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The SERVO i Ventilator System is intended for treatment and monitoring of patients in the range of neonates, infants, and adults with respiratory failure or respiratory insufficiency. SERVO-i is a ventilator system to be used only by healtheare providers in hospitals or healthcare facilities and for in-hospital transport.

The added indications for use of the NAVA option is when the electrical signal from the diaphragm is intact; NA VA will improve synchrony between the ventilator and patients with no contraindication for insertion/exchange of a Naso-Gastric tube.

The SERVO-i Ventilator is classified as MR Conditional for 1.T. 1.5T and 3T MR scanners. This means that it is safe to use in the MR environment if the MR Environment Declaration for SERVO-i are met.

The SERVO-i Ventilator System with Heliox option is indicated for use with the delivery of Air, Oxygen, or Heliox (a mixture of Helium and Oxygen).

The SERVO-s Ventilator System is intended for treatment and monitoring of patients in the range of neonates, infants, and adults with respiratory failure or respiratory insufficiency. SERVO-s is a ventilator system to be used only by healthcare providers in hospitals or healthcare facilities and for in-hospital transport.

The SERVO-i Ventilator System (here after called SERVO-i) is intended to provide continuous ventilation for neonate to adult patients in the weight range 0.5-250 kg and with tidal volumes from 2 mL to 4000 mL. SERVO-i consists of a Patient Unit where gases are mixed and administered, and a User Interface where the settings are made and ventilation is monitored. The ventilator delivers controlled or supported breaths to the patient, with either constant flow or constant pressure, using a set oxygen concentration. SERVO-i will produce visual and audible alarms if vital parameters vary beyond pre-set, or default, limits. The system contains provisions for at least two battery modules to supply the system in the case of mains power failure or during in-hospital transport. The ventilator functionality is controlled by software. The SERVO-i Ventilator System is available in three software versions. Infant. Adult and Universal.

The NAVA (Neurally Adjusted Ventilatory Assist) option is a supported mode for SERVO-i that uses the Edi signal (the electrical activity of the diaphragm) as an addition to the flow/pressure trigger to synchronize the patient efforts with the onset and cycle off. The NAVA option is available in invasive and non-invasive mode.

SERVO-i is MR conditional. The SERVO-i ventilator with MR option have been tested with 1.0, 1.5, 3.0 T scanners without impairing its performance or the image quality of the scanner. Each scanner and its environment form an individual device. The MR Environment Declaration describes how a SERVO-i with MR option can be qualified to be used with an MR scanner forming a safe Medical System. All vital parts of the ventilator have been tested for performance in excessive magnetic fields.

The SERVO-i with Heliox option requires a different mechanical adaptor on the air supply inlet to allow a mixture of Helium and Oxygen to be connected. Furthermore is the software updated to allow safe delivery and monitoring of the Heliox gas mixture.

Accessories for CO2-monitoring, nebulization and flow monitoring at the Y -piece (Y-sensor) are integrated as options in the SERVO-i and the drivers are controlled by the software in the ventilator.

This 510(k) submission for the SERVO-i include changes to receive a new baseline based on compatibility to the third edition standard package of AAMVANSI 60601-1 :2005 and its collateral and particular standards for intensive care ventilators. The submission does also include modifications of the software and hardware to update existing functionalities since the last submission (K073149).

The SERVO-s ventilator system (here after called SERVO-s) is based on the SERVO-i ventilator family platform. SERVO-s ventilation system is a downscaled version based on the SERVO-i ventilator system notified in K041223.

The SERVO-s Ventilator System is intended to provide continuous ventilation for neonate to adult patients in the weight range 2-250 kg and with tidal volumes from 10 mL to 2000 mL. The SERVO-s Ventilator System consists of a Patient Unit where gases are mixed and administered, and a User Interface where the settings are made and ventilation is monitored. The ventilator delivers controlled or supported breaths to the patient, with either constant flow or constant pressure, using a set oxygen concentration. SERVO-s Ventilator System will produce visual and audible alarms if vital parameters vary beyond preset, or default, limits. The system contains two internal batteries to supply the system with power in the case of mains power failure or during inhospital transport. The ventilator functionality is controlled by software. The SERVO-s Ventilator System is available in two software versions, Infant and Adult.

This 510(k) submission for the SERVO-s include changes to receive a new baseline based on compatibility to the third edition standard package of IEC 60601-1 :2005 and its collateral and particular standards for intensive care ventilators. The submission does also include addition of the Infant option, patient weight range 2-10 kg, with tidal volumes from 10 mL to 350 mL and modifications of the software and hardware to update existing functionalities.

Here's a breakdown of the acceptance criteria and the studies mentioned in the provided 510(k) summary for the GETINGE GROUP SERVO-i and SERVO-s Ventilator Systems, organized according to your requested format.

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. Therefore, the "studies" described are primarily verification and validation activities rather than formal clinical trials designed to prove efficacy from scratch. The acceptance criteria are largely implied by compliance with standards and successful performance in these verification and validation tests.

Acceptance Criteria and Device Performance

This section synthesizes the implicit acceptance criteria from the various verification and validation activities described and attempts to align them with the reported "performance" based on the conclusions drawn in the document.

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The proposed OMNISPAN Meniscal Repair System is intended for use in the arthroscopic fixation of soft tissue procedures such as meniscal repair.

The proposed OMNISPAN Meniscal Repair System consists of two sterile PEEK (polyetheretherketone) implants connected by a sliding loop and fixed leg of absorbable size #2-0 Orthocord suture, a sterile, disposable Deployment Gun with malleable Graft Retractor. The implants together with the suture provide compression across the tear in the meniscus.

This submission describes the OMNISPAN Meniscal Repair System, a medical device for arthroscopic fixation of meniscal tears. The submission asserts substantial equivalence to previously cleared devices.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K092836) is a 510(k) summary for a medical device seeking substantial equivalence, rather than a clinical study reporting specific performance metrics against pre-defined acceptance criteria. Therefore, a direct table of acceptance criteria and reported device performance, as would be found in a clinical trial report, is not present in this document.

Instead, the document states: "Results of performance and safety testing have demonstrated that the modified device is suitable for its intended use." This general statement indicates that internal testing was conducted to support the device's suitability, but the specific acceptance criteria and detailed performance results are not disclosed in this summary. The FDA's decision to clear the device implies that the agency found these undisclosed tests satisfactory.

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

This document does not describe a clinical test set with a specific sample size, nor does it detail data provenance (e.g., country of origin, retrospective/prospective). The submission relies on demonstrating substantial equivalence to predicate devices based on technological characteristics and indications for use, supported by internal performance and safety testing, the details of which are not provided in this summary.

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

Given that no clinical test set is described in detail, there is no information provided regarding experts used to establish ground truth.

4. Adjudication Method for the Test Set

As no clinical test set is described, there is no information on any adjudication method.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. The submission focuses on substantial equivalence based on device characteristics and predicate devices, not on direct comparison of human readers with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This device is a physical medical implant (OMNISPAN Meniscal Repair System), not an AI algorithm. Therefore, a standalone (algorithm only) performance study is not applicable and was not reported.

7. Type of Ground Truth Used

The document does not describe a specific "ground truth" as would be used in an AI or diagnostic device study. The "ground truth" here pertains to the device's functionality and safety, which would have been established through internal engineering tests, biocompatibility assessments, and mechanical testing, rather than expert consensus on diagnostic images or pathology.

8. Sample Size for the Training Set

This device is a physical medical system; it does not involve an AI algorithm with a training set. Therefore, this question is not applicable.

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

As this device does not involve an AI algorithm, the concept of a "training set" and its associated ground truth is not applicable.

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