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The Luna® G3 BPAP System is a Bi-level PAP (Bi-level Positive Airway Pressure) device designed for the treatment of adult Obstructive Sleep Apnea (OSA). The integrated humidification and warming of air from the flow generator device. These devices are intended for single-patient use by prescription in the home or hospital/ institutional environment on adult patients. It is to be used on patients > 66 lbs / 30 kg for whom CPAP therapy has been prescribed.

The Luna® G3 BPAP system is a microprocessor controlled, blower-based system that generates positive airway pressure to support treatment of obstructive sleep apnea. Its hardware design is identical to the previously cleared Luna® G3 BPAP 25A (K201620). The subject device includes two models, with different pressure ranges. They both have four therapy modes, which are CPAP, Spontaneous (S), Timed (T) and Spontaneous/Timed (S/T).

This 510(k) summary (K212263) describes a device modification to an existing Bi-level PAP system (Luna G3 BPAP System). The core of the submission revolves around demonstrating substantive equivalence to a predicate device (Luna G3 BPAP 25A, K201620) and referencing a device (Juno VPAP ST-A, K153061) for new functionalities.

It is crucial to understand that this document describes a device intended for treatment of Obstructive Sleep Apnea (OSA), providing positive airway pressure. It is not an AI/ML powered diagnostic device that would typically involve a multi-reader multi-case (MRMC) study or complex ground truth establishment from expert consensus or pathology, as might be seen for an imaging AI.

Therefore, many of the typical "acceptance criteria" and "study types" for AI/ML-powered devices, such as those related to standalone performance (e.g., sensitivity, specificity, AUC), MRMC studies, and expert ground truth establishment for a diagnostic output, are not applicable to this type of medical device submission.

Instead, the acceptance criteria and supporting studies are focused on engineering and performance characteristics of the medical device itself, ensuring it functions safely and effectively as intended and is equivalent to previously cleared devices.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a single aggregated table of "acceptance criteria" versus "reported performance" for a diagnostic output as would be seen for AI/ML diagnostic tools. Instead, it details specific performance tests and standards met, comparing the subject device's characteristics to its predicate and reference devices. The "acceptance criteria" are implied by adherence to recognized standards and demonstrated equivalence to the cleared predicate.

Here's an interpretation of relevant performance characteristics that serve as de facto acceptance criteria and their reported performance:

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The Luna® G3 BPAP 25A is a Bi-level Positive Airway Pressure) device designed for the treatment of adult Obstructive Sleep Apnea (OSA). The integrated humidification and warming of air from the flow generator device. These devices are intended for single-patient use by prescription in the home or hospital/ institutional environment on adult patients. If is to be used on patients >66lbs/30kg for whom CPAP therapy has been prescribed. The system can deliver bi-level therapy or auto bi-level therapy.

The Luna® G3 BPAP 25A is a microprocessor controlled, blower-based system that generates bi-level positive airway pressure (IPAP/EPAP) to support treatment of obstructive sleep apnea. The system provides fixed or auto-adjust pressure from 4 to 25 cmH2O above the ambient atmospheric pressure to a patient's oral/nasal airway.

This document, primarily a 510(k) Pre-market Notification to the FDA, describes a medical device called the Luna® G3 BPAP 25A, a Bi-level Positive Airway Pressure (BPAP) device for treating Obstructive Sleep Apnea (OSA). The document outlines its intended use, technological characteristics, and compares it to predicate devices to prove substantial equivalence.

Acceptance Criteria and Device Performance:

The acceptance criteria for the Luna® G3 BPAP 25A are not explicitly stated as quantitative performance metrics (e.g., accuracy, sensitivity, specificity) but are derived from comparing its technological characteristics and performance against legally marketed predicate and reference devices, as well as adherence to recognized regulatory standards. The "reported device performance" refers to the demonstrated compliance with these standards and the equivalence of its characteristics to established devices.

Here's a table summarizing the implicit acceptance criteria (based on predicate device characteristics and regulatory standards) and the reported performance of the subject device:

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The Aer X oxygen concentrator device is used on a prescriptive basis by patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Aer X may be used in home, institution, vehicle and various mobile environments.

