Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

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. The "test set" here refers to the device itself being subjected to bench tests, not a dataset for an AI algorithm. Therefore, there is no sample size of patients or images, nor data provenance in the context of an AI 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)

Not applicable. The ground truth for CPAP device performance is established by recognized engineering and medical device standards (e.g., ISO 80601-2-70). It does not involve expert interpretation of clinical data in the same way an AI diagnostic device would.

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

Not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations of clinical data, which is not part of this device's performance evaluation.

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 Auto CPAP System, a therapy device, not an AI diagnostic tool intended to assist human readers.

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

This application is for an Auto CPAP System, which is a therapeutic device that delivers continuous positive airway pressure. While it contains algorithms for automatic pressure adjustment and respiratory event detection, these algorithms are integral to the device's function and are not presented as a standalone diagnostic tool. The performance of these internal algorithms is validated through the general device bench testing (e.g., "Dynamic pressure testing," "Algorithm" section, which states it utilizes the "same algorithm as the primary predicate device").

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

The "ground truth" for the device's performance is adherence to established international and national medical device standards (e.g., ISO 80601-2-70, IEC 60601 series) for safety and essential performance, as well as demonstrating equivalence to the predicate device's established performance characteristics (e.g., pressure delivery accuracy, sound levels).

8. The sample size for the training set

Not applicable. This device is not an AI/ML diagnostic system that reports on training data. The algorithms within the CPAP device (e.g., for auto-adjusting pressure, respiratory event detection) are stated to be the "same algorithm as the primary predicate device," implying they were previously developed and validated, not newly trained for this submission.

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

Not applicable, as there is no mention of a new training set for AI/ML development in this submission. The algorithms are inherited from a predicate device.

Ask a specific question about this device