ApneiCare Connection Center/Internet Analysis is a software device, intended to be used as an aid in the diagnosis of sleep and respiratory related sleep disorders. ApneiCare Connection Center/Internet Analysis is used for analysis (semi-automatic and manual rescoring), display, redisplay (retrieve), edit, summarize, to generate user defined reports, networking and managing of data received from devices that are typically used to evaluate sleep- and sleep related respiratory disorders. ApneiCare Connection Center/Internet Analysis software also provides scoring of desaturation events as they related to sleep breathing disorders.

ApneiCare Connection Center/Internet Analysis is intended to be used as an information and decision management tool to import/record and transmit/transfer data typically captured to evaluate sleep and respiratory related sleep disorders.

ApneiCare Connection Center/Internet Analysis itself is not a diagnostic tool. It is an information and decision management tool which allows medical personnel to upload, view, and score data related to a sleep study and provide output reports to a physician.

The use of this software is to be under the supervision of a physician, sleep technologies, or clinician.

Device Description

ApneiCare Connection Center / Internet Analysis is composed of two components: The Connection Center and the Internet Analysis Application. The ApneiCare Connection Center and the ApneiCare Internet Analysis Application function in a client server relationship.

The purpose of ApneiCare Connection Center is to download stored data from supported devices that are typically used to evaluate sleep and sleep related respiratory disorders. It allows users to export sleep data, and interact with the ApneiCare Internet Analysis to run analysis reports on sleep studies.

ApneiCare Connection Center will operate under Windows XP and Windows Vista; but more importantly is built on Microsoft .NET Framework. The ApneiCare applications have been designed on Microsoft .NET Framework to take advantage of the latest laver of abstraction to allow for Operating System changes in the future while lowering the probability of the application being negatively impacted by operating system changes. "ApneiCare Connection Center is responsible for binding patient information to the study and downloading the data off of the source device. The ApneiCare Connection Center is a small program on the PC with functionality limited to that of general purpose data entry, storage and communication, it performs no data manipulation functions. The data is then communicated to ApneiCare Internet Analysis via an Internet connection, where the sleep analysis and reporting is performed. The ApneiCare Connection Center has built in features to insure that required patient information is entered and that internet connectivity is available. All Internet activity is encrypted and secure. Each transaction between ApneiCare Connection Center and ApneiCare Internet Analysis is conducted over at least 128-bit HTTPS using private and public encryption.

Saved tests can be converted into ASCII format for importing to spreadsheets or databases. The patient information consists of the patient name and address, an ID number, patient insurance and other relevant information. The ApneiCare Internet Analysis Application provides information pertaining to the waveform patterns, such as those of the SpO2 and pulse recording, to aid physicians with the diagnosis of sleep and breathing disorders. Individual desaturation and respiratory events in series (cycles) are scored by algorithm. These patterns are identified using DPAR objects. In addition, to the Internet Analysis the ApneiCare Internet Analysis DPAR Case Viewer application module may also be used to manually score events and visually compare and analyze across multiple channels of data.

The ApneiCare Internet Analysis Application is primarily a mathematical data processing function that reports cycling respiratory events across multiple channels of data. The functionality of the ApneiCare Internet Analysis Application is not time critical or real time. Therefore delays in internet transfer do not impact functionality. The ApneiCare Internet Analysis Application also performs a data management functions which allows the various authorized users of the system to access, view, report and analyze individual cases. The ApneiCare Connection Center is compiled for .NET 2.0, and dependent upon the .NET Framework as the OTS. .NET 2.0 is provided by Microsoft and contains the CLR (Common Language Runtime) which has abstracted ApneiCare Connection Center away from specific Microsoft Windows Operating System Versions. The ApneiCare Internet Analysis application is a server application, runs on Windows Server 2008 and SQL Server 2005, and .NET 3.5, it is managed in a centralized location by ApneiCare.

AI/ML Overview

The provided text describes the ApneiCare Connection Center / Internet Analysis, a polysomnography scoring software, and its FDA 510(k) clearance (K082968). However, it lacks granular details regarding the specific acceptance criteria and the empirical study results for device performance. The information provided is primarily focused on the device description, indications for use, and its substantial equivalence determination to predicate devices.

Based on the provided text, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or provide a table of performance metrics. Instead, it states a qualitative performance criterion:

Attribute	Acceptance Criteria (Stated)	Reported Device Performance (Implied)
Performance	Comparative testing demonstrate equivalence to the predicate	The FDA determined the device is substantially equivalent to predicate devices (Vitascore K072014 and ProFox Software K001708). "There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate device."

Missing Information: Specific quantitative performance metrics (e.g., sensitivity, specificity, agreement rates with predicate devices or ground truth) are not provided. The study that "demonstrates equivalence" is not described in detail.

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

The document does not provide any details about the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). It only mentions "comparative testing."

Missing Information: The number of sleep studies or patients included in the comparative testing is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not provide any details about the number or qualifications of experts used to establish ground truth for the test set. It mentions the "ApneiCare Internet Analysis DPAR Case Viewer application module may also be used to manually score events," implying manual scoring is a component, but does not elaborate on how this was used for validation.

Missing Information: No information is given about who performed the "ground truth" scoring for the comparative testing, nor their credentials.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for the test set.

Missing Information: Details regarding how discrepancies in manual scoring (if any were performed for ground truth) were resolved are not present.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size related to human readers improving with or without AI assistance. The device is described as "Polysomnography Scoring Software" and "a mathematical data processing function that reports cycling respiratory events," with semi-automatic and manual rescoring capabilities, but not specifically an AI-assisted interpretation tool in the context of improving human reader performance.

