(188 days)
The Embletta MPR (Multiple Parameter Recorder) Sleep Data Recording System is a digital recording system designed to be used under the direction of a physician or trained technician or applied by a layperson under the direction of a physician or trained technician.
The system records multiple physiological parameters for the purpose of simultaneous (on-line recording) or subsequent (ambulatory recording) uploading to a separate PC based data presentation software for graphical and numerical representation to allow trained personnel to identify sleep disorders. The data collected by this recording system will provide physicians with information to make a diagnosis of sleep disorders such as:
• Obstructive Sleep Apnea Syndrome
• Central Alveolar Hypoventilation Syndrome
• Central Sleep Apnea Syndrome
• Restless Legs Syndrome
• Periodic Limb Movement Disorder
• Primary Snoring
• Sleep-Related Neurogenic Tachypnea
• Cheyne-Stokes-Breathing
The Embletta MPR is a digital recording device designed to be used under the direction of a physician or trained technician but may be applied by a layperson. The Embletta MPR records multiple physiological parameters from a sleeping patient for the purpose of simultaneous or subsequent display of the parameters. The displayed data assists in the identification of sleep-related medical disorders by trained personnel.
The Embletta MPR is intended to be used for adult and pediatric (excluding neonatal and infant) studies. The device is not equipped with alarms and is not intended to be used as a monitor.
The intended environments include any clean, dry, dust free environment suitable for a patient's relative comfort.
The device does not monitor or diagnose the patient and does not issue any alarms.
The Embletta MPR Sleep Data Recording System is the third in the Embla series of small ambulatory sleep recorders. The first was the Embla Compass (also called the Embletta, K041904, Product Code MNR) and the second is the Embletta Gold (K073682, Product Code MNR).
The Embletta MPR Sleep Data Recording System records multiple physiological parameters for the purpose of simultaneous or subsequent uploading to a separate PC based data presentation software. The data collected by this recording system will provide physicians with information to make a sleep disorder diagnosis.
The Embletta MPR Sleep Data Recording System consists of three small devices that can be used in two separate configurations. The simplest configuration is the battery operated Embletta MPR recorder which is worn by the patient and used alone for small scale sleep studies (2 input + 3 derived channels). The other configuration is the battery operated Embletta MPR *PG' unit (similar to the Embletta MPR but with 6 input + 3 derived channels) which is worn by the patient and used with wireless communication to a separate mains powered Embletta 'TX' unit located remotely from the patient. The Embletta 'TX' unit can also record inputs from separate patient devices (such as CPAP devices).
Each of these two configurations basically consists of a simple signal recording unit that can be connected with several electrodes and sensors non-invasively attached to a patient during sleep. The Embletta MPR and the Embletta MPR 'PG' are secured to the patient with a belt and holder.
The provided document is a 510(k) summary for the Embletta MPR Sleep Data Recording System, which is a medical device for recording physiological parameters related to sleep disorders. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a specific study proving the device meets those criteria.
Therefore, much of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, and specific study designs (like MRMC or standalone performance) is not explicitly available in the provided text.
However, based on the available information, I can construct the following:
1. Table of Acceptance Criteria and Reported Device Performance
The document defines acceptance criteria primarily through the concept of "substantial equivalence" to predicate devices. The performance is assessed by comparing technical specifications and intended use.
