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The Datex-Ohmeda S/5 Avance Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The device is intended for volume or pressure control ventilation. The S/5 Avance is not suitable for use in a MRI environment.

The Datex-Ohmeda S/5 Avance Anesthesia System supplies set flows of medical gases to the breathing system using electronic gas mixing. Gas flows are selected by the user using the keypad and rotary controller on the main display unit and then displayed as electronic flow meters on the system display unit. The Avance is equipped with a pneumatic back-up O2 delivery system and traditional flow tube, as well. A large selection of frames, gases, and vaporizers are available to give the user control of the system configuration. The S/5 Avance is also available in wall-mount and pendant models. It is available with two or three gases, up to two vaporizer positions and up to three cylinder connections. All models have O2. The S/5 Avance comes with up to two optional gases (air, N2O). The S/5 Avance systems accept Tec 4, Tec 5, Tec 6, and Tec 7 vaporizers on a Selectatec manifold. Safety features and devices within the S/5 Avance are designed to decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures. The Avance system is available with optional integrated respiratory gas monitoring. When supplied as an option, the integrated respiratory gas monitoring is provided via the Datex-Ohmeda M-Gas Module (M-CAiO and M-CAiOV software revision 3.2 and above K# 001814) which is physically integrated into the Avance, receives electronic power from the Avance and communicates measured values to the Avance for Cisplay on the system display unit.

The Datex-Ohmeda 7900 Anesthesia Ventilator is used in the S/5 Avance Anesthesia System. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. The 7900 ventilator is equipped with a built-in monitoring system for inspired oxygen, airway pressure and exhaled volume. Sensors in the breathing circuit are used to control and monitor patient ventilation as well as measure inspired oxygen concentration. This allows for the compensation of compression losses, fresh gas contribution and small leakage in the breathing absorber, bellows and system. User setting and microprocessor calculations control breathing patterns. The user interface keeps settings in memory. The user may change settings with a simple and secure setting sequence. A bellows contains breathing gasses to be delivered to the patient. Positive End Expiratory Pressure (PEEP) is regulated electronically. Positive pressure is maintained in the breathing system so that any leakage that occurs is outward. An RS-232 serial digital communications port connects to and communicates with external devices. Ventilator modes for the device include Volume Mode, Pressure Control Mode, Pressure Support with Apnea Backup Ventilation (Optional) and Synchronized Mandatory Intermittent Ventilation(SIMV) (Optional) Mode. Ventilator parameters and measurements are displayed on the system display unit.

This looks like a 510(k) premarket notification for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical study results or acceptance criteria in the way a clinical trial report would.

Based on the provided text, here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define acceptance criteria in terms of specific performance metrics (e.g., accuracy, sensitivity, specificity) for a clinical outcome or diagnostic task. Instead, the "acceptance criteria" appear to be compliance with relevant medical device standards and the demonstration of substantial equivalence to predicate devices.

• UL 2601 General requirements for Medical Electrical Equipment
• EN 740 Anesthetic Work Stations
• EN/IEC 60601-1: General requirements for Medical Electrical Equipment
• EN/IEC 60601-1-2: 1998 Medical Electrical Equipment Electromagnetic Compatibility
• EN 475 Electrically Generated Alarm Signals
• ASTM F1463-93 Standard Specification for Alarm Signals
• ASTM F1208-94 Anesthesia Breathing Circuit Standard
• ASTM F1101-90 Standard Specification for Ventilators Intended for Use During Anesthesia
• ISO 5358 Anesthetic Gas Machines |
  | Substantial Equivalence to Predicate Devices | The Datex-Ohmeda S/5 Avance Anesthesia System is stated to be substantially equivalent to the Datex-Ohmeda S/5 Avance Anesthesia System (K032803) and Datex-Ohmeda 7900 Ventilator Enhancements (K023366). The document explicitly states: "The Datex-Ohmeda S/5 Avance Anesthesia System and the currently marketed device are substantially equivalent in design concepts, technologies and materials." The FDA's letter confirms: "We have determined the device is substantially equivalent... to legally marketed predicate devices." |
  | Safety Features | The S/5 Avance includes "Safety features and devices...designed to decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures." (This is a design intent, not a quantified performance measure in this document). |
  | Integrated Monitoring Performance | When supplied as an option, "the integrated respiratory gas monitoring is provided via the Datex-Ohmeda M-Gas Module (M-CAiO and M-CAiOV software revision 3.2 and above K# 001814) which is physically integrated into the Avance, receives electronic power from the Avance and communicates measured values to the Avance for display on the system display unit." (Performance of this module is referenced by its own 510(k) and software revision, not detailed here.) |
  | Ventilator Monitoring Performance | The 7900 ventilator is "equipped with a built-in monitoring system for inspired oxygen, airway pressure and exhaled volume." "Sensors in the breathing circuit are used to control and monitor patient ventilation as well as measure inspired oxygen concentration. This allows for the compensation of compression losses, fresh gas contribution and small leakage in the breathing absorber, bellows and system." (Statements of functionality, not quantified performance here). |

2. Sample Size Used for the Test Set and the Data Provenance

The document does not describe a specific clinical "test set" in the context of an algorithm or diagnostic device. The "rigorous testing" mentioned is referred to as demonstrating compliance with standards and supporting substantial equivalence, which typically involves bench testing, engineering verification, and validation (V&V) activities. There is no mention of patient data (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not applicable/provided as the document describes a hardware anesthesia system and ventilator, not a diagnostic algorithm requiring ground truth established by experts for a test set. The validation focuses on engineering and regulatory standards compliance.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable/provided for the same reasons as point 3.

