Search Results

MySign® S is a handheld pulse oximeter with accessory sensors indicated for continuous non-invasive monitoring of the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult and pediatric (excluding neonatal and infant) patients in hospitals, hospital-type facilities, and mobile transport units. For professional use only.

The EnviteC MySign® S Pulse Oximeter is a handheld pulse oximeter monitor validated for use in portable applications, including out of hospital transport. The MySign® S Pulse Oximeter features large readable numeric displays for SpO2 and pulse rate and a pulse bar indicator or waveform for visual assessment of pulsation. The device has settable alarms and an audible pulse tone which varies with saturation level. The MySign® S is offered with a family of Reusable and Disposable SpO2 Sensors for adult and pediatric applications. MySign® PC Software may be used to obtain retrospective monitoring data from MySign® series monitors and to perform utility functions such as setting the institution identification.

The EnviteC MySign® S Pulse Oximeter, Accessory SpO2 Sensors, and MySign® PC Software are evaluated based on their performance in measuring functional oxygen saturation (SpO2) and pulse rate.

Here's an analysis of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for the Test Set

• Sample Size: The document does not explicitly state the number of subjects (the sample size) used in the clinical test. It mentions that "All testing was performed under an institutionally approved protocol with subject informed consent."
• Data Provenance: The clinical testing was performed to validate performance "under controlled hypoxia versus arterial oxygen saturation as determined by co-oximetry." This implies a prospective study design where subjects were intentionally desaturated. The country of origin of the data is not specified, but the submission is from a German company (EnviteC-Wismar GmbH by Honeywell).

3. Number of Experts and their Qualifications for Ground Truth

• The document implies that the ground truth for SpO2 was established by co-oximetry readings from arterial blood samples. This is a standard and highly accurate method for determining arterial oxygen saturation.
• The document does not mention the use of human experts to establish ground truth for the device's primary measurements (SpO2 and pulse rate). The gold standard for SpO2 measurement in these types of studies is the direct measurement of arterial blood gases using a co-oximeter, not expert consensus on visual assessment. Therefore, the concept of "number of experts" is not directly applicable in the context of establishing ground truth for SpO2 accuracy.

4. Adjudication Method for the Test Set

• There is no mention of an adjudication method in the context of the clinical accuracy testing. The ground truth was established by co-oximetry, which is a direct measurement, and thus expert adjudication would not be typical for this type of quantitative assessment.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported. This device is a pulse oximeter, and its performance is assessed against a gold standard (co-oximetry), not by comparing human reader performance with and without AI assistance.

6. Standalone Performance Study

• Yes, a standalone performance study was done for the algorithm (the pulse oximeter device itself). The clinical testing described directly assesses the accuracy of the EnviteC MySign® S Pulse Oximeter with its sensors in measuring SpO2 against co-oximetry, and pulse rate against what is presumed to be the co-oximeter's pulse rate measurement or an ECG/reference monitor. This is a standalone performance assessment of the device.

7. Type of Ground Truth Used

• The ground truth for SpO2 accuracy was established by arterial oxygen saturation as determined by co-oximetry. This is considered a highly accurate and direct measure for oxygen saturation.

8. Sample Size for the Training Set

• The document does not provide information regarding a "training set" or its sample size. Pulse oximeters typically rely on established physiological principles and spectrophotometric measurements. While their algorithms are developed and refined, the concept of a distinct "training set" for a machine learning model, as seen in AI/ML medical devices, is not explicitly detailed or a standard regulatory requirement for conventional pulse oximeters. The development process would involve calibration and internal testing, but not typically a labeled "training set" as understood in current AI contexts.

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

• Since a "training set" is not explicitly mentioned or described, there is no information on how its ground truth was established.

Ask a specific question about this device

The oxygen measuring device MySign® O is designed for continuous or spot monitoring of inspired oxygen concentrations in breathing gas.

MySign® O can be used for monitoring the breathing gases dispensed by the following devices:

Anaesthesia breathing systems
Respiratory equipment
Infant incubators
Oxygen therapy systems

The system is suitable for use inside hospitals as well as during transport (except by air), emergencies, and artificial respiration provided at home.

