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This mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home and multi-patient use in the hospital/institutional environment. The mask is to be used on patients > 7 years old (>40 lbs) for whom CPAP or bi-level therapy has been prescribed.

The Magneto Nasal Mask includes two cushion type options: a nasal, cradle cushion and nasal, pillows cushion. The nasal cradle cushion seals around the bottom of the patient's nose, and comes in five sizes (extra small, medium wide, large). The nasal pillows cushion tips seal at the entrance to the nares. The pillows cushion base sits under the nares, and comes in five sizes (extra small, small, medium wide, large). Both of the cushion design options contain enclosed magnets.

The mask frame also contains enclosed magnets, and connects to the mask cushion magnetically for easy and secure assembly by the user. The mask frame comes in one size and connects to the tubing with a snap fit, which allows the frame attached to the tubing.

The fabric headqear goes over the top of the mask frame and around the patient's head. The headgear comes in one size and includes adjustment sliders to allow for a large or small fitting on the patient's head.

The mask includes 10 mm tubing. The 10 mm tubing contains built-in exhalation at the top of the tube where the tubing connects to the mask frame. The tubing also includes an ISO 5356-1 compliant, 22 mm male conical swivel. The tubing swivel connects directly to ISO 5356-1 compliant, 22 mm female connections used on therapy device tubing. The tubing swivel detaches from the mask tubing, via a quick disconnect feature. The tubing connects to 12 mm connections when the tubing swivel is detached.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "Magneto Nasal Mask." It describes the device, its intended use, and compares it to a predicate device to demonstrate substantial equivalence.

This document does not contain the acceptance criteria or a study proving the device meets acceptance criteria in the format typically required for performance studies of AI/ML-driven medical devices. The Magneto Nasal Mask is a physical medical device (a mask for CPAP/bi-level therapy), not an AI/ML software device.

Therefore, many of the requested categories in the prompt (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to the information provided in this 510(k) summary for a physical medical device.

However, I can extract the closest analogous information regarding performance testing and acceptance criteria for this physical device.

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this physical device are primarily based on demonstrating equivalence to the predicate device and meeting relevant international standards for safety and performance. The "reported device performance" refers to the measurements taken for the Magneto Nasal Mask compared to the predicate.

Note: The acceptance criteria are largely implied by compliance with standards (e.g., ISO 17510 for masks, ISO 10993 for biocompatibility) and demonstrating that differences from the predicate do not raise new questions of safety and effectiveness. Specific numerical "acceptance criteria" are not explicitly stated as pass/fail thresholds in this summary for most metrics, but rather performance values are presented for comparison.

