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The Nellcor® DuraMax® reusable oximetry sensor is indicated when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing 40 kg or more.

The DuraMax is a reusable sensor, sized appropriately to fit the digit of a pediatric or adult patient weighing 40 kg or more.

The DuraMax sensor consists of an internal frame containing the optical components and flexible circuit encapsulated in a synthetic, latex-free rubber overmold.

The DuraMax sensor plug contains a memory chip carrying information about the sensor which the oximeter needs for correct operation, including Advanced Signal Evaluation, Intention and data set revision, and sensor model. The DuraMax sensor is compatible with Nellcor and other monitors incorporating either Nellcor R-Cal or OxiMAX (DigiCal) oximetry technology.

Nellcor® DuraMax® Reusable Oximetry Sensor

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

The submission does not explicitly state quantitative acceptance criteria in a table format. However, it indicates adherence to the ISO 9919:2005 standard and states that "Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications." The implicit acceptance criterion, therefore, is conformance to the accuracy and precision specifications outlined in ISO 9919:2005 for pulse oximeters. The submission concludes that the device meets these requirements.

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

The submission states that "Human... tests were performed to support the determination of substantial equivalence" and that "Human oxygenation evaluations were conducted." However, the document does not specify:

• The exact sample size used for the human test set.
• The country of origin of the data.
• Whether the study was retrospective or prospective.

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 in the submission. The submission mentions "Human oxygenation evaluations," which implies direct physiological measurements rather than expert review of data. In the context of pulse oximetry, the "ground truth" for oxygen saturation is typically established through co-oximetry measurements of arterial blood samples. Expert review for ground truth establishment is not typically the primary method for this type of device.

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

This information is not provided in the submission. Given that the ground truth for oxygen saturation is usually established by direct or highly accurate indirect physiological measurements (e.g., co-oximetry), a multi-reader adjudication method would not be applicable in the traditional sense for the device's primary function.

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

A multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. The DuraMax® sensor is an oximetry sensor, not an AI-powered diagnostic device that assists human readers in case interpretation.

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

The device itself is a passive sensor that provides data (oxygen saturation and pulse rate) to an oximeter; it does not contain a standalone "algorithm" in the sense of an AI-driven component. The "Advanced Signal Evaluation" and "Intention and data set revision" are mentioned as information carried by the sensor's memory chip, indicating internal processing logic for signal quality, but this is part of the integrated system and not a standalone algorithm evaluated independently for diagnostic performance.

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

For oxygen saturation measurements, the ground truth is typically established using arterial co-oximetry, where arterial blood samples are analyzed to determine actual oxygen saturation (SaO2). The submission states "Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications," which strongly implies comparison against a gold standard for oxygen saturation, most commonly co-oximetry.

8. The sample size for the training set

The submission does not mention a distinct "training set" for the device, as it is a hardware sensor rather than a machine learning model that requires training. The development and verification process for such a device would involve design, bench testing, and human testing for performance validation.

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

As there is no mention of a "training set" in the context of a machine learning model, this question is not applicable. The ground truth for performance validation (the human oxygenation evaluations) would have been established through methods like co-oximetry as described in point 7.

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The Nellcor OxiMax N-600x Pulse Oximeter is indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The Nellcor OxiMax N-600x Pulse Oximeter is intended for use with neonatal, pediatric, and adult patients, and for patients who are well or poorly perfused, in bospitals, hospital-type facilities, intra-hospital transport, and home environments. For prescription use only

The OxiMax N-600x Pulse Oximeter is a modification OxiMax Pulse Oximetry System with N-595 Pulse Oximeter and OxiMax Sensors and Cables. The N-600x is designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate using OxiMax pulse oximetry sensors and the DOC-10 cable. The N-600x Pulse Oximeter displays digital values of SpO2 and Pulse Rate. Pulse Amplitude is displayed by means of a "blip bar" presentation or plethysmographic waveform. The N-600x can be powered by an internal power supply operating on AC from a standard electrical utility receptacle (manually switchable from 115V to 230V) or alternatively by an internal 6V rechargeable sealed lead-acid battery. The OxiMax N-600x Pulse Oximeter is intended for prescription use with adult, pediatric and neonatal patients in hospitals, hospital-type facilities, intra-hospital transport, and home environments.

