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Disposable ECG Cable and Leadwires are intended to be used with ECG monitoring devices to measure a patient's ECG for general monitoring and/or diagnostic evaluation by heath care professional.

Disposable ECG Cable and Leadwires meets the requirements of the standard ANSI/AAMI EC53, ECG TRUNK CABLES and PATIENT LEADWIRES. This leadwire set is intended for single-patient use.

Disposable ECG Cable and Leadwires with specific various lengths are the replacements for similar cables manufactured by Original Equipment Manufacturers (OEM) and other third party after market manufacturers for their respective monitors.

These devices consist of connectors on each cable end and a shielded bulk cables are used to transfer the signals from the electrodes to the patient monitor.

These devices use the same type of constructions and have the same technological characteristics as the predicate devices. They use a medical grade PVC and TPU cable jacket with medical grade PVC and ABS over molded connectors with integral relief.

The provided text describes the regulatory clearance of a medical device, the "Med-link Disposable ECG Cable and Leadwires," but it does not contain information about a study proving the device meets acceptance criteria in the way you've outlined.

The document is a 510(k) premarket notification summary, which aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through clinical or detailed standalone studies.

Here's a breakdown of why this document doesn't fit your request and what information it does provide:

• Type of Device: The device is a Disposable ECG Cable and Leadwires, which is an accessory to ECG monitoring devices, not a diagnostic algorithm or AI system. Therefore, the concepts of "sensitivity," "specificity," "AI improvement," "training sets," "test sets," "ground truth," or "expert adjudication" as typically applied to AI/ML medical devices are not relevant here.
• Purpose of 510(k): The primary goal of a 510(k) submission is to show that a new device is "substantially equivalent" to a predicate device already on the market, meaning it has the same intended use and technological characteristics, or if there are differences, those differences do not raise new questions of safety and effectiveness.

Given this context, I cannot fill out your requested table and information points as they pertain to a different type of device evaluation (e.g., for an AI/ML diagnostic software).

However, I can extract the information that is relevant to the document provided:

Summary of Device Evaluation (as per the 510(k) Summary):

Acceptance Criteria and Device Performance (based on regulatory standards rather than clinical endpoints):

Here's why the other points you requested are not available in this document:

1. Sample size used for the test set and data provenance: Not applicable. This device is an accessory (cable/leadwire) and its performance is evaluated against engineering/safety standards (IEC, AAMI, ISO), not clinical data sets with "test sets" or "data provenance" in the context of an algorithm. The testing involves bench and type testing of the physical device according to standards.
2. Number of experts used to establish the ground truth... and their qualifications: Not applicable. There is no "ground truth" to establish through experts for an ECG cable's performance in the way a diagnostic algorithm requires. Compliance to standards is verified through laboratory testing.
3. Adjudication method: Not applicable. No human adjudication is mentioned or relevant for electrical and biocompatibility testing of a cable.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is not an AI/ML diagnostic device, so MRMC studies are irrelevant.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
6. The type of ground truth used: Not applicable. The "ground truth" here is compliance with established engineering and safety standards, verified through bench testing.
7. The sample size for the training set: Not applicable. There is no "training set" for an ECG cable.
8. How the ground truth for the training set was established: Not applicable.

In conclusion, the provided document details the "substantial equivalence" of an ECG cable to a predicate device by demonstrating compliance with relevant international and national standards for electrical safety, performance, and biocompatibility through non-clinical (bench and type) testing, not through a clinical study with acceptance criteria for diagnostic accuracy metrics.

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The Stasis Monitoring System is intended for use by clinicians and medically qualified personnel for sinqle or multi-parameter vital signs monitoring of adult patients (≥21 years of age). It is indicated for 3 lead ECG, respiration rate (RESP), heart rate (HR), noninvasive blood pressure (NIBP), noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpOz), pulse rate (PR), and skin temperature (TEMP) in hospital-based facilities; including, general medical-surgical floors, intermediate care floors, and emergency departments. The Stasis Monitoring System includes bedside patient monitors that communicate with mobile tablets through wireless Bluetooth Low Energy (BLE) communication. The Stasis Monitoring System can generate alerts when rate-based cardiac arrhythmias such as asystole are detected, and when physiological vital signs fall outside of selected parameters.

