Search Results

The OxyMinder Pro is an oxygen monitor with integrated pressure monitoring intended for continuous monitoring of the concentration of oxygen and pressure being delivered to patients ranging from newborns to adults. This device can be used in the hospital and subacute settings. The monitor is not intended as a life supporting device or for diagnostics.

The OxyMinder Pro is an oxygen and pressure monitor capable of measuring the oxygen concentration from 18 to 100% (cleared under K213948) and pressure from 0 to 60 cmH2O (subject of this submission) that for convenience can be mechanically mounted on to the cleared blender.

The pressure is measured via a disposable pressure tubing that connects from the monitor to an adapter placed in the patient circuit. This sampling line is identical to that cleared in predicate Maxtec K221734. We have only updated the labeling to reflect the name of the sponsor.

As indicated the oxygen monitoring portion has been previously cleared, K213948. It utilizes a cleared oxygen sensor which outputs a voltage to determine the concentration of oxygen. The OxyMinder Pro calibrates at ambient air (21%) and 100% oxygen. The OxyMinder Pro is software controlled. Again, the oxygen monitoring feature and functions are unchanged and previously cleared under reference K213948.

The new pressure monitoring feature utilizes a pressure sensor which measures the pressure within a patient circuit. There is a disposable pressure tubing that connects between the patient circuit and the pressure sensor.

This document, K251245, describes the 510(k) clearance for the OxyMinder Pro, an oxygen and pressure monitor. It uses the Maxtec MaxO2ME+p (K221734) as its predicate device for the combined oxygen and pressure monitoring features, and the Bio-Med Devices OxyMinder (K213948) as a reference for the oxygen monitoring aspects, which were previously cleared.

The core of the submission focuses on the new pressure monitoring feature, as the oxygen monitoring component is largely based on a previously cleared device (OxyMinder, K213948). The acceptance criteria and testing detailed largely pertain to the performance of the device's measurement capabilities and adherence to relevant safety and performance standards.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the performance specifications of the OxyMinder Pro and compares them to the predicate and reference devices. These specifications serve as the acceptance criteria for the device's functionality. The "Reported Device Performance" is implied by the similarity claims and the statement that "The test results met the applicable standards".

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

The document states that "Bench testing was performed" and lists various types of tests (Shelf-life / Aging, Software Verification and Validation, Safety and ElectroMagnetic Compatibility, etc.). It claims that "The test results met the applicable standards". However, the sample size for the test set is not explicitly stated.

The data provenance is not explicitly mentioned as country of origin, nor is it specified if the testing was retrospective or prospective. Given it's bench testing for a device clearance, it is implicitly prospective testing within a laboratory/manufacturing environment.

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

This type of information (number of experts, their qualifications, and their role in establishing ground truth) is not applicable or not provided for this specific 510(k) submission. Medical device performance testing, especially for devices like oxygen and pressure monitors, relies on calibrated instruments and established physical and electrical standards to determine "ground truth" (e.g., a calibrated gas mixture for oxygen concentration, a pressure calibrator for pressure measurements), not human expert consensus.

4. Adjudication Method for the Test Set

The concept of an adjudication method (like 2+1 or 3+1 used in clinical trials or image interpretation studies) is not applicable here. The "ground truth" for the device's performance (e.g., accuracy of oxygen or pressure readings) is established through comparison to validated and calibrated measurement standards, not through human interpretation that would require adjudication.

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

An MRMC study is not applicable and was not done for the OxyMinder Pro. MRMC studies are typically used to assess human reader performance, often in diagnostic imaging, with and without AI assistance. The OxyMinder Pro is a direct measurement device; its performance is based on its physical and electrical accuracy, not on human interpretation or an AI algorithm assisting human interpretation.

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

The OxyMinder Pro itself is a standalone device. Its performance, as described by its measurement accuracy, resolution, response time, etc., is its standalone performance without a human-in-the-loop influencing the measurement itself. The device is intended to present data to a human for monitoring, but its core function (measurement) is standalone. The testing conducted, as per the "Non-Clinical Testing Summary," assesses the device's inherent performance.

7. Type of Ground Truth Used

The ground truth for the performance testing is established using calibrated instruments and reference standards. For oxygen measurements, this would involve calibrated gas mixtures with known oxygen concentrations. For pressure measurements, this would involve calibrated pressure sources or transducers with known pressure values. It is based on physical and engineering measurements against established standards, not expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

The OxyMinder Pro uses an oxygen sensor (galvanic cell) and a pressure transducer. While it is "software controlled," it does not appear to employ machine learning or AI algorithms that would require a "training set" in the conventional sense (i.e., a dataset used to train a model). The software is likely for control, data processing, display, and alarm functions, using fixed algorithms based on physical principles, not learning from data. Therefore, a training set sample size is not applicable.

