Search Results

The Longfian Oxygen Concentrator, Model JAY-5AW is intended to be used by patients with respiratory disorders who require supplemental oxygen. A high concentration of supplemental oxygen is supplied and a nasal cannula is used to channel oxygen from the concentrator to the patient. The Longfian Oxygen Concentrator, Model JAY-5AW, can be used at home or healthcare environments. The Longfian Oxygen Concentrator, Model JAY-5AW, does not nor is it intended to sustain or support life. The device is intended for use in adults.

The Longfian Oxygen Concentrator, Model JAY-5AW adopts pressure swing adsorption principle, which can separate oxygen, nitrogen and other gas from the air, at constant temperature. As soon as power is connected, the air is taken in and compressed by oilless air compressor through filtering, then the compressed air goes through the cooler and it is cooled. After that, the air is taken into absorption tower by control valve and the oxygen can be separated in the absorption tower. At the same time, the high purity oxygen is collected into the oxygen tank, and it goes through the flow meter and humidifier, finally the oxygen that meets medical standards can be supplied. Oxygen is generated by pure physical method.

The device is capable of providing oxygen flow up to 5 LPM. The concentration of supplied oxygen is from 90%-96%. The weight of Jay-5AW is around 16kg (~351bs). There is no influence on indoor oxygen percent during the generator operating.

The biocompatibility contact classification of the device is as permanent contact externally communicating with dry and humified gas pathway.

The life-time/use life of the oxygen concentrator is set at 5 years or 20.000 hours after the product is sold, whichever comes first.

The reusable components:

• Intake air filter (two pieces, part number:GL-01)
• Secondary filter (one piece, part number:GL-02)
• nasal oxygen tube and
• humidifier.

JAY-5AW medical oxygen concentrator contains the following items:

• One (1) JAY-5AW Oxygen Concentrator Unit
• One (1) AC Power Supply
• One (1) Nasal Oxygen Tube
• One (1) Firesafe Cannula Valve
• One (1) Humidifier
• One (1) Operation Manual

The provided document is a 510(k) premarket notification for an Oxygen Concentrator, Model JAY-5AW. It details the device's technical specifications, indications for use, and a comparison to a predicate device. However, it does not contain information about a study proving the device meets acceptance criteria related to AI or a "human-in-the-loop" performance study of the type usually associated with the questions asked.

The document discusses "acceptance criteria" and "device performance" in the context of non-clinical bench testing for safety and performance (e.g., biocompatibility, electrical safety, EMC, software verification, and oxygen concentration/flow performance), not for an AI-driven diagnostic or assistive device that would involve human readers, ground truth establishment by experts, or MRMC studies.

Therefore, I cannot populate the table or answer the specific questions related to AI-driven device performance, sample sizes for test sets, expert adjudication, MRMC studies, standalone algorithm performance, or ground truth establishment in that context.

The document focuses on demonstrating substantial equivalence to a predicate device through engineering and safety testing of a physical medical device (an oxygen concentrator), not a software-based AI system.

Here's what can be extracted regarding the "acceptance criteria" and "device performance" as presented in this document for the Oxygen Concentrator:

Acceptance Criteria and Reported Device Performance (Based on the provided document for an Oxygen Concentrator):

Responses to Specific Questions (based on the provided document and its scope):

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

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

   • The document describes bench testing of a physical device (oxygen concentrator prototypes/production samples), not a study involving patient data or AI algorithm validation with a "test set" in the common sense of AI/diagnostic imaging.
   • Therefore, no information on sample sizes of patient data or data provenance (country, retrospective/prospective) is provided or relevant to the type of testing detailed in this document. The testing describes electrical, functional, and biocompatibility tests performed on the physical device itself.

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. This document is for an oxygen concentrator, not an AI diagnostic device. There is no concept of "ground truth" derived from expert interpretation of medical images or data from a patient population, nor a need for radiologists or similar experts in this context. The "truth" for this device's performance is determined by meeting engineering and safety standards.

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

   • Not applicable. There is no "adjudication method" involved as there are no expert interpretations to be reconciled.

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. No MRMC study was performed as this is not an AI-assisted diagnostic device.

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

   • Not applicable. This is a physical medical device (oxygen concentrator), not an algorithm. The software mentioned (software verification and validation) pertains to the embedded control software of the device itself, not a standalone diagnostic algorithm.

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

   • The "ground truth" for this device's performance is adherence to established international and national standards (e.g., IEC 60601 series, ISO 80601 series, ISO 18562 series, ISO 10993 series) and its stated design specifications (e.g., oxygen concentration, flow rate). These are technical performance metrics, not clinical diagnostic "ground truth."

