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Intended for use in collecting and recording physiological data to be used in polysomnography and sleep disorder studies. The Sandman Pocket is intended for pediatric through adult patient populations, and can be used in either home or hospital environments. The Sandman Pocket is not intended for use as life supporting equipment such, as a vital sign monitoring in an intensive care unit. The device does not produce alarms and is not intended as an automated apnea monitor. The Sandman Pocket is only to be used under the direction or supervision of a physician, technologist or clinician.

The Sandman Pocket is a physiological data recorder that is part of a polysomnography system. It consists of two units: the Recorder Unit, which stores the data and sends it to a USB port, and Headbox Unit, which is the connection point for all patient sensors with the exception of the Nellcor Puritan Bennett oximetry probe. The role of the Sandman Pocket is only to capture the data and pass it to the host with the necessary accuracy and reliability according to the product and communication control specifications. A fundamental characteristic of the Sandman Pocket is the ability to be an ambulatory/portable physiological data recorder. Because of its small size and light weight (about 210 grams including the battery), the system is compact and durable. The Headbox Unit is used for connecting patient electrodes and sensors. It includes Bipolar channels, pressure sensors, power supply for a dedicated body position sensor, an abdomen sensor, a chest sensor, a snore sensor and a thermistor. The patient inputs are isolated with a CF type isolation level. The Sandman Pocket device is provided without standard sensors. The system builder should integrate the device with FDA cleared Nellcor Puritan Bennett sensors only and specified for the usage with NELL-1 module. The Headbox Unit captures the biological signals from the human body surface through specialized sensors and electrodes, while the Recorder Unit amplifies the very low electrical signal and filters the signals to make an optimal ANALOG to DIGITAL conversion. The data, once converted in numerical form, are sent to a host computer for review and analysis. The host can "program" the amplifier behavior by setting the sampling frequency and the dynamic range allowed and so on. The host computer reads the acquired data through a dedicated interchange protocol, and allows a clinician to analyze the data using sleep review analysis software, provided by the end user or system builder. The clinician must use an electrically isolated computer (with a medical grade isolation transformer or medical grade power supply) or batterysupplied laptop when the Sandman Pocket device is connected to the host PC and the patient is connected to the Sandman Pocket Headbox. The Sandman Pocket system is not in any way involved in the data management performed by the host. The host computer must operate using one of the following Operating System: Microsoft Windows 98 / ME / NT / 2K / XP. The device has a built-in impedance meter. This function allows the clinician to check the electrode contact impedance and display the results of the check on the display. The display is located in the Recorder Unit, while the circuitry controlling the impedance meter is located in the Headbox Unit. The Sandman Pocket can be powered through 3 Alkaline 1.5V standard non rechargeable batteries or via the USB cable. The user is recommended to use a medical grade type PC. The Sandman Pocket system consists of two interconnected units: the Headbox Unit and the Recorder Unit.

The Sandman Pocket is a physiological data recorder intended for use in collecting and recording physiological data for polysomnography and sleep disorder studies in pediatric through adult patients, in both home and hospital environments. It is not intended for life support, vital sign monitoring in an ICU, or as an automated apnea monitor. It must be used under the direction or supervision of a physician, technologist, or clinician.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document, a 510(k) summary, primarily focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting a table of acceptance criteria and performance against those criteria in a typical evaluation study format.

However, the "Technological Characteristics Substantial Equivalence Comparison Table" implicitly serves to show that the performance characteristics of the Sandman Pocket are comparable to the legally marketed predicate devices, thereby meeting the unstated "acceptance criteria" of being as safe and effective as the predicates.

I will construct a table showing key performance characteristics of the Sandman Pocket alongside its predicate devices, as this is the closest equivalent to stated "acceptance criteria" through comparison. The "reported device performance" is implicitly shown to be acceptable by its similarity to the predicates.

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

The provided 510(k) summary does not contain information about a specific clinical study with a test set of patient data to evaluate the performance of the Sandman Pocket.

Instead, the submission relies on demonstrating substantial equivalence to predicate devices (Nellcor Puritan Bennett Inc. SUZANNE K990565 and Respironics, IN Alice S K040595) through direct comparison of technological characteristics, intended use, and conformance to recognized consensus standards (e.g., electrical safety, EMC).

Therefore:

• Sample size for the test set: Not applicable/Not provided, as a clinical performance study on patient data is not described.
• Data provenance: Not applicable/Not provided.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

Since no clinical study with a test set requiring ground truth establishment is described in the provided document:

• Number of experts: Not applicable/Not provided.
• Qualifications of experts: Not applicable/Not provided.

4. Adjudication Method for the Test Set

As there is no described clinical study with a test set, there is no adjudication method mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned or described in the provided 510(k) summary. The submission focuses on substantial equivalence based on technical specifications and intended use comparison.

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

This device is a physiological data recorder, not a diagnostic algorithm. Its primary function is to capture and store physiological signals for subsequent review and analysis by a clinician using sleep review analysis software. It does not perform automated diagnoses or interpretations; therefore, a "standalone algorithm only" performance study, as typically understood for AI/CADe devices, is not relevant or described for this type of device.

The study presented focuses on the device's technical specifications - how accurately and reliably it records data, and its compliance with relevant safety and performance standards.

7. The Type of Ground Truth Used

As no clinical performance study involving diagnostic interpretation is described, the concept of "ground truth" (e.g., pathology, outcomes data, expert consensus) is not directly applicable in the traditional sense for evaluating the device's output. The device itself is recording raw physiological data, not producing interpretations that require a ground truth for validation. Its "truth" lies in its ability to faithfully capture the actual electrical signals.

The "ground truth" for the device's functioning is implicitly its adherence to:

• Its own product and communication control specifications for data capture accuracy and reliability.
• International standards for electrical safety (IEC 60601-1, UL 2601, CSA C22.2 No 601-1-M90), and electromagnetic compatibility (IEC 60601-1-2, etc.).

8. The Sample Size for the Training Set

The provided 510(k) summary does not describe any training sets as part of a machine learning or algorithmic development process. The Sandman Pocket is a hardware data acquisition device, and its design and verification are based on engineering principles and regulatory standards, not on model training with large datasets.

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

Since no training set is described, the method for establishing its "ground truth" is not applicable.

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