Search Results

The Breathe Technologies Life2000 Ventilation System is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult patients who require the following types of ventilatory support: - Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask). - Assist/Control mode of ventilation. The ventilator is suitable for use in home and institutional settings.

The Breathe Technologies Life2000 Ventilation System is a portable, battery powered, critical care ventilator. The Ventilator administers the physician-prescribed volume to the patient via the attached Breathe Technologies Patient Universal Connector which connects into the patient's tracheostomy tube, endotracheal tube, or any off the shelf non-invasive mask. It can also be used with the Breath Technologies NIOV Pillows Interface, a type of nasal mask. The ventilator is small and light enough to be worn on a patient's belt, or slung over their shoulder. It is connected to a separate, third party, gas supply. The Ventilator is intended for Institutional or Home Use. It is not intended for use during emergency/medical transportation.

The Breathe Technologies Life2000 Ventilation System is a portable, battery-powered critical care ventilator for adult patients requiring continuous or intermittent ventilatory support.

Here's an analysis of its acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

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

   • The document does not specify sample sizes for specific performance tests (e.g., comparative waveform testing, human factors).
   • The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective, beyond general statements of compliance with international and US standards.

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)

   • The document identifies general "qualified, trained personnel under the direction of a physician" as the intended operators for the device. However, it does not specify the number or qualifications of experts used to establish ground truth or conduct specific performance assessments for the testing mentioned (e.g., comparative waveform testing, human factors).

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

   • The document does not specify any adjudication methods for the test sets.

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 comparative effectiveness study is mentioned, as this device is a mechanical ventilator, not an AI-assisted diagnostic tool. The "comparative effectiveness" studies mentioned are related to device performance compared to a predicate, not human reader performance.

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

   • This is not applicable to a mechanical ventilator device. The device's performance is inherently standalone in its function, but its operation always involves a human user (qualified personnel under a physician's direction).

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

   • For the "Summary of Supporting Data," the ground truth for device performance is established through compliance with recognized standards such as ISO 10993-1, FDA Draft Reviewer Guide for Ventilators, ASTM F1246-91, IEC 60601-1, IEC 60601-1-2, and ISO 80601-2-12. This implies engineering and clinical performance metrics defined by these standards serve as the "ground truth" for the device's functional and safety capabilities.
   • Specific tests mentioned like "Ventilator Cleaning validation," "Risk characterization of VOC's," "Static Analysis Tool verification of software," "Comparative Waveform Testing," and "Human Factors and Usability Testing" would have their own defined ground truths based on established protocols for those types of evaluations (e.g., cleanliness standards, toxicology limits, software quality metrics, physiological waveform accuracy, human-computer interaction success rates).

8. The sample size for the training set

   • This is not applicable for a mechanical ventilator. Training sets are typically associated with machine learning or AI models, which are not described as integral to this device's function.

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

   • This is not applicable for a mechanical ventilator.

Ask a specific question about this device

The Swift™ Air channels airflow noninvasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel device.

The Swift Air is:

• to be used by patients (> 66 lb/30 kg) for whom positive airway pressure has been prescribed
• intended for single-patient re-use in the home environment and multipatient re-use in the hospital/institutional environment.

The Swift™ Air provides an interface such that air flow from a positive pressure source is directed to the patient's nasal nares. The mask is held in place with adjustable headgear that straps the mask to the face.

Swift™ Air is a prescription device supplied non-sterile.

This document describes the premarket notification for the ResMed Swift™ Air nasal mask. The acceptance criteria and supporting studies are based on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

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

The review document does not specify a "test set" in the context of clinical data for performance evaluation of the Swift™ Air mask. The evaluation relied heavily on bench testing and comparison to predicate devices to demonstrate substantial equivalence.

