(104 days)
The A7 Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.
The A7 is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used in adult and pediatric populations.
The A7 Anesthesia System is a continuous flow inhalation gas anesthesia system that delivers anesthetic vapor and provides for automatic and manual modes of ventilation. The A7 incorporates O2, CO2, N2O and Agent concentration monitoring (Desflurane, Isoflurane, Enflurane, Sevoflurane and Halothane). The A7 consists of a main unit (includes an anesthetic ventilator and flow meter monitor assembly) and a detachable breathing system.
This document is a 510(k) premarket notification for the Mindray A7 Anesthesia System and primarily focuses on establishing substantial equivalence to a predicate device (K142552). It does not contain specific acceptance criteria for a study demonstrating performance, nor does it detail a standalone study or an MRMC comparative effectiveness study for a new AI feature.
The submission revolves around a modification to an existing A7 Anesthesia System (K142552) to include a "Fresh Gas Flow Optimizer feature." The key point is that "This feature does not change the fresh gas flow setting nor does it supply an alarm if the user does not follow the recommended fresh gas flow setting." This implies the feature is advisory and doesn't directly control the device's critical functions in a way that would necessitate extensive clinical performance studies for efficacy or safety.
Therefore, many of the requested details about acceptance criteria, study design, ground truth, and expert involvement are not present because the submission's purpose is to demonstrate equivalence of a modified, non-critical feature, rather than proving the performance of a new diagnostic or AI system.
However, based on the provided text, I can extract information related to general performance testing and the comparison between the subject device and its predicate.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a typical "acceptance criteria" table with specific thresholds for a novel diagnostic or AI performance. Instead, it presents a technical comparison table between the subject A7 Anesthesia System and its predicate (K142552), demonstrating that their technical characteristics are largely identical or equivalent. The "performance data" section mentions compliance with various standards, which serve as the implicit acceptance criteria for the device's safety and fundamental operational performance.
| Technical Characteristic | Subject Device (A7 Anesthesia System) | Predicate Device (A7 Anesthesia System K142552) | Acceptance Criteria / Observation (from document) |
|---|---|---|---|
| Fresh Gas Flow Optimizer feature | Included (displays recommended value, does not change setting or alarm) | Not provided | The new feature is advisory and does not change established safety or effectiveness. The implicit acceptance is that this addition does not negatively impact existing device performance or safety. |
| Vaporizers | Two or Three, variable bypass | Two, variable bypass | Identical in function, subject device offers more options. |
| Agent Monitoring (Sevoflurane, etc.) | Yes (identical accuracy specified below) | Yes (identical accuracy specified below) | Accuracy specifications are considered the "acceptance criteria" for these aspects, and they are identical between devices. |
| Ventilation Modes | VCV, PCV, PCV–VG, SIMV-VC, SIMV–PC, PS | VCV, PCV, PCV–VG, SIMV-VC, SIMV–PC, PS | Identical. |
| Tidal Volume Range | 20 - 1500 ml | 20 - 1500 ml | Identical. |
| Rate, bpm | 4-100 bpm | 4-100 bpm | Identical. |
| Inspiratory Flow, L/min | 110 L/min + fresh gas flow | 110 L/min + fresh gas flow | Identical. |
| I:E Ratio | 4:1 to 1:8 with 0.5 increment | 4:1 to 1:8 with 0.5 increment | Identical. |
| Inspiratory Pause | Off, 5 - 60% of insp. Period | Off, 5 - 60% of insp. Period | Identical. |
| Individual Gas Flow Accuracy | ±50 ml/min or ±5% of setting value, whichever is greater | ±120 ml/min or ±10% of setting value, whichever is greater | Subject device has improved accuracy. This is presented as an equivalent or superior performance, meeting or exceeding predicate's performance. |
| Pressure Limit, cm H2O | 0 - 100 | 0 - 100 | Identical. |
| PEEP, cm H2O | Off, 3-30, 1 cmH2O increment | Off, 3-30, 1 cmH2O increment | Identical. |
| System Checks | Auto at start | Auto at start | Identical. |
| Alarm Systems (High/Low Airway, etc.) | Yes (all listed alarms operate identically) | Yes (all listed alarms operate identically) | Identical alarm functionalities are considered acceptable. |
| O2 Sensor Type | Paramagnetic | Paramagnetic or Galvanic | Paramagnetic is utilized for integrated gas module in both, subject device standardizes to paramagnetic. Considered acceptable. |
| Anesthetic Gas Module Accuracy (CO2, N2O, Desflurane, Sevoflurane, Enflurane/Isoflurane/Halothane, O2, awRR) | All stated accuracies are identical to predicate. See document for specific ranges and +/- values. | All stated accuracies are identical to predicate. See document for specific ranges and +/- values. | The stated accuracy values are the "acceptance criteria" for these measurement capabilities, and the subject device meets them identically to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable. This document refers to the validation of a physical medical device and its embedded software, not a diagnostic algorithm or AI system. The testing is based on engineering verification and validation against specified standards and product specifications.
- Data Provenance: Not applicable. The "study" here is a technical validation against engineering specifications and industry standards, not a clinical data collection study for a diagnostic algorithm.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Number of Experts: Not applicable. This relates to the device's engineering performance and compliance with standards, not expert-adjudicated ground truth from clinical images or data.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. This concept applies to expert review of clinical cases rather than engineering testing. Performance data refers to objective measurements against specifications and standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The new feature ("Fresh Gas Flow Optimizer") is described as providing a "recommended value" to assist clinicians but "does not change the fresh gas flow setting nor does it supply an alarm if the user does not follow the recommended fresh gas flow setting." This indicates it's an informational, non-critical, non-diagnostic feature that wouldn't typically warrant an MRMC study for improved reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Study: No, a standalone study for an AI algorithm's performance was not explicitly done or reported in this document in the typical sense. The "Fresh Gas Flow Optimizer" is an embedded software feature, and its performance would have been verified as part of the overall software validation (mentioned in section 4: "Software – The A7 Anesthesia System software has been fully verified and validated..."). However, there are no specific performance metrics like sensitivity/specificity for a standalone algorithm presented.
7. The Type of Ground Truth Used:
- Type of Ground Truth: For the device's overall performance, the "ground truth" consists of established engineering specifications, performance tolerances (e.g., accuracy for gas measurements), and compliance requirements of recognized medical device standards (e.g., ANSI/AAMI ES60601-1, IEC 60601-2-13, ISO 80601-2-55, IEC 62304).
8. The Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable. The device's software is "verified and validated" but not described as a machine learning or AI model trained on a dataset. The "Fresh Gas Flow Optimizer" likely uses predefined algorithms and parameters based on physiology and anesthesia principles, rather than learning from a "training set."
9. How the Ground Truth for the Training Set was Established:
- Ground Truth for Training Set: Not applicable, as there is no mention of a machine learning "training set" or corresponding ground truth in the context of this 510(k) submission. For the device itself, as stated in point 7, the "ground truth" is defined by engineering specifications and industry standards.
§ 868.5160 Gas machine for anesthesia or analgesia.
(a)
Gas machine for anesthesia —(1)Identification. A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.(2)
Classification. Class II (performance standards).(b)
Gas machine for analgesia —(1)Identification. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).(2)
Classification. Class II (performance standards).