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Intended for use to conserve oxygen for patients prescribed supplemental oxygen and use nasal cannulas as part of an oxygen delivery system including an oxygen concentrator, compressed oxygen cylinders, or liquid oxygen system.

The Inogen Satellite Conserver is a battery operated electronic device that is microprocessor controlled and contains a breath sensor and normally closed valve. The device is connected to an oxygen supply source and upon detecting the beginning of an inhalation; the device delivers a bolus of oxygen that is equivalent in most users, depending on the flow setting, to 1 to 5 liters per minute constant flow. The Inogen Satellite Conserver can be used with bottled oxygen systems and as an accessory to the Inogen One Oxygen Concentrator (K032818). The device uses these systems as its oxygen supply and is connected by an oxygen supply tube.

The provided document is a 510(k) summary for a medical device (Inogen Satellite Conserver) and does not contain the information requested about acceptance criteria and a study proving device performance against those criteria in the context of an AI/ML powered device.

Specifically, the document focuses on demonstrating substantial equivalence to predicate devices for a modified oxygen conserver, which is a hardware device, not an AI/ML powered medical device. The "Summary of Testing" section (Page 2) refers to "extensive software validation testing, safety testing, mechanical testing, performance testing, and EMI/EMC testing" for the original device, and "Comprehensive performance testing with compressed oxygen cylinders and liquid oxygen systems" for the new device to ensure it "functioned within its specifications."

However, none of this testing aligns with the requirements of describing acceptance criteria and a study for an AI/ML powered device, which would involve:

• Acceptance criteria related to AI performance metrics (e.g., sensitivity, specificity, AUC, F1-score).
• A test set with ground truth established by experts.
• Details on reader studies (MRMC) or standalone algorithm performance.
• Information about training sets and their ground truth.

Therefore, I cannot provide the requested information based on the input text.

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The Inogen Satellite Conserver is intended for use to conserve oxygen for patients prescribed supplemental oxygen and use nasal cannulas and an oxygen concentrator.

The Inogen Satellite Conserver intended to be used as an accessory to the Inogen One Oxygen Concentrator (K032818). The device uses the Inogen One Oxygen Concentrator as its oxygen supply and is connected by an oxygen supply tube. The Inogen Satellite Conserver is a battery operated electronic device that is microprocessor controlled and contains a breath sensor and normally closed valve. Upon detecting the beginning of inhalation, the device delivers a bolus of oxygen that is equivalent in most users to 1 to 5 liters per minute constant flow, depending on the flow setting.

This 510(k) premarket notification for the Inogen Satellite Conserver does not contain the results of a study with acceptance criteria and device performance.

The document is a submission to the FDA claiming substantial equivalence to predicate devices (Medical Electronic Devices Corporation unmodified POCD and the Airsep Lifestyle Oxygen Concentrator). The content focuses on:

• Device Description: The Inogen Satellite Conserver is an accessory to an oxygen concentrator, designed to conserve oxygen by delivering a bolus during inhalation. It's microprocessor-controlled with a breath sensor and valve.
• Technological Characteristics: Claims identical electronic circuitry to a predicate, with software modifications to control the valve for oxygen bolus delivery. The dosing algorithm is stated to be identical to another predicate device.
• Summary of Testing: A statement is made that "Appropriate performance, mechanical, and electrical testing was performed to demonstrate that the Inogen Satellite Conserver would perform as intended." However, no specific acceptance criteria or detailed results of these tests are provided in this document.
• Conclusion: Based on the above, the manufacturer concludes the device is substantially equivalent to marketed devices and is safe and effective.
• FDA Response: The FDA's letter acknowledges receipt and review, confirming substantial equivalence based on the provided information, but does not detail the specific testing or acceptance criteria.

Therefore, I cannot provide the requested information in the table format or answer the specific questions about sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth details. This document is a regulatory submission, not a study report.

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The modified Medical Electronic Devices Corp. POCD Pulsed Oxygen Conserving Device is intended for use in the same manner as the unmodified device, i.e., to conserve oxygen for patients prescribed 1 to 4 liters per minute of supplemental oxygen and use nasal cannulas and USP bottled oxygen.

The Medical Electronic Devices Corp. POCDFR intended to be used as an accessory to an oxygen supply system to reduce or conserve the amount of oxygen used by the patient. The POCDEe is a battery operated electronic device that is microprocessor controlled and contains a breath sensor and normally closed valve. It delivers boluses of oxygen every breath that is equivalent to 1 to 4 liters per minute constant flow, depending on the flow setting.

The provided text describes a Special 510(k) submission for a modified Pulsed Oxygen Conserving Device (POCDEB). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device that requires extensive clinical studies with specific acceptance criteria related to accuracy or diagnostic performance.