The provided text is a 510(k) Summary for the Nellcor OxiMax N-600x Pulse Oximeter and primarily describes the device, its intended use, and its technological characteristics. It mentions that clinical and non-clinical tests were performed but does not provide specific details about acceptance criteria, the results of those tests, or the study design.

Therefore, many of the requested details cannot be extracted from this document, specifically:

• Acceptance Criteria and Reported Performance Table: Not provided.
• Sample size for the test set and data provenance: Not provided. The document states "Clinical studies were conducted following regulations under Title 21 of the Code of Federal Regulations (21 CFR), Part 812 - Investigational Device Exemptions, Part 50 - Protection of Human Subjects and Part 56 - Institutional Review Boards," which implies prospective human subject research, but no details on size or origin.
• Number of experts and qualifications for ground truth: Not provided.
• Adjudication method: Not provided.
• MRMC comparative effectiveness study: Not mentioned.
• Standalone algorithm performance: Not explicitly stated or detailed, although the device itself is a standalone algorithm within the oximeter.
• Type of ground truth used: Not provided.
• Sample size for the training set: Not provided, as the document doesn't explicitly discuss an "AI" or machine learning training phase in the modern sense. The "algorithm" mentioned is for processing signals from the sensor.
• How ground truth for the training set was established: Not provided.

Summary of available information:

The document broadly states that:

• "Clinical and non-clinical tests were performed to support the determination of substantial equivalence."
• "Clinical studies were conducted following regulations under Title 21 of the Code of Federal Regulations (21 CFR), Part 812 - Investigational Device Exemptions, Part 50 - Protection of Human Subjects and Part 56 - Institutional Review Boards."
• "The technological characteristics of the OxiMax N-600x Pulse Oximetry System and the results of non-clinical and clinical tests do not raise new questions of safety or effectiveness when compared to the legally marketed predicate devices."

This indicates that studies were conducted to show substantial equivalence to a predicate device, rather than to meet specific performance acceptance criteria for a novel technology in the way AI/ML devices might. The FDA's letter (K060576) confirms that the device was deemed substantially equivalent based on the submitted information.

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The Nellcor® OxiMax® NeoMAX adhesive forchead reflectance sensor is indicated for single patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for neonatal and pediatric patients (≤ 40 kg).

The OxiMax NeoMAX is a sterile, latex-free, single patient use forehead sensor, sized appropriately to fit the forehead of a neonatal or pediatric patient.

The OxiMax NeoMAX sensor contains a memory chip carrying information about the sensor which the oximeter needs for correct operation, including in-sensor data. Advanced Signal Evaluation, lot code and data set revision, and sensor model. The OxiMax NeoMAX sensor is compatible with OxiMAX monitors.

The provided text describes the OxiMax NeoMAX Adhesive Forehead Reflectance Oximetry Sensor, but it does not contain a table of acceptance criteria or detailed results from a study proving the device meets specific criteria. The document states that "Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications," but it does not present these specifications or the results in detail.

Therefore, many of the requested items cannot be answered directly from the provided text.

Here is what can be extracted based on the input:

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

• Acceptance Criteria: Not explicitly stated in the provided text. The text mentions "accuracy and precision specifications" were confirmed, but the specific values for these specifications are not given.
• Reported Device Performance: Not explicitly stated in the provided text. The document indicates that testing was performed and concluded that "The technological characteristics of the OxiMax NeoMAX sensor and the results of testing do not raise new questions of safety or effectiveness when compared to the legally marketed predicate device." However, the actual performance metrics (e.g., accuracy, bias, standard deviation of SaO2 readings) are not provided.

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

• Sample Size for Test Set: Not specified. The document only states "Human oxygenation evaluations were conducted."
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• Not applicable/Not specified. This device is an oximeter sensor, and ground truth for oxygen saturation measurements is typically established through arterial blood gas analysis, not expert consensus on images. The document does not describe how ground truth was established.

