Search Results

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.

Ask a specific question about this device

The IQ Electrocardiograph is a non-invasive prescription device that is indicated for use:

• The proposed IQ Electrocardiograph is indicated for use to acquire, analyze, display and print electrocardiograms.
• The device is indicated for use for pediatric and adult populations, diseased or non-diseased. The device is not indicated for use for neonatal (birth to 28 days) of infants (29 days up to 2 years).
• The interpretations of ECG data offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data.
• The device is indicated for use in a clinical setting, by qualified medical professionals, properly trained for ECG monitoring and use of the system. The person proust he experienced in cardiovascular problematic situations and emergency procedures or pathologies related to cardiac involvements. It is not intended as a sole means of diagnosis.
• The device is not intended to be used as a vital signs physiological monitor.
• It is not designed for out of hospital transport.
• lt is not designed for use in highly invasive environments, such as an operating theatre.
• The cardiac data and analysis provided is reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns.

The proposed Spaulding IQ is an electrocardiograph that combines proprietary hardware, current industry technologies and an off-the-shelf personal computer to achieve a highly reliable electrocardiograph. The IQ is a standard 12-lead non-interpretive electrocardiograph system that is indicated for use by qualified medical professionals in a clinical setting. The IQ combines proprietary hardware and an off-the-shelf personal computer. The concept behind the IQ is to provide the user with an ECG acquisition module that can also transfer the acquired ECG record to a participating PC. The PC side of the system will employ installed proprietary software applications to record and process it for display, printing and storage, or further processing. The device may be used in medical clinics and offices of any size, to include Clinical Research Organizations.

The system will be based on two major components:

• An ECG acquisition module that can (1), acquire the patient demographics by means of an incorporated voice signal input component that uses current industry voice recognition technology and (2) acquire a patient 12-lead ECG. The patient ECG and voice signal data will, be stored on the module in local memory and subsequently transferred to a PC Station via a standard USB connection.
• Proprietary Software Application(s) (Mason Protocol) installed on a participating networked PC, that will receive the ECG data from the Acquisition Module and will communicate bi-directionally to the Clinical Server (CTS) and gather/transmit information about the patient's demographics, visit information as well as acquired ECG data. The application controls user access and authentication, submits the resulting ECG and demographic and visit information to the Clinical Server and allows the user to select the appropriate visit protocol and enter patient's demographic and visit data.

This document is a 510(k) premarket notification for the Spaulding Clinical IQ Electrocardiograph. It establishes substantial equivalence to predicate devices, but does not contain a study demonstrating the device meets specific acceptance criteria.

The document describes the device, its intended use, and indications for use, and confirms its clearance by the FDA. However, it does not provide the kind of performance data, study design, or ground truth establishment that would typically be detailed in a clinical validation study.

Therefore, I cannot provide the requested information, particularly:

1. A table of acceptance criteria and the reported device performance: This document does not specify performance acceptance criteria or report device performance data.
2. Sample size used for the test set and the data provenance: No test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No test set or ground truth establishment is described.
4. Adjudication method: Not applicable as no test set or ground truth is described.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned or provided. The device is a non-interpretive ECG system, meaning it acquires and displays ECGs but does not provide automated interpretations that would be compared to human readers. The document explicitly states: "The interpretations of ECG data offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data."
6. Standalone performance: While the device is "non-interpretive," meaning it doesn't provide automated diagnostic outputs in the way an AI algorithm might, its core function is to acquire and display ECGs accurately. This document does not describe technical performance metrics (e.g., signal-to-noise ratio, frequency response, common mode rejection ratio, bandwidth) that would typically be assessed for an ECG device to demonstrate its standalone accuracy in acquiring the ECG signal itself. Thus, a standalone accuracy study for the core signal acquisition is not detailed here.
7. Type of ground truth used: Not applicable as no ground truth is described.
8. Sample size for the training set: Not applicable as this document pertains to a traditional medical device, not an AI/ML algorithm that would typically have a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, this document is a regulatory submission for device clearance and does not detail a study comparing the device's performance against specific acceptance criteria.

Ask a specific question about this device