(93 days)
Current indications for use of the ACS™ Model NCP-2 are:
. Stable Angina Pectoris
. Unstable Angina Pectoris
Acute Myocardial Infarction .
Cardiogenic Shock .
Congestive Heart Failure
The ACS Model NCP-2 External Counterpulsation Device (ECP) is comprised of three major components, a Control Console, a Treatment Bed, and a set of patient Cuffs. The device 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 therary.
The Control Console is comprised of a signal amplifier module, a power module, a microprocessor control module, a keyboard control panel with trackball, a Liquid Crystal Display (LCD) panel, and a Personal Computer (PC) with storage drives, data entry QERTY keyboard, network card, and printer. Control console input and data from the ECG, finger plethysmograph, and the pressure/vacuum transducers are processed by the microprocessor to control the valve timing and pressure delivered to the cuffs. Treatment pressure is monitored with an internal pressure sensor and the operator-selected set point maintained by a closed-loop control system. Valve inflation and deflation timing is also set by the operator based on the relative position of the R-wave of the patients ECG.
The PC is used to enter patient demographics, record pre and post-treatment data, and process data acquired by the microprocessor module to display user feedback for the ECP treatment on the LCD showing treatment parameters and patient waveforms during use.
An internal hard disk drive is used to store data on the system, a CD/DVD drive is used to record data onto removable media, and a printer is used to produce hard copy of a report that includes all of the pertinent treatment data for individual treatments and a session summary of all treatment data collected for 35 or more days.
The Treatment Bed accommodates the air compressor, a pressure and vacuum reservoir, inflation and deflation valves and a motorized lifting mechanism for the mattress assembly. The motorized lifting mechanism is used to move the mattress up and down, providing a convenient height for patient and operator use. The valve assembly consists of three pairs of inflation and deflation valves that open and close on command to inflate or deflate the patient Cuffs with air. The valve manifold assembly is connected to the air compressor and pressure/vacuum reservoir components via connecting air hoses. External pressure is delivered to the lower extremities of the patient in synchronization with the heart, i.e. the cuffs compress vascular beds in the calves, lower thighs and upper thighs/buttocks on inflation.
When the heart is in its relaxed state during the diastolic period, pressure is applied sequentially from the calves, to the lower thighs, to the upper thighs and buttocks, forcing blood back to the heart, increasing coronary perfusion pressure and coronary blood flow (diastolic augmentation), as well as venous return, Immediately before the heart begins to eject blood during the next systolic phase, the Cuffs are rapidly deflated and all externally applied pressure is eliminated. The vasculature in the lower extremities re-conforms and is able to receive the output of the heart with lessened resistance, thereby reducing systolic pressure and the workload of the heart (decreased after-load).
Stretchable treatment pants comprised of cotton and Lycra (Spandex) are worn by the patient under the Patient Cuff Set to allow for greater comfort during treatment.
The provided text does not contain detailed acceptance criteria and performance data in a quantifiable manner that would typically be found in a study demonstrating device efficacy to meet specific thresholds. Instead, it focuses on regulatory submission aspects, including comparison to a predicate device and non-clinical/clinical testing for substantial equivalence.
However, based on the information provided, here's an attempt to structure the answer according to your request, acknowledging the limitations of the input text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission for the ACS Model NCP-2 External Counterpulsation Device primarily focuses on demonstrating substantial equivalence to a predicate device (Nicore NCP (ESP) External Counterpulsation Device). Therefore, the "acceptance criteria" are implied by meeting the established safety and performance characteristics of the predicate. The "reported device performance" is essentially that it operates identically and safely.
| Acceptance Criteria Category | Specific Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Functional Equivalence | Identical principles of operation and functionality to the predicate device. | "Principles of operation are identical." |
| Safety | Meet safety requirements as identified in safety risk analysis (EN 1497-1-1, IEC 601-1-4). | Non-clinical testing included safety risk analysis and verification of system operation to these standards. |
| Software Validation | Software functions as defined in requirements specifications, undergoes boundary/stress testing, and validated according to FDA guidance (May 1998, January 2002) and IEC 601-1-4. | Software verification and validation performed, addressing functional, boundary, stress, and safety requirements. |
| Biocompatibility | Meet recognized standards for biocompatibility (ISO 10993-1, -5, -10, -12). | Additional verification tests performed at the component level to recognized ISO standards for biocompatibility. |
| Intended Use | Device is safe and effective for the same indications for use as the predicate device. | "ACS Model NCP-2 ... is a non-invasive external Counterpulsation device intended for the use in the treatment of patients with stable or unstable angina pectoris, acute myocardial infarction, cardiogenic shock or congestive heart failure." |
| Clinical Equivalence | Clinical results demonstrate substantial equivalence to the predicate device. | "An Independent Review Board has overseen the clinical investigation... Results have demonstrated substantial equivalence to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "An Independent Review Board has overseen the clinical investigation of the External Counterpulsation Device. Results have demonstrated substantial equivalence to the predicate device."