The Aer X oxygen concentrator utilies a molecular sieve and a differential pressure swing adsorption methodology to separate the gases in ambient air. The device takes the room air and concentrates the oxygen portion to produce a pulse of oxygen between 87-94% in purity. When the patient inhales, the device senses the pressure change and is triggered to release the oxygen pulse. In between breaths, the device regenerates an oxygen pulse and waits for the next inhalation breath before dispensing it

The provided document is a 510(k) Pre-Market Notification for a medical device, the Aer X Portable Oxygen Concentrator. It does not contain the specific details of a clinical study demonstrating the device's performance against detailed acceptance criteria that would typically be found in a clinical trial report.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device (VBOX Trooper) through bench testing and technical comparison, which is a different regulatory pathway than requiring a full clinical effectiveness study with defined acceptance criteria for effectiveness.

Therefore, many of the requested elements for a study proving the device meets acceptance criteria are not present in this type of submission. However, I can extract the information available regarding the functional and performance aspects of the device and how conformity was demonstrated.

Here's an attempt to answer your questions based on the provided text, indicating where information is not available:

1. Table of acceptance criteria and the reported device performance

The document doesn't explicitly state "acceptance criteria" for a clinical performance study. Instead, it lists technical specifications and demonstrates that the device meets these specifications which are consistent with the predicate and industry standards.

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

This document describes bench testing, not a human-subject clinical trial.

• Sample Size: Not specified for bench testing, typically involves a small number of production or early-stage devices to verify specifications.
• Data Provenance: Not applicable for bench testing. Bench tests are typically conducted in a laboratory environment, not involving patient data.
• Retrospective/Prospective: Not applicable for bench 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. Bench testing relies on objective measurements against established technical standards, not expert interpretation of results on patient data.

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

Not applicable, as this was bench testing, not a clinical study requiring adjudication of expert opinions.

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 an oxygen concentrator, not an AI diagnostic tool that would involve human readers.

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

Not applicable. This device does not involve an "algorithm only" component in the sense of AI or diagnostic interpretation. Its performance is intrinsic to its mechanical and electrical function.

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

The "ground truth" for the performance specifications (e.g., oxygen concentration, flow rate) is defined by technical standards and industry benchmarks for portable oxygen concentrators. Bench testing physically measures the device's output and compares it to these predetermined specifications (e.g., a gas analyzer for oxygen purity, flow meters for flow rate).

8. The sample size for the training set

Not applicable. There is no "training set" as this is not a machine learning or AI-driven device.

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

Not applicable. There is no "training set."

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iCodeConnect, in conjunction with a Luna CPAP or Auto-CPAP device, is intended for use in treating obstructive sleep apnea (OSA) on adult patients (>30 kg).

iCodeConnect is intended to augment the standard follow-up care of patients diagnosed with obstructive sleep apnea by displaying usage and therapeutic information that has been transmitted from the patient's Luna CPAP or Auto-CPAP therapy device located in the home to the clinician or healthcare professional. iCodeConnect also provides remote settings capabilities.

iCodeConnect is a web based patient management system used to store and manage sleep compliance and efficacy data uploaded from a Luna CPAP or Auto-CPAP device.
iCodeConnect allows device patient data to be uploaded using a variety of methods, including manual entry, SD Card, and wireless transmission. Use of wireless transmission (i.e. WiFi) can provide wireless compliance monitoring and remote settings update functions.

For wireless transmission, iCodeConnect consists of the wireless data transmission module Wi-Fi kit and web based iCodeConnect patient management software. The Wi-Fi Kit is intended to be used in conjunction with the Luna CPAP System (E-20C-H-O), Auto-CPAP System (E-20A-H-O / E-20AJ-H-O), which were cleared in K141770.

1. iCodeConnect Software is an analysis and management platform for the patient's therapy data. This platform, adopting the form of a website, not only realizes the uniform management of the patient's data and the information of the provider, the doctor and the patient, but also allows for the Wi-Fi Kit or other wireless communication module to transmit data and remotely updating therapy device settings, which reduces the inconvenience brought by the traditional mailing of SD card and makes data collection more timely.

Wi-Fi Kit is an accessory module that attaches via USB cable to the data output port of a Luna® CPAP or Auto-CPAP devices. The wireless module Wi-Fi Kit uploads the device's therapy data to the iCodeConnect software with the help of Wi-Fi off-the-shelf technology. After connecting to the internet. the wireless kit shall automatically collect the user information, statistical information and detailed information in the therapy device for uploading.

The provided text describes the iCodeConnect device and compares it to a predicate device, EasyCare Online, to establish substantial equivalence. However, it explicitly states that clinical testing was NOT required to demonstrate the safety and effectiveness of iCodeConnect. Therefore, the document does not contain information about acceptance criteria for device performance based on a clinical study, nor does it detail a study proving the device meets such criteria.

