(84 days)
The Bio-logic Sleepscan Product is intended for use when it is necessary for a trained health care professional (for example, a Respiratory or EEG Technologist) to perform a Sleep diagnostic study on a patient with a possible Sleep disorder. This test consists of monitoring and recording various electrical signals from the patient, such as EEG siqnals from the brain, EOG, respiratory signals from transducers which measure air flow, effort, etc., arm and leg movement, body position while sleeping, pulse rate, and level of oxygen in the blood. Analysis features of the Sleepscan product allow for manipulation and presentation of this data in ways which enhance the physician's ability to reach informed diagnostic decisions quickly and efficiently. Although the addition of an internal oximeter does not, in itself, add to the features or capabilities of the Sleepscan product, it provides a simplification in hardware design which results in faster patient setup with fewer potential errors in setup. This latest modification to the Sleepscan product with Built-In Oximeter does not introduce any changes to the intended use of the product.
This Modification to the Bio-logic Sleepscan product with Internal Oximeter (Sleepscan Recorder) consists of a newly-designed hardware device for data recording. It is intended to complement the predicate device hardware in the Bio-logic Sleepscan product line offering new features which enhance ease-of-use and transportability. The design of this new device is nearly identical to that of the Biologic CEEGRAPH TRAVELER (tm) Ambulatory EEG Recorder (K954954), in that it provides for the data collection and storage of up to 24 channels of patient data in a digital form. The only significant difference in the design of these two devices is that the Sleepscan device includes the addition of an internal oximeter made by NONIN, The oximeter provides heartrate and blood oxygen level data to Inc. the Bio-logic data recording electronics, and this data is recorded along with the other patient data (EEG, body position, etc.). After the recording is completed, it can be analyzed using the existing Sleepscan (tm) analysis system, since the data file format is compatible with that employed in current Bio-logic Sleepscan equipment. It provides an improvement in data recording capacity through the use of the Bio-logic proprietary lossless data compression technique (SMART-PACK). This allows for the storage of up to 12 hours of typical Sleep patient data (EEG, oximetry, etc.) onto a single high-capacity PCMCIA hard disk. Power for the device is supplied by batteries inside the unit. Patient setup is accomplished by connecting the Sleepscan Recorder through an isolated serial link to a computer system running the patient setup program. After the electrodes are attached to the patient and other setup functions are completed (ie, impedance and calibration), the computer is disconnected, the Recorder is closed up, and it is placed close to the patient bedside for the duration of the Sleep recording. All setup functions, including periodic replacement of hard disk and batteries, must be performed by a qualified health care professional trained in the use of this product.
The Sleepscan Recorder is housed in a 2-part enclosure made of highstrength ULTEM 1000 plastic. This material was selected due to its high impact strength over a wide temperature range, resistance to alcohol, acetone and other chemicals, and non-flammability. The size of the enclosure is approximately 4.9" W x 6.4" L x 2.35" H (115 mm x 150 mm x 55 mm). The total weight with hard disk and batteries installed is approximately 2.1 lb (955 g). When closed, the Recorder is water-resistant, conforming to the IEC 529 IPX4 Splash-Proof specification.
The initial patient setup of the Sleepscan Recorder is accomplished through the connection of a computer system running the Sleepscan patient setup program. This connection is made between the serial port on the Recorder and a serial port on the computer system. When the computer used is a battery operated laptop, the connection is made via a standard "null modem" cable. If an AC-powered desktop computer is used, the connection to the Recorder must be made through the serial cable isolation device which provides for proper patient isolation.
There is a 62-pin cable connector on the Recorder which is used to connect to the patient electrodes and sensors. A variety of these cable-electrode assemblies are available, depending on the specific collection montage being used. The Recorder automatically senses which montage cable is in use, and records this in the data file being recorded. The ending time is also specified, or the recording will stop when the montage (electrode) cable is unplugged from the unit.
