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The Sandman Duo and Sandman Duo ST are indicated for the treatment of obstructive sleep apnea in spontaneously breathing patients weighing more than 30kg (66lb) within homecare and hospital environments.

The Sandman Duo and Sandman Duo ST are designed to deliver Continuous Positive Airway Pressure between 3 and 20 cmHzO, and may come in different configurations including an optional integrated pass-over or heated humidifier.

The Sandman Duo and Sandman Duo ST are designed to deliver two levels of pressure in Bilevel mode. The positive inspiratory pressure (IPAP) is delivered during the inspiratory phase and can be set up to 25 cm H2O. The positive expiratory pressure (EPAP) is delivered during the expiratory phase and can be set to 20 cm H2O.

The Sandman Duo and Sandman Duo ST 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 Sandman Duo and Sandman Duo ST are double-insulated so that grounding is not required.

The Sandman Duo and Sandman Duo ST are for use by prescription only and displays the appropriate labeling.

The Sandman Duo and Sandman Duo ST are configured for patient use by a homecare dealer according to the prescription using the Clinician Manual provided. The devices are operated according to the instructions contained in the Patient Manual.

The Sandman Duo and Sandman Duo ST do not contain any drugs or biological products as components. However, the devices can be used to provide the patient with supplemental oxygen. The device and accessories are not supplied sterile, nor are they intended to be sterilized.

The Sandman Duo and Sandman Duo ST are for multiple use.

The Sandman Duo and Sandman Duo ST contain no patient contact components.

The Sandman Duo and Sandman Duo ST tubing is equivalent to that of the CPAP predicate devices. The Sandman Duo and Sandman Duo ST and the air filter are for multiple use. Accessories such as the patient circuit and nasal masks are for single patient use.

The Sandman Duo and Sandman Duo ST relv on 1 microprocessor for setting and viewing various control parameters and turning features on and off, and for controlling the heated humidification.

Pressure delivery for The Sandman Duo ST is regulated by a pressure sensor which monitors both ambient and output pressure and provides feedback to the control system.

The Sandman Duo and Sandman Duo ST use software to set the various device parameters such as the prescription pressure and the ramp starting pressure, and to provide heated humidification.

The provided 510(k) summary for the Puritan Bennett Sandman Duo and Sandman Duo ST does not describe a study involving a test set, expert readers, or ground truth in the way typically associated with AI/ML device evaluations. This document pertains to a medical device from 2008, well before the widespread use of AI in medical image analysis or diagnostics, and focuses on demonstrating substantial equivalence to predicate devices through performance testing, not clinical effectiveness studies with explicit acceptance criteria related to a specific medical condition's diagnosis or treatment outcome.

Therefore, many of the requested categories cannot be directly addressed from the provided text. The submission describes functional performance testing against regulatory standards and existing predicate devices.

However, based on the information provided, here's a breakdown of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. The submission describes laboratory performance testing (e.g., electrical safety, mechanical, software verification), not a clinical study with a patient test set as would be relevant for AI/ML performance evaluation.
• Data Provenance: Not applicable. The document refers to engineering and software validation, not clinical data from patients.

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

• Not applicable. There was no clinical test set requiring expert ground truth for this type of device submission.

4. Adjudication method for the test set:

• Not applicable.

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 is not an AI/ML device; it's a non-continuous ventilator/CPAP device.

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

• Not applicable. This device is a hardware medical device with embedded control software, not a standalone algorithm. Its "standalone" performance would refer to its physical operation and pressure delivery, which was tested.

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

• Not applicable in the context of clinical "ground truth" for diagnostic or treatment efficacy. The "ground truth" for the engineering performance tests would be defined by the specifications of the device and the requirements of the standards (e.g., a pressure reading must be within X tolerance of the set pressure).

8. The sample size for the training set:

• Not applicable. This device does not use machine learning that would require a "training set."

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

• Not applicable.

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The Sandman Info and Sandman Auto are indicated for the treatment of obstructive sleep apnea in spontaneously breathing patients weighing more than 30kg (66lb) within homecare and hospital environments.

The Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto are designed to deliver Continuous Positive Airway Pressure between 3 and 20 cmHJO, and may come in different configurations including an optional integrated pass-over or heated humidifier.

The Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto 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 Puritan Bennett Sandman Info and the Puritan Bennett Sandman Auto are double-insulated so that grounding is not required.

The Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto are for use by prescription only and displays the appropriate labeling.

The Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto are configured for patient use by a homecare dealer according to the prescription using the Clinician Manual provided. The devices are operated according to the instructions contained in the Patient Manual.

The Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto do not contain any drugs or biological products as components. However, the devices can be used to provide the patient with supplemental oxygen.

The device and accessories are not supplied sterile, nor are they intended to be sterilized.

The Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto are for multiple use.

The Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto contain no patient contact components.

The Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto tubing is equivalent to that of the CPAP predicate device.

The Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto and the air filter are for multiple use. Accessories such as the patient circuit and nasal masks are for single patient use.

The Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto rely on 1 microprocessor for setting and viewing various control parameters and turning features on and off, and for controlling the heated humidification.

The Puritan Bennett Sandman Info operates only in Constant mode: the main function of the device is to deliver constant positive airway pressure to the patient at a fixed level prescribed by the practitioner.

The Puritan Bennett Sandman Auto operates in either Constant or Automatic mode. In Constant mode, the main function of each device is to delier constant positive airway pressure to the patient at a fixed level prescribed by the practitioner and between 4 and 20 cmHO.

In Automatic mode (APAP mode), the practitioner determines and sets a maximum and minimum pressure range above and below the prescribed reference pressure and between 4 and 20 cmH2O. The pressure is adjusted within the maximum and minimum limits according to the patient's respiratory pattern and the type of events detected.

Pressure delivery for the Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto is regulated by a pressure sensor which monitors both ambient and output pressure and provides feedback to the control system.

The Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto use software to set the various device parameters such as the prescription pressure and the ramp starting pressure, and to provide heated humidification.

The Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto comply with certain voluntary standards, specifically the draft ARDB Reviewer Guidance for Premarket Notification Submissions (Nov 1993) and IEC60601-1.

The Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto are not part of a kit.

The provided text describes a 510(k) summary for the Puritan Bennett Sandman Info and Sandman Auto CPAP devices. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a de novo study with acceptance criteria for a novel algorithm.

Therefore, the document does not contain the detailed information requested regarding specific acceptance criteria for algorithm performance, a dedicated study proving device meets acceptance criteria, sample sizes for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for training sets.

The submission focuses on:

• Predicate Device Equivalence: Asserting the new devices are equivalent to existing Puritan Bennett GoodKnight CPAP devices (K020886 and K042184).
• Performance Testing: Stating that "Functional testing confirms that the Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto are capable of meeting its stated performance specifications. The device passed all tests."
• Compliance with Standards: Highlighting compliance with the November 1993 draft "Reviewer Guidance for Premarket Notification Submissions" and the May 2005 "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
• Safety and Effectiveness: Concluding that the devices meet performance specifications and criteria, operate safely, and are effective for their intended use based on these tests and compliance.

In summary, this 510(k) submission does not provide the specific details usually associated with proving an AI/algorithm's performance against predefined acceptance criteria for a novel functionality. It focuses on demonstrating that the new CPAP devices perform as expected for a CPAP device and are substantially equivalent to a predicate.

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KnightControl is a remote control for use by clinicians to adjust the settings of the GoodKnight 418, GoodKnight 420, GoodKnight 425 and Knightstar 330 devices.

The KnightControl is designed to control the GoodKnight 418, GoodKnight 420, GoodKnight 425, and Knightstar 330 devices in hospital, sleep laboratories, or other clinical settings. The KnightControl is powered by AC mains (100 VAC to 240 VAC nominal). The KnightControl is doubleinsulated so that grounding is not required. The KnightControl is set up for use by the clinician according to the instructions provided in the manual. The devices are operated according to the instructions contained in their respective Patient Manual and Clinical Manual. The KnightControl relies on a microprocessor for setting and viewing main control parameters and status of the attached device, and turning features on and off. The microprocessor is also required for getting data of some signals from the devices in order to output these signals to allow these signals to be recorded. The KnightControl is linked via an RS232 serial port to one of the following devices: GoodKnight 418 series, GoodKnight 420 series, GoodKnight 425 series, or Knightstar 330. The KnightControl uses software to recognize the device to which it is connected and automatically adapt its menu to the device. The KnightControl is not for use in life-supporting or life-sustaining situations. The device and it's accessories are not intended for sterile use. The KnightControl is for multiple use. The KnightControl contains no patient contact components. The KnightControl is for use in by physicians, nurses, and sleep lab technicians in a clinical (hospital, sleep laboratory, etc.) environment. The KnightControl does not contain any drugs or biological products as components. The KnightControl is not part of a kit.