The document focuses on non-clinical testing for functional verification and device performance, and software verification to demonstrate substantial equivalence to the predicate device.

Here's a breakdown of the information available based on your request, with an emphasis on what is not present:

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

• No specific acceptance criteria for a clinical study are provided. The table in the "Substantial Equivalence" section (pages 8-9) compares features and functions of the proposed device (iCodeConnect) with the predicate device (EasyCare Online). This table demonstrates equivalence in various aspects, but these are generally functional and technical specifications, not clinical performance metrics with acceptance criteria.
• Reported device performance (clinical): Not applicable, as clinical testing was not performed/required.
• Reported device performance (non-clinical/functional): The document states that "Non-clinical testing of the iCodeConnect has been carried out to cover functional verification and device performance. The proposed iCodeConnect has been tested to appropriate standards and other applicable requirements." (page 6). It further concludes that "Hardware testing carried out for iCodeConnect indicates it meets design and performance functional requirements. Software verification demonstrates that device features and the system configuration functions are substantially equivalent to the predicate device." (page 11). No specific quantitative performance metrics from these tests are reported in the summary provided.

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

• Not applicable as clinical testing was not conducted. Sample sizes for non-clinical functional testing are not specified.

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 as clinical testing was not conducted, and thus there was no "test set" requiring expert-established ground truth in a clinical context.

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

• Not applicable as clinical testing was not conducted.

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. The iCodeConnect device is a patient management system for CPAP/Auto-CPAP data and remote settings, not an AI-assisted diagnostic tool that would typically involve an MRMC study.

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

• This device is a patient management system and wireless data transmission module. Its "standalone" performance would likely refer to its functional accuracy in data transfer, storage, display, and remote setting capabilities. The document indicates these aspects were verified through non-clinical testing and software verification, concluding they meet design and performance requirements and are substantially equivalent to the predicate (pages 6, 11). However, specific metrics for this "standalone" performance are not provided.

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

• Given the absence of clinical testing, there is no mention of ground truth established through expert consensus, pathology, or outcomes data. For functional testing, the "ground truth" would likely be defined by the expected behavior and output based on design specifications and engineering standards.

8. The sample size for the training set

• Not applicable. The iCodeConnect is described as a web-based patient management system and a wireless data transmission module. There is no indication it uses machine learning or AI that would require a "training set" in the context of typical clinical algorithm development.

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

• Not applicable for the reasons mentioned in point 8.

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The Luna® CPAP and Auto CPAP System are intended to deliver pressure for the treatment of Obstructive Sleep Apnea. The optional integrated hunidifier is indicated for the humidification and warming of air from the flow generator. These devices are intended for single patient use by prescription in the home or hospital/institutional environment on adult patients.

The materials of water chamber of Luna® CPAF and Auto CPAP device were changed. The suppliers of Polycarbonate and silicone were changed. The basic functional and performance characteristics of the Luna® CPAP and Auto CPAF devices are unchanged from the predicate devices (K141770).

This document (K153387) is a 510(k) premarket notification for a medical device (Luna® CPAP and Auto CPAP System) to the U.S. Food and Drug Administration (FDA). It is not a study report that describes the acceptance criteria and performance of an AI/ML device in the way requested. Instead, it is a submission seeking clearance to market a modified version of an existing device (K141770) based on demonstrating "substantial equivalence" to the predicate device.

Therefore, the specific information requested about acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies for an AI/ML device is not present in this document.

The document primarily focuses on:

• Device Modification: The only modification is a change in the materials used for the water chamber of the Luna® CPAP and Auto CPAP system. The suppliers of Polycarbonate and silicone were changed.
• Demonstration of Substantial Equivalence: The submission asserts that the modified device is substantially equivalent to the predicate device (K141770) because it has the "same intended use, same operating principle, same technology, and same manufacturing process."
• Non-Clinical Testing for Material Change: To address the material change, biological and mechanical tests were conducted on the new materials and the water chamber.

