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The microMESAM® Basic-Set is used for recording the patient's respiratory nasal pressure during sleep. The device is intended for use as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's test score.

The MicroMESAM® Basic-Set consists of a reusable microMESAM® recorder, disposable nasal pressure cannula and patient's instruction manuals, microMESAM® installation CD, system instruction manual for specialist medical personnel, batteries, reusable belt for attaching the microMESAM® recorder, USB cable, carrying bag, and Luer-lock caps. The microMESAM® recorder is a single channel battery-powered respiratory pressure sensor system and provides recordings of respiratory pressure during sleep. The physician prescribed device will help to recognise sleep-related respiratory disorders and lead to comprehensive clinical diagnosis and therapy. The patient may actually perform the recording at home by himself. The microMESAM® recorder must be fastened with the reusable belt on the patient's chest. All relevant respiratory information during sleep will be collected via nasal pressure cannula. The disposable plastic nasal pressure cannula is connected to the microMESAM® recorder and fixed at the patient's nose. After recording, the microMESAM® recorder must be returned to the physician. With the microMESAM® software installed on a personnel computer the physician has the possibility to generate a report with the recorded and analysed data.

Here's a breakdown of the acceptance criteria and study information for the microMESAM® Basic-Set, based on the provided text:

Acceptance Criteria and Study Information for microMESAM® Basic-Set

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a table format with numerical targets. However, the performance data section implies the criteria for substantial equivalence were met by demonstrating high correlation with the gold standard (PSG) and effective detection of Sleep Disordered Breathing (SDB). I've interpreted the key correlating factors and the derived sensitivities/specificities as the performance outcomes that demonstrate meeting implicit acceptance criteria for a screening device.

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

• Sample Size for Test Set: 50 patients
• Data Provenance: The document does not explicitly state the country of origin, but the submitting company is based in Germany. It is a prospective study, as it involved "50 patients suspected of having obstructive sleep apnoea" where microMESAM-generated automated analysis was compared with simultaneously collected PSG data.

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

The study compared "MicroMESAM-generated automated analysis with manually scored results of simultaneously collected PSG data." This indicates that human experts were involved in scoring the PSG data, which served as the ground truth.

• Number of Experts: Not specified.
• Qualifications of Experts: The document does not explicitly state the qualifications of the experts who manually scored the PSG data. However, the phrasing "manually scored results of simultaneously collected PSG data" implies qualified sleep specialists or technicians trained in PSG scoring, as PSG is the "gold standard in the diagnosis of sleep disordered breathing (SDB)."

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (such as 2+1 or 3+1). It states that the microMESAM's automated analysis was compared to "manually scored results" of PSG. This suggests a direct comparison to a single expert's or a consensus's manual scoring of the PSG, but the specific process isn't detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not explicitly described. The study compared the device's automated analysis to manually scored PSG data, not to human readers with vs. without AI assistance.

• Effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as no MRMC study was conducted.

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

Yes, the performance study describes the standalone performance of the microMESAM® Basic-Set's automated analysis. It explicitly states comparing "MicroMESAM-generated automated analysis" with the ground truth (manually scored PSG data). The device automates the analysis of apnoeas, hypopnoeas, flow limitations, and snoring.

7. The Type of Ground Truth Used

The primary ground truth used was expert consensus / manual scoring of Polysomnography (PSG) data. PSG is referred to as the "gold standard in the diagnosis of sleep disordered breathing (SDB)." Additionally, there was an initial comparison of signal quality where "pneumotachograph-generated curves" served as a ground truth for microMESAM's flow-time curves.

8. The Sample Size for the Training Set

The document does not specify a separate training set or its sample size. The study described focuses on the validation of the device, implying that the algorithm and its analysis capabilities were already developed.

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

Since a training set is not explicitly mentioned, the method for establishing its ground truth is also not described in this document.

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The Papillon® Mask Set is intended to be used with positive airway pressure devices such as CPAP (Continuous Positive Airway Pressure), operating at or above 4 cm H,O for the treatment of adult obstructive sleep apnea. The mask is single patient reusable.

The Papillon® Mask Set is a patient interface accessory for use with nasal Continuous Positive Airway Pressure (CPAP) and bi-level systems used in the treatment of Obstructive Sleep Apnea (OSA).

One mask set consists of a mask cushion, forehead pad, mask frame, hose connector system and the AeroFix headgear with the AeroFix plus hose clip. The mask cushion is available in two different sizes.

The mask fame integrates the standard mask frame and the forehead frame into one piece with an adjustable hinge design, which forms the central and supporting part of the Papillon nasal mask cushion and forehead pad are fixed to the mask frame prior to use. The mask cushion and forehead pad are both made of a hypoallergenic silicone material. The mask cushion and outer shell are comprised of a single, soft, silicone piece that covers the entire nasal area. The cushion includes an exhalation system consisting of six exhalation vents. The hose connection system allows a standard respiratory hose to be connected to the Papillon nasal mask. The hose connection system includes two connectors for external pressure measurement and for administering O.. The Aerofix headgear and Aerofix plus hose clip are easily connected to the mask frame and the respiratory hose using fasteners. The Aerofix headgear secures the nasal mask to the head of the patient.

The provided text does not contain detailed information about specific acceptance criteria for performance metrics or a study designed to prove the device meets such criteria. This document is a 510(k) summary for a medical device (a nasal mask for CPAP therapy) and generally focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against specific acceptance criteria.

