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Invacare® Platinum® Mobile Oxygen Concentrator: The Invacare® Platinum® Mobile Oxygen Concentrator is intended to provide supplemental oxygen to patients with respiratory disorders. The device can be used in a home, institution, vehicle, or other environments outside the home. The device is not intended to be life supporting or life sustaining.

Invacare Mobile Medical Application Accessory PICCOLO O2: The Invacare Mobile Medical Application Accessory PICCOLO O2 is intended to allow patients via their Android™ or iOS™ mobile phone or tablet to display device settings, control flow setting, and to collect device performance and usage information for maintenance/servicing purposes.

The purpose of this this Premarket Notification [510(k)] submission is to obtain commercial clearance for Invacare Mobile Medical Application Accessory Piccolo O2 which is compatible with the previously cleared Invacare® Platinum® Mobile Oxygen Concentrator, cleared under K160630 on September 27, 2016. Invacare Mobile Medical Application Accessory PICCOLO O2 is a Mobile App is intended to provide useful device performance information to the previously cleared Invacare® Platinum® Mobile Oxygen Concentrator end users such as dosage level setting and fault codes as well as allow the user to control the selected dosage level.

• . Invacare® Platinum® Mobile Oxygen Concentrator with Connectivity
• . Invacare Mobile Medical Application Accessory for Piccolo O2 use on iOS and Android devices
• POC1 USB Bluetooth Dongle .

The provided text describes a 510(k) submission for the Invacare Platinum Mobile Oxygen Concentrator with Connectivity and its associated mobile application. However, the document does not contain the information required to answer your specific questions about acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI/ML-driven medical device.

This document primarily focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for medical devices that are similar to devices already legally marketed. It highlights design verification testing, risk management, software verification, electrical safety, wireless coexistence, cybersecurity, and biocompatibility testing. It explicitly states that clinical testing was not required for this submission.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, test set sample size, expert involvement, or AI/MRMC studies because the provided text does not contain this information. The device in question is a portable oxygen concentrator with a mobile app for displaying settings and controlling flow, not an AI/ML diagnostic or therapeutic device which would typically require the kind of performance studies you are asking about.

I can only confirm that based on the provided text:

• Clinical testing was not required for this submission. This implies there was no study proving the device meets acceptance criteria related to clinical performance on a test set of patient data, as would be expected for an AI/ML device.
• The "study" that proves the device meets acceptance criteria in this context appears to be the design verification testing, software verification testing, electrical safety/EMC testing, wireless coexistence, and cybersecurity documentation. These tests demonstrate the device functions as intended and safely, but not in the way an AI/ML algorithm's diagnostic or therapeutic performance would be evaluated.
• The ground truth for these engineering performance tests would be established by direct measurements against known standards and specifications, not by expert consensus or pathology on patient data.

If you have a document describing an AI/ML device, please provide that, and I would be able to answer your questions more comprehensively.

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The Invacare® Platinum™ Mobile Oxygen Concentrator is intended to provide supplemental oxygen to patients with respiratory disorders. The device can be used in a home, institution, vehicle, or other environments outside the home.

The Invacare® Platinum™ Mobile Oxygen Concentrator is a portable oxygen concentrator that provides oxygen in pulsed demand flow dosages at settings of P1 through P4. The oxygen concentration level of the output gas ranges from 87% to 95.6%. The device is used with a nasal cannula to direct oxygen from the device to the patient. The Invacare® Platinum™ Mobile Oxygen Concentrator can be used in a home, institution, vehicle, or other environments outside the home. The device is not intended to be life supporting or life sustaining.

This document is a 510(k) premarket notification for the "Invacare® Platinum™ Mobile Oxygen Concentrator." It asserts that the device is substantially equivalent to a legally marketed predicate device. The information provided heavily focuses on non-clinical performance and comparison to a predicate, rather than an AI/ML-driven device with detailed acceptance criteria for diagnostic performance outcomes.

Given the nature of the document, the questions about acceptance criteria and study details for an AI/ML device are not directly applicable. This is a traditional medical device submission, not specifically one for software as a medical device (SaMD) or an AI/ML diagnostic tool. Therefore, many of the requested fields about AI/ML specific criteria (like "multi-reader multi-case comparative effectiveness study," "standalone algorithm performance," "sample size for training set," "number of experts," etc.) cannot be answered from this document.

However, I can extract the closest analogous information from the provided text regarding performance testing and acceptance.

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

The document does not explicitly present a table of "acceptance criteria" against which specific numerical performance metrics are reported in the way demanded by an AI/ML diagnostic device (e.g., sensitivity, specificity, AUC). Instead, it lists various performance tests that were conducted to ensure the device's functionality, safety, and equivalence to the predicate. The implication is that successful completion of these tests, demonstrating that the device operates within expected parameters and similar to the predicate, serves as the acceptance basis for this type of device.