Therefore, much of the requested information regarding acceptance criteria, sample sizes for test and training sets, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, are not applicable in this context. The document primarily discusses device modifications and functional equivalence.

Here's a breakdown of the relevant information from the provided text, addressing the requested points where possible, and noting where information is not available or not applicable given the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

This kind of table is not present in the document because the submission is for a modification of an existing device (POCD) and primarily claims substantial equivalence based on technological characteristics and functional testing, not on clinical performance metrics like sensitivity, specificity, or accuracy for a diagnostic task.

The key "performance" aspect is that the modified software delivers oxygen on every breath, similar to another predicate device.

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

Not applicable. This submission concerns a physical device modification, not an AI/ML algorithm requiring a test set of data for performance evaluation in the way a diagnostic device would. There is no mention of a "test set" in the context of data. The "testing" mentioned refers to functional, mechanical, electromagnetic, and environmental testing of the device itself.

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

Not applicable. There is no "ground truth" established by experts in the context of diagnostic data for this device. The evaluation is based on device functionality and equivalence to predicate devices.

4. Adjudication Method for the Test Set

Not applicable. There is no test set in the context of data requiring an adjudication method.

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 is not an AI/ML diagnostic or assistive device. It is an oxygen conserver, and no MRMC study was performed or needed for this type of submission.

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

Not applicable. This is not an AI/ML algorithm requiring standalone performance evaluation. The "algorithm" here refers to the device's dosing mechanism, which is embedded in its function.

7. The Type of Ground Truth Used

Not applicable. "Ground truth" in the context of clinical outcomes, pathology, or expert consensus on diagnostic images is not relevant to this device's submission. The "truth" here is established by demonstrating that the device functions as described and is equivalent to predicate devices.

8. The Sample Size for the Training Set

Not applicable. There is no AI/ML model being trained with a dataset, so there is no training set.

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

Not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply.

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The DOCD Demand Oxygen Conserving Device is indicated for use to conserve oxygen for patients prescribed 0 to 6 liters per minute of supplemental oxygen and use nasal cannulas and USP bottled oxygen.

The DOC Demand Oxygen Conserving Device is indicated for use to conserve oxygen for patients prescribed 1 to 6 liters per minute of supplemental oxygen and oxygen for paliente procente oxygen.

The Demand Oxygen Conserving Device or "DOCD" is intended to be used as an accessory to an oxygen supply system to reduce or conserve the amount of oxygen used by the patient. The DOCD is a battery operated electronic device that is microprocessor controlled and contains a capacitive breath sensor and a normally closed valve. When installed between the oxygen supply and patient's nasal cannula, the device detects the patient's inhalation opens the valve for 1 second and delivers the flow rate of oxygen set at the regulator to the patient. The valve closes and conserves the oxygen that would have been wasted during exhalation.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Demand Oxygen Conserving Device (DOCD). Unfortunately, the supplied text is quite limited regarding detailed study information, especially for what would typically be considered "acceptance criteria" in a medical device study (e.g., specific quantitative benchmarks like sensitivity, specificity, accuracy, etc., for a diagnostic device). This document focuses more on the functional performance of the device and its substantial equivalence to existing predicate devices.

Summary of Acceptance Criteria and Reported Device Performance

In-Depth Analysis of Study Information:

Based on the provided text, the "study" conducted for the Demand Oxygen Conserving Device (DOCD) primarily consisted of "Extensive functional testing" and environmental/power supply testing. This appears to be more of a verification and validation (V&V) effort against design specifications rather than a clinical trial or a formal statistical study with defined acceptance criteria for diagnostic accuracy or clinical outcomes.

Here's what can be extracted based on your requested points:

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

   • See table above. The acceptance criteria are inferred from the description of the device's intended function and the types of tests explicitly mentioned. Specific quantitative thresholds for these criteria are largely absent from this summary.

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

   • Sample Size: Not specified. The document states "Extensive functional testing" and lists various categories of tests (environmental, power supply). It does not indicate the number of devices or test conditions used for this testing.
   • Data Provenance: Not specified. Given the nature of V&V testing, it would generally be prospective data generated in a lab setting, likely at the manufacturer's facility in Torrance, California, USA (Medical Electronic Devices Corp. location).

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/Not specified. This device performs a mechanical/electronic function (oxygen delivery based on breath detection) rather than an interpretative or diagnostic one that would typically require expert ground truth. The "truth" in this context would be whether the device correctly detects a breath, whether it opens the valve for 1 second, whether alarms function, etc., which are measurable physical parameters.

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

   • Not applicable/Not specified. Adjudication methods are typically used in studies where there is subjective interpretation or borderline cases (e.g., image reading). For functional and environmental testing of a mechanical device, performance is typically objectively measured against pre-defined specifications.

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. This type of study (MRMC, AI assistance) is not relevant to a Demand Oxygen Conserving Device, which is a therapeutic rather than a diagnostic or imaging-assistance device.

