue to help minimize motion artifacts due to patient motion during scanning. The subject dS Sentinelle Breast 16ch 1.5T Coil system also includes a tabletop compression system which facilitates immobilization of the breast for imaging and interventional procedures and serves to hold the individual imaging coils in proximity to the breast(s). The intent of this is to reduce motion artifacts and ensure the imaging elements are positioned as close to the breast(s) as possible to optimize signal-to-noise ratio and image quality.

The provided document is a 510(k) Pre-market Notification for the dS Sentinelle Breast 16ch 1.5T Coil, a medical device used with MRI scanners. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study of the device's diagnostic performance. Therefore, many of the requested details about acceptance criteria, study design, and performance metrics for an AI/CADe device are not applicable or not present in this regulatory submission.

However, I can extract and infer some information related to the device's performance assessment and acceptance as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the device meets safety and effectiveness requirements as outlined in FDA guidance: Magnetic Resonance (MR) Receive-only Coil – Performance Criteria for Safety and Performance Based Pathway, issued December 11, 2020. This guidance would contain specific performance criteria, but the document provided does not list them explicitly or provide a detailed table comparing them to the device's reported performance. Instead, it generally states that the criteria were met.

The performance testing mentioned includes:

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

The document does not specify a distinct "test set" in the context of an AI/CADe evaluation. For the "Performance Testing – Clinical" section, it only mentions that acquired image quality was assessed. It doesn't specify the number of patients/cases used for this assessment, nor does it provide information about the data provenance (e.g., country of origin, retrospective or prospective). This type of information is typically not included in a 510(k) for a basic hardware component like an MRI coil.

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

For the "Performance Testing – Clinical" section, it states: "Acquired Image quality was assessed by a U.S. Board Certified radiologist...". It indicates one expert (a U.S. Board Certified radiologist), but does not specify their years of experience or if more than one assessed the images. There is no "ground truth" to be established in the context of a diagnostic outcome for a coil itself, as the coil simply produces images. The expert's role was to confirm the diagnostic usability of the images.

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

Not applicable, as there isn't a "test set" and ground truth establishment in the traditional sense for a diagnostic algorithm. The assessment described is a qualitative review of image quality by a single radiologist.

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 an MRI coil, a hardware component that produces images, not an AI or CADe device that assists human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this submission.

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

Not applicable. This device is an MRI coil and does not perform any diagnostic algorithm in a standalone manner.

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

Not applicable in the context of a diagnostic algorithm's performance. The "ground truth" for this device's performance is whether the images it produces are of sufficient quality for diagnostic use, which was determined by a radiologist's assessment. There is no disease outcome or pathology as a "ground truth" for the coil itself.

8. The sample size for the training set:

Not applicable. This device is an MRI coil, not an AI or machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set for this device.

Ask a specific question about this device

The Nelson Sentinel Series Basic Chlorine Sentinel is an instrument that is intended for use by hemodialysis professionals as an auxiliary device to provide continuous monitoring of Total chloramines plus ammoniated free chlorine) concentration. It is not intended to replace the primary method for monitoring total chlorine as part of the hemodialysis water treatment system. It functions completely independent of the water treatment system and does not come into direct contact with feed water used to prepare dialysate.

The Nelson Sentinel Series Basic Chlorine Sentinel is a complete system that attaches to the drain of a hemodialysis water treatment system sample port. The Basic Chlorine Sentinel detects dissolved chlorine by an auxiliary meter detection technology, self-monitors for maintenance-required conditions, loss of electrical power, as well as two other system conditions such as flooding and the status of RO shutdown alarm. The device chlorine monitoring probe is preferably placed after the second carbon filter, before the RO machine or at the beginning of the patient water treatment loop.

The device has three components - a lockable master control enclosure, a lockable probe/tester enclosure, and the remote module installed in the patient area.

A chlorine concentration equal to or above the set-point (default: 0.10mg/L) will activate the buzzers and the red CHLORINE alarm indicators for as long as the condition exists. The buzzers can only be muted for 3 minutes (then automatically reset) for as long as the condition exists. The yellow AUTO-TEST OK/CL DETECTED indication will latch. The AUTO-TEST/CL DETECTED indication can be deactivated after the event by pressing the blue RESET PUSHBUTTON on the front cover of the controller.