Here's how the information provided in the document relates to your request, highlighting what can be extracted and what cannot:

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

• Not Applicable in the AI/ML context. This document is about a material change in a CPAP device, not an AI/ML diagnostic or prognostic tool.
• What is shown: The document refers to "appropriate biological tests conducted and passed for these components, in accordance with FDA guidance #G95-1" and "Series mechanical tests were also conducted to demonstrate the mechanical performance of the water chamber, including: drop test, leak test, and humidity performance test." The specific acceptance criteria for these tests (e.g., maximum allowable leakage, specific drop test pass/fail conditions) are not detailed in this summary, nor are the quantitative results of these tests, beyond a statement that they "demonstrated substantial equivalence."

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

• Not Applicable in the AI/ML context. This is not an AI/ML study.
• What is shown: The document does not specify sample sizes (e.g., number of water chambers tested for biocompatibility or mechanical performance). It also does not mention data provenance in the context of clinical studies, as this is a non-clinical material change submission.

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 in the AI/ML context. There is no "ground truth" establishment in the sense of expert review of images or clinical data for this type of submission. The "ground truth" here is the biological and mechanical safety/performance of the new materials, assessed through standardized lab tests.

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

• Not Applicable in the AI/ML context. No adjudication method is described as there's no diagnostic or interpretative task involved.

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 is not an AI/ML device, and no MRMC study was performed or is relevant to this submission.

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

• Not Applicable. This is not an AI/ML algorithm.

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

• What is shown: The "ground truth" for this submission are the results of standardized biocompatibility tests (ISO 10993 series, including Genotoxicity, Cytotoxicity, Implantation, Sensitization, and Irritation tests, plus Intracutaneous Reactivity, Ames test, In vitro Mammalian Cell Gene Mutation Test, Skin Sensitization Mammalian Test, In vitro Chromosome Aberration In Vitro Cytotoxicity Test and Muscle Implantation Test) and mechanical performance tests (drop test, leak test, and humidity performance test). The acceptance is that the new materials and components pass these established safety and performance standards.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device where a training set is relevant.

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

• Not Applicable. See point 8.

In summary, this document is a regulatory submission for a minor device modification (material change) of a CPAP system and does not contain the information typically found in an AI/ML device study report.

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The 3B Luna CPAP and Auto CPAP Systems are intended to deliver positive pressure for the treatment of Obstructive Sleep Apnea. The optional integrated humidifier is indicated for the humidification and warming of air from the flow generator. These devices are intended for single patient use by prescription in the home or hospital / institutional environment on adult patients.

The Luna CPAP and Auto CPAP System is a microprocessor-controlled, blower-based system that generates positive airway pressure from 4 to 20 cm H20. The device is intended for use with a patient interface (mask). The device has been modified to include a color LCD, menu driven user interface, and a redesigned enclosure. The electrical circuit was redesigned to incorporate the color LCD. The basic functionality and performance characteristics of the Luna CPAP and Auto CPAP are unchanged from the predicate device RESmart CPAP and Auto CPAP (K132967).

This document is a 510(k) premarket notification for the 3B™ Luna CPAP and Auto-CPAP System, which includes an integrated heated humidifier. It compares the proposed device to a predicate device, the RESmart® CPAP and Auto-CPAP Systems (K132967). The main purpose of the notification is to demonstrate substantial equivalence to the predicate device, not necessarily to independently prove the device meets specific performance criteria beyond those of the predicate.

Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in the traditional sense of a new technology proving its efficacy against established benchmarks. Instead, it aims to demonstrate that the proposed device is substantially equivalent to a predicate device. Therefore, the "acceptance criteria" can be inferred as matching or performing similarly to the predicate device based on various technical specifications and non-clinical testing.

Device Performance Evidence Summary: The study essentially asserts that the proposed device performs equivalently to the predicate device. The performance data presented is a side-by-side comparison of specifications for both devices, highlighting that the proposed device shares the same intended use, operating principle, technology, materials, and manufacturing process as the predicate, or has comparable or slightly improved characteristics.

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

This document describes a premarket notification (510(k)) that relies heavily on bench testing and comparison to a predicate device, not clinical trials with human subjects.

• Test Set: No independent human subject test set is described. The "test set" consists of bench performance tests comparing the proposed device to the predicate.
• Sample Size: Not applicable in the context of human data. The sample size for non-clinical testing (e.g., number of devices tested for pressure accuracy) is not specified, but it's implied that sufficient units were tested to demonstrate performance.
• Data Provenance: The document does not provide information about the country of origin for any human data (as there isn't any mentioned). The testing itself is non-clinical, likely conducted by the manufacturer (BMC Medical CO., LTD, CHINA). The study is retrospective in the sense that it refers to the performance and testing of the predicate device (K132967) for many aspects, and current bench testing for the proposed device.

