Search Results

VentStar Dual Heated / VentStar Heated: Disposable inspiratory heated breathing circuit with humidifier chamber for connection to a Fisher & Paykel MR850 humidifier, for conveying moistened breathing gas between the humidifier and adult patients with a body weight of at least 40 kg (88 lbs).

VentStar Heated (N) / VentStar Heated (N) basic: Disposable inspiratory heated breathing circuit for connection to a Fisher & Paykel MR850 humidifier, for conveying moistened breathing gas between the humidifier and neonatal patients with a body weight of up to 5 kg (11 lbs).

Infinity ID Breathing Circuit Heated (N): Inspiratory heated breathing circuit for connection to a Fisher & Paykel MR850 humidifier, for moping moistened breathing gas between the humidifier and neonates with a body weight of up lo 5 kg (11 Ibs) Intended for single-use only. Breathing circuit with integrated transponder. The transponder serves as a carrier of product-specific data for processing by Dräger Infinity ID equipment.

Infinity ID Breathing Circuit Dual Heated / Infinity ID Breathing Circuit Heated: Heated breathing circuit for connection to a Fisher & Paykel MR850 humidifier, for conveying moistened breathing gas between the humidfier and adults with a body welght of at least 40 kg (88 moration broaining goo Doching circuit with integrated transponder. The transponder. The transponder serves as a carrier of product-specific data for processing by Dräger Infinity ID equipment.

The 510(k) comprises heated breathing gas hose systems including a humidifier chamber for the ventilation of neonatal or adult patients in Intensive Care Units. The hose systems consist of two breathing hoses (inspiratory and expiratory limb) with an additional y- piece.

Inside the inspiratory and in case of the dual heated systems also in the expiratory limb of the hose system there is a heating wire which can be connected to a Fisher & Paykel humidifier MR850 to heat up the breathing gas to minimise condensation. An expiratory limb without heating wire includes a water trap. There are additional sensor ports where the temperature sensors of the Fisher & Paykel humidifier MR850 (e.g. Fisher & Paykel 900MR868) can be placed in.

In case of the neonatal system, the hose is equipped with an incubator extension for use inside an incubator.

The Infinity ID heated breathing circuits are based on the heated breathing circuits additionally equipped with an RFID identification tag. The tag stores characteristics of the breathing hose (e.g. patient type, hose diameter, resistance and compliance values, manufacturing date and shelf life) and is automatically be readout when connected to the outlets of a ventilator device which supports this function.

The provided document (K102618) describes heated breathing circuits manufactured by Dräger Medical AG & Co. KG. The summary of testing indicates that the device has undergone performance evaluations; however, it does not provide specific quantitative acceptance criteria or detailed study results that would allow for a precise filling of the table requested.

Therefore, many sections of your request cannot be fully answered with the information given. I will extract what is available and indicate where information is missing.

Acceptance Criteria and Device Performance Study for Dräger Heated Breathing Circuits (K102618)

The provided document describes the safety and performance testing for Dräger's VentStar Heated and Infinity ID Breathing Circuit Heated devices. However, explicit quantitative acceptance criteria and detailed quantitative performance results are not presented in a traditional "acceptance criteria vs. reported performance" format. The document generally states that "product performance is given within the range the device can be used by clinicians" and that "the technological characteristics and the results of the performance data demonstrated that the heated breathing hoses issued no new risks." This suggests a qualitative assessment of performance against design specifications or clinical utility rather than specific numerical thresholds.

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Detailed quantitative acceptance criteria (e.g., temperature ranges, flow rates, humidity levels, specific electrical thresholds) and corresponding numerical performance data are not available in this document.

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

• Test Set Sample Size: Not specified. The document mentions "the following testing has been performed on the breathing systems," but does not list the number of units tested for each type of assessment.
• Data Provenance: The manufacturer is Dräger Medical AG & Co. KG, based in Lübeck, Germany. The data would therefore be prospective product development and validation testing conducted by the manufacturer, likely in Germany.

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

This section is not applicable or not provided in the document. The testing described appears to be engineering and biocompatibility validation, not clinical studies requiring a ground truth established by medical experts in the traditional sense of diagnostic accuracy algorithms. Performance is likely measured against engineering specifications and relevant international standards.

4. Adjudication Method for the Test Set

This is not applicable as the tests performed are primarily engineering and compliance checks, not diagnostic interpretations requiring adjudication.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or at least not described in this document. This typically applies to AI systems assisting human readers in diagnostic tasks, which is not the nature of this device.

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

This is not applicable in the context of this device. The heated breathing circuits are passive disposables designed to work in conjunction with other medical equipment (humidifiers, ventilators) and human clinicians. They do not involve an AI algorithm operating independently.

