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510(k) Data Aggregation
(88 days)
The SleepWeaver Anew Full Face Soft Cloth PAP Mask is intended to provide an interface for Positive Airway Pressure (PAP) therapy. This mask is intended for single-patient reuse in the home and in the hospital/institutional environment. This mask is to be used on patients greater than 66 lbs (30 kg).
The SleepWeaver Anew Full Face Soft Cloth PAP Mask consists of a cloth cushion, headgear, and a 90° elbow swivel connector with anti-asphyxia valve.
The Circadiance LLC SleepWeaver Anew Full Face Soft Cloth PAP Mask is intended to provide an interface for Positive Airway Pressure (PAP) therapy. It is for single-patient reuse in home and hospital/institutional environments for patients greater than 66 lbs (30 kg).
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Evaluation Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Material Evaluation | Materials suitable for intended use and patient contact | Biocompatibility requirements met, materials previously used or tested according to ISO 10993-1 and EDA G95-1. |
| Product Performance Testing | Device functions as intended for PAP therapy | Functioned as intended; results observed "as expected" for all tests (Physical Dead Space, Anti-Asphyxia Resistance, Anti-Asphyxia Operation, Pressure Drop, Carbon Dioxide Washout, Leak Rate). |
| Connector Performance | Connector functions as intended and safely | Functioned as intended; results observed "as expected". |
| Product Usability Evaluation | Device is usable by target population | Functioned as intended; results observed "as expected". |
| Biocompatibility | No adverse biological reactions | Biocompatibility requirements met. External surface of oral interface subject to Cytotoxicity, Sensitization, and Irritation testing. |
| Reliability | Device maintains performance over expected lifespan | Functioned as intended; results observed "as expected". |
| Packaging | Packaging protects the device and maintains sterility (if applicable) | Functioned as intended; results observed "as expected". |
| Accessory Interfacing | Device interfaces correctly with specified accessories | Functioned as intended; results observed "as expected". |
| Storage Testing | Device maintains integrity under specified storage conditions | Functioned as intended; results observed "as expected". |
| Labeling Review | Labeling is clear, accurate, and compliant | Functioned as intended; results observed "as expected". |
| Design Analysis | Design meets all functional and safety requirements | Functioned as intended; results observed "as expected". |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample size used for each specific test or the data provenance (e.g., country of origin, retrospective/prospective). The performance data section lists various tests and evaluations, concluding with a general statement that "In all instances, the SleepWeaver Anew Full Face Soft Cloth PAP Mask functioned as intended and results of each test observed were as expected." This suggests the testing was likely internal validation rather than a clinical study with a large patient-based test set commonly associated with AI/software performance evaluations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The device is a physical medical device (PAP mask), and its performance evaluation relates to physical and material properties, rather than diagnostic interpretation requiring expert-established ground truth like in AI algorithms.
4. Adjudication method for the test set:
Not applicable. The description of testing does not involve adjudication by multiple experts in the way an imaging diagnostic algorithm would. Performance was assessed through engineering and materials testing.
5. 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. The device is a PAP mask, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is not an algorithm. Its function is to provide an interface for PAP therapy, which inherently involves human interaction (patient wearing the mask).
7. The type of ground truth used:
For the performance testing mentioned (e.g., Physical Dead Space, Anti-Asphyxia Resistance, Pressure Drop, Carbon Dioxide Washout, Leak Rate), the "ground truth" would be established by industry standards, engineering specifications, regulatory limits, and established scientific principles for the safe and effective operation of PAP masks. For biocompatibility, the ground truth is established by international standards like ISO 10993-1.
8. The sample size for the training set:
Not applicable. This device is a physical medical device, not an AI algorithm, and therefore does not have a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
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(42 days)
The SleepWeaver élan Nasal CPAP Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or Bi-Level therapy. The SleepWeaver élan Nasal CPAP Mask is intended for single-patient reuse in the home and multi-patient, multi-use in the hospital/institutional environment. This mask is to be used on patients greater than 66 Ibs (30 kg).
