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The Infinity CentralStation (ICS) is intended for use by trained healthcare professionals for the purpose of centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment. Centralized monitoring involves the display and management of data from networked patient monitors including the annunciation of visual and audible physiologic parameter alarms at a central monitoring workstation.

Infinity CentralStation with Rest ECG is intended for the production of diagnostic electrocardiograms for adult and pediatric patients when connected to a monitor with diagnostic 12-Lead ECG monitoring enabled.

The Infinity M300/M300+ is intended for use with the ICS to monitor ECG and pulse oximetry and nonambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network.

The Infinity M300/M300+ with TruST is intended for 12-Lead ECG monitoring with a reduced set of electrodes. Reconstructed leads are intended for real-time assessment of ST segment changes.

The Infinity® CentralStation (ICS) Wide (or widescreen) is a Central monitoring station capable of real-time display and storage of multi-parameter physiological patient data and alarm annunciation for networked devices including but not limited to ambulatory and non-ambulatory wireless telemetry monitoring.

The Infinity M300/M300+ is a wireless telemetry, patient-worn device with rechargeable lithiumion battery which monitors ECG and SpO2 physiological data and features a color display, local alarm alerts and keypad interface. ECG functions include heart rate, arrhythmia detection and ST segment analysis and SpO2 functions include pulse plethysmogram and pulse rate. Infinity M300/M300+ with TruST allows for 12-lead ECG monitoring with a reduced set of electrodes by deriving values for missing leads.

The provided text is a 510(k) premarket notification summary for the Draeger Medical Systems Infinity CentralStation Wide, Infinity M300, and Infinity M300+ devices. It details the device's indications for use, technological characteristics, and performance data to demonstrate substantial equivalence to predicate devices. However, it does not explicitly contain detailed acceptance criteria tables with reported device performance or specific study details regarding sample sizes, ground truth establishment for test sets, expert qualifications, or adjudication methods for this specific submission's changes.

The document states that the changes related to cybersecurity and M300+ swappable battery were evaluated through verification and validation testing. It emphasizes that these modifications do not raise new issues of safety and effectiveness and do not change the fundamental scientific technology of the cleared devices, meaning the previous performance characteristics are considered to remain valid.

The key performance data described pertains to compliance with various standards related to electrical safety, EMC, alarm systems, electrocardiographic monitoring, and pulse oximetry. These standards implicitly contain acceptance criteria.

Based on the provided information, I can extract the following, though some requested details related to individual device performance metrics and specific study designs for this particular 510(k) are not explicitly stated in this summary.

1. A table of acceptance criteria and the reported device performance:

The document doesn't provide a table of performance acceptance criteria directly. Instead, it refers to compliance with established international and national standards for medical electrical equipment. The "reported device performance" is implicitly that the device meets these standards.

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 detail specific sample sizes for test sets for the verification and validation of the changes in this submission. The testing done refers to internal company verification and validation efforts rather than clinical studies with patient data for assessing core performance metrics like arrhythmia detection accuracy. Data provenance is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable/Not provided. The document summarizes the regulatory submission for changes to existing devices, focusing on technical compliance and safety/effectiveness equivalence, not new clinical performance evaluation requiring external expert ground truth establishment for a diagnostic output. The modifications are for cybersecurity and hardware components (swappable battery).

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

Not applicable/Not provided. Adjudication methods are typically used in clinical studies involving interpretation of medical data, which is not the focus of the performance data section for this specific submission's changes.

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 submission is for modifications (primarily cybersecurity and a new battery component) to existing patient monitoring devices, not for a new AI/CAD system. Therefore, an MRMC study is not relevant to the described changes.

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

The performance data focuses on compliance with technical standards for the device's functions (e.g., ECG monitoring, pulse oximetry, alarm systems) and validation of the cybersecurity and hardware changes. These are "standalone" in the sense that the device's technical functions are tested against defined standards. However, it's not "algorithm only" in the context of a new diagnostic algorithm. The monitoring functions (like arrhythmia detection, ST-segment measurement for 12-lead ECG) are inherent to the device and would have been evaluated in prior clearances against ANSI/AAMI EC57.

