(223 days)
The device is intended to measure, amplify, and record physiological signals acquired from a patient for archival in a Sleep Study. The physiological signals are recorded and conditioned for analysis and display. The data may be analyzed in real-time or offline on dedicated polysomnography software running on a personal computer by a qualified sleep clinician to aid in the diagnosis of Sleep Disorders.
This device, or any accessory, is not to be used alone as an apnea monitor or as a component in an apnea monitoring system.
This device, or any accessory, is not to be used alone as a life support device or as a critical component of a life support system.
This device is intended for use on both adults and children only under the direction of a physician or qualified sleep technician.
The device is intended to amplify and record physiologic potentials used for Polysomnography (PSG) or Sleep Studies. The bio-potentials are transferred to Polysmith polysomnography software running on a personal computer. Qualified practitioners use the information to score Polysomnograms and diagnose Sleep Disorders. The device is intended for use on both adults and children only under the direction of a physician or qualified sleep technician.
This 510(k) summary for the Polysmith Sleep System (K062943) focuses on its substantial equivalence to predicate devices based on technological characteristics, safety, and performance standards, rather than clinical performance acceptance criteria based on a specific study. Therefore, much of the requested information regarding performance metrics, sample sizes, expert involvement, and ground truth types is not present in the provided document.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide specific quantitative acceptance criteria related to a device's diagnostic performance (e.g., sensitivity, specificity for detecting sleep disorders) or a study reporting such performance. Instead, the "acceptance criteria" are implied through compliance with various safety and industrial standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with IEC 601-1 subclause 56.3(c) (Electrode Lead Wires and Patient Cables) | Complies with IEC 601-1 subclause 56.3(c) |
| Compliance with UL 60601-1 | Complies with UL 60601-1 |
| Compliance with EN 60601-1 | Complies with EN 60601-1 |
| Compliance with EN 60601-1-4 | Complies with EN 60601-1-4 |
| Compliance with IEC 60601-2-26:2002 | Complies with IEC 60601-2-26:2002 |
| Compliance with IEC 60601-1-2:2001 | Complies with IEC 60601-1-2:2001 |
| Compliance with IEC 60601-1:1998 | Complies with IEC 60601-1:1998 |
| Compliance with CAN/CSA 22.2 No 601.1 M90 | Complies with CAN/CSA 22.2 No 601.1 M90 |
| Compliance with CAN/CSA-ISO13485:2003 | Complies with CAN/CSA-ISO13485:2003 |
| Compliance with 21 CFR Part 820 (Quality System Regulation) | Complies with 21 CFR Part 820 |
| Compliance with MDD: 93/42/EEC Annex II, IIa | Complies with MDD: 93/42/EEC Annex II, IIa (per manufacturer) |
| Compliance with CISPR 11 Group 1, Class B | Complies with CISPR 11 Group 1, Class B |
| Device designed by a company with a full quality system | Yes, implied by compliance with ISO13485 and 21 CFR 820 |
| Meets safety and performance criteria for Electrical Medical Device in EU | Yes, stated to be guaranteed by compliance with listed standards |
| Verification and validation according to product specifications | Verified and validated |
| Test criteria consist of standardized levels and internal product requirements | Yes, explicitly stated |
| Passing environmental and mechanical stress testing | Tests performed include environmental and mechanical stress |
| Passing electromagnetic immunity and emissions testing | Tests performed include electromagnetic immunity and emissions |
| Passing medical device safety testing | Tests performed include medical device safety |
| Software verified and validated according to device functionality | Software verified and validated |
| Test results confirm device is in accordance with specifications | Yes, stated |
| Class II protection against electric shock | Provides Class II protection |
| Degree of protection against ingress of water: IPX0 | IPX0 |
| Not sterile | Not sterile |
| Not suitable in presence of flammable anesthetic mixture | Not suitable in presence of flammable anesthetic mixture |
| Continuous mode of operation during normal conditions | Continuous mode of operation |
| Externally supplied by direct current source | Externally supplied by direct current source |
| Portable | Portable |
2. Sample size used for the test set and the data provenance
The document does not describe a clinical test set with a specific sample size. The testing described focuses on device safety, electrical performance, and compliance with standards, rather than a clinical validation study involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set requiring expert-established ground truth is described.
4. Adjudication method for the test set
Not applicable, for the same reason as above.
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 described as an amplifier and recorder of physiological signals for use in Polysomnography (PSG) by a qualified sleep clinician to aid in diagnosis. It is not an AI-driven diagnostic tool intended to supercede or augment human reading in the way an MRMC study would evaluate. It is a data acquisition device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device itself is not an algorithm performing diagnosis. It's a data capture system. Its "performance" is in accurately acquiring and conditioning physiological signals, not in interpreting them. That interpretation is explicitly stated to be done by a "qualified sleep clinician."
7. The type of ground truth used
For the safety and performance testing described, the "ground truth" would be the established requirements and limits set by the various industrial standards (e.g., maximum leakage current, electromagnetic interference limits, stress test resilience, accurate signal amplification).
8. The sample size for the training set
Not applicable. This document describes a medical device for data acquisition, not a machine learning model that requires a training set of data.
9. How the ground truth for the training set was established
Not applicable, for the same reason as above.
Summary of the Study Proving the Device Meets Acceptance Criteria:
The provided 510(k) summary does not detail a single "study" in the sense of a clinical performance trial. Instead, it describes a comprehensive set of engineering, safety, and quality assurance activities that collectively demonstrate the device's adherence to its specifications and relevant regulatory standards.
The "study" comprises:
- Voluntary Compliance with Industrial Standards: The device underwent testing to ensure compliance with a range of international and national standards for medical electrical equipment (e.g., UL 60601-1, EN 60601-1-4, IEC 60601-2-26, CAN/CSA 22.2 No 601.1 M90, CISPR 11). These standards cover aspects like electrical safety, electromagnetic compatibility, and specific requirements for EEG/PSG devices.
- Quality System Compliance: The manufacturer's adherence to 21 CFR Part 820 (Quality System Regulation) and CAN/CSA-ISO13485:2003 (Medical Devices Quality Management Systems) ensures that the device was designed, manufactured, and tested under a robust quality management framework.
- Verification and Validation Activities: The device was "verified and validated according to the product specifications." This included:
- Environmental and mechanical stress testing.
- Electromagnetic immunity and emissions testing.
- Medical device safety testing.
- Software verification and validation according to its functionality.
The overall conclusion is that "The test results confirm that the device is in accordance with its specifications," thereby meeting the implicit acceptance criteria set by these standards and internal product requirements for a device intended to measure, amplify, and record physiological signals for Polysomnography. The device's substantial equivalence to predicates was based on similar indications for use, intended use, and technological characteristics, as well as adherence to these safety and performance standards.
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).