Search Results

ULTepap ™ is indicated for use in the treatment of mild to moderate Obstructive Sleep Apnea (OSA) in adults> 66bs.

The ULTepap™ is a single patient, reusable device intended to treat mild to moderate OSA. It is comprised of a soft silicon rubber body that contains a pair of bi-resistance airflow cartridges, has flanges to attach headgear, and has nasal pillows to interface with the nares. The device is held in place on the patients face by means of a common CPAP mask headgear which is provided in the packaging. The device creates a therapeutic level of positive pressure on exhalation by means of the airflow cartridges that allow air to enter the patient's upper airway without resistance on inhalation and created resistance to airflow on exhalation. The airflow cartridges are comprised of a cylinder and a flexible thin-walled shell which are aligned with the nasal pillows to allow unimpeded inspiration and partially restricted expiration to create the appropriate level of therapeutic back pressure. The thin-walled shells collapse on inspiration and re-inflate on expiration and create a restricted area for expiration by inflating and sealing the inner diameter of the cylinder, forcing expiration through a series of channels molded in the cylinder.

This is a 510(k) summary for a medical device called ULTepap, an intranasal device intended to treat mild to moderate Obstructive Sleep Apnea (OSA) in adults.

Based on the provided information, I can answer your questions:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" with specific thresholds for performance. Instead, it describes non-clinical tests conducted to demonstrate the device's substantial equivalence to predicate devices. The reported device performance is presented as a comparison to these predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily discusses non-clinical testing. It does not provide details on sample sizes for any of the non-clinical tests (e.g., how many devices were subjected to airflow cartridge fatigue or comfort evaluation).

For clinical testing, the document explicitly states: "No clinical testing was performed in association with this submission." Therefore, there is no clinical test set, sample size, or data provenance to report.

3. 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)

Since "No clinical testing was performed," there was no clinical ground truth established by experts for a test set. The document does not describe the use of experts in establishing ground truth for the non-clinical tests mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as "No clinical testing was performed" and no clinical test set was used to assess the device's performance against a ground truth established by experts.

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 ULTepap™ is a physical medical device (an intranasal device for OSA treatment) and not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The ULTepap™ is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests, the "ground truth" was based on established engineering and materials science standards (e.g., ISO 10993 for biocompatibility) and comparisons to existing predicate devices (e.g., for back pressure range). Since no clinical trials were conducted, no clinical ground truth (expert consensus, pathology, outcomes data) was used in this submission.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable. As this is not an AI/machine learning device, there is no training set or associated ground truth.

Ask a specific question about this device

A patient interface accessory for use with CPAP and bi-level systems used in the treatment of adult OSA and / or ventilatory support. Single patient, multi-use. Environment of use – hospital, sub-acute institutions, sleep laboratories and home

The proposed nasal pillow patient interface incorporates a number of features, which are designed to maximize seal and comfort, and maintain the mask in the correct position throughout use.

• . Three (3) sizes of nasal pillows to assure a good fit
• Integral fixed leak port, identical to the predicate .
• . Headgear for attachment

This submission for the LifeSource CPAP nasal mask with pillows (K071773) is a 510(k) premarket notification. These types of submissions aim to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving safety and efficacy through extensive clinical trials with specific acceptance criteria in the same way a PMA (Premarket Approval) submission would.

Therefore, the study conducted here is comparative testing to demonstrate that the new device performs similarly to the predicate device, not a study against a pre-defined acceptance criterion for a novel device.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

For a 510(k) submission, "acceptance criteria" are typically demonstrating equivalence to a predicate device's performance. The "reported device performance" is the new device exhibiting similar characteristics.

The study proving the device meets the acceptance criteria is described as "Comparative testing for safety and efficacy." This testing specifically investigated:

• Flow vs. Leak / Pressure: This likely involved measuring the flow characteristics and leak rates at various pressure settings to ensure performance similar to the predicate and within acceptable ranges for CPAP therapy.
• Dead space: Measurements were taken to confirm the dead space volumes (26 ml for interface, 2-4 ml for pillows) are identical to the predicate device.

The premise of a 510(k) clearance is that no significant differences that affect the safety or effectiveness exist between the proposed device and the predicate. The "comparative testing" implicitly demonstrated this by showing similar performance in key areas like flow characteristics, leak, and dead space, along with material biocompatibility.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for the comparative testing (Flow vs. Leak / Pressure, Dead space). It also does not mention the country of origin of the data or whether the study was retrospective or prospective. Given the nature of bench testing for a medical device accessory, it's typically prospective bench testing conducted in a lab environment.

3. 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)

This information is not applicable and not provided in the document. For a physical device like a CPAP mask, "ground truth" related to expert consensus is not typically established. The performance metrics (flow, leak, dead space) are measured objectively by engineering and testing personnel, not clinical experts establishing a ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies where subjective assessments (e.g., image interpretation, clinical outcomes) require consensus among multiple observers. The performance testing for this device (flow, leak, dead space) is objective measurement.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/radiology devices where human interpretation is involved. This submission is for a physical medical device (CPAP mask) and does not involve AI or human readers for diagnostic interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance evaluation was not done. This device is a physical product, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the "comparative testing" of the CPAP mask, the "ground truth" for parameters like dead space and flow/leak characteristics would be based on objective physical measurements using calibrated equipment and engineering standards. It is not based on expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set

This information is not applicable and not provided. "Training set" refers to data used to train machine learning models. This submission is for a physical medical device, not a machine learning or AI system.

9. How the ground truth for the training set was established

This information is not applicable and not provided for the same reason as point 8.

Ask a specific question about this device

The Nasal Jacks Mask is an accessory to a non-continuous ventilator (respirator), intended for single-patient multiple use for adult patients prescribed continuous positive airway pressure (CPAP) and bi-level therapy in hospital, clinical, and home environments.

The Nasal Jacks Mask is designed for adult patients for the delivery of non-invasive ventilatory support using continuous positive airway pressure or bi-level therapy. It is intended for singlepatient, multi-use and is minimally obtrusive to the user providing a high level of comfort, ease-ofuse and seal. The Nasal Jacks Mask is supported by headgear to allow a seal with the patients nostrils via the nasal cushions, then connected via tubing to a CPAP or bi-level flow generator. Positive pressure ventilation is thus applied to the lungs in a non-invasive manner. The Nasal Jacks Mask comes in one frame size and has three nasal cushion sizes.

The provided text describes the 510(k) summary for the Nasal Jacks Mask, a device intended for non-invasive ventilatory support. Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample sizes used for the test set or the data provenance (country of origin, retrospective/prospective). It generally states that "Performance testing has been carried out to verify and validate the safety and effectiveness."

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

The document does not provide any information about the number of experts used to establish ground truth or their qualifications. The testing appears to be primarily engineering/objective performance testing rather than human expert assessment of outcomes.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method as the studies described are performance tests and biocompatibility tests, not clinical studies requiring human adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size.

No, an MRMC comparative effectiveness study was not done. The study described focuses on the physical and material characteristics of the device compared to predicate devices.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done.

Not applicable. This device is a medical mask, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the performance tests (pressure-flow, dead space, flow impedance), the ground truth was based on objective measurements and comparison to established predicate device performance. For material biocompatibility, the ground truth was based on ISO 10993 standards or the existing approval of predicate materials.

8. The Sample Size for the Training Set

Not applicable. This device is a physical mask and does not involve a "training set" in the context of machine learning or algorithms.

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

Not applicable, as this is not an algorithm-based device.

Ask a specific question about this device