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

• Not applicable/Not specified. Adjudication methods are typically used in studies involving expert interpretation of data (e.g., images), which is not the primary form of evaluation for an oximeter sensor.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

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

• This device is a sensor. Its "performance" inherently refers to its ability to accurately measure oxygen saturation and pulse rate. The evaluation would be of the sensor's direct measurement capabilities, which is analogous to a standalone performance evaluation in the context of a medical device's fundamental function. The document states "Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications," implying a direct measurement efficacy study.

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

• Not explicitly stated, but for oxygen saturation measurements, the common gold standard (ground truth) is arterial blood gas analysis. It is highly probable this method was used, though not specified in the text.

8. The sample size for the training set

• Not applicable/Not specified. This device is a sensor; it does not involve a "training set" in the context of machine learning algorithms.

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

• Not applicable. This device does not involve a training set.

In summary, the provided 510(k) summary focuses on establishing substantial equivalence to a predicate device and mentions that human and bench tests were performed to confirm accuracy and precision. However, it lacks the detailed quantitative data, sample sizes, and ground truth methodologies that would be necessary to fully answer many of the questions regarding acceptance criteria and study particulars.

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The Nellcor OxiMax Pulse Oximetry Sensors, models MAX-A, MAX-AL, MAX-N, MAX-P, MAX-I and MAX-FAST are indicated for single patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients in the sizes indicated in the respective sensor directions for use.

Nellcor OxiMax Pulse Oximetry Sensors, models MAX-AL, MAX-AL, MAX-P, MAX-I and MAX-FAST are designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate in conjunction with a Nellcor pulse oximeter. Nellcor OxiMax Pulse Oximetry Sensors, models MAX-A, MAX-AL, MAX-N, MAX-P, MAX-I and MAX-FAST are intended for prescription use with adult, pediatric and neonatal patients in hospitals, hospital-type facilities, intra-hospital transport, and home environments.

These OxiMax sensors each contain a memory chip carrying information about the sensor which the oximeter needs for correct operation including sensor model, Advanced Signal Evaluation, and data set revision. The memory chip is also cable of storing including in-sensor data when connected to an OxiMax-capable monitor, and lot code.

Here's a breakdown of the acceptance criteria and study information for the Nellcor OxiMax Pulse Oximetry Sensors, based on the provided text:

Nellcor OxiMax Pulse Oximetry Sensors: Acceptance Criteria and Study Information

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The provided text is a 510(k) summary, which often provides a high-level overview. Detailed performance data and specific acceptance criteria (e.g., ARMS values for SpO2 accuracy) are typically found in the full 510(k) submission, not always in the public summary. The summary confirms that studies were performed to support accuracy specifications, but doesn't report the specific numerical values of these specifications or the device's performance against them.

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

• Sample Size: Not explicitly stated in the provided text. The document mentions "Clinical tests were performed" and "Clinical studies were conducted" but does not specify the number of subjects or data points in the test set.
• Data Provenance: Not explicitly stated. The document confirms that clinical studies were conducted, implying human subject data collection, but does not specify the country of origin or whether it was retrospective or prospective. Given the context of a 510(k) submission for new sensors, it is highly probable these were prospective clinical studies conducted specifically for this submission.

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

• This information is not provided in the given text. For pulse oximetry, the "ground truth" for SpO2 accuracy is typically established by comparing the device's readings to arterial blood gas (ABG) measurements or co-oximetry, not usually by human expert consensus on the device's output itself. Therefore, the concept of "experts establishing ground truth for the test set" in the context of reader evaluation isn't directly applicable here. The experts involved would more likely be the clinicians performing the ABG measurements or managing the study, and their qualifications are not detailed.

4. Adjudication Method for the Test Set

• This information is not provided in the given text. Adjudication methods (like 2+1 or 3+1) are typically used when multiple human readers interpret data (e.g., medical images) to establish a consensus ground truth. For pulse oximetry, the direct comparison to ABG/co-oximetry as a reference standard eliminates the need for such adjudication of the device's output.