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

   • Yes, in essence. The "Extensive functional testing" and environmental/power supply testing represent the standalone performance of the device. The device's operation (detecting breath, opening valve, alarming) is algorithmic/automatic based on its programming and sensor input, without continuous human intervention during its core function. The reported performance relates to the device operating independently.

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

   • The "ground truth" for this device's performance testing would be objective physical measurements and adherence to design specifications. Examples would include:
     • Breath Detection: Verified by simulating inhalation (negative pressure) and observing if the valve opens.
     • Oxygen Delivery Duration: Measuring the actual valve open time (e.g., using a flow sensor and timer) to confirm it is 1 second.
     • Alarm Functionality: Triggering specific conditions (e.g., no detected breath for 30s, low battery voltage) and verifying the correct alarm output.
     • Environmental Performance: Exposing the device to specified conditions (e.g., temperature ranges, drop height) and then verifying continued functional operation.

8. The sample size for the training set

   • Not specified. This device does not appear to employ machine learning algorithms that require a "training set" in the conventional sense. Its operation is based on pre-programmed logic and sensor thresholds.

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

   • Not applicable, as there's no mention of a traditional "training set" for a machine learning model. The device operates based on fixed engineering principles and pre-set parameters.

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The POCD Pulsed Oxygen Conserving Device is indicated for use to conserve oxygen for patients prescribed 1 to 4 liters per minute of supplemental oxygen and use nasal cannulas and USP bottled oxygen.

The Pulsed Oxygen Conserving Device or "POCD" is intended to be used as an accessory to an oxygen supply system to reduce or conserve the amount of oxygen used by the patient. The POCD is a battery operated electronic device that is microprocessor controlled and contains a capacitive breath sensor and a normally closed valve. When installed between the oxygen supply and patient's nasal cannula, the device detects the patient's inhalation opens the valve according to the device's breath skipping algorithm and delivers a preset bolus of oxygen to the patient. The valve closes and conserves the oxygen that would have been wasted during the end of inhalation and during exhalation.

The provided text describes a 510(k) submission for a Pulsed Oxygen Conserving Device (POCD). The submission focuses on demonstrating substantial equivalence to predicate devices through functional and environmental testing. However, the document does not contain the level of detail requested for acceptance criteria and a study proving those criteria, especially regarding clinical performance, human readers, or detailed ground truth establishment.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes functional, environmental, and power supply testing, and states that the device "meets its performance objectives and complies with applicable FDA guidelines." However, specific quantitative acceptance criteria for these tests are not provided, nor are the reported numerical results to compare against such criteria.

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

• Test Set Sample Size: Not specified. The document mentions "Extensive functional testing" and testing under "various environmental conditions," but does not quantify the number of devices or test conditions.
• Data Provenance: Not specified. The testing described appears to be laboratory-based and conducted by the manufacturer, Medical Electronic Devices Corp. There is no mention of clinical data, patient origin, or retrospective/prospective study design regarding performance.

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

Not applicable. The described testing is technical and functional, not clinical where expert-established ground truth would typically be relevant (e.g., for diagnostic accuracy). The intended use is described, but no clinical study with expert ground truth is detailed.

4. Adjudication Method for the Test Set

Not applicable. Since no clinical test set with human assessment and ground truth establishment is described, there's no mention of an adjudication method.

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

No. The document makes no mention of an MRMC study or any study comparing human readers with and without AI assistance. The device is a "Pulsed Oxygen Conserving Device," not an AI diagnostic tool.

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

The device itself is an "algorithm only" device in a sense, as its core function (breath sensing, valve actuation, breath skipping) is automated. The "Performance Data" section describes "Extensive functional testing" which would fall under standalone testing of the device's operational characteristics. However, this is not a diagnostic algorithm.

7. The Type of Ground Truth Used

For the functional and environmental testing described:

• Ground Truth: Engineering specifications, design requirements, and applicable FDA guidelines. The device's performance was likely compared against these pre-defined technical standards.

For the breath skipping algorithm, the document states it is a "clinically proven method of maintaining equivalent blood oxygen saturation versus prescribed continuous oxygen flow rates and used in all three of the predicate devices." This implies that the concept of the algorithm has clinical backing from predicate devices, but the document does not detail a clinical study where the POCD's breath-skipping performance was verified against physiological ground truth (e.g., direct blood oxygen saturation measurements) for this specific device.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware-based electromechanical device controlled by software and a fixed algorithm (breath skipping algorithm, alarm logic). It does not appear to use machine learning or AI that would require a "training set" in the conventional sense for a diagnostic algorithm.

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

Not applicable, as there's no mention of a training set for machine learning. The "ground truth" for its operational logic would be based on engineering design, clinical understanding of oxygen delivery, and the established principles demonstrated by its predicate devices.

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