(294 days)
The Silent Night V is indicated for use in the diagnostic evaluation of adults with possible sleep disorders. The Silent Night V can score obstructive apneas, which includes mixed apneas.
The Silent Night V is a portable, line-powered ventilatory effort recorder for use in the home for the diagnostic evaluation of the patient. The device consists of a bedside unit which is positioned on the patient and the sensors are placed on the patient's body and connect into the patient module. The Silent Night V contains the same functions as its predecessor, Silent Night II, with the addition of two other functions. The functionality of Silent Night V has been expanded from the previous estimation device, (Silent Night II K973902) to include ventilatory effort monitoring. The Silent Night V provides the following data:
- Arterial oxygen saturation level (SP02)
- Pulse rate
- Respiration effort signal
- Respiration sound corrected for ambient room noise.
Throughout a typical sleep study, sleep-disordered breathing information and statistics are stored into the memory. The stored information includes time and duration of apneas and hypopneas, block apneas, number of apneas and hypopneas, number of central apneas, number of mixed apneas, number of obstructive apneas, number of desaturation events, number of pulse events, number of respiratory effort events, number of sound events, minimum saturation levels, pulse rate, respiratory effort level, sound measurement level, open in intervals, pulse rate, respiratory effort level, sound measurement level, open in intervals. Current storage capacity is 512 Kbytes, which is sufficient to retain three 8-hour studies. Software has been developed to retrieve, score, display and print the collected data on a personal computer. The collected data is provided to the physician to view the sleep data.
Here's a summary of the acceptance criteria and the study proving the Silent Night V device meets those criteria, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Apnea Detection: | High sensitivity for apnea detection (relative to PSG) | Sensitivity: 83.2% |
| False Positive Apnea Events per Hour | Low number of false positive apneas (relative to PSG) | False Positives: 3.5 events/hour |
| Overall Event Detection (Apneas + Hypopneas): | High overall sensitivity for events (relative to PSG) | Overall Sensitivity: 90.7% |
| False Positive Events per Hour | Low number of false positive events (apneas + hypopneas) | False Positives: 3.8 events/hour |
| RDI Correlation (PSG vs. Silent Night V): | High correlation coefficient | Correlation Coefficient: 97.7% |
| RDI Classification (RDI=15 cutoff): | High sensitivity and specificity for RDI classification | Sensitivity (RDI=15): 95%Specificity (RDI=15): 91% |
Note: The document doesn't explicitly state "acceptance criteria" but rather presents performance metrics from the clinical study as evidence of equivalence to the predicate device. Therefore, the "acceptance criteria" column is populated with implied targets based on the documented performance.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the total number of patients/studies in the clinical test set. It mentions "using the overall number of patients as the basis of calculation" for RDI, but a specific number is not provided.
- Data Provenance: Prospective. The study involved patients undergoing a sleep laboratory evaluation with a standard polysomnograph, and the Silent Night V was used "concomitantly for a side-by-side comparison." This indicates a prospective collection of data in a clinical setting. The country of origin is not explicitly stated, but the company address is Palo Alto, CA, USA, suggesting the study was conducted in the US.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not provide details on the number of experts or their qualifications used to establish the ground truth. It states that the ground truth was derived from "a standard polysomnograph" and that "The data were compared on an event-by-event basis." This implies that the PSG data was expertly scored, but no specifics about the scorers are given.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method. It states, "The data were compared on an event-by-event basis." This suggests a direct comparison, likely by an expert, between the PSG and Silent Night V outputs. However, specific methods like 2+1 or 3+1 for resolving discrepancies are not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described. The study compared the device against a standard polysomnograph (PSG), not an AI-assisted human reader vs. a human reader without AI assistance. Therefore, there is no effect size reported for human readers improving with AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone study was performed. The reported performance metrics (sensitivity, false positives, correlation) represent the performance of the Silent Night V device itself in detecting and classifying respiratory events, directly compared to the PSG. This is "algorithm only without human-in-the-loop performance" for the device under evaluation.
