The External Counterpulsation System, Soulaire 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, and increased blood flow. It is intended for use under the oversight of a healthcare professional.

The External Counterpulsation System, Soulaire device has similar design to the External Counterpulsation System Model ECP-MC3.

The Soulaire system is computer-controlled system that inflates and deflates three pairs of air cuffs in synchronization with the patient's cardiac cycle. The three pairs of cuffs are wrapped around the calves, lower thighs, and upper thighs/buttocks of the patients. As diastde begins, the cuffs inflate separately in sequence from the calves, to the lower thighs, to the upper thighs including the lower buttocks. This inflation sequence generates and impels a counter-pulsation wave, increasing diastolic blood pressure (diastolic augmentation), coronary perfusion pressure and coronary blood flow, and raising cardiac output.

The start of inflation, deflation and cuff pressure can be adjusted by the operator. The system will deflate simultaneously before systole, this will reduce the heart's workload and resistance of blood vessel.

Before ECP treatment, ECG electrodes and Finger Clip plethysmograph Sensor are placed on the patient. The ECG waveform is used to generate triggering signals for cuff inflation and deflation. The plethysmograph waveform is used to monitor the proper timing of the inflation cycle and to indicate the effect of ECP treatment on patient homodynamic.

This FDA 510(k) summary does not contain information about acceptance criteria or specific study results for the Soulaire External Counterpulsation System.

The document indicates that the Soulaire device is a modification of a previously cleared predicate device (ECP-MC3, K190683). The modifications described are primarily related to external structure (adding storage drawers, a keyboard tray, an integrated cool air outlet), changes in dimensions and weight, and a software company logo change.

Crucially, the document states that these modifications did not result in changes to the technological characteristics or performance of the device. Therefore, the submission leverages performance and electrical testing from the previous submission (K190683) and concludes that "Clinical performance is not deemed necessary."

This means:

1. Acceptance criteria and reported device performance: Not applicable from this document, as no new performance data was generated for the modified device. The document asserts that the modified device's performance is equivalent to the predicate.
2. Sample size for test set and data provenance: No new test set data or studies are presented.
3. Number and qualifications of experts for ground truth: Not applicable.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not conducted or reported in this document.
6. Standalone (algorithm only) performance: Not applicable, as this device is not an algorithm-only diagnostic device. It's a therapeutic medical device for physical counterpulsation.
7. Type of ground truth used: Not applicable.
8. Sample size for training set: Not applicable.
9. How ground truth for training set was established: Not applicable.

In essence, the Soulaire device's clearance is based on its similarity to a previously cleared device, with the argument that the minor changes do not impact safety or effectiveness. Therefore, no new clinical or performance studies were provided for this specific 510(k) submission. To understand the original acceptance criteria and studies for the predicate device (ECP-MC3, K190683), one would need to refer to its 510(k) submission documentation.

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

Enhanced External Counterpulsation Device Plus OM-A is a computer-controlled system that applies external pressure via cuffs to the patient's lower extremities in synchronization with the patient's cardiac cycle. When the heart is in its relaxed state (diastole), pressure is applied sequentially; distal to proximal, from the lower legs (calves) to the lower thighs and then the upper thighs and buttocks, to propel blood back to the heart. The consequence is an increase in arterial blood pressure during diastole (diastolic augmentation) resulting in increased coronary perfusion pressure and coronary blood flow. Compression of the extremities also results in an increase in venous return to the heart. Just before the heart ejects blood (systole), air is released rapidly from all the cuffs simultaneously to release the externally applied pressure, allowing the compressed vessels to recover to their normal shape, thereby reducing vascular impedance. As a result, arterial pressure during systole is reduced (systolic unloading), as is cardiac workload. The patient's calves, lower thighs and buttocks are wrapped with cuffs containing air bladders. The patient's ECG is monitored via conventional, high-quality electrodes and detection of the R-wave is used to signal the System when to command sequential inflation of the cuffs. The start and duration of inflation, as well as the start of deflation, are adjustable by the Operator, within limits determined by the System. An algorithm is used to prevent the start of inflation during ejection of blood from the heart and to end inflation and begin deflation prior to the occurrence of the next heartbeat. The pressure applied by the cuffs is also adjustable by the Operator from 150mmHg to 300mmHg (for a patient with a heart rate of 60 bpm). The device also utilizes the following cleared components: ECG/EKG and SpO2: K123711