The SleepWeaver élan Nasal CPAP Mask serves as a mechanism for reliably connecting a patient > 66 lbs (30 kg) diagnosed with sleep apnea to a source of continuous or bi-level positive air pressure needed to maintain an open airway. The nasal mask is placed over a patient's nose and held in place by use of an adjustable elastic headgear. A cloth cushion contacts the patient's face. The mask assembly has an L-shaped tubing swivel connector which is compatible with the industry standard 22 mm air tubing. Air is supplied to the mask by a CPAP device (which can be standard CPAP or a bi-level device). The patient inhales air from the mask and exhales into the mask where continuous airflow from the CPAP device purges the exhaled carbon dioxide from the mask exhalation holes. The SleepWeaver élan can be used in the home environment (single-patient, multi-use) or the institutional environment (multi-patient, multi-use). Cleaning instructions are provided for each environment. Home use calls for washing with warm water and a mild non-abrasive soap. The institutional environment calls for cleaning a validated cleaning agent and a high-level disinfecting agent/process. The mask features a cloth cushion made of polyester fabric with a polyester/lycra/nylon interface material. The mask exhalation feature is incorporated into the cloth cushion. Attached to the cushion is an L-shaped 22-mm tubing swivel connector that can rotate 360°. The tubing connector can be detached by unscrewing the nut off the threaded connector for ease of cleaning and cushion replacement. The cloth headgear is connected to the mask through slots in the cushion wings. The headgear is removable for ease of cleaning and replacement. The SleepWeaver élan Nasal CPAP Mask also offers two optional accessories, the Feather Weight tube and the tether strap. The Feather Weight tube is an 18" plastic home-use only extension tube to improve flexibility at the mask connection point. The tether strap, when used, keeps the tubing from resting on the patient's head while he/she sleeps.
The SleepWeaver élan Nasal CPAP Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or Bi-Level therapy for patients weighing over 66 lbs (30 kg). It is designed for single-patient reuse in the home and multi-patient, multi-use in hospital/institutional environments.
1. Acceptance Criteria and Reported Device Performance
The submission states that Design Verification tests were performed, and the device meets the safety and effectiveness requirements. However, specific numerical acceptance criteria and reported device performance values are generally detailed in the accompanying testing reports which are not provided in this extract. The table below outlines the performance characteristics mentioned in the "Substantial Equivalency Matrix" and implies that the performance must be comparable to the predicate device.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Implied) |
|---|---|---|
| Pressure drop | Positive pressure delivered to patient airway within +/-5 cm H2O of inspiratory pressure setting on CPAP machine up to 20 cm H20. Includes expiratory resistance. | Device meets this criterion. |
| Expiratory resistance | Pressure drop at patient connection port no greater than 5 cm H2O at a flow of 50 L/min. | Device meets this criterion. |
| Fixed leakage | Flow rate of the exhalation port at 5 and 20 cm H20 (comparable to predicate). | Device meets this criterion. |
| Inadvertent leak | Mask inadvertent leak should be less than 20 l/min at a pressure of 20 cmH2O. | Device meets this criterion. |
| Device Interface | Waveform testing on Bi-level machines shall include basic waveform data (comparable to predicate). | Device meets this criterion. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The submission refers to "Design Verification tests" being performed, but details regarding these tests, including the size and nature of the test set, are not included.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The testing appears to be primarily engineering performance testing rather than clinical or expert-reviewed ground truth assessment.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method, as the tests mentioned are primarily performance-based engineering assessments.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned in the provided text. The submission focuses on demonstrating substantial equivalence to a predicate device through design verification and material changes, not on comparing human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
This device is a physical CPAP mask, not an AI algorithm. Therefore, a standalone (algorithm only) performance study is not applicable and not mentioned. The "performance" assessment refers to engineering specifications like pressure drop and leakage.
7. Type of Ground Truth Used
The ground truth for the performance criteria appears to be based on engineering specifications, industry standards (e.g., ISO 5367, ISO 5356-1), and comparison to the predicate device's established performance ranges. For biocompatibility, the ground truth is established by adherence to ISO 10993 standards (e.g., cytotoxicity, sensitization, irritation tests).
8. Sample Size for the Training Set
As this device is a physical product and not an AI/machine learning algorithm, the concept of a "training set" is not applicable in this context.
9. How the Ground Truth for the Training Set Was Established
Similarly, as there is no training set for this type of device, this question is not applicable.
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(90 days)
The SleepWeaver™ Nasal CPAP Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. This mask is intended for single-patient reuse in the home and multi-patient, multi-use in the hospital/institutional environment. This mask is to be used on patients greater than 66 lbs/ 30 kg.
