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The 'Transcend 365 miniCPAP Auto System' provides positive airway pressure to support treatment of adults over 66 pounds (30 kg) with Obstructive Sleep Apnea (OSA). The device is intended for home and hospital/institutional use. The integrated humidifier provides humidification of air delivered from the Transcend 365 devices. The use of the humidifier is optional.

The Transcend 365 miniCPAP Auto System (Transcend 365) is a new member of Somnetics' family of devices used to treat obstructive sleep apnea which includes the Transcend Auto and Transcend Heated Humidifier devices and accessories cleared via K132127 and K131388. The Transcend 365 utilizes the same blower and the same algorithm as the Transcend Auto for respiratory event detection and therapy for sleep disordered breathing events. The Transcend 365 includes the following main modifications:

• Integrated CPAP and humidification system .
• . Modifications from predicate Transcend Auto device
  • Graphic LCD interface vs LED in predicate o
  • Housing design O
• Updated air inlet filter o
• Use of a standard 22-mm connection port for air hose attachment O
• Integrated heated humidifier with water reservoir attached with magnets o
• Integrated humidifier uses Capillary Force Vaporization™ (Vapore) technology ●
  • o Wick to a ceramic heater vaporizes water (instead of continuous heating with a heater plate)
  • Similar to PARI Hydrate V (K072982); same supplier (Vapore) o
  • Allows for a smaller water reservoir and footprint o
    The Transcend 365 is a microprocessor-controlled, blower-based system that generates positive airway pressure to support treatment of obstructive sleep apnea. It utilizes a differential pressure sensor connected to an internal pneumotach positioned in the airstream to determine flow levels. When interfaced with a mask though use of a 22 mm breathing hose, this flow signal, coupled with pressure sensing, is used to monitor breathing and adjust pressure. The system provides fixed or auto-adjust pressure from 4 to 20 cmH20 above the ambient atmospheric pressure to a patient's oral/nasal airway.
    The humidifier uses Capillary Force Vaporization technology similar to that used in the PARI Hydrate V (Humidifier, Respiratory Gas (Direct Patient Interface); 868.5450, Product Code BTT) cleared under K072982. Water is drawn from a reservoir by a wick to a ceramic heater, which vaporizes the water resulting in comparable humidification output to the predicate devices. There is no heater plate and the water reservoir is not heated. Several humidification levels are available, with higher settings increasing the amount of water vapor. The humidifier is attached to the lower portion of the PAP through the use of magnets.
    It includes the following components and accessories, which are all single patient reusable:
• . Filter Media
• P10 Battery ●
• Transcend 365 miniCPAP Unit .
• USB cable* ●
• Heater Cartridge .
• Wick
• Reservoir .
• Power supply PSA3 ●
• US 2-prong power cord

Here's a breakdown of the acceptance criteria and study information for the Transcend 365 miniCPAP Auto System, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of acceptance criteria with corresponding performance numbers for the Transcend 365. Instead, it lists the various tests and assessments conducted and states that "Results of tests and assessments did not raise new safety or efficacy questions" and that the device "meets acceptance criteria." It also notes specific performance metrics for some features in the "Substantial Equivalence Comparison" table.

However, based on the provided comparison table and performance data section, we can infer some criteria and the device's meeting of those criteria:

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

The 510(k) summary does not specify sample sizes for specific test sets (e.g., patient data for algorithm testing). The performance data cited are primarily related to general device performance (biocompatibility, electrical safety, mechanical, software validation) rather than a clinical study involving patient data.

• Sample Size: Not explicitly stated for any clinical or patient-related test sets. The tests mentioned are largely bench-top, engineering, and compliance tests.
• Data Provenance: Not applicable in the context of clinical trials/patient data. The data provenance is from various engineering and laboratory testing according to international standards (e.g., ISO, IEC, UL, RTCA).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the summary, as the performance data submitted are primarily for engineering and regulatory compliance rather than clinical efficacy studies requiring expert reader ground truth. The device is a "non-continuous ventilator" (CPAP), whose core function for OSA treatment is well-established, and the submission focuses on demonstrating substantial equivalence to existing cleared devices rather than proving a new clinical efficacy claim through extensive clinical data/expert review.

4. Adjudication Method

Not applicable, as no clinical study requiring a ground truth established by expert adjudication is detailed in this 510(k) summary.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. This type of study is typically done for diagnostic or screening devices to compare human performance with and without AI assistance on a set of cases. The Transcend 365 is a therapeutic device (CPAP), and the submission focuses on its engineering performance and equivalence to predicate devices, not on physician interpretation or diagnostic aid effectiveness.

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

Yes, a standalone performance of the algorithm (e.g., for auto-adjust functionality and AHI measurement) was implicitly done. The document states:

• "The Transcend 365 utilizes the same blower and the same algorithm as the Transcend Auto for respiratory event detection and therapy for sleep disordered breathing events."
• Under "Substantial Equivalence Comparison," for "Algorithm," it explicitly states: "Algorithm is identical to primary predicate" for "Auto-adjust," "AHI Measurement," and "Ramp."
• "Mechanical and Acoustic Testing" included "auto adjust functionality" as a tested parameter.

This indicates that the algorithm's performance, being identical to a previously cleared predicate device, was evaluated, but likely through engineering tests simulating respiratory events rather than a new full-scale clinical trial. The "results of tests and assessments did not raise new safety or efficacy questions" applies to this functionality as well.

7. The Type of Ground Truth Used

For the integrated algorithm's performance (respiratory event detection and therapy adjustment), the ground truth would have been established during the original clearance of the predicate device (Transcend Auto, K132127). For a CPAP device, this typically involves:

• Polysomnography (PSG) data: For validating the accuracy of event detection (apneas, hypopneas) and pressure titration algorithms against direct physiological measurements.
• Bench-top simulation: Using standardized breathing simulation equipment and models to test the device's response to various respiratory patterns and ensure accurate pressure delivery and adjustment.

For non-algorithmic aspects (e.g., biocompatibility, electrical safety, mechanical durability), the ground truth is established by the specifications of the relevant international standards (ISO, IEC, UL, RTCA).

8. The Sample Size for the Training Set

The 510(k) summary provides no information on the sample size for a training set. This is consistent with the nature of the submission, which relies on the algorithm being identical to a previously cleared predicate. Any algorithm training would have occurred during the development of the predicate device (Transcend Auto).

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

As above, the 510(k) summary provides no information on how the ground truth for an algorithm training set was established. This process would have been part of the original development and clearance of the predicate Transcend Auto (K132127). For sleep apnea algorithms, ground truth for training data would typically involve:

• Expert-scored polysomnography (PSG) studies: A large dataset of sleep study recordings where respiratory events (apneas, hypopneas, RERAs) are manually identified and classified by sleep disorder experts according to established scoring rules (e.g., AASM guidelines). This forms the "ground truth" labels for algorithm development and training.
• Standardized physiological signals: Using calibrated sensors and data from patients or simulations that accurately represent the physiological changes associated with sleep-disordered breathing.

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