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The PADnet Xpress is a non-invasive device used to assess the lower and upper extremity arterial circulatory systems in order to assist in the identification of vascular disease in adults. To assess the arterial system, PADnet Xpress uses pulse volume recording. It is intended to be used by healthcare professionals in either a professional medical or home environment. The device is not intended for pediatric or fetal use. It is also not intended for the use on or near non-intact skin.

PADnet Xpress, like the PADnet 2.0 aids clinicians in the diagnosis of vascular disease by measuring blood volume changes using volume plethysmography in the Brachial, Posterior Tibial/Dorsalis Pedis arterial distributions. From these signals it calculates a result that is predictive of Peripheral Artery Disease (PAD). Following each test PADnet Xpress provides documented results, including waveforms, as part of the final report, which may be viewed on the system display, in printed form, and/or digitaly saved. PADnet Xpress was designed, in response to consumer feedback, to perform a subset of tests, namely PAD screening, which the predicate PADnet 2.0 device is capable of in a smaller, more portable form factor. The design modifications did not alter the intended use and are modest departures from the existing, previously cleared technological characteristics of the PADnet 2.0. While the intended use is not altered, there are minor modifications for use to remove elements of the indication not associated with arterial pulse contour analysis, and segmental systolic blood pressure measurements, as well as to allow for home use by a trained operator.

When performing an assessment, the clinician places a sensor and takes a measurement on each lower extremity. The sensor detects changes in arterial blood volume. This signal is digitized and sent to a computer via a wired connection, where it runs a proprietary software application calculates the result, which is based on the features of the volume plethysmographic signals from the Brachial, Anterior Tibial arterial distributions. The indications for use are almost identical to the PADnet 2.0, the predicate device, but PADnet Xpress has also been tested for compliance with IEC 60601-1-11 home use electrical safety standards and is indicated for use in that environment as well with no change to the safety or effectiveness of the device. The PADnet Xpress sensor used with the predicate, is made from Makrolon plastic.

This document is a 510(k) summary for the PADnet Xpress device. It outlines the device's indications for use, comparison to a predicate device (PADnet 2.0), and provides a summary of non-clinical and/or clinical tests. However, the document explicitly states that no additional performance testing was needed to demonstrate substantial equivalence for the PADnet Xpress because the underlying technology is unchanged from the predicate device.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found in this document as a study proving the device meets acceptance criteria was not conducted for the PADnet Xpress due to the nature of this 510(k) submission.

The document indicates:

• Non-Clinical and/or Clinical Tests Summary & Conclusions: "Since the underlying technology for aiding in the disease is unchanged between the predicate PADnet 2.0 device and the modified PADnet Xpress, a risk analysis determined that additional performance testing was not needed to demonstrate the substantive equivalence of the safety and effectiveness of the device."

This means that the information you are requesting about a study proving the device meets acceptance criteria, including details about sample sizes, experts, ground truth, etc., is not present because such a study was deemed unnecessary for this 510(k) submission. The FDA cleared the device based on its substantial equivalence to a previously cleared predicate device whose performance data would have been evaluated during its initial clearance.

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The device provides non-invasive measurement of pulse waveform and heart rate by photoelectric plethysmography. For Professional Use only. Not for use in individuals under the age of 18 years.

The ASI Device is intended to be used to measure pulse waveform in the finger. The measurement oximeter is an optoelectronic sensor consisted of a light- emitting diode (infrared LED) and a photodiode placed on opposite side as a light receiver. The ASI System incorporates an FDA approved pulse oximeter fingertip probe. The light from the LED is transmitted through the tissue at the sensor site and a photodiode in the sensor measures the transmitted light and calculating how much light is absorbed. This device converts the changes of transmitted light from a photodiode into a waveform and displays a graphic display of the pulse waveform on computer screen. As well as the optoelectronic sensor, the system utilizes a Texas Instrument designed circuit board which in turn transfers the signal to the computer contains the downloaded ASI proprietary algorithm which analysis the generated plethysmograph. The ASI System measures and analyzes the generated pulse waveforms to produce heart rate and plethysmograph of the patient's blood circulation.

The provided document is a 510(k) Premarket Notification for the ASI Plethysmograph Analyzer Model 3.01. It details the device's indications for use, description, comparison to predicate devices, and a summary of safety and effectiveness, including references to clinical and non-clinical tests.

