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OxiScan II Oximetry Data Management Software (OxiScan II) is a central server based software system that uses a personal computer based application written in Microsoft Dot Net protocol to capture oximetry data from an oximeter, and then transmit this data, in a secure encrypted file, via internet, to the central server. At the central server the data is used to render a standard report that is then transmitted via fax and/or email to the prescribing physician. The intended use of the report is to provide a physician with information to help determine the best pulmonary treatment.

The OxiScan II Oximetry Data Management Software is intended to collect, report and archive oximetry trend data to provide information to a medical professional, as a supplemental tool to assist in the timely identification of pulmonary needs.

The OxiScan II Oximetry Data Management Software is intended to (1) transfer oximetry data from a pulse oximeter to a central server data base in order to maintain unique records per patient and test of this pulse oximetry data, and (2) to generate and archive standard reports drawn from this data. A list of approved oximeters appears in the Capture software.

The OxiScan II Oximetry Data Management Software is not a diagnosis tool. It is a decision management support tool that allows medical personnel to securely and accurately upload and view data related to pulse oximetry and to provide output reports as feedback which may be used by a Heathcare professional to form a patient history.

OxiScan II Oximetry Data Management Software is an accessory for use with compatible pulse oximeters. OxiScan II Oximetry Data Management Software collects and stores patient information containing raw oximetery data captured by a pulse oximeter. This information is transferred by a personal computer to an internet Web server where a report which summarizes and graphically presents the data is prepared. This report is delivered to a Healthcare Professional who then uses it along with other information to determine a course of pulmonary treatment. The report may be retrieved, reviewed, and retransmitted via the OxiScan II Oximetry Data Management Software web site.

The OxiScan II Oximetry Data Management Software is a software system intended to collect, report, and archive oximetry trend data from compatible pulse oximeters to provide information to a medical professional. It acts as a supplemental tool for timely identification of pulmonary needs and to form a patient history, but it is not a diagnostic tool.

The acceptance criteria for the OxiScan II Oximetry Data Management Software are primarily focused on its functional characteristics, safety, and effectiveness in meeting its stated intended use, and its substantial equivalence to a predicate device. The study demonstrating that the device meets these criteria is described as "Functional and Safety Testing."

Here's the breakdown of the information requested, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a numerical sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that "Representative samples of OxiScan II Oximetry Data Management Software were successfully performance tested."

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The testing mentioned appears to be software performance testing rather than clinical validation with expert review.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

The document does not describe any adjudication method for a test set. The validation described focuses on functional, safety, and effectiveness testing of the software itself and its equivalence to a predicate device.

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, an MRMC comparative effectiveness study was not done. The device is data management software, not an AI-assisted diagnostic tool. Its purpose is to collect, report, and archive oximetry data for review by healthcare professionals, not to provide interpretations or assist human readers in making diagnoses in the way an AI algorithm might.

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

The device, OxiScan II, is described as "Oximetry Data Management Software." Its standalone performance would relate to its ability to accurately capture, transmit, process, and report oximetry data as per its specifications. The document states that "Representative samples of OxiScan II Oximetry Data Management Software were successfully performance tested to verify compliance to appropriate functional characteristics." This implies standalone testing of the software's data management capabilities. However, it explicitly states it is "not a diagnosis tool" and relies on a "Healthcare Professional" for interpretation, meaning its intended use always involves human-in-the-loop for clinical decision-making.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document does not detail the type of "ground truth" in the sense of clinical diagnoses or outcomes. Given the nature of the device as data management software, the "ground truth" for its performance testing would likely involve:

• Expected data values/formats: Verifying that captured oximetry data matches the source.
• Report accuracy: Confirming that generated reports correctly reflect the stored data.
• System functionality: Ensuring features like secure transmission, archiving, and retrieval work as designed.
• Compliance with specifications: Testing against pre-defined functional and technical requirements.

8. The Sample Size for the Training Set

The document does not mention a training set, as the device is not described as utilizing machine learning or artificial intelligence that would typically require a training set. The "Functional and Safety Testing" refers to performance verification, not an AI model's training.

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

As no training set is mentioned or applicable to this type of software, this information is not provided.

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The intended use of the TidalWave Sp (Models 710/715) is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia / recovery, in the intensive care unit (ICU), and in Emergency Medicine/Transport or Respiratory care. Separate airway adapters are provided for pediatric/adult and neonatal/pediatric use.