Here's an analysis of the provided 510(k) summary for the PURITAN BENNETT KnightControl, extracting the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

The provided 510(k) summary is a high-level overview and does not contain the detailed quantitative acceptance criteria or specific performance metrics that would typically be found in a comprehensive test report. The summary states that tests were performed and passed, but not what the specific pass/fail thresholds were for each test (e.g., specific voltage limits for electrical safety, EMI/EMC radiation levels).

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

• Sample Size: Not specified. The document refers to "testing" but does not give the number of devices or iterations used for any of the performance tests.
• Data Provenance: Not specified. The summary does not provide details on the country of origin or whether the data was retrospective or prospective. Given the nature of a remote control device and the type of tests conducted (functional, electrical, EMC, mechanical, environmental), it's highly likely these were laboratory-based, prospective tests conducted on the manufactured device samples.

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

This information is not applicable to this type of device and study. The KnightControl is a hardware accessory (remote control) for medical devices, not a diagnostic or AI-driven system requiring expert interpretation or ground truth establishment based on clinical data. The tests focus on engineering performance, safety, and compatibility.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical or image-based studies, which is not relevant here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. The KnightControl is not an AI-assisted diagnostic or decision-support device. It's a remote control for CPAP machines. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or would be relevant.

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

This information is not applicable. The KnightControl does not contain an algorithm that operates "standalone" in a diagnostic or interpretive sense. Its software controls the associated CPAP devices and processes signals, but it doesn't perform diagnostic functions independently of clinician interaction. Performance testing (functional, electrical, etc.) inherently evaluates the device itself (standalone in an engineering context) but not in the sense of a standalone AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device would be its objective engineering specifications and compliance with recognized standards. For example:

• Functional Ground Truth: Whether the commands sent by the remote control are accurately received and executed by the connected CPAP device, and whether the displayed information is accurate.
• Electrical Safety Ground Truth: Compliance with established electrical safety standards (e.g., leakage current within limits, insulation integrity).
• EMC Ground Truth: Compliance with established electromagnetic compatibility standards (e.g., radiated emissions below limits, immunity to interference).
• Mechanical/Environmental Ground Truth: Ability to withstand specified physical stresses (e.g., vibration, temperature) without functional degradation.

These are verified through direct measurement and observation against pre-defined engineering requirements and regulatory standards, not expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

This information is not applicable. The KnightControl is not a machine learning or AI device that requires a "training set." Its software is traditionally programmed and verified, not trained on data.

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

This information is not applicable for the same reason as point 8.

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The Puritan Bennett GoodKnight H2O is an accessory intended to warm and add moisture to the inspiratory gas flow for administration to a patient undergoing CPAP or bi-level therapy.

It is intended for use with adult patients receiving CPAP or Bi-level therapy for the treatment of Obstructive Sleep Apnea in the homecare and hospital environments.

The GoodKnight H2O is a microprocessor-controlled heated passover humidifier used to provide evaporated water content to dry breathing gases, during treatment of Obstructive Sleep Apnea.

The GoodKnight H2O has an ABS enclosure and a heater plate positioned in the front of the unit. A humidification chamber slides onto the heater plate and is held in place by a rim on the enclosure. The unit controls are located at the back of the device.

The technological characteristics of the GoodKnight H2O Heated Humidifier are equivalent to that of the predicate device.

The GoodKnight H2O is equivalent in terms of type (heated passover humidification), configuration (chamber, mounting arrangements), environmental conditions of use and control method (software).

Non-clinical testing of the GoodKnight HyO has been carried out and covered mechanical safety, electrical safety, thermal safety, EMC, software verification and validation and performance.

The GoodKnight H2O meets the performance and safety requirements of ISO 8185 related to humidification systems and which includes also the requirements of IEC 60601-1. The product complies also to the relevant USA deviations from UL 2601-1 and to the applicable requirements of the FDA Reviewers Guidance (November 1993).

The provided text is a 510(k) summary for the Puritan Bennett GoodKnight H2O Heated Humidifier. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a specific study proving the device meets those criteria, particularly in the context of an AI-powered device.

The document discusses non-clinical testing for mechanical, electrical, thermal safety, EMC, software verification, validation, and performance. It also states the device "meets the performance and safety requirements of ISO 8185 related to humidification systems and which includes also the requirements of IEC 60601-1."

Since this is a non-AI medical device (a heated humidifier), many of your questions related to AI-specific elements (like sample size for test/training sets, experts for ground truth, MRMC studies, standalone algorithm performance) are not applicable or cannot be answered from the provided text.