However, the document does not contain specific acceptance criteria (e.g., target accuracy, precision, or sensitivity/specificity metrics) or a detailed breakdown of the study that proves the device meets these criteria. The safety and effectiveness section broadly states "The results of both bench testing and clinical trial data indicates that the new device is as safe and effective as the predicate devices," but it does not quantify this.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, expert qualifications, and ground truth establishment cannot be extracted directly from this document.

Here's an attempt to answer what can be inferred from the provided text, and where information is missing:

Device: ASI Plethysmograph Analyzer Model 3.01

Indications for Use: The device provides non-invasive measurement of pulse waveform and heart rate by photoelectric plethysmography. For Professional Use only. Not for use in individuals under the age of 18 years.

1. Table of Acceptance Criteria and Reported Device Performance

Information Not Fully Provided in Document.

The document claims the device is "as safe and effective as the predicate devices" based on bench testing and clinical trial data. However, it does not provide a specific table of quantitative acceptance criteria (e.g., specific accuracy ranges for heart rate, or waveform fidelity metrics) or the measured performance results against such criteria.

The similarity table (Section 6) instead focuses on features and intended use rather than detailed performance specifications.

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

Information Partially Provided.

• Test Set Sample Size: The document mentions "clinical trial data" and "Clinical studies were conducted," but it does not specify the sample size (number of participants/patients) used in these clinical trials.
• Data Provenance: The clinical studies were conducted by "independent CRO Prism Research at 1000 Westgate Drive, Saint Paul, Minnesota 55114." This suggests the data is likely prospective given the mention of a clinical study, and the location implies the data is from the USA.

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

Information Not Provided.

The document does not detail how ground truth was established for the clinical trial data, or the number and qualifications of any experts involved in this process.

4. Adjudication Method for the Test Set

Information Not Provided.

There is no mention of any adjudication method (e.g., 2+1, 3+1 consensus) used for the test set data.

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

Information Not Applicable/Provided.

• The ASI Plethysmograph Analyzer Model 3.01 is a device that provides measurements (pulse waveform, heart rate) directly, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images. Therefore, a MRMC study comparing human readers with and without AI assistance is not relevant for this type of device.
• No information about human readers or AI assistance in interpretation is mentioned. The device directly presents the measurements.

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

Information Partially Inferred.

The device operates by acquiring a signal and then an "ASI proprietary algorithm which analysis the generated plethysmograph." The clinical trial data would inherently represent the "standalone" performance of the device and its algorithm in producing heart rate and pulse waveform measurements. The document states "Clinical and non-clinical tests were performed to support the determination of substantial equivalence." While this implies standalone performance was evaluated, specific metrics of this standalone performance are not provided.

7. Type of Ground Truth Used

Information Not Provided.

The document states "Clinical studies were conducted," but it does not specify the method by which "ground truth" for heart rate and pulse waveform was established in these studies (e.g., comparison to a "gold standard" device, expert consensus on a different measurement, etc.).

8. Sample Size for the Training Set

Information Not Applicable/Provided.

The document describes the device as performing measurement and analysis of a signal using a proprietary algorithm. It does not explicitly state that this algorithm involves machine learning or what would be considered a "training set" in that context. If the algorithm is rule-based or derived from physiological models, a "training set" for an AI model might not exist in the traditional sense.

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

Information Not Applicable/Provided.

As a "training set" is not explicitly mentioned or implied for an AI model, the method for establishing its ground truth is also not provided.

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The MESI mTABLET ABI is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD).

MESI mTABLET ABI is intended for the rapid measurement of ankle-brachial pressure index (AB) and pulse volume plethysmography in adults.

It is suitable for use in wound care assessment, for assessing symptomatic PAD, and as a screening device for PAD. It may also be used on patients with venous or arterial ulcers prior to application of compression therapy.

MESI mTABLET ABI can be used on patients with unilateral lower limb amputation. The MESI mTABLET ABI is intended to be used to spot-check patients.

The MESI mTABLET ABI provides information regarding patient risk.

The physician has the responsibility of making proper judgments based on this information.

Prescription Use: Federal law restricts the use of this device to sale by or on the order of a physician.