7. Type of Ground Truth Used

The "ground truth" for this device's performance would be defined by:

• Engineering Specifications: Design tolerances and intended operational parameters for temperature, flow, humidity, and material integrity.
• International Standards: Compliance with ISO standards (e.g., ISO 10993-1 for biocompatibility) and other relevant safety and performance mandates for medical devices (e.g., electrical safety standards).
• Clinical Requirements: The ability to effectively humidify and convey breathing gas to patients within clinically acceptable and safe ranges, as determined by medical device regulations and established clinical practice.

8. Sample Size for the Training Set

This is not applicable. This device is not an AI algorithm trained on data; it is a physical medical device (breathing circuit).

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

This is not applicable for the same reason as point 8.

Ask a specific question about this device

The VentStar Resuscitaire CEU with PEEP valve is indicated as an accessory to add positive end expiratory pressure breathing capability. The valve is designed into the breathing circuit T-Piece with a standard fitting for face mask, laryngeal mask or endotracheal tube.

The VentStar Resuscitaire CEU is a disposable breathing circuit for the transmission of breathing gases from a breathing gas source (Resuscitation Module) to the newborn patient in labor and delivery environments. It is suitable for newborn patients from birth to 1 month of age (maximum body weight of 10 kg (22 lb)). It is intended exclusively for use in combination with the Resuscitaire Radiant Warmer.

The VentStar Resuscitaire CEU is a prescription device.

The VentStar Resuscitaire CEU with PEEP valve is indicated as accessory to add positive end expiratory pressure breathing capability. The valve is designed into the T-Piece of the breathing circuit with a standard fitting for face mask, laryngeal mask or endotracheal tube.

The provided text describes the 510(k) summary for the Dräger VentStar Resuscitaire CEU, a medical device for neonates. It focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive study proving the device meets specific acceptance criteria in the way a new, innovative AI/software device would. Therefore, many of the requested elements for an AI study are not applicable or cannot be extracted from this document.

However, I can extract information related to the device itself, the comparison to the predicate, and the type of testing performed.

Summary of Acceptance Criteria and Device Performance (Based on Substantial Equivalence):

The acceptance criteria for the VentStar Resuscitaire CEU are rooted in demonstrating substantial equivalence to a predicate device, the NeoPeep Neonatal Resuscitation Circuit. The "acceptance criteria" here are implicitly that the key performance parameters of the new device match or are functionally equivalent to the predicate.

Study Information (Based on provided document):

1. Sample size used for the test set and the data provenance: Not applicable. This document describes a medical device, not an AI/software device that would have a "test set" in the context of data. The testing was primarily non-clinical bench testing.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. As this is not an AI/software device, there is no "ground truth" derived from expert consensus on images or data.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. 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: Not applicable. This is a physical medical device, not an AI or software component requiring MRMC studies.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device; there is no "algorithm only" performance to evaluate.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of a "test set" for an AI device. The "ground truth" for this device's performance would be established by physical measurements and adherence to engineering standards (e.g., ISO, internal specifications) during the bench testing. The regulatory ground truth is its substantial equivalence to the legally marketed predicate.
7. The sample size for the training set: Not applicable. This is a physical medical device; it does not have a "training set" in the AI sense.
8. How the ground truth for the training set was established: Not applicable.

Additional Information from the Document regarding "Study":

• Device Performance Assessment: The assessment of the VentStar Resuscitaire CEU involved non-clinical bench testing.
• Standards Used for Bench Testing:
  • ISO 5356 Anesthetic and Respiratory Equipment - Conical Connectors Part 1
  • ISO 5367 Breathing tubes intended for use with anesthetic apparatus and ventilators
  • System compatibility testing
• Biocompatibility Testing: Performed per ISO 10993 - Biological Evaluation of Medical Devices Parts 1, 5 & 12.
• Conclusion of the Study (Bench Testing): "In summary Dräger Medical AG & Co. KG has demonstrated that the proposed device is safe and effective and is substantially equivalent, based on intended use, design, operational and technological characteristics, and principles of operation, to the NeoPeep Neonatal Resuscitation Circuit."

In essence, the "study" demonstrating the device meets "acceptance criteria" for regulatory clearance (510(k)) was a series of non-clinical bench tests and biocompatibility tests designed to show that the VentStar Resuscitaire CEU performs equivalently to its predicate device and meets relevant safety standards for its classification.

Ask a specific question about this device

The Dräger Dräger Infinty MCable Mainstream CO2 sensor is meant to be used for continuous, real time measurement of CO2 concentrations of ventilated patients from neonates to adults. This sensor is only intended for use with devices made by Dräger Medical, or with devices which are approved for use with Dräger CO2 components (Dräger-compatible devices).

