Search Results

The Comfort Twin Nasal Mask is an accessory to a non-continuous ventilator (respirator), intended for use by adult patients prescribed continuous positive airway pressure (CPAP) or bi-level therapy in hospital, clinic and home environments.

The Comfort Twin Nasal mask is a respiratory nasal mask using a dual cushion design with built-in bellows and an inner sealing flap for improving unintentional leak. It is a single patient use accessory for use with CPAP or bi-level devices. The Comfort Twin mask is strapped to the patient's face covering the nose, and connected to tubing to a CPAP or bi-level flow generator. Positive pressure ventilation is then able to be applied to the lungs in a non-invasive way.

The provided text describes a 510(k) summary for the Comfort Twin Nasal Mask, which is a new device. The acceptance criteria and the study proving the device meets them are discussed in the context of demonstrating substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document states, "The new device was validated using bench data." This indicates that the testing was performed in a laboratory setting. The specific sample size for the test set is not provided. The provenance of the data is bench data, implying controlled experimental conditions rather than human or animal studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Not applicable. Since the validation was performed using "bench data," there was no need for human experts to establish ground truth in the way it would be required for clinical image analysis or diagnostic studies. The ground truth would be defined by the technical specifications and measurements of the device components and its interaction with test equipment.

4. Adjudication Method for the Test Set:

Not applicable. As the validation was based on "bench data," an adjudication method for reconciling expert opinions is not relevant. The "adjudication" would involve comparing measurements against predefined technical specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The study focused on demonstrating substantial equivalence through bench data, comparing the performance characteristics of the new device to predicate devices. There is no mention of human readers or AI assistance in this context.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance):

Yes, in spirit, but not in the context of an algorithm. The study essentially evaluates the "standalone" performance of the physical device itself (the Comfort Twin Nasal Mask) in a controlled bench setting, without human intervention or interpretation that would typically be associated with an algorithm. It's an engineering performance evaluation, not an AI algorithm evaluation.

7. Type of Ground Truth Used:

The ground truth used was technical specifications and performance characteristics of the predicate devices (Respironics Reusable II Contour Nasal Mask and Resmed Mirage Activa), against which the new device's "bench data" was compared. The statement "All performance characteristics performed within specification and comparable to the cited device predicates" implies that the predicate devices' established performance benchmarks served as the ground truth for comparison.

8. Sample Size for the Training Set:

Not applicable. This device is a physical medical device (nasal mask), not an AI algorithm that requires a training set. The concept of a "training set" is not relevant to this type of product submission.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As a physical device, there is no training set in the context of machine learning.

Ask a specific question about this device

The Respironics BiPAP Synchrony 2 is intended to provide non-invasive ventilation for pediatric patients 7 years or older (> 40 lbs) or adult patients (> 66 lbs) with respiratory insufficiency or obstructive sleep apnea, in the hospital or home.

The Respironics BiPAP Synchrony 2 device is unchanged from K063533. The only change is to include a Respironics pediatric mask as a second option for use by its pediatric users. This mask is the same mask design as is used by the cleared Respironics Reusable Contour Deluxe Nask (K991648). The mask consists of a silicon cushion, polycarbonate faceplate with an elbow that contains the exhalation feature. The anthropometric profile of the Respironics Pediatric Mask matches that of the Resmed Kidsta previously cleared in K063533.

This document describes a 510(k) premarket notification for the BiPAP Synchrony 2 Ventilatory Support System with the addition of a Respironics pediatric mask. The core device itself (BiPAP Synchrony 2) is unchanged from a previously cleared predicate device (K063533). The submission specifically addresses the compatibility of the new pediatric mask.

Here's an analysis of the acceptance criteria and supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance

The general acceptance criteria and performance are reported qualitatively in the document. No specific numerical thresholds are provided, as the study focused on compatibility and function rather than a new "performance metric."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated in the provided text. The document refers to "mask compatibility testing" but does not detail the number of masks, devices, or test subjects used in this testing.
• Data Provenance: Not explicitly stated, however, the testing was performed by Respironics, Inc. and is part of a submission to the FDA in the United States. It's likely a controlled, in-house laboratory study. It would be considered prospective for the specific purpose of this submission (testing the new mask's compatibility).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The testing was conducted by the manufacturer, Respironics, likely by their engineering and R&D teams.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/specified. The testing described appears to be objective, functional performance testing (e.g., pressure, waveform analysis, discrete function activation) rather than subjective expert assessment. There is no indication of multiple readers or an adjudication process for these technical tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This submission focuses on the compatibility of a new mask with an existing device, involving technical performance testing, not the clinical effectiveness or human-in-the-loop performance with or without AI.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study: No, a standalone performance study in the context of an algorithm or AI was not done. This device is a ventilatory support system, not an AI/algorithm-based diagnostic or therapeutic device.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this testing was based on pre-defined engineering specifications and performance requirements for the ventilatory support system. The "acceptance criteria" for the mask compatibility testing (pressure, waveform, triggering, cycling, alarm functionality) refer to these established technical standards for proper device function.

8. Sample Size for the Training Set

• Sample Size: Not applicable. This submission concerns a physical medical device and mask, not an AI or machine learning algorithm that would require a 'training set.'

9. How the Ground Truth for the Training Set Was Established

• Ground Truth Establishment: Not applicable, as there is no training set for an AI/ML model.

Ask a specific question about this device