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This device is intended to provide continuous positive airway pressure (CPAP) for the treatment of adult Obstructive Sleep Apnea (OSA) patients who are spontaneously breathing. It is intended for single patient reuse in the home environment.

The modified iCH CPAP with PVA 9S-007XXX Series is a modification of predicate iCH CPAP with PVA 9S-007XXX (K141522). It changed the material of impeller as well as PCB layout compare to the predicate device. A built-in heated humidifier of iCH CPAP with PVA 9S-007XXX Series is designed to increase the humidity of the air from the CPAP thereby relieving the symptoms of a dry nose and throat resulting from constant airflow that some patients may experience.

The provided text describes a 510(k) premarket notification for a medical device, the iCH CPAP with PVA 9S-007XXX Series. This is a modified version of a previously cleared predicate device (K141522). The document focuses on demonstrating substantial equivalence to the predicate device, rather than proving the device meets acceptance criteria in the sense of a clinical performance study with specific metrics like sensitivity or specificity.

Instead, the "acceptance criteria" here are defined by compliance with recognized standards and successful performance of a suite of engineering and functional tests designed to show that the modified device performs as safely and effectively as the predicate. The study described is a design verification and comparison study against a predicate device.

Here's a breakdown based on your request, interpreting "acceptance criteria" as the performance benchmarks and regulatory compliance targets set by the referenced standards and the comparison with the predicate device.

Acceptance Criteria and Reported Device Performance

The document doesn't present a table of specific acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy for a diagnostic device). Instead, it establishes acceptance by demonstrating substantial equivalence to a predicate device and compliance with relevant safety and performance standards.

The "acceptance criteria" implicitly include:

• Compliance with various safety, EMC, and performance standards (e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2, ISO 17510-1, ISO 8185).
• Demonstration that changes (impeller material, PCB layout) do not negatively impact the device's safety or effectiveness compared to the predicate.
• Successful completion of design verification tests, including (but not limited to):
  • Safety and EMC tests
  • Firmware Validation
  • Noise Test
  • Performance Tests (Pressure Long-term Stability, Dynamic Pressure Stability, Static Pressure Stability, Maximum Temperature, Maximum Flow, Limitation of Maximum Pressure, Overflow Test, Expected Useful Life Validation)
  • Humidification Performance
  • PVA Function Comparison Test (Endurance Operation, Dynamic Testing, APAP Auto titration & AHI Test, PVA Waveform comparison, PVA feature handling disordered breathing, PVA Waveform upper and lower pressure control, PVA Pressure Average and Tolerance Error, Performance Characteristics of PVA Comparison)
  • Biocompatibility Assessment
  • Particle Test
  • VOC Test

The reported device performance is that the "modified iCH CPAP with PVA 9S-007XXX Series complies with the applicable voluntary and mandatory standards" and the "above tests demonstrate that the modified iCH CPAP with PVA 9S-007XXX Series perform as safe and effective as the predicate device - iCH CPAP with PVA 9S-007XXX (K141522)."

No specific numerical performance metrics (e.g., accuracy percentages, error rates) are provided in this summary, as the focus is on equivalence and compliance, not novel clinical performance claims.

Study Details

1. A table of acceptance criteria and the reported device performance

   • Acceptance Criteria (Implicitly from Standards & Predicate Comparison):
     • Safety and EMC compliance (ANSI/AAMI ES60601-1, IEC 60601-1-2)
     • Firmware validation according to FDA guidance.
     • Noise levels within acceptable limits (ISO 11201, ISO 7779).
     • Performance (pressure stability, flow, temperature, maximum pressure limitation) meets ISO 17510-1.
     • Humidification performance meets ISO 8185.
     • PVA function comparable to predicate (Endurance, Dynamic, APAP Auto titration & AHI, Waveform, disordered breathing handling, pressure control, average/tolerance error, performance characteristics).
     • Biocompatibility (ISO 10993 series).
     • Particle and VOC emissions meet US EPA standards.
     • Overall substantial equivalence to predicate device (K141522) in terms of intended use, operating principle, technology, and manufacturing process.
   • Reported Device Performance:
     • "The modified iCH CPAP with PVA 9S-007XXX Series complies with the applicable voluntary and mandatory standards..."
     • "...the above tests demonstrate that the modified iCH CPAP with PVA 9S-007XXX Series perform as safe and effective as the predicate device - iCH CPAP with PVA 9S-007XXX (K141522)."
     • Specific comparative details were provided (e.g., intended user, air outlet, user, operating environment, pressure range, increment, ramp time, pressure/altitude compensate, APAP mode, PVA, alarm system) showing equivalence.