The Infinity MCable - Mainstream CO2 uses infrared absorption technology to accomplish mainstream CO2 measurements. The sensor is able to measure end-tidal CO2 and inspired CO2 and calculates the respiratory rate. This measurement module is integrated inside the sensor and no longer part of the host device (e.g. ventilator). CO2 compensation has been advanced for the foreign gases helium and nitrous oxide.

The provided text is a 510(k) summary for the Dräger Infinity MCable - Mainstream CO2, a device designed for continuous, real-time measurement of CO2 concentrations. The summary primarily focuses on establishing substantial equivalence to a predicate device and does not contain information about specific acceptance criteria, a dedicated study proving device performance against those criteria, or the detailed aspects of a clinical study typically associated with AI/ML device evaluations. Therefore, a table of acceptance criteria and reported device performance cannot be generated, nor can details about sample size, expert ground truth, adjudication methods, or MRMC studies be provided from this document.

The document states that "All modifications have been evaluated for safety and effectiveness. The summary of the design control activities and the risk analysis show that these types of modifications do not change the device operating principle or mechanism of action. The modifications do not alter the fundamental scientific technology and therefore the safety and effectiveness is substantially equivalent to the legally marketed predicate device." This indicates that the evaluation of the device relied on demonstrating substantial equivalence to a predicate device rather than conducting a de novo study with explicit acceptance criteria and performance metrics described in this summary.

Information that can be extracted from the provided text:

While the detailed study information is not available, here's what can be inferred or directly stated from the document:

• Device: Dräger Infinity MCable - Mainstream CO2
• Purpose: Continuous, real-time measurement of CO2 concentrations in ventilated patients (neonates to adults).
• Technological Principle: Uses infrared absorption technology (specific dual wavelength infrared absorption by CO2 molecules).
• Measured Parameters: CO2 waveform, end-tidal CO2, inspired CO2, and respiration rate from capnogram.
• Measurement Range: 0 to 100 mmHg.
• Predicate Device:
  • K051263 - Evita XL, Option SmartCare with Option Capno Package CO2 Mainstream sensor #6871500 (Dräger Medical AG & Co. KG)
  • K042601 - CAPNOSTAT 5 (RESPIRONICS NOVAMETRIX, INC.)

The following details are not present in the provided 510(k) summary:

1. Table of acceptance criteria and reported device performance: Not included. The document focuses on substantial equivalence rather than explicit performance metrics against pre-defined acceptance criteria.
2. Sample sized used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
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: Not relevant or mentioned. This is a CO2 measurement sensor, not an AI/ML-driven diagnostic imaging device requiring human reader improvement studies.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not explicitly detailed, but as a sensor, its performance is inherently standalone in generating the measurements. There is no "human-in-the-loop" performance as described for AI/ML diagnostic tools.
7. The type of ground truth used: Not explicitly stated, as the evaluation was based on substantial equivalence to predicate devices and design control activities. For CO2 sensors, ground truth would typically come from calibrated gas mixtures or established reference methods.
8. The sample size for the training set: Not applicable and not mentioned, as this device primarily relies on a physical principle (infrared absorption) rather than a machine learning model trained on data.
9. How the ground truth for the training set was established: Not applicable and not mentioned.

Ask a specific question about this device

Dräger cuffs are intended to be used for automatic non-invasive blood pressure measurement. Dräger cuffs are compatible with Dräger and Siemens patient monitors. Neonatal cuffs are designed for single-patient use.

The devices comprise tubing attached to an inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook-and-loop fastener. The devices tubing is connected to a non-invasive blood pressure measurement system with an extension hose. The portfolio includes different standard sizes reusable and single-patient-use non-invasive blood pressure cuffs for adults, paediatrics, infants and single-patient-use NiBP-cuffs for neonates. Longer cuffs are marked with an additional range to which they can be safely used.

The provided 510(k) summary for the Dräger NBP Cuff (K092999) does not contain detailed information regarding specific acceptance criteria, a corresponding study, or performance metrics beyond a general statement of "product performance is given within the range the device can be used by clinicians."

This submission primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices based on design and intended use, rather than a detailed performance study with specific quantitative acceptance criteria.

Therefore, the requested information cannot be fully extracted from the provided text.

However, based on the context of a 510(k) submission for a non-invasive blood pressure cuff, we can infer general expectations and provide what little information is present:

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

"The technological characteristics and the results of the performance data demonstrated that the NBP cuffs issued no new risks during design verification and validation which could question device use." |

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

• Sample Size for Test Set: Not mentioned.
• Data Provenance: Not mentioned.

