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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 Life2000 Ventilation System consists of the Life2000 Ventilator and the Life2000 Compressor.

The System is intended for use by qualified, trained personnel under the direction of a physician. Specifically, the System 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 System is suitable for use in home and institutional settings and is not intended for ambulance or air transportation.

The Breathe Technologies Life2000 Ventilation System includes a portable, battery powered, continuous ventilator that was cleared in K141943 along with the Breathe Pillows Interface, Universal Connector and various other dedicated accessories.

In this submission, the Life2000 Ventilation System is expanding with the inclusion of additional components, including the Life2000 Compressor, a portable air compressor. This Life2000 Compressor provides a primary source of compressed air for the Life2000 Ventilator, in addition to the previously cleared gas sources of facility in-wall compressed gas (air & oxygen) and tanks of compressed medical gas. The Life2000 Compressor provides a dedicated docking station for the Life2000 Ventilator.

The Ventilator administers the physician-prescribed volume to the patient via the previously cleared Breathe Technologies 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 previously cleared Breathe Technologies Pillows Interface (K141943), a type of nasal mask.

This submission includes new versions of the Pillows Interface, labeled as the Breathe Pillows Entrainment Interface, that have an inlet for supplemental oxygen. It also includes labeling for the use of third party supplemental Oxygen Adapters for use with the Universal Connector. These inlets or Adapters allow the physician to administer supplemental oxygen into the patient circuit or interface.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes a Breathe Technologies Life2000™ Ventilation System seeking 510(k) clearance, intending to demonstrate substantial equivalence to its predicate device (the previous version of the Life2000 Ventilation System, K141943) and a reference device (Siemens Compressor Mini, K023354). The acceptance criteria are largely implied by compliance with various medical device standards and through bench testing and human factors validation. The "device performance" is primarily assessed against the predicate and reference devices, demonstrating functional equivalence and safety.

Since specific quantitative acceptance criteria with numerical targets and direct performance comparisons are not explicitly laid out in a table in the provided text, I will infer them from the comparisons made to the predicate and reference devices, and the standards listed.

Inferred Acceptance Criteria and Reported Device Performance:

2. Sample Sizes and Data Provenance

• Test Set (Human Factors Validation - HFV): "over 100 participants"

  • Data Provenance: Not explicitly stated, but the context of an FDA submission for a US company (Breathe Technologies, Irvine, CA) suggests the data is likely from the USA and would be prospective as it involves active testing with participants for validation.
  • Test Set (Bench Testing): Not explicitly stated, but typically involves a number of units sufficient to demonstrate design validation and compliance with standards.

• Training Set: Not mentioned in the provided text. The document describes a 510(k) submission, which primarily focuses on demonstrating substantial equivalence to a predicate device through testing and comparison, rather than developing a new algorithm/AI from a training set.

3. Number of Experts and their Qualifications (for Ground Truth)

• Human Factors Validation: No explicit mention of experts establishing a "ground truth" for the test set in the traditional sense (e.g., radiologists interpreting images). The HFV tests evaluated user performance against usability objectives (safe and effective use).
  • The study involved diverse user groups: Patients, Caregivers, Respiratory Therapists, and Physicians and Critical Care Nurses. Their performance in using the device constituted the primary evaluation in the HFV. Their "qualifications" are implied by their roles as end-users of the device.

4. Adjudication Method (for Test Set)

• The document does not describe an adjudication method in the context of expert consensus, as it is not an interpretative study. The Human Factors Validation (HFV) tests assessed user performance directly.

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

• No, an MRMC comparative effectiveness study was not done. The document describes a substantial equivalence submission for a physical medical device (ventilator system), not an AI/software device requiring human reader interpretation or assistance. Therefore, there is no discussion of AI assistance or its effect size on human readers.

6. Standalone Performance Study (Algorithm Only)

• Not applicable. This is a hardware medical device (ventilator system and accessories), not an algorithm or AI. Standalone performance for this device would refer to its functional performance as a ventilator (volume, pressure, alarms, etc.), which was tested through bench testing and compliance with various standards, as listed. The "algorithm" in this context would be the device's control software, which is implicitly validated through the functional and performance testing.

7. Type of Ground Truth Used

• For Human Factors Validation: The ground truth was implicitly the observed safe and effective use of the device by representative users (patients, caregivers, respiratory therapists, physicians, and critical care nurses) in simulated environments, as evaluated against predefined usability goals and error detection.
• For Bench Testing and Compliance: The ground truth was established by approved engineering specifications, international/national standards, and regulatory guidelines (e.g., ISO 10993-1, FDA Draft Reviewer Guide for Ventilators, ASTM F1246-91, AAMI/ANSI 60601-1, IEC 60601-1-2, ISO 80601-2-12, ISO 80601-2-72, IEC 62133, IEC 62366, FDA Guidance Documents). The device's performance was measured against these objective criteria.

8. Sample Size for the Training Set

• Not applicable / Not mentioned. The document does not describe a machine learning algorithm or AI component that would require a distinct training set. The submission focuses on validating hardware components and their integrated system.

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

• Not applicable. As no training set for an AI/algorithm is mentioned, the method for establishing its ground truth is not discussed.

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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.

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