Missing Information: No MRMC study was described.

6. Standalone Performance Study

The document implies a standalone performance (algorithm only) comparison through "comparative testing demonstrate equivalence to the predicate." The statement, "Individual desaturation and respiratory events in series (cycles) are scored by algorithm," suggests the algorithm has standalone scoring capabilities that were validated against the predicate devices. However, specific standalone performance metrics are not reported.

Missing Information: While implied that the algorithm scores events independently, precise standalone performance metrics (e.g., sensitivity, specificity, accuracy) are not quantified in the provided text.

7. Type of Ground Truth Used

The document indicates that the device's performance was evaluated by "demonstrat[ing] equivalence to the predicate." Therefore, the implied ground truth was the scoring or outputs of the predicate devices: Vitascore K072014 and ProFox Software K001708.

Missing Information: The specific methodology of how "equivalence" was established (e.g., direct comparison of event counts, epoch-by-epoch agreement) is not detailed. It's unclear if "expert consensus" or "pathology/outcomes data" were directly used as an independent gold standard, or if the outputs of the predicate devices served as the de facto reference.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set. The text focuses on the device's functionality and its substantial equivalence, not on the development process, training data, or model architecture.

Missing Information: The size of the dataset used to train the "algorithm" for scoring events is not mentioned.

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

The document does not provide any information on how the ground truth for the training set was established.

Missing Information: Details on the methods and expertise used to generate ground truth labels for the training data are absent.

Summary of what's provided vs. missing:

The document primarily serves as a 510(k) summary, emphasizing the device's function, indications, and substantial equivalence to existing predicate devices. It lacks the detailed empirical evidence typically expected for a scientific study proving performance against explicit acceptance criteria. The "comparative testing" is mentioned as the basis for performance claims, but the specifics of this study (sample size, methodology, detailed results, ground truth establishment) are not disclosed in this summary.

Summary

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K082968

Non-Confidential Summary of Safety and Effectiveness

Page 1 of 4 30-Dec-2008

JAN - 2 2009

Company

ApneiCare, LLC PO Box 418 Worthington, OH 43085

Official Contact:

ApneiCare, LLC Craig Pickerill, Vice President craig@apneicare.com P 614-774-6003

Proprietary or Trade Name:

ApneiCare Connection Center / Internet Analysis

Common/Usual Name:

Polysomnography Scoring Software

Classification Information:

Regulation Number: 21 CFR 868.2375 Regulation Name: Ventilatory Effort Recorder Regulatory Class: Class II Product Code: MNR

Device: ApneiCare Connection Center / Internet Analysis

Predicate Devices: Vitascore BV - Vitascore - 510(k) K072014 Respironics - ProFox Software - 510(k) K001708

Device Description:

The purpose of ApneiCare Connection Center is to download stored data from supported devices that are typically used to evaluate sleep and sleep related respiratory disorders. It allows users to

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Non-Confidential Summary of Safety and Effectiveness Page 2 of 4 30-Dec-2008

export sleep data, and interact with the ApneiCare Internet Analysis to run analysis reports on sleep studies.

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Non-Confidential Summary of Safety and Effectiveness Page 3 of 4 30-Dec-2008

Indications for Use:

The use of this software is to be under the supervision of a physician, sleep technologies, or clinician.

Attributes
Intended useGeneral	ApneiCare Connection Center/Internet Analysis is intended tobe used as an aid in the diagnosis of sleep and respiratoryrelated sleep disorders. The ApneiCare Connection Centerand ApneiCare Internet Analysis Application is intended to beused as an information and decision management tool toimport/record and transmit/transfer data typically captured toevaluate sleep and respiratory related sleep disorders.
Intended useSpecific	ApneiCare Connection Center/Internet Analysis is intended tobe used as an aid in the diagnosis of sleep and respiratoryrelated sleep disorders. The ApneiCare Connection Centerand ApneiCare Internet Analysis Application is intended to beused as an information and decision management tool toimport/record and transmit/transfer data typically captured toevaluate sleep and respiratory related sleep disorders.
Environments of use	home care, nursing home, sub-acute institutions, sleep clinicsor hospitals
Patient Population	All individuals
Contraindications	None
Prescription	Prescription
Materials	None in patient contact
Performance	Comparative testing demonstrate equivalence to the predciate

Device Attributes:

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Non-Confidential Summary of Safety and Effectiveness Page 4 of 4 30-Dec-2008

Differences Between Other Legally Marketed Predicate Devices

The is viewed as substantially equivalent to the following predicate devices - Vitascore K072014 ProFox Software K001708.

There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ApneiCare, LLC C/O Mr. Paul E. Dryden President ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134-2958

. .

Re: K082968

Trade/Device Name: ApneiCare Connection Center/Internet Analysis Regulation Number: 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: October 2, 2008 Received: October 6, 2008

IAN - 2 2009

Dear Mr. Dryden:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the 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 Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Dryden

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Clas

Chiu S. Lin, Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number:

K082968

Device Name:

ApneiCare Connection Center / Internet Analysis

Indications for Use:

ApneiCare Connection Center/Internet Analysis itself is not a diagnostic tool. It is an . information and decision management tool which allows medical personnel to upload, view, and score data related to a sleep study and provide output reports to a physician. The use of this software is to be under the supervision of a physician, sleep technologies, or clinician.

Prescription Use XX (Part 21 CFR 801 Subpart D) or

Over-the-counter use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K082968

Regulation Number and Section

§ 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).