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)

• Not mentioned. Given this is a medical device accessory (cuff) rather than an AI-driven diagnostic tool, "ground truth" in the AI sense would not typically apply here. Performance would be validated against established measurement standards and potentially clinical trials.

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

• Not applicable/mentioned.

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

• No, this is not an AI device. This question is not applicable.

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

• No, this is a physical medical device accessory (cuff). This question is not applicable.

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

• Not explicitly stated. For a medical device like a blood pressure cuff, performance data would likely involve comparing measurements obtained with the cuff against a gold standard method (e.g., direct arterial line measurement), or against predicate devices in controlled clinical settings, rather than "ground truth" derived from expert consensus on diagnostic images or pathology.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that would require a training set.

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

• Not applicable. This is not an AI/machine learning device that would require a training set.

Summary of available information:

The 510(k) submission for the Dräger NBP Cuff (K092999) primarily relies on demonstrating substantial equivalence to existing predicate devices. It states that "product performance is given within the range the device can be used by clinicians" and that "design verification and validation" showed no new risks. However, it does not provide specific quantitative acceptance criteria or detailed results from a performance study (e.g., sample sizes, specific performance metrics, or study methodology) that would typically be associated with such criteria. The submission confirms general safety, effectiveness, and substantial equivalence based on its intended use, general construction, materials, and technological characteristics being similar to predicate devices.

Ask a specific question about this device

Long-term ventilator for intensive care. For adults, children, and neonates with a minimum body weight of 3 kg (6.6 lbs). For premature infants with a minimum body weight of 0.5 kg (1.1 lbs) with the NeoFlow option.

Evita XL is a time-cycled microprocessor-controlled intensive care ventilator intended to provide continuous ventilation for adults, children, neonates and infants with Neoflow option. The device can be also operated in the mask ventilation mode if the according option is installed. Software modification implements these new software options:

• . Option Mask Ventilation Plus (NIV Plus)
• Option Inspiratory Termination Criteria (Insp. Term. PIF) .
• . Option Proportional Pressure Support (PPS)
  NIV Plus is a supplement to the existing Mask ventilation option (NIV), which improves ventilation performance (triggering and patient comfort) through higher leakage compensation and smooth ending of Assistant Spontaneous Breathing (ASB) strokes. NIV Plus implements Standby Plus an alternative for starting the active ventilation mode in mask ventilation when the patient takes the first spontaneous breath. Anti Air Shower detects disconnection during mask ventilation if the mask is deliberately removed from the face and reduces the flow supplied for the time of the disconnection.
  Insp. Term. PIF is an adjustable stop criterion for pressure support strokes. At the end of the inspiratory phase the delivered inspiratory flow falls under a certain level of the maximum inspiratory flow. The ventilator cycles from inspiration phase to expiration phase when a fixed level was reached. The software modification allows it to adjust this inspiration termination criterion. The device can be configured by the user (adjustable inspiration termination criterion or fixed value is active).
  The ventilation mode Proportional Pressure Support (PPS) is a software option for the ventilator Evita XL designed to assist the spontaneous breathing patient. In PPS, the device supports the patient's spontaneous breathing in proportion to the breathing effort. The degree of support in PPS mode can be set separately according to resistive and elastic components directly proportional to the patient effort.

Here's an analysis of the provided information, focusing on acceptance criteria and a study proving device performance, as requested.

Based on the provided 510(k) summary, the device is the Draeger Evita XL continuous ventilator with new software options. This document is a premarket notification for a medical device rather than a detailed study report. Therefore, it does not contain the typical structure of a clinical study with explicitly defined acceptance criteria and performance data in the format you've requested.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices. This regulatory pathway typically relies on engineering data, performance testing (often bench testing), and risk analysis to show that the new device options are as safe and effective as existing legally marketed devices, rather than a large-scale clinical trial with specific performance metrics like accuracy, sensitivity, or specificity against a ground truth in a clinical setting.

Therefore, many of the specific questions you asked about sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, and standalone performance metrics are not addressed or present in this 510(k) summary.

However, I can extract information related to the device's intended performance and the general nature of the validation conducted:

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

As mentioned, the 510(k) summary does not present acceptance criteria and device performance in the typical format of a clinical study (e.g., sensitivity, specificity, AUC). Instead, it states that the improvements are related to "ventilation performance (triggering and patient comfort) through higher leakage compensation and smooth ending of Assistant Spontaneous Breathing (ASB) strokes" and enabling adjustable inspiration termination. The 'acceptance' in this context is based on demonstrating that these software changes function as intended and do not introduce new safety concerns, while maintaining or improving existing performance.

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

• Not explicitly stated in the 510(k) summary. The document refers to "performed software validation measures" and "risk analysis," which would typically involve bench testing and simulations rather than clinical data sets. Therefore, there's no mention of a "test set" in the context of clinical data with human subjects or retrospective/prospective data collection from a specific country of origin.