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

• No, an MRMC comparative effectiveness study was not done as described in the provided text. MRMC studies are designed to assess the impact of an AI algorithm on human reader performance, usually in diagnostic tasks involving interpretation of visual data. Pulse oximetry is a direct measurement device; its performance is evaluated against a reference standard (like ABG), not by how it assists human readers in interpreting its output.

6. Standalone (Algorithm Only) Performance

• Yes, standalone performance was done. The entire premise of pulse oximetry testing for regulatory approval is to establish the accuracy of the device's (algorithm's) measurements of SpO2 and pulse rate against a
  reference standard (typically arterial blood gas/co-oximetry). The statement "Clinical tests were performed to support accuracy specifications for SpO2 performance" directly refers to evaluating the device's intrinsic measurement capabilities. The device processes electrical information "by use of an algorithm to provide real time values of SpO2, pulse rate and pulse amplitude," indicating a standalone algorithmic evaluation.

7. Type of Ground Truth Used

• The type of ground truth used is physiological reference data, specifically arterial blood oxygen saturation (SaO2) and heart rate measurements, likely obtained through arterial blood gas (ABG) analysis or co-oximetry. While not explicitly named, this is the universally accepted gold standard for determining the accuracy of pulse oximeters. The text states "Clinical tests were performed to support accuracy specifications for SpO2 performance," which implies comparison to a highly accurate and independent measure of arterial oxygen saturation.

8. Sample Size for the Training Set

• This information is not provided in the given text. For pulse oximetry devices, "training set" doesn't apply in the same way it would for a machine learning model that learns from large datasets. Instead, the device's algorithm is developed and refined based on engineering principles, physiological models, and data collected during R&D. If the "data set revision" mentioned in the memory chip refers to an internal algorithm update, the data used for its development (not necessarily a distinct "training set" in the ML sense) is not specified. The summary focuses on the clinical validation of the device's performance.

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

• This information is not applicable/provided in the traditional sense of a "training set" for a machine learning model. The pulse oximetry algorithm relies on empirical relationships between light absorption and blood oxygenation. The ground truth for developing and refining such an algorithm would have been established through extensive physiological studies, often involving human subjects under controlled desaturation protocols, where arterial blood samples (co-oximetry) provide the reference standard. However, the summary does not detail the specific methods or data used during the initial algorithm development or "training." It focuses on the validation of the final device.

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The OxiMax™ NPB-40 handheld pulse oximeter is indicated for continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric and neonatal patients in hospital type facilities, transport and mobile environments as well as in the home care environment.

The OxiMax NPB-40 is a handheld, battery powered pulse oximeter used for monitoring of pulse rate and saturated oxygen in arterial blood. The OxiMax NPB 40 include the addition of audible alarms, addition of keys and display icons in the user interface board to access the alarm settings and the OxiMax in-sensor data features. The OxiMax NPB-40 also has menu features to allow the user to set the time, date and measurement alarm limits

The provided document is a 510(k) premarket notification summary for the OxiMax™ NPB-40 Pulse Oximeter. It states that the device is substantially equivalent to legally marketed predicate devices and demonstrates this through performance data. However, it does not contain specific acceptance criteria with numerical targets or detailed results of a study that directly proves the device meets those criteria, as typically presented in a table with performance metrics.

The document broadly mentions "performance data includes results from environmental testing, in-house clinical studies and laboratory testing" to evaluate "oxygen saturation and pulse rate accuracy... during non-motion and motion conditions as well as low perfusion levels." It concludes that this data "demonstrates substantial equivalence" to predicate devices.

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

Here's an attempt to answer based on the available information, with clear indications where information is not present.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set: Not specified in the document.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The studies are referred to as "in-house clinical studies and laboratory testing."

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

• Not specified. The document does not describe the methodology for establishing ground truth within the context of expert review.

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

• Not specified.

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. This device is a pulse oximeter, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not applicable and was not performed.

