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The Home-Away System, Model 1041 is intended as an accessory to an oxygen concentrator and liquid oxygen storage system for use as an aid or adjunct to delivering supplemental oxygen therapy in the home. It is intended to be used with both pediatric and adult patients. It is not intended to be a life-sustaining or life-supporting device. The device has no contraindications.

The Home-Away System, Model 1041 is an accessory to an oxygen concentrator and liquid oxygen (LOX) stroller. It liquefies oxygen that is received from an oxygen nquia entygen (t, and delivers it to a LOX stroller for patient use. While performing these functions, it is also capable of delivering up to 3 L/min of gaseous oxygen directly to the patient. In these respects, the Home-Away System, Model 1041 is the same as its to the payment Home-Away System. The Home-Away System, Model 1041 incorporates prounders from the cleared device that enhance its usability, manufacturability, consistent performance, durability, reliability, and safety.

The provided text is a 510(k) summary for the "Home-Away System, Model 1041." This document focuses on demonstrating substantial equivalence to a predicate device, not on presenting acceptance criteria and detailed study results for a new, standalone medical device, especially one involving AI or diagnostic performance.

Therefore, many of the requested categories related to device performance, ground truth, expert involvement, and AI studies cannot be addressed from this document because it is not designed to provide that information.

Here's how much of the requested information can be extracted or reasonably inferred from the provided text:

Acceptance Criteria and Device Performance

The document doesn't explicitly state quantitative acceptance criteria or detailed performance metrics in a format suitable for the requested table. Instead, it describes "performance testing" to establish substantial equivalence.

Study Details (Based on the provided document)

Since this is a 510(k) for substantial equivalence of an oxygen accessory, the study described is a performance testing regimen focused on comparing the new device against its predicate and relevant standards. It is not a clinical study evaluating diagnostic accuracy or a specific medical outcome in human patients.

1. 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 mentions "performance testing" of the Home-Away System, Model 1041, which would involve testing of physical units. The number of units tested is not provided.
   • Data Provenance: Not specified. Given the company is U.S.-based (Denver, Colorado), it's highly likely the testing was conducted within the U.S.
   • Retrospective or Prospective: This type of engineering performance testing is inherently prospective in the sense that the new device (Model 1041) was actively tested.

2. 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 is not a study requiring expert clinical "ground truth" establishment (e.g., for image interpretation or diagnosis). The testing involves objective measurements against engineering specifications and industry standards.

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

   • Not applicable. Adjudication methods like "2+1" are relevant for expert consensus in clinical data, which is not the nature of the "performance testing" described here.

4. 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 device is an accessory to an oxygen concentrator/LOX storage system. It does not involve human readers, diagnostic imaging, or Artificial Intelligence (AI).

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

   • No. This device is electro-mechanical hardware; it does not involve an algorithm or AI.

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

   • The "ground truth" for this type of device and testing would be engineering specifications, industry standards (e.g., USP 93% oxygen purity), and functional performance requirements. For example, the "ground truth" for oxygen purity is the measured oxygen concentration compared to the USP 93% standard.

7. The sample size for the training set:

   • Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.

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

   • Not applicable. As there is no training set.

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The Minolta Pulsox-3 and Pulsox-3i are the devices for determination of saturation of hemoglobin (SpO₂) non-invasively from light signals of two wavelengths transmitted through from tissues of patients who have pulmonary disease, pulmonary dysfunction or who need sleep study.

The Minolta Pulsox-3 and Pulsox-3i are the devices for determination of saturation of hemoglobin (SpO2) non-invasively from light signals of two wavelengths transmitted through from tissues of patients who have pulmonary disease, pulmonary dysfunction or who need sleep study. SpO2 is, as defined in 1.3.14 of ISO 9919:1992, percent of hemoglobin saturation with oxygen measured by a pulse oximeter and displayed as a percentage. The measurement principle depends on a changing signal caused by the pulsatile nature of blood flow.

The provided text is a 510(k) summary for the Minolta PULSOX-3 and PULSOX-3i pulse oximeters, filed in 2000. These summaries are designed to establish substantial equivalence to a predicate device, not necessarily to detail comprehensive clinical studies with acceptance criteria as would be found in a full efficacy study.

Here's an analysis based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The provided text does not specify quantitative acceptance criteria (e.g., "accuracy within X% of a reference standard") or specific performance metrics (e.g., mean absolute difference). Instead, it makes broad statements of equivalence and compliance. This is typical for 510(k) summaries which focus on demonstrating "substantial equivalence" rather than presenting detailed clinical trial results with specific numerical acceptance thresholds.

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

The document does not specify the sample size used for any test set or the data provenance (country of origin, retrospective/prospective). It only generally states "The testing conducted demonstrates..." without providing details on how that testing was performed.

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

The document does not provide any information regarding the number or qualifications of experts used to establish ground truth for any test set. Given the nature of a pulse oximeter, ground truth often involves co-oximetry, which is a laboratory blood gas analysis, rather than expert interpretation of images. However, the text does not elaborate on the specific ground truth method used.

4. Adjudication Method for the Test Set

The document does not provide any information on an adjudication method for a test set.

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

This section is not applicable to the provided document. The Minolta PULSOX-3 and PULSOX-3i are pulse oximeters, which are direct measurement devices, not AI-assisted diagnostic tools that involve human readers interpreting images.

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

This question is also not directly applicable in the context of this device. A pulse oximeter is inherently a standalone device that provides a numerical reading. Its "performance" refers to how accurately it measures SpO2 compared to a reference standard, not its performance in an AI-algorithm sense. The summary implies the device's standalone performance was evaluated against the predicate and published literature, but no specific study details are provided.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used. For pulse oximeters, the gold standard for SpO2 is often arterial blood gas analysis with co-oximetry. However, the summary does not detail the methods used for "testing." It implies comparison to the predicate device, which would involve comparing sensor readings, but the exact ground truth for the accuracy of those readings is not specified.

8. The Sample Size for the Training Set

The document does not specify any sample size for a training set. This is not an AI/machine learning device, so the concept of a "training set" as it relates to AI model development is not relevant here.

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

This question is not applicable as the device is not an AI/machine learning model and therefore does not have a "training set" in that context.

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