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

As there is no indication of a training set in the context of machine learning, this question is not applicable. The device's operation is based on pre-programmed algorithms and calibrated sensor outputs.

Ask a specific question about this device

The Smart Check O2 is a tool used to measure oxygen purity, flow and pressure at the outlet of an oxygen concentrator. The Smart Check is intended to be used in an environment where oxygen concentrators are being serviced or repaired. This includes hospitals, nursing homes, extended care facilities, patient homes, and respiratory device service and repair centers.

The Smart Check O2 is an ultrasonic oxygen analyzer, used to verify the performance of oxygen concentrators. The device is typically used by durable medical equipment technicians while servicing concentrators in their workshops or while visiting patient homes, but it is not left with the patient and is not patient contacting.

The device measures the performance of the oxygen concentrator by making ultrasonic time-of-flight measurements, both upstream and downstream. Gas flow rate and oxygen concentration are determined using the resulting data. Temperature and pressure sensors inside the sample cell allow for accurate flow and oxygen readings over the range of specified operating environment conditions.

Oxygen and flow readings are shown to the user on the display. The Smart Check O2 can be toggled into a mode for testing pulsing (conserving) oxygen concentrators wherein it displays oxygen concentration and pulse volume instead of flow rate. The user may initiate a pressure check mode by stopping the sample exhaust port with their finger during which the Smart Check O2 measures and displays the maximum pressure generated by the concentrator. The user may also enter a calibration check mode and deliver pure oxygen to the Smart Check O2 to verify its performance. However, it does not require regular calibration after manufacturing.

The Smart Check O2 is for prescription use only.

Key Components:

• Handheld analyzer unit
• Removable battery door
• Replaceable sample tube
• Two Alkaline AA cells

The provided FDA 510(k) Clearance Letter for the Smart Check O2 device does not contain the specific details of a study proving the device meets acceptance criteria, nor does it present acceptance criteria in a structured table format with reported performance. The document focuses on demonstrating substantial equivalence to a predicate device, and the "Non-Clinical Performance Data" section primarily lists compliance with consensus standards, rather than presenting test results against performance specifications.

Therefore, for the purpose of answering your request, I will extract relevant performance specifications from the "Substantial Equivalence Comparison Table" and present them as "Acceptance Criteria" and "Reported Device Performance." Please note that these are derived from the comparison table and are not explicitly stated as "acceptance criteria" within the provided text.

Here's an attempt to reconstruct the requested information based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

As the document does not explicitly present acceptance criteria or detailed study results in a table, the following table is constructed from the performance specifications listed in the "Substantial Equivalence Comparison Table" where the Subject Device (K250002) performance characteristics are taken as the "Reported Device Performance" and are implicitly assumed to have met an internal "Acceptance Criteria" derived from either design requirements or predicate device performance.

The provided document describes a 510(k) submission, which primarily focuses on demonstrating "substantial equivalence" to a predicate device. It does not describe a clinical study involving human subjects or interpretation of medical images. Instead, it details the technical performance of a medical device (an oxygen gas analyzer) used for servicing other medical equipment (oxygen concentrators).

Therefore, many of the requested items related to clinical studies, expert consensus, and human reader performance are not applicable to this type of device submission as described in the provided text.

Based on the information given, here's what can be inferred for the other requested points:

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

• Sample Size: Not explicitly stated. The document refers to "non-clinical tests" and demonstrates compliance with standards. Testing would involve a number of units of the Smart Check O2 device under various conditions.
• Data Provenance: Not explicitly stated. Given it's a device performance test, the data would likely be generated in a lab setting by the manufacturer, Life Spark Medical. It would be prospective data collected during device testing and verification.

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

• Not applicable. This device measures physical parameters (oxygen purity, flow, pressure, pulse volume). The 'ground truth' is established by calibrated reference standards and test equipment, not by human experts interpreting clinical data.

4. Adjudication Method for the Test Set

• Not applicable. Since the ground truth for device performance is based on measurements against calibrated physical standards, there is no human interpretation or adjudication process as would be seen in, for example, a radiology study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size of AI vs. Human Assistance

• Not applicable. This is not an AI-powered diagnostic device that assists human readers. It's a measurement tool.

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

• Yes, implicitly. The performance metrics (accuracy, range, resolution, response time, etc.) are characteristics of the device itself (its internal sensors and algorithms) without human intervention in the measurement process, beyond initiating the test. The "Substantial Equivalence Comparison Table" lists these standalone performance characteristics.

