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Simon™ is a multichannel recording system designed to record and store physiological signals acquired from adult and pediatric patients during sleep. The portable design of the device facilitates its use in any clinical setting or in the home environment.

Physiological signals are acquired via transducers attached to the patient and directly connected to the recorder. Additionally, a modem may be used to connect to the Host PC during acquisition, to interface with a Respironics CPAP or BiPAP device for titration or to download the data post acquisition. Once downloaded, the recorded data can be scored for physiological events using the associated Simon™ HOST Software.

The clinician can review, validate, edit and print scored data. The software allows the user to configure / customize all reports to best meet individual needs.

Simon™ is a multichannel recording system, which may be used for adult or pediatric patients in a variety of settings. The system is comprised of the Simon Recorder, Host Software, auxiliary CPAP / BiPAP devices (as applicable), computer equipment (CPU and monitor) and various accessories (modem, etc.). The recorder is small, lightweight and may be worn while the patient sleeps. The recorder collects physiologic signals from sensors attached to the patient. This eight-channel system records Nasal Flow or Pressure, Body Position, Snoring Sounds, Oximetry, Respiration via Chest Effort, Respiration via Abdominal Effort, Actigraphy, Pressure and Flow from auxiliary Respironics CPAP / BiPAP devices.

The Simon™ Host Software is a Windows-based application, which facilitates remote titration of CPAP / BiPAP settings via modem, as well as download of recorded data onto a personal computer. Once downloaded, the Host software scores the recorded data for physiological events per user-defined parameters.

The software allows user validation/editing of all events, and provides reporting capabilities that are fully user-configurable.

This 510(k) summary describes the Simon™ Multichannel Recording System (Model 5500), manufactured by Respironics, Inc. The device is a portable system designed to record and store physiological signals from adult and pediatric patients during sleep, for use in clinical or home settings. It collects data from eight channels, including Nasal Flow or Pressure, Body Position, Snoring Sounds, Oximetry, Respiration via Chest Effort, Respiration via Abdominal Effort, Actigraphy, and Pressure/Flow from auxiliary CPAP/BiPAP devices. The associated Host Software facilitates data download, scoring of physiological events, and allows clinicians to review, validate, edit, and print scored data.

Acceptance Criteria and Study for Simon™ Multichannel Recording System

Based on the provided 510(k) summary, the acceptance criteria and study that prove the device meets these criteria are detailed below. It's important to note that this submission did not include clinical testing. The evaluation was based on non-clinical testing to demonstrate functionality, safety, and effectiveness, and substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: "Bench testing utilized simulated data." No specific number of simulated cases or data points is mentioned.
• Data Provenance: The data used for testing was entirely simulated data. There is no mention of data provenance in terms of country of origin or whether it was retrospective or prospective, as it was not real patient data.

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

• Number of Experts: Not applicable. The testing utilized simulated data and no clinical experts were involved in establishing ground truth for a test set based on real patient data.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. As no clinical testing was performed and simulated data was used, there was no adjudication method involving human interpretation of real patient data.

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

• MRMC Study: No. The document explicitly states, "No Clinical testing was performed." Therefore, no MRMC study, with or without AI assistance, was conducted.

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

• Standalone Performance: The testing described ("Operational and Performance testing," "Hardware Test Plan," "Software Test Plan") would largely constitute standalone performance assessment of the device's components and system functionality against its defined requirements using simulated data. However, it is not presented as a formal "standalone performance study" in terms of diagnostic accuracy with real patient data compared to a clinical ground truth. The device includes software that scores physiological events, but the validation of this scoring against clinical outcomes or expert consensus on real data was not part of this 510(k) submission. The intended use states the clinician reviews, validates, and edits scored data, indicating a human-in-the-loop workflow.

7. The Type of Ground Truth Used:

• Ground Truth Type: For the non-clinical testing performed, the "ground truth" was based on defined hardware and software requirements and expected outputs from simulated data. There was no clinical ground truth (e.g., expert consensus, pathology, or outcomes data) established from real patient cases.

8. The Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. This document describes a medical device, not an AI/ML algorithm that undergoes a training phase using a specific training dataset in the typical sense. The "software engine" is mentioned as being the same as the predicate device, suggesting a previously developed and established system, rather than a newly trained model requiring a distinct training set for this specific submission.

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

• Ground Truth for Training Set: Not applicable. As it is not an AI/ML algorithm requiring a training set with established ground truth, this information is not relevant to this submission. The software's event scoring parameters are described as "user-defined parameters," implying configurability rather than a fixed algorithm established through a training process with ground truth data.

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The Nasal Interface is intended for use with nasal CPAP and bilevel devices for the treatment of adult patients with Obstructive Sleep Apnea. The Nasal Interface may be used in the home, hospital, nursing home, sub-acute care center or other location where nasal CPAP or bilevel therapy is applied. The Nasal Interface will facilitate nasal CPAP or bilevel therapy via a silicone seal which makes contact solely with the patient's nose on the external aspects of the nares. This device is further supported by padded protuberances, which rest on the patient's cheeks below the zygomatic processes. The device is held in place with headgear, which extends back from the nasal interface around the back and top of the patient's head.

