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The Drive DeVilbiss iGo2 Portable Oxygen Concentrator is indication of supplemental oxygen. The device is not intended for life support, nor does it provide any patient monitoring capabilities.

The proposed Drive DeVilbiss iGo2 Portable Oxygen Concentrator (POC) is similar to the predicate devices, pressure-vacuum swing adsorption based on molecular sieve technology using two containers filled with molecular sieve (sieve beds). Ambient air is drawn into the concentrator via a piston style compressor and compressed into a single sieve bed. As pressure increases nitrogen is adsorbed and concentrated oxygen exits one end of the bed and is collected in a product tank. Simultaneously in the other sieve bed, nitrogen is desorbed as the pressure decreases to a vacuum and is exhausted into the atmosphere. Once the pressure or vacuum reaches a defined maximum a valve switches the compressor connections to the sieve beds. The sieve bed previously connected to the pressure head will be connected to vacuum. The oxygen collected in the product tank is then dispensed to the patient upon detecting a patient inhalation, much like an oxygen conserving device.

The proposed Drive DeVilbiss iGo2 POC provides pulse dose oxygen in the same manner as primary predicate device (DeVilbiss Model 306 POC, K081468). The "Smart Dose" feature has been added to the proposed device, which is substantially equivalent to the feature in the reference device (Model 350G gas conserver, K090421). Smart Dose will automatically increase the patient's prescription setting by one if the system determines the patient has increased rate of breathing.

This document describes the regulatory filing for the Drive DeVilbiss iGo2 Portable Oxygen Concentrator (POC). It focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a detailed study proving the device meets specific acceptance criteria in a traditional clinical research sense.

However, based on the provided text, we can extract information regarding acceptance criteria for performance testing (non-clinical) and the types of studies conducted.

Here's a breakdown of the requested information:

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

The document states: "All bench tests confirmed that the predetermined acceptance criteria were met. This includes oxygen output and breathing detection." and "The proposed Drive DeVilbiss iGo2 Portable Oxygen Concentrator was designed and tested to demonstrate compliance with the applicable sections of the following standards: ... passing all test protocols."

While specific numerical acceptance criteria and precise performance values are not fully detailed in a table format within the provided text, the document lists key performance specifications under the "Comparison of Substantial Equivalence and Differences" table. We can infer the acceptance criteria are met by confirming these specifications are in line with the predicate device or standards.

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

The document primarily discusses non-clinical bench testing rather than clinical studies with patient test sets. Therefore, the concept of "sample size used for the test set" in the context of human subjects is not applicable here. The testing was conducted on the device itself.

Data provenance: Not explicitly stated, but assumed to be internal testing by DeVilbiss Healthcare, LLC, based in Somerset, Pennsylvania, USA. The testing is prospective in the sense that the device was designed and then tested against pre-defined standards and requirements.

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)

This information is not applicable. For non-clinical bench testing of a medical device like an oxygen concentrator, "ground truth" is typically established by engineering specifications, validated measurement equipment, and compliance with recognized industry standards (e.g., ISO, IEC). There are no "experts" establishing a "ground truth" for a test set in the way a radiologist would for an imaging study.

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

Not applicable. Adjudication methods are typically employed in clinical studies where there's subjectivity in interpreting results (e.g., by human readers). Bench testing relies on objective measurements against engineering specifications and standards, negating the need for adjudication by multiple experts.

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 a medical device for oxygen delivery, not an AI-assisted diagnostic or therapeutic tool with "human readers" or AI components in that sense. The filing is for a physical medical device.

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

Not applicable. The device is a hardware product. While it has software/firmware for control ("Smart Dose" feature operates automatically, "over-pressure protection achieved through software and electronic control"), it's not an AI algorithm that functions standalone in the way a diagnostic AI would. The "standalone" performance here refers to the device's functional operation meeting its specifications.

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

For the non-clinical performance testing, the "ground truth" is established by:

• Engineering Specifications: The design parameters and target performance levels set by the manufacturer.
• International and National Standards: Compliance with recognized standards such as ISO 80601-2-69 (Oxygen Concentrator Equipment), ISO 80601-2-67 (Oxygen Conserving Equipment), and various IEC 60601 series standards for medical electrical equipment safety and essential performance.
• Validated Measurement Equipment: The actual measurements obtained during bench testing using calibrated instruments are compared against these specifications and standards.

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 development.

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

Not applicable, as there is no training set for this type of device.

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The DeVilbiss Healthcare DV6WM Wireless Modem is intended to be used as a data collection tool for DeVilbiss IntelliPAP Series with SmartLink II Bluetooth module, IntelliPAP2, and DeVilbiss Blue Series CPAPs for patients in a home or healthcare environment. It is not intended to be used as a diagnostic tool.