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

For the specific changes in this submission (cybersecurity, swappable battery), the "ground truth" would be the successful implementation and verification of design requirements and risk mitigations, as tested internally by Dräger. For the underlying physiological monitoring capabilities (ECG, SpO2, arrhythmia, ST-segment), the ground truth for performance evaluation in predicate devices would typically be established through recognized test databases (e.g., MIT-BIH Arrhythmia Database for arrhythmia detection, or similar validated datasets for ST-segment analysis) or expert review against reference standards, as per standards like ANSI/AAMI EC57. The document for this submission does not detail these for the underlying performance.

8. The sample size for the training set:

Not applicable. The described changes and performance data do not relate to machine learning model training.

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

Not applicable. Not a machine learning submission.

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The Infinity M300 is intended for use with the ICS to monitor ECG and pulse oximetry on ambulatory and nonambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network.

The Infinity M300 with TruST is intended for 12-Lead ECG monitoring with a reduced set of electrodes. Reconstructed leads are intended for real-time assessment of ST segment changes.

The Infinity M300 is a wireless telemetry, patient-worn device with rechargeable lithium-ion battery which monitors ECG and SpO2 physiological data and features a color display, local alarm alerts and keypad interface. ECG functions include heart rate, arrhythmia detection and ST segment analysis and SpO2 functions include pulse plethysmogram and pulse rate. Infinity M300 with TruST allows for 12-lead ECG monitoring with a reduced set of electrodes by deriving values for missing leads.

The provided text is a 510(k) summary from the FDA, detailing the premarket notification for the Draeger Medical Systems' Infinity M300 device. While it mentions "Verification Testing" and "Validation Testing" and refers to meeting criteria and supporting substantial equivalence, it does not provide the specific acceptance criteria, method, or results in a detailed, quantifiable manner that would allow for a comprehensive answer to your request.

The document is a regulatory communication, not a scientific study report. It states that "The results of Verification testing confirm the modified device continues to meet the criteria for substantial equivalence to the predicate device" and that "Validation test results support substantial equivalence to the predicate device." However, it does not disclose what those criteria are or the specific performance metrics achieved.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or details on sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text. This information would typically be found in the full submission to the FDA, which is not included here.

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The intended use of the M300 & M400 powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

M300 & M400 Powered Wheelchair is battery powered, center wheel motor driven and is controlled by the PG power wheelchair VR-2 90 amp or R-net 120 amp controller. The user interface is a joystick. M300 & M400 is powered by two 12VDC 60Ah, Group M34 batteries, approximate driving range on fully charged batteries is up to 25km (15,5 miles), depending on use and the terrain the chair is driven on. The chair frame is a rived nut and welded steel construction and includes two center drive wheels with drive units (motor, gear, brake), batteries and front and rear pivoting casters. Depending on users needs, the joystick motor control is mounted to the left or right armrest. When the user activates the joystick, the controller receives a signal to release the brakes. With the brakes released, the chair is allowed to move in the direction the joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user stop by letting go of the joystick.

The Permobil M300 & M400 powered wheelchairs were assessed for substantial equivalence to the predicate device Permobil C350 (K071650). The performance data indicates that the M300 & M400 functioned as intended in all instances based on various ISO and RESNA standards.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" but lists various characteristics and their values for both the new device and the predicate device, implying these are the performance metrics against which substantial equivalence is judged. The "reported device performance" are the values for the M300 & M400.

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

The document does not explicitly state the sample size for a "test set" in the context of human subjects or a specific data set. The performance testing was based on compliance with various international and national standards for wheelchairs (ISO and RESNA). These standards typically involve testing a representative sample of the devices. The data provenance is derived from the testing conducted by Permobil AB, based in Timrå, Sweden. The testing described is likely prospective, as it's part of the premarket notification for a new device.

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 in the document. The device is a powered wheelchair; its performance is evaluated against engineering and safety standards, not against "ground truth" established by medical experts in diagnosing conditions.

4. Adjudication method for the test set:

This information is not applicable and not provided in the document. As mentioned above, the evaluation is against established engineering and safety standards, not expert consensus requiring adjudication.

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 information is not applicable and not provided in the document. The device is a powered wheelchair; it is not an AI-assisted diagnostic tool involving human readers.

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

This information is not applicable and not provided in the document. The device is a physical powered wheelchair, not an algorithm.