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

This type of information is not applicable to this 510(k) submission.

• Ground Truth: The "ground truth" for this submission is established through engineering and performance specifications and compliance with international standards (e.g., ISO, IEC), rather than expert consensus on medical outcomes or pathology.
• Experts: The document does not describe the involvement of medical experts to establish a "ground truth" for a test set. Engineering and regulatory specialists would be involved in designing and evaluating the bench tests.

4. Adjudication Method for the Test Set

This is not applicable. There is no "test set" in the sense of a set of cases requiring adjudication by multiple experts. The evaluation is based on objective measurements from bench testing against predefined engineering specifications.

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 CPAP/Auto-CPAP system for delivering positive pressure, not an AI-assisted diagnostic or interpretative tool that would involve human "readers" or AI assistance in a clinical setting.

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

This question is not applicable as the device is not an algorithm that functions in a standalone diagnostic capacity. It is a medical device for therapeutic delivery of positive pressure.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" used for this submission is based on:

• Engineering Specifications and Performance Standards: Defined by international standards (ISO 17510-1:2007, IEC 60601 series) and the specifications of the predicate device.
• Performance Bench Testing: Objective measurements conducted in a laboratory setting to verify that the device meets its design specifications (e.g., pressure accuracy, sound level, humidification, electrical safety).
• Biocompatibility Testing: Conducted in the predicate device against ISO 10993 standards, and carried over due to identical materials.

8. The Sample Size for the Training Set

This is not applicable. The device is not based on machine learning or AI that requires a "training set" of data.

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

This is not applicable as there is no training set for this device.

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The 3B and BMC RESmart® BPAP system is a Bi-level PAP (Bi-level Positive Airway Pressure) device designed for the treatment of adult Obstructive Sleep Apnea (OSA). The optional integrated humidifier is indicated for the humidification and warming of air from the flow generator device. These devices are intended for single-patient use by prescription in the home or hospital/intuitional environment on adult patients. It is to be used on patients (>66lbs/30kg) for whom positive airway pressure therapy has been prescribed. The system can deliver bi-level therapy or auto bi-level therapy.

The RESmart BPAP is a microprocessor controlled blower based bilevel positive pressure system that delivers two different positive pressure levels (IPAP/EPAP) from 4 to 25 cmH₂O. The dual pressure levels provide a more natural means of delivering pressure support therapy to the patient resulting in improved patient comfort. Two operation modes are being introduced, including the Auto Bi-Level mode and Spontaneous Bi-Level mode. Bi-Level therapy with automatically adjusting IPAP and EPAP levels is delivered in the Auto Bi-Level mode at the prescribed pressure range. The Spontaneous Bi-Level mode delivers fixed prescribed inspiratory and expiratory pressure. The BPAP device is intended for use with a patient circuit that is used to connect the device to the patient interface (mask).

This document is a 510(k) summary for the RESmart® BPAP 25A device, which is a Bi-level Positive Airway Pressure (BPAP) device. The purpose of this submission is to demonstrate substantial equivalence to predicate devices, not to establish new acceptance criteria through clinical trials. Therefore, much of the requested information about acceptance criteria and study details for proving a device meets them is not present in this type of document.

However, based on the provided text, here's what can be extracted and inferred:

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

The document states that "Extensive testing was conducted in accordance with ISO 17510-1:2007, Sleep Apnea Breathing Therapy-Part I: Sleep Apnea Breathing Therapy Equipment." and mentions several performance aspects. It also states, "Design verification tests were performed on the RESmart BPAP to ensure product requirements and evaluate risk analysis. All tests were verified to meet the required acceptance criteria." However, the specific quantitative acceptance criteria and their corresponding reported performance values are not explicitly listed in a table format in this summary.

Based on the text, we can infer some general performance aspects that met their acceptance criteria, likely established by the ISO standard and internal design verification:

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

The document does not specify a "test set" in the context of human subjects or clinical data for performance evaluation. The testing described appears to be primarily bench testing and engineering verification. Therefore, information on sample size and data provenance (country of origin, retrospective/prospective) for a clinical test set is not provided.

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

Since the document describes bench testing and engineering verification rather than a clinical study with a "ground truth" derived from expert diagnosis, this information is not applicable and therefore not provided.

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

As no clinical test set requiring expert adjudication is described, this information is not applicable and therefore not provided.

