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510(k) Data Aggregation
(87 days)
The Invacare Twilight Full Face Mask is intended to be used with positive airway pressure (PAP) devices, such as CPAP and Bi-Level, which provide 4-20 cmH2O for the treatment of adult obstructive sleep apnea. There is a port on the mask to allow for pressure measurement. The mask is to be used on adult patients (>30 kg) for whom positive airway pressure therapy has been prescribed. The mask is intended for single or multiple patient re-use.
The Twilight full Face Mask consists of a mask that fits over the nose and mouth of a patient and a headgear to hold the mask in place. The mask has a removable molded silicone cushion that seals around the patient's nose and mouth. The cushion mounts to a rigid clear plastic frame. The frame has built in exhalation ports, a full swivel for locating the pressure device hose, a tubing swivel to allow for twisting of the hose, and a built in anti-asphyxia valve to allow the inner volume of the mask to be open to the outer atmosphere when there is no pressure being supplied by the flow generator device. Mounted to the frame is an adjustable forehead support for resting against the patient's forehead. The headgear has quick release clips and loop adjustment on the straps.
The provided document describes a 510(k) Pre-market Notification for the Invacare Twilight Full Face Mask, which aims to demonstrate substantial equivalence to legally marketed predicate devices rather than necessarily proving the device meets specific acceptance criteria in a quantitative performance study. The document focuses on comparing the proposed device's specifications and intended use to those of existing devices.
Therefore, the requested information elements related to detailed study methodologies (sample size, ground truth, expert adjudication, MRMC studies, training sets) are largely not applicable in the context of this 510(k) submission, as it relies on a comparison of device characteristics and adherence to general performance standards rather than a clinical efficacy trial.
However, I can extract the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The "Acceptance Criteria" here are implicitly defined by the specifications of the predicate devices. The "Reported Device Performance" is the Invacare Twilight Full Face Mask's own specifications. Substantial equivalence is demonstrated by showing that these specifications are comparable.
| Specification | Invacare Twilight Full Face Mask (Reported Performance) | ResMed Mirage Full Face Mask Series 2 (Predicate) | Respironics Spectrum 2 Reusable Full Face Mask (Predicate) | Acceptance Criteria (Implied by Predicates) |
|---|---|---|---|---|
| Intended Use | With PAP devices (CPAP/Bi-Level, 4-20 cmH2O) for adult (>30kg) obstructive sleep apnea. Single/multiple patient re-use. | Multi-patient use for adult (>30kg) CPAP/bi-level therapy. | Adults with Respironics CPAP/bi-level devices. Covers nose/mouth. Built-in exhalation. Single/multiple patient re-use. | Comparable intended use for adult obstructive sleep apnea with PAP devices in the 4-20 cmH2O range, suitable for single or multiple patient re-use. |
| Patient Use | Adults >30Kg | Adults >30Kg | Adults | For adult patients, generally >30kg. |
| Single/Multiple Patient Use | Multiple-patient | Multiple-patient | Multiple-patient | Multiple-patient re-use. |
| Input Device Range | 4-20 cmH2O | 4-20 cmH2O | 3-40 cmH2O | Within a clinically acceptable range for PAP therapy, generally including 4-20 cmH2O. |
| Mask Frame Material | Polycarbonate | Polycarbonate | Polycarbonate | Biocompatible and durable material, such as polycarbonate. |
| Nasal Cushion Material | Silicone | Silicone | Silicone | Biocompatible and comfortable material, such as silicone. |
| Anti-asphyxia Valve | Yes - silicone | Yes - silicone | Yes - silicone | Presence of an anti-asphyxia valve, typically silicone. |
| Hose Connection Input | For Ø22mm hose | For Ø22mm hose | For Ø22mm hose | Standard Ø22mm hose connection. |
| Exhalation Ports | 5 | 6 | 44 | Sufficient exhalation ports to prevent re-breathing (specific number may vary but must be effective). |
| Swivel Connections | 360° Rotation | 360° Rotation | 360° Rotation | 360° rotation for hose flexibility. |
| Ports | 1 port (for pressure measurement) | 2 ports | 1 port (for pressure measurement) | At least one port for pressure measurement. |
| Exhaust Flow | 23 LPM @ 4 cmH2O53 LPM @ 20 cmH2O | 22 LPM @ 4 cmH2O54 LPM @ 20 cmH2O | Below 5 cmH2O, unknown~ 43 LPM @ 20 cmH2O | Comparable exhaust flow rates to ensure proper CO2 washout, particularly at common therapy pressures. |
| Pressure Drop at patient connection | < 0.3 cmH2O @ 50 LPM< 1.0 cmH2O @ 100 LPM | Unknown (for predicate devices) | Unknown (for predicate devices) | Low pressure drop across the mask to ensure effective therapy delivery, likely conforming to relevant standards (e.g., ISO 17510-2 requirements). |
| Internal volume (Dead space) | < 303ml (varies by size) | < 258mL (varies by size) | 274ml - 428ml (varies by size) | Internal volume (dead space) within a clinically acceptable range to minimize re-breathing of exhaled gases, varying by cushion size. |
The study proving the device meets these "acceptance criteria" is the 510(k) submission itself, which argues for substantial equivalence. The document states: "The performance data found in this submission shows that the Invacare Full Face Mask performs as intended and in a manner that is substantially equivalent to the predicate devices." This substantial equivalence argument is supported by the detailed comparison table and performance testing against recognized standards.
Specifically, the device performance was evaluated against the following standards:
- ISO 17510-2:2003: Sleep apnoea breathing therapy - Part 2: Masks and application accessories
- ISO 5356-1:2004: Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets
- ISO 13485:2003: Medical devices - Quality management systems -- Requirements for regulatory purposes
- ISO 14971:2000 (Amendment 2003): Medical devices -- Application of risk management to Medical Devices
- EN 980:2003: Graphical symbols for use in the labeling of medical devices
- EN 1041:1998: Information supplied by the manufacturer with medical devices
These standards represent the "acceptance criteria" for the performance and safety aspects of the mask, and conformance to them is asserted by the manufacturer.
Information Not Applicable or Not Provided in the Document:
Due to the nature of a 510(k) submission predominantly focused on substantial equivalence to predicate devices and adherence to recognized standards, the following detailed study methodologies are not described or are not relevant to this type of regulatory filing.
- Sample size used for the test set and the data provenance: Not applicable. Performance testing typically involves engineering tests on prototypes/production samples, not a clinical "test set" in the sense of patient data for a diagnostic algorithm. No country of origin for such data is specified beyond the device being from Invacare Corporation in Elyria, Ohio, USA. The testing is laboratory-based, not retrospective/prospective patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context refers to engineering specifications and performance benchmarks from international standards, not expert clinical assessment of a diagnostic outcome.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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. This is a medical device (face mask), not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device (face mask), not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for the device's performance is adherence to the specified technical parameters (e.g., exhaust flow, pressure drop, internal volume) and compliance with relevant international standards (ISO, EN). This is established through engineering testing and quality management systems.
- The sample size for the training set: Not applicable. This is a medical device, not an AI/machine learning model that requires a training set.
- How the ground truth for the training set was established: Not applicable.
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