7. The type of ground truth used:

The "ground truth" in this context is the fulfillment of requirements outlined in the specified international and national standards (ISO 7176 series and RESNA WC-1/WC-2). These standards define objective performance thresholds and test methodologies for characteristics like climatic resistance, power and control systems, electromagnetic compatibility, weight bearing capacity, speed, braking, etc.

8. The sample size for the training set:

This information is not applicable and not provided in the document. The development of a powered wheelchair does not typically involve a "training set" in the way that machine learning algorithms do. The design and engineering process is iterative, based on established mechanical and electrical engineering principles, and validated through testing against standards.

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

This information is not applicable and not provided in the document for the reasons stated in point 8.

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The Infinity CentralStation (ICS) is intended for use by trained healthcare professionals for the purpose of centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment. Centralized monitoring involves the display and management of data from networked patient monitors including the annunciation of visual and audible physiologic parameter alarms at a central monitoring workstation. Infinity CentralStation with REST ECG is intended for the production and interpretation of diagnostic electrocardiograms for adult and pediatric patients when connected to a monitor with diagnostic 12-Lead ECG monitoring enabled.

The Infinity M300 is intended for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network.

The Infinity M300 with TruST is intended for 12-Lead ECG monitoring with a reduced set of electrodes. Reconstructed leads are intended for real-time assessment of ST segment changes.

The Infinity CentralStation® (ICS) is an information technology workstation that gathers and displays data for simultaneous central monitoring and critical care management of up to 32 patient monitors connected to the Infinity Network using an optional dual-screen configuration. The ICS system consists of a central processing unit (CPU), one or two displays, a keyboard and a mouse. If an optional second monitoring unit is configured, an additional 32 patients can be monitored, for a total of 64 patients. The ICS acquires and displays waveforms, parameters and alarms from Infinity bedside monitors and Infinity M300.

The Infinity M300® is a patient-worn transceiver that uses the ICS as the primary patient monitoring display and primary alarm source. The M300 provides continuous ambulatory monitoring for the following parameters:

• ECG including heart rate, arrhythmia, and ST segment analysis
• Pulse oximetry including SpO2, pulse plethysmogram waveform, and pulse rate

The M300 has a color display for displaying parameter information, waveforms, and alarms. It also has a rechargeable battery that can be charged using the bedside charger or the central charger. The M300 is restricted to be used on one patient at a time. The M300 also includes the following accessories:

• M300 bedside charger
• M300 central charger
• M300 programming kit

This document is a 510(k) summary for the Draeger Infinity CentralStation with Infinity M300, a physiological patient monitoring system. It primarily focuses on demonstrating substantial equivalence to a predicate device and outlines the device's intended use and technical specifications. It does not contain information about specific acceptance criteria, study findings, model performance metrics, sample sizes, ground truth establishment, or expert involvement as typically required for evaluating the performance of an AI/ML powered device.

Therefore, I cannot fulfill your request for the detailed table and study information as it is not present in the provided text. The document is concerned with regulatory clearance based on substantial equivalence and safety/effectiveness testing against established standards, not a specific performance study for an AI algorithm.

Here's what I can extract from the provided text, highlighting the absence of the requested AI/ML specific information:

1. A table of acceptance criteria and the reported device performance

• Information not provided. The document states: "The modified Infinity CentralStation with Infinity M300 has been tested in accordance with applicable standards and internal design control procedures and was determined to be as safe and effective for its intended use as the predicate devices." This is a general statement of compliance, not a report of specific performance metrics against acceptance criteria. The relevant standards listed are for electromagnetic compatibility (IEC 60601-1-2: 2007).

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

• Information not provided. No details on a test set sample size or data provenance are mentioned.

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)

• Information not provided. The device is a physiological monitor, not an interpretive AI system that would typically require expert-established ground truth in this context.

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

• Information not provided. Not applicable given the nature of the device and information 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

• Information not provided. This device is a monitoring system, not an AI-assisted diagnostic tool for human readers.

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

• Information not provided. The device performs physiological monitoring, including arrhythmia detection and ST segment analysis, which are algorithmic functions, but the document does not detail specific "standalone performance studies" in the context of an AI/ML algorithm being evaluated. Its performance is evaluated for safety and effectiveness against predicate devices and standards.