The Stasis Monitoring System has a notification system that communicates data and alarms to a Stasis Tablet. It is intended to supplement the primary alarms which originate at the Stasis Monitor device.

The Stasis Monitoring System consists of a compact six-parameter vital signs monitor that sits at the patient's bedside and communicates via Bluetooth with off the shelf Android tablets running a custom Stasis application. The parameters measured include the following: 3 lead ECG, respiration rate (RESP), heart rate (HR), noninvasive blood pressure (NIBP), noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), and skin temperature (TEMP). The System uses traditional wired sensor technology (i.e., sensors cables are connected to back of Monitor with sensors applied to patient) to acquire the vital signs. All sensors and cables used are off-the-shelf and are already 510(k) cleared as identified in the bulleted list on the following page below. The primary data display and control for the monitoring system is on the Android tablet (see Fig 1 below).

The provided document is a 510(k) summary for the Stasis Monitoring System. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence.

Based on the nature of the device (a vital signs monitor) and the information provided, it's important to note that the acceptance criteria and study details requested are primarily focused on diagnostic or AI/machine learning devices that generate specific outputs requiring human-expert adjudication or comparison to a ground truth.

For a vital signs monitoring system like the Stasis Monitoring System, the "acceptance criteria" are typically related to the accuracy and precision of its measurements (e.g., heart rate, respiration rate, blood pressure, SpO2, temperature) compared to established reference methods or standards, and its ability to correctly generate alarms when vital signs fall outside set parameters. The "study" for such devices often involves bench testing with simulators and/or clinical performance studies to demonstrate measurement accuracy and alarm functionality.

The document refers to various tests performed, but does not provide granular details in the format requested for a diagnostic AI/ML device.

Here's an attempt to extract and interpret the information based on the provided text, addressing each point of your request as much as possible:

1. Table of acceptance criteria and the reported device performance

The document primarily focuses on demonstrating substantial equivalence to the predicate device, Sotera Wireless ViSi Mobile Monitoring System. This means the Stasis Monitoring System is expected to perform "as well as" or similarly to the predicate device. Specific numerical acceptance criteria are not explicitly stated for all parameters in a pass/fail outcome, but rather a comparison of specifications with the predicate.

Note on "Acceptance Criteria": For vital signs monitors, acceptance criteria for accuracy are often specified in relevant IEC standards (e.g., IEC 80601-2-56 for clinical thermometers, IEC 80601-2-27 for ECG, IEC 80601-2-30 for NIBP, etc.). The document states that these standards were used for testing (e.g., IEC 60601-2-27, IEC 80601-2-30, IEC 80601-2-56). The table above primarily lists the performance specifications rather than explicit "acceptance criteria" thresholds.

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

The document states:

• "Testing was conducted in-house by trained personnel using simulators to obtain the functional and accuracy test results."
• "Testing was also conducted by 3rd party trained personnel using simulators to obtain the functional and accuracy test results."

This indicates that the "test set" primarily consisted of simulated data generated by inanimate simulators, not human patient data.

• Sample size: Not specified in terms of number of simulated cases or data points.
• Data provenance: Not applicable in the context of human patients, as simulators were used. The testing was reported as "in-house" and by "3rd party."
• Retrospective or prospective: Not applicable, as simulated data was used.

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)

This question is not directly applicable in the typical sense for this device.

• The "ground truth" for vital signs measurements from simulators is the known output of the simulator itself, which is designed to produce precise and accurate physiological signals according to specifications.
• The document does not mention any human experts establishing ground truth for the simulator outputs; rather, the accuracy of the device's measurements would be compared against the simulator's known parameters.

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

Not applicable. There was no mention of human adjudication for the simulator-based testing. The device's measurements were compared against the simulator's known values.

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. The Stasis Monitoring System is a vital signs monitor, not an AI-assisted diagnostic tool that interprets medical images or complex data for human readers. It provides raw vital sign data and alerts based on pre-set parameters. Therefore, an MRMC study comparing human performance with and without AI assistance is not relevant to this device.

