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The Shape-HFTM 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 Testing System is a stationary device that monitors parameters during laboratory or clinical conditions. The Shape-HF™ Cardiopulmonary Testing System evaluates multiple variables of cardiorespiratory function. The System is intended to be used as a tool to aid in:

1. Cardiopulmonary health assessment;
2. Assessing heart and lung disease and defining probable sources of heart and/or lung limitations;
3. Assessing patient risk in heart and/or lung disease;
4. Assessing and monitoring physiological response to therapy, including pharmaceutical and/or medical device intervention; and
5. Assessing fitness levels and exercise tolerance.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Shape-HFTM Cardiopulmonary Testing System:

Summary of Device Performance and Acceptance Criteria

The document provided is a 510(k) summary for a modified medical device. The primary goal of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than to establish new safety and efficacy through extensive clinical trials with predefined acceptance criteria. Therefore, the "acceptance criteria" here are largely focused on demonstrating that the modified device performs comparably to the predicate and meets relevant safety standards.

The key change in the modified device is the oxygen sensor (from electrochemical fuel cell to paramagnetic cell) and associated software/housing updates.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a specific "test set" sample size in terms of patient data. The testing described is "System Verification and Validation test, Software Validation, and a Comparison verification test utilizing the current and modified systems." This suggests bench testing and comparative measurements between the two systems, likely using controlled gas mixtures and simulated physiological conditions, rather than a clinical study with a specific patient sample size.

• Data Provenance: Not specified in terms of country of origin or retrospective/prospective. Given it's device verification, it would be laboratory/bench data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Experts are not mentioned in the context of establishing ground truth for the device's performance in this document. The "ground truth" for verification testing would likely be based on established reference standards for gas concentrations and flow rates, and potentially comparison to the performance of the previously cleared predicate device.

4. Adjudication Method for the Test Set

Not applicable. The "adjudication method" (e.g., 2+1) typically applies to clinical studies where human reviewers assess data for ground truth. Here, the testing is technical verification and validation.

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

Not applicable. This device is a predictive pulmonary function value calculator, not an AI-assisted diagnostic imaging device requiring human readers or interpretation improvement studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The testing described ("System Verification and Validation test, Software Validation, and a Comparison verification test utilizing the current and modified systems") aligns with standalone performance verification of the device's measurement capabilities. The device generates "predictive pulmonary function values," which is an algorithmic output based on physiological measurements. While a human interacts with the system, the core performance verification would focus on the accuracy of these measurements and calculations themselves.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for this type of device verification would be reference standards and established physiological principles. For example:

• Gas Measurements: Calibrated gas mixtures with known concentrations of O2 and CO2 for testing the accuracy of the gas analyzers.
• Flow/Volume Measurements: Calibrated flow generators or spirometers with known flow rates and volumes.
• Software Validation: Ensuring calculations are performed correctly according to established algorithms, likely by comparing software outputs to manual calculations or a gold-standard reference.
• Comparison to Predicate: The predicate device itself acts as a "ground truth" for demonstrating equivalence in performance.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning in a way that requires a "training set" for an AI algorithm in the typical sense (e.g., image classification). It's a physiological measurement system with embedded algorithms for calculating pulmonary function values. The software updates mentioned are to accommodate the new O2 sensor and adjust workload protocols, not to "train" a predictive model from data, beyond the initial development of the physiological models it uses.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no mention of a machine learning "training set" in the context of this 510(k) submission. If the device uses predictive models based on established physiological equations, their "ground truth" would be derived from decades of physiological research and clinical data that informed the development of those equations, rather than a specific training set for this particular 510(k) submission.

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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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