The provided document is a 510(k) summary for the "Enhanced External Counter Pulsation Device Plus Omay-A." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a new device meets specific performance acceptance criteria for an AI or imaging diagnostic tool.

Therefore, many of the requested categories for describing an AI/imaging device study (e.g., acceptance criteria for diagnostic performance, sample size for test sets, expert ground truth establishment, MRMC studies, standalone performance, training set details) are not applicable to this document.

This document describes a medical device called an "Enhanced External Counter Pulsation Device," which is a therapy device, not a diagnostic AI or imaging device. The performance data provided are related to safety and efficacy standards (biocompatibility, electrical safety, EMC), and comparative functional features, not diagnostic performance metrics.

Specifically addressing your points based on the provided text:

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

• Acceptance Criteria: The document does not define specific "acceptance criteria" in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) because it is a therapeutic device, not a diagnostic tool utilizing AI or advanced image analysis. The "acceptance" here is for market clearance based on substantial equivalence to an existing predicate device, primarily by meeting safety and performance standards (IEC 60601-1, IEC 60601-1-2) and demonstrating similar functional characteristics.
• Reported Device Performance:
  • Biocompatibility: Passed Cytotoxicity, Sensitization, and Irritation tests according to ISO 10993-5 and ISO 10993-10.
  • Non-clinical (Safety & EMC): Passed tests according to IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012 (General requirements for basic safety and essential performance) and IEC 60601-1-2:2014 (Electromagnetic compatibility).
  • Functional Comparison to Predicate (K130439 P-ECP/TI):
    • Triggering Mechanism: Same (R-Wave trigger)
    • Microprocessor: Same (Windows Based)
    • Emergency System Power-down: Same (Red)
    • Pressure Setting: Subject device range (5mmHg to 350mmHg, Error: ± 10mmHg) is within predicate device range (1kPa~50kPa, Error: ± 2kPa)
    • Treatment Time: Subject device range (1min45min) is within predicate device range (1min60min)
    • Cuff System: Same (Three parts: calf, thigh, buttocks)
    • Major Components: Same (Base Unit, Air-Tubes, ECG/SPO2, three Cuffs)
    • Operating Environment: Same (10°C ~30°C; Relative humidity:

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The ECP-MC3 device is intended for the treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization. It is intended for use in healthy patients to provide improvement in vasodilation, and increased blood flow. It is intended for use under the oversight of a healthcare professional.

ECP-MC3 is the most updated designed External Counter Pulsation System for non-invasive treatment of certain cardiovascular and other ischemia related diseases. The ECP-MC3 system is computer-controlled system that inflates and deflates three pairs of air cuffs in synchronization with the patient's cardiac cycle. The three pairs of cuffs are wrapped around the calves, lower thighs, and upper thighs/buttocks of the patients. As diastole begins, the cuffs inflate separately in sequence from the calves, to the lower thighs, to the upper thighs including the lower buttocks. This inflation sequence generates and impels a counter-pulsation wave, increasing diastolic blood pressure (diastolic augmentation), coronary perfusion pressure and coronary blood flow, and raising cardiac output. The start of inflation, deflation and cuff pressure can be adjusted by the operator. The system will deflate simultaneously before systole, this will reduce the heart's workload and resistance of blood vessel. Before ECP treatment, ECG electrodes and Finger Clip plethysmograph Sensor are placed on the patient. The ECG waveform is used to generate triggering signals for cuff inflation and deflation. The plethysmograph waveform is used to monitor the proper timing of the inflation cycle and to indicate the effect of ECP treatment on patient homodynamic.

