(68 days)
The S/5™ Anesthesia Monitor with L-ANE03 and L-ANE03A software is intended for multiparameter patient monitoring with optional patient care documentation.
The S/5™ Anesthesia Monitor with L-ANE03 and L-ANE03A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, Bispectral index (BIS), Entropy (State Entropy and Response entropy) and neurophysiological status of all hospital patients. The S/5™ Anesthesia Monitor with L-ANE03 and L-ANE03A software when using BIS is for monitoring the state of the brain by data acquisition and processing of electroencephalograph signals and may be used as an aid in monitoring the effects of certain anesthetic agents. The S/5TM Anesthesia Monitor with L-ANE03 A software is also indicated for documenting patient care related information. The S/57M Anesthesia Monitor with L-ANE03 and L-ANE03A software is indicated for use by qualified medical personnel only.
The S/5™ Anesthesia Monitor is a patient monitor, which displays the measurement of patient physiological parameters in the hospital setting. The measurement of patient physiological parameters is accomplished by specialized measurement modules which, when plugged into the frame, allow the modules to communicate with the monitor. The care giver can select from a variety of available measurements (parameters) and apply those parameters that are best suited to patient care. Modules perform the functions of parameter measurement and minor data processing. The S/5™ Anesthesia Monitor displays parameters on screen, signals alarms and performs advanced data processing. There are two software options available for the S/5TM Anesthesia Monitor: L-ANE03 and L-ANE03A is equipped with extended arrhythmia analysis capability. Other than arrhythmia analysis capabilities, this software option is identical to L-ANE03.
The modifications to the device are:
- Support for M-Entropy module has been added. M-Entropy has its own 510(k) clearance.
- Improvement in the QRS detection with rather low QRS amplitude ECG, to avoid false Asystole alarms.
- The definition for Ventricular Tachycardia have been modified: now 6 beats at a heart rate of 120 (previously 5 beats at a heart rate of 100).
- Invasive pressure cursor added to the inv.bp waveform field. The cursor is used for marking the reference pressure levels during a monitoring period.
- MAC (Mean Alveolar Concentration) age calculation added. User can select the calculation of age-dependent MAC values.
- Invasive pressure Mean Arterial Pressure (Art mean) value added to vital parameters numerical trend page.
- New catheter types added to the selection list for the Cardiac Output measurement.
- Automatic case reset disabled during Cardio Pulmonary Bypass (CPB) mode.
- Messages related to the communication between S/5 monitor and D-O Central have been modified. "HR limit changed" and "PVC rate changed" messages have been replaced with the message "Alarm setup changed from Central".
- Menu and Data Card symbols and Network symbol have been modified. Layout changes have been done so that the same symbols can be displayed with all of the different display resolutions.
- A 19" LCD display and a 43″ plasma display secondary display option have been added along with a display controller specific for the 19" LCD (B-DISP19).
The provided text describes a Premarket Notification (510(k)) for the Datex-Ohmeda S/5™ Anesthesia Monitor with L-ANE03 and L-ANE03A software. This document primarily focuses on establishing substantial equivalence to a predicate device (Datex-Ohmeda S/5™ Anesthesia Monitor with L-ANE02 and L-ANE02A software (K021279)) and outlines the device's intended use and the results of nonclinical testing.
The document does not describe specific acceptance criteria and a study proving the device meets those criteria in the typical format of a clinical or performance study with detailed metrics like sensitivity, specificity, or reader agreement. Instead, it focuses on compliance with recognized safety and performance standards and affirms the device's substantial equivalence to a legally marketed predicate.
Therefore, many of the requested details (sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not explicitly provided in this type of regulatory submission. The "study" proving the device meets acceptance criteria, in this context, refers to the nonclinical testing and compliance with standards.
