(90 days)
The MAC-LAB System is intended for use under the direct supervision of a licensed healthcare practitioner to monitor and/or calculate and/or record cardiovascular data from patients as they undergo cardiac catheterization. Cardiovascular data may be manually entered or acquired via an interfaced GE Marquette TRAM modules (K921669), MUSE cardiovascular system and other interfaced information systems. Data includes: ECG waveforms, heart rate, pulse oximetry (SpO-), respiration rate, valve gradients and areas, cardiac output, hemodynamic measurements, invasive and noninvasive blood pressure, procedural information, and optional intracardiac electrocardiogram (IECG).
Applicable to pediatric/adult patients requiring cardiac/circulatory system catheterization
Intended for use in catheterization and related cardiovascular specialty labs
The MAC-LAB Systems ioin together the TRAM module which is housed in a Remote Acquisition Unit (RAU) with computer processors, software, high resolution display monitors, power supply, thermal printer and a keyboard. Data acquisition modules, depending upon application, are inserted into the RAU and then digital data is transmitted, via cable, to the computers for An optional IECG module (K935394) processing. enables electrophysiological investigations of the heart to be performed. The IECG module consists of electronic amplifiers and other signal processing devices. An IECG cable connects an intracardiac catheter (not covered by this submission) to the IECG system.
This document (K992948) describes a 510(k) premarket notification for the MAC-LAB System, a device intended for monitoring and recording cardiovascular data during cardiac catheterization.
Here’s a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Safety | Compliance with voluntary standards (as detailed in Section 9 of the submission, but not provided in this excerpt). | "The results of these measurements demonstrated that the MAC-LAB system is as safe, as effective, and performs as well as the predicate devices." |
| Effectiveness | The device performs its intended functions (monitor, calculate, record cardiovascular data) comparably to predicate devices. | "The results of these measurements demonstrated that the MAC-LAB system is as safe, as effective, and performs as well as the predicate devices." |
| Performance | Comparison to predicate devices (MAC-LAB Cardiac System, K895801, and MAC-LAB Electrophysiology (IECG) Option, K935394). | "The proposed MAC-LAB Cardiac Catheterization Laboratory System Technology: employs the same functional technology as the predicate devices." |
| "The results of these measurements demonstrated that the MAC-LAB system... performs as well as the predicate devices." | ||
| Quality/Development Process | Adherence to quality assurance measures in development. | Requirements specification review, Code inspections, Software and hardware testing, Safety testing, Environmental testing, Final validation. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The "Test Summary" only lists quality assurance measures and general testing without detailing patient-specific data or cohorts.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The provided text does not mention any expert review or establishment of ground truth for a test set in the context of clinical performance evaluation. The "Test Summary" focuses on internal development and verification processes rather than independent clinical validation with expert consensus.
4. Adjudication Method for the Test Set
The provided text does not describe any adjudication method. This type of detail is typically associated with clinical studies where independent reviewers resolve discrepancies in interpretations or diagnoses, which is not described here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, the provided text does not indicate that an MRMC comparative effectiveness study was done. The focus is on demonstrating substantial equivalence to predicate devices, not on comparing reader performance with and without AI assistance.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
The MAC-LAB System described is a comprehensive cardiac catheterization laboratory system that assists human healthcare practitioners. It is not a standalone algorithm in the sense of an AI-only diagnosis or measurement device. Its intended use is "under the direct supervision of a licensed healthcare practitioner," implying a human-in-the-loop system. The tests described are for the integrated system, not a decoupled algorithm.
7. The Type of Ground Truth Used
The provided text does not explicitly specify the type of ground truth used for performance evaluation in a clinical sense. Given that the device monitors and records various physiological data (ECG, heart rate, blood pressure, etc.) and performs calculations (valve gradients, cardiac output), the "ground truth" would likely involve comparison against:
- Reference standards for physiological measurements: e.g., precisely calibrated sensors or other established methods for measuring heart rate, blood pressure, oxygen saturation.
- Clinical expert interpretation: For waveforms and more complex analyses, though not explicitly detailed here.
- Predicate device output: The primary "ground truth" for demonstrating substantial equivalence seems to be the performance of the legally marketed predicate devices.
8. The Sample Size for the Training Set
The provided text does not mention any "training set." The MAC-LAB System, as described, appears to be a deterministic system for data acquisition, processing, and display, rather than a machine learning or AI-based system that undergoes a separate training phase with a distinct dataset.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set, the establishment of its ground truth is not applicable here.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).