The provided text describes the 510(k) premarket notification for the "External Counter Pulsation System; Model ECP-MC3". This document focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than proving the device's efficacy through clinical trials or detailed performance metrics against defined acceptance criteria typically seen for AI/ML devices. As such, the standard information requested for AI/ML device acceptance criteria and study design is not present in this document.

Here's a breakdown of why this document doesn't contain the requested information:

• Device Type: The ECP-MC3 is an External Counterpulsation System, a mechanical medical device, not an AI/ML diagnostic or therapeutic device.
• Regulatory Pathway: A 510(k) submission primarily relies on demonstrating substantial equivalence to a predicate device, meaning it has the same intended use, technological characteristics, and safety/effectiveness profile, or if there are differences, they do not raise new questions of safety or effectiveness. This is different from the rigorous performance testing and clinical trials often required for novel or AI/ML-driven devices.
• Focus of Testing: The non-clinical testing mentioned focuses on reliability, pressure control timing, pressure range accuracy, electrical safety, electromagnetic compatibility (EMC), and software verification/validation. These are standard engineering and safety tests for this type of device, not an assessment of AI algorithm performance.
• Lack of AI/ML Specifics: There is no mention of algorithms, machine learning models, training data, ground truth establishment, expert readers, or MRMC studies, which are all pertinent to AI/ML device evaluations.

Therefore, I cannot provide the requested information in the format of a table for acceptance criteria and reported performance, nor can I detail the specifics of an AI/ML study (sample size, experts, adjudication, MRMC, standalone performance, training data) because this information is not applicable to or contained within the provided 510(k) summary for the ECP-MC3 device.

The document explicitly states: "Clinical data were not required in this submission to support a finding of substantial equivalence." and "Clinical performance is not deemed necessary." This further emphasizes that direct performance measurement against clinical outcomes or a specific ground truth, as would be expected for an AI/ML device, was not part of this regulatory submission.

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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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The Renew NCP-5 External Counterpulsation System 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 VO2, and increased blood flow. It is intended for use under the oversight of a healthcare professional.

The Renew"" NCP-5 External Counterpulsation System (ECS) is comprised of the following major components, a switch panel, laptop PC computer, a foldable treatment bed, main unit, and a set of patient cuffs. The device is a microprocessor-controlled system that sequentially inflates then deflates three pairs of air cuffs, which compress vascular beds in the muscles of the calves, thighs, and buttocks in synchrony with the heart cycle to achieve the desired therapy.

This document describes a 510(k) premarket notification for the Renew™ NCP-5 External Counterpulsation System. Unfortunately, the provided text does not contain details about acceptance criteria, a specific study proving the device meets those criteria, or information relevant to an AI/ML-based device evaluation.

The document focuses on:

• The FDA's 510(k) clearance for the Renew™ NCP-5 External Counterpulsation System.
• The device's intended use and technological characteristics (external counterpulsation).
• Biocompatibility, electrical safety, EMC compatibility, and software/firmware validation.
• A "literature review regarding the use of external counterpulsation in healthy patients" to support an additional indication.
• The conclusion of substantial equivalence to its predicate device (ACS Model NCP-2 External Counterpulsation Device).

There is no mention of an AI/ML component in the Renew™ NCP-5 External Counterpulsation System. Therefore, the requested information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, expert adjudication, or MRMC studies for an AI/ML device cannot be extracted from this text.

To answer your specific questions, I would need a different document that details the validation of an AI/ML medical device.

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The intended use of the ECP device is to provide external counterpulsation (ECP) therapy, and is indicated for use in the treatment of stable or unstable angina pectoris, congestive heart failure, cardiogenic shock, and acute myocardial infarction.

Not Found

Here's an analysis of the provided text regarding acceptance criteria and study information for the "External Counterpulsation Device with SPO2 Monitoring, Models P-ECP/T1 and P-ECP/TM":

Based on the provided document, there is no information regarding specific acceptance criteria for device performance, nor details about a study that proves the device meets such criteria.