7. The Type of Ground Truth Used

• The ground truth for the performance metrics (oxygen purity, flow, pressure, pulse volume) would be established by calibrated reference standards and test equipment (e.g., precise gas mixtures for oxygen purity, calibrated flow meters, and pressure gauges).

8. The Sample Size for the Training Set

• Not applicable/Not stated. This document describes a physical measurement device, not a machine learning or AI model. Therefore, there is no "training set" in the context of data for model training. The device's underlying technology is ultrasonic time-of-flight measurements, which is a physics-based method, not a data-driven learning algorithm.

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

• Not applicable. As a non-AI/ML device, the concept of a training set and its ground truth is not relevant here. The device's accuracy relies on its design, component quality, and calibration procedures.

Ask a specific question about this device

The MaxO2 ME+p is an oxygen monitor with integrated pressure monitoring intended for continuous monitoring of the concentration of oxygen and pressure being delivered to patients ranging from newborns to adults. It can be used in the hospital and sub-acute settings. The MaxO2 ME+p is not intended as a life-supporting device or life sustaining device.

The MaxO2 ME +p is a battery powered oxygen and pressure monitor in a single assembly. The oxygen monitor measures the oxygen concentration from a gas source, displays these measured concentrations, and provides user selectable high and low oxygen alarms. It also the user to monitor pressure simultaneously and provides user selectable high and low pressure alarms.

The MaxO2 ME+p device is an oxygen monitor with integrated pressure monitoring. The acceptance criteria and supporting study details are as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document compares the MaxO2 ME+p (proposed device) to two predicate devices: Maxtec - MaxO2 ME (K153659) for oxygen monitoring and Caradyne - Criterion 40 (K992101) for pressure monitoring.

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

• The document does not specify a sample size for a test set in terms of clinical data or patient samples.
• The study primarily relies on non-clinical testing (bench testing and adherence to standards) to demonstrate performance.
• No human clinical testing or animal testing was performed.
• The data provenance is not applicable as it's not a study involving patient data.

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

• This information is not provided in the document. Given that the testing was non-clinical (adherence to standards and bench testing), the "ground truth" would be established by the requirements of those standards and the accuracy of reference measurement equipment. Experts involved would be in engineering, quality assurance, and regulatory affairs, but specific numbers and qualifications are not detailed.

4. Adjudication method for the test set:

• An adjudication method is not applicable as there was no study involving human readers or interpretation of results that would require consensus among experts. The testing involved verifying the device's performance against defined technical specifications and industry standards.

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 was done. This device is an oxygen and pressure monitor, not an AI-powered diagnostic imaging device or a system designed to assist human readers in interpretation. Therefore, this type of study is not relevant to the MaxO2 ME+p.

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

• This question is not directly applicable in the context of this device. The MaxO2 ME+p is a standalone physical device (monitor) that measures oxygen concentration and pressure. Its performance is evaluated through non-clinical bench testing against established standards and specifications, not through an "algorithm only" performance study in the way it might be for a diagnostic AI. The device's functioning is its standalone performance without human input beyond its operation.

7. The type of ground truth used:

• The "ground truth" for the performance evaluation was established by technical specifications, measurements from calibrated reference equipment, and compliance with recognized industry standards. These include:
  • AAMI ANSI ES 60601-1: Medical electrical equipment safety and essential performance.
  • IEC 60601-1-2: Electromagnetic Disturbances.
  • AIM Standard 7351731: Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers.
  • IEC 60601-1-8: Alarm systems.
  • ISO 80601-2-55: Respiratory gas monitors.
  • ISO 10993-5, -10, -11, -18: Biocompatibility.
  • ISO 18562-2, -3: Particulate material and VOCs.

8. The sample size for the training set:

• This information is not applicable. This device is a hardware monitor, 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:

• This information is not applicable, as there is no training set for this type of device.

Ask a specific question about this device

Percent Oxygen Sensors are intended to replace the original oxygen-sensing component of an oxygen analyzer that measures oxygen concentration in breathing gas mixtures.

The subject device is a family of Medical Oxygen Sensors which may be used as industry replacement types with various medical inspired-oxygen measuring devices. The oxygen sensors are all electrochemical galvanic type devices. The difference between models is merely the physical shape of the external housing (the basic oxygen sensor is often time encapsulated in a secondary housing), signal connection, signal output and the response time. The family of oxygen sensors concept extends to OEM manufacturers of anesthesia and respiratory therapy equipment. Again, the difference between models is merely the physical shape of the external housing (the basic oxygen sensor is often time encapsulated in a secondary housing), signal connection, signal output and the response time in order for the OEM to exercise a degree of control over the recurring replacement of oxygen sensors.

