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The Deployable Oxygen Generator System - Small (DOGS-S) is intended for the administration of supplemental oxygen. This device is not intended for life support nor does it provide any patient monitoring capabilities. The system will be operated by trained personnel.

The DOGS-S system is a portable battery powered oxygen concentrator that will be operationally used for ground-based medical assemblages, such as the Expeditionary Medical Support (EMEDS), and En-Route Patient Staging System (ERPSS) in deployed scenarios, including wartime operations, deterrence, humanitarian and contingency operations.

The provided text describes a 510(k) premarket notification for a medical device called the "Deployable Oxygen Generator System - Small (DOGS-S)". This document focuses on demonstrating substantial equivalence to a predicate device (OMNI 2 (SAROS)), not on proving the device meets individual acceptance criteria through a clinical study in the way an AI/ML device would be evaluated for diagnostic accuracy.

Therefore, many of the requested criteria (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable to this type of regulatory submission and are not present in the document.

The document primarily focuses on bench testing to confirm the device's technical specifications and compliance with relevant engineering and safety standards.

Here's an analysis based on the information available in the provided text:

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

The document doesn't present "acceptance criteria" in the typical format of a clinical performance study with specific metrics and thresholds (e.g., sensitivity, specificity). Instead, it provides a comparison table of technological characteristics between the DOGS-S device and its predicate, the OMNI 2 (SAROS), to demonstrate substantial equivalence. The "acceptance" here is that the DOGS-S performs comparably or meets the standards for an oxygen concentrator.

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The intended use of the Device is to generate and deliver USP 93% oxygen for supplemental oxygen use only or filling cylinders. The device must not be used for or with any life-supporting applications.

The Device is intended to be used only by trained personnel in hospitals, health care facilities or remote locations where bottled oxygen is not readily available.

The instruction manual of the device recommends an alternate source of supplemental oxygen in the event of a power outage, alarm condition, or mechanical failure.

Air contains 21 % oxygen, 78% nitrogen, 0.9% argon, and 0.1% other gases. AirSep PSA Oxygen units separate this small percentage of oxygen from the compressed air through a unique Pressure Swing Adsorption (PSA) process. The compressed air flows through a filter assembly before the air enters the adsorber vessels. A particulate/foam filter removes condensed water, oil, dirt, scale, etc. from the feed air, and then, a separate coalescing filter (if present) removes additional oil and water vapor.

The oxygen generator uses in its adsorber vessels an inert ceramic material called molecular sieve to separate compressed air into oxygen and other gases. The unique properties of molecular sieve allow it to attract, or adsorb, nitrogen physically from air under pressure. This allows oxygen to exit the adsorbers as a product gas.

While one adsorber produces oxygen, the other depressurizes to exhaust the waste gases it adsorbed (collected) during the oxygen production cycle. The entire oxygen generating process is completely regenerative, which makes it both reliable and virtually maintenancefree. The molecular sieve does not normally require replacement.

The medical devices in this submission refer to the following oxygen concentrators manufactured by AirSep Corporation:

| Model | Flow (scfh) | Oxygen Delivery
Pressure (psig) |
|---------|-------------|------------------------------------|
| Centrox | 32 | 50 |
| Ultrox | 17 | 20 |
| Reliant | 17 | 50 |

All of these devices are designed to deliver the oxygen with USP 93 % purity. Centrox and Reliant units are also available for cylinder filling option. Ultrox is used only to fill cylinders.

Centrox, Ultrox and Reliant units are comprised of an air compressor that uses ambient air to produce higher pressure feed air.

These models have the same indications for use. Together these products are referred to as Device.

The device is intended to be USP 93% oxygen generator. As such, to assure the purity, an Oxygen Analyzer is integrated in each device and an alarm is activated if the purity is outside of the safe range.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

Acceptance Criteria and Device Performance

Study Details

• Sample size used for the test set and the data provenance: Not explicitly stated. The document mentions "various phases, internal testing, verification and validation as well as external testing and validation" and that "every device to deliver USP 93% oxygen was verified." This suggests a comprehensive internal testing process on a representative sample of devices, but specific numbers and provenance (e.g., country of origin, retrospective/prospective) are not detailed. An "Independent laboratory testing" was also performed.

• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is an oxygen concentrator, and its performance (purity, flow rate) is measured objectively using instruments, not subjective expert assessment.

• Adjudication method for the test set: Not applicable. Performance metrics are objective and measurable by instruments.

• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done. This type of study is relevant for diagnostic imaging devices where human interpretation is involved.

• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, the performance testing described is a standalone evaluation of the device's ability to produce oxygen of a certain purity at specified flow rates and pressures. There is no human involved in the core function of oxygen generation.

• The type of ground truth used: Instrumental measurements and chemical analysis.

  • Oxygen purity (USP 93%) was measured directly.
  • Flow rate and pressure were measured directly.
  • VOC's and particulates were measured through independent laboratory testing.

• The sample size for the training set: Not applicable. This device is a mechanical system, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The design and engineering process involved iterative testing and refinement, but not a formally defined "training set" of data.

• How the ground truth for the training set was established: Not applicable, as there isn't a "training set" in the AI/ML context. The design was likely developed and refined based on engineering principles, predicate device performance, and iterative physical testing during the design process to meet the specified performance targets (e.g., USP 93% oxygen).

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OxiScan II Oximetry Data Management Software (OxiScan II) is a central server based software system that uses a personal computer based application written in Microsoft Dot Net protocol to capture oximetry data from an oximeter, and then transmit this data, in a secure encrypted file, via internet, to the central server. At the central server the data is used to render a standard report that is then transmitted via fax and/or email to the prescribing physician. The intended use of the report is to provide a physician with information to help determine the best pulmonary treatment.

The OxiScan II Oximetry Data Management Software is intended to collect, report and archive oximetry trend data to provide information to a medical professional, as a supplemental tool to assist in the timely identification of pulmonary needs.

The OxiScan II Oximetry Data Management Software is intended to (1) transfer oximetry data from a pulse oximeter to a central server data base in order to maintain unique records per patient and test of this pulse oximetry data, and (2) to generate and archive standard reports drawn from this data. A list of approved oximeters appears in the Capture software.

The OxiScan II Oximetry Data Management Software is not a diagnosis tool. It is a decision management support tool that allows medical personnel to securely and accurately upload and view data related to pulse oximetry and to provide output reports as feedback which may be used by a Heathcare professional to form a patient history.

OxiScan II Oximetry Data Management Software is an accessory for use with compatible pulse oximeters. OxiScan II Oximetry Data Management Software collects and stores patient information containing raw oximetery data captured by a pulse oximeter. This information is transferred by a personal computer to an internet Web server where a report which summarizes and graphically presents the data is prepared. This report is delivered to a Healthcare Professional who then uses it along with other information to determine a course of pulmonary treatment. The report may be retrieved, reviewed, and retransmitted via the OxiScan II Oximetry Data Management Software web site.

The OxiScan II Oximetry Data Management Software is a software system intended to collect, report, and archive oximetry trend data from compatible pulse oximeters to provide information to a medical professional. It acts as a supplemental tool for timely identification of pulmonary needs and to form a patient history, but it is not a diagnostic tool.

The acceptance criteria for the OxiScan II Oximetry Data Management Software are primarily focused on its functional characteristics, safety, and effectiveness in meeting its stated intended use, and its substantial equivalence to a predicate device. The study demonstrating that the device meets these criteria is described as "Functional and Safety Testing."

Here's the breakdown of the information requested, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a numerical sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that "Representative samples of OxiScan II Oximetry Data Management Software were successfully performance tested."

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The testing mentioned appears to be software performance testing rather than clinical validation with expert review.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

The document does not describe any adjudication method for a test set. The validation described focuses on functional, safety, and effectiveness testing of the software itself and its equivalence to a predicate device.

