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The IVUS modality of the iLab™ Polaris Multi-Modality Guidance System is intended for ultrasound examinations of intravascular pathology. Intravascular ultrasound is indicated in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy.

FFR and DFR™ are intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. FFR and DFR are indicated to provide hemodynamic information for use in the diagnosis and treatment of patients that undergo measurement of physiological parameters.

The Imaging Catheters generate ultrasound images and are intended for ultrasound examination of vascular and cardiac pathology. Boston Scientific manufactures a wide variety of catheters for different applications. The recommended use of each of these catheters may vary depending on the size and type of the catheter. Please refer to the Imaging Catheter Directions for Use, packaged with each catheter.

Indications for Auto Pullback Use (IVUS Only)

Automatic Pullback is indicated when the following occurs:

• The physician/operator wants to standardize the method in which intravascular ultrasound images are obtained and documented: procedure-to-procedure, operator-to-operator.

• The physician/operator wants to make linear distance determinations post-procedurally, which requires the imaging core of a catheter to be pulled back at a known uniform speed.

• Two-dimensional, longitudinal reconstruction of the anatomy is desired.

The iLab™ Polaris Multi-Modality Guidance System is a non-patient contacting, diagnostic device designed to provide three (3) primary modalities: IVUS (Intravascular Ultrasound), FFR (Fractional Flow Reserve) and Diastolic hyperemia-Free Ratio (DFR). The iLab Polaris Multi-Modality Guidance System is supported by the Polaris 2.14 (iLab 3.14) software.

The iLab™ Polaris Multi-Modality Guidance System is offered in both mobile (cart) and integrated (installed) configurations consisting of hardware and software components supporting intravascular ultrasound (IVUS), fractional flow reserve (FFR) and Diastolic hyperemia-Free Ratio™ (DFR™) functionalities and includes additional Auto Pullback options.

Hardware components of the iLab™ Polaris Multi-Modality Guidance System include: Data Acquisition Processor, Imaging Processor, Control Panel Primary Image display (LCD flat panel), System Power supply/transformer, updated Motor Drive Unit (MDU5+), Motor Drive cable storage, Printer, removable Storage Media, CD/DVD Recorder, Mouse/Mouse Pad, and Bluetooth Communication Module (BCM).

The iLab Polaris Multi-Modality Guidance System includes automatic pullback functionality to aid the physician/operator during IVUS modality when the following occur:

• the physician/operator wants to standardize the method in which intravascular ultrasound images are obtained and documented: procedure-to-procedure, operator-to-operator,

• the physician/operator wants to make linear distance determinations post-procedurally, ● which requires the imaging core of a catheter to be pulled back at a known uniform speed,

• two-dimensions, longitudinal reconstructions of the anatomy is desired. ●

The document provided is an FDA 510(k) clearance letter for the Boston Scientific Corporation iLab Polaris Multi-Modality Guidance System. This document focuses on demonstrating substantial equivalence to a predicate device based on non-clinical performance data (hardware verification and validation), rather than clinical studies proving the device meets specific performance acceptance criteria for diagnostic accuracy or effectiveness.

Therefore, the requested information regarding acceptance criteria for device performance, clinical study details (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance), and training set information is not present in the provided text, as the clearance was based on non-clinical data.

The letter explicitly states:

• "Clinical Performance Data: Not applicable. A determination of Substantial Equivalence for this modification is not based on clinical data. Substantial Equivalence is based on non-clinical performance data."

This means no clinical study was performed or required for this particular 510(k) submission to demonstrate the device meets performance acceptance criteria relevant to medical diagnosis or treatment outcomes. The focus was on ensuring the updated hardware (MDU5+ Motor Drive Unit) and new auto pullback functionality did not introduce new safety or effectiveness concerns, and that the device maintained the same intended use and fundamental design as the predicate device.

To answer your request, here's what can be inferred from the document:

The provided document describes the FDA 510(k) premarket notification for the iLab™ Polaris Multi-Modality Guidance System. However, this submission specifically states that the determination of substantial equivalence is based on non-clinical performance data and that clinical performance data is not applicable. Therefore, the document does not contain information about clinical acceptance criteria, a study proving device performance against such criteria, sample sizes for test or training sets, expert qualifications, or details of ground truth establishment for diagnostic accuracy.

The clearance is for an updated MDU5+ Motor Drive Unit supporting additional Auto Pullback functionality within an existing system, demonstrating that this modification does not raise different questions of safety or effectiveness compared to the predicate device (K201178).