The document is an FDA 510(k) clearance letter, which primarily states that the device is "substantially equivalent" to legally marketed predicate devices. This type of clearance typically relies on demonstrating equivalence to an existing device rather than necessarily conducting new, extensive performance studies against pre-defined acceptance criteria.

Therefore, the following points will indicate "No information provided" where the requested details are not present in the document.

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)

No information provided. The 510(k) clearance letter does not describe a test set or data provenance for a performance study.

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)

No information provided. The 510(k) clearance letter does not describe a performance study involving expert assessment or ground truth establishment.

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

No information provided. The 510(k) clearance letter does not describe a performance study or adjudication method.

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 information provided. This device is an External Counterpulsation Device, which is a therapeutic device, not an AI-assisted diagnostic device that would typically involve human readers or MRMC studies.

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

No information provided. This is a therapeutic device, not an algorithm-based diagnostic tool.

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

No information provided. The 510(k) clearance letter does not describe a performance study or the type of ground truth used.

8. The sample size for the training set

No information provided. The 510(k) clearance letter does not describe any training set or machine learning components.

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

No information provided. The 510(k) clearance letter does not describe any training set or how ground truth was established.

Summary of Document Contents Related to Performance:

The document is an FDA 510(k) clearance letter, which confirms that the identified devices are substantially equivalent to predicate devices already on the market. This often means that the manufacturer provided data (e.g., engineering specifications, performance testing against industry standards, or comparison to the predicate device's known performance characteristics) to demonstrate that the new device performs as intended and is as safe and effective as the predicate. However, the letter itself does not contain the details of these performance studies or any specific acceptance criteria used. To find such information, one would typically need to review the full 510(k) submission itself, which is not provided here.

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Indications: The Circulator Boot System alone - or in combination with other drug or device therapies - may be prescribed by the physician to treat:

Poor arterial flow in extremities associated with:

• . Ischemic ulcers
• Rest pain or claudication (pain with walking) ◆
• t Threatened gangrene

• Insufficient blood supply at an amputation site

• Persisting ischemia after embolectomy or bypass surgery
• . Pre- and post-arterial reconstruction to improve runoff

Diabetes complicated by the above or other conditions possibly related to arterial insufficiency including:

• Nocturnal leg cramps .
• Necrobiosis diabeticorum

Venous diseases (once risk of emboli minimized):

• . Prophylaxis of deep vein thrombophlebitis
• Edema and induration associated with chronic venous stasis .
• Venous stasis ulcers .

Athletic injuries: "Charlie horses", pulled muscles, and edematous muscles

The Circulator Boot Systems are designed to allow pneumatic compression therapy to any extremity (its whole or a part) as prescribed by a physician. A computer within a heart monitor delays compressions after the detection of the QRS complex to allow maximum inflow of blood into the extremities and signals release of the extremity 0.04 seconds before the time of the next QRS complex to maximally reduce afterload and heart work. The part to be treated is first placed into a double-walled plastic disposable bag (legs or arms) or enclosed by a small cuff (such as an elbow). The bagged extremity is then placed within a rigid plastic boot which is adjusted to limit the dead space around the leg. In the case of K792354, adjustment for differences in the length of the extremity is made by applying one of three different length Long Boots ("A". "B" or "C") while adjustments in the width of the extremity is made by moving inner walls snuggly against the part; adjustments for the A-P (anterior-posterior) dimension are accomplished by arcing the thick plastic aprons attached to the inner side of the lateral movable walls tightly down over the extremity.

