(165 days)
The Advantage TM is used with commercially available CPAPs to reduce or alleviate nighttime snoring and obstructive sleep apnea (OSA) for adults weighing more than 66 lb (30 Kg) used at home, hospital or other clinical settings per order of a physician.
The CPAP/Pro Interface with Advantage ™ is available for upper and lower teeth. As such, it utilizes two typical "boil & bite" devices to be placed in patient's upper and lower dental arches. They are then affixed to one another anteriorly to limit the mouth opening, while still permitting a degree of mouth opening through spacers and resiliency. The upper member is slotted and slides forward and backward on a fixed post for patient comfort. Additionally, it allows lateral movement with the post as a pivot point. The CPAP/Pro Interface with Advantage TM, similar to chin straps or mouth tapes, minimizes the mouth breathing but provides comfort and ease of use for patients. The device is used for adult patients at home or clinical facilities, such as hospitals or sleep labs.
The provided text describes the CPAP/Pro Interface with Advantage™, a device intended to reduce or alleviate nighttime snoring and obstructive sleep apnea (OSA). Based on the information available, a detailed acceptance criteria table and study breakdown can be presented as follows:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bench Testing | Meets design requirements and specifications. | "Bench testing was performed and confirms that the device meets design requirements and specifications." |
| Validation | Satisfactory completion of validation. | "Validation was also satisfactory completed." |
| Product Equivalency | Demonstrate product equivalency with the predicate device. | "The Advantage™ has also been validated to demonstrate product equivalency with the predicate." |
| Safety and Effectiveness | Support the safety and effectiveness of the product (referencing predicate's post-market studies). | "Post-market studies of CPAP/Pro has supported the safety and effectiveness of the product." |
| Substantial Equivalence | Demonstrates substantial equivalence to the predicate device and performs as well. | "Based on the information drawn from the Testing and Validation as well as the risk assessment, it is demonstrated that the device is substantially equivalent and performs as well as the predicate device." |
| Material Equivalence | Materials of the new device are similar to the predicate. | "Similar" (for materials listed: Teflon, polyethylene, silicone, elastomer, styrene, nylon, EVA thermoplastic) |
| Intended Use Equivalence | Intended use of the new device is similar to the predicate. | "Similar" |
| Design Equivalence (CPAP nasal) | CPAP nasal design is similar to the predicate. | "Similar" |
| Design Equivalence (Oral Appliance - core component) | Core oral appliance design is similar, with the addition of the Advantage™ mouthpiece. | "Same with additional mouth-piece (AdvantageTM) for minimizing mouth-breathing" |
| Performance Standard Equivalence | Adherence to similar performance standards (e.g., ASTM D1238). | "Similar" |
| Reusable Equivalence | Reusability (single patient) is similar. | "Similar" |
| Cleaning/Disinfection Equivalence | Method of cleaning/disinfection is similar. | "Similar" |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a sample size for a specific "test set" in the context of a clinical study or performance evaluation for the Advantage™ component. The summary mentions "Bench testing was performed" and "Validation was also satisfactory completed," but does not provide details on the number of subjects or cases involved in these validations for the new device. Instead, it relies heavily on the substantial equivalence to the predicate device (CPAP/PRO, K992384).
The data provenance is largely retrospective in the sense that the new device's safety and effectiveness are supported by "Post-market studies of CPAP/Pro [the predicate device]." There is no mention of a prospective clinical trial specifically for the Advantage™ component to establish its independent performance metrics.
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. As the evaluation relies on bench testing, validation, and equivalency to a predicate, the concept of "ground truth established by experts" in a clinical setting for a test set is not directly applicable or reported here.
4. Adjudication Method for the Test Set
This information is not applicable as there is no described clinical test set involving human interpretation that would require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done for the CPAP/Pro Interface with Advantage™ as described in this document. The submission focuses on demonstrating substantial equivalence through bench testing, validation, and material/design similarities to the predicate.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, if we interpret "standalone performance" as the device functioning independently to meet its design specifications and demonstrating performance (e.g., material properties, fit, mechanical function), then this aligns with the "Bench testing" and "Validation" mentioned. These tests would evaluate the device itself, without human interpretation or real-time clinical assessment beyond general use.
7. The Type of Ground Truth Used
The "ground truth" for the Advantage™ device appears to be primarily based on:
- Engineering specifications and design requirements: For bench testing and validation where the device's physical and functional properties are assessed against predetermined criteria.
- Predicate device's established safety and effectiveness: The new device's safety and effectiveness are inferred by its substantial equivalence to a legally marketed predicate device, for which post-market studies had already supported its performance.
8. The Sample Size for the Training Set
This information is not applicable as the device is a mechanical medical product, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
§ 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).