(16 days)
The intended use of this device is to monitor heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia, temperature, arterial oxygen saturation and pulse rate, central apnea is accomplished through impedance plethysmography and apnea through capnography, end-tidal carbon dioxide, and ST Segment Analysis. This device will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings. This device will connect to R50 recorders, either directly or via the INFINITY network.
The INFINITY Gamma, like the INFINITY GammaXL, supports the "look and feel" of the Draeger Medical product line, including the Draeger logo, colors, menu structure, and physical form. The Infinity Gamma also has an alarm at the top center that illuminates in red or yellow for the purpose of displaying both life threatening and serious alarms respectively. The primary difference between the INFINITY GammaXL and the new INFINITY Gamma is the smaller size.
The provided document is a 510(k) summary for the INFINITY Gamma, a patient physiological monitor. It primarily focuses on demonstrating substantial equivalence to a predicate device (INFINITY GammaXL) and does not contain detailed acceptance criteria or a study that specifically proves the device meets such criteria in the way typically expected for a new, novel AI/ML medical device.
Instead, the document states performance has been verified through "internal design control procedures" and refers to the predicate device's established safety and effectiveness.
Therefore, for almost all the requested information, the answer will be "Not Applicable" or "Not Provided in this document" because the submission is for a device modification of an existing device, not a new device requiring extensive clinical or standalone performance studies against defined acceptance criteria.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
Not provided in this document. The submission states: "Testing in accordance with internal design control procedures has verified that the INFINITY Gamma is as safe and effective as the INFINITY GammaXL as submitted in 510(k) K033600." Specific performance metrics and acceptance criteria for these metrics are not detailed.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not provided.
- Data Provenance: Not provided. The document mentions "internal design control procedures," implying testing was likely conducted internally, but no specifics on data origin (e.g., country, retrospective/prospective) are given for any test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable / Not provided. This type of information is typically relevant for studies involving subjective interpretation (e.g., image analysis) where expert consensus is needed. For a physiological monitor, ground truth would likely be established through calibrated instruments or established clinical values, not expert consensus on interpretations. No details are given.
4. Adjudication method for the test set:
Not applicable / Not provided.
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 physiological monitor, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The "device" itself performs the monitoring; there isn't a separate "algorithm" being tested in a standalone fashion distinct from the hardware and embedded software. The document states "Testing in accordance with internal design control procedures has verified that the INFINITY Gamma is as safe and effective as the INFINITY GammaXL". This implies comprehensive device testing, not an isolated algorithm evaluation.
7. The type of ground truth used:
Not provided. For physiological monitors, ground truth would typically come from reference devices or established physiological standards for accuracy validation, but no specifics are mentioned in this document.
8. The sample size for the training set:
Not applicable / Not provided. This document describes a traditional medical device, not a machine learning model, so there isn't a "training set" in the sense of AI/ML development.
9. How the ground truth for the training set was established:
Not applicable / Not provided.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.