The new "Multicrus" boot K082134 is likewise a rigid plastic boot but telescoping and adjustable in all three dimensions: length, height and width to minimize the space around the bagged leg. It is composed of eight overlapping right-angled plastic pieces which are applied firmly against the extremity. Thus, a piece might be placed under the thigh and knee and against the inner part of the leg (as high up the leg as desired). A second piece may be placed against the lateral aspect of the thigh and knee with its bottom section under the first part. These two parts are pushed together to snuggly hug the inner and lateral parts of the extremity. A third part may then be placed against the inner calf and under the heel and distal part of the first part. A fourth part is placed against the lateral calf and foot and under the heel and the third part and under the second part. The third and fourth parts are again pushed together to snuggly hug the calf and foot. The vertical wall of the fifth part is placed between the vertical walls of the first and third parts while its horizontal wall is placed over the upper leg, again as far up the leg as desired. The vertical wall of the sixth part is placed between the vertical walls of the second and fourth parts and its horizontal part is placed to overlap the thigh and the fifth part. Finally, a seventh and eighth part are placed over the top of the lower leg and foot and over the distal horizontal aspects of the fifth and sixth parts and again are pushed together to minimize the dead space around the lower leg. All are held in place by Velcro patches between the overlapping parts and by straps surrounding the assembled boot.

The valve assembly is attached to a plate included on the top of the eighth part and connected then to the compressed air line and the heart monitor. The technician adjusts the pressure knob of the valve assembly as needed to achieve the desired pressure in all of the boot systems. Desired pressures were gained in every patient treated with the Multicrus boot during its five weeks of clinical usage. With all of our boot systems, the physician is encouraged to improvise as necessary to treat patients with special needs (e.g. deformed legs that cannot be straightened out sufficiently to enter our rigid boots). A small cuff is one such improvisation that has allowed treatment of portions of any extremity in concert with treatment of the legs in the Long Boots. This small "Cuff Boot"consists of a juvenile blood pressure cuff to surround the extremity (perhaps a tennis elbow) with a bladder from an adult blood pressure cuff connected to both it and a air-bulb. The bladder is placed over the thigh and beneath the plastic airbag of the Long Boot and, hence, is compressed simultaneously with the leg. The small cuff applies pressure in end-diastole with the same pressure introduced into the Long Boot.

The provided text does not contain information about acceptance criteria or a study designed to prove a device meets specific performance metrics. Instead, it is a Premarket Notification 510(k) Summary for the "Multicrus Circulator Boot System," focusing on demonstrating substantial equivalence to a predicate device.

The document discusses the device's description, intended use, and a summary of technological characteristics compared to predicate devices. It states: "The summary above shows that there are no new questions of safety and effectiveness for the Multicrus Boot as compared to the predicate device."

It includes a section titled "SUMMARY OF NONCLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807 .92(b)( 1 Y)3)", which mentions: "The Verification and Validation data was accumulated in the clinic." However, no details about specific acceptance criteria, study design, sample sizes, ground truth establishment, or performance metrics are provided.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding sample sizes, ground truth, adjudication methods, or MRMC studies, as this information is not present in the provided text.

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The intended use of the ScottCare Genesis ECP device is to provide external counterpulsation (ECP) therapy, and is indicated for use in the treatment of stable or unstable angina pectoris, congestive heart failure, cardiogenic shock, and acute myocardial infarction.