The proposed DeVilbiss DV6WM Wireless Modem is an accessory to a DeVilbiss CPAP machine. The proposed device provides automatic wireless telemetry of CPAP usage and performance data to a healthcare provider.

The provided text describes a 510(k) premarket notification for the DeVilbiss DV6WM Wireless Modem. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific quantitative acceptance criteria for a new medical device function. Therefore, much of the requested information regarding specific performance metrics, sample sizes for test/training sets, expert adjudication, or MRMC studies for AI performance is not present.

However, I can extract information related to the device's technical specifications and the non-clinical testing performed to establish safety and effectiveness.

Here's a breakdown of the available information structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

This device is a wireless modem for CPAPs, not a diagnostic or therapeutic AI device. Its performance is evaluated against technical standards and the functionality of its predicate devices. The "acceptance criteria" here are compliance with relevant standards and functional equivalence.

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

• Sample Size: Not applicable/not provided. The submission describes non-clinical engineering and usability testing, not performance on a dataset of clinical cases.
• Data Provenance: Not applicable. The device's function is data transmission, not analysis of clinical data.

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

• Not applicable. This is not an AI/diagnostic device requiring expert ground truth for clinical cases.

4. Adjudication method for the test set:

• Not applicable.

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 device is a data collection tool, not an AI-powered diagnostic aid for human readers.

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

• The device's standalone function is to wirelessly collect and transfer CPAP usage/performance data to a secure server. This function was confirmed through non-clinical testing against relevant standards. The "performance testing" section indicates this was verified by passing test protocols for communication, electrical safety, EMC, and environmental factors.

7. The type of ground truth used:

• Not applicable. For a device like this, the "ground truth" would be the successful and accurate transmission of data from the CPAP to the server, and compliance with all technical safety standards. This is verified through engineering testing and certification rather than clinical ground truth like pathology or outcome data.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that uses a training set.

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

• Not applicable.

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The DeVilbiss Intellipap2/DeVilbiss BLUE Series is intended for use in treating OSA in spontaneously breathing patients 30 Kg (66 lbs) and above by means of application of positive air pressure. The Device is to be used in Home and Healthcare Environments.

The proposed DeVilbiss Intellipap2/DeVilbiss BLUE are devices for treating obstructive sleep apnea by means of applied airway pressure. Predicates devices DeVilbiss IntelliPAP DV5 Series (K071689), and Respironics, Inc, Remstar Auto A-Flex HT (K113068) operate by the same basic principal of creating pressurized air that is delivered to the patient's airway by a nasal or oralnasal mask. The devices maintain a set pressure, prescribed by a physician, at the patient's mask for flow rates up to approximately 100 L/m.

The document K143677 describes the DeVilbiss Intellipap2/DeVilbiss BLUE device, which is intended for use in treating Obstructive Sleep Apnea (OSA). A clinical study was performed to validate the respiratory event detection and pressure change decisions made by the proposed device.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state quantitative acceptance criteria or a direct comparison of the device performance against specific numerical targets for the respiratory event detection algorithm. Instead, it states the study's primary objective was to "demonstrate effectiveness of therapy provided by the DeVilbiss AutoAdjust CPAP device as reported by an expert human reviewer" and to determine "whether the machine results are equivalent to hand scores." The conclusion states that the device is "substantially equivalent to the predicate devices in terms of meeting performance criteria and functioning as intended."

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

• Sample size for the test set: 28 subjects
• Data provenance: A single-center, prospective, controlled study in the U.S.

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

• Number of experts: The document mentions "an expert human reviewer" (singular) for assessing therapy effectiveness and "hand-scored PSG" for equivalence, implying one or more experts for scoring. However, a specific number and detailed qualifications are not provided beyond "expert."

4. Adjudication method for the test set

• The document implies that the "expert human reviewer" or "hand-scored PSG" served as the reference standard against which the device was compared. The method for resolving discrepancies among multiple experts, if multiple were involved, is not explicitly stated.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance

• No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not described. The study focused on validating the device's algorithm against human-scored PSG.

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

• Yes, a standalone study of the algorithm's performance was done. The study "compared to hand-scored PSG to determine whether the machine results are equivalent to hand scores," which indicates an evaluation of the device's algorithm performance directly.

7. The type of ground truth used

• Type of ground truth: Expert human reviewer and hand-scored Polysomnography (PSG).

8. The sample size for the training set

• The document does not provide information on the sample size used for the training set.

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

• The document does not specify how the ground truth for any training set was established. It only describes the validation study for the "new Respiratory event detection algorithm."

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