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Respiration Data Management Software is installed in a computer to perform patient management by treatment data viewing, treatment data reporting and remotely adjusting the prescribed compatible BMC CPAP and BPAP devices' settings. It is intended for healthcare professionals in healthcare facilities use only.

The Respiration Data Management Software is a softwareonly device, which allows physicians and other clinical staff to transmit, analyze and review respiration data from the compatible CPAP and BPAP devices (non-life support systems), thus to assist the users in patient management and follow-up work. This also includes remote modification of the treatment parameters of the compatible devices. It can also store patient data, upload data to the cloud platform, generate and print reports.

The provided text is a 510(k) Summary for the "Respiration Data Management Software." It highlights the device's indications for use and its substantial equivalence to a predicate device, but it does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.

The document focuses on:

• Software Verification and Validation: Stating that it was conducted according to FDA guidance.
• Cybersecurity: Stating that it was considered and evaluated according to FDA guidance.
• Comparison to Predicate Device: Detailing similarities and differences in functionality, compatible devices, and communication mediums, and asserting that differences do not raise new questions of safety or effectiveness.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because this information is not present in the provided text. The document is a regulatory submission demonstrating substantial equivalence, not a detailed performance study.

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The BPAP System is a Bi-level PAP (Bi-level Positive Airway Pressure) device, which is intended to provide noninvasive ventilation for patients with Obstructive Sleep Apnea (OSA) or Respiratory Insufficiency. The integrated humidifier is indicated for the humidification and warming of air from the flow generator device. The device is intended for adult patients weighing more than 66lbs (30 kg) by prescription. The device is intended for single patient use in the home environment and multi-patient re-use in the hospital/institutional environment.

The proposed device is a non-invasive, continuous positive airway pressure ventilator, incorporating a heated respiratory humidifier. The device is intended to treat obstructive sleep apnea or respiratory insufficiency by delivering a flow of positive airway pressure at a level prescribed by a physician to splint open the airway and prevent airway collapse.

The proposed device is available in different models designed with different therapy modes and pressure ranges. The therapy modes are available in six types, which are CPAP, Spontaneous (S), Spontaneous/Timed (S/T), Timed (T), Auto CPAP and Auto S. The pressure range for the proposed devices is available in two types, which are 4-25cm H2O and 4-30 cm H2O.

Alarm module is incorporated in the device. The device will generate audio and visual alarm for any abnormal conditions. The proposed device is provided non-sterile, and not to be sterilized by the user prior to use. The proposed device can be reused by single patient and multi-patients

The provided text describes a 510(k) premarket notification for a BPAP System, stating that "No clinical study is included in this submission." Therefore, there is no information in the provided document about acceptance criteria, device performance, sample sizes for test and training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone performance. The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical tests and feature comparison.

However, I can extract the non-clinical test conclusions and how they "prove the device meets acceptance criteria" in that context.

Here's a breakdown of what the document does provide:

Non-Clinical Test Data and Compliance

The document states that non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated compliance with various international standards, which serve as the "acceptance criteria" for these non-clinical aspects.

1. A table of acceptance criteria (standards) and the reported device performance (compliance):

Additionally, the device's specific technical performance attributes were compared to predicate devices, demonstrating substantial equivalence rather than meeting independent clinical acceptance criteria:

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

No clinical study test set or data provenance is mentioned as "No clinical study is included in this submission." The "test set" in this context refers to the physical device prototypes undergoing non-clinical bench testing.

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

Not applicable, as no clinical study or expert-driven ground truth establishment is described. The "ground truth" for non-clinical tests is based on engineering specifications and adherence to international standards.

4. Adjudication method for the test set:

Not applicable, as no clinical study is conducted.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

No. As explicitly stated: "No clinical study is included in this submission." Therefore, no MRMC study or effect size for human reader improvement with AI assistance was performed or reported here.

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

Not applicable. This is a physical medical device (BPAP system), not an AI algorithm. Its performance is inherent to the device itself, as demonstrated through non-clinical testing against standards.

7. The type of ground truth used:

For the non-clinical tests, the "ground truth" is defined by the requirements and specifications of the cited international standards (e.g., IEC 60601 series, ISO 80601 series, ISO 10993 series, ISO 18562 series) and the manufacturer's internal design specifications.

8. The sample size for the training set:

Not applicable, as "No clinical study is included in this submission." This is a hardware device cleared based on substantial equivalence, not a machine learning algorithm requiring a training set.

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

Not applicable for the same reason as above.

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Auto CPAP System is a CPAP (Continuous Positive Airway Pressure) device designed for the treatment of adult Obstructive Sleep Apnea (OSA) only, either in the hospital or at home.
Auto CPAP System is for prescription use only. It is a travel CPAP device intended for single-patient use.
LightTrip App is a mobile application for patients to remotely operate BMC Mini serial devices, and transmit, store and display usage and treatment information. It can also receive parameters and device firmware upgrade data from the cloud, and then transmit these data to the device. The LightTrip app also allows healthcare professionals to remotely configure compatible OSA therapy devices. LightTrip App is for prescription use only.