Nasal Interface

The provided document is a 510(k) clearance letter from the FDA for a medical device called "Nasal Interface Model 7910." This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device.

It is critical to understand that this type of FDA clearance letter (510(k)) generally does not include detailed device performance acceptance criteria or the study data that "proves" the device meets these criteria.

Instead, a 510(k) submission demonstrates that a new device is as safe and effective as a legally marketed predicate device. This typically involves comparing technological characteristics, intended use, and performance data if necessary, to show substantial equivalence. The actual performance data and acceptance criteria would be contained within the 510(k) submission itself, which is not publicly released in this format.

Therefore, based solely on the provided text:

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

• Not available in the provided document. The document describes the device's intended use and design, but does not list specific quantitative acceptance criteria or performance metrics (e.g., leakage rate, pressure stability, comfort scores, etc.) for the Nasal Interface.

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

• Not available in the provided document. The letter does not mention any specific test sets, sample sizes, or data provenance (e.g., country of origin, retrospective/prospective).

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

• Not available in the provided document. No information regarding ground truth establishment or expert involvement in a test set is provided.

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

• Not available in the provided document. No information about test set adjudication is 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:

• Not applicable. The device is a Nasal Interface (likely for CPAP/Bilevel therapy), not an AI-powered diagnostic imaging or interpretation tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device.

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

• Not applicable. As above, this device is a physical medical device, not an algorithm. Standalone performance for an algorithm is not relevant.

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

• Not available in the provided document. Information on ground truth for any potential studies is not mentioned.

8. The sample size for the training set:

• Not available in the provided document. Information on any training set is not mentioned.

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

• Not available in the provided document. Information on how ground truth for any training set was established is not mentioned.

In summary: The provided FDA 510(k) clearance letter confirms the regulatory status of the device but does not contain the detailed technical performance data, study designs, or acceptance criteria that would typically be found within the full 510(k) submission itself. Without access to the actual submission, these details cannot be extracted.

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The Model 7410 series CPAP system is a device that is intended to provide continuous positive airway pressure to adults who experience obstructive sleep apnea (OSA). The device will automatically adjust and maintain airway pressure based on the continuing needs of the patient. The device may be used in either the home or hospital environment.

Model 7410 Series CPAP System

I am sorry, but the provided text is a 510(k) clearance letter from the FDA to Healthdyne Technologies for their Model 7410 Voyager CPAP System. It states that the device is substantially equivalent to a legally marketed predicate device.

This document does not contain information about the acceptance criteria and the study details (like sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details) that would prove the device meets specific performance criteria. It primarily focuses on regulatory clearance based on substantial equivalence.

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The Twister Oxygen Concentrator is intended to provide oxygen to persons requiring low flow oxygen therapy. This device is not intended to be life supporting nor life sustaining.

The Twister produces concentrated oxygen from room air for delivery to a patient requiring low flow oxygen therapy. The oxygen from the air is concentrated using a molecular sieve and a pressure swing adsorption process.

"This document, a 510(k) premarket notification letter from the FDA, approves the marketing of the ""Twister Oxygen Concentrator."" However, it does not contain any information regarding specific acceptance criteria, device performance metrics, or study details. The letter primarily addresses the regulatory classification and substantial equivalence of the device to previously marketed devices.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, or study design based on the provided text."

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The Alice® 4 System is a polysomnographic system that is intended to record, display, and print EEG and other physiological information to clinicians/physicians. The device will be used in hospitals, institutions, sleep centers or clinics, or other test environments where adult or infant patients require the documentation of various sleep or other physiological disorders.

polysomnographic system that is intended to record, display, and print EEG and other physiological information

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for the Alice® 4 System, an electroencephalograph (EEG). This document primarily serves as an administrative notice of substantial equivalence. It does not include the information required to answer your questions about acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This means the FDA found the device to be as safe and effective as a device already on the market, but the clearance letter itself doesn't contain the specific technical study details that would typically be found in the 510(k) submission itself or related publications.

Therefore, I cannot provide the requested table and study details based on the given text.

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The intended use for the liquid oxygen system is to provide supplementury oxygen at a prescribed flow rate to patients with lung disorders such as COPD (Chronic Obstructive Pulmonary Disease) or other conditions as prescribed by a physician.

Portable Liquid Oxygen System BYJ

The provided document is a 510(k) clearance letter from the FDA for the "Protégé Liquid Oxygen System". This document
DOES NOT CONTAIN
information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. This type of document merely grants market clearance based on substantial equivalence to a predicate device, it does not detail the specifics of performance testing.

Therefore, I cannot fulfill your request using the provided text.

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Ask a specific question about this device

Ask a specific question about this device