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. The device is data management software, not an AI-assisted diagnostic tool. Its purpose is to collect, report, and archive oximetry data for review by healthcare professionals, not to provide interpretations or assist human readers in making diagnoses in the way an AI algorithm might.

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

The device, OxiScan II, is described as "Oximetry Data Management Software." Its standalone performance would relate to its ability to accurately capture, transmit, process, and report oximetry data as per its specifications. The document states that "Representative samples of OxiScan II Oximetry Data Management Software were successfully performance tested to verify compliance to appropriate functional characteristics." This implies standalone testing of the software's data management capabilities. However, it explicitly states it is "not a diagnosis tool" and relies on a "Healthcare Professional" for interpretation, meaning its intended use always involves human-in-the-loop for clinical decision-making.

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

The document does not detail the type of "ground truth" in the sense of clinical diagnoses or outcomes. Given the nature of the device as data management software, the "ground truth" for its performance testing would likely involve:

• Expected data values/formats: Verifying that captured oximetry data matches the source.
• Report accuracy: Confirming that generated reports correctly reflect the stored data.
• System functionality: Ensuring features like secure transmission, archiving, and retrieval work as designed.
• Compliance with specifications: Testing against pre-defined functional and technical requirements.

8. The Sample Size for the Training Set

The document does not mention a training set, as the device is not described as utilizing machine learning or artificial intelligence that would typically require a training set. The "Functional and Safety Testing" refers to performance verification, not an AI model's training.

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

As no training set is mentioned or applicable to this type of software, this information is not provided.

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The portable AirSep LifeStyle Oxygen Concentrator is intended to provide supplemental, high-purity oxygen in a home, institutional, or travel environment.

Not Found

I am sorry, but the provided text does not contain the information requested regarding acceptance criteria and a study that proves a device meets those criteria. The text is a letter from the FDA to Airsep Corp. regarding the 510(k) premarket notification for the LifeStyle Oxygen Concentrator. It states that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory compliance requirements. It does not include details about device performance, study methodologies, sample sizes, expert qualifications, or ground truth establishment.

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The HealthLife Oxygen Concentrator delivers supplemental oxygen in a nominal 9 liters-per-minute flow of 38% oxygen for inhalation with mask delivery to the patient.

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I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving a device meets them.

The document is a 510(k) clearance letter from the FDA for a device called "HealthLife Oxygen Concentrator." It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements the manufacturer must follow.

Here's a breakdown of why I cannot extract the requested information based on the text:

• No acceptance criteria or device performance data: The letter does not describe any specific performance metrics (e.g., accuracy, sensitivity, specificity, flow rate stability over time, oxygen concentration percentage variance) that the device was tested against, nor does it present the results of any such tests.
• No mention of a study: While the FDA grants clearance based on data showing substantial equivalence, the letter itself does not describe any specific study design, sample sizes, data provenance, expert involvement, or ground truth establishment. These details would typically be found in the 510(k) submission itself, not the clearance letter.
• No AI component: The device is an "Oxygen Concentrator," a hardware medical device. There is no indication of any artificial intelligence (AI) component, which means questions about MRMC studies with AI assistance or standalone algorithm performance are not applicable.

In summary, the provided document is a regulatory approval letter and does not contain the technical study details you are asking for.

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The Artisan™ is intended to be used by Physicians or trained technicians for acquisition of EEG and polygrasomnography signals and transmission of these signals to a PC during recording of neurophysiology examinations commonly used in clinics. It does not involve any patient monitoring or diagnosis.

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I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a device named "Artisan™ Acquisition System for EEG and Polysomnography." It confirms the device's substantial equivalence to a predicate device and outlines regulatory compliance requirements.

However, it does not include:

• A table of acceptance criteria or reported device performance.
• Details about sample sizes for test or training sets, data provenance, expert qualifications, or adjudication methods for ground truth.
• Information about MRMC studies, standalone algorithm performance, or the type of ground truth used.

Therefore, I cannot fulfill your request based on the provided text.

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