The EnviteC MySign® O Oxygen Measuring Device is a hand held oxygen monitor which uses the established technology of the EnviteC electrogalvanic oxygen sensor type OOM111. The EnviteC OOM111 medical oxygen sensor has been previously evaluated and cleared under 510(k) K082655.

The MySign® O Oxygen Measuring Device incorporates a medical oxygen sensor placed in the inspired air path or gas supply, a sensor cable, and a monitor to display the measurements. The device is intended for continuous or spot monitoring of inspired oxygen concentrations in breathing gas and provides settable low and high alarm limits.

The optional MySign® PC Software can be used to configure MySign® devices and to transmit data from the device to the PC for the readout of measurement data which is stored in the memory of MySign® monitor. The PC software is not intended for diagnostic functions nor will it influence essential performance functions of the monitor - the MySign® O monitor will not perform measurements when PC connected.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text only explicitly states the acceptance criteria for a general category and does not detail specific numerical targets or thresholds for each test within that category. It also doesn't provide specific numerical performance results beyond stating that the device "met test acceptance criteria."

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

The document does not specify a "test set" in the context of clinical or performance data with a sample size. The testing described refers to bench testing of the device and its components. No patient data or clinical data is mentioned for testing.

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

Not applicable. No ground truth based on expert assessment of a test set is mentioned. The ground truth for the technical performance tests would be established by reference standards or direct measurement instruments.

4. Adjudication method for the test set

Not applicable. No adjudicated test set is 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

Not applicable. This device is an oxygen measuring device and doesn't involve human readers or AI assistance in the way a diagnostic imaging AI would.

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

This refers to a standalone performance study in the context of an algorithm. The device, an oxygen monitor, is itself a standalone measuring device. Its performance was assessed through bench testing as described. There is no mention of a human-in-the-loop aspect for its core function.

7. The type of ground truth used

For the linearity, measurement accuracy, and drift tests, the "ground truth" would have been established by precisely controlled oxygen concentrations generated by calibrated equipment or reference standards. For electrical safety, EMC, risk management, software, and biocompatibility, the ground truth refers to compliance with the respective recognized standards.

8. The sample size for the training set

Not applicable. This device is a measurement device with established physical principles, not a machine learning or AI algorithm that requires a training set of data.

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

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

EnviteC Reusable SpO2 Sensors are indicated for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult and pediatric (excluding neonatal and infant) patients in hospitals, hospital-type facilities, mobile units and home environments.

The EnviteC Reusable SpO2 Sensors type Nihon Kohden are pulse oximeter sensors designed and validated for compatibility with the predicate oximeter manufacturer.

EnviteC's Reusable SpO2 Sensors type Nihon Kohden are comprised of a connector and a cable which terminates into a sensor housing. One housing half contains a dual LED light source, and the other half contains a light sensitive photodetector for pulse oximetry by transmittance method. Two types of sensor housings are offered in this submission:

• A soft rubber finger sensor with unitary sealed tube type construction (two sizes: large and medium)
• An ear clip with rigid halves positioned by mild spring force and an ear hanger for the cable

Each sensor has unique labeling and specifications designed for compatibility with the specific monitor manufacturer.

Each sensor type includes the following features:

• Connector pin-outs specific for the manufacturer type
• Component specifications specific for the manufacture type

Each sensor clearly specifies the manufacturer type with two compatibility statements:

• One printed on or attached to the sensor
• One on the instructions for use.

Here's an analysis of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text only explicitly states that "All sensors met the acceptance criteria" for non-clinical tests and that "Clinical test results support the stated accuracy claims for the specified range of 70% to 100% SaO2." However, it does not provide the specific numerical acceptance criteria for SpO2 accuracy or other performance metrics. Without these, a detailed table cannot be created.

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

The text states that "Clinical testing was performed to validate the performance and accuracy of the EnviteC Reusable SpO2 Sensors type Nihon Kohden under controlled hypoxia versus arterial oxygen saturation as determined by cooximetry."

• Sample Size for Test Set: Not explicitly stated. The text mentions "subjects," but no number is provided.
• Data Provenance: Not explicitly stated, but the testing was performed "under an institutionally approved protocol with subject informed consent," suggesting a prospective clinical study. The country of origin is not specified, though the submitter is from Germany.