A probe failure or the activation of one of the auxiliary input relays will activate the yellow MAINTENANCE needed indicators as well as the Buzzers which will remain activated as long as the condition exists. However, the buzzers can be muted by the key mute switch while the maintenance issue is being resolved.

The provided document is a 510(k) summary for the Nelson Sentinel Series Basic Chlorine Sentinel, a device intended for continuous monitoring of total chlorine in water purification systems for hemodialysis.

However, the document does not contain the level of detail requested for acceptance criteria and the study proving the device meets these criteria in the context of an AI/ML-based medical device performance study. This document describes a hardware device for chemical measurement and its equivalence to predicate devices, not an AI/ML algorithm.

Therefore, many of the specific questions about AI/ML study design, such as sample size for test/training sets, data provenance, expert ground truth, adjudication, MRMC studies, and standalone algorithm performance, cannot be answered from the provided text.

Here's an attempt to extract what is available regarding acceptance criteria and performance, reinterpreting some points for a hardware device context where applicable, and explicitly stating where information is missing for an AI/ML context:

Acceptance Criteria and Device Performance (Based on the provided document for a hardware device)

The document primarily focuses on establishing "substantial equivalence" of the Nelson Sentinel Series Basic Chlorine Sentinel to predicate and reference devices, rather than defining explicit acceptance criteria in terms of metrics like sensitivity, specificity, or AUC as one would for an AI/ML diagnostic. The equivalence is shown through comparison of intended use, technological characteristics, and performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a hardware device for chemical detection and not an AI/ML algorithm, the "acceptance criteria" are implied by performance tests to demonstrate safety and effectiveness for its intended use and similarity to established devices. The "reported device performance" refers to the results of these bench tests demonstrating the device's operational range and accuracy within its specified function.

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

• Sample Size for Test Set: Not explicitly stated in the document. The document mentions various "studies" (Linearity, Precision, LoB/LoQ/LoD, Method Comparison, Free Chlorine, 15 Weeks Calibration), but does not provide details on the number of samples or measurements used in these bench tests.
• Data Provenance: The studies were performed as "Bench Testing." The origin of the water samples or the specific laboratory where tests were conducted is not specified, but it would be laboratory-based testing relevant to water purification for hemodialysis. The document does not specify if the data was retrospective or prospective in the context of an AI/ML study, as it's not an AI/ML device.

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

• This question is not applicable as the device is a chemical sensor, not an AI/ML device requiring expert interpretation for ground truth. Ground truth for chlorine concentration would be established by analytical chemistry methods (e.g., lab-grade spectrophotometry, titration).

4. Adjudication Method for the Test Set

• Not applicable for a chemical sensor device.

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

• Not applicable. This is a hardware device for chemical detection; MRMC studies are relevant for evaluating diagnostic image interpretation by humans, often with and without AI assistance.

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

• Not applicable as this is not an AI/ML algorithm. The "performance" refers to the device's ability to accurately measure chlorine and provide alerts.

7. The Type of Ground Truth Used

• For the performance testing mentioned (Linearity, Precision, etc.), the ground truth for chlorine concentration would have been established by accurate chemical analysis methods in a laboratory setting (e.g., using reference standards and validated analytical techniques). It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

Summary of Document Relevance to AI/ML Device Analysis:

This document is a regulatory submission for a physical medical device (a chlorine monitor) demonstrating its substantial equivalence to pre-existing devices. It details the device's functional characteristics, intended use, and bench testing performed to ensure safety and effectiveness. It does not provide information related to the development, validation, or performance of an AI/ML algorithm, which would require a significantly different set of acceptance criteria and study designs focusing on model performance metrics, data sets, and human-AI interaction.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The SENTINEL System is intended for use by patients who either have or are at risk of having cardiac disease and those that demonstrate intermittent symptoms indicative of cardiac disease and require cardiac monitoring on a continuing basis.

The device continuously records the ECG data and transfers the data to the Server. Upon detection by an ECG analysis algorithm at the Server the recorded cardiac activity is flagged for review by a medical professional. The data received from the SENTINEL device can be used by another cleared device for arrhythmia analysis, reporting and signal measurements. The SENTINEL System is not intended to sound any alarms.