MESI mTABLET ABI is a medical device comprised out of three parts. Diagnostic modules with a tubeless cuff (ABISYS) that is attached to a patient upper arms and ankles, a medical grade tablet used to display the measurement (MTABSYSW) and a charging station (CS4SYS). It is used in a professional clinical environment by trained medical experts for diaqnostic and screening purposes.

MESI mTABLET ABI is a device used for screening of Peripheral Arterial Disease (PAD). The measurement is performed non-invasively by measuring blood pressure in the brachial artery and pressures in the foot arteries (dorsalis pedis and the posterior tibial artery). After the blood pressures have been measured the MESI mTABLET ABI calculates the ration between higher of the two arm values and both ankles.

The provided text is a 510(k) summary for the MESI mTABLET ABI, an automated ankle-brachial pressure index measuring device. This document focuses on demonstrating substantial equivalence to a predicate device (ABPI MD) and includes information about the device's design, intended use, and general testing compliance, rather than detailed performance study results that would typically include specific acceptance criteria and their outcome.

Therefore, I cannot provide a table of acceptance criteria and reported device performance directly from this document. The document states that the new device has "same performances and effectiveness" as the predicate device and that the "ABI results: Coefficient of correlation r with the standard Doppler probe method" for both the predicate and the new device is "r= 0.88". This is the closest the document comes to a performance metric, but it is presented as a characteristic shared with the predicate rather than an acceptance criterion for the new device's performance study.

Based on the provided text, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: These are presented as characteristics shared with the predicate device, implying they are met by the new device. The document does not detail specific performance study acceptance criteria for the MESI mTABLET ABI itself beyond asserting "same performances and effectiveness" as the predicate.

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

• Sample Size: Not specified in the provided text for any performance studies.
• Data Provenance: Not specified. The document describes a comparison to a predicate device and general testing (biocompatibility, software, electrical, EMC, usability), but not a specific clinical test set for performance evaluation.

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

• Not specified. The document states the device provides "information regarding patient risk" and "The physician has the responsibility of making proper judgments based on this information." This implies human expert involvement in diagnosis and judgment, but not their role in establishing ground truth for a test set for the device's performance validation.

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

• Not specified.

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 specified. The device is for automated measurement of ABI and plethysmography, not an AI-assisted diagnostic imaging tool that would typically involve human readers.

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

• The device is described as an "Automated ankle-brachial pressure index measuring device." This inherently suggests standalone algorithm performance for the measurement aspect. However, no specific standalone performance study details (metrics, results, methodology) are provided beyond the stated correlation and error limits.

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

• The document mentions "Coefficient of correlation r with the standard Doppler probe method." This strongly suggests the Doppler probe method is considered the "ground truth" or reference standard against which the device's measurements are compared.

8. The sample size for the training set:

• Not specified. This document is a 510(k) summary for a measurement device, not an AI/Machine Learning model that would typically have a "training set."

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

• Not applicable as this is not an AI/ML device in the context of a training set. If considering "ground truth" for the device's development and calibration, it would likely be established through comparison to established, accurate methods like the Doppler probe.

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VitalScan ANS is intended for non-invasive measurements of pulse waveforms by photoelectric plethysmography (PPG), heart rate electrocardiograph (ECG), Heart Variability measurements (HRV) and blood pressure (NIBP) in response to paced respiration and controlled testing procedures for physician assessment of the Cardiovascular Systems.

VitalScan ANS also measures/calculates a patient's Brachial and Ankle Blood Pressure, Ankle Brachial Pressure Index (ABPI) and Ankle Brachial Index (ABI) and provides Pulse Volume Recording (PVR) / volume plethysmography for assessing development of peripheral arterial disease (PAD).

The device is intended for use on transitional adolescents and adults, including those with unilateral lower limb amputation, in medical clinics, healthcare practices and out-patient departments of hospitals.

The physician has the responsibility of interpreting the significance of the resulting data.

VitalScan ANS system collects multi-parameter patient data including: Electrocardiography (ECG), Plethysmogram (PPG), Pulse Volume Recording (PVR), Blood Pressure, Heart Rate, and Peripheral capillary Oxygen saturation (SpO2).

The system comprises: USB plug and play device hardware and Software installed on a computer.