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not explicitly stated. However, the ground truth was "determined by cooximetry," which is a laboratory method, not typically established by clinical experts in the same way, for example, diagnosing an image. The cooximetry results themselves would serve as the objective ground truth.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by cooximetry, an objective measurement, not by expert consensus requiring an adjudication method.

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

• Was it done?: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study described focuses on the direct accuracy of the device against an objective measurement (cooximetry), not on human reader performance with or without AI assistance.
• Effect size of human readers improvement: Not applicable, as no MRMC study was performed.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone study was performed. The clinical testing described directly assesses the sensor's performance ("performance and accuracy of the EnviteC Reusable SpO2 Sensors") against an objective ground truth (arterial oxygen saturation determined by cooximetry). This is a direct test of the device's accuracy without a human in the loop for interpretation or intervention.

7. Type of Ground Truth Used

The ground truth used was cooximetry, which provides an objective measurement of arterial oxygen saturation (SaO2).

8. Sample Size for the Training Set

Not applicable. The device is a medical sensor (SpO2 sensor), not an AI algorithm that requires a training set. The "training" in this context would refer to calibration or manufacturing parameters, not a data-driven machine learning step.

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

Not applicable, as there is no training set in the AI/machine learning sense for this type of device.

Ask a specific question about this device

EnviteC Reusable SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult and pediatric (excluding neonatal and infant) patients in hospitals, hospital-type facilities, mobile units and home environments. Prescription device.

The EnviteC Reusable SpO2 Sensors are a family of oximeter sensors designed and validated for compatibility with the predicate oximeter manufacturers listed above. EnviteC's Reusable SpO2 Sensors are comprised of a connector and a cable which terminates into a sensor housing. One housing half contains a dual LED light source, and the other half contains a light sensitive photodetector for pulse oximetry by transmittance method. Three types of sensor housings are offered in this submission: A finger clip with rigid halves positioned by mild spring force, An ear clip with rigid halves positioned by mild spring force and an I ear hanger for the cable, I A soft rubber finger sensor with unitary sealed tube type construction. A unique sensor type exists for each compatible manufacturer above, and each sensor has unique labeling and specifications designed for compatibility with the specific monitor manufacturer (HP/Philips, Minolta). Each sensor type includes the following features: r Connector pin-outs specific for the manufacturer type, Component specifications specific for the manufacture type. Each sensor clearly specifies the manufacturer type with two compatibility statements: One printed on or attached to the sensor r, 트 One on the instructions for use.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Device: EnviteC Reusable SpO2 Sensors

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific numerical acceptance criteria for the clinical study (e.g., a specific SpO2 accuracy range with a defined root mean square error (RMSE) or bias/precision). Instead, it states that the clinical test results "support the stated accuracy claims for the specified range of 70% to 100% SaO2."

However, based on regulatory expectations for SpO2 devices, the general acceptance criteria for accuracy are often inferred from standards like ISO 80601-2-61 (which might not have been fully in effect or the exact version used at the time of this filing in 2009 for the clinical study). A common requirement for pulse oximeters is an accuracy of ±2% or ±3% across the specified range.

Therefore, the table below reflects what can be inferred rather than explicitly stated.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "patients" and "subjects" but does not provide a specific number for the cohort involved in the clinical testing.
• Data Provenance:
  • Country of Origin: Not explicitly stated whether the clinical study was conducted in a specific country. However, the manufacturer is German (EnviteC-Wismar GmbH, Germany), and the 510(k) submission is to the FDA in the USA, implying potential international or US-based studies.
  • Retrospective or Prospective: The study was prospective. This is indicated by the statement: "All testing was performed under an institutionally approved protocol with subject informed consent." This implies a planned, ethics-committee-approved study with new data collection.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not explicitly stated, though "co-oximetry" is the gold standard for measuring SaO2 in these types of studies, typically performed by trained laboratory personnel or medical professionals. The interpretation of the co-oximetry results themselves does not usually require "experts" in the sense of physicians reviewing images, but rather proper execution and interpretation of laboratory-based physiological measurements.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not mentioned. The ground truth for SpO2 studies is typically a direct physiological measurement (co-oximetry), which does not usually involve multi-reader adjudication as seen in image-based diagnoses.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed as described. This type of study is typically used for diagnostic imaging devices where human readers interpret medical images. The EnviteC device is a sensor for direct physiological measurement (SpO2 and pulse rate), not an imaging device requiring human interpretation of output data for primary diagnosis.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