The device does not deliver any therapy, administer any drugs, provide interpretative or diagnostic statements or provide for any life support.

The SENTINEL System is for prescription use only.

Cardiomedix ECG SENTINEL System is a self-use, 2-lead ECG continuous acquisition and transmission system. The SENTINEL device connects via Bluetooth to a proprietary mobile phone-based, dedicated ECG acquisition, storage, and transmission application. The phone application facilitates the self-use of the device by providing messages and alerts for specific parameters.

ECG SENTINEL System refers to the complete system with all component parts.

SENTINEL refers to the monitoring device only. The SENTINEL data is continuously (long-term) transmitted by the phone to a designated server for storage, analysis, decision support, and response by a qualified and dedicated team.

The SENTINEL is intended for use on patients with weighing more than 10 kg (22lbs)

The SENTINEL monitoring device is a dedicated electronic device that records ECG and consists of electronic circuit board, batteries, a plastic enclosure, and lead wires. The data transmission to the smart phone is via low energy Bluetooth transmission. The smart phone mobile device acts as in in-home communication relay, stores the data, and transfers the data via the WEB, using secure communication, to a call center. The Call Center provides a service platform to monitor, analyze, store, and report ECG data sent from the patient.

The provided text describes the ECG SENTINEL System and its review for substantial equivalence to a predicate device, the RhythmStar System. The document focuses on demonstrating that the new device is as safe and effective as the predicate, rather than providing detailed acceptance criteria and a study to prove the device meets these criteria in the traditional sense of a diagnostic performance study.

Instead, the "acceptance criteria" appear to be compliance with various safety and performance standards for medical electrical equipment, and the "study" is a comparison to a predicate device.

Here's an analysis based on the provided text:

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

The document does not present explicit "acceptance criteria" in the form of quantitative performance targets tied to a diagnostic accuracy study. Instead, the performance is demonstrated through compliance with established industry standards and a comparison of features and technical characteristics with a legally marketed predicate device.

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

The document does not describe a clinical performance study with a "test set" in the context of diagnostic accuracy. The performance testing section mentions "Bench testing verifies that the ECG SENTINEL System can record ECG signal, store data, transmit data to the Call Center, where the data can be analyzed." This suggests laboratory-based functional testing, not a clinical study involving a patient sample size. Therefore, sample size and data provenance for a clinical test set are not applicable here.

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

Not applicable. As noted above, there is no clinical diagnostic accuracy test set described.

4. Adjudication method for the test set

Not applicable. There is no clinical diagnostic accuracy test set described.

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

No MRMC comparative effectiveness study is mentioned. The device's "ECG analysis algorithm at the Server" flags cardiac activity for review by a medical professional, implying a human-in-the-loop system. However, the document does not include a study comparing human performance with and without AI assistance, nor does it quantify any effect size. The focus is on the device's ability to transmit data for professional review.

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

The document describes "an ECG analysis algorithm at the Server" that flags recorded cardiac activity for review. It explicitly states that the analyzed data is presented to a medical professional for review. The system is designed such that the automated analysis serves to flag events for human review, indicating it's not a standalone diagnostic device. The document does not describe a standalone performance evaluation of the algorithm independent of human review.

7. The type of ground truth used

For the bench testing, the ground truth would inherently be the known, controlled electrical signals or simulated ECG patterns injected into the device to verify its basic functionalities (recording, storage, transmission).
For the "ECG analysis algorithm at the Server," the document states that the flagged activity is reviewed by a "medical professional." While the implication is that the professional's review establishes the ground truth for the flagged events, the document doesn't detail any specific ground truth methodology (e.g., expert consensus, pathology, outcome data) for validating the algorithm's flagging accuracy. The goal is to ensure the data is available for review, not necessarily to validate the algorithm's diagnostic accuracy against a definitive ground truth in this submission.

8. The sample size for the training set

Not mentioned. The document focuses on performance relative to standards and a predicate device, not on the development or training of the ECG analysis algorithm.

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

Not mentioned. As above, the details of the algorithm's training are not provided in this submission.

Ask a specific question about this device

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

Ask a specific question about this device

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.

Ask a specific question about this device