However, based on the available information, here's what can be extracted and inferred regarding the study that demonstrated substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation:
The document states that "Verification testing has been performed and demonstrates that the exhalation vents perform equivalently in preventing CO2 re-breathing as compared to the predicate mask system." This implies that the acceptance criterion was "equivalent performance in CO2 re-breathing prevention" compared to the predicate device. The other criteria are inferred from the statements about compliance with standards and the claim of substantial equivalence, meaning the new device performs similarly to the predicate for its intended purpose.

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

• Sample Size: Not explicitly stated. The document refers to "verification testing," but the number of subjects or samples included in this testing is not provided.
• Data Provenance: Not explicitly stated. Given that the submitter is a German company (MAP Medizin-Technologie GmbH), it's plausible the testing was conducted in Germany or a European context. It's also not specified if the data was retrospective or prospective, though "verification testing" generally implies prospective testing specifically for the device approval.

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

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

4. Adjudication Method for the Test Set

• Not mentioned. The focus of this 510(k) is on the physical device and its performance against standards and a predicate, not on subjective assessments requiring adjudication.

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, an MRMC comparative effectiveness study was not done. This device is a physical medical device (nasal mask), not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

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

• Not applicable. As stated above, this device is a physical medical device and does not involve an algorithm. Performance testing was likely focused on mechanical and physiological parameters (e.g., CO2 re-breathing, fit, biocompatibility).

7. The Type of Ground Truth Used

• The "ground truth" for the device's performance appears to be established through:
  • Direct measurement and comparison: For CO2 re-breathing, the performance was compared directly to a legally marketed predicate device (Sullivan® Mirage™ Mask System) through verification testing.
  • Compliance with established standards: The mask was tested and found compliant with ISO 10993-1 (biocompatibility) and prEN ISO 17510-2 (mask performance for sleep apnea therapy). These standards themselves define the "ground truth" or acceptable benchmarks for these aspects.

8. The Sample Size for the Training Set

• Not applicable. This device does not use machine learning or AI, so there is no "training set."

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

• Not applicable. As there is no training set, this question is not relevant.

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Exhalation outlet for use between masks without openings and air tube for sleep apnoea therapy including quick connector/disconnector

The Aero-Click ® is a passive exhalation outlet which is placed in the patient circuit between the mask and the air tube of a sleep apnoea therapy device to provide a continuous leak path for the patients exhaled air. It is placed near the patient's face and allows quick connection/disconnection of the mask from the sleep apnoea therapy device.
The device consists of 2 parts which can be easily disconnected. It can be cleaned with dish-washing detergents. Cleaning requires disconnection of the device.
The device can be desinfected with Cidex ®.

The provided text describes the Aero-Click® device, a passive exhalation outlet for sleep apnea therapy, and its substantial equivalence to a predicate device, the Respironics Whisper Swivel II. However, this document does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or the detailed aspects of a study typically requested for performance evaluation.

The document is a "Non-Confidential Summary of Safety and Effectiveness" for a 510(k) submission, primarily focusing on demonstrating substantial equivalence to a predicate device. This type of submission relies heavily on comparing the new device's design, intended use, and performance attributes to a legally marketed equivalent, rather than presenting a standalone study with quantitative acceptance criteria and results.

Here's an analysis based on the information available in the provided text, while also explicitly stating what is not present regarding a study proving acceptance criteria:

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

The document does not explicitly state quantitative acceptance criteria or report specific performance values for the Aero-Click® that would correspond to these criteria. The "Performance Standards/Specifications" section only states "Meets design requirements after cleaning" with a "Yes," without providing what those design requirements are or how "meeting" them was quantified.

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

This information is not provided in the document. There is no mention of a "test set" in the context of a performance study.

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)

This information is not provided in the document. The concept of "ground truth" established by experts for a test set is not applicable to the type of information presented here, which focuses on device comparison rather than diagnostic accuracy or specific performance against a gold standard.

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

This information is not provided in the document.

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

An MRMC study is not mentioned and is not relevant to this type of device (a passive exhalation outlet). This device does not involve human interpretation of images or data, nor does it incorporate AI.

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

A standalone performance study of an algorithm is not mentioned and is not relevant to this mechanical device.

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

The concept of "ground truth" in the context of a clinical study is not applicable to the information provided for this device. The "ground truth" in this submission is the predicate device's established safety and effectiveness.

8. The sample size for the training set

This information is not provided in the document. There is no mention of a "training set" as this device does not involve machine learning.

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

This information is not provided in the document.

Summary of available information regarding the device comparison:

The document describes the Aero-Click® and compares its attributes to the predicate device, Respironics Whisper Swivel II, to demonstrate substantial equivalence.

Key Differences and How Equivalence is Addressed:

• Connector/disconnector capabilities: Aero-Click® has this feature, while the predicate does not. The document implies this is an additional convenience feature, not a detractor from safety or effectiveness.
• Materials: Aero-Click® uses a stainless steel spring instead of polycarbonate for connection, which is presented as a factor that "assure[s] safe connection." This difference is presented as an improvement or a non-compromising change.
• Flow at 100% relative humidity: Aero-Click® has a higher flow, which is mentioned as a difference without further explanation of its clinical significance or how it impacts equivalency at this level of detail.
• Quick connection/disconnection: The ability to quickly connect/disconnect without removing the mask is highlighted as a benefit of the Aero-Click®.

Conclusion based on the document:

The provided document is a 510(k) submission summary. The "study" that proves the device meets acceptance criteria is primarily a comparison to a predicate device to demonstrate substantial equivalence, rather than a standalone performance study with explicit quantitative acceptance criteria and results. The "acceptance criteria" are implicitly met by showing that the device performs as intended and is as safe and effective as the predicate device, despite minor design differences. The FDA's letter (K993094) confirms their review of the submission and their determination of substantial equivalence.

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