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Savina 300 is a ventilator intended for the ventilation of adults and pediatric patients starting from 5 kg (111bs) bodyweight.

Savina 300 offers mandatory ventilation modes supporting spontaneous breathing, and airway monitoring.

Savina 300 is intended for the following environments of use:

• In intensive care wards, recovery rooms and generally for hospital use

• During the transport of ventilated patients within the hospital

• During secondary transport from one hospital to another (without trolley, monitor not mounted on Savina 300)

• During transport flights with aircraft (without trolley, monitor is not mounted on Savina 300)

Savina 300 is a turbine driven ventilator with a 12.1" color touch screen for easy handling, providing tube and mask based ventilation capabilities. Air is taken from ambient. O2 can be taken from central gas supply, bottle supply (with appropriated accessories) or from another low pressure oxygen source (LPO).

The ventilation unit of the Savina 300 is a microprocessor-controlled ventilator. The Savina 300 provides overpressure ventilation and adjustable oxygen concentration with pressureand volume-controlled automatic and spontaneous breathing modes.

This document is a 510(k) Summary for the Dräger Savina 300 ventilator, claiming substantial equivalence to previously cleared devices. It does not contain a study proving that the device meets specific acceptance criteria in the way a clinical validation study for an AI/ML software device would. Instead, it demonstrates compliance with recognized performance standards to establish substantial equivalence.

Here's an breakdown based on the information provided, and where certain requested information might not be applicable or present for this type of submission:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly provide a table of "acceptance criteria" paired with "reported device performance" in the context of specific outcome metrics like sensitivity, specificity, or accuracy for a diagnostic device.

Instead, the "acceptance criteria" are implied by compliance with listed international and national standards relevant to medical electrical equipment, particularly for lung ventilators. The "reported device performance" is demonstrated by the device's design, functional specifications, and its claim of equivalence to existing devices that have already met these standards.

Here's a summarization of the relevant information provided under "List of Performance Testing" and "Comparison of Technological Characteristics":

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable (N/A) in the context of this 510(k) submission. This document does not describe a clinical validation study involving a "test set" of patient data for evaluating a software algorithm. The "testing" referred to is performance testing against recognized standards for medical devices and a comparison of technical specifications to predicate devices. There is no patient data involved in this type of submission for this device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is N/A. As explained above, there is no "test set" or "ground truth" establishment in the context of expert review for a diagnostic AI/ML device in this submission. The device is a ventilator, and its performance is assessed against engineering standards and comparison to similar devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is N/A. No adjudication method for a test set is relevant to this 510(k) submission.

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 N/A. The device is a ventilator, not a diagnostic imaging device or AI assistance tool for human readers. Therefore, an MRMC study is not relevant to this submission.

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

This information is N/A. The Savina 300 is a physical medical device (ventilator) with integrated software, not a standalone algorithm. Its operation involves continuous interaction with a patient under the supervision of trained medical personnel.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is N/A. "Ground truth" in the context of diagnostic accuracy is not relevant to this type of device and submission. The "truth" here is compliance with established performance standards and the functional equivalence of its technical characteristics to predicate devices.

8. The sample size for the training set

This information is N/A. As this is a medical device (ventilator) and not an AI/ML software device trained on data, there is no "training set."

9. How the ground truth for the training set was established

This information is N/A. No training set exists for this device.

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The anesthesia workstation Perseus is intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing.

Perseus is equipped with airway monitoring, gas measurement and device monitoring, O2 insufflation, and an anesthetic gas receiving system.

Anesthesia is achieved through a mixture of pure oxygen and Air (medical compressed air) or pure oxygen and nitrous oxide, with the addition of volatile anesthetic agents.

Ventilation is accomplished on the patient through a laryngeal mask, a mask, or an endotracheal tube.

The integrated breathing system can be used with partial rebreathing (low-flow or minimumflow).

A non-rebreathing system such as the Kuhn or Medec Water System may be used at the external fresh-gas outlet (optional).

Perseus A500 is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions.

The Perseus A500 is a continuous flow gas anesthesia system that delivers anesthetic vapour, provides for automatic and manual modes of ventilation, and is equipped with a monitoring system for ventilation, inspired and expired gas, and agent identification.

The main functionality of the anesthesia system comprises

• gas delivery for mixing oxygen and carrier gases, -
• anesthetic agent delivery (via vaporizers such as Dräger Vapor 3000),
• anesthesia ventilator (blower based), -
• anesthesia breathing system ABS, -
• airway monitoring (flow, pressure, gas concentrations) .

The Perseus A500 consists of the following main components:

• M3 Blower based Anesthesia Ventilator, electrical driven, supporting the Ventilation . modes
  • o Man/Spont
  • o Volume Controlled
  • Pressure Controlled o
• Embedded control display with touch screen technology and rotary/confirm knob for selecting and confirming parameters.
• . Gas Mixer
• . Heated integrated Anaesthesia Breathing System ABS
• Patient Gas Monitoring with agent mixture detection and Oxygen monitoring .
• Integrated Anesthesia Gas Scavenging System -
• Auxiliary Oxygen Therapy w/ flow indicator -
• Oxygen cylinder support (reserve gas inlet) -

The provided document is a 510(k) premarket notification for the Dräger Perseus A500 anesthesia machine. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results often found for novel devices or AI/ML-driven diagnostics.

