(294 days)
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:
- Cardiopulmonary health assessment;
- Assessing heart and lung disease and defining probable sources of heart and/or lung limitations;
- Assessing patient risk in heart and/or lung disease;
- Assessing and monitoring physiological response to therapy, including pharmaceutical and/or medical device intervention; and
- 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
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate System: The modified device should perform as well as the existing Shape-HF™ system (K090722). This implies that a change in the oxygen sensor and associated software should not negatively impact the accuracy or reliability of the cardiopulmonary measurements. | "The modified Shape-HF™ Cardiopulmonary Testing System was tested to verify its equivalence to the current predicate Shape-HFTM system. Testing included System Verification and Validation test, Software Validation, and a Comparison verification test utilizing the current and modified systems. All testing was successful and demonstrated that functional performance requirements were met." |
| Safety Standard Conformance: Adherence to relevant medical electrical equipment safety and EMC standards. | "The modified Shape-HFTM Cardiopulmonary Testing System has been tested and conforms to the following standards: IEC 60601-1 Medical Electrical Equipment Part 1 and IEC 60601-1-2 Medical Electrical Equipment - Part 1-2." |
| Biocompatibility: No changes to patient-contacting materials that would introduce new biocompatibility concerns. | "No change to the patient contacting materials." |
| Indications for Use Equivalence: Maintain the same indications for use as the predicate device. | "The Shape-HFTM Cardiopulmonary Testing System has the identical indications for use as the currently marketed device..." |
| Technological Characteristics Equivalence: Maintain similar technological characteristics and principle of operation, with justified changes. | "The modified Shape-HF™ Cardiopulmonary Testing System has the same principle of operation and technology characteristics as the predicate Shape-HF™ Cardiopulmonary Testing System. The primary change is the Oxygen Sensor... Both are considered standard oxygen sensing technologies." |
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.
§ 868.1890 Predictive pulmonary-function value calculator.
(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).