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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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The Transcend Auto provides positive airway pressure for treatment of obstructive sleep apnea (OSA) in adults weighing over 66 pounds (30 kg). The device is intended for home and hospital/institutional use.

The Transcend Auto 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. This flow signal, coupled with pressure sensing, is used to monitor breathing and adjust pressure. When interfaced with a mask, the system provides pressure from 4 to 20 cmHzO above the ambient atmospheric pressure to a patient's oral/nasal airway.

Here's a breakdown of the acceptance criteria and study information for the Transcend Auto device, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Information

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: 41 adult patients.
   • Data Provenance: The document does not explicitly state the country of origin. It does state that the study was a clinical evaluation, which implies it was prospective.

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

   • The document describes a clinical evaluation based on "apnea hypopnea index (AHI) during treatment." While an AHI is a clinical metric derived from sleep study data, the document does not specify if multiple independent experts reviewed the sleep studies to establish this "ground truth" or the qualifications of any such experts. It focuses on the device's performance in reducing AHI, rather than the process of establishing AHI as ground truth.

3. Adjudication Method for the Test Set:

   • The document does not describe an adjudication method for establishing ground truth for the AHI. The focus is on the measured AHI during treatment rather than a consensus interpretation of raw data.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not done in the context of human readers analyzing cases. This study was a clinical evaluation comparing two devices (Transcend Auto vs. REMstar Auto) based on their therapeutic effectiveness (AHI reduction) in patients. The comparison was of device performance, not human reader performance with or without AI assistance.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

   • Yes, the clinical evaluation essentially represents a standalone performance. The Transcend Auto device automatically adjusts pressure without direct human intervention during the night. The study assessed the device's ability, by itself, to achieve non-inferiority in AHI compared to a predicate auto-CPAP device.

6. Type of Ground Truth Used:

   • The ground truth used was clinical outcome data, specifically the apnea hypopnea index (AHI) during treatment. AHI is a measure of the severity of sleep apnea based on the number of apneas and hypopneas per hour of sleep. The study aimed to demonstrate non-inferiority in reducing this index.

7. Sample Size for the Training Set:

   • The document does not provide information about a separate "training set" for the Transcend Auto's algorithm. The study described is a clinical validation study, not an algorithm development study where training sets are typically discussed.

8. How the Ground Truth for the Training Set Was Established:

   • As no training set is described, there is no information on how its ground truth might have been established. It's common for such devices to rely on established physiological principles and prior clinical knowledge in their auto-adjusting algorithms, rather than training on a specific, explicitly defined dataset in the way a machine learning model would be.

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The Transcend Heated Humidifier is indicated for the humidification of the air delivered from a compatible Transcend positive airway pressure therapy device. The Humidifier is intended for single patient re-use in the home environment and in a hospital/institutional environment. The Humidifier is for use only as recommended by a physician.

The Transcend Heated Humidifier is a humidifier that is designed to humidify the air delivered to the airway during positive airway pressure (PAP) therapy with a compatible Transcend PAP device.

The provided document describes the acceptance criteria and supporting studies for the Transcend Heated Humidifier, a medical device for humidifying air during positive airway pressure (PAP) therapy.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Transcend Heated Humidifier are primarily based on compliance with recognized consensus standards and direct comparison to a predicate device (ResMed HumidAire 2i™). The document presents a comparison of various characteristics, some of which serve as performance criteria.

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

The document does not detail specific sample sizes for particular performance tests. The studies conducted are described as "Device design was qualified through the following tests and assessments" which implies these were bench and lab-based tests, not human studies. Therefore, typical "sample sizes" (as in patient data) and "data provenance" (e.g., country of origin, retrospective/prospective) are not applicable in the context of this device's premarket submission, which focuses on engineering, safety, and performance characteristics rather than clinical diagnostic accuracy. The studies performed are:

• Electrical Safety
• Electromagnetic Compatibility
• Biocompatibility Assessment
• Cleaning Validation
• Software Validation
• Packaging and Shipping
• Performance: physical (cycling), resistance to flow, spillage, flow sensing, sound power level, humidification output, out of water shutdown, temperature, runtime, warm-up duration, and reservoir gas leak

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

This section is not applicable. The device relies on physical and electrical performance data, and compliance with engineering standards (e.g., ISO 8185, IEC 60601-1). Ground truth is established by the specifications defined in these standards and by direct laboratory measurements, not by expert interpretation of patient data.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where multiple experts evaluate ambiguous cases to reach a consensus for ground truth. This submission focuses on engineering and performance testing, where outcomes are determined by objective measurements against predefined criteria.

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 done. This type of study is typically performed for diagnostic devices where human readers (e.g., radiologists) interpret images or data, and their performance with and without AI assistance is compared. The Transcend Heated Humidifier is a therapeutic accessory, not a diagnostic device involving human interpretation of complex data.

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

This section is not applicable in the typical sense of AI algorithms. The "device" itself operates "standalone" in its function as a humidifier, based on its internal programming and hardware. However, it's not an AI algorithm in the context of data analysis or diagnostic support where a "human-in-the-loop" would be relevant. The software validation mentioned ensures the device's internal algorithms and controls function correctly, which is a standalone performance test.

7. The Type of Ground Truth Used

The ground truth for the device's performance is based on:

• Engineering Standards and Specifications: Metrics defined by standards such as ISO 8185 (e.g., maximum output humidity, pressure drop, gas leak, sound power level, temperatures).
• Predicate Device Characteristics: Direct comparison of physical, functional, and safety attributes against a legally marketed predicate device.
• Laboratory Measurements: Objective measurements of the device's performance against the specified criteria (e.g., humidification output, temperature, water capacity).

8. The Sample Size for the Training Set

This section is not applicable. This device is not an AI/machine learning model where a "training set" of data would be used to develop an algorithm. Its design and validation are based on traditional engineering principles and testing.

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

This section is not applicable as there is no "training set" in the context of this device.

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