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:

This document describes a medical device (BPAP system) for the treatment of Obstructive Sleep Apnea, not an AI-assisted diagnostic or interpretive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and not mentioned in this submission.

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

The device itself is a standalone medical device that delivers therapy. The "algorithm" mentioned refers to the software controlling the bi-level functionality. The performance testing outlined (max flow rate, static pressure, dynamic pressure, sound pressure, air quality, electrical safety, EMC) inherently evaluates the device's standalone performance, including its embedded algorithms, against engineering and safety standards. There is no mention of a separate "standalone algorithm only" performance study in the context of a human-in-the-loop comparison.

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

For the engineering and performance testing described, the "ground truth" would be established by the specified engineering standards (e.g., ISO 17510-1:2007, IEC 60601-1) and the performance characteristics of the predicate device. For example, the ground truth for electrical safety is defined by the IEC 60601-1 standard. For functional equivalence, the performance of the predicate device (Respironics BiPAP Auto) serves as the reference.

8. The sample size for the training set:

The term "training set" is typically used in the context of machine learning. While the device contains a microprocessor and software with an algorithm for bi-level functionality, this document does not describe the development or training of a machine learning model. Therefore, a "training set" in that sense is not applicable and not mentioned.

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

As there is no mention of a machine learning training set, this information is not applicable. The "ground truth" for the device's design and performance is based on engineering principles, safety standards, and the performance characteristics of the predicate device.

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The iVolve® Mask channels airflow non-invasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or Bi-level system. The iVolve "Mask is: to be used by adult patients (>66lb/30 kg) for whom positive airway pressure has been prescribed. intended for single-patient re-use in the home, hospital, and sub-acute environment.

The iVolve® N2 and Nasal Masks are respiratory nasal mask interfaces that directs airflow from a positive pressure device to the patient's nose. The iVolve® Full-Face Mask is a mask interface that directs air flow from a positive pressure device to the patient's nose or mouth. The iVolve® Mask Series is held in place with adjustable headgear that straps the mask to the face. The iVolve® is safe when used under the conditions and purposes intended as indicated the labeling provided with the product. The iVolve® is a prescription device supplied non-sterile.

The iVolve® Nasal Mask Series (iVolve® Nasal Mask, iVolve® Full Face Mask, iVolve® N2) is a respiratory mask intended to channel airflow non-invasively to patients from a positive airway pressure device. The device was seeking substantial equivalence to existing predicate devices (Mirage Activa LT Nasal Mask (Resmed, K030798), Mirage Quattro Full Face Mask (Resmed, K113127), and Willow Nasal Mask (BMC, K112271)).

Here's an analysis of the acceptance criteria and the study performed:

1. Table of Acceptance Criteria and Reported Device Performance:

The primary acceptance criteria for the iVolve® Mask Series were based on functional performance metrics relative to predicate devices, with the objective for the device to meet intended product specifications and fall within a ±15% range of the predicate devices for key characteristics.

Additional Performance Characteristics (Comparison to predicates):

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

• Sample Size: For each performance test (Flow/Pressure Curve, Pressure Drop/Resistance, Dead Space), 3 samples of each mask type (iVolve Nasal Mask, iVolve N2 Nasal Mask, iVolve Full-Face Mask) were tested. For Dead Space, all sizes (S, M, L) were tested. For Flow/Pressure Curve and Pressure Drop/Resistance, a medium size (M*) was tested.
• Data Provenance: The document does not specify the country of origin. The data is from non-clinical performance bench testing, implying it's laboratory-generated data rather than patient-derived (retrospective or prospective).

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

• Not applicable. This study relies on bench testing for physical and mechanical performance, not expert-derived ground truth from clinical images or diagnoses.

4. Adjudication Method for the Test Set:

• Not applicable. Adjudication methods are typically associated with human expert review in clinical studies. This study involved direct measurement against established physical/mechanical parameters and comparison to predicate device specifications.

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

• No, an MRMC comparative effectiveness study was not done. This submission focuses on non-clinical performance bench testing for substantial equivalence of a medical device (respiratory mask), not on AI-assisted diagnostic or interpretative tasks that would involve human readers.

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

• Not applicable. This device is a physical medical device (a respiratory mask), not an algorithm or AI system. Its performance evaluation is based on its physical characteristics and functionality.