Here's a breakdown of the requested information based on the provided text:

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

• Acceptance Criteria: Not explicitly stated as clinical performance metrics for diagnostic accuracy are not assessed in this submission. The acceptance was based on non-clinical performance (hardware verification and validation) ensuring the updated MDU5+ Motor Drive Unit and new Auto Pullback functionality meet safety and performance standards equivalent to the predicate device.
• Reported Device Performance: The document only states: "Testing was conducted according to applicable international standards, FDA recognized consensus standards, and the same well-established test methods and criteria applied to the predicate device." No specific numerical performance results are provided.

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 clinical test set data was used or described. The submission relied on non-clinical hardware verification and validation.

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 clinical ground truth was established as no clinical study for diagnostic performance was conducted for this 510(k) submission.

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

• Not applicable. No clinical test set and thus no adjudication method used.

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. No MRMC study was done. The device description does not imply AI assistance for human readers in a diagnostic capacity; it describes a guidance system for intravascular procedures.

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

• Not applicable. No standalone algorithm performance study was mentioned as the submission was based on non-clinical data for hardware modification.

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

• Not applicable. No clinical ground truth was used for this submission. The "ground truth" for the non-clinical assessment was adherence to engineering standards and safety/performance criteria for hardware functionality.

8. The sample size for the training set

• Not applicable. No training set for an algorithm was mentioned in this non-clinical submission.

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

• Not applicable. No training set was mentioned.

Summary: The FDA 510(k) clearance for the iLab™ Polaris Multi-Modality Guidance System with the updated MDU5+ Motor Drive Unit was based solely on non-clinical performance data (hardware verification and validation), as explicitly stated in the document. Therefore, none of the requested clinical performance study details are available in this text.

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The IVUS modality of the iLab™ Polaris Multi-Modality Guidance System is intended for ultrasound examinations of intravascular pathology. Intravascular ultrasound is indicated in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy.

FFR and DFR™ are intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices.

FFR and DFR are indicated to provide hemodynamic information for use in the diagnosis and treatment of patients that undergo measurement of physiological parameters.

The Imaging Catheters generate ultrasound images and are intended for ultrasound examination of vascular and cardiac pathology. Boston Scientific manufactures a wide variety of catheters for different applications. The recommended use of each of these catheters may vary depending on the size and type of the catheter. Please refer to the Imaging Catheter Directions for Use, packaged with each catheter.

Indications for Auto Pullback Use (IVUS Only)

Automatic Pullback is indicated when the following occurs:

• The physician/operator wants to standardize the method in which intravascular ultrasound images are obtained and documented: procedure-to-procedure, operator-to-operator.

· The physician/operator wants to make linear determinations post-procedurally, which requires the imaging core of a catheter to be pulled back at a known uniform speed.

· Two-dimensional, longitudinal reconstruction of the anatomy is desired.

The iLab™ Polaris Multi-Modality Guidance System is a non-patient contacting, diagnostic device designed to provide three (3) primary modalities: IVUS (Intravascular Ultrasound), FFR (Fractional Flow Reserve) and Diastolic hyperemia-Free Ratio (DFR).

The Polaris 2.12 (iLab 3.12) software update supports the iLab™ Polaris Multi-Modality Guidance System and supports existing device IVUS, FFR and DFR™ functionality as well as includes scaling updates to DFR™ equalization values, enhanced imaging modes and OS patches for additional security.

Diastolic hyperemia-Free Ratio™ (DFR) is a resting index that measures multiple diastolic portions during the cardiac cycle. DFR™ calculates the diastolic portion of the cardiac cycle averaged over five beats, using two criteria for the measurement windows: 1) Pa less than mean Pa and 2) down sloping Pa values. No hyperemic agent is required for DFR™ calculation. The Polaris 2.12 software update adds an automatic scaling feature for DFR™ equalization.

This looks like an FDA 510(k) clearance letter and summary for a software update to an existing medical device, the iLab Polaris Multi-Modality Guidance System. Based on the provided text, the submission focuses on non-clinical performance data for a software update, not a new AI/ML-based diagnostic algorithm requiring extensive clinical validation.

Therefore, many of the requested points regarding the study that proves the device meets acceptance criteria (especially those related to clinical performance, ground truth, expert adjudication, and MRMC studies) are explicitly stated as "Not applicable" in the document.

Here's a breakdown of the available information:

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

The document does not provide a specific table of acceptance criteria with corresponding performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic AI/ML algorithm. Instead, it states that
"Determination of substantial equivalence is based on an assessment of non-clinical performance data which includes software verification and validation carried out on Polaris 2.12 (iLab 3.12) software. Testing was conducted according to applicable international standards, FDA recognized consensus standards, and the same well-established test methods and criteria applied to the predicate device."

