(270 days)
The Apogee is a gas conserver intended as a delivery device for medical grade oxygen from a high-pressure oxygen cylinders. Apogee is an ambulatory device which allows patients to ambulate longer than they would with continuous flow regulator on the same cylinder. The Apogee is intended to be used in the hospital, healthcare facilities, or home care environments.
The proposed device, Apogee, senses each nostril independently through a bifurcated cannula and responds to the dynamic changes in nasal air-flow making a breath-to-breath determination of where to deliver the next bolus of oxygen: to the left, the right, or both nostrils. The Apogee Device is composed of the main components as detailed below: Control Unit, Control Board (Regulated Voltage Supply), Embedded Processor, User supplied Demand Cannula, The Apogee Bypass Cannula and Restrictor and Cylinder Tubing.
This document is an FDA 510(k) summary for the Apogee oxygen conserver. It describes the device, its intended use, and compares it to a predicate device (Inspired Technologies Model 350G). The information provided focuses on the device's design, technology, and non-clinical performance testing rather than clinical study results involving human patients or complex AI algorithms with specific performance metrics like sensitivity, specificity, or AUC.
Therefore, many of the requested elements for acceptance criteria and study details (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance, and training set details) are not applicable or not present in this type of regulatory document concerning a mechanical-electronic medical device like an oxygen conserver. The "performance data" section primarily refers to engineering and safety bench testing, not clinical performance studies with diagnostic accuracy targets for AI.
Here's a breakdown based on the provided document:
Acceptance Criteria and Device Performance for Apogee Oxygen Conserver
This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through engineering and safety testing. It does not contain specific "acceptance criteria" in the context of diagnostic performance (e.g., sensitivity, specificity, AUC) for an AI algorithm. Instead, the "acceptance criteria" are implied by compliance with recognized standards and comparable performance to the predicate device in bench tests.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a non-AI, mechanical-electronic device, the acceptance criteria are not typically expressed as diagnostic accuracy metrics. Instead, they relate to engineering specifications and performance in bench testing to ensure safety and effectiveness comparable to the predicate. The document highlights the following:
| Acceptance Criteria (Implied by Standards/Predicate Comparison) | Reported Device Performance | Comments |
|---|---|---|
| Electrical Safety & EMC Compliance | ||
| (e.g., AAMI ANSI ES 60601-1, IEC 60601-1-11, IEC 60601-1-2) | Complies with AAMI ANSI ES 60601-1: 2005 + A1: 2012, IEC 60601-1-11, and IEC 60601-1-2: 2014. | Demonstrated compliance with relevant electrical safety and electromagnetic compatibility standards. |
| Software Verification & Validation | ||
| (for "moderate" level of concern software) | Verification and validation testing conducted. | Software testing completed for safety and functionality. |
| Mechanical Integrity & Durability | ||
| (e.g., storage, aging, drop, durability) | Testing performed related to storage, effects of aging, drop, and durability. | Device withstands expected physical stresses. |
| Biocompatibility | ||
| (for patient-contacting materials - permanent duration) | Testing included: |
- Gas emission VOC
- Particulate Matter (PM2.5)
- Inorganic gases CO, CO2 and Ozone
- Toxicological Risk Assessment | Materials are safe for patient contact. |
| Oxygen Bolus Delivery Equivalence
(compared to predicate, volume and time) | Bench testing demonstrated that both devices (Apogee and predicate) delivered an equivalent amount of oxygen bolus to the patient in the same time. | Key functional performance matched the predicate. |
| Trigger Sensitivity
(compared to predicate) | Bench testing performed, details not quantified but implied comparable to predicate (-0.3 cmH2O for Apogee vs. +0.03 to -0.2 cmH2O for predicate). | Demonstrated a similar ability to sense patient inhalation. |
| Volume Flow Performance | Bench testing performed. | Functional flow characteristics validated. |
| Performance Pre- and Post-Cleaning | Bench testing performed. | Device maintains performance after cleaning. |
| Breath Range Capability
(e.g., up to 35 BPM for predicate) | Apogee: Up to 40 BPM | Apogee performs across a relevant physiological breath rate range, slightly better than predicate. |
| Patient Oxygen Outlet Pressure
(e.g., 19-25 psig for predicate) | Apogee: 19-30 psig | Comparable and within safe operating range. |
| Water Ingress Protection
(e.g., IPX1 for predicate) | Apogee: IP22 | Improved liquid ingress capability (IP22 for Apogee vs. IPX1 for predicate). No differences in safety or effectiveness found due to this improvement. |
Study Proving Device Meets Acceptance Criteria:
The study described is a series of non-clinical bench tests and compliance assessments against recognized industry standards, rather than a diagnostic accuracy or comparative effectiveness study involving human subjects or AI-assisted diagnostic tasks.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in terms of patient data. The "test set" refers to physical units of the device tested in a lab setting. The number of units tested is not provided, but it would typically be a small number of engineering samples.
- Data Provenance: Not applicable in the context of patient data. This involves laboratory bench testing of physical device units, not patient data sets. The testing was presumably conducted by the manufacturer or contracted labs.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable. Ground truth for an oxygen conserver's performance in bench testing is based on engineering specifications, calibrated measurement equipment, and industry standards, not expert interpretation of medical images or clinical data.
- Qualifications of Experts: Not applicable. The "ground truth" for this device's performance is objective measurement against engineering specifications.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. This is not a study where human interpretations are being adjudicated.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- MRMC Study: No. This type of study is typically performed for diagnostic devices (e.g., imaging AI) where human readers' performance is evaluated with and without an AI assist. This document concerns a therapeutic mechanical device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance: The "software" in this device controls the mechanical function (sensing breath and delivering oxygen bolus). Its "standalone performance" is implicitly assessed through the bench testing described (e.g., bolus delivery accuracy, trigger sensitivity). It's not a diagnostic algorithm with standalone performance metrics like sensitivity/specificity.
7. The Type of Ground Truth Used:
- Type of Ground Truth: The ground truth for this device's performance is based on engineering specifications, physical measurements from calibrated instruments, and compliance with recognized national and international standards for medical device safety and performance (e.g., AAMI ANSI ES 60601-1, IEC 60601-1-11, ISO 80601-2-67).
8. The Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable. This is a non-AI mechanical device. The "software" mentioned is embedded control software, not a machine learning model that requires a training set in the conventional sense of AI development.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth for Training Set: Not applicable. As there's no machine learning training set, no such ground truth establishment occurred. The control logic for the device's functions (e.g., breath sensing, oxygen delivery) is derived from engineering design principles, physiological understanding, and validated algorithms for precise control, not from a data-driven training process.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).