(231 days)
Innocor is indicated for the determination of a number of hemodynamic parameters. Cardiac Output (CO) is the principal measured parameter. Utilizing inert gas rebreathing, Innocor measures the relative levels of two inhaled gases of differing blood solubility over approximately 3-4 respirations and calculates pulmonary blood flow (PBF). In the absence of a significant intrapulmonary shunt (arterial oxygen saturation ≤ 95% as measured by a pulse oximeter incorporated in the Innocor), PBF is equal to CC. As an optional accessory, Innocor includes a noninvasive Blood Pressure (NIBP) monitoring system. This option provides systolic, diastolic and mean arterial pressures. With the NIBP option, Innocor provides values for the following measured and calculated hemodynamic parameters: Cardiac Output, Arterial Oxygen Saturation, Heart Rate, Stroke Volume, Lung Volume, Cardiac Index, troke Index, Blood Pressures (Systolic, Diastolic, Mean Arterial), ystemic Vascular Resistance, Systemic Vascular Resistance Index.
Innocor is a compact point-of-care device intended to be used for measurement of a) cardiac output (CO) utilizing inert gas rebreathing (IGR) technology and b) other hemodynamic parameters. Two Models will be made available initially in the U.S: Innocor, Innocor with NIBP option. With the NIBP module option, the device will provide values for the hemodynamic parameters included in the Indications for Use below.
The provided text for K051907 describes the Innocor device and its substantial equivalence to predicate devices, focusing on its ability to measure cardiac output and other hemodynamic parameters. However, it does not contain the detailed information required to fill out the table and answer the study-related questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement in a clinical study for the Innocor device itself.
The document primarily focuses on establishing substantial equivalence for regulatory purposes by comparing the Innocor's intended use and components (inert gas rebreathing for cardiac output, pulse oximeter, NIBP) to already cleared predicate devices. It lists the predicate devices and the parameters Innocor measures but does not include a specific study design with acceptance criteria and performance metrics for the Innocor.
Therefore, I cannot provide the requested table and detailed study information based solely on the provided text. The output below reflects the information that is not present in the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter / Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Not specified in the provided text | Not specified in the provided text | Not specified in the provided text |
2. Sample Size for Test Set and Data Provenance
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
3. Number of Experts and Qualifications for Ground Truth Establishment
- Number of Experts: Not specified in the provided text.
- Qualifications of Experts: Not specified in the provided text.
4. Adjudication Method for Test Set
- Adjudication Method: Not specified in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? Not specified in the provided text. The document focuses on device equivalence, not human reader performance with or without AI assistance.
- Effect Size of Human Reader Improvement: Not applicable, as an MRMC study is not mentioned.
6. Standalone (Algorithm Only) Performance Study
- Was a standalone study done? The document describes the device's functionality for measuring various parameters. While it performs these measurements, a formal "standalone study" with specific performance metrics against an established ground truth (as typically reported for AI/algorithm performance) is not detailed. The text implies a comparison to methods like Thermodilution and Direct Fick for cardiac output, but not in the format of a standalone performance study with defined criteria and results.
7. Type of Ground Truth Used
- Type of Ground Truth: For the cardiac output measurement, the document mentions substantial equivalence to "Thermodilution Cardiac Output Computers" and the "Direct Fick Method preamendment calculation method." These predicate methods serve as a comparative basis for the Innocor's measurements, implying they represent the "truth" against which the new device is compared. However, a specific ground truth dataset and its source (e.g., pathology, outcomes data, expert consensus on a test set) for Innocor's own validation is not described.
8. Sample Size for Training Set
- Sample Size: Not applicable. The Innocor is described as a device utilizing inert gas rebreathing technology and other measurement components, not an AI/machine learning algorithm that requires a training set in the conventional sense.
9. How Ground Truth for Training Set Was Established
- How Established: Not applicable, as there is no mention of a training set for an AI/machine learning component.
§ 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).