VitalScan ANS is intended to measure a patient's variations in the heart rate (R-R beat-to-beat intervals from ECG) and perform Heart Rate Variability (HRV) analysis to assess Autonomic Nervous System (ANS) Function;

VitalScan ANS also measure a patient's Brachial and Ankle Blood Pressure, Ankle Brachial Pressure Index (ABPI) and Ankle Brachial Index (ABI) and provides Pulse Volume Recording (PVR) / volume plethysmography for assess the risk of developing peripheral arterial disease (PAD).

The results are saved in a backup and can also be printed.

The device does not provide any direct diagnosis rather the device provides information to the physician for inclusion in their decision making process.

The provided document is a 510(k) summary for the VitalScan ANS device. It primarily focuses on demonstrating substantial equivalence to predicate devices through technological characteristic comparison and non-clinical testing.

Here's an analysis of the provided information regarding acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a comparison table (pages 7-8) that highlights the VitalScan ANS device's specifications against predicate devices. While this table shows performance characteristics, it does not explicitly state "acceptance criteria" in a quantifiable sense for the VitalScan ANS itself. Instead, it demonstrates that the VitalScan ANS either matches or is similar to the established performance of legally marketed predicate devices.

Here's an extracted and summarized table based on the direct comparison for the VitalScan ANS device's performance, using the predicate device values as a proxy for what would be considered acceptable based on substantial equivalence:

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

The document explicitly states: "No Clinical testing was necessary to determine substantial equivalence." (Page 6, section b2). This means there was no test set of patient data used to evaluate the device's clinical performance. The evaluation was based on non-clinical (bench) testing and comparison to predicate devices, not on direct human data.

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

Since no clinical testing was performed, there were no experts used to establish ground truth for a clinical test set. The substantial equivalence was determined by comparing the device's technical specifications and safety/performance data (from bench testing) to those of already approved predicate devices.

4. Adjudication method for the test set

Not applicable, as no clinical test set was 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. This device is not an AI-assisted diagnostic tool that would typically involve human readers.

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

Yes, if we interpret "standalone" as the device operating according to its technical specifications and algorithms during non-clinical (bench) testing. The document states:

• "Bench testing was carried out on the following characteristics: Electrocardiograph (ECG), Heart rate variability (R-R interval), Heart rate, SpO2 and Plethysmogram, Blood-Pressure Measurement accuracy, Communication, data transmission and storage integrity, Electromagnetic compatibility (EMC), Electrical safety testing, Software verification and validation testing, Biocompatibility verification." (Page 5, section b1)
• And, "The VitalScan ANS device was tested and meets the applicable requirements of following performance Standards and is in accordance with FDA Class II Special Controls Guidance Document" followed by a list of relevant IEC and ISO standards (pages 5-6).

These non-clinical tests demonstrate the device's performance in a standalone capacity against established technical and safety standards.

7. The type of ground truth used

For the non-clinical testing, the "ground truth" would be established by the specifications and measurement accuracies defined in the referenced standards (e.g., IEC 60601-1, AAMI / ANSI 80601-2-30 for blood pressure accuracy). The device's measurements were compared against calibrated instruments or reference signals as part of these bench tests. The substantial equivalence argument also uses the established performance of the legally marketed predicate devices as a form of "ground truth" for acceptable performance.

8. The sample size for the training set

Not applicable. This device is not described as utilizing machine learning or artificial intelligence that would require a "training set" of data. Its functionalities are based on established physiological measurement principles and algorithms.

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

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

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The ABPI MD system is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD). The ABPI MD system is intended for the rapid measurement of ankle-brachial pressure index (ABPI), or ankle-brachial index (ABI) and pulse volume recording (PVR)/volume plethysmography in adults. It is suitable for use in wound care assessment, for assessing symptomatic PAD, and as a screening device for PAD. It may also be used on patients with venous or arterial ulcers prior to application of compression therapy. ABPI MD system can be used on patients with unilateral lower limb amputation.

The ABPI MD system is intended to be used to spot-check patients. The ABPI MD system provides information regarding patient risk. The physician has the responsibility of making proper judgments based on this information.

Prescription Use: Federal law restricts the use of this device to sale by or on the order of a physician.

