(87 days)
To prevent backflow of oxygen or water from patient circuit into Respironics CPAP or BiPAP device when the unit is not functioning
The Pressure Valve is an in-line one-way valve which prevents oxygen or water in the patient circuit from backflowing into the Respironics CPAP or bi-level device when the unit is not functioning. The Pressure Valve incorporates a valve disc, spring, and housing. The device vents any backflow to the atmosphere when the pressure output of the Respironics CPAP or BiPAP unit drops below 0.5 cm H2O.
This document is a 510(k) premarket notification for a medical device (a "Pressure Valve" or "one-way valve") and does not contain the type of robust study data typically associated with acceptance criteria and performance evaluation for AI/ML-based diagnostic devices. The information provided focuses on device description, intended use, and comparison to a predicate device, rather than detailed clinical study results with specific acceptance criteria and performance metrics (e.g., sensitivity, specificity, AUC).
Therefore, a direct answer to your request regarding acceptance criteria and performance studies for an AI/ML device cannot be extracted from this particular document.
However, if we interpret "acceptance criteria" and "device performance" in the context of this specific medical device filing, we can infer some information:
Inferred "Acceptance Criteria" and "Device Performance" for the Respironics Pressure Valve:
The document heavily relies on demonstrating "substantial equivalence" to a predicate device. Therefore, the "acceptance criteria" are implicitly tied to a qualitative comparison with the predicate device, showing that the new device is as safe and effective.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Inferred from Predicate Comparison) | Reported Device Performance (as stated or implied) |
|---|---|
| Functional Equivalence: | |
| A. Establishes directional flow in a patient circuit to prevent backflow. | Meets: "Indicated - to establish directional flow in a patient circuit and thus prevent backflow" (Yes) |
| B. Prevents backflow of oxygen or water into CPAP or bi-level device when unit not functioning. | Meets: "Prevents backflow of oxygen or water from patient circuit into Respironics CPAP or BiPAP device when the unit is not functioning." (Yes) This is the primary intended use and is stated. Its venting mechanism also supports this. |
| C. Minimized resistance to flow while in-line. | Meets: "Has minimal resistance to flow while in-line" (Yes) |
| Design/Compatibility: | |
| D. Placed in-line in patient breathing circuit with standard 22mm fittings. | Meets: "Placed in-line in patient breathing circuit" (Yes), "Has standard 22 mm fittings" (Yes) |
| E. Compatible for use with Respironics CPAP and bi-level systems. | Meets: "Intended equipment - to be used only with Respironics, Inc. CPAP and bi-level systems" (Yes) - This is a specific design choice for the new device, differing from the predicate but stated as its intended use. |
| F. Operates effectively in Hospital and Home environments. | Meets: "Intended environment - Hospital and Home" (Yes) |
| G. Maintains design requirements after cleaning (reusability). | Meets: "Reusable - multiple use, can be cleaned" (Yes), "Meets design requirements after cleaning" (Yes) |
| Safety: | |
| H. Effectively vents backflow of oxygen or water (when not functioning) to atmosphere. | Meets: "Vents backflow to atmosphere" (Yes) - This is a key differentiating feature from the predicate, and it's presented as an enhancement to safety/functionality for the intended purpose of preventing backflow into the device. The device "vents any backflow to the atmosphere when the pressure output of the Respironics CPAP or BiPAP unit drops below 0.5 cm H2O." |
| I. Materials are appropriate and safe (Polycarbonate body/valve, Phosphor Bronze spring). | Meets: Materials are specified: "Polycarbonate" for Body and Valve, "Phosphor Bronze" for Spring. These are presumably considered appropriate and safe for the intended use and compared favorably to the predicate's materials (Silicone Rubber valve, N/A spring). |
| J. No other significant differences in design, intended use, safety, and effectiveness compared to predicate. | Meets by declaration: The document concludes: "There are no other significant differences in design, intended use, safety and effectiveness between the Pressure Valve and the predicate device." This is the ultimate "acceptance criteria" for 510(k) clearance based on substantial equivalence. |
Regarding the specific questions about AI/ML studies:
As this is a 1996 510(k) for a mechanical one-way valve, none of the following questions are applicable. The concept of AI/ML devices in medical filings was not prevalent at that time, and this device is purely mechanical.
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. This is not an AI/ML device, and no such test set or data provenance details are provided.
- 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. No "ground truth" establishment for an AI/ML test set is mentioned. Device performance is likely based on engineering testing and comparison.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No adjudication for an AI/ML test set.
- 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. No MRMC study was conducted or is relevant for this type of mechanical device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI/ML ground truth. Performance is likely validated through engineering specifications, bench testing, and comparison to the predicate's known performance.
- The sample size for the training set: Not applicable. There is no AI/ML training set.
- How the ground truth for the training set was established: Not applicable. There is no AI/ML training set.
§ 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).