• Extra small: 13.6 ml
• Small: 17.9 ml
• Medium: 18.5 ml
• Medium wide: 16.9 ml
• Large: 23.7 ml
  Nasal Pillows Cushion:
• Extra small: 11.4 ml
• Small: 11.6 ml
• Medium: 12.0 ml
• Medium wide: 13.0 ml
• Large: 12.4 ml | - Small size: 37.4 ml
• Medium size: 48.7 ml
• Large size: 72.8 ml |
  | Pressure Drop | Nasal Cradle Cushion:
• XS: 1.7 cm H₂O @ 50 SLPM, 6.3 cm H₂O @ 100 SLPM
• S: 1.5 cm H₂O @ 50 SLPM, 6.5 cm H₂O @ 100 SLPM
• M: 1.4 cm H₂O @ 50 SLPM, 6.1 cm H₂O @ 100 SLPM
• MW: 1.6 cm H₂O @ 50 SLPM, 6.1 cm H₂O @ 100 SLPM
• L: 1.5 cm H₂O @ 50 SLPM, 5.3 cm H₂O @ 100 SLPM
  Nasal Pillows Cushion:
• XS: 1.9 cm H₂O @ 50 SLPM, 7.5 cm H₂O @ 100 SLPM
• S: 2.0 cm H₂O @ 50 SLPM, 7.2 cm H₂O @ 100 SLPM
• M: 1.5 cm H₂O @ 50 SLPM, 6.1 cm H₂O @ 100 SLPM
• MW: 1.6 cm H₂O @ 50 SLPM, 6.3 cm H₂O @ 100 SLPM
• L: 1.8 cm H₂O @ 50 SLPM, 6.8 cm H₂O @ 100 SLPM | - 0.8 cm H₂O @ 50 SLPM
• 3.1 cm H₂O @ 100 SLPM |
  | A-weighted Sound Power Level | 28 dBA | 26.5 dBA |
  | A-weighted Sound Pressure Level | 20 dBA | 18.5 dBA |
  | Total Mask Leak | - 9.2 SLPM @ 4 cm H₂O
• 10.8 SLPM @ 5 cm H₂O
• 17.2 SLPM @ 10 cm H₂O
• 26.7 SLPM @ 20 cm H₂O
• 34.6 SLPM @ 30 cm H₂O | - 19.8 SLPM @ 5 cm H₂O
• 29.5 SLPM @ 10 cm H₂O
• 43.6 SLPM @ 20 cm H₂O |
  | Biocompatibility | Compliant with ISO 10993 series and ISO 18562 series. (No specific numerical performance reported, only compliance) | (Implied compliance, not explicitly detailed in the predicate comparison for this summary) |
  | Cleaning & Disinfection Validation | Validated (Cleaning residuals, disinfection residuals confirmed). (No specific numerical performance reported, only validation status) | (Methods outlined for predicate, no direct comparison of validation results) |
  | Magnetic Strength | Tested (No specific numerical performance reported, only tested status) | (Not mentioned for predicate, but implies acceptable levels to prevent interference while providing secure connection) |
  | CO2 Rebreathing | Tested (No specific numerical performance reported, only tested status) | (Not mentioned for predicate, implies meeting safety standards for CO2 washout) |
  | Resistance (Pre & Post Cleaning/Disinfection) | Tested (derived from pressure drop, implies within acceptable limits after reprocessing) | (Covered by pressure drop for predicate, implies acceptable limits after reprocessing) |
  | Conical Connectors | Complies with ISO 5356-1:2015 (No specific numerical performance reported, only compliance) | (Implied compliance for predicate, not explicitly detailed) |

Study Proving Device Meets Acceptance Criteria:

A series of non-clinical tests were performed to verify the safety and effectiveness of the device and demonstrate substantial equivalence to the predicate device. These tests assessed various physical and performance characteristics of the mask.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not explicitly stated in terms of number of masks or specific test replicates for each performance metric, but the tests were conducted on the "Magneto Nasal Mask."
• Data Provenance: The tests were performed by the manufacturer, Respironics, Inc., to verify the device modifications. This is retrospective testing done on manufactured devices. The country of origin of the data is implicitly the USA, where Respironics is based and where the FDA submission occurred.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a physical medical device, not an AI/ML software. "Ground truth" in the AI/ML sense (e.g., expert annotation of images) is not used. Performance is assessed through objective physical and functional measurements against standards and predicate device data.

4. Adjudication method for the test set

Not applicable. This is a physical medical device, not an AI/ML software. Performance is measured objectively according to specified test protocols for physical devices.

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 is a physical medical device, not an AI/ML software. No human readers or AI assistance are involved in interpreting its output.

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

Not applicable. This is a physical medical device, not an AI/ML software.

7. The type of ground truth used

The "ground truth" for this medical device is established by:

• International standards (e.g., ISO 17510 for mask performance, ISO 10993 for biocompatibility).
• Performance data of the legally marketed predicate device (Simple T Youth Nasal Mask, K140268).
• Engineering specifications and safety requirements for medical devices.
• The tests themselves produce objective physical measurements.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML software. It does not use a "training set" in the context of machine learning.

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

Not applicable. This is a physical medical device, not an AI/ML software.

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