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

• Information not provided. For physiological monitoring, ground truth would typically come from standardized simulated signals, known clinical cases validated by other medical equipment, or direct physiological measurements, but the document does not elaborate on how "ground truth" was established for its internal performance evaluations.

8. The sample size for the training set

• Information not provided. There is no mention of a "training set" as this document does not describe an AI/ML model development or validation.

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

• Information not provided. Not applicable.

In summary, this document is a regulatory submission for a medical device that monitors physiological parameters. It does not provide the kind of detailed performance and validation data typically associated with studies proving an AI/ML device meets specific acceptance criteria.

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The intended use of the M300 & M400 powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

M300 & M400 Powered Wheelchair is battery powered, center wheel motor driven and is controlled by the PG power wheelchair VR-2 90 amp or R-net 120 amp controller. The user interface is a joystick. M300 & M400 is powered by two 12VDC 60Ah, Group M34 batteries, approximate driving range on fully charged batteries is up to 25km (15,5 miles), depending on use and the terrain the chair is driven on. The chair frame is a rived nut and welded steel construction and includes two center drive wheels with drive units (motor, gear, brake), batteries and front and rear pivoting casters. Depending on users needs, the joystick motor control is mounted to the left or right armrest. When the user activates the joystick, the controller receives a signal to release the brakes. With the brakes released, the chair is allowed to move in the direction the joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user stop by letting go of the joystick.

The provided document is a 510(k) Summary for a Permobil M300 & M400 Powered Wheelchair. It is a regulatory filing for a medical device that establishes substantial equivalence to a legally marketed predicate device, rather than a study demonstrating clinical performance or acceptance criteria in the context of diagnostic accuracy or similar AI/algorithm-driven devices.

Therefore, many of the requested elements (like acceptance criteria for AI performance, sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this type of regulatory submission for a powered wheelchair.

However, I can extract the relevant information from the document as requested, interpreting "acceptance criteria" and "device performance" in the context of device function and regulatory equivalence.

Acceptance Criteria and Device Performance (Permobil M300 & M400 Powered Wheelchair)

1. Table of acceptance criteria and the reported device performance

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

• Sample Size: Not applicable. This is a regulatory submission for a physical device, not an AI/algorithm. Performance data is mentioned generally ("In all instances, the M300 & M400 functioned as intended"), but no specific test set sample size (e.g., number of units tested, number of user trials) or data provenance for such a test set is provided in this summary.
• Data Provenance: Not applicable in the context of "country of origin of the data, retrospective or prospective." The manufacturer, Permobil AB, is located in Timrå, Sweden.

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

• Not applicable. This is a physical product (powered wheelchair). Ground truth in the sense of expert annotation or clinical diagnosis is not relevant here.

4. Adjudication method for the test set

• Not applicable. No adjudication method for a test set (e.g., consensus among experts) is mentioned or relevant for this type of device submission.

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/diagnostic imaging device.

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

• Not applicable. This is a powered wheelchair; it does not have a "standalone algorithm performance" in this context.

7. The type of ground truth used

• The "ground truth" for a device like this would be its functional performance against engineering specifications, safety standards, and its intended use. The document states "In all instances, the M300 & M400 functioned as intended," which implies it met its design and functional requirements. Substantial equivalence relies on comparing these functional and safety aspects to a predicate device.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device.

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

• Not applicable. This is not an AI/machine learning device.

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Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording and alarming of multiple physiological parameters of adult, pediatric and neonatal patients in a hospital environment and during transport inside and outside of hospital environment.

The modified device Philips M3001A Multi Measurement Server is substantially equivalent to the leqally marketed M3001A Multi Measurement Server (K030973, K033715). The modification consists of the integration of the Nellcor OxiMax SpO2 measurement module which is substantially equivalent to the legally marketed Nellcor OxiMax N-600x Pulse Oximeter (K060576). The modification adds to the M3001A Multi Measurement Server the Nellcor OxiMax SpO2 measurement module as an option in order to use the full Nellcor OxiMax technology. The modification is the integration of the Nellcor OxiMax SpO2 measurement module into the M3001A with minor hardware and software adaptations. The modification leads to a compact Multi measurement Server with integrated full Nelloor OxiMax technology.

