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The Shape-HF™ Cardiopulmonary Testing System is a pulmonary function stationary testing system intended to be used to monitor cardiopulmonary functions during stress testing, rehabilitation, sports medicine, and other related procedures for which cardiopulmonary gas exchange measurements are medically indicated. The System provides predictive pulmonary function values that are calculated based on the data obtained during testing. The System can be used on adults and children older than 14 years old in a laboratory or clinical facility setting.

The Shape-HF Cardiopulmonary Exercise Testing System is a stationary device that monitors parameters during laboratory or clinical conditions. The Shape-HF system is comparable to the Cortex Metalyzer 3BTM system (K993641). The device is software driven and electrically operated.

The provided text is a 510(k) summary for the Shape-HF™ Cardiopulmonary Testing System. It describes the device, its intended use, and its comparison to a predicate device (Cortex Metalyzer 3B™). The summary emphasizes the substantial equivalence of the new device to the predicate.

However, the provided document does not contain details about specific acceptance criteria or a study that rigorously proves the device meets such criteria with defined metrics and statistical analysis. It focuses on establishing substantial equivalence based on similarities in intended use, applications, usage location, and technology with the predicate device.

Therefore, many of the requested items cannot be extracted directly from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided. The document does not specify quantitative acceptance criteria (e.g., accuracy, precision) for device performance or present a table of reported performance against such criteria. It instead states that the device is "substantially equivalent" to a predicate, implying that its performance is expected to be similar or within acceptable limits as defined for the predicate.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Cannot be provided. The document does not describe any specific test set size, data provenance, or study design (retrospective/prospective) for evaluating the Shape-HF system's performance.

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)

• Cannot be provided. There is no mention of a test set, ground truth establishment, or experts involved in such a process.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Cannot be provided. As no test set or expert evaluation is described, there is no mention of an adjudication method.

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

• Cannot be provided. This document describes a "Predictive Pulmonary Function Value Calculator" and general cardiopulmonary testing. There is no indication of AI assistance, human reader involvement, or an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Cannot be fully determined, but it's implied. The device is described as "software driven" and provides "predictive pulmonary function values that are calculated based on the data obtained during testing." This suggests an algorithmic component. However, the document does not detail a standalone performance study where the algorithm's output was evaluated independently of any human interpretation or intervention, nor does it present specific performance metrics for such a standalone evaluation. The focus is on the overall system's equivalence to a predicate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Cannot be provided. There is no mention of ground truth in the context of the device's performance evaluation in this document.

8. The sample size for the training set

• Cannot be provided. While the device calculates "predictive pulmonary function values," and such calculations often involve algorithms trained on data, the document does not provide any information about a training set, its size, or how it was used.

9. How the ground truth for the training set was established

• Cannot be provided. As there is no mention of a training set, there is no information on how its ground truth was established.

Summary of what the document focuses on instead:

The provided document, a 510(k) summary, primarily aims to demonstrate "substantial equivalence" of the Shape-HF™ Cardiopulmonary Testing System to a legally marketed predicate device (Cortex Metalyzer 3B™). This is achieved by highlighting:

• Equivalent Intended Use: Both devices monitor cardiopulmonary functions during stress testing, rehabilitation, sports medicine, etc., for adults and children over 14 years old in laboratory/clinical settings.
• Similar Technology: Both use non-dispersive infrared for CO2 sensing and electrochemical fuel cells for O2 sensing. They also measure the same variables for pulmonary function calculations.
• Minor Differences in Standard Technology: While there are differences (e.g., pulse oximeter vs. Polar Belt for heart rate, fixed orifice pneumotach vs. digital rotameter for volume transducer), these are considered "standard technology" and not significant enough to raise new questions of safety or effectiveness.

In summary, the document asserts that because the Shape-HF system is substantially equivalent to an already approved device, it meets the necessary regulatory requirements without needing to present novel performance data against specific, quantitative acceptance criteria in this submission.

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