7. The Type of Ground Truth Used:

• The ground truth in this submission is based on intended product specifications and the performance range of legally marketed predicate devices, specifically:
  • Biocompatibility Standards: ISO 10993 for materials (cytotoxicity, animal skin irritation, implantation, genotoxicity, Kligman maximization).
  • Performance Standards: Internal product specifications for Flow/Pressure, Resistance/Pressure Drop, and Dead Space, and the established ranges of predicate devices (ResMed Mirage Activa LT Nasal Mask (K030798), ResMed Mirage Quattro Full Face Mask (K113127), and BMC Willow Nasal Mask (K112271)).
  • Durability: 200 cycles of home cleaning validated the mask's material integrity.

8. The Sample Size for the Training Set:

• Not applicable. This is a physical medical device, not an AI or machine learning model. There is no "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.

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The 3B and BMC RESmart CPAP and Auto-CPAP Systems are intended to deliver positive pressure for the treatment of Obstructive Sleep Apnea. The optional integrated humidifier is indicated for the humidification and warming of air from the flow generator device. These devices are intended for single patient use by prescription in the home or hospital/institutional environment on adult patients.

The RESmart CPAP and Auto CPAP System is a microprocessor-controlled, blower-based system that generates positive airway pressure from 4 to 20 cm H2O. The device is intended for use with a patient circuit that is used to connect the device to the patient interface (mask). The RESmart CPAP and Auto CPAP device has been modified to include a smaller and quieter blower. The air circuit, embedded software, and controller board were upgraded to provide better performance. The basic functional and performance characteristic of the RESmart CPAP and Auto CPAP are unchanged from the predicate device RESmart CPAP and Auto CPAP (K110629).

This document is a 510(k) summary for the RESmart CPAP and Auto CPAP nP1.5 system. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving performance against specific acceptance criteria.

Therefore, much of the requested information regarding acceptance criteria, study details, and expert involvement is not available within the provided text. The document states that "Extensive non-clinical testing was conducted in according Non-Clinical Testing with ISO 17510-1:2007, Sleep Apnea Breathing Therapy-Part I: Sleep Apnea Breathing Therapy Equipment." and "Performance Bench Testing demonstrated substantial equivalence with the predicate device." However, it does not provide the specific acceptance criteria or the results of these tests in a detailed manner.

Here's a breakdown of what can be extracted and what is not available:

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

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

• Not available. The document refers to "non-clinical testing" and "performance bench testing" but does not specify sample sizes or data provenance.
• Data Provenance: The manufacturing company is BMC MEDICAL CO., LTD in Beijing, CHINA. The testing location is not specified, but typically, this type of non-clinical bench testing would be conducted in a lab environment.

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/Not available. This device is a CPAP machine, not an AI diagnostic tool requiring expert ground truth for image interpretation or similar tasks. The "testing" mentioned is non-clinical bench testing against a standard and comparison to a predicate device, not a study involving human experts to establish ground truth on patient data.

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

• Not applicable/Not available. Adjudication methods are typically used in clinical studies where expert disagreement on ground truth needs to be resolved. This document describes non-clinical bench testing for device equivalence.

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 device, not an AI-assisted diagnostic device. Therefore, MRMC studies are not relevant to its evaluation.

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

• Yes, implicitly. The "Performance Bench Testing" and "non-clinical testing" would represent standalone testing of the device's physical and functional performance (e.g., pressure output, noise levels, flow characteristics) without human interaction. This is the nature of testing for a standalone medical device like a CPAP.

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

• Not applicable in the conventional sense. For a CPAP device, the "ground truth" for performance would likely be established according to the requirements and specifications of the ISO 17510-1:2007 standard. This standard dictates the acceptable ranges for parameters like pressure accuracy, flow rates, humidification, and noise levels. The performance of the predicate device would also serve as a reference point for substantial equivalence.

8. The sample size for the training set

• Not applicable/Not available. This is a hardware medical device with integrated software, not a machine learning algorithm that undergoes "training" on a dataset in the typical sense.

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

• Not applicable/Not available. As above, there is no "training set" in the context of this device.

Summary of what is known from the document:

• Device: RESmart CPAP and Auto CPAP nP1.5 system.
• Intended Use: Deliver positive pressure for the treatment of Obstructive Sleep Apnea.
• Key Change from Predicate: Smaller and quieter blower, upgraded air circuit, embedded software, and controller board.
• Basis for Approval: Substantial equivalence to predicate device RESmart CPAP and Auto CPAP (K110629).
• Testing Conducted: Extensive non-clinical testing according to ISO 17510-1:2007, and Performance Bench Testing.
• Conclusion: The device is substantially equivalent to the predicate device due to the same intended use, operating principle, technology, materials, and manufacturing process, supported by design validation, verification, and performance bench testing.