• Pulse Volume/Pulse Time/Trigger Sensitivity / Oxygen Purity Test
• External Battery Charger Charge Time
• Oxygen Sensor Accuracy
• Oxygen Purity at AC Supply Mains Extremes
• Oxygen Purity at DC Power Extremes
• Oxygen Purity after Storage Thermal Cycling
• Oxygen Purity at Low and High Temperature
• Hot – Swapping Batteries
• Battery Discharge Times
• Battery Charge Times
• Oxygen Purity at Low and High Altitude
• Software Functional Test
• Oxygen Alarms Test
• Operational Alarms Test
• Full Assembly Sound Performance Test
• POC1 Battery Charge Time When POC1 Unit Not Running | - Device consistently provides oxygen within specified ranges (87% to 95.6% purity).
• Alarms function correctly (e.g., low oxygen purity, oxygen sensor failure, no breath detect indication).
• Battery performance (charge/discharge) meets specifications.
• Device maintains performance under various environmental conditions (temperature, altitude, power extremes).
• Product weight is as specified.
• Software functions as intended.
• Pulse volume, pulse time, and trigger sensitivity are within specifications. | - Output gas ranges from 87% to 95.6%.
• Alarms for low oxygen purity and oxygen sensor failure are present. (The predicate device had "No breath detect" with specific actions, while the subject device lists "No breath detect" as an alarm, but without detailed actions, noting "No 'Auto-Pulse' feature").
• Overall Conclusion: "The non-clinical laboratory data support the substantial equivalence of Invacare® Platinum™ Mobile Oxygen Concentrator and demonstrates that the subject device performs as intended in the specified use conditions." Specific numerical results for each test are not provided in this summary. |
  | Electrical Safety and EMC | - AAMI ES60601-1
• IEC 60601-1
• ISO 80601-2-67
• ISO 80601-2-69
• IEC 60601-1-2
• IEC 60601-1-6
• IEC 62366
• IEC 60601-1-8
• IEC 60601-1-11 | - Compliance with all listed consensus standards for electrical safety, electromagnetic compatibility, usability, and alarm systems. | - Overall Conclusion: "The non-clinical laboratory data support the substantial equivalence of Invacare® Platinum™ Mobile Oxygen Concentrator and demonstrates that the subject device performs as intended in the specified use conditions." Implies successful compliance with all standards. |
  | Software Verification Testing | - Testing conducted as recommended by "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." | - Software functions correctly and reliably, consistent with a "minor level of concern" where failure will not result in injury (as the device is not life-supporting). | - Overall Conclusion: "The non-clinical laboratory data support the substantial equivalence of Invacare® Platinum™ Mobile Oxygen Concentrator and demonstrates that the subject device performs as intended in the specified use conditions." Implies successful verification. |
  | Biocompatibility Testing | - AAMI / ANSI / ISO 10993-5 (in vitro Cytotoxicity)
• AAMI / ANSI / ISO 10993-10 (Skin Irritation)
• ISO 10993-11 (Systemic Toxicity)
• Volatile Organic Chemicals Using the EPA TO-17 Method
• Particulate Matter (PM) | - Raw materials making contact with the patient meet biocompatibility standards as per ISO 10993 series and FDA guidance. | - "The test results demonstrated that the subject device is biocompatible." |

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

This information is not provided in a detailed format within this 510(k) summary. For device testing (e.g., respiratory, electrical safety, biocompatibility), the "sample size" would typically refer to the number of device units tested. This is usually a small number (e.g., 3-5 units) sufficient to demonstrate manufacturing consistency and design performance. The document only states that "Respiratory testing was performed," "Electrical Safety and Electromagnetic Compatibility testing was performed," etc., without specifying the number of units or any "data provenance" like country of origin for the data. This type of testing is typically prospective, performed in a lab setting by the manufacturer, rather than on patient data.

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 device is a portable oxygen concentrator, not an AI/ML diagnostic device requiring expert interpretation for ground truth. The "ground truth" for this device's performance is established through physical measurements, adherence to engineering specifications, and compliance with recognized standards.

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

Not applicable. No expert adjudication method is mentioned or required for the type of testing described (physical performance, electrical safety, biocompatibility).

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 conducted. This is not an AI/ML diagnostic device for human reader assistance.

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

Not applicable. This is not an algorithm-only device. It's a hardware device with embedded software for control and monitoring. Its performance is inherent in the device's physical operation.

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

For this device, the "ground truth" is based on:

• Physical Measurements and Engineering Specifications: Regarding oxygen purity, flow rates, battery life, weight, dimensions, alarm thresholds, etc.
• Compliance with Recognized Standards: Such as those for electrical safety (IEC 60601 series), biocompatibility (ISO 10993 series), and software validation.
• Functional Verification: Ensuring the device operates as designed under various conditions.

8. The sample size for the training set

Not applicable. This device does not use a "training set" in the context of machine learning or AI models. It's not an AI/ML device.

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

Not applicable. As there is no training set for AI/ML, there is no ground truth established in that context.

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