• Clinical Data: "Use of vented nasal masks with CPAP or Bilevel therapy is proven technology and is well accepted by the medical community. Bench testing is sufficient to demonstrate substantial equivalence to the predicate devices." This indicates no new clinical studies with a specific patient "test set" were conducted for the Swift™ Air for this submission.
• Bench Testing: The sample sizes for the various bench tests (CO2 performance, pressure-flow, mechanical integrity, cleaning/reuse) are not explicitly stated in the provided text. The data provenance is presumed to be internal laboratory testing conducted by ResMed.

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

Not applicable. As noted above, the evaluation was based on bench testing and comparison to predicate devices, not on expert-adjudicated clinical patient data or specific "ground truth" established by experts for a test set.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical "test set" requiring expert adjudication.

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

No. An MRMC study was not performed. This device is a medical accessory, and its effectiveness is determined by its physical and functional characteristics in delivering CPAP/Bilevel therapy, rather than diagnostic interpretation requiring human readers.

6. Standalone Performance Study (Algorithm only without Human-in-the-Loop Performance)

Yes, implicitly. The performance data presented (CO2, pressure-flow, mechanical integrity, cleaning/reuse) represents the "standalone" performance of the device itself, under bench test conditions. This is the equivalent of "algorithm only" in the context of a physical medical device.

7. Type of Ground Truth Used

The "ground truth" for the Swift™ Air device in this submission was established by:

• Predicate Device Performance: The primary "ground truth" was the established performance and safety profiles of the predicate devices (Mirage FX, Swift™ FX, Ultra Mirage II) that have already been cleared by the FDA.
• Industry and Regulatory Standards: Adherence to standards such as FDA Guidance #G95-1, ISO 10993-1 (Biocompatibility), ISO 14971:2007 (Risk Management), and ISO 5356-1:2004 (Conical Connectors) served as additional "ground truth" for safety and performance requirements.
• Predefined Pass/Fail Criteria: For the bench tests (e.g., CO2 performance, mechanical integrity), "predefined pass/fail criteria" were used as the immediate ground truth, though these criteria would have been derived from relevant standards and predicate performance.

8. Sample Size for the Training Set

Not applicable. There is no mention of a "training set" in the context of this device. This is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How Ground Truth for the Training Set Was Established

Not applicable. As there was no training set, there was no ground truth for a training set to be established.

Ask a specific question about this device

The 3B Flex-Lite™ channels airflow noninvasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or a bilevel system. The 3B Flex-Lite™ is:

• to be used by adult patients (>66lb / 30 kg); (1)
• to be used for single-patient reuse in the home environment and multipatient (2) reuse in the hospital/institutional environment.
• (3) to be used in the following environments: home, hospital, and sub-acute institutions.
• intended for prescription use. (4)

The 3B Flex-Lite™ is a mask interface, of the nasal pillow variety, that directs airflow from a positive pressure device to the patient's nose. The mask is held in place with adjustable headgear that straps the mask to the face.

The 3B Flex-Lite™ is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product.

The 3B Flex-Lite™ is a prescription device supplied non-sterile.

The provided document describes the 3B Flex-Lite Nasal Mask, a device intended to channel airflow noninvasively to a patient from a positive airway pressure (PAP) device. The document focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel performance criteria. Therefore, the information provided does not directly outline "acceptance criteria" as distinct performance thresholds that the device must meet for a specific clinical task. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices through comparable technological characteristics and performance.

Here's an analysis based on the provided text, focusing on how the device meets the implicit acceptance criteria of substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

As explicit acceptance criteria with numerical targets are not stated, this table will frame the "acceptance criteria" as comparability to predicate devices for key performance and safety characteristics.

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

The document refers to "Performance bench testing of both the 3B Flex-Lite™ and the Nasal Aire II were conducted" and explicitly mentions a "Piper Medical" test report dated March 23, 2011, annexed at Appendix A. However, the specific sample size for these bench tests (e.g., number of units tested) and the country of origin of the data are not detailed in the provided text. The testing appears to be retrospective in the sense that it evaluates the manufactured device against established performance benchmarks and comparisons to existing devices, rather than a prospective clinical trial with human subjects.