The provided text describes a 510(k) premarket notification for "Percent Oxygen Sensors" by CareOx, LLC, referencing the predicate device K952736 by Analytic Industries Percent Oxygen Sensors. The submission argues for substantial equivalence based on identical technology, principle of operation, indications for use, and similar operating specifications, environment of use, and patient population.

However, the document does not contain the detailed acceptance criteria for standalone device performance, nor the specific results of a study proving the device meets those criteria. It states that "The subject devices are manufactured by Analytical Industries Inc. and were cleared under K952736. CareOx, the sponsor of this submission is purchasing final, finished oxygen sensors from Analytical Industries Inc. with the private label of CareOx." This implies that the device itself is identical to the predicate.

The document mentions "Non-clinical Testing" including "Accuracy, Precision, Specificity, Sensitivity, Linearity, Range, Response time" and states that "We have performed the applicable test from ISO 80601-2-55." However, it does not provide the acceptance criteria for these tests or the reported performance results against those criteria.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is a summary of what can be extracted, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The testing mentioned is "Non-clinical Testing" performed to ISO 80601-2-55.

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

• This information is not applicable and not provided. The testing described is non-clinical (device performance against standards), not clinical evaluation requiring expert ground truth for interpretation like imaging studies.

4. Adjudication method for the test set

• Not applicable and not provided. See point 3.

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 study was not done. This device is an oxygen sensor, not an AI-assisted diagnostic tool.

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

• Yes, the non-clinical testing described (Accuracy, Precision, Specificity, Sensitivity, Linearity, Range, Response time) is considered standalone performance testing of the device itself. Specific results are not provided in this document, but the claim is that "applicable test[s] from ISO 80601-2-55" were performed.

7. The type of ground truth used

• For the non-clinical tests, the ground truth would typically be established by calibrated reference standards (e.g., known concentrations of oxygen for accuracy and linearity testing). The document does not explicitly state the specific reference standards used.

8. The sample size for the training set

• Not applicable. This device is a sensor, not a machine learning algorithm that requires a training set.

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

• Not applicable. See point 8.

Ask a specific question about this device

The OxyMinder is intended for continuous monitoring of the concentration of oxygen being delivered to patients ranging from newborns to adults. This device can be used in the hospital and subacute settings. The monitor is not intended as a life supporting device or for diagnostics.

The OxyMinder is an air / oxygen blender mounted oxygen monitor capable of measuring the oxygen concentration from 18 to 100%. A Bio-Med specified oxygen sensor mounted to the blender outputs a voltage which is used by the OxyMinder to determine the concentration of oxygen. The OxyMinder calibrates at ambient air (21%) and 100% oxygen. The OxyMinder is software controlled. To measure the gas mixture of the blender the OxyMinder takes a sample of the gases to the sensor through a separate port and manifold which is separate from the gas pathway to the patient. This sample is then exhausted to the room. The OxyMinder sampling stream is not part of the gas pathway to the patient.

The OxyMinder is used for continuous monitoring of the concentration of oxygen delivered to patients via air oxygen blenders. The monitor provides the following features:

• Continuously displays the concentrated Oxygen level delivered to a patient.
• Accepts user inputs via touch screen or button (power button).
• Provides visual alarm messages, and audible alarms.
• Displays the current alarm setting levels (High and Low O2 alarms).
• Provides on-screen configuration tools such as O2 sensor calibration, touchscreen calibration, audio test, etc.
• Monitors and displays the battery level and power source.
• Ensures clean hospital airlines by automatically purging system periodically.

The OxyMinder is designed to be mounted to a Bio-Med Devices air / oxygen blender via a manifold that houses the oxygen sensor and a solenoid.

In addition to the primary function of monitoring oxygen concentration, the OxyMinder provides an automatic gas supply line purge function.

The provided text is related to a 510(k) premarket notification for the "OxyMinder" device, an oxygen gas analyzer. It describes the device, its intended use, and compares it to a predicate device (Maxtec MaxO2ME). The document states that "A series of non-clinical performance / bench testing was performed" and lists the types of tests, concluding that "The test results met the applicable standards and are similar to the reported performance of the predicate device." However, the document does not provide detailed acceptance criteria or the specific results of these tests. It only broadly states that the performance was similar to the predicate and met applicable standards.

Therefore, many of the requested details about the study cannot be extracted from this document.

Here's a summary of what can be inferred or explicitly stated:

Acceptance Criteria and Reported Device Performance

Study Details:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • The document mentions "a series of non-clinical performance / bench testing" but does not specify the sample size for any of these tests nor the data provenance. It implies laboratory testing rather than patient data.

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

   • Not applicable/Not provided. The testing appears to be bench/performance testing against specifications and standards, not expert-adjudicated clinical data.

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

   • Not applicable/Not provided.