Auto CPAP System is a microprocessor controlled, blower-based system that generates continuous positive airway pressure (CPAP) to support treatment of obstructive sleep apnea. The system provides fixed or auto-adjust pressure from 4 to 20 cmH2O above the ambient atmospheric pressure to a patient's oral/nasal airway.
The Auto CPAP System is designed and developed on the basis of the predicate device Luna CPAP and Auto CPAP System (K153387). The parameters and algorithms of the two devices, such as the treatment mode (CPAP and AutoCPAP), the pressure range (4 to 20 cm H2O), and the Respiratory Event Detection, are consistent. Compared with the predicate device, the subject device does not include a humidifier and an LCD screen. The parameters of subject device are displayed and set via the LightTrip App.

The provided document is a 510(k) summary for the BMC Medical Co., Ltd. Auto CPAP System. Unlike typical AI/ML device submissions, this document focuses on the substantial equivalence of a CPAP device to existing predicate devices, primarily through bench testing for various physical and electrical performance metrics. It does not describe a study involving an AI algorithm that diagnoses or assists in the diagnosis of a medical condition in the way that would typically involve acceptance criteria related to diagnostic performance.

Therefore, many of the requested elements for describing AI/ML device performance, such as sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this specific submission.

The "Performance Data" section primarily details bench testing and standards compliance, which are the acceptance criteria for a device like a CPAP system.

Here's an interpretation of the provided document in the context of your request, noting where information is not applicable:

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

For a CPAP device, the acceptance criteria are generally defined by performance standards that ensure the device delivers therapy accurately and safely. The document states that "bench testing were conducted according to ISO 80601-2-70:2015" and lists specific tests. The implication is that the device met the requirements of these standards.

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The BMC-NM, BMC-NM2 Nasal Mask and BMC-FM full face mask channel airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or Bi-level system.

The BMC-NM, BMC-NM2 Nasal Mask and BMC-FM full face mask are:

• To be used by adult patients (>661bs />30kg) for whom positive airway pressure has been prescribed.
• Intended for single-patient reuse in home environment and multi-patient re-use in the hospital/institutional environment.

BMC-NM and BMC-NM2 Nasal Masks are interfaces such that airflow from a positive pressure source is directed to the patient's nose. The masks are held in place with adjustable headgear that straps the mask to the face. BMC-NM and BMC-NM2 Nasal Masks have hard plastic body and softer silicone seal that touches the face and include a pad that rests on the forehead. The seal may inflate once the machine is turned on so the straps do not need to be too tight.

The BMC-NM and BMC-NM2 are safe when used under the conditions and purposes intended as indicated in the labeling provided with the product.

The BMC-NM and BMC-NM2 are prescription devices supplied non-sterile.

BMC-FM full face mask is interfaces such that airflow from a positive pressure source is directed to the patient's mouth and nose. The masks are held in place with adjustable headgear that straps the mask to the face. BMC-FM Full face Mask has plastic body and softer silicone seal that touches the face and include an adjustable pad that rests on the forehead. The seal may inflate once the machine is turned on so the straps do not need to be too tight.

The BMC-FM is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product.

The BMC-FM is prescription device supplied non-sterile.

Here's an analysis of the acceptance criteria and supporting studies for the BMC Medical Co., Ltd. Nasal Mask (BMC-NM, BMC-NM2) and Full Face Mask (BMC-FM) based on the provided 510(k) summary (K133009):

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantitative "acceptance limit" vs. "result" format as might be seen for a new technology with novel performance targets. Instead, the acceptance criteria are implicitly defined by demonstrating "substantial equivalence" to predicate devices through a series of performance tests. The reported device performance is presented in comparison tables against the predicate devices for various specifications.

Here's a table summarizing the implicit acceptance criteria (similarity to predicate) and the reported device performance from the provided document:

Table of Acceptance Criteria (Implicit) and Reported Device Performance

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

The document describes "performance bench testing" and "nonclinical tests." These tests are typically conducted on physical samples of the device in a laboratory setting, not with patient data.

• Sample Size: The exact number of samples used for these bench tests (e.g., number of masks tested for resistance, dead space, leak) is not specified in the provided summary.
• Data Provenance: The tests are explicitly described as "bench tests" and "nonclinical tests." This implies the data is generated in a laboratory setting. No information on country of origin for the data or whether it's retrospective or prospective is relevant or provided, as these are not human subject studies.

3. Number of Experts and Their Qualifications for Ground Truth

• Number of Experts: Not applicable. This submission relies on objective engineering and performance data derived from bench testing, not expert interpretation of clinical data.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where human interpretation or ground truth establishment is subjective and requires consensus. This is a technical performance study based on objective measurements against standards and predicate device specifications. Therefore, an adjudication method is not applicable and not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done. This type of study involves human readers interpreting cases (e.g., medical images) with and without AI assistance. The device in question is a physical medical mask, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

• No standalone performance study of an algorithm was done. This device is a physical medical mask, not an algorithm or software.

7. Type of Ground Truth Used

The "ground truth" for demonstrating substantial equivalence is based on:

• Objective Technical Specifications: Measurements of physical properties and performance characteristics (e.g., intentional leak, dead space, resistance, operating/storage conditions, materials) derived from international standards (like ISO 17510-2 for the full face mask) and comparison against the technical specifications of the legally marketed predicate devices.
• Bench Testing Results: The results of the laboratory tests (pressure-flow characteristics, CO2 re-breathing, flow impedance, damp heat, disinfection validation) serve as the evidence to support the claim of similarity to predicates.

8. Sample Size for the Training Set

• Training Set: Not applicable. This is not a machine learning or AI device that requires training data. The devices are physical medical accessories.

9. How Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

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