(63 days)
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
| Acceptance Criteria (Demonstrated Equivalency) | Reported Device Performance and Compliance |
|---|---|
| Functional Performance Specifications: Capable of meeting stated performance specifications for CPAP and Bilevel modes (3-20 cmH2O CPAP, 3-25 cmH2O IPAP, 3-20 cmH2O EPAP) in spontaneously breathing patients over 30kg for Obstructive Sleep Apnea. | "Functional testing confirms that the Sandman Duo ST are capable of meeting its stated performance specifications. The device passed all tests." |
| Compliance with Regulatory Guidance: Adherence to the November 1993 draft "Reviewer Guidance for Premarket Notification Submissions" (Division of Cardiovascular, Respiratory, and Neurological Devices). | "Testing confirms that the Sandman Duo and Sandman Duo ST comply with the November 1993 draft 'Reviewer Guidance for Premarket Notification Submissions' published by the Division of Cardiovascular, Respiratory, and Neurological Devices. The device passed all tests." |
| Software Compliance: Adherence to the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 2005). | "All software is tested in accordance with the 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' dated May 2005. The devices passed all tests." |
| Electrical Safety, Electromagnetic Compatibility, Mechanical and Environmental Testing: Compliance with relevant standards and demonstration of safety and effectiveness. | "The safety and effectiveness of the Sandman Duo and Sandman Duo ST were verified through performance related testing that consisted of Electrical Safety, Electromagnetic Compatibility, Mechanical and Environmental Testing. The Sandman Duo and Sandman Duo ST had been found compliant and had been certified to the standards referenced in the 'FDA Reviewer Guidance for Premarket Notifications'." |
| Equivalence to Predicate Devices: Performance is equivalent to Puritan Bennett Sandman Intro (K071575), Sandman Info (K080439), GoodKnight 425 (K041819), and GoodKnight 425 ST (K050072) for relevant modes/features. | "The Sandman Duo and Sandman Duo ST are equivalent to the Puritan Bennett Sandman Intro (K071575) for all aspects except the Bilevel mode, to the Puritan Bennett Sandman Info (K080439) only for detection of apneas and hypopneas, the Puritan Bennett GoodKnight 425 (K041819) for the Bilevel mode. The Sandman Duo ST is equivalent to the Puritan Bennett GoodKnight 425 ST (K050072) for the Bilevel mode including optional backup frequency." This is a statement of the conclusion of the equivalency assessment rather than specific performance details. |
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.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).