Here's what can be extracted and inferred:

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

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

This document describes non-clinical testing on the device itself, not a machine learning model. Therefore, "test set" and "data provenance" in the AI context are not applicable. The testing was likely conducted in a laboratory setting (Mallinckrodt Développement France).

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. Ground truth for a physical device's performance is established through objective measurements against a standard, not by expert consensus on data interpretation.

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

Not applicable. This is for an AI algorithm evaluating data.

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 physical medical device, not an AI assistance system.

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

Not applicable. There is no algorithm in the AI sense. The device operates "standalone" in its intended function.

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

The "ground truth" for this device's performance would be established through objective physical measurements against the specified limits and ranges defined in the referenced international standards (ISO 8185, IEC 60601-1, UL 2601-1, and FDA Reviewers Guidance). For example, temperature measurements for thermal safety, electrical measurements for electrical safety, or humidity measurements for humidification performance.

8. The sample size for the training set

Not applicable. There is no AI training set for this physical device.

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

Not applicable.

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The Puritan Bennett GoodKnight 425 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 425 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 425 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 double-insulated so that grounding is not required. The GoodKnight 425 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 425 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 425 is regulated by a pressure sensor which monitors both ambient and output pressure and provides feedback to the control system. The GoodKnight 425 uses the same pass over humidifier and interfaces as those approved for use with the GoodKnight 420S. The GoodKnight 425 tubing is equivalent to that of the GoodKnight 420S. The GoodKnight 425 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 425 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 425 is for multiple use. Accessories such as the patient circuit and nasal masks are for single patient use. The GoodKnight 425 is for use by prescription only and display the appropriate labeling. The GoodKnight 425 is for use in a hospital and homecare environment. The GoodKnight 425 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 425 is not part of a kit. The GoodKnight 425 uses software to set the various device parameters such as the prescription pressure and the ramp starting pressure.

This document is a 510(k) summary for the Puritan Bennett GoodKnight 425, a Noncontinuous Ventilator. It details the device's technical characteristics and claims substantial equivalence to a predicate device. The information provided is not from a study involving AI or machine learning models. Instead, it refers to regulatory compliance and functional performance testing of a physical medical device.

Therefore, many of the requested details about acceptance criteria, study types, ground truth, and expert involvement are not applicable to this kind of regulatory submission for a traditional medical device.

Here's an attempt to answer the questions based only on the provided text, highlighting where the information is not present or relevant:

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

The document does not explicitly present a table of specific numerical acceptance criteria for performance against which the device's numerical performance is reported. Instead, it states that "Functional testing was performed to confirm that the GoodKnight 425 is capable of meeting its stated performance specifications. The device passed all tests."

The primary "acceptance criteria" mentioned are:

• Compliance with its "stated performance specifications" (not detailed in this summary).
• Compliance with the November 1993 draft "Reviewer Guidance for Premarket Notification Submissions" published by the Division of Cardiovascular, Respiratory, and Neurological Devices.
• Compliance with relevant standards: IEC 60601-1 and EN ISO 17510-1.

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 document. The testing described is functional and compliance testing of the physical device, not a study involving patient data or test sets in the context of AI/ML.

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 applicable/provided. There is no "ground truth" establishment in the context of patient data analysis for this submission. The "ground truth" for functional testing would be the engineering specifications and regulatory standards.

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

This information is not applicable/provided. Adjudication methods are typically relevant for clinical studies or reviews of diagnostic interpretations, which this is not. The testing involves engineering verification and validation.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic AI tools, which this device is not. This is a physical medical device (ventilator).

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

This information is not applicable/provided. This is not an algorithm-only device in the AI/ML sense. The device's "brain" is a microprocessor that controls mechanical functions based on set parameters and sensor feedback. The "performance" being evaluated is of the integrated system.

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

The "ground truth" as typically discussed in AI/ML contexts (e.g., expert consensus on images, pathology reports) is not applicable here. For this device, the "ground truth" for functional testing would be:

• Engineering design specifications.
• Regulatory standards (e.g., IEC 60601-1, EN ISO 17510-1).
• Draft "Reviewer Guidance for Premarket Notification Submissions" requirements.

8. The sample size for the training set

This information is not applicable/provided. This is a physical medical device, not an AI/ML model that requires a training set.

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

This information is not applicable/provided. No training set in the AI/ML sense.

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