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

• Yes, in essence. The performance data mentioned (clinical and non-clinical laboratory testing for oxygen saturation and pulse rate accuracy) refers to the performance of the device itself (the "algorithm only" in this context) under various conditions. The document states this testing "was conducted to evaluate oxygen saturation and pulse rate accuracy of the OxiMax NPB-40." This implies a standalone evaluation of the device's measurement capabilities.

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

• For oxygen saturation and pulse rate accuracy, the ground truth in such studies typically comes from arterial blood gas analysis (ABG) for oxygen saturation and a simultaneous ECG or direct measurement for pulse rate, often used in conjunction with a controlled desaturation study in human subjects (for SpO2). While the document doesn't explicitly state "ABG," it is the standard reference method for validating pulse oximeter accuracy.

8. The sample size for the training set:

• Not applicable. This device is a pulse oximeter, which relies on established physiological principles and sensor technology, not a machine learning algorithm that requires a separate "training set" in the conventional sense of AI/ML devices.

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

• Not applicable (see point 8).

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The Puritan Bennett GoodKnight 425ST is indicated for use in treating obstructive sleep apnea (OSA) in spontaneously breathing patients weighing over 30 kg within a homecare and hospital environment.

The GoodKnight 425ST is designed to deliver Positive Airway Pressure between 3 and 20 cmH2O in CPAP mode or between 3 and 25 cmH2O in bi-level mode (EPAP maximum 20 cmH2O). The GoodKnight 425ST can be powered either by AC mains (100 VAC to 240 VAC nominal) or by an external 12 VDC battery. The blower motor nominal voltage is 13 VDC. The GoodKnight 425 is doubleinsulated so that grounding is not required. The GoodKnight 425ST is set up for use by the homecare dealer using the Clinician Manual provided. The devices are operated according to the instructions contained in the Patient Manual. The GoodKnight 425ST rely on a microprocessor for setting and viewing various control parameters and turning features on and off. The microprocessor is also required for the treatment of various signals from the devices including signals relating to patient cycle detection. Pressure delivery for the GoodKnight 4253T is regulated by a pressure sensor which monitors both ambient and output pressure and provides feedback to the control system. The GoodKaight 425ST uses the same pass over humidifier and interfaces as those approved for use with the GoodKnight 425. The GoodKnight 425ST tubing is equivalent to that of the GoodKnight 425. The GoodKnight 425ST can also be connected to a computer via an RS232 serial port. The device can be configured from the computer using the SilverLining™ software which is required for downloading and displaying compliance data stored in the device memory. The GoodKnight 425ST is not for use in life-supporting or life-sustaining situations. The devices and/or their accessories are not intended for sterile use. The GoodKnight 425ST is for multiple use. Accessories such as the patient circuit and nasal masks are for single patient use. The GoodKnight 425ST is for use by prescription only and display the appropriate labeling. The GoodKnight 425ST is for use in a hospital and homecare environment. The GoodKnight 425ST does not contain any drugs or biological products as components. However, the devices can be used to provide the patient with supplemental oxygen. The GoodKnight 425ST is not part of a kit. The GoodKnight 425ST uses software to set the various device parameters such as the prescription pressure and the ramp starting pressure.

The provided document, K050072 for the PURITAN BENNETT GoodKnight 425ST, largely focuses on establishing substantial equivalence to a predicate device (GoodKnight 425) and does not detail a study proving specific acceptance criteria in the manner of an AI/ML medical device submission.

Instead, the submission for this conventional medical device relies on:

• Functional testing: To confirm the device meets its stated performance specifications.
• Compliance with guidance documents and standards: Specifically, the November 1993 draft "Reviewer Guidance for Premarket Notification Submissions" and international standards like IEC 60601-1 and EN ISO 17510-1.
• Comparison to a predicate device: Demonstrating that the technological characteristics and performance are sufficiently similar to a device already cleared for market.

Therefore, many of the requested categories for AI/ML device studies are not applicable to this 2005 510(k) submission for a CPAP system.