Device Performance Reported: The core performance claim is "substantial equivalence" to the predicate device (iLab Polaris Multi-Modality Guidance System K191008). This is based on:

• Non-clinical performance data: software verification and validation.
• Compliance with standards: IEC 62304 and FDA Guidance for Premarket Submissions for Software Contained in Medical Devices.

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

• Sample Size for Test Set: This information is not provided in the document. As the submission is based on non-clinical software verification and validation, it's unlikely to involve traditional clinical "test sets" with patient data in the same way an AI diagnostic algorithm would.
• Data Provenance: This information is not provided and is likely not relevant given the non-clinical nature of the submission (software V&V).

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

• Not Applicable. The submission explicitly states "Clinical Performance Data: Not applicable. A determination of Substantial Equivalence for this modification is not based on clinical data." Therefore, there was no ground truth derived from expert review of patient cases in the context of this 510(k).

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

• Not Applicable. As no clinical "test set" with expert review was used for performance evaluation, no adjudication method was employed.

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. The document clearly states: "Clinical Performance Data: Not applicable." Therefore, no MRMC study was conducted.

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

• No, not in the context of a new diagnostic algorithm. The device is a "Multi-Modality Guidance System" with IVUS, FFR, and DFR functionalities, intended for use by clinicians. The software update (Polaris 2.12 / iLab 3.12) supports these existing functionalities and includes "scaling updates to DFR™ equalization values, enhanced imaging modes and OS patches for additional security." This is a software update to a guidance system, not a standalone diagnostic algorithm that makes a diagnosis.

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

• Not Applicable. As no clinical performance data was submitted, there was no ground truth established from patient data. The "ground truth" for software verification and validation would be adherence to specified software requirements and functionality, confirmed through various engineering tests.

8. The sample size for the training set

• Not Applicable. This submission is for a software update to an existing device, not a de novo AI/ML algorithm that requires a "training set" of data.

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

• Not Applicable. Since there was no "training set" of data for an AI/ML algorithm, no ground truth was established for it.

In summary: This FDA 510(k) submission primarily relies on non-clinical software verification and validation to demonstrate substantial equivalence for a software update to an existing medical device. It does not introduce a new AI/ML diagnostic algorithm that would typically require the extensive clinical study data (including test sets, ground truth, expert review, and MRMC studies) you've inquired about.

Ask a specific question about this device

The IVUS modality of the iLab™ Polaris Multi-Modality Guidance System is intended for ultrasound examinations of intravascular pathology. Intravascular ultrasound is indicated in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy.

FFR and DFR™ are intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices.

FFR and DFR are indicated to provide hemodynamic information for use in the diagnosis and treatment of patients that undergo measurement of physiological parameters.

The Imaging Catheters generate ultrasound images and are intended for ultrasound examination of vascular and cardiac pathology. Boston Scientific manufactures a wide variety of catheters for different applications. The recommended use of each of these catheters may vary depending on the size and type of the catheter. Please refer to the Imaging Catheter Directions for Use, packaged with each catheter.

Indications for Auto Pullback Use (IVUS Only)

Automatic Pullback is indicated when the following occurs:

· The physician/operator wants to standardize the method in which intravascular ultrasound images are obtained and documented: procedure-to-procedure, operator-to-operator.

· The physician/operator wants to make linear distance determinations post-procedurally, which requires the imaging core of a catheter to be pulled back at a known uniform speed.

· Two-dimensional, longitudinal reconstruction of the anatomy is desired.

iLab™ Polaris Multi-Modality Guidance System consists of hardware and software components which aid in supporting Intravascular Ultrasound (IVUS), Fractional Flow Reserve (FFR) and Diastolic hyperemia-Free Ratio™ (DFR™) functionalities.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the DFR™ (Diastolic hyperemia-Free Ratio) feature of the iLab™ Polaris Multi-Modality Guidance System:

1. Table of Acceptance Criteria and Reported Device Performance

The primary acceptance criteria for the DFR™ feature is its equivalence to the iFR® (Instantaneous Wave-Free Ratio) modality, with both being compared against Fractional Flow Reserve (FFR) as a reference standard. The study aimed to demonstrate that DFR™ has comparable diagnostic performance to iFR® when assessing coronary lesion severity without hyperemia.

