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The CCS-200 Spirometer is intended for prescription use only to conduct diagnostic spirometry testing of adults and pediatric patients who are at least 16 years old, in general practice, specialty physician, industrial, and hospital settings.

The CCS-200 Spirometer System consists of Microsoft Windows based personal computer (PC) software (BUL) and the CCS-200 flow sensing instrument. The BUL software is installed on a desktop or laptop PC to which the CCS-200 flow sensing instrument is connected.

In order to conduct spirometry testing the CCS-200 flow sensing instrument is used in combination with a single-use disposable airway tube with integrated mouthpiece (U-tube).

The flow sensing instrument measures transit time of ultrasound pulses through the air in the U-tube to determine flow velocity and volume. The collected data are transferred to the PC for pulmonary function evaluation and data management. The results of the testing are stored in a database. Reports can be displayed or printed.

Here's a breakdown of the acceptance criteria and the study details for the CCS-200 Spirometer, based on the provided text:

Acceptance Criteria and Device Performance

The core acceptance criteria are based on the American Thoracic Society (ATS) recommendations for accuracy and precision in diagnostic spirometry.

Study Information

1. Sample size used for the test set and the data provenance:

• Test set for dynamic wave-form testing: Not explicitly stated how many waveforms were used, but it involved performing standardized waveforms (FVC, FEV1, FEF25-75, PEF) using a mechanical flow-volume simulator (FVS). Data provenance is from mechanical simulation, not human subjects for this part.
• Test set for human testing: Not explicitly stated how many human subjects participated. The text mentions "human testing" as a comparison, implying prospective data collection during the study. Country of origin is not specified.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as the ground truth for the primary performance test (dynamic waveform testing) was established by the standardized values provided in the ATS 1994 guidelines, simulating known physiological conditions. For human testing, the "ground truth" would be the physiological output of the humans, measured by both devices for comparison. It does not mention expert consensus for ground truth on this.

3. Adjudication method for the test set:

• Not applicable in the traditional sense. For dynamic waveform testing, the device's output was directly compared to the ATS-defined standard values. For human testing, the CCS-200 results were compared against a predicate device, and both were expected to be within ATS acceptance criteria (implying a comparison to a known standard, not an adjudication between multiple expert opinions).

4. 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 a diagnostic spirometer, not an AI-powered image analysis tool or a system designed to assist human readers (e.g., radiologists). No MRMC study was mentioned or relevant to this type of device.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Yes, the primary performance evaluation was a standalone test. The "Dynamic wave-form testing" using a mechanical flow-volume simulator directly assessed the device's ability to measure spirometry parameters according to ATS standards, without human interpretation in the loop influencing the measurement itself. The software verification and validation also represent standalone algorithm testing.

6. The type of ground truth used:

• For dynamic wave-form testing: Standardized values defined by the American Thoracic Society (ATS) 1994 guidelines. These are established, recognized benchmarks for spirometry performance.
• For biocompatibility: ISO 10993 standard requirements.
• For electrical safety and EMC: IEC 60601 standards.

7. The sample size for the training set:

• Not applicable. This is a medical device for direct measurement, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its "training" or calibration would be part of its manufacturing process and verified by the described bench testing.

8. How the ground truth for the training set was established:

• Not applicable for the same reasons as above.

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The CCA-220 Audiometer is an air-conduction audiometer designed to provide automatic hearing testing. A series of tones is presented by the CCA-220 through a Telephonics TDH-39 headset. The test subject then presses a hand switch to indicate to the CCA-200 that the tone has been heard. The CCA-220 proceeds with the hearing testing, and records the subject's responses. The resultant test data are available to print on an integral printer or to store in the CCA-220's hard drive.

The CCA-220 has an integral computer which provides all of the capabilities of the instrument. The instrument's display panel shows the setup and control screens that are used to perform. the test functions. The instrument is based on an integral PC compatible computer with a Pentitura processor, running the operating system of Microsoft Windows 95. Control of the CCA-220 is handled by selecting the desired test elements on the touch screen monitor. The instrument also incorporates an internal printer for printing test results. The CCA-220 has a range of options for both computer interfacing and automatic testing, such as error detection and multilingual voice instruction. These options are selected using the setup screen on the touch-screen monitor.

The provided text is a 510(k) premarket notification letter and the "Indications for Use" statement for the CCA-220 Audiometer. It describes the device's function and intended use but does not contain any information about acceptance criteria, study details, or performance metrics.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval and the device's general capabilities, not on clinical performance studies or specific acceptance criteria.