Here's an attempt to extract and interpret the information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly met by compliance with standards) | Reported Device Performance (Summary from Nonclinical Testing) |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1:1988+Amdt.1:1991+Amdt.2:1995, EN 60601-1:1990+A1:1993+A2:1995+A13:1996, CAN/CSA-C22.2 No.601.1-M90 +S1:1994+Amdt.2:1998, UL 2601-1:1997, IEC 601-2-10:1987/HD 395.2.10:1988 + Am.1:2000, IEC 60601-2-26:1994/EN60601-2-26, IEC 60601-2-27:1994/EN 60601-2-27:1994, IEC 60601-2-30:1995/EN 60601-2-30:1995, IEC 60601-2-34:1994/EN 60601-2-34:1994, IEC 60601-2-40:1998, ANSI/AAMI ES-1:1993, ANSI/AAMI EC57:1998 | The device has been "thoroughly tested including electrical safety." (The specific results or metrics are not detailed, but compliance implies meeting the safety limits of these standards.) |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2(2001)/EN 60601-1-2 | The device has been "thoroughly tested including... electromagnetic compatibility." (Compliance with the standard confirms it meets the immunity and emissions requirements.) |
| Mechanical & Environmental Tolerance | Compliance with IEC 60068-2 | The device has been "thoroughly tested including... mechanical and environmental tolerance." (Compliance with the standard indicates it withstands specified mechanical and environmental stresses.) |
| Software Validation & Verification | Compliance with IEC 60601-1-4:1996+Amdt.1:1999/EN 60601-1-4 | The device has been "thoroughly tested including... software validation and verifications." (This ensures the software performs as intended and meets its design specifications.) |
| Physiological Monitoring Performance (Specific to parameters) | Compliance with ISO 9918:1993/EN 864:1996 (Anesthesia/Respiratory equipment), ISO 9919:1992/EN865:1997 (Pulse oximetry - likely relevant to respiratory monitoring components), ISO 7767:1997/EN12598:1999 (Spirometers - likely relevant to ventilatory monitoring), ISO 11196:1995 + Corr. 1:1997/EN ISO11196:1997 (Anesthetic and respiratory equipment, specific requirements for gas monitoring) | The document states "The S/5™ Anesthesia Monitor with L-ANE03 and L-ANE03A software complies with the safety standards below and is therefore safe and effective for the intended use." Specific performance metrics (e.g., accuracy, precision for each parameter) are not provided in this summary but are implicitly considered compliant with the relevant ISO standards. The primary functional change mentioned as undergoing improvement is "Improvement in the QRS detection with rather low QRS amplitude ECG, to avoid false Asystole alarms." (This implies a performance improvement over the predicate for this specific scenario.) The definition for Ventricular Tachycardia was also changed. |
| Regulatory Compliance | Compliance with FDA 21 CFR 898.12 | "Verification of compliance with the following mandatory... standards has been made." |
| Substantial Equivalence | No new questions of safety and effectiveness compared to the predicate device (Datex-Ohmeda S/5™ Anesthesia Monitor with L-ANE02 and L-ANE02A software (K021279)). | "The summary above shows that there are no new questions of safety and effectiveness for the Datex-Ohmeda S/5™ Anesthesia Monitor with L-ANE03 and L-ANE03A software as compared to the predicate device." Final FDA determination: "the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." |
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document refers to "nonclinical testing" and "software validation and verifications," which would involve testing, but details on sample size (e.g., number of ECG recordings, duration of tests) are not provided.
- Data Provenance: Not specified, but given the nature of the testing described (electrical safety, EMC, mechanical, software validation), it would involve internal laboratory testing and simulations rather than patient data in the context of clinical trials. The improvements mentioned (QRS detection, VT definition) would have been validated using internal test datasets, likely derived from various sources where such events occur.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not specified. For performance improvements like QRS detection and VT definition, internal experts (e.g., biomedical engineers, cardiologists/anesthesiologists involved in medical device development or review) would establish reference or "ground truth" data, but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set
- Not specified. Given the compliance testing nature, formal adjudication by a panel is unlikely for most of the listed tests. For specific software algorithm changes (like QRS detection improvement or VT definition), internal processes for verifying correctness would be in place, but a specific "adjudication method" like 2+1 or 3+1 is not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No, an MRMC comparative effectiveness study was not done. This type of study assesses how human readers perform with and without AI assistance and is typically associated with AI/CAD systems that interpret images or complex data for diagnostic purposes. This device is a patient monitor, which provides raw and processed physiological data directly to medical personnel, rather than an AI interpreting images for a reader.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, standalone performance was implicitly done for the algorithm components, particularly for the "Improvement in the QRS detection" and the "modified... Ventricular Tachycardia" definition. The "software validation and verifications" would encompass testing the algorithms' performance against defined specifications (e.g., accuracy of QRS detection, correct classification of arrhythmias based on the new definition). However, specific performance metrics (e.g., sensitivity, specificity, accuracy) from such standalone tests are not detailed in this summary.
7. The type of ground truth used
- For the nonclinical testing described, the ground truth would likely be based on:
- Defined Standards: For electrical, EMC, mechanical, and environmental tests, the "ground truth" is compliance with the limits and methodologies specified in the respective international and national standards (e.g., IEC 60601 series).
- Reference Devices/Simulators: For physiological parameter measurement accuracy, calibrated reference devices or patient simulators would likely be used.
- Expert Definitions/Reference Annotations: For algorithm improvements like QRS detection and VT definition, the ground truth would be based on expertly annotated ECG waveforms or established physiological criteria for these events.
8. The sample size for the training set
- Not specified. As this is a 510(k) submission primarily focused on hardware and software updates to an existing monitor, and not a de novo AI/Machine Learning device where "training sets" are explicitly described, information on training set size is not provided. The development and refinement of algorithms (like QRS detection) would have involved internal datasets, but these are not quantified here as "training sets."
9. How the ground truth for the training set was established
- Not specified. Similar to point 8, the concept of a formally defined "training set" with ground truth established by external experts (as might be seen in advanced AI submissions) is not explicitly discussed in this type of 510(k). For algorithmic development, internal R&D processes would involve creating or acquiring data where the correct physiological events are identified (e.g., by manual review against established clinical criteria or by using highly accurate reference systems), but the specifics are not disclosed.
§ 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.