The Tidal Wave Models 710/715 handheld combined pulse oximeter/capnograph are designed for continuous, non-invasive monitoring of carbon dioxide and functional oxygen saturation. Oxygen saturation is measured with ratiometric technique using red and infrared absorbance of oxy- and deoxyhemoglobin and pulse rate is measured using the time between successive pulses. Carbon dioxide is measured on-airway using an infrared absorption (IR) technique. The airway adapters and O2 saturation sensors are already legally marketed as accessories to the Model 610 and Model 510 monitors, respectively. The TidalWave Sp monitor is a microprocessor based data acquisition system consisting of CO2 and SpO2 measurement, control circuitry and a high speed serial interface. The monitor uses SRAM for data storage and an EEPROM to store system parameters. The firmware resides in a PROM. The operations performed by the TidalWave Sp monitor include data acquisition, parameter calculation, zeroing, heater control and corrections to the CO2 signal for N2O, O2 and barometric pressure.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Tidal Wave Sp, Models 710/715 device. It's important to note that the provided document is a 510(k) summary (K032971) which focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed study report with all the specific data points requested in your prompt. Therefore, some of the information you asked for may not be explicitly stated or not applicable in this type of submission.

Acceptance Criteria and Device Performance for Tidal Wave Sp, Models 710/715

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly list quantitative acceptance criteria in a formal table like a performance specification. Instead, it states that "inter-device comparison studies were conducted to establish the TidalWave Sp accuracy and to ensure that the sensors meet their currently published accuracy specifications with the specified predicate devices."

The key performance indicators are implied to be accuracy for CO2 measurement and accuracy for SpO2 and pulse rate measurement.

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

The document does not explicitly state the sample sizes (number of patients or measurements) used for the "inter-device comparison studies."

• Data Provenance: Not explicitly stated, but the submission is from Respironics Novametrix, Inc. in Wallingford, CT, USA. Given the context of a 510(k) submission to the FDA, it is highly likely that the testing was conducted in a controlled environment, potentially with healthy volunteers or clinical patients. The studies were retrospective in the sense that they were comparing the new device's performance against established predicate devices rather than observing real-world outcomes over a long period.

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

This information is not provided in the summary. For devices like pulse oximeters and capnographs, the "ground truth" for accuracy is typically established by using highly accurate, calibrated reference measurement devices (e.g., co-oximeters for SpO2, calibrated gas analyzers for CO2) rather than expert consensus.

4. Adjudication Method for the Test Set

This is not applicable and not mentioned. Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers interpret medical images or clinical data, and their interpretations need to be reconciled to establish a ground truth. For objective physiological measurements like CO2 and SpO2, adjudication by experts is not the standard method for establishing ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not conducted or reported. MRMC studies are primarily relevant for AI-powered diagnostic tools interpreting complex medical data where human readers are involved. This device is a physiological monitor providing objective measurements, not an interpretative AI tool that assists human readers.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance evaluation of the device's algorithms was implied and conducted as part of the "inter-device comparison studies." The device's SpO2 and pulse rate algorithms are explicitly stated to be "identical" to the predicate device (Model 510 Pulse Oximeter). The CO2 algorithm is based on established IR absorption linearity and factory calibration to known concentrations. The "accuracy" reported for these measurements is inherently the standalone performance of the device's algorithms and sensors against reference standards.

7. Type of Ground Truth Used

Based on the description of the devices (pulse oximeter/capnograph):

• For CO2: Ground truth would typically be established using calibrated gas analyzers with known CO2 concentrations. The document mentions "the photodetector's response to a known concentration of CO2 is stored in the monitor at the factory," implying calibration against such standards.
• For SpO2: Ground truth would typically be established using laboratory co-oximetry (or similar invasive arterial blood gas analysis) which is considered the gold standard for measuring fractional oxygen saturation in blood.
• For Pulse Rate: Ground truth would likely be established using simultaneous ECG monitoring or other highly accurate cardiac rhythm detection methods.

8. Sample Size for the Training Set

This information is not provided and is largely not applicable in the context of this device. The Tidal Wave Sp is described as a traditional physiological monitor, not an AI/machine learning device that relies on a "training set" in the modern sense. Its algorithms are based on established biophysical principles (infrared absorption, light absorption by hemoglobin) and fixed factory calibrations, not statistical learning from a large dataset.

9. How Ground Truth for the Training Set Was Established

As there is no "training set" in the context of modern AI/ML for this device, this question is not applicable. The device's operational parameters and calibration are set at the factory based on known physical properties and reference standards (e.g., known CO2 concentrations, specific light absorption properties of hemoglobin).

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The Model 512 Handheld Pulse Oximeter is intended to provide non-invasive spot checking of functional arterial oxygen saturation and pulse rate in neonatal, pediatric and adult patients in hospital, hospital-type facilities and intra-hospital transport.

The Model 513 Handheld Pulse Oximeter is intended to provide continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate in neonatal, pediatric and adult patients in hospital, hospital-type facilities and intra-hospital transport.

