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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.

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.

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:

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.

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