- Sample Size for Test Set: Not specified in the provided text.
- Data Provenance: Not specified. It's unclear if the data was retrospective or prospective, or the country of origin.
3. Number of Experts and their Qualifications for Ground Truth
The document mentions an "Independent Review Board" overseeing the clinical investigation.
- Number of Experts: Not specified.
- Qualifications of Experts: The specific qualifications (e.g., medical specialty, years of experience) of the members of the Independent Review Board are not specified.
4. Adjudication Method for the Test Set
The document does not provide details on the adjudication method used for the clinical investigation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned. The submission focuses on demonstrating substantial equivalence of the device itself rather than its effectiveness in aiding human readers in interpretation or diagnosis.
6. Standalone (Algorithm Only) Performance
The device described is a physical medical device (External Counterpulsation Device) that provides therapy, not an algorithm for diagnosis or interpretation. Therefore, the concept of "standalone (i.e. algorithm only without human-in-the loop performance)" does not apply in this context.
7. Type of Ground Truth Used
The "clinical investigation" demonstrating substantial equivalence suggests that patient outcomes, clinical parameters, and potentially comparisons to the efficacy of the predicate device would form the basis of the "ground truth." However, the specific type of ground truth data (e.g., detailed clinical endpoints, symptom resolution, physiological measurements) is not specified.
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of an AI/ML algorithm. The device is a hardware and software system for therapy. The software validation involved functional testing and stress testing, but this is distinct from data-driven training of a machine learning model.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set for an AI/ML algorithm, this question is not applicable. The "ground truth" for the device's functionality and safety was established through adherence to engineering specifications, recognized safety and biocompatibility standards, and clinical investigation demonstrating equivalence to the predicate device.
§ 870.5225 External counter-pulsating device.
(a)
Identification. An external counter-pulsating device is a noninvasive, prescription device used to assist the heart by applying positive or negative pressure to one or more of the body's limbs in synchrony with the heart cycle.(b)
Classification. (1) Class II (special controls) when the device is intended for the treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization. The special controls for this device are:(i) Nonclinical performance evaluation of the device must demonstrate a reasonable assurance of safety and effectiveness for applied pressure, synchronization of therapy with the appropriate phase of the cardiac cycle, and functionality of alarms during a device malfunction or an abnormal patient condition;
(ii) Reliabilities of the mechanical and electrical systems must be established through bench testing under simulated use conditions and matched by appropriate maintenance schedules;
(iii) Software design and verification and validation must be appropriately documented;
(iv) The skin-contacting components of the device must be demonstrated to be biocompatible;
(v) Appropriate analysis and testing must be conducted to verify electrical safety and electromagnetic compatibility of the device; and
(vi) Labeling must include a detailed summary of the device-related and procedure-related complications pertinent to use of the device.
(2) Class III (premarket approval) for the following intended uses: Unstable angina pectoris; acute myocardial infarction; cardiogenic shock; congestive heart failure; postoperative treatment of patients who have undergone coronary artery bypass surgery; peripheral arterial disease associated with ischemic ulcers rest pain or claudication, threatened gangrene, insufficient blood supply at an amputation site, persisting ischemia after embolectomy or bypass surgery, and/or pre- and post-arterial reconstruction to improve runoff; diabetes complicated by peripheral arterial disease or other conditions possibly related to arterial insufficiency including nocturnal leg cramps and/or necrobiosis diabeticorum; venous diseases, including prophylaxis of deep vein thrombophlebitis, edema (e.g., chronic lymphedema) and/or induration (e.g., stasis dermatitis) associated with chronic venous stasis, venous stasis ulcers, and/or thrombophlebitis; athletic injuries, including Charley horses, pulled muscles and/or edematous muscles; necrotizing cellulitis.
(c)
Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with FDA on or before March 31, 2014, for any external counter-pulsating device, with an intended use described in paragraph (b)(2) of this section, that was in commercial distribution before May 28, 1976, or that has, on or before March 31, 2014, been found to be substantially equivalent to any external counter-pulsating device, with an intended use described in paragraph (b)(2) of this section, that was in commercial distribution before May 28, 1976. Any other external counter-pulsating device with an intended use described in paragraph (b)(2) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.