The monitor and its sensors are intended to be used by trained operators when pulse oximetry monitoring is required in the judgment of a licensed medical practitioner.

The Model 512/53 Pulse Oximeters are designed for non-invasive measurement 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 deoxyhemoglobin and pulse rate is measured using the time between successive pulses. The O2 saturation sensors are already legally marketed as successories to the Model 510 monitor. The Model 510 displays digital values of SpO2 and pulse rate. The Model 512/513 consists of a microprocessor based data acquisition system that measures oxygen saturation data. The Model 513 also contains additional circuitry to support battery backed trend data storage and retrieval. Data is stored in a 16Kbyte serial Flash RAM, with time and date retrieved from a separate serial real time clock. The trend data may be transferred serially to a printer or PC via an IRDA compatible chipset.

Acceptance Criteria and Device Performance for Model 512/513 Pulse Oximeter

The provided document describes the predicate device equivalence of the Model 512/513 Pulse Oximeter, rather than a standalone study with defined acceptance criteria and performance metrics for the new device. The core of the submission relies on demonstrating that the Model 512/513 is substantially equivalent to the legally marketed Model 510 Pulse Oximeter and that its sensors meet the currently published accuracy specifications of the Model 510.

Therefore, the "acceptance criteria" for the Model 512/513 can be inferred as meeting or performing comparably to the Model 510's established accuracy specifications. The document does not explicitly state these numerical specifications for the Model 510, nor does it provide specific novel performance data for the Model 512/513 beyond stating that "inter-device comparison studies were conducted to establish the Model 512/513s accuracy and to ensure that the sensors meet their currently published accuracy specifications with the Model 510."

However, based on the information provided, we can structure the response by inferring the likely acceptance criteria based on standard pulse oximetry requirements and what is typically tested for equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Given the lack of explicit numerical acceptance criteria for the Model 512/513 in the provided text, and the reliance on demonstrating equivalence to the Model 510, the table below reflects this approach. The "Reported Device Performance" is derived from the statement that the device meets the predicate's specifications.

Note: The FDA's Oximeter regulation (21 CFR 870.2700) typically requires accuracy testing against arterial blood gas (SaO2) measurements over a range of saturations (e.g., 70-100% SpO2), often using hypoxic challenge studies. The absence of these specific details indicates that the submission focuses on predicate equivalence through comparison studies, implying the Model 510 already met these regulatory standards.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "inter-device comparison studies were conducted," but details on the number of subjects, measurements, or data points are absent.
• Data Provenance: Not explicitly stated. The document does not mention the country of origin for the data or whether the studies were retrospective or prospective. Given the nature of medical device testing for regulatory submission, it is highly probable these were prospective clinical studies, but this is not confirmed in the text.

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

• Number of Experts: Not applicable/not stated in the context of expert review for ground truth in this submission. The ground truth for pulse oximetry accuracy studies is typically established through direct arterial blood gas (SaO2) measurements performed by trained medical personnel, not by a panel of experts reviewing images or other subjective data.
• Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Pulse oximetry accuracy studies generally rely on direct physiological measurements (arterial blood gas analysis) as the gold standard, rather than expert adjudication of subjective assessments.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically performed for diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is assessed. This device is a measurement device, not an interpretive one.

6. Standalone Performance Study (Algorithm only without human-in-the-loop)

• Standalone Study: Yes, in essence, the "inter-device comparison studies" to establish the Model 512/513's accuracy and ensure sensors meet published specifications of the Model 510 represent a standalone performance assessment of the device's measurement capabilities. While not using the explicit term "standalone study," the objective of these comparisons was to verify the device's inherent accuracy in measuring SpO2 and pulse rate, independent of a human interpreting its output.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for pulse oximetry accuracy is typically established by arterial blood gas (SaO2) measurements, which are considered the gold standard for arterial oxygen saturation. While not explicitly stated in the provided text, this is the standard methodology for validating pulse oximeter accuracy.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/not stated. The document indicates that the Model 512/513 uses the "identical SpO2 and pulse rate software algorithm" as the predicate device, Model 510. This implies the algorithm was already developed and validated with the Model 510. There is no mention of a new algorithm requiring a separate training set for the Model 512/513, suggesting it leverages the existing, validated algorithm from the predicate device.

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

• How Ground Truth for Training Set Was Established: Not applicable. As the Model 512/513 uses the identical algorithm from the predicate device (Model 510), any "training" would have occurred during the development of the Model 510. The document does not provide details on the training set or ground truth establishment for the Model 510's algorithm development. It focuses solely on the equivalence of the 512/513 to the already-cleared 510.

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