(281 days)
The Combined VersaPAP™ and Aerobika® OPEP device is intended for use as a Positive Airway Pressure (PAP) device and a Positive Expiratory Pressure (PEP) device. The combined device has the ability to provide supplemental oxygen when used with compressed oxygen. The combined device is for patients (ages 5 years and above) who are capable of following directions for Positive Airway Pressure Therapy and capable of generating exhalation flow of 10 lpm for 3 - 4 seconds. The combined device is a single patient, multiple use device intended to be used in a hospital environment under the supervision of a healthcare professional.
The Aerobika® OPEP device and VersaPAP™ device can be used independently or combined. When combined for ease of use. The combined device creates oscillations during the exhalation phase (OPEP) to aid in secretion clearance and during the inhalation phase (PAP) helps to maintain positive airway pressure for the treatment and prevention of atelectasis.
The provided text is a 510(k) summary for the "Combined VersaPAP™ device and Aerobika® OPEP" and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with specific acceptance criteria in the format requested.
Therefore, I cannot directly extract "acceptance criteria and the study that proves the device meets the acceptance criteria" in the detailed format you requested (table, sample size, expert information, MRMC study, standalone performance, ground truth). The document is a regulatory submission for a medical device that performs a physical function (providing positive airway pressure and positive expiratory pressure), not an AI/software as a medical device (SaMD) that typically undergoes rigorous performance studies with the criteria you outlined.
However, I can extract the information relevant to what I can infer as "acceptance criteria" and "study" within the context of this device application:
The "acceptance criteria" for this type of device are primarily demonstrating substantial equivalence to existing legally marketed predicate devices, meaning it is as safe and effective as the predicates. The "study" that proves this involves bench testing and comparison of features and performance characteristics to the predicates.
Here's how I can reframe the information based on the provided text:
Inferred Acceptance Criteria and Study to Prove Device Meets Them:
For this device, "acceptance criteria" are not reported as specific numerical thresholds for diagnostic performance (like sensitivity/specificity for AI), but rather as proof of substantial equivalence to legally marketed predicate devices. The "study" involves bench testing and a detailed comparison of technical and performance characteristics to demonstrate this equivalence.
1. Table of Acceptance Criteria (as inferred) and Reported Device Performance:
| Acceptance Criteria Category (Inferred from S.E. requirements) | Reported Device Performance (from text) |
|---|---|
| Indications for Use Identity | Identical: "The proposed indications for use... are identical to the predicate and reference devices." |
| Patient Population Identity | Identical: "The patient population is identical to the predicates." |
| Environment of Use Similarity | Similar: "The environments of use are similar to the predicates." (Note: Combined device only in hospital, not home like individual OPEP). |
| Technology Identity | Identical: "The technology for generating OPEP and PAP is identical to the predicates. The technology of having a device which offers the combination of OPEP and PEP is similar to the reference device." |
| Performance - Pressure | Acceptable: "The pressure... is less than that of the reference device, [but] higher than that of the predicates when they are tested as standalone devices." "The difference in performance is within the range of the separate predicate devices and the reference device and does not raise new safety or effectiveness concerns." |
| Performance - Frequency (Oscillations) | Comparable/Acceptable: "The frequency of the combined device is higher than that of the reference MetaNeb device, however, the measured frequency is comparable to the Aerobika® OPEP predicate device and is within acceptable clinical frequency efficacy range." "The frequency generated by the subject device does not add risk to the patient compared to other FDA cleared devices." |
| Biocompatibility | Met: Materials in patient contact/gas pathway are the same as predicates. "Additionally testing was performed. ISO 18562, which supported patient exposure in new configurations." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable in the context of an FDA 510(k) for this type of physical device; there isn't a "test set" of patient data for diagnostic performance. The "testing" refers to bench testing of the device's physical performance. The document states, "We performed comparative testing at adult and child breathing setting to the predicates and reference." However, no specific number of test runs or 'samples' is given.
- Data Provenance: Not applicable in the way it would be for an AI model (e.g., retrospective/prospective patient data, country of origin). The data provenance is from bench testing conducted by the manufacturer, Trudell Medical International (located in London, ON, Canada).
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable. This is not a study requiring expert consensus for ground truth as it's a physical device, not an AI diagnostic tool.
4. Adjudication Method for the Test Set:
- Not applicable. There's no "test set" that requires adjudication by human readers/experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study is typically done for AI-assisted diagnostic tools to assess human reader improvement. This is a physical medical device.
6. Standalone (Algorithm Only) Performance:
- Not applicable. This is a physical device, not an algorithm. Its "standalone" performance would refer to its physical output which is measured via bench testing as described in bullet 1.
7. Type of Ground Truth Used:
- The "ground truth" for this device's performance is established by engineering and physiological measurement standards (e.g., measuring pressure, flow rate, and frequency) during bench testing, and comparing these measurements to the established performance of predicate devices and expected physiological ranges.
8. Sample Size for the Training Set:
- Not applicable. This is a manufactured physical device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. There is no concept of a "training set" or "ground truth establishment" in the AI sense for this device. Its design and manufacturing (analogous to "training") are based on engineering principles and regulatory requirements for medical devices.
§ 868.5690 Incentive spirometer.
(a)
Identification. An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.(b)
Classification. Class II (performance standards).