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Nonin's Models 6000CA and 7000A Single-Patient Use Disposable Pulse Oximeter Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of adult pediatric patients who are well or poorly perfused, weighing greater than 60 pounds (30 kilograms). It is intended for use in environments including operating room, surgical recovery, critical care, emergency room, long-term care, home use and mobile environments.

Nonin's Models 6000CP and 7000P Single-Patient Use Disposable Pulse Oximeter Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of pediatric patients who are well or poorly perfused, weighing greater than 22 pounds (>10 kilograms). It is intended for use in environments including operating room, surgical recovery, critical care, emergency room, long-term care, home use and mobile environments.

Nonin's Models 6000Cl and 70001 Single-Patient Use Disposable Pulse Oximeter Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of infant patients who are well or poorly perfused, weighing greater than 4 pounds (>2 kilograms). It is intended for use in environments including operating room, surgical recovery, critical care, emergency room, long-term care, home use and mobile environments.

Nonin's Models 6000CN and 7000N Single-Patient Use Disposable Pulse Oximeter Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of neonate/adult patients who are well or poorly perfused, weighing less than 4 pounds (30 kilograms) . It is intended for use in environments including operating room, surgical recovery, critical care, emergency room, long-term care, home use and mobile environments.

The 6000CX are single-patient use disposable, cloth transmittance sensors. They are comprised of woven cloth material (like a Band-Aid) that allows the sensor to be applied to the patient's appendices with the ability to stretch the sensor material for improved position and comfort. The optical components are identical to the currently marketed Model 7000X single-patient use disposable sensor. The modification that was made to the currently marketed 7000X sensor series is a transparent envelope was added to the sensor optics to improve sensor performance. The sensors are compatible with all Nonin-branded pulse oximeters.

The provided text describes Nonin Medical, Inc.'s Model 6000CX and 7000X Sensor Series for pulse oximetry. However, the document does not contain specific acceptance criteria for performance metrics (like accuracy or precision of SpO2 measurements) nor a detailed study report proving the device meets said criteria.

Instead, it primarily focuses on:

• Substantial Equivalence: The document states that the new sensor series is "substantially equivalent to Nonin's currently marketed Model 7000X sensors" and lists predicate devices.
• Safety and Functional Testing: It mentions that the devices "successfully undergone both bench and clinical testing in order to demonstrate that it meets the requirements of ISO 9919:2005 Clause 50 Accuracy of Operating Data, Clause 102 section 102.2 Labeling, and IEC 60601-1:1998 (ISO 10993-1:2003) Clause 48 Biocompatibility." However, the results of these tests and the specific acceptance criteria for "Accuracy of Operating Data" are not detailed.
• Comparison to Predicate: A table compares the new sensors (6000CX and 7000X) to the predicate 7000X sensor, highlighting similarities in indications for use, application site, patient use/reuse, sterility, and measurement technique. Differences are noted in operating/storage temperatures and sensor optic housing material (cloth for 6000CX vs. microfoam for 7000X).

Therefore, based solely on the provided text, I cannot fill out the requested table for acceptance criteria and reported device performance, nor can I provide answers to most of the study-related questions. The document implies that performance was evaluated against ISO 9919:2005 Clause 50, but it does not specify the numerical acceptance criteria or the reported performance values.

Unavailable Information:
The document does not provide:

• Specific numerical acceptance criteria for SpO2 accuracy (e.g., Accuracy Root Mean Square (ARMS) values).
• Reported device performance values for SpO2 accuracy.
• Details of the clinical study (sample size, data provenance, ground truth establishment, number/qualifications of experts, adjudication method).
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.
• Sample size for the training set or how its ground truth was established, as this device appears to be a hardware sensor, not an AI/software algorithm evaluated in the same manner.

Summary of what can be extracted:

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

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 (Test Set): Not specified.
• Data Provenance: Not specified (clinical testing was performed, but details are not provided).
• Retrospective/Prospective: Not specified.

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. For pulse oximetry accuracy studies, arterial blood gas analysis is typically the ground truth reference, performed by lab technicians or medical professionals, not experts in image interpretation.

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

• Not applicable/Not specified. Ground truth for pulse oximetry is usually direct measurement (e.g., co-oximetry), not expert adjudication of subjective data.

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 is a hardware pulse oximeter sensor, not an AI/software device. MRMC studies are not relevant here.

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

• Not applicable. This is a hardware sensor. Its performance is measured directly, not as an algorithm's standalone output.

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

• The document mentions "clinical testing" for "Accuracy of Operating Data" as per ISO 9919:2005 Clause 50. Standard practice for pulse oximetry accuracy testing involves comparing the device's SpO2 readings to reference SpO2 values obtained via arterial blood gas co-oximetry. This is the most likely ground truth used, though not explicitly stated in the document.

8. The sample size for the training set

• Not applicable. This is a hardware sensor, not a machine learning model requiring a training set in the typical sense.

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

• Not applicable. See point 8.

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