Here's an attempt to answer the questions based on the available information, noting where information is not present or not applicable:

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 specified. This type of submission for a conventional device typically involves bench testing on a limited number of manufactured units, rather than a "test set" of patient data as would be used for an AI/ML device.
• Data Provenance: Not applicable in the context of patient data. The testing is bench testing of the physical device.

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

• Number of Experts: Not applicable. Ground truth, in the context of device performance verification, is established by measurement against known standards and specifications, not by expert consensus on clinical data.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. Functional tests typically have clear pass/fail criteria based on objective measurements and specifications.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• MRMC Study: No, this type of study was not done. MRMC studies are typically used to assess the impact of an AI algorithm on human reader performance, which is not relevant for this device.

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

• Standalone Performance: Not applicable in the context of an AI algorithm's performance. The device itself has software, but its performance is measured as part of the integrated system (e.g., pressure delivery accuracy, adherence to settings), not as a standalone "algorithm."

7. The type of ground truth used

• Type of Ground Truth: The "ground truth" for this device's performance validation is its engineering specifications and established regulatory standards (e.g., IEC 60601-1, EN ISO 17510-1, FDA guidance documents). Functional testing verifies that the device operates within these predefined parameters.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device does not use machine learning in a way that requires a "training set" of data to learn patterns or make predictions. The software controls predefined functions.

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

• Ground Truth for Training Set: Not applicable for the same reason as above.

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The Reprocessed Oxisensor II and OxiMax Sensors are intended for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. They are intended for use with neonatal, pediatric, and adult patients during both no motion and motion conditions and for patients who are well or poorly perfused, in hospitals, hospital-type facilities, intra-hospital transport, and home environments.

The Reprocessed Nellcor Oxisensor and OxiMax Sensors are designed for use with Nellcor and Nellcor-licensed pulse oximetry monitors that provide continuous noninvasive measurement of pulse rate and arterial oxygen saturation. The sensor contains three optical components: two light emitting diodes (LEDs) that serve as light sources and one photodiode that acts as a light detector. Both the LEDs and the photodiode are contained within a laminated envelope with an adhesive bandage for attachment to a patient. Attached to a laminated envelope is a sensor cable which terminates in a connector element that connects to the oximeter.

The sole difference between the OxiMax sensors and the Oxisensor II sensors is the OxiMax sensors each contain a memory chip carrying information about the sensor which the oximeter needs for correct operation, including in sensor data, Advanced Signal Evaluation, lot code and data set revision, and sensor model.

The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets those criteria for the Reprocessed Oxisensor II and OxiMax Sensors.

Instead, the document primarily focuses on the device description, indications for use, and a comparison of technological characteristics to predicate devices within the context of a 510(k) submission. The key assertion is that:

• "The Reprocessed Oxisensor II and OxiMax Sensors meet the same performance requirements as the predicate devices."
• "The technological characteristics of the Reprocessed Oxisensor II and OxiMax Sensors and the results of bench tests and laboratory tests do not raise new questions of safety or effectiveness when compared to the legally marketed predicate devices."

This indicates that the acceptance criteria for the reprocessed sensors were implicitly the same as those established for the original, legally marketed predicate devices. The "study" proving the device meets these criteria appears to be a series of "bench tests and laboratory tests" demonstrating technological equivalence and performance parity. However, the document does not provide specifics on:

• Quantitative acceptance criteria (e.g., specific accuracy ranges, precision values).
• Detailed results of the bench and laboratory tests.
• Sample sizes, data provenance, ground truth establishment, or expert involvement for any testing done.
• MRMC or standalone studies.

Without these details, it's impossible to populate the requested table and provide specific answers to the numbered questions. The current document focuses on regulatory approval based on substantial equivalence rather than a detailed performance study with explicit acceptance criteria and results.

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The Shiley FlexTra Tracheostomy Tube with Disposable Inner Cannula is intended to provide tracheal access for airway management.

Cuffed Shiley FlexTra products sizes 7.0, 8.0, and 9.0 mm ID are also intended for use with Percutaneous Dilatational Tracheotomy (PDT) procedures.