The ABPI MD system, is an automated ankle brachial pressure index measuring device, the system includes the following components:

• -ABPI measuring unit
• -Arm cuff size M
• -Left ankle cuff size M
• -Right ankle cuff size M
• -AC/DC power supply
• Tubes -
• -USB cable
• -Instructions for use, Installation and User guide, Certificate of Calibration, Certificate of Conformity and Warranty
• Software installed on a computer -

It is intended to measure a patient's Ankle Brachial Pressure Index (ABPI) and Ankle Brachial Index (ABI) and provides Pulse Volume Recording (PVR) / volume plethysmography. This is done through an automated process. The operator places the three color coded cuffs on the right or left arm, and on each ankle as described in the instructions for use, and connects to the device. When connected, the operator clicks start button to begin measurement. The device will then automatically control the inflation of the cuffs and monitor variations in individual pressures to determine values to be used for the calculation of the ABI values for the both left and right of the patient.

The provided text describes the MESI ABPI MD device, an automated ankle-brachial index measuring device, and its substantial equivalence to a predicate device, the TM-ABI System. However, the document does not contain an independent clinical study that directly proves the ABPI MD device meets specific acceptance criteria in terms of accuracy or performance metrics beyond those stated for the predicate device.

Instead, the submission relies on the assertion of identicality to the predicate device, TM-ABI, for which the original testing results are then applied. The core argument for the ABPI MD meeting acceptance criteria is that it is essentially the same device (manufactured by the same OEM) as the already cleared TM-ABI.

Here's the information extracted and organized based on your request, with the caveat that the "study that proves the device meets the acceptance criteria" refers to the predicate device's performance, as the ABPI MD itself did not undergo separate performance studies for this 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states, "The same testing and validation performed to qualify the TM-ABI is the testing for the ABPI MD." Therefore, information regarding the specific sample size, country of origin, and retrospective/prospective nature of the data for these performance metrics would come from the original 510(k) submission for the TM-ABI System (K143152). This information is not provided in the current document (K172655).

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

This information is not provided in the current document (K172655). It would be found in the original 510(k) submission for the predicate device (TM-ABI System).

4. Adjudication Method for the Test Set

This information is not provided in the current document (K172655). It would be found in the original 510(k) submission for the predicate device (TM-ABI System).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

An MRMC study is typically for evaluating devices involving human interpretation of medical images or data. The ABPI MD (and its predicate) is an automated measuring device that produces numerical values (ABI, pressures). Therefore, an MRMC comparative effectiveness study in the traditional sense, comparing human readers with and without AI assistance, is not applicable to this type of device. The comparison is between the automated device and a gold standard measurement method (like a standard Doppler probe method, as indicated by the correlation coefficient).

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

Yes, the device (ABPI MD, and by extension, its predicate TM-ABI) is described as an "automated ankle brachial pressure index measuring device." This strongly implies that its performance metrics (like the ABI results and correlation with Doppler) are based on the standalone performance of the algorithm/device itself in comparison to a reference standard, without human-in-the-loop assistance influencing the measurement outcome.

7. The Type of Ground Truth Used

The ground truth for evaluating the accuracy of the ABI measurement is indicated by the "Coefficient of correlation r with the standard Doppler probe method." This suggests that the standard Doppler probe method was used as the reference or "ground truth" to which the automated device's measurements were compared.

8. The Sample Size for the Training Set

The document states that the ABPI MD is "identical to the predicate device" and that the "same test results apply to both devices" because MESI, d.o.o. is the OEM for both. This implies that the ABPI MD did not undergo a separate training process or study. Information regarding any training set used for the predicate device's development is not provided in the current document (K172655).

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

Similar to point 8, this information is not provided in the current document (K172655). It would pertain to the development of the predicate device (TM-ABI System).

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The TBL-ABI is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD). TBL-ABI is intended for rapid measurement of ankle-brachial pressure index (ABPI) or ankle-brachial index (ABI) in adults and pulse volume recording (PVR) / volume plethysmography in adults.

It is suitable for use in wound care assessing symptomatic PAD, and as a screening device for PAD. It may also be used on patients with venous or arterial ulcers prior to the application of compression therapy.

TBL-ABI can be used on patients with unilateral lower limb amputation.

The TBL-ABI System is intended to be used to spot-check patients. The TBL-ABI provides information regarding patient risk. The physician has the responsibility of making proper judgments based on this information.

TBL-ABI System comprises:

• 3 Bluetooth blood pressure devices with attached cuffs.
• Software installed on a computer

It is intended to measure a patient's Ankle Brachial Index (ABI) and provide Pulse Volume Recording (PVR) / volume plethysmography.