• Standalone Performance Study: Yes, a standalone performance study was performed. The clinical testing described directly assesses the accuracy of the EnviteC Reusable SpO2 Sensors (the algorithm/device only) against a reference standard (co-oximetry) under controlled conditions. This is the primary method for evaluating pulse oximeter accuracy.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth used was co-oximetry. The text states: "Clinical testing was performed to validate the performance and accuracy of the EnviteC Reusable SpO₂ Sensors under controlled hypoxia versus arterial oxygen saturation as determined by co-oximetry." Co-oximetry is considered the gold standard for measuring fractional hemoglobin oxygen saturation.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/not mentioned. The document describes a medical device sensor, not an AI/ML algorithm that typically undergoes a distinct training phase with a dedicated dataset. The "validation" studies are for performance evaluation, not algorithm training. If there were internal iterative design/development tests, those datasets (and their sizes) are not detailed here.

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

• How Ground Truth for Training Set was Established: Not applicable/not mentioned, as there is no indication of a distinct "training set" for an AI/ML algorithm. The device's underlying technology relies on established pulse oximetry principles and sensor design rather than a trainable model.

Ask a specific question about this device

The EnviteC Medical Oxygen Sensors are intended to replace the original oxygen-sensing component of an oxygen analyzer that measures oxygen concentration in breathing gas mixtures.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

The subject of this 510(k) is a family of EnviteC Medical Oxygen Sensors which may be used as industry replacement types with various medical inspired-oxygen measuring devices.
The EnviteC Medical Oxygen Sensors all utilize the commonly accepted electro-galvanic operating principle with defined variations in the mounting configuration and electrical connections to correspond to common industry family replacement types.

The provided text describes the EnviteC Medical Oxygen Sensors and its 510(k) summary. However, it does not include detailed information regarding specific acceptance criteria, a separate study proving its capabilities, or the methodology for establishing ground truth for a training set. The device is a physical sensor, not an AI/ML algorithm, which explains the absence of some of the requested information.

Here's a breakdown of the available information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The text states that the sensors were evaluated against applicable standards for respiratory gas monitors and "met all of the performance criteria." However, the specific quantitative acceptance criteria or the reported performance values are not provided.

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

• Sample Size for Test Set: Not explicitly mentioned. The text indicates "compliance tests included evaluation of basic safety, mechanical characteristics, and environmental operation and storage conditions" and "evaluation of device performance characteristics." However, the number of sensors tested or the amount of data collected for these evaluations is not specified.
• Data Provenance: The testing was conducted by EnviteC-Wismar GmbH (Germany), implying the data originated from their internal testing processes. The text does not specify if the tests were retrospective or prospective, but the context generally suggests prospective testing during device development and validation.

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

This question is largely not applicable in the context of a physical oxygen sensor's performance evaluation. The "ground truth" for sensor performance is typically established through calibrated reference instruments and defined environmental conditions, not through expert human interpretation. Therefore, there's no mention of experts establishing a ground truth for a test set in the way it would be done for, for example, image analysis.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review of complex data (e.g., medical images) to establish a consensus ground truth. For a physical sensor, performance is measured against established physical standards and calibrated instruments, not subjective expert judgment that requires adjudication.

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

No. The document is for a physical oxygen sensor. MRMC studies are typically performed for diagnostic tools that involve human interpretation, often in the field of AI/ML, to assess the impact of the tool on human reader performance. This type of study is not relevant to the described device.

6. Standalone Performance Study

Yes, implicitly. The "Non-Clinical Tests Submitted" section describes the evaluation of the sensors' performance characteristics independently. The sensors were "evaluated for device performance characteristics including signal characteristics in the presence of temperature, pressure, humidity, and interfering gases." This constitutes a standalone performance evaluation of the device itself, without human-in-the-loop.