The Shiley FlexTra disposable tracheostomy tubes are double cannula tracheostomy tubes with disposable inner cannula. The device is latex-free, sterile, and for single patient use only.

The device is intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The device is used to provide an artificial airway in order to assist in the treatment of a variety of respiratory diseases and airway management for adult patients. After insertion in place through a tracheotomy incision in the patient's neck and trachea, the device is then secured in place through the tracheostomy tube's swivel neck plate/flange with the use of a neck strap. Once in place, the device provides a secure artificial airway for spontaneous breathing or direct hook-up to ventilation or anesthesia equipment.

Selected cuffed Shiley FlexTra products are also intended for use in conjunction with Percutaneous Dilatational Tracheotomy. The device is inserted into the patient using the appropriate loading dilator provided in a separate percutaneous dilatational kit. The device is intended to be used as an artificial airway immediately post tracheotomy.

This document is a 510(k) premarket notification for the Shiley® FlexTra™ Tracheostomy Tube. It does not contain information about acceptance criteria or a study proving device performance against such criteria. Instead, it focuses on demonstrating substantial equivalence to legally marketed predicate devices.

Therefore, I cannot provide the requested information. The document explicitly states:

• "The technological characteristics of the Shiley FlexTra tracheostomy tube and the results of bench tests do not raise new questions of safety or effectiveness when compared to the legally marketed predicate devices."

This indicates that the submission relies on comparing the device's characteristics and bench test results (which are not detailed) to existing predicate devices, rather than presenting a study with specific acceptance criteria for performance metrics.

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The Nellcor OxiMax SoftCare adult oxygen sensor, model SC-A, is indicated for single patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for adults weighing more than 40 kg.

The Nellcor OxiMax SoftCare preterm infant oxygen sensor, model SC-PR, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for neonates weighing less than 1.5 kg.

The Nellcor OxiMax SoftCare neonatal oxygen sensor, model SC-NEO, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for neonates weighing 1.5 kg to 5 kg.

The Nellcor OxiMax SoftCare neonatal oxygen sensor, model SC-N, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for neonates weighing less than 3 kg.

The OxiMax SoftCare Sensors are indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required.

The OxiMax SoftCare sensors are sterile, latex-free, single patient use, non-adhesive Sensors. These sensors have a noon and soft and soft as a more is eliminated.

These sensors contain a memory chip carrying information about the sensor which the oximeter needs for correct operation, including in-sensor data, Advanced Signal Evaluation, lot code and data set revision, and sensor model. The OxiMax SoftCare sensors are compatible with OxiMAX monitors.

The provided text is a 510(k) summary for the Nellcor OxiMax SoftCare Sensors. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance metrics in the typical format for a medical device's performance study.

Based on the information provided, here's what can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications." However, it does not provide a specific table of acceptance criteria or the reported device performance metrics (e.g., accuracy, precision values, specific thresholds for SpO2 or pulse rate) during these evaluations. This is common for 510(k) summaries which often refer to conformance to established standards or predicate device performance without detailing the exact numbers.

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

• Sample Size for Test Set: Not specified. The document only mentions "Human oxygenation evaluations."
• Data Provenance: Not specified, but likely from a clinical setting, given "human oxygenation evaluations." It does not clarify if it was retrospective or prospective.

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

This information is not provided. For oxygen saturation sensors, ground truth for human oxygenation evaluations is typically established by arterial blood gas analysis performed by trained medical professionals, but the document does not elaborate on this.

4. Adjudication Method for the Test Set:

This information is not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improve with AI vs without AI assistance:

This is not applicable to this device. The OxiMax SoftCare Sensors are an oxygen sensor (hardware) designed for continuous noninvasive arterial oxygen saturation and pulse rate monitoring, not an AI-assisted diagnostic tool that would involve human readers interpreting images or data.

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

This is not applicable in the context of device performance as typically understood for AI/software devices. The device itself is a sensor that outputs data, not an algorithm that interprets complex inputs for diagnosis. Its performance is measured by its accuracy and precision in measuring SpO2 and pulse rate. The document states "human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications," implying a standalone performance assessment against a clinical reference standard.