4. 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 or human-in-the-loop study was done or mentioned. This is a standalone oxygen analyzer, not an AI-assisted diagnostic tool.

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

   • Yes, performance testing was done on the device (OxyMinder) as a standalone unit. The "Oxygen Accuracy with Blender" test refers to its performance when integrated with a Bio-Med Devices air/oxygen blender, but it's still about the device's accuracy rather than human interpretation.

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

   • For the bench testing, the "ground truth" would be the known and controlled oxygen concentrations and environmental conditions used during calibration and testing against established performance standards and specifications.

7. The sample size for the training set:

   • Not applicable. This device is not described as using machine learning or AI that would require a 'training set' in the traditional sense. It's an oxygen gas analyzer, likely with embedded software and algorithms based on known physics and engineering principles for sensor readings.

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

   • Not applicable, as there's no mention of a training set for machine learning.

Ask a specific question about this device

The PM5950 Accu O2 Analyzer is intended as a tool for use by qualified personnel to spot-check or measure oxygen concentration of a delivered air/oxygen mixture. The PM5950 Accu O2 Analyzer is not intended for use in continuous monitoring of oxygen delivery to patient.

The PM5950 Accu O2 Analyzer measures and displays the amount of oxygen present, percent (%), in an air/oxygen breathing circuit. Oxygen measurement is accomplished by placing an oxygen sensor into a breathing circuit. The sensor employs amperometric electrochemical measurement principles (e.g. galvanic fuel cell; lead oxygen battery). The sensor is connected to the analyzer unit via an interface cable. The analyzer unit is battery powered. The analyzer is microprocessor based and interfaces with user push buttons and a LCD display. User push buttons allow the user to turn the unit on/off and to initiate calibration. The LCD provides indication of the per-cent oxygen measured, low battery indication and calibration required. The device consists of four basic elements: Base Device, Extendible Cable, Oxygen Sensor W/ Diverter Fitting, and Tee Adaptor.

Here's a breakdown of the acceptance criteria and study information for the Precision Medical Inc. PM5950 Accu O2 Oxygen Analyzer, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes for tests related to accuracy, drift, response time, etc. It lists a series of compliance reports and tests performed by Precision Medical Inc. to demonstrate substantial equivalence. These are:

• Ingress of water ISO 80601-2-55 (201.11.6.5)
• Oxygen Analyzer Measurement Accuracy ISO 80601-2-55:2011 (201.12.1.101,102,104)
• Shock & Vibration Testing for PM5950 Oxygen Analyzer ISO 80601-2-55:2011 (201.15.3.5.101)
• EMC Testing for PM5950 Oxygen Analyzer ISO 80601-2-55:2011 (202.6.2)
• Oxygen Analyzer - Leakage to Atmosphere ISO 80601-2-55:2011 (201.102)
• Operating and Storage Temp
• Operating and Storage Temperature of the PM5950 O2 Analyzer Review
• Software Validation of PM5950
• Effects of Elevation-Barometric Pressure Change
• Drop Test of PM5950 in Shipping Box
• Performance Test
• Process Validation of the PM5950
• Life Expectancy of the Keypad
• Label Durability
• Cleaning and disinfection of ME Equipment of ME Systems
• Compatibility with substances used with ME Equipment

The data provenance is from in-house testing conducted by Precision Medical, Inc. in the USA. The data is prospective in nature, as it was generated specifically for the 510(k) submission to demonstrate compliance.

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

This information is not provided in the document. The testing appears to be primarily engineering and performance verification against specified technical standards and internal criteria, rather than expert-based ground truth establishment for a diagnostic output.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the device (an oxygen analyzer), testing would likely involve direct measurement against known gas concentrations or calibrated reference instruments, rather than human adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging or interpretative AI devices where human readers are involved in making diagnoses or assessments. The PM5950 Accu O2 Analyzer is a measurement device for oxygen concentration.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

Yes, a standalone performance evaluation was done. The entire suite of tests (accuracy, response time, drift, environmental robustness, software validation, etc.) outlined in section "8. Declarations of Conformity and Summary Reports" represents the standalone performance evaluation of the device itself. The device is designed to provide direct measurements without human interpretation or algorithm modification once calibrated.

7. The Type of Ground Truth Used

The ground truth for the device's performance (e.g., accuracy, response time) would be established using calibrated reference standards and instruments to generate known oxygen concentrations. For other tests (like shock, vibration, ingress of water, EMC), the ground truth is defined by the specific requirements and methodologies of the referenced international and national consensus standards (e.g., ISO 80601-2-55, IEC 60601 series).

8. The Sample Size for the Training Set

This information is not applicable/not provided. The PM5950 Accu O2 Analyzer is a hardware-based measurement device that relies on a galvanic fuel cell sensor and a microprocessor. It does not appear to utilize machine learning or AI models that require a "training set" in the conventional sense. The "software validation" mentioned refers to traditional software engineering verification.

