(379 days)
The Cosmed K4 is a metabolic measurement system that allows telemetry monitoring of cardiorespiratory function during physical activities as well as in sports medicine and rehabilitation. The K4 measures, in real conditions, the O2 consumption the CO, production and the heart rate of the person being monitored.
The subject wears equipment by a harness and breathes into a face mask held on by an anatomic cap. The respiratory flow, expiratory flow, gas concentrations (02 and C02) and heart rate are measured and transmitted to the Receiver Unit. Data collected are stored for later analysis on a personal computer for which software is supplies and run in Windows Application.
The Cosmed K4 Portable Metabolic Measuring System is deemed substantially equivalent to the AeroSport Teen 100 / KB1-C Ambulatory Metabolic Measurement System. However, the provided text does not contain specific acceptance criteria for the Cosmed K4 device, nor does it detail a standalone study proving the device meets particular acceptance criteria.
The submission focuses on demonstrating substantial equivalence to a predicate device, the AeroSport KB1-C, rather than presenting a study against predefined acceptance metrics for the new device.
Here's a breakdown of the information that is available in the provided text, and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Not available. The document does not explicitly state acceptance criteria (e.g., specific accuracy thresholds, precision targets, or ranges for V02, VC02, VE, HR measurements) for either the Cosmed K4 or the AeroSport KB1-C.
The document states:
- "No, metabolic measurements are still accurately measured with both products. The software validation included in Attachment #6, demonstrates accuracy."
- "Performance has been verified via Quality Control testing as explained in Attachment #8."
However, the contents of Attachment #6 and Attachment #8, which would presumably contain the actual performance data and what constitutes "accuracy" and "verified performance," are not provided in this extract.
The comparison chart lists the metabolic measurements provided by both devices (V02, VC02, VE, HR), but does not give performance metrics for these measurements for either device.
2. Sample Size Used for the Test Set and Data Provenance
Not available. The provided text does not describe a "test set" in the context of an accuracy or performance study with a specified sample size. It refers to "software validation" and "Quality Control testing," but no details on the participants, number of tests, or data provenance (country of origin, retrospective/prospective) are given for these activities.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not available. Since an external test set with ground truth is not described, there is no information about experts used for this purpose.
4. Adjudication Method for the Test Set
Not available. No test set or expert adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not available. The document describes a comparison between two devices, but not an MRMC study related to human reader performance with or without AI assistance. This device measures physiological parameters, not typically something that would involve human "readers" interpreting output in the same way, for example, a radiologist reads an image.
6. Standalone Performance Study
Partially indicated, but details missing. The text mentions "The software validation included in Attachment #6, demonstrates accuracy" and "Performance has been verified via Quality Control testing as explained in Attachment #8." These suggest that some form of standalone performance evaluation was done. However, specific results, methodologies, and quantitative data are not provided in the extracted document. The conclusion states, "The Cosmed K4 Portable Metabolic Measuring System and the AeroSport Teen 100 / KB1-C Ambulatory Metabolic Measurement System are substantially equivalent as demonstrated by information and literature contained in this pre-market notification document." This implies the "performance data" was primarily to support the claim of equivalence rather than meeting independent acceptance criteria for the new device.
7. Type of Ground Truth Used (for standalone performance)
Not available directly from the text. While it can be inferred that for metabolic measurements (V02, VC02, VE, HR), the ground truth would likely involve highly accurate reference measurement systems or established physiological standards, the document does not specify how the ground truth was established for the "software validation" or "Quality Control testing" mentioned.
8. Sample Size for the Training Set
Not applicable/Not available. Since the device appears to be hardware-based with associated software for data elaboration and does not explicitly refer to "AI" or machine learning models requiring training data for a test set described here, the concept of a "training set" in this context is not directly applicable. If "software validation" involved internal model calibration, those details are not provided.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not available. (See point 8.)
§ 868.1880 Pulmonary-function data calculator.
(a)
Identification. A pulmonary-function data calculator is a device used to calculate pulmonary-function values based on actual physical data obtained during pulmonary-function testing.(b)
Classification. Class II (performance standards).