The provided text describes the Philips M3001A Multi Measurement Server with Nellcor OxiMax SpO2 measurement module. However, it does not contain a discrete "acceptance criteria" section with specified thresholds for performance metrics. Instead, the document focuses on demonstrating substantial equivalence to predicate devices and adherence to standards.

Here's an attempt to extract and infer information based on the provided text, structured as requested:

Acceptance Criteria and Study Details for Philips M3001A Multi Measurement Server with Nellcor OxiMax SpO2 Measurement Module

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document explicitly states "Pass/Fail criteria were based on the specifications cleared for the predicate device." While specific numerical acceptance criteria other than the accuracy ranges for SpO2 and pulse rate are not provided, it's inferred that the acceptance criteria revolved around demonstrating performance equivalent to the legally marketed predicate devices and compliance with ISO 9919:2005.

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

• Sample Size for Test Set: The document mentions "controlled hypoxia studies with healthy non-smoking adult volunteers" for establishing calibration curves, but it does not specify the sample size for the test set used to validate the accuracy of the final device.
• Data Provenance: The SpO2 calibration curves are based on "controlled hypoxia studies with healthy non-smoking adult volunteers." The location or country of origin for these volunteers is not specified. The nature of the study for these calibration curves is prospective, as they involve controlled studies. The verification, validation, and testing activities mentioned for the full device are likely internal tests, but no further details on their provenance are provided.

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

The document does not mention the use of experts to establish ground truth for a test set in the context of the device's performance validation. The SpO2 values are derived from a physiological principle (absorption of light and ratio of oxygenated hemoglobin) and calibrated against in vivo hypoxia studies, not expert interpretation.

4. Adjudication Method for the Test Set

Since there is no mention of experts establishing ground truth or subjective assessments, there is no adjudication method described.

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

No MRMC comparative effectiveness study is mentioned in the provided text. The evaluation focuses on the standalone performance of the device's physiological measurements.

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

Yes, the information provided describes a standalone performance evaluation of the device. The accuracy of SpO2 and pulse rate, and the overall functionality, were tested without explicit human-in-the-loop interaction for interpretation or decision-making related to the device's core measurements. The SpO2 measurement is "based on the absorption of light" and calculated through "Out of calibration curves."

7. Type of Ground Truth Used

The ground truth for the SpO2 measurement accuracy relies on:

• Physiological principle: The definition of SpO2 as the percentage ratio of oxygenated hemoglobin to total hemoglobin.
• Controlled hypoxia studies: Data obtained from "controlled hypoxia studies with healthy non-smoking adult volunteers" was used to establish calibration curves, which then serve as the reference for determining SpO2 values from the light absorption ratio. This implicitly means that the actual blood oxygen levels during these controlled studies served as the ground truth for calibration curve development.

For the general functional and reliability testing, the ground truth was "specifications cleared for the predicate device" and compliance with ISO 9919:2005.

8. Sample Size for the Training Set

The document does not explicitly use the term "training set." However, the "calibration curves" for SpO2 are based on "controlled hypoxia studies with healthy non-smoking adult volunteers." The sample size for these studies (which serve as the basis for the device's internal calibration/training equivalent) is not specified.

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

The "calibration curves" (analogous to a training set for the SpO2 algorithm) were established using data from "controlled hypoxia studies with healthy non-smoking adult volunteers." In these studies, subjects are typically desaturated under controlled conditions, and their arterial blood oxygen saturation is measured directly using a co-oximeter (considered the gold standard for oxygen saturation in blood), which would serve as the ground truth. The ratio of red and infrared light absorption from the oximeter is then correlated with these direct blood oxygen measurements to create the calibration curves.

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Indicated for use whenever there is a need for monitoring, transport monitoring, recording, and alarming of the physiological parameters arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric and neonatal patients in a hospital environment by health care professionals.

X2 (M3002A) Multi-Measurement Module is indicated for transport monitoring outside hospitals.