7. Type of Ground Truth Used

The ground truth for evaluating the EnviteC Medical Oxygen Sensors would be based on:

• Calibrated Reference Measurements: Oxygen concentration, temperature, pressure, humidity, and the presence of interfering gases would be precisely controlled and measured using highly accurate and calibrated reference instruments.
• Established Physical Standards: Compliance to applicable elements of standards for respiratory gas monitors indicates comparison against predefined benchmarks and acceptable ranges of performance.

Therefore, the ground truth is derived from instrumentation and physical standards, not expert consensus, pathology, or outcomes data in the usual sense.

8. Sample Size for the Training Set

Not applicable/Not specified. This device is a physical sensor operating on "electro-galvanic operating principle." It is not an AI/ML algorithm that requires a "training set" in the computational sense. The device's operational parameters are inherent to its design and manufacturing, not learned from data.

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

Not applicable. As the device is not an AI/ML algorithm, there is no training set or ground truth established in this manner. The device's functionality is determined by its physical and chemical properties and engineering design.

Ask a specific question about this device

The EnviteC OxiPen Pulse Oximeter is intended for noninvasive spot-check measurement of functional oxygen saturation of arterial hemoglobin (SpO2), and pulse rate (measured by SpO2 sensor accessories).

The monitor is intended for use on adult and pediatric patients in hospitals, hospital-type facilities, mobile, and home environments.

The OxiPen Pulse Oximeter is a compact battery-powered handheld monitor designed for simplicity and portability for spot checking applications. It does not provide alarms or settable alarm limits.

The OxiPen features large readable numeric displays for SpO2 and pulse rate and a pulse bar indicator for visual assessment of pulsation. Additional indicators include a signal quality LED and heart symbol which show pulsation, a sensor symbol for disconnection alert, and a battery capacity symbol.

Like the referenced predicate device, the OxiPen provides an audible pulse tone which varies with saturation level, as well as audible and visual alerts for conditions like sensor disconnect and power-off. The LCD display may be backlit by briefly pressing any key.

The OxiPen is provided with sensors specifically designed for use with the device, and features a compact connector with EnviteC proprietary pinout.

The EnviteC OxiPen Pulse Oximeter and accessory sensors employ the same technological characteristics as the predicate device and other oximeters to determine functional arterial oxygen saturation - arterially perfused tissue is illuminated sequentially by two wavelengths of light emitted by light emitting diodes (LED's), and the time varying absorbance of the tissue is measured from a photodiode light sensor. The resultant electrical signal is amplified, digitized, and analyzed to determine the functional oxygen saturation and pulse rate. The information is displayed on a liquid crystal display with pulse bar graph and audible pulse tone.

The OxiPen utilizes a two-layer architecture in which the oximeter-specific functions are managed by a dedicated subsystem (ChipOx) and the monitor functions including power management, display, and user interface are controlled separately.

Here's a summary of the acceptance criteria and study information based on the provided document:

Acceptance Criteria and Device Performance Study for EnviteC OxiPen Pulse Oximeter

The document primarily focuses on demonstrating substantial equivalence to a predicate device and fulfilling regulatory requirements for safety and efficacy. While it states that clinical tests were performed to validate accuracy claims, it does not explicitly list specific numerical acceptance criteria for performance metrics (e.g., accuracy range for SpO2 or pulse rate) in a table format. Instead, it broadly states that the device "passed all of the tests" and "Clinical test results support the stated accuracy claims for the specified range of 70% to 100% SaO2."

Therefore, the table below reflects what can be inferred or directly stated from the provided text regarding performance. Specific numerical acceptance criteria are not available in this document.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify the exact number of subjects or cases used in the clinical testing. It only states, "Clinical testing was performed... All testing was performed under an institutionally approved protocol with subject confidentiality and informed consent."
• Data Provenance: The document does not explicitly state the country of origin of the clinical data. It is a submission by a German company, so it is plausible it could be European or international.
• Retrospective or Prospective: Not explicitly stated, but the phrase "Clinical testing was performed... under an institutionally approved protocol with subject confidentiality and informed consent" strongly suggests a prospective study.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• No adjudication method is described in the provided text.