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

   • The document does not specify sample sizes in terms of patient data or clinical cases. This is primarily an engineering and performance verification study, likely using a limited number of device units for testing against established standards and the predicate.
   • The data provenance is not explicitly mentioned as a clinical study with patients; rather, it refers to laboratory testing and design verification.

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

   • Not applicable in the context of this engineering and predicate comparison study. "Ground truth" here is defined by compliance with recognized standards and the performance of the predicate device. The experts involved would be engineers and technical specialists conducting the tests, not clinical adjudicators establishing a diagnostic ground truth from patient data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

   • Not applicable. This is not a clinical study involving human interpretation of results requiring adjudication. Performance is assessed against quantitative engineering specifications and comparative data to the predicate.

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 machine, not an AI-powered diagnostic tool. No MRMC studies were conducted.

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

   • This is a standalone medical device (CPAP machine) but not an "algorithm only" device in the context of AI/ML. Its performance is measured directly through engineering tests.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

   • The "ground truth" for this submission is implicitly established by:
     • Recognized International and National Standards: e.g., ISO 17510-1 for sleep apnea breathing therapy equipment, ISO 8185 for humidifiers, ISO 10993 series for biocompatibility, etc.
     • The Performance of the Predicate Device: The modified device's performance is compared directly to its legally marketed predecessor (K141522) to demonstrate substantial equivalence.

8. The sample size for the training set

   • Not applicable. This is not a machine learning or AI device that requires a "training set."

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

   • Not applicable, as there is no training set for this type of device submission.

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This device is intended to provide continuous positive airway pressure (CPAP) for the treatment of adult Obstructive Sleep Apnea (OSA) patients who are spontaneously breathing. It is intended for single patient reuse in the home environment.

The iCH CPAP with PVA 9S-007XXX Series are intended to provide continuous positive airway pressure for the treatment of adult obstructive sleep apnea (OSA). It is a modification of iCH CPAP 9S-007XXX (K120035) with the same algorithm of XT Auto with PVA 9S-005720 (K112079). It shares the same construction and auto adjustment algorithm with iCH CPAP 9S-007XXX but adds the identical Pressure Variation Algorithm with the predicate device XT Auto with PVA 9S-005720 (K112079). The Pressure Variation Algorithm provides a release pressure during expiration phase which is designed for patients who have difficulty exhaling against high CPAP pressure. It works by reducing the CPAP setting pressure in the normal breath status of expiratory phase from the treatment pressure in either CPAP or APAP mode.

A built-in heated humidifier of iCH CPAP with PVA 9S-007XXX Series are designed to increase the humidity of the air from the CPAP thereby relieving the symptoms of a dry nose and throat resulting from constant airflow that some patients may experience. The modified iCH CPAP series (with PVA) are from the iCH CPAP 9S-007XXX (K120035), but the algorithm for pressure variation algorithm(PVA) of the device comes from XT Auto with PVA (K112079).

The PVA Pressure Variation Alqorithm for the subject and predicated device (K112079) is an exhalation pressure relief function which is designed for patients who have difficulty exhaling against high CPAP pressure. Pressure can be reduced to three different levels (according to patient need) during the transition from Inspiration to Expiration phase. This reduced pressure level (depending on the PVA setting) will be maintained during Expiration phase and will return to the therapeutic pressure in the end of Expiration phase. In order to ensure the effectiveness of CPAP therapy, PVA will be automatically suspended if apneas are detected. After apneas disappear, PVA will re-start.