7. The Type of Ground Truth Used
The ground truth used was expertly interpreted polysomnography (PSG) data. This is considered a gold standard for sleep disorder diagnosis. The document states, "Patients underwent a sleep laboratory evaluation with a standard polysomnograph." The Silent Night V's data was then compared directly to this PSG data.
8. The Sample Size for the Training Set
The document does not provide any information regarding a training set sample size. This suggests that if the device utilizes a machine learning algorithm, the training data details were not included in this 510(k) summary. Alternatively, the device may be based on traditional signal processing rather than machine learning, eliminating the need for a "training set" in that context.
9. How the Ground Truth for the Training Set was Established
Since no information about a training set is provided, there is no information on how its ground truth was established.
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NOV 1 6 2000
SLEEP SOLUTIONS, INC. Paio Alto, CA
510 (k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the f
eather and the 1900 and 21 CEP & 807 92 This summary of SMDA 1990 and 21 CFR § 807.92.
| Submitted by: | Sleep Solutions, Inc. |
|---|---|
| 2450 El Camino Real, Suite 101 Palo Alto CA 94306 | |
| Phone: (650) 320-8090 Fax: (650) 320-8190 |
November 14, 2000 Date of Summary:
Silent Night V Device Name:
Ventilatory effort recorder (MNR) Class 1 1 Device Classification Name:
Devices of Devices to Which Equivalence is Claimed: The Egally murketed predicate devices Legally Marketed Toeries to Which Equivalence is Claimed: Trip it more of and the Sessentedies 4000
arc the Silent Vight To Stadust (K973902), the Stadust (K973902), the Sess 2005 - 11 (K9810). The Silent Night V was celented in the clinical setting in comparison to the legally
Series (K915850). The Silent Night V was celaused in the clinical sett Series (K915850). The Sucht Right + Was Fries sleep system (K915856).
Device Description: The Silent Night V is a portable, line-powered ventilatory of a bedside unit Device Description: The Silent Night V is a portuble, Inte-powers, The device oursists of a bedside unit
for use in the home for the diagnostic evalualion of the positioned o for use in the home for the diagnostic which is positioned on the patient and the sensors are with a cable the patient's body and connect into the patient module. The Silent Vight V contains the sume functions as its predecessor, Silent Night II, with the widting of two other finctions, The sume functions as its predecessor, Silent Night II, who use assumation device, (Silent Night II
functionality of Silent Night V has been expanded from the previous estimation functionality of Silent Night V bas been expunded Iron the previous generatory effort monitoring. The Silent Night V provides the following data:
- Arterial oxygen saturation level (SP02) ●
- Pulse rate �
- Respiration effort signal ●
- Resphanon circa corrected for ambient room noise .
Throughout a typical sleep study, siccp-disordered breathing information and statistics are stored into the Throughout a typical sleep stilled beating modulation of announces and hypopulas, block anyem
memory. The stored includes time and duration of apped and hambers and paused ti memory. The stored information includes time includes and intension in the more and possed ime.
saturation levels, pulse respiratory effort level, sound measury level open in intervals, pulservite, respiratory effor level, some maint to retain thee 8-hour studies.
intervals. Current storage and is 5 L Kbytes, which is and print the collected data Software has been developed to retireve, score, display and print the collected data on a personal
Software has been developed to retireve, score, display and print the colle Software has been developed to retrieve, score, display and provided to the physician to view the sleep data.
Comment Chec. The Silent Night V is indicated for use in the diagnostic of adults with possible Intended Use: The Silent Night V is indicated for use in the diaground of the Supplied appeas.
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SLEEP SOLUTIONS, INC. Palo Alto, CA
Performance Data:
Engineering data - Silent Night V was evaluated according to appropriate stadiance IDCCALL LLCC mechanical and environmentul wsting. The device is in compliance with IBC 60601-1 and IEC 801-X (for mechanical and environmental stresses) standards.