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

This information is not applicable/not provided for the reasons stated above (no AI/ML training set).

Ask a specific question about this device

The MaxO2ME oxygen monitor is intended for continuous monitoring of the concentration of oxygen being delivered to patients ranging from newborns to adults. It can be used in the pre-hospital, hospital and sub-acute settings. The MaxO2ME is not intended as a life supporting device.

The MaxO-ME is a handheld oxygen analyzer/monitor capable of measuring the oxygen concentration from 0% to 100% in a sample gas. A MAX-550E oxygen sensor outputs a voltage which is used by the Max O2ME to determine the concentration of oxygen based on a calibration at room air or 100% oxygen. The MaxO2ME contains alarms that can be controlled by the user to set a maximum or minimum allowable oxygen concentration.

Below is an analysis of the provided text regarding the MaxO2ME oxygen monitor's acceptance criteria and studies.

1. Table of Acceptance Criteria and Reported Device Performance

The document outlines acceptance criteria implied by the "Performance Specifications" and the reported performance of the MaxO2ME device compared to a predicate device (Precision Medical PM5900 - K063096) and a reference device (MiniOX - K961644). The "Discussion" section for "Non-clinical Testing" states, "In all cases the proposed device passed or meets the acceptance criteria," but does not explicitly list the criteria themselves or the specific values for each test type in the Performance Testing section beyond the initial performance specifications table.

Based on the "Performance Specifications - The following is a list of the differences between the proposed device and the predicate" and the subsequent "Discussion" for performance, some criteria and performance points can be inferred:

Study Proving Acceptance Criteria:
The document states: "We performed a number of tests to demonstrate that the proposed device performed as intended."
The following non-clinical performance tests were conducted:

• ISO 80601-2-55 Performance of respiratory gas monitors
• ISTA2A Shipping Validation Test Report
• Sensor performance Test Report
• Gas leakage Test Report
• Interfering gas effects Test Report
• Temperature compensation Test Report
• Drift of measurement accuracy Test Report
• MaxO2ME Operating and Storage Environment Report
• Device Cleaning Report and Disinfection Test
• Measurement accuracy Test Report
• IEC 60601-1 Electrical safety
• IEC 60601-1-2 - EMC
• IEC 60601-1-8 - Alarms
• Shelf-life / Real-time

The document concludes: "In all cases the proposed device passed or meets the acceptance criteria."

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 does not specify the sample size for any test set or the data provenance. The tests listed are general performance and safety tests for a medical device, which typically involve device units rather than patient data.

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. The tests performed are objective, non-clinical engineering and performance tests on the device itself, not requiring expert ground truth for interpretation.

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

Not applicable. As noted above, the tests are objective, non-clinical performance and safety tests, not requiring adjudication of results from multiple reviewers.

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 not an AI/imaging device. No MRMC study was conducted. The device is an oxygen monitor, and its performance tests are related to its physical and functional specifications.

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

Yes, the studies conducted were standalone tests of the device itself ("algorithm only" in the sense of the device's functionality) without human-in-the-loop performance being evaluated. The device is an oxygen monitor and its performance is measured against technical specifications.

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

The ground truth for the performance and safety tests would have been established by calibrated reference equipment and standardized testing protocols (e.g., ISO and IEC standards). For example, a gas analyzer would be calibrated against known gas concentrations to determine its accuracy.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-based device, so there is no "training set."

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

Not applicable. As there is no training set for an AI/machine learning model, this question is not relevant.

Ask a specific question about this device

The CARESCAPE Respiratory Modules (E-sCO, E-sCOV, E-sCAiO, E-sCAiOV) are indicated for use with a host device for monitoring respiratory parameters (CO2, O2, N2O, anesthetic agents, anesthetic agent identification, and respiratory rate) and ventilatory parameters (airway pressure, flow and volume) of adult, pediatric, and neonatal patients. When monitoring neonatal or other patients that have high respiration rate or low tidal volume these modules shall be used within the limits of respiration rates and tidal volumes to ensure specified measurement accuracy. These modules are intended for use by qualified medical personnel only.