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

This information is not provided in the document. The "ground truth" for the bench tests would typically be defined by engineering specifications, regulatory standards, and the performance characteristics of the predicate devices. The individuals conducting and reporting the tests (e.g., Piper Medical) would be engineers or technicians with expertise in medical device testing, but their specific qualifications or the number involved are not stated.

4. Adjudication Method for the Test Set

This information is not provided. Given that the tests are bench tests, an adjudication method in the clinical sense (e.g., 2+1 physician consensus) is not directly applicable. The "adjudication" would be based on comparison of test results to predefined criteria or to the predicate device's measured performance.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this device. The 3B Flex-Lite™ Nasal Mask is a physical medical device (mask interface), not an AI-powered diagnostic or assistive technology for human readers. Therefore, there is no discussion of human reader improvement with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

A standalone performance study of an algorithm is not applicable to this device, as it is a physical device, not an algorithm or AI system. The performance tests ("Non-clinical Tests") evaluated the physical mask's characteristics.

7. The Type of Ground Truth Used

The ground truth used for evaluating the 3B Flex-Lite™ appears to be based on:

• Engineering specifications and regulatory standards for medical devices (implicitly, concerning safety, materials, and performance parameters like dead space, CO2 rebreathing, flow vs. leak pressure).
• Performance characteristics of legally marketed predicate devices (InnoMed Nasal-Aire II and Resmed Swift FX) as established through their own testing and marketing. The goal was to demonstrate that the new device is "substantially equivalent" in terms of performance to these predicates.

8. The Sample Size for the Training Set

This is not applicable. The 3B Flex-Lite™ Nasal Mask is a physical medical device, not a machine learning model, and therefore does not have a "training set" in the context of AI.

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

This is not applicable for the same reasons as #8.

Ask a specific question about this device

The Mirage Echo channels airflow noninvasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel system. The Mirage Echo is: to be used by adult patients (> 66 lb/30 kg) for whom positive airway pressure has been prescribed intended for single-patient re-use in the home environment and multipatient re-use in the hospital/institutional environment.

The Mirage Echo provides an interface such that airflow from a positive pressure source is directed to the patient's nose. The mask is held in place with adjustable headgear that straps the mask to the face. Mirage Echo is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product. Mirage Echo is a prescription device supplied non-sterile.

Here's an analysis of the Mirage Echo Traditional 510k, based on the provided text, focusing on acceptance criteria and supporting studies.

Based on the provided information, the 510(k) submission for the Mirage™ Echo nasal mask describes a comparative study against predicate devices (Mirage Micro and Ultra Mirage II Mask) to demonstrate substantial equivalence, rather than a study with explicit, quantitative acceptance criteria for device performance as one might see for an AI algorithm.

The core of the "study" is a set of comparisons and assertions of substantial equivalence, relying on bench testing and the existing clinical acceptance of similar technology.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a traditional 510(k) for a medical device (nasal mask), the "acceptance criteria" are primarily established implicitly by demonstrating substantial equivalence to predicate devices, focusing on safety, performance characteristics, and intended use. The performance is reported as "substantially equivalent" to the predicates.

2. Sample Size for the Test Set and Data Provenance

The provided text does not mention a "test set" in the context of clinical data or patient-specific evaluation. The performance data refers to bench testing. Therefore, information regarding:

• Sample size for the test set
• Data provenance (e.g., country of origin, retrospective/prospective)
  is not applicable as no clinical test set data is described. The submission relies on "bench testing" and comparison of technical specifications.

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

This information is not applicable. Since no clinical test set data is described, there's no mention of experts establishing a ground truth for such a set. The "ground truth" for this type of submission is typically derived from established engineering principles, international standards (e.g., ISO), and the performance of legally marketed predicate devices.