Clinical data - Silent Night V was evaluated in the clinical setting. Patients underwent a sleep laboratory evaluation with a standard polysomnograph. Silent Night V was used concomitantly for a side-by-side comparison. The number of apneas, bypopneas and the resulting Respiratory Disturbance Index (RDI) companson. The number of appeared with the data gathered simultaneously by the standard polysomnograph. The dala were compared on an event-by-event basis. The RDI scares were determined and compared with the RDI score from the PSG using the Peurson r. The correlation coefficient between the PSG and the Silent Night V was 97.7%. Using the total number of apneas as the basis for calculation, the sensitivity between the two devices for apnea detection was 83.2% and the number of false positive wents per hour was 3.5 (# of false positive apness per hour). Using the total number of events (appreas and hypopuleas) as the basis for calculation, the overall schsitivity was 90.7% and the number of false positive events per hour was 3.8.
The definition for RDI is the 10tal number of apneas and hypopneas, divided by the study duration (in hours). For RDI, using the overall number of patients as the hasis of calculation, and a cut-off of RDI=15, the Silent Night V achieved a sensitivity of 95% and a specificity of 91% when compared to the 1786.
The results of the clinical study demonstrated the performance of the Silent Night V in detecting disordered breathing events, which can be indicative of sleep apnea. In view of the noninvasive, userfricadly design and simple operational features of the Silent Night V offers potential benefit as a cost effective home use device for the evaluation of patients with possible sleep disorders.
Conclusion: The information and data, provided in this 510(k) notification established that the Silem Night V is substantially equivalent to legally marketed predicate devices.
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Image /page/2/Picture/1 description: The image is a black and white logo. The logo is circular and contains an emblem of a bird-like figure with three curved lines representing its wings. The bird-like figure is positioned in the center of the circle. The text "U.S. Department of Health & Human Services" is arranged around the upper half of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 6 2000
Mr. J. Scott Adams Sleep Solutions, Inc. 2450 El Camino Real, Suite 101 94306 Palo Alto, CA
K000253 Re : Silent Night V II (two) Regulatory Class: 73 MNR Product Code: October 5, 2000 Dated: October 6, 2000 Received:
Dear Mr. Adams:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is the device ferenced above and no indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the interstate Commerce prior co May con results have been reclassified in accordance with the provisions of the Federal Food, Drag, and In accordance with the provisione, market the device, subject to cosmeral controls provisions of the Act. The general controls the general concroro provinements for annual registration, provisions of the nee incrumentacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II Special II your device IS classiciou (ket Approval), it may be subject to such Controls) of Class III (Fremaintains affecting your device additional concrold. Entrol Fegulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. co 033. A Subbeansed in ufacturing Practice requirements, as set with the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. assumptions. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this concerning your as retification submission does not affect any response to your premained have under sections 531 through 542 of the Act obrigation you might have andric Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. J. Scott Adams
This letter will allow you to begin marketing your device as described inis fected will arrow you co ication. The FDA finding of substantial in your 310(K) premarket necessarily marketed predicate device would equivalence of your device of a vour device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling II you desire specific advicionally 809.10 for in vitro regulation (21 cr. Farlease comment the Office of Compliance at ulaghostic devices), presse y, for questions on the promotion and (301) 394-4090. Addresmaily, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, (301) 39-4059. Tirov promarket notification" (21 CFR 807.97).
"Misbranding by reference to premarket notification under the Agt may "MISDFanding by reference to pour responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its interest be obcained from the bridge. I or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
sincerely yours,
flm
a James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INTENDED USE STATEMENT 3.0
K 000 253 510(k) Number (if known):
【Jnknown
Device Name:
Silent Night V
Indications for Use:
Indications for USe:
The Silent Night V is indicated for use in the diamostic evaluation withod one many The Stient Night V is might V can score obstructive apneas, which includes mixed apacas.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CITR 801.109)
OR
Over-the Counter Use
Division of Cardiovascular & Respiratory Devices
510(k) Number K000253
CONFIDENTIAL
11/14/2000
§ 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).