The CARESCAPE™ Respiratory Modules, E-sCO, E-sCOV, E-sCAiO and E-sCAiOV and accessories measure respiratory parameters (concentrations of Carbon Dioxide, Oxygen, Nitrous Oxide and anesthetic agents in the patient's breath, as well as the patient's respiration rate) and ventilatory parameters (airway pressure, flow and breathing volumes) of hospital patients. Parameters measured by the CARESCAPE™ Respiratory Modules and accessories are CO2, N2O, O2, Anesthetic agents, Agent ID and Spirometry depending on the model used. The CARESCAPE™ Respiratory Modules is a family of single-width plug-in parameter modules for modular monitoring systems. The CARESCAPETM Respiratory Modules are of the diverting type, which means that a small continuous flow of gas is sampled from the patient's breath to the module for measuring the gas concentrations. The CARESCAPE™ Respiratory Modules acquire the detected signals from the sensors of the modules, calculate the parameter values and communicate them to the host device. The CARESCAPE™ Respiratory Modules measure the patient's respiration rate and activate a status signal if no breaths are detected in 20 second time and the modules activate relevant status signals upon detecting failures or anomalies in the operation of the module hardware, software or gas sampling system. The CARESCAPE™ Respiratory Modules do not trigger or issue any physiological or technical alarms by themselves. All management of alarms is entirely performed by the host monitors based on parameter and status data received from the modules, as well as on the alarm condition data stored in the host device.

This 510(k) summary describes a device submission for the CARESCAPE™ Respiratory Modules, which are intended for monitoring respiratory and ventilatory parameters in adult, pediatric, and neonatal patients.

Based on the provided text, the device did not undergo clinical studies to support substantial equivalence. The submission relies on non-clinical testing and comparison to a predicate device. Therefore, a direct response to some of the requested points regarding acceptance criteria and a study demonstrating performance against those criteria cannot be fully provided from this document alone, as the document states that clinical studies were not required.

However, I can extract information related to the device's technical specifications, non-clinical evaluations, and safety considerations, which serve as the basis for its substantial equivalence determination.

Acceptance Criteria and Device Performance (Based on Non-Clinical Tests and Standards Compliance)

Since no clinical study demonstrating device performance against specific acceptance criteria is provided, the "acceptance criteria" here refer to compliance with voluntary standards and the predicate device's performance, as asserted by the manufacturer in the context of a 510(k) submission. The device's "performance" is implicitly deemed acceptable by virtue of its substantial equivalence to the predicate device and successful completion of non-clinical tests.

Table 1: Acceptance Criteria (Standards Compliance) and Reported Device Performance

Note on ISO 21647:2009 Non-Compliances:
The document explicitly states non-compliance with several clauses of ISO 21647:2009 for certain older monitoring systems when used with the new modules. These pertain to:

• Clause 49.101: RGM providing a medium priority alarm signal when power falls below minimum.
• Clause 57.3 aa): Detachable power supply cord protection against accidental disconnection.
• Clause 102: Compliance with all requirements of IEC 60601-1-8:2003 (alarm systems).
• Clause 201.1.2: RGM providing a means to detect gas reading alarm conditions and alarm priority for unidentified anesthetic agents.
• Clause 201.1.2: Alarm signals for mixtures of halogenated agents based on MAC levels.
• Clause 201.8.3: Manufacturer-configured alarm preset for audio-paused or alarm-paused interval.

These non-compliances are acknowledged and apply to specific older monitor models (S/5 Anesthesia monitor, S/5 Critical Care Monitor, S/5 Compact Anesthesia Monitor, S/5 Compact Critical Care Monitor, CARESCAPE B650, CARESCAPE B850). The FDA's substantial equivalence determination implies these non-compliances were deemed acceptable in the context of the overall safety and effectiveness of the device as cleared.

Study Details (Based on available information)

1. Sample size used for the test set and the data provenance:

   • No specific sample size for a clinical test set is mentioned. The device did not require clinical studies. Non-clinical tests were performed, but details on sample sizes for these internal verification and validation activities (e.g., how many units tested, how many scenarios) are not provided in this summary.
   • Data Provenance: Not applicable for clinical data. For non-clinical testing, the tests were conducted by the manufacturer, GE Healthcare Finland Oy.

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

   • Not applicable. No clinical test set with expert-established ground truth was used for this 510(k) submission. The ground truth for non-clinical performance and safety testing would be based on engineering specifications, reference measurement standards, and accepted validation methodologies.

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

   • Not applicable. No clinical test data requiring adjudication was involved in this submission.

4. 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 device is a respiratory gas monitor, not an AI software intended to assist human readers (e.g., in medical image interpretation). Therefore, an MRMC study is not relevant here.

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

   • Not applicable for a "standalone" algorithmic performance study in the context of AI. The device itself performs measurements and calculates parameters. Its "standalone" performance is implicitly covered by the performance testing and compliance with standards. It is a measurement device, not an interpretative AI algorithm.

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

   • Not applicable for clinical ground truth. For non-clinical testing, the "ground truth" would be established by calibrated reference equipment, known physical quantities, and compliance with the specified requirements and standards.