After the Sleep Recording period has been completed (typically 8 hours), the PCMCIA hard disk containing the patient data is analyzed using the standard Bio-logic Sleepscan Analysis programs. The data is first decompressed and transferred to a file format identical to that used by the predicate Sleepscan with Oximeter device. All analysis functions currently used in existing Bio-logic Sleepscan systems are available to use in the analysis of the data from the Sleepscan Recorder.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Modified Bio-logic Sleepscan product with Built-In Oximeter:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Parameter | Reported Device Performance |
|---|---|
| Intended Use (Safety & Effectiveness) | "This latest modification to the Sleepscan product with Built-In Oximeter does not introduce any changes to the intended use of the product." |
| "The Bio-logic Sleepscan Product is intended for use when it is necessary for a trained health care professional... to perform a Sleep diagnostic study on a patient with a possible Sleep disorder." | |
| Performance: "The system, for which this 510(k) notification is submitted, was verified and validated; it was found to perform in accordance with specifications." | |
| Patient Population | "Sleepscan with Built-In Oximeter can be used for patients of all ages, although most Sleep disorders occur in adults." |
| Performance: "The Sleepscan Recorder can be used for any patient who is a candidate for sleep diagnostic evaluation. This will typically be an adult population, but it can be used for patients of all ages." | |
| Storage Sample Rate | Predicate device: 256 Hz. |
| Performance: Subject device: 256 Hz. | |
| Electrical Safety (Patient Isolation) | Criteria: Prevent serious injury due to electrical shock. |
| Performance: "In the normal operation... power source is only from the internal batteries, and no voltage inside the unit is greater than 9 Volts DC." | |
| If AC-powered computer used, "the serial cable isolation device is required to be used. This device provides optical isolation of all wires in the cable, up to 2500 Volts RMS." | |
| Conclusion: "there is no danger to the patient of serious injury due to electrical shock." | |
| Electromagnetic Compatibility (EMI) & Electrostatic Discharge (ESD) | Criteria: Operate properly without adverse effects from EMI and ESD. |
| Performance: "Laboratory testing was performed on the Sleepscan Recorder with Internal Oximeter to verify proper operation with respect to EMI and ESD standards. The following testing was performed, with satisfactory results:" |
- Radiated Emissions: CISPR 11 / EN55011 (Satisfactory)
- Electrostatic Discharge Immunity: IEC 801-2 (Satisfactory)
- Radiated RF Immunity: IEC 801-3 (Satisfactory)
- Magnetic Fields Emissions: RE101 (Satisfactory)
- Magnetic Field Immunity: RS101 (Satisfactory)
- Quasi-Static Electric Fields: Tested per Reviewer's Guide (Satisfactory) |
| Software Safety & Effectiveness | Criteria: Prevent "runaway software" condition and perform according to specifications.
Performance: "a 'watchdog timer' circuit is included in the hardware design... effectively prevents a 'runaway software' condition of unknown consequences."
"The system... was verified and validated; it was found to perform in accordance with specifications."
"To establish the safety and effectiveness of the software... the system was validated in accordance with the IEEE Standards for Software Engineering, as well as Bio-logic internal software development policies and procedures modeled after the IEEE Standards."
"The program in the Sleepscan Recorder, the patient setup program... and the data decompression/transfer program, were all developed and tested as specified in these procedures." |
| Material Durability (Housing) | Criteria: High impact strength, resistance to chemicals, non-flammability, water-resistant.
Performance: "housed in a 2-part enclosure made of high-strength ULTEM 1000 plastic. This material was selected due to its high impact strength over a wide temperature range, resistance to alcohol, acetone and other chemicals, and non-flammability."
"When closed, the Recorder is water-resistant, conforming to the IEC 529 IPX4 Splash-Proof specification." |
| Data Recording Capacity | Criteria: Store typical sleep patient data.
Performance: "Provides an improvement in data recording capacity through the use of the Bio-logic proprietary lossless data compression technique (SMART-PACK). This allows for the storage of up to 12 hours of typical Sleep patient data (EEG, oximetry, etc.) onto a single high-capacity PCMCIA hard disk." |
| Data File Format Compatibility | Criteria: Compatible with existing Sleepscan analysis system.
Performance: "data file format is compatible with that employed in current Bio-logic Sleepscan equipment."
After recording, "The data is first decompressed and transferred to a file format identical to that used by the predicate Sleepscan with Oximeter device. All analysis functions currently used in existing Bio-logic Sleepscan systems are available to use in the analysis of the data from the Sleepscan Recorder." |
| Power Supply | Criteria: Provide power to the device.
Performance: "Power for the device is supplied by batteries inside the unit." (Standalone operation) and "power source is only from the internal batteries" during normal operation. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided text does not specify a sample size for a test set related to patient data or clinical performance. The testing mentioned (EMI, ESD, Software validation) refers to engineering and software verification, not clinical evaluation with a patient data set. There is also no information about the country of origin of any data or whether it 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 section is not applicable as the document describes a 510(k) summary for a hardware modification, focusing on engineering validation and demonstrating substantial equivalence to a predicate device, rather than a study involving expert-established ground truth for patient data or diagnostic accuracy. The device's purpose is data collection and recording, with analysis performed by existing Sleepscan systems and interpreted by a "trained health care professional."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. The document does not describe a test set requiring adjudication by multiple experts, as it is not a diagnostic device with an AI component being evaluated for accuracy against specific ground truth labels.
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
There is no mention of an MRMC comparative effectiveness study, nor any evaluation of human readers with or without AI assistance. The device is a data recorder, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a data recorder and relies on human interpretation for diagnosis. It does not describe an "algorithm only" standalone performance in a diagnostic context. The software validation mentioned covers the device's internal software functions (data recording, compression, transfer, setup), confirming it performs "in accordance with specifications."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the engineering and software validation, the "ground truth" was essentially the pre-defined engineering specifications and relevant international standards (e.g., CISPR 11, EN55011, IEC 801-2, IEEE Standards for Software Engineering). There is no patient-specific ground truth (like pathology or outcomes data) mentioned in this documentation for evaluating the device's performance.
8. The sample size for the training set
The document does not mention a training set as it is not describing a machine learning or AI algorithm in the context of diagnostic performance. The software development and testing mentioned relate to traditional software engineering validation.
9. How the ground truth for the training set was established
This is not applicable as there is no mention of a training set or AI model development.
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).