Therefore, the document does not contain the detailed information requested regarding specific acceptance criteria for performance metrics (like sensitivity, specificity, accuracy), nor does it describe a study explicitly designed to "prove the device meets the acceptance criteria" in the way one would for a diagnostic or AI algorithm.

Instead, the submission demonstrates compliance with recognized safety, performance, and electromagnetic compatibility standards, and states that the device's functionality and performance are substantially equivalent to its predicate devices.

Here's an attempt to answer the questions based on the available information, noting where information is not present:

Acceptance Criteria and Study for Dräger Perseus A500 Anesthesia Machine

The Dräger Perseus A500 anesthesia machine is a Class II medical device, and its 510(k) submission (K133886) focuses on demonstrating substantial equivalence to predicate devices and compliance with relevant industry standards for safety and performance. This is a different regulatory pathway than for novel diagnostic devices, especially those utilizing AI, which would typically involve detailed performance metrics like sensitivity, specificity, and ROC curves.

1. Table of Acceptance Criteria and Reported Device Performance

As this is an anesthesia machine and not a diagnostic device, the acceptance criteria are based on compliance with harmonized standards, functional equivalence to predicate devices, and safety. Quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are not presented in this 510(k) summary in the way they would be for an AI model.

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

Not applicable in this context. The "test set" here refers to the device itself being tested against standards and its predicate, not a dataset for an algorithm. The evidence presented focuses on engineering verification and validation, and demonstrating equivalence. No specific "data provenance" related to a test set for an algorithm is mentioned.

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

Not applicable. This is not a study requiring expert-established ground truth for an AI algorithm. The "ground truth" for this device's performance is compliance with established engineering and medical device standards, and functional equivalence to legally marketed predicate devices.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of an adjudication process for a test set in the context of this device.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done, nor would it be expected for this type of device (anesthesia machine). This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and the effect of AI assistance on their performance is being evaluated.

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

Not applicable. The Perseus A500 is an anesthesia machine, not a standalone algorithm. Its performance is inherent to its mechanical and electronic functions.

7. Type of Ground Truth Used

The "ground truth" for this submission is multifaceted:

• Compliance with harmonized standards: The device's performance is measured against the requirements of international and national standards (e.g., IEC 60601 series, ISO 8835 series, ISO 21647, ISO 10993, ISO 15001, ISO 17664).
• Engineering specifications: The device is verified and validated against its own design specifications.
• Functional equivalence to predicate devices: The functionality, indications for use, and general performance are compared directly to previously cleared anesthesia machines.
• Risk analysis: Hazard identification and mitigation are based on established risk management processes.
• Usability evaluation: User feedback validates the intuitiveness and safety of operation.

8. Sample Size for the Training Set

Not applicable. The Perseus A500 is an anesthesia machine, not an AI/ML algorithm that requires a training set.

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

Not applicable, for the same reasons as #8.

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General Purpose Temperature probes Dräger disposable general purpose temperature probes are intended for patient core body temperature measurement in combination with Dräger and Siemens patient monitoring systems. The probes are inserted into the oesophagus or the rectum. Skin Temperature probes Dräger disposable skin temperature probes are intended for patient skin temperature measurement in combination with Dräger and Siemens patient monitoring systems. The probes are affixed on the patient's skin with an adhesive cover.

Temperature probes are used during patient temperature measurement and consist of a plug connected to a patient monitor and a thermistor on the patient end. The thermistor consists of a resistor which is sensitive to temperature changes. The portfolio includes General Purpose Temperature probes to be inserted into the oesophagus or the rectum and Skin Temperature Probes. The devices are intended for single patient use and can be used with Dräger and Siemens patient monitors.

Here's an analysis of the provided 510(k) summary, aiming to describe the acceptance criteria and the study proving the device meets them, based on the input text:

Acceptance Criteria and Device Performance for Dräger Temperature Probes (K121999)

Based on the provided 510(k) summary (K121999) for Dräger Temperature Probes, the document outlines verification and validation measures, but it does not explicitly state specific numerical acceptance criteria or detail the quantitative results of a study demonstrating these criteria have been met for accuracy. Instead, it relies on demonstrating substantial equivalence to predicate devices and adherence to general performance and safety tests.

The document indicates that the device's performance is within an acceptable range for clinicians, implying that the acceptance criteria for these tests were met, but the specific metrics are not provided.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not specify the sample size used for the test set or the country of origin of the data. It mentions "Verification & validation measures include but are not limited to the following key tests," implying these tests were conducted, but offers no details about the testing methodology, sample sizes, or data provenance (retrospective or prospective) for each specific test.

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

The document does not mention the use of experts to establish ground truth for a test set. This type of device (temperature probes) typically relies on metrological standards and comparisons to reference instruments rather than expert opinion for ground truth.

4. Adjudication Method for the Test Set

As there's no mention of expert ground truth establishment, there is no adjudication method described.