The SpO2 measurement is based on the absorption of light, which is emitted through human tissue (i.e. index finger). Two light sources transmit red and infrared light through the human tissue. The ratio of the different absorption of the red and infrared light is calculated. The saturation value is defined by the percentage ratio of the oxygenated hemoglobin [HbO₂] to the total amount of hemoglobin [Hb] (SpO2 = [HbOz]/({Hb]+[HbO2]). Out of calibration curves, which are based on controlled hypoxia studies with healthy non-smoking adult volunteers over a specified saturation range (SaO2 from 70%-100%), the ratio determines the SpO2 value. The measurement accuracy of SpO2 in the range of 70% to 100% is between 2% and 4% RMS dependent on the Philips sensor type. The measurement accuracy of pulse rate in the range of 30 bpm to 300 bpm is 2% or 1 bpm (whichever is greater).

The modification is a hardware and firmware improvement and reduces the manufacturing costs.

Here's an analysis of the acceptance criteria and study details for the picoSAT IIP408 SpO2 pulse oximetry module, 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

• Sample Size: 10 volunteers
• Data Provenance: Controlled hypoxia studies with healthy non-smoking adult volunteers. Since the submitter is Philips Medizin Systeme Böblingen GmbH (Germany), it's highly likely the study was conducted in Germany or a similar Western country, but the specific country of origin is not explicitly stated. The study was prospective in nature due to it being a "controlled desaturation study."

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

• Number of Experts: Not applicable in this context.
• Qualifications of Experts: The ground truth was established by a CO-Oximeter as a reference, not human experts. CO-Oximeters are laboratory-grade instruments used for highly accurate blood gas analysis, including oxygen saturation.

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

• Adjudication Method: Not applicable. The ground truth was established by instrumental reference (CO-Oximeter) rather than human expert interpretation requiring adjudication.

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

• MRMC Study Done: No. This device is a pulse oximeter, not an AI-assisted diagnostic tool that would involve human readers interpreting cases.

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

• Standalone Study Done: Yes, essentially. The accuracy of the SpO2 measurement is a direct output of the device's hardware and firmware, compared against a reference standard. There is no human "in-the-loop" for the direct SpO2 measurement process itself.

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

• Type of Ground Truth: Instrumental reference – a CO-Oximeter was used to provide SaO2 (arterial oxygen saturation) reference values.

8. The Sample Size for the Training Set

• Sample Size: Not explicitly stated as a distinct "training set" in the context of machine learning model development. For traditional medical device calibration (as described here), "calibration curves" are developed. While the text mentions "Out of calibration curves, which are based on controlled hypoxia studies with healthy non-smoking adult volunteers over a specified saturation range (SaO2 from 70%-100%), the ratio determines the SpO2 value," it does not specify a separate sample size for developing these curves, implying some overlap or that the 10 volunteers may have contributed to this process. It explicitly states "at least 20 data samples per volunteer" for the validation study.

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

• Ground Truth Establishment: The "calibration curves" (analogous to a training process for establishing the device's core functionality) were "based on controlled hypoxia studies with healthy non-smoking adult volunteers over a specified saturation range (SaO2 from 70%-100%)." This implies that during these hypoxia studies, a reference method (likely a CO-Oximeter, similar to the validation) was used to establish the true SaO2 values against which the device's internal light absorption ratios were mapped to create the SpO2 output.

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Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in patient transport and healthcare environments.

The modification creates the Masimo SET SpO₂ pulse oximetry module for use in Philips host patient monitors.

The provided text is a 510(k) summary for the Philips Medical Systems Masimo SET SpO2 module. This document focuses on establishing substantial equivalence of a new device to a legally marketed predicate device, rather than presenting a detailed study with acceptance criteria and performance metrics for the new device's specific clinical efficacy or accuracy.

Therefore, much of the requested information cannot be directly extracted from the provided text. The summary explicitly states: "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved system level tests, integration tests, environmental tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. The results demonstrate that the pulse oximetry module functionality meets all reliability requirements and performance claims."

This indicates that the testing performed largely confirmed the new device's ability to operate similarly to the predicate under various conditions, rather than a clinical study establishing new performance benchmarks.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document states: "Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence." It does not provide specific acceptance criteria or reported device performance metrics in a table format for the new device. The focus is on equivalence, not on new performance claims.

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

This information is not provided in the 510(k) summary. The summary refers to "system level tests, integration tests, environmental tests, and safety testing," which are typically laboratory or engineering tests, not clinical studies with a "test set" in the context of 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)

This information is not provided. As noted above, the "test set" likely refers to engineering testing, not a clinical dataset requiring expert ground truth.