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)

• Not applicable / Not explicitly stated. Since there is no mention of a clinical test set requiring human expert-established ground truth, this information is not provided. The validation would have involved engineering experts and possibly medical professionals advising on functional requirements and safety.

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

• Not applicable. As no clinical test set requiring expert adjudication is described, this information is absent.

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

• No MRMC study was mentioned or implied. The Evita XL is a ventilator, not an AI-assisted diagnostic imaging device with "human readers." The software options enhance the ventilator's function directly.

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

• The device is the algorithm/software operating the ventilator. The performance evaluation would be of the ventilator's output and responsiveness as controlled by the new software features. This isn't a "standalone AI" in the sense of a decision support system, but rather the core functionality of the device. The phrase "standalone" might not apply as neatly here, as the software is fundamental to the device's (ventilator's) operation. The validation would have assessed the ventilator's performance with the new software features, ensuring they meet specifications (e.g., accurate flow delivery, appropriate termination).

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

• For software-driven medical devices like ventilators, the "ground truth" for validation is typically defined by engineering specifications, physiological models, and recognized standards for ventilator performance (e.g., accuracy of delivered pressure/volume/flow, response time to patient effort, leakage compensation effectiveness). It's based on objective measurements against these predefined targets, often conducted in a lab or simulation environment. There would likely be no "pathology" or "outcomes data" ground truth in the clinical trial sense for this type of submission.

8. The sample size for the training set

• Not applicable / Not explicitly stated. This device is not described as involving machine learning or AI that requires a "training set" of data in the common sense (e.g., for image classification). The software development would follow traditional software engineering principles, with design, implementation, and verification/validation processes.

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

• Not applicable. See point 8.

In summary: The provided 510(k) summary for the Draeger Evita XL ventilator focuses on establishing substantial equivalence for new software features. It indicates that "software validation measures" and "risk analysis" were performed, leading to the conclusion that the new options are safe, effective, and substantially equivalent to predicate devices. However, it does not present detailed clinical study data with specific acceptance criteria, sample sizes, expert involvement, or statistical analyses typical of AI/ML device submissions that rely on extensive clinical datasets.

Ask a specific question about this device

The Primus US "Apollo" is indicated as a continuous flow anesthesia system. The Primus US "Apollo" may be used for manually assisted, or automatic ventilation, and delivery of gases (O2, N2O and CO2 - in combination with the CO2 module [i.e. Fourth Gas Module]), anesthetic vapor, and monitoring of oxygen and CO2 concentrations, breathing pressure, respiratory volume, and anesthetic agent identification and concentration. Federal law restricts this device to sale by or on the order of a physician.

The Fourth Gas Module provides an optional means of delivering carbon dioxide (CO2) into the fresh gas coming from the gas mixer of the anesthesia machine Primus US "Apollo".

The Fourth Gas Module consists of a means of flow and pressure control for CO-; a colorcoded control knob; a means of flow and pressure measurement for CO;; a means to mount a CO2 E-size cylinder; and an enclosure for the various components.

The Fourth Gas Module has been verified to provide the Primus US "Apollo" anesthesia workstation (K042607) with a means of delivering carbon dioxide as a medical gas.

I am sorry, but based on the provided text, there is no information available regarding acceptance criteria or a study proving the device meets those criteria for the "Fourth Gas Module with CO2 for Primus US 'Apollo' Anesthesia machine."

The document is a 510(k) Summary, which primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices. It states:

• "Design, development, verification and validation of the device was performed in accordance with FDA regulations and guidance and company internal standards. The testing and analysis of results provide assurance that the device meets its specifications and is safe and effective for its intended use."

However, it does not provide details about specific acceptance criteria or the study data that supports this assurance.

Therefore, I cannot provide the requested table or answer the specific questions about sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or training set details.

Ask a specific question about this device

The mask ClassicStar noninvasive ventilation (NV) with standard elbow (SE) and the mask NovaStar noninvasive ventilation (N); with standard elbow (SE) are intended to provide a patient interface for application of noninvasive ventilation. The masks are to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure or respiratory insufficiency. The masks are intended for use on adult patients (>30 kg/66 lbs), who are appropriate candidates for noninvasive ventilation in the hospital or institutional environment.

The mask ClassicStar NV, with standard elbow is disposable and for single patient use.

The mask NovaStar NV, with standard elbow can be used multiple times on multiple patients. Reuse, however, is limited up to 5 times.

