(265 days)
The SV600, SV800 Ventilator is intended to be used in intensive care situations for long-term or during transport within a professional healthcare facility. The SV600, SV800 Ventilator is intended to provide ventilation assistance and breathing support for adult, pediatric and neonate patients with a minimum body weight of 0.5 kg. The SV600, SV800 Ventilator should be operated by properly-trained and authorized medical personnel. This equipment is not suitable for use in an MRI environment.
The SV600 and SV800 Ventilators are pneumatically-driven and electronically-controlled ventilators. The Ventilators consists of a main unit (including pneumatic circuit, electronic system, mechanical structure, display, CO2 module, SpO2 module), trolley and support arm. The device also includes a neonatal flow sensor and neonatal flow sensor cable, which are used to measure the patient inspiration/expiration flow in neonatal ventilation modes.
The provided FDA 510(k) Clearance Letter for the SV600, SV800 Ventilator describes modifications to an existing device, primarily the addition of neonatal ventilation capabilities and updated monitoring modules. However, the document does not contain the level of detail typically found in a clinical study report for evaluating acceptance criteria and device performance in the way you've requested for studies involving AI algorithms, image analysis, or expert consensus with specific metrics like sensitivity, specificity, or AUC.
This document focuses on providing evidence of substantial equivalence to predicate devices through technical comparisons and various forms of bench testing, software verification, and compliance with consensus standards. It does not present a performance study with acceptance criteria specific to an AI device's output (e.g., accuracy against ground truth, reader performance improvements).
Therefore, I cannot fill out your requested table and answer many of your specific questions as the information is not present in the provided text.
Here's what can be extracted based on the document's content:
Acceptance Criteria and Device Performance (Based on available information)
The document doesn't define "acceptance criteria" in terms of specific performance metrics (like sensitivity, specificity, accuracy) that would be typically found for an AI or diagnostic device. Instead, "acceptance criteria" are implied by compliance with various technical specifications and international standards. Device performance is generally reported as "meets specifications" or "is equivalent to the predicate."
| Acceptance Criteria (Implied by Standards/Specifications) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility: Conformance to ISO 10993 and ISO 18562 series. | Testing performed, device meets standards. |
| Software Verification & Validation: Conformance to FDA Guidance for Software. | Verification and validation conducted; product works as designed and meets design/performance checks. |
| Electromagnetic Compatibility (EMC) & Electrical Safety: Conformance to IEC 60601-1 and related collateral standards. | Testing performed, device meets standards. |
| Functional & System Level Performance (Bench Testing): Meets accuracy specifications and demonstrates equivalence to predicate for new/modified features (e.g., neonatal ventilation parameters, CO2/SpO2 modules). | Bench testing shows device meets accuracy specifications and is substantially equivalent to the predicate. |
| Usability: Conformance to IEC 60601-1-6. | Testing performed, ensuring usability. |
| Alarm Systems: Conformance to IEC 60601-1-8. | Testing performed, ensuring alarm system effectiveness. |
| Critical Care Ventilator Specifics: Conformance to ISO 80601-2-12. | Testing performed, device meets standards. |
| Respiratory Gas Monitors: Conformance to ISO 80601-2-55. | Testing performed, device meets standards. |
| Pulse Oximeter Equipment: Conformance to ISO 80601-2-61. | Testing performed, device meets standards. |
| Ventilator Endurance: Conformance to ASTM F1100-90. | Testing performed, ensuring endurance. |
| Key Technical Parameters (e.g., TV range, O2% range, SpO2 accuracy): Achieves specified ranges and accuracies (as detailed in the comparison tables). | The comparison tables indicate specific ranges and accuracies for various parameters, demonstrating the device's adherence to these specifications (e.g., SpO2 accuracy of ±2% for adult/pediatric, ±3% for neonate in certain ranges). |
Study Details (Based on available information in the 510(k) Summary)
-
Sample size used for the test set and the data provenance:
- The document does not specify sample sizes for test sets in the context of clinical performance evaluation (e.g., number of patients, number of readings). The "testing" mentioned refers to engineering, software, and standards compliance evaluations.
- Data provenance is not provided, as this is not a clinical study report.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The document describes engineering and standards compliance testing, not a clinical study involving expert-established ground truth for performance evaluation of an AI component or diagnostic output.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a clinical study with an adjudication process for ground truth.
-
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:
- No MRMC comparative effectiveness study was done. This document describes a ventilator, not an AI diagnostic or assistance tool in that context. While it includes "Intellicycle" and "Lung Recruitment (SI)" features, these are not presented as AI assistance augmenting human reader performance in a diagnostic capacity.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies standalone performance testing for various technical aspects of the ventilator and its integrated modules (CO2, SpO2 sensors) against their respective specifications and standards. For example, SpO2 sensor accuracy is stated as "Measurement accuracy: 70 to 100%: ±2% (adult/pediatric mode)" for the Mindray SpO2 module. However, this is for sensor performance, not a complete "algorithm only" evaluation in the context of AI diagnostic output as typically measured.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the technical and performance testing, the "ground truth" would be established by reference standards, calibrated equipment, and design specifications. For example, a flow sensor's accuracy would be tested against a known, precise flow rate. For biocompatibility, the ground truth is defined by the toxicological profiles dictated by the ISO standards. For software, the ground truth is the functional requirements and design specifications.
- There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for clinical performance evaluation of an AI component.
-
The sample size for the training set:
- Not applicable. This document does not describe the development or validation of an AI algorithm with a training set. The "Intellicycle" feature is mentioned, but no details regarding its development, training data, or validation as an AI algorithm are provided.
-
How the ground truth for the training set was established:
- Not applicable, as no AI training set is described.
Summary Limitations:
The provided text is a 510(k) summary, which aims to demonstrate substantial equivalence to legally marketed predicate devices. It details technical changes, compliance with regulatory standards (e.g., biocompatibility, electrical safety, EMC, software V&V), and functional testing results. It does not outline a clinical performance study with the types of metrics and methodologies commonly associated with evaluating AI-driven diagnostic devices or those requiring expert consensus for ground truth. Therefore, many of your specific questions are not addressed by the provided document.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).