The "Genesis" is a non-invasive medical device for performing external, sequential counterpulsation. It is a microprocessor-controlled system that inflates and deflates three pairs of air cuffs, which compress vascular beds in the muscles of the calves, thighs, and buttocks to achieve the desired therapy. The microprocessor's primary function is to serve as an R-wave detector, calculate the R-wave rate (heart rate), and deliver triggering signals to actuate valves that allow the cuffs to be filled during the diastolic period and then emptied prior to systole. The secondary function of the microprocessor is to output, through a serial port, information necessary for displaying patient treatment data on a video monitor. This data allows a trained operator to finetune the inflation/deflation signals to optimize a patient's diastolic augmentation. The cuffs are snugly wrapped around the patient's calves, thighs, and buttocks to allow compression of vascular beds in these body areas. To prevent skin irritation the patient is typically dressed in tight fitting, stretchable treatment pants prior to being fitted with the cuffs. As diastole begins, the cuffs inflate sequentially proceeding from the calves, to the thighs, to the buttocks, with the inflation sequence taking a total of approximately 200ms. The inflation sequence generates and drives an arterial counter pulsation wave creating an increase in coronary perfusion pressure and coronary blood flow. The compression sequence also increases venous return, which increases stroke volume and cardiac output. At the end of diastole, and just before the next QRS complex, the cuffs are evacuated simultaneously over a period of approximately 120ms. The course of treatment is typically 35 1-hour treatments administered 5 days a week. The device automatically stops compression of the cuffs and releases all pressure in the cuffs upon completion of the pre-set treatment timer. The system consists of two major assemblies: 1) the patient bed that houses the electronic pneumatic controls / valves, compressor / vacuum pump and associated power supplies and 2) the operator's console that consists of an all-in-one computer/monitor, computer peripherals (keyboard and pointing device) and a control panel.

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) summary for the "ScottCare Genesis ECP Device," primarily focused on demonstrating substantial equivalence to a predicate device.

It lists:

• Device Description: How the ECP device works.
• Indications for Use: The medical conditions the device is intended to treat.
• Substantial Equivalence Comparison: A table comparing features of the new "Genesis" model with the predicate device "NCP-1 Counter Pulsation Device."
• Conclusion: States that testing (without details on specific acceptance criteria or results) demonstrated the device functioned as designed and complied with IEC60601 safety and EMC requirements. It concludes substantial equivalence to the predicate device.
• FDA Clearance Letter: Confirms the 510(k) clearance based on substantial equivalence.

There is no mention of:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets or data provenance.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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The intended use of the ECP Health System Model 2005 is for the treatment of patients with: (1). Stable or unstable angina pectoris. (2). Acute myocardial infarction (3). Cardiogenic shock (4). Congestive heart failure

ECP Health System Model 2005 is a positive and negative pressure integrated, non-invasive medical device for performing external sequential counterpulsation. It is a microprocessor-controlled system that inflates and deflates three parts of air cuffs which compress vascular beds in the calves, lower thighs, and upper thighs /buttocks to achieve the desired therapy.

This 510(k) premarket notification is for an External Counterpulsation Device (ECP Health System Model 2005). It does not involve an AI/ML component, therefore, many of the requested categories (acceptance criteria, study details, expert involvement, ground truth, training data, etc.) are not applicable in the context of an AI/ML device.

The submission focuses on establishing substantial equivalence to a predicate device (S-TCT Health External Counterpulsation Device, K030587), primarily by demonstrating similar technological characteristics and expanding the indications for use.

Here's a breakdown of the requested information based on the provided text, highlighting where the information is not applicable for a non-AI/ML device:

1. Table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly defined in terms of quantitative performance metrics for a novel AI/ML algorithm. For this type of device, acceptance is based on demonstrating substantial equivalence to a legally marketed predicate device. This involves showing similar technological characteristics and safety/effectiveness.
• Reported Device Performance: Not reported in terms of specific performance metrics that would be applicable to an AI/ML device (e.g., sensitivity, specificity, AUC). The "performance" is implicitly demonstrated through the claim of substantial equivalence to the predicate device, which itself has established safety and effectiveness. The device's function is described as inflating and deflating three parts of air cuffs to achieve desired therapy.

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

• N/A. This is not an AI/ML device and therefore does not have a "test set" for algorithm evaluation in the traditional sense. The submission relies on a comparison to a predicate device already on the market.

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)

• N/A. This is not an AI/ML device and does not involve establishing ground truth for evaluating an algorithm's performance on a test set.

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

• N/A. This is not an AI/ML device.

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. This is not an AI/ML device, so no MRMC study comparing human readers with and without AI assistance was conducted.

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

• No. This is not an AI/ML device. It is a physical medical device (External Counterpulsation System) for therapy. Its operation does not involve a standalone algorithm performing diagnostic or predictive tasks.