The full face mask NovaStar, noninvasive ventilation (NV), with anti-asphyxia valve (AAV) is intended to be used with positive airway pressure devices, operating at or above 3 mbar (3 cmH2O). The mask contains exhalation ports and does not require the use of a separate exhalation device. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation in the hospital, institutional and in the home environments. The mask can be used multiple times on multiple patients. Reuse, however, is limited up to 5 times.

Within the medical device family "Noninvasive Ventilation Masks" are devices to provide a patient interface for the application of noninvasive ventilation.

The masks ClassicStar and NovaStar are Full-Face masks which cover the mouth and the nose and are available with a standard elbow (SE) or an anti-asphyxia valve (AAV). Masks with a standard elbow (SE) may only be used on ventilation devices, which incorporate adequate alarm and safety systems for ventilation failure.

A mask with an anti-asphyxia valve (AAV) incorporates the anti-asphyxia valve in the mask elbow.

The ClassicStar Masks are disposable, while the NovaStar Masks are reusable up to 5 times for multiple patients. Further differences are the headgears, which are similar in materials but differ in means of connection to the mask. The headgears are generally provided with the masks, for the reusable masks further headgears are available as optional accessory.

All noninvasive ventilation masks are available in three different sizes (S, M, L),

The provided text is a 510(k) summary for non-invasive ventilation masks. It is a regulatory submission to the FDA for market clearance, not a scientific study reporting device performance against acceptance criteria in the way a research paper would. Therefore, much of the requested information (like specific performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth details) is not typically found in this type of summary.

Instead, a 510(k) summary focuses on demonstrating "substantial equivalence" to legally marketed predicate devices. This typically involves showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to the predicate. The "acceptance criteria" here are essentially the regulatory requirements for substantial equivalence, and the "study" is the overall 510(k) submission process itself, where testing (e.g., biocompatibility, materials testing, performance under simulated conditions) is conducted to ensure the device meets recognized standards and performs similarly to its predicates.

Given this context, here's an attempt to answer your questions based on the provided text, recognizing the limitations:

Acceptance Criteria and Device Performance (Based on 510(k) Submission)

The "acceptance criteria" in a 510(k) context are primarily demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety/effectiveness. The "reported device performance" is not quantified in the typical sense of a human-AI study but rather implied through comparison to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Additional Requested Information:

Since this is a 510(k) summary for a physical medical device (masks) and not an AI/software device, many of your specific questions related to AI study design are not applicable.

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

   • Not applicable for this type of device and document. A 510(k) for a physical device like a mask does not typically involve "test sets" of data in the AI/machine learning sense. Performance is generally assessed through engineering testing (e.g., airflow resistance, dead space, seal integrity, materials biocompatibility, pressure drop) and clinical use data collection, if necessary, to demonstrate equivalence. Specific sample sizes for such tests are not detailed in this summary.
   • Data Provenance: The applicant is Dräger Medical AG & Co. KG from Lübeck, Germany. Any internal testing data would likely originate from their facilities.

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)

   • Not applicable. Ground truth for a physical medical device like a mask is established through objective engineering measurements, adherence to recognized standards, and, if applicable, clinical validation (though not usually required for 510(k) unless a new significant performance claim is made or equivalence is challenged). There are no "experts establishing ground truth" in the diagnostic context.

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

   • Not applicable. This relates to diagnostic interpretation consensus, which is not relevant for a respiratory mask.

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

   • Not applicable. This is a physical medical device, not an AI or diagnostic tool. MRMC studies are not relevant.

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

   • Not applicable. This is a physical mask, not an algorithm.

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

   • Not applicable in the AI/diagnostic sense. The "ground truth" for a non-invasive ventilation mask would be derived from:
     • Engineering specifications and standards: Adherence to ISO, ASTM, or other recognized standards for breathing devices (e.g., dead space, flow resistance, pressure integrity).
     • Biocompatibility testing: Ensuring materials are safe for human contact.
     • Bench testing: Actual performance measurements in a laboratory setting.
     • Clinical experience/literature: Supporting the general safety and effectiveness of non-invasive ventilation masks of similar design.

8. The sample size for the training set

   • Not applicable. This is not an AI/machine learning device.

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

   • Not applicable. This is not an AI/machine learning device.

In summary: The provided document is a regulatory submission aiming for market clearance based on substantial equivalence to existing devices. It demonstrates this equivalence through a comparison of intended use and technological characteristics, implicitly supported by internal testing and adherence to recognized standards by the manufacturer. It does not provide the detailed scientific study results typically found for AI/diagnostic devices.

Ask a specific question about this device

The Fabius MRI is indicated as a continuous flow anaesthesia system. The Fabius MRI may be used for spontaneous, manually assisted or automatic ventilation, delivery of gases and anaesthetic vapor, and monitoring of oxygen concentration, breathing pressure and respiratory volume.