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

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

This information is not provided. The device is an SpO2 module, which provides a physiological measurement, not an AI-powered diagnostic tool requiring human reader studies to improve interpretation. An MRMC study would not be relevant in this context.

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

The device is a pulse oximetry module, which inherently provides a standalone measurement (SpO2, pulse rate). The summary confirms its "functionality" and "performance claims," implying its ability to provide these measurements independently. However, the exact details of standalone performance metrics are not explicitly stated beyond meeting predicate specifications.

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

For a pulse oximeter, "ground truth" for accuracy is typically established through controlled desaturation studies compared against arterial blood gas measurements. The provided text does not detail the type of ground truth used for specific accuracy validation, but implies it was sufficient to demonstrate equivalence to the predicate.

8. The sample size for the training set

This information is not provided. Pulse oximeters do not typically employ a "training set" in the machine learning sense. Their algorithms are based on established physiological principles and signal processing, often calibrated and validated against clinical data, but not "trained" as an AI model would be.

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

As there is no "training set" in the AI sense for this device, how its ground truth was established is not applicable and therefore not provided.

In summary, the provided 510(k) document is a regulatory submission focused on demonstrating substantial equivalence to a predicate device, not a detailed clinical study report on the new device's performance metrics against specific acceptance criteria.

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The Fugo Blade ® for peripheral iridotomy is indicated for intraocular creation of iridotomies.

The intended use of the device is to create an opening or iridotomy in iris tissue where lasers are not capable or desirable, thereby surgical intervention is required.

The Fugo Blade for PI is an electrosurgical device that is powered by the electromagnetic (EM) energy from flashlight size batteries. This energy is conditioned, tuned (9,8 x 10 6 Hz) and focused on a thin, blunt cutting filament. Moreover, EM energy from flashlight size ("C" cell) batteries is fed into a proprietary electronic network system which is activated by the surgeon with an on/off switch. This electronic system is fed EM energy from the battery energy supply source then conditions, tunes (9.8 x 10 6 ) and focuses this EM energy into a 50-100 micron column of EM energy surrounding a blunt 100 micron diameter cutting filament at the end of the Fugo Blade hand piece. This column of EM field energy is capable of reacting with iris tissue. This column of EM field energy causes the molecular bonds in the iris tissue which comes in contact with the EM field to ionize momentarily and thereby break apart, a condition that physicists refer to as a momentary "plasma formation". In this way, the molecular lattice of the iris is broken down, thereby creating a peripheral iridotomy.

The provided text describes a 510(k) premarket notification for the "Fugo Blade for Peripheral Iridotomy, Model M300", submitted by MediSURG Ltd. The submission claims substantial equivalence to existing predicate devices.

Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The text does not explicitly state quantitative "acceptance criteria" for the Fugo Blade for Peripheral Iridotomy in the manner of specific thresholds (e.g., "sensitivity must be > 90%"). Instead, the acceptance is based on demonstrating substantial equivalence in safety and effectiveness to predicate devices. The performance is reported in terms of achieving this equivalence.

*Note on Technological Equivalence: The Fugo Blade for PI is declared technologically equivalent to the Fugo Blade for Capsulotomy because they share the same electronic system. Its equivalence to the ND:Yag Laser for PI is based on functional and outcome equivalence, despite different technological mechanisms, both resulting in "plasma formation" to break down iris tissue.

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

• Test Set Description:
  • Clinical Study: 25 subjects with acute angle closure glaucoma and 25 subjects with phakic IOL insertion.
  • Preclinical Study: Porcine eye models (specific number not provided).
• Data Provenance:
  • Clinical Study: Prospective clinical data, likely from the study conducted by MediSURG Ltd. The country of origin is not specified but is implied to be within the scope of the FDA submission (likely USA).
  • Historical Controls: Retrospective data obtained from "peer-reviewed literature" and "8 separate ND: Yag PI studies on angle closure patients published in Index Medicus peer-reviewed journals."

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

The text does not explicitly state the number of experts used to establish ground truth or their specific qualifications for either the preclinical or clinical studies.