This is done through an automated process.

The operator places the three devices with different color-coded electronic boxes on the right or left arm, and on each leg as described in the instructions for use, and the devices connect to the computer via Bluetooth.

Once the devices are connected, the operator clicks start on the software to start the measurement. The devices will then automatically control the inflation of the cuffs and monitor the variations in individual pressures to determine values to be used for the calculation of the ABI values for both the left and right of the patient.

TBL-ABI uses pneumo-plethysmography in order to obtain physiologic measurements from the patient's limbs.

Measurements are conducted as a single occurrence on the three limbs, thus eliminating any requirement to rest the patient between measurements.

The test period takes approximately 3 minutes.

ABI values, as well as the Pulse Volume recording (PVR), are displayed on the software installed in a computer. The results are saved in a backup file and can also be printed.

The TBL-ABI System, a device for measuring Ankle-Brachial Index (ABI) and Pulse Volume Recording (PVR), was reviewed for substantial equivalence to a legally marketed predicate device (TM-ABI, K143152). The provided document is a 510(k) summary, which typically presents a summary of verification and validation testing, rather than detailed study protocols and results for clinical performance. Therefore, information regarding human reader studies, ground truth establishment for clinical data, and specific sample sizes for clinical accuracy testing (if any were performed on human subjects) is not extensively detailed.

However, based on the provided text, the device primarily relies on non-clinical performance and engineering validation to demonstrate substantial equivalence, particularly concerning the accuracy of its physiological measurements and the safety of its technological changes (e.g., Bluetooth communication).

Here's an analysis of the acceptance criteria and the non-clinical study that proves the device meets these criteria, as described in the document:

1. Table of Acceptance Criteria (Performance Specifications) and Reported Device Performance (as claimed by the manufacturer and deemed sufficient by FDA):

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

• Sample Size: The document does not specify a "test set" in terms of human subjects or patient data for clinical performance evaluation. The study primarily relies on non-clinical testing (bench testing, engineering validation, software verification). The performance claims related to pressure accuracy and ABI accuracy (± 3mmHg and ± 0.1 respectively) are presented as specifications that are met, likely through calibration and validation against established standards or measurement principles rather than a patient-based test set.
• Data Provenance: Not applicable as the "study" described is verification and validation, predominantly on the device itself and its components. The document implies comparison to the predicate device's established performance, rather than new clinical data generation.

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

• Not applicable. As the evaluation focused on non-clinical performance and substantial equivalence to a predicate device with established performance specifications, "ground truth" was likely established through engineering standards, calibration references, and predicate device specifications. No mention of expert radiologists or similar clinical experts is found for establishing ground truth from patient data.

4. Adjudication Method for the Test Set:

• Not applicable, as the evaluation focused on non-clinical performance testing.

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

• No, a MRMC comparative effectiveness study was not done. The device is a diagnostic tool that provides objective measurements (ABI, PVR) and does not involve human interpretation of images or signals that would typically necessitate an MRMC study to show human reader improvement with AI assistance.

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

• The device inherently operates as a "standalone" algorithm in that it performs automated measurements and calculations (Ankle-Brachial Index and Pulse Volume Recordings). The performance specifications for pressure and ABI accuracy (± 3mmHg, ± 0.1 ABI respectively) represent the algorithm's performance. The "study" (non-clinical testing) demonstrated that the device (including its algorithm for measurement calculation) meets these specified accuracy limits.

7. The Type of Ground Truth Used:

• For the core physiological measurements (pressure, ABI), the ground truth is implicitly based on metrological standards and established physiological measurement accuracy limits (e.g., ± 3mmHg for blood pressure, which is a widely accepted standard for non-invasive blood pressure devices). The device's performance is claimed to meet these standard accuracy limits, similar to its predicate device.
• For software and hardware functionality, the ground truth is derived from engineering specifications, test protocols (SRS/SDS/STD/STR), and standard compliance (e.g., IEC 60601 series).
• For biocompatibility, the ground truth is established by ISO 10993 standards.

8. The Sample Size for the Training Set:

• Not applicable. The document describes a 510(k) submission for substantial equivalence. This type of submission relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often through a combination of non-clinical testing and comparison of technological characteristics. It does not typically involve training a machine learning model, which would require a training set. The device performs calculations based on established physical principles (pneumo-plethysmography), not learned patterns from data.