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

• N/A. For this type of device, ground truth in the context of AI/ML evaluation is not relevant. The device's effectiveness is tied to its physiological mechanism and clinical outcomes (treatment of conditions like angina, MI, CHF), which would have been established for the predicate device through clinical trials. The current submission focuses on technological equivalence.

8. The sample size for the training set

• N/A. This is not an AI/ML device and does not have a "training set" in the context of machine learning.

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

• N/A. This is not an AI/ML device.

Summary regarding the study and acceptance:

The "study" in this context is the 510(k) premarket notification process itself, which aims to demonstrate that the ECP Health System Model 2005 is substantially equivalent to a predicate device (S-TCT Health External Counterpulsation Device, K030587).

• Basis for Acceptance: The FDA's acceptance (clearance) is based on the determination of substantial equivalence. This means the device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness as compared to the predicate device.
• Key Differences & Justification: The key differences noted for the ECP Health System Model 2005 are enlarged indications for use (adding Congestive Heart Failure and Unstable Angina Pectoris) and the addition of a finger pulse oximetry function. The submission explicitly states that "Technological and functional characteristics... are essentially the same as those of the predicate device." This assertion, combined with supporting documentation (not fully provided in the excerpt but implied by the 510(k) process), forms the basis for the FDA's "finding of substantial equivalence."
• No specific performance study in the AI/ML sense: The provided text does not describe a clinical study with performance metrics (like sensitivity, specificity, accuracy) that would be typical for an AI/ML device. Instead, the focus is on the device's design, intended use, and comparison to an already cleared device.

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The Cardiomedics, Inc., CardiAssist Counter Pulsation System - Series 4000 is intended to provide external Counterpulsation (ECP) for the treatment of ischemic heart disease by increasing perfusion during diastole in people with chronic angina pectoris, congestive heart failure, myocardial infarction and cardiogenic shock. Use of this device may reduce pain and impairment associated with angina pectoris, congestive heart failure or myocardial infarction and may enhance coronary function.

The Cardiomedics CardiAssist External Counter Pulsation System - Series 4000 is a non-invasive circulatory assist device, which provides increased circulation via external counterpulsation (ECP) for the treatment of ischemic heart disease including congestive heart failure, chronic angina pectoris, acute myocardial infarction and cardiogenic shock. External counterpulsation therapy improves cardiac function by enhancing the perfusion of the coronary vasculature, the development of coronary collateral circulation, and by reducing the workload of the heart. The CardiAssist External Counter Pulsation System - Series 4000 consists of the portable console containing the computer and pumps with a touch screen for user interface, an integral patient chart printer, and leg cuffs and hoses. Additional components provided with the System include a finger plethysmograph and 5-lead ECG cable and leads (12 lead optional) and blood pressure cuff. This CardiAssist ECP System sequentially compresses the legs from the calves, thighs and buttocks, 40 milliseconds apart, by inflating three sets of flexible fabric cuffs during diastole. This results in movement of blood from the legs to the heart and entire upper body. Pressure, up to 310 mmHg, is applied with the timing and duration of each pulse, synchronized with the patient's ECG. When properly triggered, the pressure pulses applied to the vascular bed of the legs and buttocks transmit retrograde pressure through the entire vascular system. At the aorta, the aortic valve prevents retrograde flow into the left ventricle. Thus, a peak pulse of diastolic pressure occurs at or above systolic levels, which increases the driving pressure in the coronary vasculature.

The provided document is a 510(k) notification for the Cardiomedics CardiAssist Counter Pulsation System – Series 4000. This type of document is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device.

The document describes the device, its intended use, and its similarities to predicate devices. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the performance of the device. It is a regulatory submission for substantial equivalence.

Therefore, I cannot provide the requested information based on the given text.

The document does NOT contain:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes used for the test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for the test set.
5. Information on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or effect size.
6. Information on a standalone (algorithm only) performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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