The Fabius MRI is indicated for use in MRI scanner rooms with 1.5 and 3.0 tesla magnets at a location of 40 m tesla (400 gauss) or less.

The Fabius MRI is a continuous flow anesthesia system usable in an MRI environment.

Fabius MRI is equipped with a compact breathing system, providing fresh gas decoupling, PEEP, and pressure limitation.

The following ventilation options are available:

• Volume Controlled Ventilation
• Pressure Controlled Ventilation
• Pressure Support (Optional)
• SIMV/PS (Optional)
• Manual Ventilation
• Spontaneous Breathing

Fabius MRI is equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2),

The provided text is a 510(k) summary for the Fabius MRI device, an anesthesia gas machine. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria, device performance results, sample sizes for testing, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, or standalone performance studies.

Instead, the document focuses on:

• Device Identification: Applicant/Manufacturer name, contact, device name (Fabius MRI), common name (Gas-machine, anesthesia), classification details, and date of submission.
• Device Description: Fabius MRI is a continuous flow anesthesia system usable in MRI environments (1.5 and 3 Tesla magnets,

Ask a specific question about this device

The Carina is a long-term ventilator-dependent patients or ventilator-assisted patients. The device is intended for treatment of sub-acute care patients in hospital or medical rooms. The device is intended for invasive ventilation or non-invasive ventilation. The device is intended for patients with a tidal volume of at least 100 mL. The device is intended for use by qualified medical personnel.

The Carina. is a mechanical ventilator for use inside a hospital (sub-acute care). It offers the following ventilation modes:

• · VC-SIMV (Volume controlled synchronized intermittent mandatory ventilation)
• · PC-AC (Pressure controlled assisted control)
• · PC-SIMV (Pressure controlled synchronized intermittent mandatory ventilation)
• · SPN-PS (VG) (Pressure Support + (volume guarantee))
• · SPN-CPAP (Continuous Positive Airway Pressure)
• · Apnoea ventilation in SPN group mode (for spontaneously breathing patients)
  The device can be used for invasive and non invasive ventilation (e.g. trachea tube and mask ventilation). The device offers both high pressure oxygen inlet and oxygen via a low pressure oxygen inlet (max. 500 hPa/10L/min).
  The device monitors the following ventilation parameters:
• · Airway pressure (PIP, Pmean, PEEP)
• · Inspiratory Tidal volume (VTi)
• · Breath rate (f)
• · Minutes volume (MV , MV leak)
• The device has the following user-settable alarms:
• · Airway pressure high
• · Minute volume high / low
• · Rapid shallow breathing (high frequency alarm)
• · Apnea alarm
• · Disconnection alarm
  Flow and pressure curves are displayed on the display. Spontaneous breathing (Triggered breath) of a patient is indicated on the screen by an asterisk (*).
  Airway pressure high as a dotted line is displayed on the screen.

The provided text contains a 510(k) summary for the Dräger Medical AG & Co. KG Carina Continuous Ventilator. However, it does not include information about specific acceptance criteria or a study proving the device meets those criteria. The document focuses on establishing substantial equivalence to predicate devices, describing the device, its intended use, and the regulatory process.

Therefore, I cannot provide the requested information based on the given text.

The document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes, data provenance, number of experts for ground truth, or adjudication methods for a test set.
3. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or an effect size.
4. Details of a standalone algorithm performance study.
5. The type of ground truth used.
6. The sample size for the training set or how its ground truth was established.

Ask a specific question about this device

CareStar 30 and SafeStar 55 are Breathing System Filters which are designed to reduce possible airborne or liquid-borne cross contamination with micro-organisms and particulate matter via anaesthetic or ventilator breathing systems.

The products may either be used on the patient side or on the device side of the ventilator/ anaesthetic device and are used as a hygienic measure alternatively to decontamination of breathing system and/or breathing gas conveying parts of the ventilator.

TwinStar 55 is a Breathing System Filter and a Heat and Moisture Exchanger. The combination of a filter and a Heat and Moisture Exchanger offer the benefit of both product features. Heat and Moisture Exchanger are used as a conditioning system for mechanically ventilated patients whose upper airways are bypassed. In almost all cases of mechanical ventilation they are a fully valid alternative to heated humidifiers. The products are the only conditioning opportunity of breathing gases in cases of emergency ventilation or during transport since Heated Humidifiers are almost impossible to use.

The products mentioned above are designed for disposable use and should be changed at least every 24 hours.

The filters CareStar 30 and SafeStar 55 are designed to reduce possible air or liquid borne cross contamination with microorganisms via anesthetic or ventilator breathing systems. The strategic use of an effective breathing filter protects, bi-directionally, both the patient and equipment.