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

• Test Set Description: The test set for DFR™ and Smart Minimum validation consisted of pre-recorded patient level data.
• Data Provenance: The data was acquired from two clinical trials:
  • VERIFY2
  • CONTRAST
  • Geographic Origin (implied): Not explicitly stated, but clinical trials like VERIFY2 and CONTRAST are typically multi-center studies that can involve patients from various countries. The document does not specify the countries of origin.
  • Retrospective/Prospective: The data appears to be retrospective as it is described as "pre-recorded patient level data acquired from VERIFY2 and CONTRAST clinical trials" for the purpose of validating the new software features.

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

The document does not explicitly state the number of experts used or their specific qualifications for establishing the ground truth for the test set (i.e., FFR values). However, given that FFR is considered the "reference standard" and typically relies on highly trained cardiologists/interventionalists, it can be inferred that these values were established by qualified medical professionals during the original clinical trials (VERIFY2 and CONTRAST).

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1). The FFR values used as the reference standard were presumably established as part of the original clinical trials' protocols.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported here. The study focuses on the algorithmic performance of DFR™ in comparison to iFR® and FFR, rather than evaluating human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone (algorithm only) performance study was conducted. The document describes:

• "Smart Minimum and DFR were validated with non-clinical test methods"
• "iFR data from the CONTRAST dataset was re-generated using a bench iFR setup with a commercially available Volcano FFR system."
• "BSC also demonstrated the waveform performance equivalency of the Comet pressure wire to the Volcano pressure wires... and St Jude pressure wires..."
• The primary comparison is between DFR™ and iFR® (both algorithms) against FFR (the reference standard).

The data presented (97.6% Accuracy, 99.2% Specificity, 95.8% Sensitivity) reflects the algorithmic performance of DFR™ in classifying lesions.

7. Type of Ground Truth Used

The primary ground truth used for evaluating DFR™ and iFR® was Fractional Flow Reserve (FFR).
Additionally, the "original iFR values" from the VERIFY2 dataset served as a reference for validating the bench iFR setup.

8. Sample Size for the Training Set

The document does not provide information regarding the sample size of a training set for the DFR™ algorithm. The validation was performed using pre-recorded patient data from existing clinical trials (VERIFY2 and CONTRAST). It's common for such algorithms to be developed and potentially trained on various datasets prior to this validation, but those details are not included in this submission summary.

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

Since information on a specific training set or its sample size is not provided, how its ground truth was established is also not described in the document.

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The IVUS modality of the iLab Polaris Multi-Modality Guidance System is intended for ultrasound examinations of intravascular pathology.

Intravascular ultrasound is indicated in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy.

Indications for Auto Pullback Use

Automatic Pullback is indicated when the following occurs:

• The physician/operator wants to standardize the method in which intravascular ultrasound images are obtained and documented: procedure-to-procedure, operator-to-operator.

· The physician/operator wants to make linear distance determinations post-procedurally, which requires the imaging core of a catheter to be pulled back at a known uniform speed.

· Two-dimensional, longitudinal reconstruction of the anatomy is desired.

The FFR modality of the Lab Polaris Multi-Modality Guidance System is intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers or measuring devices.

This modality is indicated to provide hemodynamic information for use in the diagnosis and treatment of patients that undergo measurement of physiological parameters, Fractional Flow Reserve (FFR).

The iLab Polaris Multi-Modality Guidance System is a diagnostic device designed to provide both intravascular ultrasound imaging (IVUS) and fractional flow reserve (FFR) modalities. Only one modality can be used at a time and are independent of one another.

The IVUS modality allows the application of ultrasound technology to see from inside blood vessels out through the surrounding blood column, enabling the physician to visualize the coronary or peripheral vasculature. The IVUS functionality consists of two non-sterile compact PC units (one for imaging processing and one for data acquisition) and two non-sterile display monitors (for the integrated system -one primary and an optional secondary). It also consists of a non-sterile Motordrive Unit (MDU), sterile bag which covers the MDU and a sterile disposable sled. The iLab Polaris Multi-Modality Guidance System interfaces with BSC imaging catheters at the Motordrive Unit (MDU), which provides the electro-mechanics for the rotating parts of the imaging catheter, and the interface between the catheter and the console and BSC proprietary software. The Motordrive Unit provides the rotation of the imaging catheter core required for cross-sectional imaging. An electro-mechanical connector interface at the proximal end of the imaging catheter makes the connection to the MDU-catheter interface consists of an integrated mechanical drive hub and electrical connection. The MDU is the primary control for catheter positioning and movement through the vessel.

The FFR modality measures the pressure gradient across lesions to determine lesion severity and thus, in conjunction with other tools help guide physicians in making treatment decisions. FFR is defined as the ratio of pressure distal of a lesion (Pd) to the pressure proximal of a lesion (Pa-aortic pressure) during maximum blood flow. Maximum blood flow is achieved by injection of a vasodilator to open up the distal arteriole bed.