The provided text describes a 510(k) summary for the iCH CPAP with PVA 9S-007XXX series, which is a modified version of an existing device. The summary focuses on demonstrating substantial equivalence to predicate devices rather than detailing a specific study to prove acceptance criteria for a novel algorithm's performance in a clinical setting.

Therefore, many of the requested details about acceptance criteria, clinical study design, sample sizes, expert involvement, and ground truth establishment are not present in this regulatory document. The focus here is on engineering verification and comparison to existing, cleared devices.

Here's an attempt to extract relevant information and note where the requested details are absent:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide specific numerical acceptance criteria for clinical performance (e.g., sensitivity, specificity for disease detection). Instead, it relies on design verification tests to ensure the modified device functions similarly and safely to the predicate devices. The "reported device performance" is framed as "equivalent" or "identical" to the predicate.

Design Verification Tests Performed:

• Safety and EMC: According to iCH CPAP 9S-007XXX series (K120035) verification procedures, including FDA reviewer guidance 638.pdf, IEC 60601-1 & IEC 60601-1-2.
• FDA Draft Reviewer Guidance for Ventilators (July 1995)
• FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)
• Side-by-side waveform testing: At various pressure and frequency levels with the predicate device(s).
• Algorithm analysis (for PVA):
  • Step function
  • PVA waveform with different breathing frequencies and flow volumes
  • PVA feature handling conditions of disordered breathing (apneas and hypopneas)
  • PVA waveform upper and lower pressure control
  • PVA pressure average and tolerance error
  • Performance characteristics of PVA

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

This information is not provided in the document. The "test set" here refers to the engineering and algorithm verification tests, not a clinical trial with human subjects. The data provenance would be from internal testing, not patient data in the context of a clinical study.

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

This information is not provided. The ground truth for engineering tests is typically established by comparing the device's output to expected behavior based on specifications and predicate device performance, often using calibrated instruments.

4. Adjudication Method for the Test Set

This information is not provided. This refers to clinical adjudication, which is not described for these engineering/algorithm verification tests.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned and is not applicable to this type of device (CPAP machine for treating OSA) or its regulatory submission, which focuses on device functionality and substantial equivalence. This device does not involve "human readers" interpreting medical images or data with AI assistance.

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

Yes, an algorithmic analysis was performed for the Pressure Variation Algorithm (PVA). The document states:

• "Algorithm analysis; by comparing the test items as below:
  • a. Step function
  • b. PVA waveform with different breathing frequencies and flow volumes
  • c. PVA feature handling conditions of disordered breathing (apneas and hypopneas)
  • d. PVA waveform upper and lower pressure control
  • e. PVA pressure average and tolerance error
  • f. Performance characteristics of PVA"

This constitutes a standalone (algorithm-only) assessment of the PVA's expected behavior. However, it's an engineering verification, not a clinical standalone performance study.

7. The Type of Ground Truth Used

For the engineering and algorithm analysis tests, the ground truth would be based on:

• Specifications and engineering requirements: For characteristics like pressure range, increment, ramp time, etc.
• Predicate device performance: The behavior of the previously cleared XT Auto with PVA (K112079) served as the reference for the PVA algorithm's expected output.
• Physiological models/simulations: To test responses to different breathing frequencies, flow volumes, and disordered breathing conditions.

8. The Sample Size for the Training Set

This information is not applicable/provided. This device is a hardware device with an algorithm for pressure variation, not a machine learning model that requires a "training set" in the conventional sense of AI/ML software. The algorithm is stated to be "the same algorithm of XT Auto with PVA 9S-005720 (K112079)," implying it was previously developed and validated.

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

This information is not applicable/provided for the reasons mentioned in point 8.

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