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

Yes, in a sense, the primary testing described is "standalone" performance of the device's measurement capabilities. The system was tested to measure vital signs and generate alerts directly from simulator inputs. The "human-in-the-loop" aspect here refers to clinicians using the monitor, but the accuracy tests evaluate the device's ability to measure and alert autonomously based on its programming and sensor inputs.

• "Testing for Stasis Monitoring System was performed to ensure that all functional requirements have been met, and that core functions execute as expected."
• "Testing was conducted in-house... using simulators to obtain the functional and accuracy test results."

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

The ground truth for the functional and accuracy testing was derived from simulators. The simulators provided known and controlled physiological signals or values against which the Stasis Monitoring System's measurements were compared.

8. The sample size for the training set

Not applicable. The Stasis Monitoring System is a traditional vital signs monitor. It does not appear to employ machine learning algorithms or AI that require a "training set" in the common computational sense (i.e., for learning patterns from data). Its logic for measurement and alarming is based on established physiological principles and programmed algorithms.

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

Not applicable, as there is no mention of a machine learning "training set." The device's operation is based on known physical principles and sensor technology, not data-driven learning.

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The Pure Flow External Counter-Pulsation device is intended for the treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization. In addition, it is intended for use in healthy patients to provide improvement in vasodilation, increased blood flow. It is intended for use under the oversight of a healthcare professional.

The Pure Flow External Counter-Pulsa-tion device is a mechanical device used to increase aortic pressure during early native heart diastole to augment myocardial perfusion, and to decrease aortic pressure during early native heart systole to reduce ventricular workload and vascular afterload.

The PureFlow consists of a main unit, and applied parts (computer monitor, keyboard, flexible tubes which connect to fabric cuffs, inside each cuff is an inflatable plastic balloon), EKG wires, and SpO2 sensors.

PureFlow works on the basis of external counter pulsation. The pressure is created by inflating a series of cuffs (similar to blood-pressure cuffs) that squeeze the extremities (calf's, thighs, buttocks) forcing blood back up to the heart on each heart cycle. This process ultimately restores (by force) sufficient blood flow to parts of the heart that is lacking oxygen. The treatment process generally spans for a period of 1 hour each day for a period of 35 total treatments. ECP Treatment is proven to develop existing pathways of oxygenated blood back to the heart muscle. In other words, External Counterpulsation Therapy restores pathways for adequate & necessary blood flow back to heart through vessels that already exist.

The device also utilizes the following cleared components: Cable/Lead wire (ECG/EKG, SpO2, and Invasive Blood Pressure): K120010 LNCS/M-LNCS Oximetry Sensor: K101896

This document, a 510(k) Summary for the Pure Flow External Counter-Pulsation Device (K173483), describes non-clinical testing performed to demonstrate substantial equivalence to a predicate device, not a study designed to prove the device meets acceptance criteria for a new clinical application or algorithm performance. Therefore, many of the requested categories are not applicable.

Here's an analysis of the provided text in relation to your request:

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

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

• Sample Size (Test Set): For the Pressure Control Timing Measurement Test and Pressure Accuracy Test, "Three models were tested."
• Data Provenance: Not specified, but the tests are non-clinical, likely internal laboratory testing. Country of origin not mentioned. The tests are prospective in the sense that they were designed to evaluate the physical device's performance.

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. This document describes non-clinical performance testing of a physical device, not an AI/algorithm-based diagnostic or prognostic tool that would require expert-established ground truth. The "ground truth" for these tests refers to the expected physical performance of the device as measured by calibrated equipment against established engineering standards.

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

• Not applicable. See point 3.

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 relates to an external counter-pulsation device, not an AI diagnostic/imaging system. No human reader studies are mentioned.

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

• Not applicable. This is a hardware medical device with some software control, not a standalone algorithm. Software verification and validation were done, but this refers to the robust operation of the device's control software, not a standalone algorithmic output.

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

• Non-clinical-specific ground truth: For the Pressure Control Timing Measurement Test and Pressure Accuracy Test, the "ground truth" was established by reference standards (JIS T0601-2-204), which define acceptable ranges for device performance. These are engineering standards, not medical ground truths like pathology or expert consensus.

8. The sample size for the training set

• Not applicable. This document describes the testing of a physical device, and therefore does not involve a "training set" in the context of machine learning or AI models.

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

• Not applicable. See point 8.

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