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510(k) Data Aggregation
(90 days)
The TAP PAP Nasal Pillow Mask is intended to be used by individuals who have been diagnosed by a Physician as requiring CPAP or Bi-Level ventilator treatment. The TAP PAP Nasal Pillow Mask is intended for single patient adult (>66lb/30kg) use in the home, hospital or other clinical setting.
The TAP PAP Nasal Pillow Mask consists of a boil & bite type dental appliance. A small bracket that extends beyond the lips to attach the mask frame (Mask - Upper Mouth Piece Adjustment Joint). Two soft silicone nasal pillows are located on the mask frame to seal against the nostrils. The nasal pillows come in three sizes and can be individually rotated to align with the user's nares. A corrugated flexible tube extends upwards from the mask frame to a 22 mm connector which connects to a breathing tube of a CPAP or bi-level device. The mask frame has exhalation vents (bias holes) that allow exhaled gases to be continually flushed.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: TAP PAP Nasal Pillow Mask
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Attribute | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Pressure Drop | No pass/fail criteria, reportable values only. (Implied: must be low enough for CPAP machines to supply required flow, and patient exhalation through mouth should have no resistance). | 50 lpm: 0.2 cm H₂O 100 lpm: 0.6 cm H₂O |
| Bias (vent) Flow / Exhaust Flow | No pass/fail criteria, reportable values only. Should be comparable to the predicate. (Implied: Higher leak rate indicates greater CO2 washout and is not clinically significant). | 6 cm H₂O: 23 lpm 10 cm H₂O: 30 lpm 20 cm H₂O: 42 lpm |
| Dead Space | No pass/fail criteria, reportable values only. Should be comparable to the predicate. (Implied: Higher reported value is acceptable if CO2 washout demonstrates effectiveness). | 95 ml |
| CO2 Washout (per ISO 17510-2) | Changes in CO2 at various pressures to be < 20% and < 60% from baseline. | 4 cm H₂O: 4% increase 5 cm H₂O: 4% increase 10 cm H₂O: 2% increase Occluded: 7% increase |
| Mask Weight | No pass/fail criteria, reportable values only. Should be comparable to the predicate. | 59 gm |
| Cleaning Durability | Visual and performance testing compared pre- and post-cleaning, found to be similar. (Implied: Device maintains performance specifications after repeated cleaning). | Met performance specifications. |
| Environmental (Hot/Cold Exposure & Drop Test) | Device meets performance specifications after exposure to 50℃ for 72 hours and 20℃ for 24 hours. | Met performance specifications after conditioning and cleaning. |
| Biocompatibility (ISO 10993-1) | Pass/fail criteria per each respective ISO 10993 test for cytotoxicity, sensitization, irritation, genotoxicity, and implantation, based on patient contact type and duration for various parts (mask shell, assembly, pillow seals, mouth tray, tubing, headgear, chin strap, nut, bolt). | All materials passed the applicable ISO 10993-1 test requirements. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of devices or individuals) used for each non-clinical test. It mentions "samples" for environmental testing but doesn't quantify them. It also does not provide information about the data provenance (e.g., country of origin, retrospective or prospective) for these non-clinical tests, as they appear to be laboratory-based performance evaluations rather than human subject studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The tests performed are non-clinical (laboratory/mechanical) performance tests, not clinical studies requiring expert-established ground truth. The "ground truth" for these tests is based on established engineering and safety standards (e.g., ISO 17510-2, ISO 10993).
4. Adjudication method for the test set
Not applicable. As these are non-clinical, objective tests, an adjudication method for a test set is not needed. The results are measured directly against predefined standard criteria.
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. This device is a CPAP patient interface, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance for human readers is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests is based on established international standards and engineering specifications, such as:
- ISO 17510-2 for CO2 washout.
- ISO 10993 series for biocompatibility.
- Standard methods for measuring physical attributes like pressure drop, bias flow, dead space, and weight.
8. The sample size for the training set
Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI that would require a ground truth for training. The product's design is validated through engineering principles and non-clinical testing.
9. How the ground truth for the training set was established
Not applicable, for the same reasons as point 8.
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