Search Results

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.

Ask a specific question about this device

Nonin's Models 6500MA and 6500SA Single-Patient Use Disposable Pulse Oximeter Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of adult and 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.

The 6500MA (wrap-around model) and 6500SA (interlocking model) are fingertip single-patient use disposable, transmittance sensors. They are comprised of a lamination of two foams (patient contact side and external side) with the optical components and a malleable wire within the lamination. The optical components are identical to the currently marketed Model 7000 single-patient use disposable sensor. The sensors are compatible with all Nonin-branded pulse oximeters.

This is a 510(k) summary for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report for a new device's absolute performance. Therefore, many of the requested details about specific study methodologies (like sample size for training sets, adjudication, or MRMC studies) are not present in this type of document.

Here's an analysis of the provided text based on your request:

Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The document states: "Nonin's Model 6500 sensor series have 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."

The table above demonstrates that the subject device (Model 6500 Sensor Series) meets or exceeds the performance criteria of the predicate device (Model 7000 Sensor Series) for SpO2 accuracy, and matches it for pulse rate accuracy. This forms the basis of the substantial equivalence claim.

Missing Information (Based on the Provided Text):

The following information is not detailed in the provided 510(k) summary:

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The document mentions "clinical testing" but does not provide details on the sample size of the test set, its provenance, or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. For pulse oximetry, the "ground truth" for SpO2 accuracy is typically established by comparing the oximeter readings to arterial blood gas measurements (co-oximetry) in induced hypoxia studies, often without "experts" in the traditional sense for reading images, but rather with clinical staff performing procedures and measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or not specified.
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 pulse oximeter sensor, not an AI diagnostic device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device itself is an algorithm (oximeter) and sensor, so its performance is standalone in the context of its function. However, the exact methodology for this standalone performance (e.g., how the clinical test dataset was used to derive the accuracy metrics) is not detailed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For SpO2 accuracy, the ground truth is typically arterial blood gas analysis with co-oximetry, under controlled desaturation conditions, which is considered the gold standard for SpO2. This is implied by the standard ISO 9919:2005 for oximeters, but not explicitly stated as the method for this specific study.
8. The sample size for the training set: Not applicable or not specified. Pulse oximeters generally use established algorithms based on optical properties of blood, rather than machine learning training sets in the modern sense.
9. How the ground truth for the training set was established: Not applicable or not specified.

Ask a specific question about this device