(294 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No information provided | No information provided |
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.
§ 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.