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The 3B and BMC RESmart CPAP and Auto CPAP Systems are intended to deliver positive pressure for the treatment of Obstructive Sleep Apnea. The optional integrated humidifier is indicated for the humidification and warming of air from the flow generator device. These devices are intended for single patient use by prescription in the home or hospital/institutional environment on adult patients.

The RESmart CPAP and Auto CPAP System is a microprocessorcontrolled, blower-based system that generates positive airway pressure from 4 to 20 cm H2O. The device is intended for use with a patient circuit that is used to connect the device to the patient interface (mask). The RESmart CPAP and Auto CPAP device has been modified to include porting the iCode software to a web-based application. The basic functional and performance characteristic of the RESmart CPAP and Auto CPAP is unchanged from the predicate device RESmart CPAP and Auto CPAP (K110629).

The provided text is a 510(k) Summary for the RESmart CPAP/Auto CPAP device (K131707). It describes modifications made to the iCode software feature of an existing device (K110629), porting it to a web-based application and developing a smartphone application for it.

The key takeaway is that this submission K131707 is NOT about the performance of the CPAP device itself in treating sleep apnea, but rather about the software modifications to the iCode feature, which is used for compliance reporting. The document explicitly states: "The basic functional and performance characteristic of the RESmart CPAP and Auto CPAP is unchanged from the predicate device RESmart CPAP and Auto CPAP (K110629)." and "There are no changes in logic, Rather the extent of the device algorithm, or function. modification is a simple change from a desktop environment to a web server based environment."

Therefore, the acceptance criteria and study information requested in the prompt, particularly those pertaining to medical device performance (e.g., effect size of human readers improving with AI, standalone algorithm performance, ground truth for medical outcomes), are not applicable to this specific 510(k) submission.

Here's the breakdown based on the provided text, focusing on the software modifications:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. The "test set" here refers to software testing, not clinical data for device performance. The evaluation was focused on the functionality and integrity of the software changes.
• Data Provenance: Not applicable, as no clinical data for device performance was generated or used for this specific submission's modifications. The modifications relate to the iCode feature, which reports compliance data from the device, not clinical data about the device's efficacy.

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

• Number of Experts: Not applicable. Ground truth in a clinical sense (e.g., expert consensus on medical images) is not relevant for this software modification. Software verification and validation are typically performed by software engineers and quality assurance personnel.
• Qualifications of Experts: The document refers to "internal procedures" for code review and verification, implying software development and QA professionals were involved.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable in the context of clinical expert adjudication. Software testing methodologies (e.g., unit testing, integration testing, system testing, user acceptance testing) would have been used to verify the new software features.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improve with AI vs. Without AI Assistance

• MRMC Study: No.
• Effect Size of Human Readers with AI: Not applicable. This device is a CPAP machine, not an AI-assisted diagnostic tool that humans read. The software modifications are for compliance reporting, not clinical interpretation or assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: While the "iCode Report Generator" could be considered an "algorithm" (processing the iCode string to generate reports), its standalone performance in a medical evaluative sense (e.g., diagnostic accuracy) is not applicable. Its function is to accurately process an input string and generate a report, verified through software testing. The smartphone app uses OCR, which is an algorithm, but its performance is in accurately recognizing the characters, not making medical diagnoses.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the software modifications, the "ground truth" would be the expected output and behavior based on the software requirements and design specifications. For the OCR component of the smartphone app, the ground truth would be the actual characters displayed on the RESmart LCD.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. There is no mention of a training set in the context of machine learning for medical outcomes. For the OCR component, the vendor would have used training data to develop the OCR model, but its specifics are not provided in this regulatory summary.

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

• Ground Truth for Training Set: Not applicable in a medical device performance context. If referring to the OCR component, the ground truth would have been established by human verification of scanned characters. This information is not provided in the 510(k) summary.

In summary: This 510(k) pertains to software modifications for a compliance reporting feature of an already cleared CPAP device. The evaluation criteria and studies are focused on software verification and validation, ensuring the new web-based and smartphone applications correctly handle the iCode data without altering the device's fundamental medical function or performance. Therefore, many of the typical questions asked about AI/medical device clinical studies are not applicable here.

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