The FFR modality will also utilize the two non-sterile compact PC units (one displays the physiological parameters and one for data acquisition) and two non-sterile display monitors (for the integrated system -one primary and an optional secondary). In addition the FFR modality consists of a Signal Processing Module (SPM- commercial name FFR Link), Bluetooth Communication Module (BCM) and Hemodynamic Cable Kit.

The iLab Polaris Multi-Modality Guidance System console interfaces with BSC's Pressure Guidewire through the optical cable connector of the pressure guidewire, the FFR Link and the Bluetooth Communication Module (BCM).

The Pressure Guidewire sensor is designed to output an optical signal that corresponds to the pressure distal (Pd) of a lesion in a blood vessel. This optical signal is acquired and processed by the FFR Link. The FFR Link also acquires and processes the patient's aortic pressure signal (Pa) obtained from a resistive bridge IBP transducer. The FFR Link processes, digitizes and wirelessly streams by Bluetooth the aortic pressure (Pa) and distal pressure (Pd). These wirelessly streamed pressure signals are received by the iLab Polaris Multi-Modality Guidance System console through the BCM. BSC's proprietary software processes the pressure signals received via the BCM for display of Pa and Pd waveforms, Pa. Pd and Pd/Pa (FFR calculation) for physician interpretation. Additionally the FFR Link provides an analog, BP-22 compliant, signal which passes the IBP measurement, unchanged, to the catheterization lab's hemodynamic system.

The provided text describes the iLab Polaris Multi-Modality Guidance System, which includes both Intravascular Ultrasound (IVUS) and Fractional Flow Reserve (FFR) modalities. The information available predominantly focuses on the FFR modality's performance testing.

Here's an analysis of the acceptance criteria and study in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance for all aspects. However, for the FFR modality, it references compliance with specific IEC and ANSI/AAMI standards, which inherently contain performance requirements.

Note: The document states that the system "performed as intended" and "demonstrates substantial equivalence" for these tests, implying that the acceptance criteria for these standards were met. Specific numerical values for accuracy or frequency response are not provided in this summary.

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

• FFR Modality (Animal Study):

  • Test Set Sample Size: 2 pigs.
  • Data Provenance: Prospective animal study in swine model, conducted with invasive blood pressure measurements.

• Bench Testing: No specific sample size is mentioned for the various bench tests, but they are described as "bench testing." Data provenance for bench tests is typically in-house laboratory testing.

• Software Verification and Validation: No specific sample size is mentioned.

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

• FFR Modality (Animal Study): The ground truth was established by invasive blood pressure (aortic pressure) measurements in the swine model, not by human experts. Therefore, the number of experts and their qualifications for establishing ground truth are not applicable in this context.

4. Adjudication Method for the Test Set

• FFR Modality (Animal Study): The adjudication method is not explicitly stated, but the comparison was made against direct, invasive aortic pressure measurements, which typically serve as the reference standard without further adjudication.

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

There is no indication of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed for human readers with and without AI assistance. The device is a diagnostic guidance system, not an AI-assisted interpretation tool in the manner implied by MRMC studies of AI.

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

• Yes, a standalone study was done. The "Performance Testing-Bench" and the "Animal Study" evaluate the device's performance (FFR modality) in isolation, specifically its ability to measure pressure accurately compared to known standards or direct invasive measurements. This represents standalone performance.
  • The "Software Verification and Validation Testing" also assesses the algorithm's functionality and adherence to requirements in a standalone context.

7. Type of Ground Truth Used

• FFR Modality (Animal Study): Outcomes data in the form of invasive blood pressure (aortic pressure) in a swine model. This is considered a gold standard for pressure measurement in such studies.
• Bench Testing: Ground truth was established by reference standards outlined in the cited IEC and ANSI/AAMI documents, and presumably by calibrated test equipment.

8. Sample Size for the Training Set

The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence rather than details of internal algorithm development. Therefore, the sample size for the training set is not provided or discussed in this document. This device is described as processing physiological parameters and displaying them, and interfaces with hardware, rather than being a "machine learning" based AI system that would typically have a distinct training set.

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

As the sample size for the training set is not provided, how the ground truth for a training set (if one existed in the context of an ML/AI algorithm) was established is also not discussed in this document. Given the description of the device (processing and displaying physiological parameters), it's highly likely that traditional signal processing and hardware integration, rather than a machine learning approach with a "training set," was used.

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