7. The Type of Ground Truth Used:

For "human oxygenation evaluations," the most common ground truth for pulse oximeters is arterial blood gas (ABG) analysis. The document does not explicitly state this, but it is the standard method for establishing ground truth for SpO2 accuracy.

8. The Sample Size for the Training Set:

This information is not provided. The device is a physical sensor, and while it contains a "memory chip carrying information about the sensor" and uses "Advanced Signal Evaluation," the document doesn't discuss a "training set" in the context of a machine learning algorithm. If there are internal calibration or signal processing algorithms, the training data for those are not described.

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

This information is not provided and likely not applicable in the context of device training as understood for AI systems. Any internal calibration data or signal processing optimization would have associated ground truth, but this is not detailed.

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The Nellcor INdGO Manual Resuscitator is a portable, nonsterile, single-patient use device intended for use on patients requiring manual ventilatory support. During artificial ventilation, the resuscitator can be operated from ambient air or provide oxygen-enriched air using the oxygen accumulator and connecting the supply tubing to a metered oxygen source. The Nellcor INdGO Manual Resuscitator is available with or without an integrated CO2 detector. The integrated CO2 detector can be used to assist the verification of tube placement during endotracheal or nasotracheal intubation. The integrated CO2 detector detects approximate ranges of CO2 by color comparison.

The Nellcor INdGO Manual Resuscitator is available in two sizes and is for use on the following patient populations:

• Adult size is for use on adults > 30kg. .
• Child size is for use on children 10 30 kg. .

The Nellcor INdGO Manual Resuscitator is intended for use by qualified healthcare professionals in any environment where pulmonary support resuscitation is indicated, such as hospital, transport, mobile, and home. This device is for prescription use only.

Nellcor INdGO Manual Resuscitator is a bag-valve-mask device with the capability of delivering supplemental oxygen. During artificial ventilation, the resuscitator can be operated from ambient air or provide oxygen-enriched air by connecting the supply tubing to a metered oxygen source.

The Nellcor INdGO Manual Resuscitator is available with and without integrated breath-to-breath CO2 detection. The integrated CO2 detector model incorporates an integral CO2 detector cartridge called INdCAP™ attached to the expiratory port of the resuscitator.

The Nellcor INdGO Manual Resuscitator is single-patient use, non-sterile, latex-free, and available in two sizes: adult and child. It has a double-swivel elbow, three oxygen accumulator styles, and comes in a variety of configurations.

The document provided is a 510(k) summary for the Nellcor INdGO Manual Resuscitator, which focuses on demonstrating substantial equivalence to a predicate device. It does not contain the detailed information typically found in a clinical study report that would include acceptance criteria, specific device performance metrics, sample sizes, expert qualifications, or ground truth establishment methods in the way a diagnostic AI device submission would.

Based on the information available in the provided text:

1. Table of acceptance criteria and the reported device performance:

The document states that "Performance and testing are consistent with the requirements for this device type specified by ASTM F920 and ISO 8382." However, it does not explicitly list the acceptance criteria or the specific numerical performance results against these standards. It implies that the device met these standards, which serves as the "reported device performance."

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

Not specified in the provided text. This document focuses on design modifications and general compliance with standards, not a specific clinical test set.

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 manual resuscitator device evaluated against engineering standards, not a diagnostic device requiring expert interpretation for ground truth.

4. Adjudication method for the test set:

Not applicable. This is a manual resuscitator device evaluated against engineering 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:

Not applicable. This is a manual resuscitator device, not an AI-assisted diagnostic device.

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

Not applicable. This is a manual resuscitator device, not an algorithm.

7. The type of ground truth used:

The "ground truth" for this device would be established by the engineering and performance specifications defined in ASTM F920 and ISO 8382. These standards define physical and functional requirements (e.g., ventilation volume, resistance, oxygen delivery performance) that the device must meet, rather than a diagnostic 'truth' based on expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

Not applicable. This is a hardware medical device, not a machine learning model requiring a training set.

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

Not applicable. This is a hardware medical device.

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