• For the clinical study, assuming standard medical practice, ophthalmologists would have assessed the outcomes (safety and effectiveness of iridotomy creation and prevention/elimination of angle closure). Their qualifications are implied by their role as treating/evaluating physicians.
• For the preclinical porcine eye studies, researchers/veterinarians with expertise in ocular anatomy and histology would have performed endothelial cell imaging and heat generation measurements.

4. Adjudication Method for the Test Set

The text does not specify an adjudication method (such as 2+1, 3+1, or none) for the clinical or preclinical test sets. Outcomes were compared to historical controls.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done as described in the text.
• The study design involved comparing the Fugo Blade for PI's clinical outcomes to historical controls from the peer-reviewed literature for the predicate ND:Yag laser. This is a comparison of device performance to existing published data, not an MRMC study where human readers' performance with and without AI assistance is directly measured and compared.

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

• Yes, a standalone performance evaluation was implicitly done, as the Fugo Blade is a surgical device, not an AI algorithm.
• The preclinical studies (endothelial cell damage and heat generation in porcine eyes) and the clinical trial (on human subjects) assessed the device's direct performance and safety without considering "human-in-the-loop" improvements, other than the surgeon utilizing the device. The device's performance as a standalone tool for creating iridotomies was the focus.

7. Type of Ground Truth Used

• Preclinical Study: Direct measurements (endothelial cell count, temperature increase) in porcine eye models.
• Clinical Study: Clinical outcomes observed in subjects (creation of iridotomies, prevention/elimination of angle closure), assessed by treating clinicians. This represents outcomes data and expert assessment of safety and efficacy.
• Historical Controls: Published clinical outcomes from peer-reviewed literature, representing established clinical efficacy and safety of the predicate device.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable to this submission, as it describes a physical electrosurgical device and its clinical/preclinical evaluation, not a machine learning model.

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

As the concept of a training set is not applicable, this question is also not relevant to the provided text.

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Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in patient transport and hospital environments.

picoSAT II SpO2 pulse oximetry module and M3001A Multi-Measurement Server

The provided text is a 510(k) summary for the picoSAT II SpO2 pulse oximetry module. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does NOT contain the detailed information required to fill out the table regarding acceptance criteria and the specific study proving the device meets those criteria.

Here's what can be extracted and what information is missing:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in the provided text. Pulse oximeter performance is typically measured by accuracy (Arms) over a specified SpO2 range.
• Reported Device Performance: Not explicitly stated. The document mentions "clinical validation studies were also conducted" but does not provide the results of these studies or any performance metrics.

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

• Sample Size (Test Set): Not mentioned.
• Data Provenance: Not mentioned.

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)

• Number of Experts: Not applicable, as this is a pulse oximetry device, not an image-based diagnosis device usually requiring expert interpretation for ground truth. The "ground truth" for a pulse oximeter would likely be arterial blood gas measurements (co-oximetry).
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable for a pulse oximetry device where direct physiological measurements usually serve as the reference.

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

• MRMC Study: Not applicable. This is not an AI-assisted diagnostic device for human readers.

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

• Standalone Performance: The core of a pulse oximeter is a standalone algorithm. The document mentions "clinical validation studies were also conducted," which would imply testing the device's accuracy in measuring SpO2. However, no specific performance results (like Arms) are provided.

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

• Type of Ground Truth: Not explicitly stated, but for pulse oximeters, the gold standard for ground truth is typically arterial blood gas analysis (co-oximetry).

8. The sample size for the training set

• Sample Size (Training Set): Not mentioned. "Training set" is generally more relevant for machine learning algorithms. While the device uses a "FAST pulse oximetry algorithm," the document doesn't detail how this algorithm was developed or if it involved a distinct "training set" in the modern machine learning sense. Clinical validation would be a more direct performance test.

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

• Ground Truth (Training Set): Not mentioned.

Summary of what is present and what is missing:

The provided text serves as a 510(k) summary, which generally focuses on demonstrating substantial equivalence to predicate devices and adherence to regulatory requirements. It confirms that "clinical validation studies were also conducted" and "all verification and validation activities were successfully completed," but it explicitly lacks the detailed results, acceptance criteria, sample sizes, and ground truth methodologies that would typically be found in a detailed study report or a more comprehensive technical document.

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