Search Results

Ask a specific question about this device

Ask a specific question about this device

The Model 2001 Pulse Oximeter is intended to provide continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate units in neonatal, pediatric and adult patients in hospital-type facilities and intra-hospital transport environments such as the operating room, emergency department and intensive care units. The Model 2001 and its sensors are intended to be used by trained operators when pulse oximetry monitoring is required in the judgement of a physician.

The Model 2001 Pulse Oximeter is designed for continuous, non-invasive monitoring of the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. Oxygen saturation is measured with ratiometric technique using red and infrared absorbance of oxy- and deoxyhemoqlobin and pulse rate is measured using the time between successive pulses. The O2 saturation sensors are already legally marketed as accessories to the Model 520A monitor. The Model 2001 displays digital values of SpO2 and pulse rate as well as a graphic display of the plethysmogram. The Model 2001 monitor consists of a dual microprocessor based data acquisition system that measures oxygen saturation data. The firmware for the primary microprocessor performs the functions of the existing Model 520A including data acquisition, display, trending and communications with external devices. The firmware for the second microprocessor, a digital signal processor, performs the filtering, pulse rate and saturation calculations of the existing algorithms and additional calculations which analyze the incoming signals and perform noise reduction on that signal when the presence of noise is detected.

The provided text is a 510(k) premarket notification for the Novametrix Medical Systems, Inc. Model 2001 Pulse Oximeter. It describes the device, its intended use, and its technological characteristics, and asserts substantial equivalence to predicate devices. However, the document does not contain explicit acceptance criteria or a detailed study report proving the device meets specific performance criteria beyond general assertions of accuracy and compliance with industry standards.

The document states: "In addition, inter-device comparison studies and non-invasive controlled hypoxia studies were conducted to establish the Model 2001 accuracy and to ensure that the sensors meet their currently published accuracy specifications with the Model 2001." This is the only mention of studies conducted to evaluate the device's accuracy.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, and MRMC studies cannot be extracted from this document.

Here's an attempt to answer the questions based on the limited information available:

1. Table of acceptance criteria and the reported device performance

Based on the provided document, specific numerical acceptance criteria and a detailed report of the device's performance against these criteria are not available. The document only generally states that "inter-device comparison studies and non-invasive controlled hypoxia studies were conducted to establish the Model 2001 accuracy and to ensure that the sensors meet their currently published accuracy specifications with the Model 2001." This implies the acceptance criteria were related to achieving accuracy comparable to previous models and meeting sensor specifications, but the specific metrics are not quantified.

A hypothetical table structure would look like this if the information were present:

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

The document only mentions "inter-device comparison studies and non-invasive controlled hypoxia studies." It does not specify the sample size (number of subjects or cases) used in these studies, nor does it provide information on the data provenance (e.g., country of origin, retrospective or prospective).

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

The document does not provide details on how ground truth was established for the "inter-device comparison studies" or "non-invasive controlled hypoxia studies." It does not mention the use of experts, their number, or their qualifications for establishing ground truth.

4. Adjudication method for the test set

The document does not describe any adjudication method for establishing ground truth in the studies mentioned.

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 MRMC comparative effectiveness study is mentioned. This device is a pulse oximeter, which provides a direct measurement (SpO2 and pulse rate) rather than diagnostic images requiring human interpretation, so an MRMC study would not be applicable in this context. The document focuses on the device's accuracy in measuring physiological parameters.

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

The device itself is a standalone algorithm (Model 2001 Pulse Oximeter) that "measures functional oxygen saturation data" and performs "filtering, pulse rate and saturation calculations of the existing algorithms and additional calculations which analyze the incoming signals and perform noise reduction." The mentioned "inter-device comparison studies and non-invasive controlled hypoxia studies" would inherently evaluate this standalone performance.

7. The type of ground truth used

While not explicitly stated with detail, "non-invasive controlled hypoxia studies" typically involve inducing controlled levels of hypoxia in subjects and comparing the device's SpO2 readings against a gold standard method, such as arterial blood gas analysis (co-oximetry) or another highly accurate reference oximeter. Therefore, the ground truth would likely be a reference measurement from an established medical device or direct physiological measurement. The "inter-device comparison studies" would likely use readings from the predicate devices as a comparative "ground truth" or reference.

