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510(k) Data Aggregation
(239 days)
ULTepap Expiratory Positive Airway Pressure (EPAP) Device
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.
| Attribute/Test | Acceptance Criteria (Implied/Compared to Predicate) | Reported Device Performance |
|---|---|---|
| Back pressure comparison | Be in the same range as two predicate devices | Creates back pressure in the same range as two predicate devices (Provent and Bongo) |
| Air flow cartridge fatigue | Maintain material integrity after cleaning | Tested while evaluating the impact of cleaning on material integrity |
| Comfort evaluation study | (Implicitly, be comfortable for patients) | (Study conducted, specific outcomes not detailed in this summary) |
| Accelerated Aging Test | Establish acceptable shelf life claims | To determine acceptable shelf life claims |
| Inhalation resistance testing | (Implicitly, demonstrate low resistance) | (Test conducted, specific outcomes not detailed in this summary) |
| Cleaning validation | (Implicitly, demonstrate effective cleaning) | (Test conducted, specific outcomes not detailed in this summary) |
| Vibration/drop testing | (Implicitly, demonstrate durability) | (Test conducted) |
| Environmental Testing | (Implicitly, perform in expected environments) | (Test conducted) |
| Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Reactivity) | Meet ISO 10993 standards | Tests completed per ISO 10993 standards; materials certified identical to reference device K034053 |
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.
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