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The CCA-200 Computer Controlled Audiometer is an air conduction audiometer designed to provide automatic hearing testing. A series of tones is presented by the CCA-200 through a TDH-39 headset to the test subject. The test subject then presses a hand switch to indicate Lo the CCA-200 that the tone bas been heard. The CCA-200 proceeds with the hearing test using the Modified Hughson-Westlake method of hearing testing, and records the subject's responses, The resultant data are available to print on an external printer connected to the control computer or to store in the computer.

The CCA-200 can perform its function only on command from a control computer. The computer monitor displays the setup and control screens that are used to perform the Lest functions. An IRM compatible computer with a 486DX2-50 or proceessor, running Windows 95 or Windows NT, is required. Control of the CCA-200 is handled through the RS232 serial port. The computer is not included with the CCA-200.

The CCA-200 is designed for use in test environments where multiple automatic hearing tests are controlled from a single computer. The CCA-200 has a range of options for both computer interfacing and automatic testing, such as multilingual voice instructions. These options are selected using a setup screen on the computer.

The CCA-200 Computer Controlled Audiometer is an air conduction audiometer designed to provide automatic hearing testing. A series of tones is presented by the CCA-200 through a TDH-39 headset to the test subject. The test subject then presses a hand switch to indicate Lo the CCA-200 that the tone bas been heard. The CCA-200 proceeds with the hearing test using the Modified Hughson-Westlake method of hearing testing, and records the subject's responses, The resultant data are available to print on an external printer connected to the control computer or to store in the computer.

The CCA-200 can perform its function only on command from a control computer. The computer monitor displays the setup and control screens that are used to perform the Lest functions. An IRM compatible computer with a 486DX2-50 or proceessor, running Windows 95 or Windows NT, is required. Control of the CCA-200 is handled through the RS232 serial port. The computer is not included with the CCA-200.

The CCA-200 is designed for use in test environments where multiple automatic hearing tests are controlled from a single computer. The CCA-200 has a range of options for both computer interfacing and automatic testing, such as multilingual voice instructions. These options are selected using a setup screen on the computer.

I'm facing a few limitations that prevent me from fully addressing your request:

1. Missing Study Information: The provided documents (FDA Premarket Notification and Indications for Use) are regulatory filings. They confirm the device's substantial equivalence to a predicate device but do not contain the detailed study information you're asking for, such as acceptance criteria, reported performance, sample sizes for test and training sets, expert qualifications, adjudication methods, or MRMC study results. This type of information is typically found in a separate clinical study report or a more comprehensive technical submission, neither of which is present here.

2. Nature of the Device (CCA-200 Audiometer): The CCA-200 is a "Computer Controlled Audiometer" designed for "automatic hearing testing" using the "Modified Hughson-Westlake method." This device is a measurement tool that automates a standard clinical procedure. Its performance is primarily assessed by its accuracy and reliability in measuring hearing thresholds, not by its ability to provide a diagnostic interpretation or assist a human in making a diagnosis in the same way an AI-powered diagnostic tool would.

Given these limitations, I cannot extract the specific details you've requested regarding acceptance criteria and the study proving device performance because that information simply isn't in the provided text.

Specifically:

• Acceptance Criteria and Reported Device Performance: This document does not specify quantitative acceptance criteria or report on device performance metrics (e.g., sensitivity, specificity, accuracy) from a study against such criteria. The FDA letter primarily confirms substantial equivalence to a legally marketed predicate.
• Sample Size for Test Set and Data Provenance: No information about a test set, its sample size, or data provenance is available.
• Number of Experts and Qualifications: The concept of "experts establishing ground truth" as it applies to AI/diagnostic imaging is not relevant here, as this is an automated audiometer.
• Adjudication Method: Not applicable for this type of device and the information provided.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. An audiometer automates a test; it doesn't "assist" a human in interpreting an image or making a diagnosis in the way MRMC studies usually evaluate.
• Standalone Performance: While the device operates standalone in terms of conducting the test, the FDA letter confirms substantial equivalence, implying its performance is comparable to existing audiometers. There isn't a detailed "standalone performance study" report in these documents.
• Type of Ground Truth Used: For an audiometer, the "ground truth" would implicitly be the actual hearing threshold of an individual, established through a gold standard measurement or a consensus of multiple audiologists. This document doesn't detail how this was established for any validation.
• Sample Size for Training Set & How Ground Truth was Established for Training Set: Since this is an audiometer automating a standard protocol, it's not an AI model that "learns" from a training set in the conventional sense. Its "training" would be its programming to accurately implement the Modified Hughson-Westlake method.

In summary, the provided FDA communication and indications for use describe regulatory clearance and the intended use of a medical device (an audiometer), but they do not contain the details of a performance study with acceptance criteria as one would find for a modern AI/diagnostic device.

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