(97 days)
The TandemHeart Escort Controller is intended to be used with the TandemHeart PTVA System. The TandemHeart PTVA System consists of the TandemHeart PTVA Blood Pump, a single use, disposable device; The TandemHeart Escort (T.H.E.) Controller, a reusable control system for the TandemHeart PTVA Blood Pump; and disposable accessory items used in conjunction with the TandemHeart PTVA System. In the U.S., the TandemHeart PTVA System is intended for extracorporeal circulatory support using an extracorporeal bypass circuit. Intended duration of use is for periods appropriate to cardiopulmonary bypass, up to six hours. It is also intended to be used as an extracorporeal circulatory support system (for periods up to six hours) for procedures not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, mitral valve reoperation, surgery of the vena cava and/or aorta, liver transplant, etc.)
The TandemHeart Escort (T.H.E) Controller is a microprocessor-based pump motor drive and infusion system. It is designed to operate on AC current (110/240 VAC, 50/60 Hz) or on internal, rechargeable batteries for intra-hospital transport. The T.H.E Controller generates the signals required to power the drive motor of the TandemHeart Blood Pump, which turns the impeller to propel blood through the Pump. The system works independently of the heart. The Controller also serves to deliver the infusate into the TandemHeart Blood Pump and to provide information regarding system performance including measured flow. It is portable and designed to be pole mounted, hung from a horizontal bed rail, or placed on a table top. It is simple to use, with an integral backup motor control circuit, and backup batteries for redundant operation.
The provided text is a 510(k) summary for the TandemHeart Escort Controller, a medical device used for cardiopulmonary bypass. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study for meeting specific acceptance criteria on clinical performance. Therefore, many of the requested elements (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, ground truth details) are not applicable or cannot be extracted from this document as no clinical performance study is described.
Here's an attempt to answer the questions based only on the provided text, indicating when information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured/verified) | Reported Device Performance (How the device performed against criteria) |
|---|---|
| Conformance to CardiacAssist performance specifications established for the device | Performance characteristics "were tested and compared with CardiacAssist performance specifications established for the device." (No specific quantitative performance metrics are provided, but the statement implies successful conformance.) |
| Conformance to voluntary standards for EMC (Electromagnetic Compatibility) | Performance characteristics "were tested and compared with... voluntary standards for EMC." (Implied conformance to these standards.) |
| Conformance to voluntary standards for Electrical Safety | Performance characteristics "were tested and compared with... voluntary standards for... Electrical Safety." (Implied conformance to these standards.) |
| Equivalence to the commercially available predicate device (AB-180 XD Blood Pump Controller) | The T.H.E. Controller "employs the same functional scientific technology as its predicate device." It has "the same intended use and indications for use as its predicate." Its "primary function... remains the same as its predicate, which is to supply Blood Pump motor power and motor control." The changes (Color LCD, smaller case, optional blood flow sensor) "raise no new safety or effectiveness issues." Based on these comparisons, the FDA determined the device is "substantially equivalent" to legally marketed predicate devices. |
2. Sample size(s) used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable / Not provided. This document describes a comparison to design specifications and predicate device characteristics, not a clinical study on a patient sample.
- Data Provenance: Not applicable / Not provided.
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 / Not provided. No test set requiring expert-established ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided.
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 MRMC comparative effectiveness study was done or reported. This device is a pump speed controller, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is hardware with integrated software for pump control, not a standalone algorithm in the typical sense of AI/ML. The performance review focused on the device's conformance to its specifications and equivalence to a predicate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / Not provided. The "truth" used for comparison was CardiacAssist's own performance specifications, voluntary standards (EMC, electrical safety), and the established characteristics of the predicate device.
8. The sample size for the training set
- Not applicable / Not provided. As no AI/ML clinical performance study is described for this device, there is no "training set" in that context.
9. How the ground truth for the training set was established
- Not applicable / Not provided.
§ 870.4380 Cardiopulmonary bypass pump speed control.
(a)
Identification. A cardiopulmonary bypass pump speed control is a device used that incorporates an electrical system or a mechanical system, or both, and is used to control the speed of blood pumps used in cardiopulmonary bypass surgery.(b)
Classification. Class II (performance standards).