(89 days)
The Endo PAT 2000 device is a non-invasive device, intended for use as a diagnostic aid in the detection of coronary artery Endothelial Dysfunction (positive or negative) using a reactive hyperemia procedure.
The Endo PAT 2000 has been shown to be predictive of coronary artery Endothelial Dysfunction in the following patient population: patients with signs or symptoms of ischemic heart disease, who are indicated for coronary artery angiography, but who lack angiographic evidence of obstructive coronary artery disease. The device is intended to be used in a hospital or clinic environment by competent health professionals
The Endo PAT 2000 device is not intended for use as a screening test in the general patient population. It is intended to supplement, not substitute, the physician's decision-making process. It should be used in conjunction with knowledge of the patient's history and other clinical findings.
The Endo PAT 2000 consists of a main control unit, finger probes and tubing and a software package. The Endo PAT 2000 main control unit is connected to two independent, thimble-shaped, finger mountable probes via two air-conducting tubes. A standard PC or Laptop is connected to the Endo PAT 2000 main control unit for on line display and archiving of device recordings and off line analysis. The output of the Endo PAT 2000 probe are pressure fluctuations sensed at its distal compartment induced by the volume changes of the pulsating digital arteries.
The Endo PAT 2000 system consists of two separate platforms connected by RS-232 channels:
- A PC platform running the custom "Endo PAT 2000 application . program"
- An Endo PAT 2000 Main Control Unit with a micro-controller (8257) . running a custom embedded program
Here's a breakdown of the acceptance criteria and the study details for the Endo PAT 2000 device, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative acceptance criteria (e.g., minimum sensitivity or specificity thresholds) for the Endo PAT 2000. It refers to "acceptable sensitivity and specificity" from a comparative study. Without specific numeric targets, it's difficult to create a table of predefined acceptance criteria versus reported performance in the conventional sense.
However, based on the description, the primary "acceptance criterion" was statistically demonstrating "acceptable sensitivity and specificity" when compared to the gold standard.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Acceptable sensitivity in detecting coronary artery Endothelial Dysfunction | Statistical analysis showed "acceptable sensitivity" |
| Acceptable specificity in detecting coronary artery Endothelial Dysfunction | Statistical analysis showed "acceptable specificity" |
| Safety (no adverse events) | "no adverse events related to the device were reported" |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in terms of a specific number of patients. The document mentions "Study population included intent to treat patients."
- Data Provenance:
- Country of Origin: Not explicitly stated, but the applicant (Itamar Medical Ltd.) is located in Caesarea, Israel.
- Retrospective or Prospective: Not explicitly stated whether the study was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: The ground truth was established by the "Intracoronary Acetylcholine (Ach) Challenge method," which is described as a procedure performed by medical professionals in a cardiac catheterization laboratory. The qualifications of the individuals performing this gold standard procedure are not detailed (e.g., "radiologist with 10 years of experience").
4. Adjudication Method for the Test Set
- No explicit adjudication method (e.g., 2+1, 3+1) is mentioned for the interpretation of the gold standard results or the Endo PAT 2000 results. The gold standard method itself involves calculations of coronary blood flow and diameter in response to the Ach challenge.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly stated as having been performed. The study compared the device against a "Gold Standard" procedure, not primarily against human readers, in the context of improving human reader performance.
6. Standalone Performance Study (Algorithm Only)
- Yes, a standalone study was performed. The "Clinical Study" directly evaluated the Endo PAT 2000 device's performance (sensitivity and specificity) against the "Gold Standard" Intracoronary Acetylcholine (Ach) Challenge method. This indicates a standalone assessment of the algorithm/device's diagnostic capability.
7. Type of Ground Truth Used
- Type of Ground Truth: Expert-defined procedure-based truth. The "Gold Standard" was the "Intra-coronary Acetylcholine (Ach) Challenge method," which measured endothelium-dependent and endothelium-independent coronary flow reserve. This method is considered the definitive measure for coronary artery Endothelial Dysfunction.
8. Sample Size for the Training Set
- The document does not mention a separate training set or its sample size. The description of the "Clinical Study" focuses on an evaluation against a gold standard, implying that the mentioned study population served as the test set for evaluating the device's performance. For a 510(k) submission, device performance is often evaluated on a single dataset without explicit mention of a training/testing split or separate training data if the algorithm was already developed.
9. How the Ground Truth for the Training Set Was Established
- As no separate training set is mentioned, this question is not applicable based on the provided text.
§ 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).