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

• No MRMC comparative effectiveness study is mentioned. The study described focuses on standalone device performance against cooximetry.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone performance study was conducted. The clinical testing "validated the performance and accuracy of the EnviteC OxiPen Pulse Oximeter and accessory sensors under controlled hypoxia versus arterial oxygen saturation as determined by cooximetry." This is a direct measure of the device's accuracy without human interpretation influencing the measurement itself.

7. Type of Ground Truth Used

• Expert Consensus: Not explicitly stated.
• Pathology: Not applicable for SpO2 measurement.
• Outcomes Data: Not applicable for SpO2 measurement.
• Other: Cooximetry was used as the ground truth for arterial oxygen saturation (SaO2). The document states, "...versus arterial oxygen saturation as determined by cooximetry."

8. Sample Size for the Training Set

• The document does not describe a machine learning model or a training set. It refers to "Embedded software in the device," but this would typically involve traditional software development and verification/validation, not a machine learning training process.

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

• Not applicable, as no machine learning training set is described.

Ask a specific question about this device

EnviteC Reusable SoftTip Y SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult, pediatric, and infant patients in hospitals, hospital-type facilities, mobile, and home environments.

EnviteC's Reusable SoftTip Y sensors are a modification of EnviteC's Multi-Site Y SpO2 Sensors listed in K043463. The modification integrates the two Y-sensor housing tips into a single molded rubber tube which facilitates placement on a digit. This modification preserves in its entirety the original optical geometry and specifications of the predicate Y-sensors.

Like the Multi-site Y SpO2 sensors, EnviteC's SoftTip Y SpO2 sensors consist of a connector and a duplex cable which divides at the distal end to the LED light source and light sensitive photodetector.

The EnviteC SoftTip Y SpO2 Sensors comprise a family of oximeter sensors designed and validated for compatibility with the same oximeter monitor manufacturers as the Y-Sensors.

A unique SoftTip Y sensor exists for each manufacturer series, and each SoftTip Y sensor has unique labeling and specifications designed for compatibility with the specific monitor manufacturer (Nellcor, CSI, etc.).

Each sensor type includes the following unique features:

• Connector pin-outs specific for the manufacturer type .
• . Component specifications specific for the manufacture type

Each sensor also specifies the manufacturer type with two compatibility statements:

• One printed on or attached to the sensor .
• . One on the instructions for use.

The provided text describes a 510(k) premarket notification for a medical device (EnviteC Reusable SoftTip Y SpO2 Sensors) and its substantial equivalence to a predicate device. The information primarily focuses on the device modification and why existing clinical data for the predicate device is sufficient.

Here's a breakdown of the requested information based on the provided text:

1. 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)

The document states that no new clinical testing was performed for the modified device. Instead, it relies on the clinical hypoxia testing performed for the predicate Y SpO2 Sensors.

• Sample size: Not specified for the predicate device's clinical testing.
• Data provenance: Not specified for the predicate device's clinical testing.
• Retrospective/Prospective: Not specified for the predicate device's clinical testing.

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, as new clinical testing with ground truth establishment was not performed for this device. The document defers to prior clinical testing of the predicate device, for which this information is not provided.

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

Not applicable, as new clinical testing with adjudication was not performed for this device. The document defers to prior clinical testing of the predicate device, for which this information is not provided.

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 device is an oximeter sensor, not an AI-powered diagnostic tool. The concept of human readers improving with or without AI assistance does not apply.

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

Not applicable. This device is an oximeter sensor, not an AI algorithm.

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

For the predicate device, the clinical hypoxia testing would have likely used a co-oximeter or arterial blood gas (ABG) analysis as the reference standard (ground truth) for SaO2 measurements. However, the document does not explicitly state the specific type of ground truth used.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm that requires a training set.

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

Not applicable. This device is not an AI algorithm that requires a training set.

Ask a specific question about this device

EnviteC Reusable Multi-site Y SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult, pediatric, infant, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.

Not recommended for use on the ear.

Prescription device.

The EnviteC Reusable Multi-site Y SpO2 Sensors are a family of oximeter sensors validated for compatibility with the predicate oximeter manufacturers listed above.

EnviteC's Reusable Multi-site Y SpO₂ Sensors consist of a connector and a cable which divides at the distal end into two sensor housings. One housing contains a dual LED light source, and the other contains a light sensitive photodetector. The housings may be positioned on various sites including the finger, thumb, toe, or foot, and are affixed by a medical grade tape.