4. Adjudication Method for the Test Set

This information is not applicable. No clinical test set data is described that would require an adjudication method.

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

A MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, potentially with AI assistance. The Mirage Echo is a medical device (nasal mask) for therapy delivery, not a diagnostic tool requiring interpretation.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was not done, nor would it be relevant for this type of device. The Mirage Echo is a physical medical device, not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" in this context is established through bench testing results, adherence to international standards (e.g., ISO 10993-1 for biocompatibility, ISO 5356-1:2004 for connectors), engineering specifications, and the established performance and safety profile of legally marketed predicate devices. There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for this submission, as it focuses on demonstrating substantial equivalence in physical and functional characteristics.

8. Sample Size for the Training Set

This information is not applicable. The Mirage Echo is a physical medical device, not an AI algorithm that undergoes a "training set" process.

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

This information is not applicable. As it's not an AI algorithm, there is no "training set" or ground truth for such a set.

Ask a specific question about this device

The BreatheX Nasal Interface System is intended for use as accessory device to CPAP machines in the treatment of obstructive sleep apnea (OSA).

The BreatheX Nasal Interface System is for use on adult spontaneously breathing (non-ventilator dependant) patients at home or in the sleep clinic.

The BreatheX Nasal Interface System is an accessory intended for use with devices that deliver Continuous Positive Airway Pressure (CPAP) and bi-level positive airway pressure in treating adult patients.

The BreatheX Nasal Interface System has been designed for use as an accessory with commonly marketed CPAP units. The device consists of a plastic manifold with integral exhaust port, nasal mask cushion, a set of nasal pillows, adjustable headgear straps, and an interface tube with a 22mm fitting.

The Nasal Interface System allows a patient to use either the nasal pillows or nasal mask cushion interchangeably. The lightweight construction of the device is designed to maximize patient comfort.

The device is labeled for single patient use.

The Hoffman Laboratories BreatheX™ Nasal Interface System is a CPAP device accessory. The provided document does not detail specific quantitative acceptance criteria or a formal study proving the device met such criteria in the way one might expect for a diagnostic or therapeutic medical device involving clinical outcomes.

Instead, the submission focuses on demonstrating substantial equivalence to already legally marketed predicate devices through non-clinical testing and comparison of technological characteristics.

Here's an breakdown of the information requested, based on the provided text:

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

2. Sample sized used for the test set and the data provenance

• Sample Size: Not specified quantitatively. The "tests" mentioned are likely engineering and bench tests, not involving human subjects. For example, "dead space" or "pressure-flow characteristics" would be measured on a single or a small number of device units.
• Data Provenance: The tests were conducted internally by Hoffman Laboratories, LLC. "Laboratory and standards compliance tests" are mentioned, suggesting controlled lab environments. No country of origin for data is stated beyond the company's location in Chatsworth, CA, USA. The data is retrospective in the sense that it was collected prior to the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not applicable and not provided. The "ground truth" for this type of device (a CPAP accessory) in a 510(k) submission is typically based on engineering specifications, industry standards, and comparison to predicate devices, rather than expert interpretation of clinical data.

4. Adjudication method for the test set

• Not applicable and not provided. As mentioned above, this is not a study requiring adjudication of expert opinions.

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 conducted. This device is not an AI-powered diagnostic or therapeutic tool that would involve human readers or AI assistance.

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

• No standalone algorithm performance study was done. This device does not involve an algorithm.

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

• The "ground truth" for the non-clinical tests was based on engineering specifications, industry standards (e.g., for environmental testing), and predefined performance characteristics that were considered acceptable or comparable to the predicate devices. For example, the "specified requirements" for dead space and pressure-flow characteristics served as the ground truth against which the device's performance was measured. Biocompatibility requirements per relevant standards also acted as ground truth.

8. The sample size for the training set

• Not applicable. This device is not an AI or machine learning system, so there is no training set.

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

• Not applicable, as there is no training set.

Ask a specific question about this device