| Acceptance Criteria Category | Specific Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (Embletta MPR) |
|---|---|---|
| Intended Use | Equivalent to predicate devices (Embla Compass, Embletta Gold) for identifying sleep disorders. | Equivalent |
| Indications for Use | Equivalent to predicate devices. | Equivalent |
| Target Population | Adult and pediatric (excluding neonatal and infants). | Adult and pediatric (excluding neonatal and infants). |
| Use Environment | Sleep clinics, home. | Sleep clinics, home. |
| Energy Used | Battery operated (2 AA). | Battery operated (2 AA). |
| Device Setup | Similar (PC-based). | Similar (PC-based). |
| Electrode Application | Identical (commercially available electrodes, Embla XactTrace belts, Nonin XPOD oximetry). | Identical |
| Design | Similar design strategy (signal sensing, conditioning, noise filtering, amplification, recording). | Identical strategy, different in technology level due to age. |
| Recording Time | Performance comparable to predicate. | 24 hours (200 total hrs) - Note: Predicate devices show 72 hrs and 48 hrs respectively. This is a divergence but implies acceptability. |
| Data Interface | USB. | USB |
| Number of Channels | Variable, comparable to predicate capabilities (e.g., specific physiological parameters). | 16 + 3 derived (MPR 'PG' configuration); 2 + 3 derived (MPR alone) - Note: Increased channels compared to predicate (11-13 vs 8+3 derived). |
| Physiological Parameters (Channels) | Ability to record EKG, EEG, EMG, Respiration, Thermistor, Oximetry, Pressure, Differential Pressure, etc., as per predicate. | All specified channels (EKG, EEG, EMG, Respiration (Abdomen/Thorax), Thermistor, Oximetry, Pressure, Dif. Pressure). Also new audio and therapy device channels. |
| Derived Channels | Actigraphy, Body Position, Snore. | All specified derived channels (Actigraphy, Body Position, Snore). |
| DC Auxiliary Channels | Functional for external signals. | 7 DC Auxiliary channels (new feature compared to predicate). |
| (C,V) PAP Data Compatibility | N/A (new feature). | Accepts data from therapy devices (new feature). |
| Audio | N/A (new feature). | Has an audio channel (new feature). |
| Standards Met | Compliance with relevant medical device standards. | IEC 60601-1, IEC 60601-1-2. Specific standards for Electrocardiographs (IEC 60601-2-25), Electroencephalographs (IEC 60601-2-26), and Electromyographs (IEC 60601-2-40) are listed, implying compliance. |
| Materials | Non-metallic (components in contact with patient). | Non-metallic |
| Biocompatibility | N/A (worn over clothes). | N/A (worn over clothes) |
| Sterility | Not sterile. | Not sterile |
| Electrical Safety | Compliance with IEC 60601-1. | IEC 60601-1 |
| Handheld | Yes. | Yes |
| Weight | Comparable weight. | 136g (compared to 146g & 190g for predicates). |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated. The document refers to "Verification testing in the design stages" and "Validation testing after design completion," but does not provide specific sample sizes (e.g., number of patients or recordings) used for these tests.
- Data Provenance: Not explicitly stated. The document describes the testing as verification of engineering specifications and validation in a "production equivalent system setting," suggesting internal testing. No information on country of origin of data or whether it was retrospective or prospective is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts & Qualifications: Not explicitly stated. The device's intended use is to provide data for "trained personnel to identify sleep disorders" and assist physicians in diagnosis. However, the testing mentioned (verification and validation of engineering specifications) does not detail the involvement of medical experts or the establishment of a "ground truth" for diagnostic accuracy in a clinical sense. The focus is on the technical performance of the data recording system itself.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not explicitly stated. Given the type of testing described (engineering verification and system validation), formal clinical adjudication methods like "2+1" or "3+1" are not mentioned, and likely not applicable to the scope of these technical tests.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This document describes a medical device for recording physiological parameters, not an AI or diagnostic algorithm that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No, a standalone performance study in the context of an algorithm's diagnostic accuracy was not done. This device is a data recorder, and its output is intended to be interpreted by trained personnel. It "does not monitor or diagnose the patient and does not issue any alarms." The performance tests focused on electrical safety, EMC, and verification/validation of design specifications, not diagnostic accuracy of an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: For the "performance data" presented, the ground truth appears to be defined by engineering specifications and established medical device standards (e.g., IEC 60601-1 for electrical safety, IEC 60601-1-2 for EMC). The intrinsic accuracy or diagnostic capability of the device itself (such as correctly identifying sleep disorders) is not a claimed function, as it is a recording system whose output is interpreted by humans. Therefore, the "ground truth" relates to the faithful and safe recording of physiological signals according to its design, rather than a clinical diagnostic truth.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This document is for the Embletta MPR Sleep Data Recording System, which is a hardware device for data acquisition. It does not describe an artificial intelligence or machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no "training set" for this hardware recording device.
§ 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).