8. The sample size for the training set:

   • Not applicable. There is no "training set" as this is not a machine learning/AI model.

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

   • Not applicable. No training set exists for this type of device submission.

Ask a specific question about this device

The Longfian Oxygen Concentrator, Model Jay-5 is intended to be used by patients with respiratory disorders who require supplemental oxygen. A high concentration of supplemental oxygen is supplied and a nasal cannula is used to channel oxygen from the concentrator to the patient. The Longfian Oxygen Concentrator, Model Jay-5 can be used in a home, institution, vehicle, and various mobile environments. The Longfian Oxygen Concentrator, Model Jay-5 does not nor is it intended to sustain or support life.

JAY-5 medical oxygen concentrator adopts pressure swing adsorption principle, which can separate oxygen, nitrogen and other gas from the air, at constant temperature. As soon as power is connected, the air is taken in and compressed by oilless air compressor through filtering, then the compressed air goes through the cooler and it is cooled. After that, the air is taken into absorption tower by control valve and the oxygen can be separated in the absorption tower. At the same time, the high purity oxygen is collected into the oxygen tank, and it goes through the flow meter and humidifier, finally the oxygen that meets medical standards can be supplied. Oxygen is generated by pure physical method.

The concentrator can supply 1-2 patients simultaneously, with steady oxygen flowing out and reliable, adjustable flow. The device is capable of providing oxygen flow up to 5 LPM. The concentration of supplied oxygen is from 90%-96%. The key parts of the generator adopt anti-tiring and anti-aging design, and the planned life of the whole generator reaches up to 20,000 hours. The weight of Jay-5 is around 25kg (~55lbs). There is no influence on indoor oxygen percent during the generator operating.

JAY-5 medical oxygen concentrator contains the following items:

• · One (1) Jay-5 Oxygen Concentrator Unit
• · One (1) AC Power Supply
• · One (1) Nasal Oxygen Tube
• One (1) Humidifier
• One (1) Operation Manual

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets those criteria:

Device: OXY.LIFE Oxygen Concentrator, Models Jay-5 (referred to as Longfian Oxygen Concentrator, Model Jay-5 in the deeper sections)
Predicate Device: Yuyue OxygenMax™ 7F-5 Oxygen Concentrator (K083559)

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" as a separate list with corresponding performance data in the same way one might see for a diagnostic AI device's sensitivity/specificity. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device through meeting relevant performance standards and having comparable technical characteristics. The "reported device performance" is embedded within the comparison table and the list of standards the device was tested against.

Summary of Comparison to Predicate (JAY-5 vs. Yuyue OxygenMax™ 7F-5)

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

• Sample Size for Test Set: The document does not specify a "test set" in the context of patient data or clinical trials. This device is an oxygen concentrator, and its evaluation relies on bench testing against engineering standards rather than clinical performance data from human subjects. Therefore, there's no sample size of patients or data provenance in the way one would describe for an AI/diagnostic device.
• Data Provenance: Not applicable as it's primarily bench testing.

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

• Number of Experts: Not applicable. The "ground truth" for this device is based on established engineering standards (IEC, ISO, ASTM, EPA, CFR) and the performance characteristics of a legally marketed predicate device.
• Qualifications of Experts: The ground truth is embedded in the standards themselves, developed by expert committees, and the regulatory review process (FDA reviewers like Tejashri Purohit-Sheth, M.D. and Erin I. Keith, M.S. who are Clinical Deputy Director and Director, respectively, in relevant divisions).

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The "tests" are objective measurements against established technical specifications and performance limits defined in the referenced standards.

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

• MRMC Study: No. This is not an AI/diagnostic device that relies on human interpretation for its primary function. It's a medical device for oxygen delivery, evaluated through engineering and performance testing.
• Effect Size of AI assistance: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study

• Standalone Study: Not applicable. This device is a hardware product. Its performance is inherent in its operation, not an algorithm being evaluated separately.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for evaluating this oxygen concentrator is primarily based on:
  • Established engineering and performance standards: Such as ISO 8359, ASTM F 1464-93, IEC 60601 series, ISO 10993-1, and EPA/CFR requirements for air quality (VOC, PM2.5, Ozone).
  • Performance data of a legally marketed predicate device (Yuyue OxygenMax™ 7F-5): The subject device must demonstrate performance comparable to, or better than, the predicate for the same intended use.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is not an AI/machine learning model that requires a "training set" of data. Its development would involve engineering design, prototyping, and testing phases, but not a data-driven training set in the AI sense.

9. How the 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 medical device.

Ask a specific question about this device