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

An MRMC comparative effectiveness study was not performed or is not mentioned in the provided document. This type of study is relevant for diagnostic imaging interpretation devices, not for basic medical instruments like temperature probes.

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

The device is a physical temperature probe, not an algorithm, so a "standalone (algorithm only without human-in-the-loop performance)" study is not applicable and therefore not mentioned. The probes' performance is evaluated standalone in terms of their physical and electrical properties when connected to a monitor.

7. Type of Ground Truth Used

The ground truth for the verification and validation tests would typically be established by metrological reference standards for temperature measurement, and possibly by laboratory testing against known environmental conditions, for tests like accuracy, electrical safety, mechanical tests, and environmental resistance. For biocompatibility, the ground truth is established by adherence to recognized biocompatibility standards (e.g., ISO 10993). The document confirms that for accuracy, the "function and principle of operation as well as the characteristic of the used NTC (YS1400) are equal" to predicate devices, implying that their inherent accuracy characteristics are comparable using established physical principles.

8. Sample Size for the Training Set

There is no mention of a "training set" in the context of this device. Temperature probes are not AI/ML devices that require training sets. Their performance is based on physical design and manufacturing.

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

As there is no training set, this question is not applicable.

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The SmartPilot View is software which monitors and logs the dosage of intravenous and volatile drugs administered to a human being. Additionally, SmartPilot View displays pharmacokinetic, pharmacodynamic (PK/PD) and interactive PD modeling information. Smart Pilot provides the health care professional with theoretical information about the modeled effect of supported anesthesia pharmaceuticals delivered to the patient.

The SmartPilot View is software for use by health care professionals trained in the application of general anaesthesia.

The SmartPilot View is intended for use with data from adults only. The demographic ranges for these patient data are as follows:

Height 59 in to 79 in (150 cm to 200 cm) Weight 88 lb to 309 lb (40 kg to 140 kg) Age 18 to 90 years

The current version of the SmartPilot View is receiving data from a dedicated anesthesia workstation or combination of workstation and other devices.

The Software SmartPilot View runs on a dedicated patient vincinity workstation (Draeger C700 for IT) with the installed Infinity Explorer Software.

The data is taken from dedicated anesthesia workstation A (Draeger Primus US "Apollo") or combination of the workstation and other devices like IV Pumps (B.Braun Perfusor Space pump) and patient monitors M (Draeger Delta/Delta XL, Kappa, Omega S).

The software visualizes the drug effect based on pharmacokinetic models and the drug interaction based on pharmacodynamic models known from scientific literature.

The software visualizes the synergetic and additive drug effect on a screen in a specially developed 2D pharmacodynamic diagram. Furthermore a new pharmacodynamic parameter (NSRI) is calculated based on the synergetic drug effects.

The software monitors and calculates data for the use during the anesthesia case. The software also logs data during the anesthesia case for a retrospective analysis.

Supported drugs:

Intravenous hypnotics – Propofol

Volatile hypnotics

• Isoflurane
• Sevoflurane
• Desflurane
• Enflurane

Intravenous opioids

• Fentanyl
• Remifentanil
• Sufentanil
• Alfentanil

Intravenous muscle relaxants

• Pancuronium
• Rocuronium

Parameters provided by the basic device (monitor and anaesthesia machine)

• Heart rate HR in 1/min
• Mean non-invasive blood pressure NIBP M or mean arterial pressure ART M in mmHg or kPa.
• End-expiratory CO2 concentration etCO2 in mmHg, Vol.% or kPa.
• Bispectral index BIS
• BIS signal quality index SQI in %

The provided text K103035 Traditional 510(k) SmartPilot View describes a medical device, the SmartPilot View software, which monitors and logs drug dosages and displays pharmacokinetic/pharmacodynamic (PK/PD) modeling information.

However, the document does not contain information about acceptance criteria, specific performance metrics (like sensitivity, specificity, accuracy), or any studies designed to prove the device meets such criteria.

The "Assessment of non-clinical testing" section states that the device "has been tested according to its specifications, including software validation," and lists standards and guidelines adhered to (ISO 14971, IEC 62304, FDA CDRH Guidance for Software). This generally refers to verification and validation activities to ensure the software functions as intended and meets design requirements, but it does not provide specific performance acceptance criteria or study results in terms of device performance metrics typically associated with AI/CAD devices.

Furthermore:

• The section for "Clinical performance data" explicitly states "Not applicable."
• There is no mention of a test set, data provenance, ground truth establishment, sample sizes for test or training sets, expert involvement, or any multi-reader multi-case studies.
• The device is described as "software which monitors and logs the dosage of intravenous and volatile drugs administered to a human being" and "displays pharmacokinetic, pharmacodynamic (PK/PD) and interactive PD modeling information." It "provides the health care professional with theoretical information about the modeled effect of supported anesthesia pharmaceuticals delivered to the patient." This sounds more like a data visualization and information system based on established pharmacological models rather than an AI/CAD system that would generate a diagnostic or screening output requiring performance metrics like sensitivity and specificity.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, or details about the studies, as that information is not present in the provided text.

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