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

• Not applicable, as there was no training set for a machine learning model.

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The TM-ABI system is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD).

TM-ABI system is intended for the rapid measurement of ankle-brachial pressure index (ABP), or ankle-brachial index (ABI), and pulse volume recording (PVR) / volume plethysmography in adults. It is suitable for use in wound care assessing symptomatic PAD, and as a screening device for PAD. It may also be used on patients with venous or arterial ulcers prior to the application of compression therapy.

TM-ABI system can be used on patients with unilateral lower limb amputation.

The TM-ABI System is intended to be used to spot-check patients. The TM-ABI provides information regarding patient risk. The physician has the responsibility of making proper judgments based on this information.

TM-ABI System is a programmable electro medical system (PEMS). The system comprises:

• Σ USB plug and play hardware.
• Software installed on a computer

It is intended to measure a patient's Ankle Brachial Pressure Index (ABPI) and Ankle brachial Index (ABI) and provides Pulse Volume Recording (PVR) / volume plethysmography.

This is done through an automated process.

The operator places the three color coded cuffs on the right or left arm, and on each ankle as described in the instructions for use, and connects to the device.

When connected, the operator clicks start on the software to begin measurement. The device will then automatically control the inflation of the cuffs and monitor variations in individual pressures to determine values to be used for the calculation of the ABI values for both the left and right of the patient.

TM-ABI uses pneumo-plethysmography in order to obtain physiologic measurements from patient's limbs. Measurements are conducted as a single occurrence on the three liminating any requirement to rest the patient between measurements. The test period takes approximately 3 minutes. The ABPI or ABI are calculated using the conventional algorithm: The device measures systolic pressures on arm and 2 ankles and then calculates the ABIs as follows:

Left ABI = Left ankle pressure / Arm pressure

Right ABI = Right ankle pressure / Arm pressure

ABPI values, as well as the Pulse Volume recording (PVR), are displayed on the LCD, and on a software installed in a computer. The results are saved in a backup and can also be printed.

Here's an analysis of the acceptance criteria and study information for the TM-ABI System, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions a "Clinical Study comparing the device results and standard Doppler method results to assess the Ankle Brachial Index." However, it does not explicitly state the sample size for this clinical study.

The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It is implied to be a prospective study comparing the device to the standard Doppler method.

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

The document does not provide details on the number of experts or their qualifications for establishing the ground truth. It refers to "the standard Doppler probe method" as the comparative reference.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method. The clinical study is described as comparing the device results directly to the standard Doppler method.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not specifically mentioned or described in the provided text. The study focused on the device's performance against a reference method (Doppler probe) rather than measuring improvements in human reader performance with or without AI assistance.

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

Yes, a standalone study was performed. The clinical study evaluated the device's ability to measure ABI/ABPI against the standard Doppler probe method. The device automates the process of inflation, pressure monitoring, and ABI calculation. The reported "r=0.88" is a measure of the algorithm's performance in correlation with the reference.

7. Type of Ground Truth Used

The ground truth used for the clinical study was the standard Doppler probe method for measuring Ankle Brachial Index (ABI). This is a well-established clinical gold standard for ABI measurement.

8. Sample Size for the Training Set

The document does not explicitly state the sample size for any training set. The device utilizes an "oscillometric method" and pre-defined algorithms for calculating ABI. While such systems are developed using data, the 510(k) summary focuses on the validation of the final device, not the specifics of its internal model training.

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

Since a training set sample size or a distinct "training set" study is not detailed, the method for establishing its ground truth is also not described. The device's underlying technology (oscillometry) and algorithms are likely based on established physiological principles and prior data, but the specifics of a training data ground truth are not provided in this document.

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QuantaFlo is intended to aid clinicians in the diagnosis and monitoring of Peripheral Arterial Disease. It provides bilateral, non-invasive physiologic studies of the upper and lower extremity arteries, using volume plethysmography of the posterior tibial and anterior tibial/dorsalis pedis arterial distributions. Additionally, QuantaFlo may be used to perform bilateral, non-invasive physiologic studies of the upper and lower extremity arteries with provocative functional maneuvers.

The device is for adult use and not for pediatric or fetal use.