8. The sample size for the training set

The document does not mention a "training set" in the context of machine learning, as this device was developed in 1999 and pre-dates widespread use of complex AI algorithms requiring large training datasets as we understand them today. The device uses "proprietary algorithms" and "artifact filtering software" developed based on "existing algorithms." Therefore, there's no explicitly defined "training set" in the modern sense.

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

As there is no mention of a "training set" for AI/machine learning algorithms, the method for establishing its ground truth is not applicable or described in the document. The algorithms were likely developed and refined based on engineering principles, signal processing, and performance against known physiological responses and noise conditions rather than a labeled training dataset.

Ask a specific question about this device

The intended use of the CO2,SMO Plus! with NICO is to provide:

• cardiac output monitoring via the method of partial rebreathing in adult patients receiving . mechanical ventilation during general anesthesia and in the intensive care unit (ICU).
• . spirometric, carbon dioxide and pulse oximetry monitoring in neonatal, pediatric and adult patients during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED). Separate flow sensors and CO2 airway adapters are provided for pediatric/adult and neonatal use.

It is intended to be used by trained operators when spirometric, capnographic, pulse oximetry, or cardiac output monitoring is indicated in the judgement of a physician.

It is intended that:

• the neonatal flow and combined CO /flow sensors be used with ET tube sizes less . than or equal to 4 mm and
• the pediatric/adult flow and combined CO2/flow sensors be used with ET tube sizes # greater than 4 mm or with 22 mm ID breathing circuit devices such as a mouthpiece.

The fittings of the flow sensors and CO2 airway adapters comply with ISO [5356-1: 1987 (E)].

The flow sensors and CO2 airway adapters may be used in conjunction with endotracheal tubes, face masks, and breathing circuit devices that also comply with the same fitting specification.

The flow sensors, combination CQ2fflow sensors, single patient use CO, airway adapters and valve assembly are single patient use devices.

The CO2SMO Plus! with NICO can calculate additional parameters such as cardiac output, pulmonary capillary blood flow, cardiac index, stroke volume and systemic vascular resistance.

The use of the CO2SMO Plus! with NICO is contraindicated in patients in which a small rise (3-5 mmHg) in their arterial partial pressure of CO, level cannot be tolerated.

Not Found

This FDA 510(k) clearance letter for the Novametrix Medical Systems, Inc. CO2SMO Plus! With NICO device does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them.

The document is a regulatory clearance letter, which confirms that the FDA has determined the device is substantially equivalent to a legally marketed predicate device. It briefly mentions the "Indications For Use" but does not describe specific performance metrics, acceptance criteria, or the methodology of a study to demonstrate these.

To fully answer your request, here's a breakdown of what's missing and why it cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: This information is typically found in the summary of the 510(k) submission itself, often in sections detailing device performance data or clinical validation. The clearance letter only states that the device is "substantially equivalent" to a predicate, implying that its performance is deemed acceptable based on comparison to existing devices. It does not provide the specific performance values or the criteria against which they were measured.

2. Sample size used for the test set and the data provenance: This level of detail would be in the study design section of the 510(k) submission, not the clearance letter.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As with sample size, this is part of the study design information, absent from this document.

4. Adjudication method: Not present in this regulatory letter format.

5. Multi Reader Multi Case (MRMC) comparative effectiveness study information: This type of study detail would be in the clinical or performance data section of the 510(k) submission. Given the device (CO2SMO Plus! with NICO for physiological monitoring), it's less likely to involve a comprehensive MRMC study in the way an imaging AI algorithm would.

6. Standalone performance: While the device functions as a "standalone" monitor, the performance study demonstrating its accuracy in a standalone mode, with specific metrics, is not detailed here. The letter only approves the device for marketing.

7. The type of ground truth used: This would be specific to each parameter being measured (e.g., CO2 values correlated with blood gas analysis, cardiac output against a gold standard method). This information is not in the clearance letter.

8. Sample size for the training set: This device is a physiological monitoring system, not an AI/ML algorithm that undergoes a "training" phase in the typical sense (unless it incorporates some adaptive algorithm, which is not mentioned). Therefore, a "training set" as understood for AI is unlikely to be relevant here, or if it were, the details would be in the detailed submission.

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

In summary: The provided document is an FDA 510(k) clearance letter. Its purpose is to inform the manufacturer that their device has been found substantially equivalent to a predicate and can be legally marketed. It meticulously avoids detailing the specific study results, acceptance criteria, or ground truth establishment methods, as those are contained within the full 510(k) submission document, which is a much more extensive technical dossier.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device