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

This information is not applicable/provided. The device is an anesthesia system, not an AI-assisted diagnostic or decision-support tool that would involve human readers interpreting cases.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable/provided. The device is an integrated anesthesia system, not a standalone algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

This information is not applicable/provided as the validation is based on engineering and performance specifications against established standards and equivalence to predicate devices, not on a ground truth related to clinical outcomes or diagnostic accuracy in the context of an AI/diagnostic algorithm.

8. The Sample Size for the Training Set

This information is not applicable/provided. There is no mention of a "training set" as this is not an AI/machine learning device in the context of diagnostic algorithms.

9. How the Ground Truth for the Training Set was Established

This information is not applicable/provided for the same reasons as point 8.

In summary:

This 510(k) summary focuses on demonstrating that the Datex-Ohmeda S/5 Avance Anesthesia System is substantially equivalent to legally marketed predicate devices and complies with relevant safety and performance standards. It achieves this through rigorous engineering and validation testing against those standards and by comparing its design and technology to existing cleared devices. The document does not describe clinical studies involving patient data or the performance of a diagnostic algorithm in the way the questions are framed.

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The Datex-Ohmeda S/5 Avance Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The device is intended for volume or pressure control ventilation. The S/5 Avance is not suitable for use in a MRI environment.

The Datex-Ohmeda S/5 Avance Anesthesia System is substantially equivalent to the following currently marketed device: Datex-Ohmeda Aestiva/5, with 7100 Ventilator, Anesthesia System - Class II -21CFR868.5160, which has been the subject of a cleared 510(k) with FDA log number K000706 Datex-Ohmeda Excel 3000 (Aestiva), with 7900 Ventilator, Anesthesia System -Class II - 21CFR868.5160, which has been the subject of a cleared 510(k) with FDA log number K973896 Datex-Ohmeda AS/3 Anesthesia Delivery Unit (ADU) - Class II -- 21CFR868.5160, which has been the subject of a cleared 510(k) with FDA log number K973985 The Datex-Ohmeda S/5 Avance Anesthesia System was designed to comply with the applicable portions of the following voluntary standards; - 1. UL 2601 General requirements for Medical Electrical Equipment - 2. EN 740 Anesthetic Work Stations - 3. EN/IEC 60601-1: General requirements for Medical Electrical Equipment - 4. EN/IEC 60601-1-2: 1998 Medical Electrical Equipment Electromagnetic Compatibility - 5. EN 475 Electrically Generated Alarm Signals - 6. ASTM F1463-93 Standard Specification for Alarm Signals - 7. ASTM F1208-94 Anesthesia Breathing Circuit Standard - 8. ASTM F1101-90 -- Standard Specification for Ventilators Intended for Use During Anesthesia - 9. ISO 5358 Anesthetic Gas Machines The Datex-Ohmeda S/5 Avance Anesthesia System and the currently marketed device are The Datest of Interious in design concepts, technologies and materials. The Datex-Ohmeda S/5 Substance Anesthesia System has been validated through rigorous testing that, in part, supports the I compliance of S/5 Avance Anesthesia System to the standards listed above.

This 510(k) premarket notification describes the Datex-Ohmeda S/5 Avance Anesthesia System. The submission establishes substantial equivalence to previously cleared devices rather than presenting a de novo study with explicit acceptance criteria for performance. Therefore, the information requested regarding a standalone study, multi-reader multi-case study, and detailed ground truth provenance is not explicitly available in this document.

Here's an analysis based on the provided text, focusing on how the device meets applicable standards rather than specific quantifiable acceptance criteria within a clinical performance study.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are primarily established by compliance with recognized voluntary standards and the performance of predicate devices. The document does not provide specific numerical performance metrics for the S/5 Avance Anesthesia System that would typically be found in a clinical study report. Instead, performance is implied by its adherence to these standards.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This 510(k) submission does not describe a clinical test set in the traditional sense with patient data. The "testing" mentioned is primarily related to engineering and system verification for compliance with voluntary standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. The submission focuses on device design and compliance with standards, not on establishing ground truth for a clinical dataset. Expert review would have been part of the regulatory body's assessment rather than part of the manufacturer's testing described here.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is an anesthesia system, not an AI-assisted diagnostic or treatment planning tool that would typically involve an MRMC study.

6. Standalone Performance Study (Algorithm Only)

Not applicable. This is a medical device (anesthesia system), not an algorithm or AI product. Its performance is integrated into its physical and functional operation, demonstrated through compliance with engineering and safety standards.

7. Type of Ground Truth Used

The "ground truth" in this context is the fulfillment of requirements outlined in recognized national and international voluntary standards (e.g., UL, EN, IEC, ASTM, ISO) for electrical safety, performance, and functionality of anesthesia systems and ventilators. This is not clinical ground truth in terms of diagnoses or outcomes but rather engineering and safety compliance.

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable. See above.

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