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The REMstar SE delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg (66 lbs). It is for use in the home or hospital/institutional environment.

The REMstar SE is a microprocessor controlled blower based positive pressure system which is comprised of the therapy device, a heated humidifier and patient tubing (15mm, or heated tubing). The REMstar SE includes a CPAP mode only. While in CPAP mode, the device delivers a continuous positive airway pressure throughout the entire therapy session. In addition to the CPAP therapy mode, the REMstar SE incorporates several optional features to aid with patient comfort. These features include ramp, adjustable pressure relief (FLEX technologies), and humidification. Humidification options include both a heated tubing. The heated humidifier adjusts the level of humidification by varying the temperature of a heated plate used to heat up a chamber of water. Optional heated tubing can then be used to maintain that air at a desired temperature until it reaches the patient's mask. The REMstar SE is intended for use with a patient circuit that connects the device to a patient interface device (mask). A typical patient circuit consists of patient tubing (15mm, or heated tubing) and an exhalation device (if one is not present in the mask). When a heated humidifier is attached to the therapy device, the patient circuit connects to the air outlet port of the heated humidifier.

The provided text is a summary of a 510(k) premarket notification for a medical device (REMstar SE CPAP system), not a study report. As such, it primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical trials or performance studies with specific acceptance criteria that would typically be found in a study for a novel device.

The information necessary to fill out many parts of your request (e.g., sample size, expert qualifications, ground truth establishment, MRMC studies, standalone performance with metrics) is not present in the provided document. This is because the submission is for a material modification to an already cleared device, and the demonstration of safety and effectiveness relies heavily on non-clinical tests and substantial equivalence.

Here's an attempt to extract and infer information based on the provided text, with clear indications where the information is not available:

REMstar SE CPAP System - Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

• Implantation (per ISO 10993-6)
• Genotoxicity (per ISO 10993-3)
• Irritation (per ISO 10993-10)
• Cytotoxicity (per ISO 10993-5)
• Sensitization (per ISO 10993-10) |
  | Cleaning and Disinfection Validation | Device is safe and effective for single-patient reuse and multi-patient use after maximum recommended cycles. Disinfection methods are effective. | Passed:
• Device withstood maximum recommended cleaning and disinfection cycles.
• Disinfection methods were found to be effective, meeting acceptance criteria for performance tests after maximum cycles. |
  | Volatile Organic Compounds (VOC) Testing | Meet established guidelines for the output of VOCs, carbon dioxide, and carbon monoxide. | Passed:
• Demonstrated ability of modified device to meet established guidelines for VOCs, carbon dioxide, and carbon monoxide output. |
  | Overall Safety & Effectiveness | Substantially equivalent to predicate device (K122769). Material modification has no impact on safety and effectiveness. | Confirmed:
• Modified device determined to be substantially equivalent to the predicate (K122769).
• All design verification tests verified to meet required acceptance criteria as a result of risk analysis and product requirements. (Specific criteria for these "design verification tests" are not detailed.) |

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

• Sample Size (Test Set): Not specified. The document refers to "new materials," "device," and "disinfection methods" without detailing the number of units or materials tested.
• Data Provenance: Not specified. It can be inferred that the testing was conducted by Respironics, Inc., likely in the US, but no explicit statement on country of origin of data or whether it was retrospective/prospective is made. Given it's verification testing for a device modification, it would inherently be prospective testing for the modified components.

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

• Not Applicable / Not Specified. This submission focuses on non-clinical (engineering and biocompatibility) testing, not on clinical performance where expert ground truth might be needed (e.g., for image interpretation or diagnosis). The "ground truth" here is compliance with established standards (like ISO 10993) and internal product requirements, which are typically assessed by qualified technical personnel rather than clinical experts assigning "ground truth" to patient data.

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

• Not Applicable / Not Specified. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, particularly for diagnostic devices, where there might be disagreement among experts. This document describes non-clinical engineering and material verification tests, which do not involve such adjudication processes.

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

• No. This is a CPAP system, not an AI-assisted diagnostic device. Therefore, a MRMC comparative effectiveness study involving human readers and AI assistance was not conducted.

