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The Konica Minolta Models PULSOX-300 and PULSOX-300i are devices designed for non-invasive measurement of the oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate from light signals of two wavelengths transmitted through tissues of adult patients who have pulmonary disease, pulmonary dysfunction, or who need sleep study.

The Konica Minolta Models PULSOX-300 and PULSOX-300i are devices designed for non-invasive measurement of the oxygen saturation of arterial hemogliobin (SpO2) and pulse rate from light signals of two wavelengths transmitted through tissues of adult patients who have pulmonary disease, pulmonary dysfunction, or who need sleep study. SpO2 is, as defined in ISO 9919:2005, percent of hemoglobin saturation with oxygen measured by a pulse oximer and displayed as a percentage. The measurement principle depends on a changing signal caused by the pulsatile nature of blood flow.

The provided document K053419 is a 510(k) summary for the Konica Minolta PULSOX-300 and PULSOX-300i. It states that the device is substantially equivalent to legally marketed predicate devices (Minolta Oxygen Saturation Monitor PULSOX-3 and PULSOX-3Si).

Because this is a 510(k) summary for a pulse oximeter, and it claims substantial equivalence to predicate devices, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are typically demonstrated through comparison to the predicate devices and adherence to relevant standards. The document states that performance indicates equivalence and compliance with published literature, but it does not provide detailed study data, acceptance criteria values, sample sizes, or information about ground truth establishment as requested.

Therefore, many of the requested fields cannot be filled directly from this document.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

This document does not provide a specific table of acceptance criteria or detailed reported device performance values. It generally states: "Performance indicates that the Konica Minolta Models PULSOX-300 and PULSOX-300i, are equivalent to the Minolta PULSOX-3 and PULSOX 3Si. The testing results are also in compliance with those in published literature for pulse oximeters. The testing conducted demonstrates that the Konica Minolta Models PULSOX-300 and PULSOX-300i are safe and effective."

To meet the requirements of ISO 9919:2005 (mentioned in the document as defining SpO2), pulse oximeters are typically evaluated for accuracy (Arms - accuracy root mean square) against a reference CO-oximeter across a range of SpO2 values, usually under conditions of induced hypoxia. However, the exact acceptance criteria (e.g., Arms ≤ 3.0% for SpO2 70-100%) and the performance achieved by the PULSOX-300/300i are not detailed in this summary.

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

• Sample size used for the test set: Not specified in the provided summary. Clinical testing for pulse oximeters often involves a small number of healthy volunteers who undergo induced hypoxia.
• Data provenance (e.g., country of origin of the data, retrospective or prospective): Not specified.

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

• Number of experts: Not applicable in the context of pulse oximetry accuracy studies.
• Qualifications of experts: Ground truth for pulse oximeter accuracy is established by a reference method, typically a co-oximeter measuring arterial blood samples, not by expert interpretation of images or other subjective assessments.

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

• Adjudication method: Not applicable for a pulse oximetry accuracy study where ground truth is based on objective physiological measurements (co-oximetry).

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:

• MRMC comparative effectiveness study: No. This device is a standalone physiological monitoring device, not an AI-assisted diagnostic tool requiring human reader interpretation change.

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

• Standalone performance: Yes, the device itself provides a direct reading of SpO2 and pulse rate. The "performance" mentioned in the summary refers to this standalone operation. The summary states that "Performance indicates that the Konica Minolta Models PULSOX-300 and PULSOX-300i, are equivalent to the Minolta PULSOX-3 and PULSOX 3Si."

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

• Type of ground truth: For pulse oximeters, the ground truth for SpO2 accuracy is typically established by co-oximetry (laboratory analysis of arterial blood samples for fractional oxygen saturation).

8. The sample size for the training set:

• Sample size for the training set: Not applicable. This is a traditional medical device, not an AI/ML device that requires a "training set" in the machine learning sense. Its operation is based on established optical principles for measuring light absorption of hemoglobin.

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

• How ground truth for training set was established: Not applicable, as there is no "training set."

In summary, as per the provided text, a detailed breakdown of the performance study is not available. The document primarily focuses on establishing substantial equivalence to predicate devices, rather than presenting detailed performance metrics and study methodologies typically found in a full efficacy report.

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The Minolta PULSOX-2 is indicated for the non-invasive monitoring of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The Minolta PULSOX-2 is intended for use with adult patients. The Minolta PULSOX-2 is for spot-checking only.

The Minolta PULSOX-2, is the device 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 or pulmonary dysfunction. 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 document is a 510(k) summary for the Minolta PULSOX-2, a pulse oximeter. It states that the device is substantially equivalent to a predicate device (Minolta PULSOX-3) and highlights its function and intended use. However, it does not contain the detailed information required to answer your specific questions regarding acceptance criteria, study details, and ground truth establishment.

A 510(k) summary focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing a detailed report of a new clinical study with specific acceptance criteria and performance metrics in the way you've outlined for AI/ML device validation.

Therefore, I cannot populate the table or answer most of your detailed questions from the provided text. The document states "Performance indicates that the Minolta PULSOX-2, is equivalent to the Minolta PULSOX-3. The testing results are also in compliance with those in published literature for pulse oximeters. The testing conducted demonstrates that the Minolta PULSOX-2 is safe and effective." but does not provide the specifics of that testing.

Here's what can be inferred or explicitly stated from the document, along with what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Missing from document.

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

• Not applicable / Missing from document. For pulse oximeters, the "ground truth" for SpO2 accuracy is typically established by arterial blood gas analysis using a co-oximeter, not by expert review of images or interpretations. The document does not describe such a study.

4. Adjudication method for the test set:

• Not applicable / Missing from document. As the ground truth isn't established by expert review, an adjudication method isn't relevant in this context.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No indication of an MRMC study. This type of study is more relevant for diagnostic imaging AI systems where human readers interpret data, rather than a standalone physiological monitor like a pulse oximeter.

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

• Yes, implicitly. A pulse oximeter is a standalone device that provides a measurement (SpO2 and pulse rate) without human interpretation affecting the output. The performance assessment would be of the device's accuracy against a reference standard. However, the details of this assessment are missing from the provided text.

7. The type of ground truth used:

• Not explicitly stated, but typically for pulse oximeters, the ground truth is established using arterial blood gas analysis with a co-oximeter. The document states: "The Minolta PULSOX-2 is the device 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 or pulmonary dysfunction." This implies direct measurement validation, but the details are not provided.

8. The sample size for the training set:

• Not applicable / Missing from document. Pulse oximeters are typically based on optical principles and calibration rather than being "trained" in the machine learning sense. Any calibration data or parameter optimization would not be typically referred to as a "training set" in this context.

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

• Not applicable / Missing from document. (See above point for rationale).

In summary, the provided 510(k) document is a regulatory submission for a basic medical device (a pulse oximeter) that relies on demonstrating substantial equivalence to an existing device and compliance with general performance expectations for its category. It does not contain the detailed study design, acceptance criteria, or performance data that would be expected for a complex AI/ML device requiring rigorous clinical validation with specific metrics and ground truth establishment by experts.

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Ask a specific question about this device