The filter CareStar 30 contains an electrostatic filter pad while the filter SafeStar 55 incorporates a mechanical pleated filter pad. Both filters consist of a plastic body which incorporates 22 female / 15 male connectors in accordance with EN ISO 5326 and a luer lock connector which may only be used for gas monitoring.

The Filter/HME TwinStar 55 is designed to combine the feature of reducing possible cross contamination with micro-organisms and an ideal heat and moisture return.

The Filter/HME TwinStar 55 consist of a plastic body which incorporates an electrostatic filter pad, 22 female / 15 male connectors in accordance with EN ISO 5326 and a gas luer lock connector which may only be used for gas monitoring.

Here's an analysis of the provided text regarding the Dräger Medical breathing system filters, focusing on the acceptance criteria and the study proving compliance.

It's important to note that this document is a 510(k) Summary, which typically provides a high-level overview of the device and its substantial equivalence to predicate devices, rather than a detailed study report. Therefore, specific details about study design, raw data, or comprehensive statistical analyses are often summarized or omitted.

1. Table of Acceptance Criteria and Reported Device Performance

The document provides performance specifications for the devices, comparing them to generally accepted standards for breathing system filters. The "acceptance criteria" are implied by the listed performance values and the claim of substantial equivalence to predicate devices.

*BFE: Bacterial filtration efficiency; VFE: Virus filtration efficiency

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

The document states filtration efficiency tests were done "by Nelson Lab." Nelson Laboratories is a well-known contract research organization specializing in microbiology and material testing for medical devices.

• Sample Size for Test Set: Not explicitly stated in the provided document. Standard laboratory testing, especially for filtration efficiency, would involve a statistically significant number of samples, but the exact count is not given here.
• Data Provenance: The document implies the data comes from laboratory testing (Nelson Labs). This is not patient-specific clinical data. It is a prospective test of the physical properties and performance of the manufactured devices. The country of origin for Nelson Labs is the United States.

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

• This type of device (breathing system filter) does not typically involve human expert adjudication for its primary performance metrics like filtration efficiency or resistance to flow. These are objective, quantifiable physical properties measured by laboratory equipment.
• Therefore, the concept of "ground truth established by experts" in the way it applies to image-based diagnostics is not relevant here. The "ground truth" for the test results is established by the methods and standards used by Nelson Laboratories, which are highly specialized technicians and scientists in their field.

4. Adjudication Method for the Test Set

• Not applicable (see point 3). Performance metrics are determined by laboratory measurements according to established test standards (e.g., for BFE/VFE, resistance to flow, moisture loss).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance

• No. This is a hardware medical device (breathing system filter), not an AI-powered diagnostic or therapeutic tool. Therefore, MRMC studies and AI assistance are not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

• No. This is not an algorithm or AI device. The performance data presented is the "standalone" performance of the physical device itself in a laboratory setting.

7. The Type of Ground Truth Used

• For physical performance metrics (filtration efficiency, resistance to flow, internal volume, moisture loss), the ground truth is derived from standardized laboratory testing methods and measurements. These methods are designed to objectively quantify the device's physical properties under controlled conditions. This is not pathology, expert consensus (in the clinical sense), or outcomes data.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical device, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML. The device's design and manufacturing processes are refined based on engineering principles and material science, not data training.

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

• Not Applicable. (See point 8).

Summary of the Study Proving Device Meets Acceptance Criteria:

The document states that the performance data for filtration efficiency was "[measured] by Nelson Lab." It also lists other performance characteristics such as resistance to flow, internal volume, and moisture loss. The study demonstrating that the device meets criteria is implicitly the laboratory testing conducted by Nelson Laboratories and Dräger Medical's internal R&D, which measured these specific physical and biological filtration properties of the filters.

The overall claim of the 510(k) submission is Substantial Equivalence. This means the applicant argues that the proposed devices (Filter CareStar 30, Filter SafeStar 55, Filter/HME TwinStar 55) are as safe and effective as existing, legally marketed predicate devices (listed in the document). The "study" isn't a comprehensive clinical trial but rather a comparison of key performance data to established values of predicate devices and relevant ISO/EN standards. The document states:

"The comparison of the data shows similar values for the key performance data. Proposed devices show similar values in filtration efficiency, dead space, resistance to flow and recommended tidal volumes when compared to the legally marketed devices."

The acceptance criteria are therefore implicitly defined by the performance benchmarks set by these predicate devices and relevant industry standards (like EN ISO 5326 and ISO 9360), which the new devices' laboratory test results must meet or demonstrate equivalence to. The FDA's clearance (K072002) signifies their agreement that this substantial equivalence has been demonstrated.

Ask a specific question about this device