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

• Not Applicable. This device is a CPAP system, not an algorithm or AI system, so the concept of "standalone algorithm performance" does not apply. The device's "standalone" performance would be its functional operation in delivering positive airway pressure, which is assessed through the non-clinical tests mentioned (e.g., pressure output, safety features).

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

• Standards/Regulatory Requirements and Internal Product Specifications. For biocompatibility, the "ground truth" is compliance with ISO 10993 standards. For cleaning/disinfection effectiveness, the "ground truth" is the predefined efficacy criteria (e.g., reduction in microbial load) and the ability of the device to withstand repeated cycles without degradation. For VOC testing, the ground truth is established guidelines for acceptable emissions. For overall device function, it's the internal product requirements and specifications. There is no clinical "ground truth" from pathology or outcomes data presented here, as no clinical study was performed.

8. The sample size for the training set

• Not Applicable / Not Specified. This device is not an AI/ML algorithm that requires a "training set."

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

• Not Applicable. Since there is no training set for an AI/ML algorithm, this question is not relevant to the provided submission.

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The REMstar SE delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg (66 lbs). It is for use in the home or hospital/institutional environment.

The REMstar SE is a microprocessor controlled blower based positive pressure system which is comprised of the therapy device, a heated humidifier and patient tubing (15mm, 22mm, or heated tubing).

The REMstar SE includes a CPAP mode only. While in CPAP mode, the device delivers a continuous positive airway pressure throughout the entire therapy session.

In addition to the CPAP therapy mode, the REMstar SE incorporates several optional features to aid with patient comfort. These features include ramp, adjustable pressure relief (FLEX technologies), and humidification. Humidification options include both a heated humidifier and heated tubing. The heated humidifier adjusts the level of humidification by varying the temperature of a heated plate used to heat up a chamber of water. Optional heated tubing can then be used to maintain that air at a desired temperature until it reaches the patient's mask.

The REMstar SE is intended for use with a patient circuit that connects the device to a patient interface device (mask). A typical patient circuit consists of patient tubing (15mm, or heated tubing) and an exhalation device (if one is not present in the mask). When a heated humidifier is attached to the therapy device, the patient circuit connects to the air outlet port of the heated humidifier.

The provided text describes modifications to an existing CPAP system (REMstar SE) and confirms its substantial equivalence to predicate devices. It does not present a study with detailed acceptance criteria and reported device performance in the format requested, nor does it provide information relevant to AI/ML device studies.

The document states that "Design verification tests were performed on the REMstar SE as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria." However, it does not enumerate these criteria or provide specific performance metrics in a table. It also explicitly states, "Clinical tests were not required to demonstrate the safety and effectiveness of the REMstar SE. Product functionality has been adequately assessed by non-clinical tests." This indicates that the device's performance was evaluated through non-clinical or bench tests rather than studies involving human subjects or complex data analysis as typically seen with AI/ML devices.

Therefore, most of the requested information cannot be extracted from the given text.

Here is what can be inferred or explicitly stated from the document, with limitations highlighted:

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

Limitations: The text does not provide quantitative acceptance criteria (e.g., "Pressure stability within X mmHg") or specific numerical performance results. It only states that specifications were met.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not applicable/Not provided. The text mentions "design verification tests" and "non-clinical tests" but does not specify sample sizes for these tests, as they are likely bench tests on the device hardware and software, not data points in a clinical study.
• Data Provenance: Not applicable/Not provided. No clinical data or patient data is mentioned as being used for testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. Ground truth as typically understood in AI/ML performance evaluation (e.g., expert consensus on medical images or diagnoses) is not described. The "ground truth" here would be the physical and functional specifications of the device, verified through engineering tests.

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

• Not applicable. This concept pertains to resolving discrepancies in expert labeling for clinical studies, which were not performed.

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

• No. This is a non-AI/ML device. No MRMC study was performed.

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

• Not applicable. This is a non-AI/ML device. Its function is to deliver positive airway pressure, not to interpret data or perform diagnostic tasks.

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

• The "ground truth" for this device's performance is its designed product specifications and compliance with relevant industry standards (e.g., ISO, IEC). These are engineering and performance specifications.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.

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

• Not applicable. See point 8.

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