A unique Y sensor exists for each manufacturer above, and each Y sensor has unique labeling and specifications designed for compatibility with the specific monitor manufacturer (Nellcor, CSI, etc.).

Each sensor type includes the following unique features:

• Connector pin-outs specific for the manufacturer type .
• Component specifications specific for the manufacture type

Each sensor also specifies the manufacturer type with two compatibility statements:

• One printed on or attached to the sensor .
• One on the instructions for use.

Here's an analysis of the provided text regarding the acceptance criteria and study for the EnviteC Reusable Multi-site Y SpO2 Sensors:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format, nor does it provide specific numerical results of the device's performance against such criteria. The clinical testing section broadly states:

• Clinical test results support the stated accuracy claims for the specified range of 70% to 100% SaO2.

This suggests that the device's accuracy within the 70% to 100% SaO2 range was deemed acceptable. However, specific performance metrics like Root Mean Square (RMS) difference, bias, or precision are not provided in this summary.

Detailed Study Information

1. A table of acceptance criteria and the reported device performance:
   As mentioned above, a quantitative table is not present in this summary. The performance is broadly stated as supporting accuracy claims within 70-100% SaO2.

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: The document does not specify the sample size (number of subjects/patients) used for the clinical testing.
   • Data Provenance: The testing was "performed under controlled hypoxia versus arterial oxygen saturation as determined by co-oximetry" and "All testing was performed at a single institutionally approved protocol." This indicates the data was prospective and collected specifically for this study. The country of origin is not explicitly stated, but given the manufacturer's location (Germany) and the submission to the FDA (USA), the testing likely occurred in one of these regions or a location approved for such clinical trials.

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

   • The ground truth was established by "arterial oxygen saturation as determined by co-oximetry." Co-oximetry is a laboratory method, not typically relying on expert interpretation for its raw result. Therefore, there's no mention of experts needed to establish this specific ground truth. Clinical staff would have performed the blood draws and laboratory analysis.

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

   • There is no mention of an adjudication method in the context of expert review for the test set. Given the ground truth method (co-oximetry), expert adjudication of the ground truth itself wouldn't be applicable in the same way it would be for an imaging study.

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:

   • This is not applicable. The device is an SpO2 sensor, not an AI-powered diagnostic tool that assists human readers.

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

   • Yes, the clinical testing describes the standalone performance of the SpO2 sensors in measuring oxygen saturation compared to co-oximetry (the "ground truth"). The device itself outputs a reading without a human interpreting an image or complex data for diagnosis.

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

   • The ground truth used was arterial oxygen saturation as determined by co-oximetry. This is a direct, objective physiological measurement.

8. The sample size for the training set:

   • The document does not provide information on a "training set" in the context of an algorithm. SpO2 sensors are typically calibrated during manufacturing and their performance is verified through clinical testing, rather than "trained" in the machine learning sense.
   • If by 'training set' it refers to the data used during the R&D phase to refine the sensor's algorithms and hardware, this information is not disclosed in the 510(k) summary. The summary focuses on the formal verification and validation (V&V) testing.

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

   • Not applicable as no "training set" in the machine learning context is described. For sensor calibration and development, manufacturers typically use a variety of controlled conditions and known oxygen saturation levels, often verified by co-oximetry or other reference methods, but this is part of the internal design and development process, not usually detailed in a 510(k) summary.

Ask a specific question about this device

Continuous or spot monitoring of non-invasive arterial oxygen saturation.

Multicompatible EnviteC Disposable and Reusable Oximeter Sensor(s)

The provided text is a 510(k) clearance letter from the FDA for a medical device: "Multicompatible EnviteC Disposable and Reusable Oximeter Sensors." This letter confirms that the device has been found substantially equivalent to a legally marketed predicate device.

However, the letter does not contain any information regarding:

• Acceptance criteria or reported device performance for a study.
• Sample sizes, data provenance, number or qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set or how ground truth for the training set was established.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or other study details based on the provided text. The document is a regulatory clearance letter, not a detailed study report.

Ask a specific question about this device