7. The sample size for the training set:

   • Not applicable. This device is a hardware and software system for physiological monitoring, not a machine learning or AI model trained on a specific dataset.

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

   • Not applicable. See point 7.

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

The UltraMaxO2 Oxygen Analyzer is a tool used to measure oxygen purity, flow and pressure at the outlet of an oxygen concentrator. The UltraMaxO2 Oxygen Analyzer is intended to be used in an environment where oxygen concentrators are being serviced or repaired. This includes Hospitals, Nursing Homes, Extended Care Facilities, Patient Homes, and Respiratory Device Service and Repair Centers.

The UltraMaxO2 device is used for checking oxygen concentrator performance with the measure of oxygen purity, and flow at the outlet of an oxygen concentrator. The UltraMaxO2 Oxygen Analyzer functions by passing an ultrasonic pulse through the gas sample and measuring the amount of time required for the pulse to transit the sample chamber. The transit time is converted into a gas concentration via calibration data stored in the device. This can be done because the transit time varies according to the molecular mass of the gas in the chamber. Flow is determined using the difference between the ultrasonic pulse traveling against the flow and the ultrasonic pulse traveling with the flow. Pressure is measured using a separate pressure sensor that measures the pressure build-up in the device when the output port is blocked. The pressure is displayed in either kPa or PSI determined by a user operable switch in the battery compartment. The materials of the UltraMaxO2 include ABS plastic for the enclosures and the ultrasonic oxygen sensor tube body, adhesive backed Polycarbonate labels, PVC tubing and nickel plated brass fittings for the flow path, electronic circuitry including transducers/receivers, pressure, temperature and humidity sensors and an LCD screen.

The UltraMaxO2 Oxygen Analyzer is a device designed to measure oxygen purity, flow, and pressure from oxygen concentrators.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the UltraMaxO2 Oxygen Analyzer are implicitly derived from the performance claims and comparison to predicate devices. The study demonstrates that the UltraMaxO2 meets or exceeds the performance of its predicates.

Study Proving Device Meets Acceptance Criteria:

The provided document refers to non-clinical functional and performance tests that were conducted to establish substantial equivalence. These tests aimed to demonstrate that the UltraMaxO2 performs as well as, or better than, the legally marketed predicate devices.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "non-clinical functional and performance tests" but does not detail the number of units tested or the number of measurements taken.
• Data Provenance: The tests were non-clinical, likely conducted in a laboratory or manufacturing environment. The country of origin of the data is not specified, but the submitter (Maxtec, LLC) is based in Salt Lake City, Utah, USA, implying the testing likely occurred in the USA. The data is prospective as it was generated specifically for the submission to demonstrate performance.

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

• Number of Experts: Not applicable. This was a non-clinical device performance test, not an evaluation requiring expert interpretation of results for ground truth. The 'ground truth' would have been established by reference standards or calibrated measurement equipment.
• Qualifications of Experts: N/A

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. As this was a non-clinical performance test comparing measurements against known standards or predicate device specifications, an adjudication method for interpretations is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed for the UltraMaxO2 as the device represents a well known technology for a recognized indication as evidenced...by comparison to the predicate devices currently cleared for sale in the US market."
• Effect Size of Human Readers Improve with AI vs. without AI Assistance: Not applicable, as no MRMC or clinical study involving human readers or AI assistance was conducted.

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

• Standalone Performance: Yes, the fundamental performance evaluation was a standalone assessment of the device's accuracy in measuring oxygen purity, flow, and pressure. While not an 'algorithm-only' test in the AI sense, it represents the device's inherent capability independent of human interpretation. The "non-clinical functional and performance tests" assess the device's outputs directly against established standards or predicate device performance.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the non-clinical functional and performance tests, the ground truth would have been established using calibrated reference standards or known gas mixtures/flow rates/pressures. For example, a known concentration of oxygen gas would be fed into the device, and the device's reading would be compared to that known concentration. Similarly, known flow rates and pressures would be applied. When comparing to predicate devices, the predicate device's established performance served as a benchmark for substantial equivalence.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. The UltraMaxO2 Oxygen Analyzer is a measurement device, not an AI/ML algorithm that requires a "training set" in the conventional sense. The device uses an ultrasonic pulse measurement method with "calibration data stored in the device." This calibration data would be established during manufacturing and testing, and is not a "training set" like those used for machine learning models.

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

• Ground Truth for Training Set: Not applicable in the AI/ML context. The device's internal calibration data is established by feeding known, precise inputs (e.g., specific oxygen concentrations, flow rates, pressures) into the device during its manufacturing and calibration process. The device's internal algorithms are then set to accurately report these known inputs. This would involve highly accurate laboratory equipment as the ground truth.

Ask a specific question about this device