Search Results

When used in combination with a Swan-Ganz catheter connected to a pressure transducer, the Edwards Lifesciences Smart Wedge algorithm measures and provides pulmonary artery occlusion pressure and assesses the quality of the pulmonary artery occlusion pressurement. The Smart Wedge algorithm is indicated for use in critical care patients over 18 years of age receiving advanced hemodynamic monitoring. The Smart Wedge algorithm is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Smart Wedge algorithm parameters.

The Smart Wedge algorithm is designed to provide the value at end-expiration of the pulmonary artery occlusion pressure (PAOP) signal, also called pulmonary wedge pressure, pulmonary capillary wedge pressure (PCWP), or pulmonary artery wedge pressure (PAWP), and to assess the quality of the pulmonary artery occlusion pressure measurement.

The Smart Wedge algorithm is intended to be used with a Swan-Ganz pulmonary artery catheter connected to a pressure cable and pressure transducer.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

The device performance is reported for two main aspects: PAOP (Pulmonary Artery Occlusion Pressure) Identification and PAOP Measurement. The acceptance criteria can be inferred from the reported performance results and the comparison to the predicate device, especially the statement: "Results for the Smart Wedge algorithm met or exceeded predicate device performance." While explicit numerical acceptance criteria aren't listed as "targets," the provided performance values serve as the acceptable outcomes.

Note: The document explicitly states for PAOP Measurement: "PAOP within mean absolute error < 4 mmHg accuracy." This serves as a clear numerical acceptance criterion for MAE.

2. Sample Sizes and Data Provenance

• Test Set (PAOP Identification): 225 PAP waveforms from 129 patients.
• Test Set (PAOP Measurement): 110 PAOP measurements from 59 patients.
• Data Provenance: Retrospectively collected from ICU and OR patients. The country of origin is not specified, but given the Edwards Lifesciences headquarters in Irvine, California, it's likely primarily US-based or multi-site.

3. Number of Experts and Qualifications

• Number of Experts: Three experienced healthcare providers (HCPs) were used to establish the ground truth.
• Qualifications: Described as "experienced healthcare providers (HCPs)." Specific qualifications (e.g., "radiologist with 10 years of experience") are not detailed, but the term "experienced" suggests domain expertise relevant to pulmonary artery occlusion pressure waveforms.

4. Adjudication Method for the Test Set

• For PAOP Identification: "Mode of three HCP annotations." This means the most frequent annotation among the three experts was
  taken as the ground truth.
• For PAOP Measurement: "Average PAOP measurement of three HCPs." This implies the numerical average of the three experts' measurements was used as the ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• The document explicitly states: "No clinical trial was performed in support of the subject 510(k)."
• Therefore, an MRMC comparative effectiveness study, which typically involves human readers improving with AI vs. without AI assistance, was not conducted. The study focuses on the algorithm's performance against expert consensus.

6. Standalone (Algorithm Only) Performance

• Yes, the reported study describes the standalone performance of the Smart Wedge algorithm. The tables ("Performance Results of PAOP Identification" and "Performance Results of PAOP Measurements") present the algorithm's capabilities (Sensitivity, Specificity, MAE, Bias, Correlation) measured against the established expert consensus ground truth. There's no mention of a human-in-the-loop component in the reported performance metrics.

7. Type of Ground Truth Used

• The ground truth used was expert consensus.
  • For PAOP Identification: "Mode of three HCP annotations."
  • For PAOP Measurement: "Average PAOP measurement of three HCPs."

8. Sample Size for the Training Set

• The document does not explicitly state the sample size used for the training set. It mentions the verification was performed using "waveforms retrospectively collected from ICU and OR patients", but the specific number for training versus testing is not provided. The provided numbers (225 waveforms/129 patients for identification, 110 measurements/59 patients for measurement) are for the test set.

9. How Ground Truth for Training Set Was Established

• Similar to the training set sample size, the document does not explicitly detail how the ground truth for the training set was established. Typically, for machine learning models, the training data also requires labeled ground truth, often established similarly to the test set (e.g., expert annotation or other reliable sources). However, this specific 510(k) summary focuses on the verification and validation of the algorithm's performance and the ground truth establishment for the test data.

Ask a specific question about this device

The CARESCAPE™* CO2 - Microstream™ parameter, when connected to the host monitor, is intended to provide professionally trained health care providers with continuous, non-invasive measurement and monitoring of carbon dioxide (CO2) during the respiration cycle, EtCO2, FiCO2, and CO2 based respiration rate for adult, pediatric and neonatal patients, utilizing Microstream™ Advance CO2 sampling lines. The CARESCAPE™* CO2 - Microstream™ parameter is intended for use in hospital-type facilities, during intra-hospital transport between and within areas of care.

The GE CARESCAPE™* CO2 -Microstream™ parameter is a module utilizing Microstream™ Capnography technology designed for use with specific GE Host monitors (CARESCAPE™* ONE. CARESCAPE™* B450 [K213234]. CARESCAPE™* B650 [K213181]. or CARESCAPE™* B850 [K213336]). The GE CARESCAPE™* CO2 -Microstream™ parameter comprised of two main sub-systems: - Microstream™ NanoMediCO2 is a Capnography module in its plastic enclosure called . the NanoPod, responsible for measuring the inspired carbon dioxide and respiration rate of adults, pediatric patients, and neonatal patients, - . U-MCO2-active cable module in its enclosure (called "Active cable" or "Bridge" or "Common block") responsible for enabling the bidirectional communication between the Host monitor and the NanoMediCo2 module, using the specific GE communication protocol (Taq-Length-Data). The Active Cable also acts as a power supply to the NanoPod, transferring power from the host to the pod and provides the user with an indication of the Pod's functional status. The NanoPod mates on one side with the Microstream™ Advance Filter Lines. On the other side the NanoPod attaches to GE patient monitoring system via the U-MCO2- active cable, allowing them to display the Microstream™ Capnography parameters. The U-MCO2 active cable module, is connected to an interface board located inside the active device (NanoPod), while on the other side of the U-MCO2 active cable, there is a proprietary GE (Amphenol) connector, designed to connect solely with GE Healthcare monitors. The NanoPod is activated by Microstream™ Advance Filter Lines that are connected through the blue door located on the upper side of the NanoPod.

The provided text describes the regulatory clearance of a medical device, the CARESCAPE™ CO2 - Microstream™ parameter, and its substantial equivalence to a predicate device. However, it does not include the detailed information required to fulfill the request about acceptance criteria and a study proving the device meets them.

Specifically, the document states:

• "The functional features and the indications for use of the CARESCAPE™ CO2 - Microstream™ parameter are substantially equivalent to the predicate device."
• "The CARESCAPE™ CO2 - Microstream™ parameter has successfully undergone performance, safety, electromagnetic and environmental testing to ensure compliance with expected performance standards."
• "Software testing was performed to validate the performance of the CARESCAPE™ CO2 - Microstream™ parameter and its substantial equivalence to the predicate device."
• "Animal Performance Testing: Not applicable. Animal performance testing was not necessary to show substantial equivalence."
• "Clinical Performance Testing: Not applicable. Clinical evidence was not necessary to show substantial equivalence."

This indicates that the key evidence for this device's performance relies on bench testing and software testing, demonstrating equivalence to a previously cleared device, rather than a de novo clinical study with specific acceptance criteria for a new mode of action or clinical outcome.

Therefore, I cannot provide the requested information about acceptance criteria, detailed study design (sample sizes, ground truth establishment, expert involvement, MRMC studies, etc.). The document explicitly states that animal and clinical performance testing were not necessary to show substantial equivalence, and no such study details are provided.

Ask a specific question about this device