QuantaFlo aids clinicians in the diagnosis of vascular disease by measuring blood volume changes using volume plethysmography in the Brachial, Posterior Tibial, and Anterior Tibial/Dorsal Pedis arterial distributions. From these signals it calculates a result that is predictive of Peripheral Arterial Disease (PAD). In addition. QuantaFlo provides hard-copy waveforms as part of the report, which may be viewed on the system display, printed, and/or saved.

The clinician places a sensor and makes a measurement on each upper extremity and each lower extremity. The sensor includes a transducer, which detects changes in arterial blood volume. This signal is digitized and sent to a computer, which runs a specifically-designed software application. The application calculates the result via a proprietary algorithm, which is based on the features of the volume plethysmography signals from the Brachial. Anterior Tibial / Dorsalis Pedis, and Posterior Tibial arterial distributions.

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

Acceptance Criteria and Device Performance

The document states that "Product testing was completed and met all of the acceptance criteria," but it does not explicitly list the acceptance criteria in a table format with specific thresholds. Instead, it broadly states that "clinical accuracy in determining the presence of PAD" was the focus for clinical performance.

Study Details

2. Sample size used for the test set and the data provenance:
* Sample Size: 333 limbs for QuantaFlo and 328 limbs for Doppler ABI.
* Data Provenance: The document does not explicitly state the country of origin. It does not mention if the data was retrospective or prospective, but the phrasing "Among six clinical sites, QuantaFlo was 80.2% accurate (n=333 limbs)" suggests a prospective collection for the purpose of the study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* The document does not specify the number of experts used to establish ground truth.
* Qualifications of Experts: Not specified.

4. Adjudication method for the test set:
* The document does not explicitly describe an adjudication method for the test set in terms of expert consensus. It states that "Duplex ultrasound and/or angiography" were used as the "reference standard" (ground truth).

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, an MRMC comparative effectiveness study was not performed as described. The study compares the device's performance (QuantaFlo) against another accepted method (Doppler ABI) in detecting PAD, using a reference standard. It does not evaluate human readers' performance with or without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Yes, a standalone performance assessment was done. The stated accuracy of 80.2% for QuantaFlo is a direct measure of the device's (algorithm's) ability to detect PAD compared to the reference standard, without human interpretation of the device's output. The device "calculates a result that is predictive of Peripheral Arterial Disease (PAD)." It's intended to "aid clinicians," implying the clinician uses the device's output.

7. The type of ground truth used:
* The ground truth used was Duplex ultrasound and/or angiography. These are considered reference diagnostic standards for Peripheral Arterial Disease (PAD).

8. The sample size for the training set:
* The document does not state the sample size used for the training set. It only provides details about the clinical performance study (test set).

9. How the ground truth for the training set was established:
* Since the training set sample size is not mentioned, how its ground truth was established is also not specified.

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The BODYTRONIC 200 is a photoelectric plethysmograph intended for the measurement of the leg vein function.

The BODYTRONIC 200 is based on light reflection rheography. A small quantity of infrared light is radiated into the legs just above the ankles, and the reflected light is measured. On the basis of the quantity of reflected light over a defined period, conclusions can be drawn about the flow of blood in the veins.

The provided text describes the 510(k) Premarket Notification for the Bauerfeind BODYTRONIC 200, a photoelectric plethysmograph. However, it does not contain any information about acceptance criteria, device performance metrics, or experimental studies performed to prove the device meets specific acceptance criteria.

The document focuses on establishing substantial equivalence to a predicate device (Elcat vasoquant VQ1000 D-PPG) based on intended use and technological characteristics, and compliance with various international standards related to electrical safety, EMC, usability, software life-cycle, risk management, biocompatibility, and photobiological safety.

Therefore, I cannot provide the requested information from the given text. The text primarily details:

• Device Description: The BODYTRONIC 200 uses light reflection rheography to measure blood flow in leg veins.
• Intended Use: Measurement of leg vein function.
• Predicate Device: Elcat vasoquant VQ1000 D-PPG (K944395).
• Regulatory Information: Classification as Class II, Product Code JOM, under 21 CFR 870.2780.
• Standards Compliance: Listing of various IEC and ISO standards the device complies with.
• FDA Premarket Notification Outcome: FDA's determination of substantial equivalence.

Without a study report or performance data, I cannot fill out the requested table or answer the specific questions about acceptance criteria, sample sizes, ground truth establishment, expert involvement, or comparative effectiveness studies.

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