The SleepWeaver™ Nasal CPAP Mask serve as a mechanism for reliably connecting an adult patient diagnosed with sleep apnea to a source of continuous or bilevel positive air pressure needed to maintain an open airway. The nasal masks are fastened over a patient's nose by use of an 'elastic strap around the head. A cloth cushion contacts the patient's face. The mask assembly has a tubing connection which is compatible with the industry standard 22mm air tubing. Air is supplied to the mask by a CPAP device (the CPAP device can be a standard CPAP or Bi-Level type device). The patient inhales air from the mask and exhales into the mask where continuous airflow from the CPAP device purges the exhaled carbon dioxide from the mask through the mask exhaust vents. The mask is made entirely of cloth which provides a comfortable, secure and leakfree interface with the patient. The positive pressure within the system keeps the cloth mask open during use, while providing a leak-free interface to the patient's face. The mask has no structure, and without air pressure it is floppy. But once the CPAP pressure is applied, the mask inflates like a balloon. The air pressure inside the mask pushes the cloth surface against the patient's face. The mask takes on the contour of the patient's facial structure. Since the mask acts like a balloon, and all points in a balloon have the same pressure, the mask makes a leak-free seal with no pressure points. The SleepWeaver Soft Cloth CPAP Mask is made entirely of cloth. The cloth is 100% polvester that is used to produce clothing. The mask features a series of pin holes that serve as an exhalation vent.
This document describes the SleepWeaver™ Nasal CPAP Mask and its performance characteristics. The primary study presented focuses on the durability and leak rate performance of the mask, comparing it to legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The primary acceptance criteria for the SleepWeaver™ Nasal CPAP Mask, as inferred from the provided text, revolve around its leak rate performance, particularly after extended use and cleaning. The device performance is consistently reported as being comparable to predicate devices.
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Initial Leak Rate Performance: Acceptably low total leak rate (fixed and inadvertent) when new, comparable to predicate devices. | The exhalation vent provides "comparable leak performance to the ResMed Mirage Swift Nasal Pillow System and the Respironics ComfortLite Nasal mask" (Appendix A, section 1). |
| Durability - Leak Rate After Long-Term Storage: Acceptably low total leak rate after being stored for a long time. | "The testing included (Appendix A, sections 5 & 6) with this submission demonstrates that the material used to produce the SleepWeaver™ Nasal CPAP Mask is very durable. Not only is the leak rate matched to the predicate devices, even after 6 months of use (as simulated by 180 washings), the leak rate through the mask is effectively the same as a new mask." (While long-term storage is mentioned, the text specifically details the washing simulation as the primary durability test, implying the stored mask would also maintain its performance). Note: Specific numerical values for "acceptably low" are not provided in the summary, but the comparison to predicate devices serves as the benchmark. |
| Durability - Leak Rate After Multiple Cleanings: Maintain acceptably low total leak rate after multiple cleaning cycles, simulating long-term use. | "The cleaning is considered to be the process which is most likely to cause deterioration of the material in the mask. The testing included (Appendix A, sections 5 & 6) with this submission demonstrates that the material used to produce the SleepWeaver™ Nasal CPAP Mask is very durable. Not only is the leak rate matched to the predicate devices, even after 6 months of use (as simulated by 180 washings), the leak rate through the mask is effectively the same as a new mask." Specific simulation: 180 washings (simulating 6 months of use). |
| Biocompatibility (Cytotoxicity and Skin Irritation): No reactivity of materials with skin. | "Cytotoxicity and skin irritation data (Appendix B) demonstrate no reactivity of the cloth material." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the number of individual masks or test subjects used in the leak rate or durability testing. It refers to "the testing included (Appendix A, sections 5 & 6)," suggesting a formal study was conducted.
- Data Provenance: The provenance of the data is not specified (e.g., country of origin). The studies appear to be prospective in nature, given they involve direct testing of the device for performance characteristics like leak rate after cleaning and assessing biocompatibility.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The studies described (leak rate, durability, biocompatibility) appear to be laboratory-based engineering tests rather than studies requiring expert interpretation of clinical data for ground truth establishment.
4. Adjudication Method for the Test Set:
This information is not applicable and is not provided. The described tests are objective measurements (e.g., leak rate), not subjective assessments requiring adjudication.
5. 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:
This information is not applicable. The device is a medical mask and not an AI-powered diagnostic or assistive technology for human readers. No MRMC study was mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
This information is not applicable. The device is a medical mask and does not involve an algorithm.
7. The Type of Ground Truth Used:
For the leak rate and durability tests, the "ground truth" would be the objective measurement of air leakage rates under specified conditions, compared against established engineering standards or the performance of predicate devices. For biocompatibility, the ground truth would be the results of standard cytotoxicity and skin irritation assays.
8. The Sample Size for the Training Set:
This information is not applicable. The device is a physical product (a mask) and not a machine learning model, therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established:
This information is not applicable, as there is no "training set" for this device.
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