(273 days)
The Model 7100 is a non-invasive battery operated device intended to acquire, record and store ambulatory cough sounds from patients for up to 24 hours. The device stores the data on a removable memory card for later playback, review, and analysis on a windows based PC.
The Model 7100 is a non-invasive battery operated device intended to acquire, record and store ambulatory cough sounds from patients for up to 24 hours. The device stores the data on a removable memory card for later playback, review, and analysis of the cough sounds on a windows based PC.
The recording of respiratory sounds to a sound file over the two channels for up to 24 hours is achieved by:
a) The contact sensor channel, which records the data for later analysis.
b) An air microphone channel. This is used to monitor and to ascertain the validity of the data obtained in the channel described in (a.) above. This can be achieved by listening, or otherwise determining, signals such as speech and other noises that will be ignored when examining channel (a) data.
These two individual analogue signals are electronically conditioned and then digitally sampled. The sampled information data is then stored to a suitable internal memory module. The data will be transferred to the PC by removing the memory card from the VitaloJAK.
The provided document, K110525 for the Vitalograph Model 7100 VitaloJAK, is a 510(k) summary for a medical device. As such, it describes the device's intended use and technological characteristics, and compares it to a predicate device to establish substantial equivalence. However, it does not contain the detailed study results, acceptance criteria, or performance metrics that would typically be presented in a dedicated clinical validation or performance study report.
The document states: "Safety and effectiveness have been assured through the extensive testing in relation to IEC 60601 standards for electrical safety and EMC/EMI, as well as device specific performance testing. ... As with the predicate device the Vitalograph Model 7100 underwent validation testing to ensure performance according to its specifications. All tests demonstrated satisfactory results. Evidence of successful validation has been provided with this submission." This indicates that such testing was performed and submitted to the FDA, but the details are not included in this publicly available summary.
Therefore, many of the requested details cannot be extracted from the provided text. Below is an attempt to address the points based only on the available information, with explicit statements where information is missing.
Acceptance Criteria and Device Performance Study for Vitalograph Model 7100 VitaloJAK
The provided 510(k) summary for the Vitalograph Model 7100 VitaloJAK does not explicitly state quantitative acceptance criteria or detailed device performance results in a comparative table format. Instead, it attests that "All tests demonstrated satisfactory results" and that "Evidence of successful validation has been provided with this submission." The focus of this 510(k) summary is on comparing the device's characteristics to a predicate device to establish substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Device Functionality | The device should accurately acquire, record, and store ambulatory cough sounds from patients for up to 24 hours via its two channels (contact sensor and air microphone). Data should be transferable to a PC for playback, review, and analysis. | "The Model 7100 is a non-invasive battery operated device intended to acquire, record and store ambulatory cough sounds from patients for up to 24 hours. The device stores the data on a removable memory card for later playback, review, and analysis of the cough sounds on a windows based PC." |
| "The recording of respiratory sounds to a sound file over the two channels for up to 24 hours is achieved by: a) The contact sensor channel... b) An air microphone channel." | ||
| "All tests demonstrated satisfactory results." | ||
| Safety and Effectiveness | Compliance with IEC 60601 standards for electrical safety and EMC/EMI. Device specific performance testing to ensure performance according to specifications. | "Safety and effectiveness have been assured through the extensive testing in relation to IEC 60601 standards for electrical safety and EMC/EMI, as well as device specific performance testing." |
| "All tests demonstrated satisfactory results." | ||
| Comparison to Predicate Device | The device's technological characteristics and performance should be similar to the predicate device (Karmelsonix Pulmotrack 5050 Wholter) without raising new questions of safety or effectiveness, specifically in its non-diagnostic function of data acquisition, recording, and storage. | "The characteristics of the Model 7100 is similar to those of the predicate device listed." |
| "As with the predicate device the Vitalograph Model 7100 does not perform diagnosis." | ||
| Accuracy of Cough Sound Recording | Explicit quantitative acceptance criteria for the accuracy of cough sound acquisition and recording are not provided in this summary. This would typically involve metrics such as signal-to-noise ratio, fidelity of sound capture, or consistency of recording over time. | The summary extensively describes the technical characteristics for recording, including two separate channels (contact sensor and ambient microphone) and digital sampling. It states, "The air microphone channel is used to monitor and to ascertain the validity of the data obtained in the channel described in (a.) above." This suggests an internal validation mechanism, but no quantitative results are given. |
| "All tests demonstrated satisfactory results." |
2. Sample Size and Data Provenance for the Test Set
- Sample Size for Test Set: This information is not provided in the 510(k) summary.
- Data Provenance (country of origin, retrospective/prospective): This information is not provided in the 510(k) summary. The document focuses on the technical characteristics and regulatory compliance, not on clinical study data.
3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)
- This information is not provided in the 510(k) summary. Since the device itself is not diagnostic and "The user identifies each incident of coughing," the role of experts in establishing a ground truth for device performance (beyond general technical specifications) is not detailed. If a study involved expert review of the recorded data, it is not mentioned here.
4. Adjudication Method for the Test Set
- This information is not provided in the 510(k) summary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No evidence of an MRMC comparative effectiveness study is presented in this 510(k) summary. The device is explicitly stated to not perform diagnosis and requires a user to identify cough incidents. Therefore, a study comparing human readers with and without AI assistance would not be applicable to this device's stated function.
6. Standalone Performance Study (Algorithm Only)
- A standalone performance study (algorithm only) was not performed or is not detailed in this 510(k) summary for automated cough detection or analysis. The device's stated function is solely to "acquire, record and store ambulatory cough sounds," and for "later playback, review, and analysis of the cough sounds on a windows based PC" where "The user identifies each incident of coughing." The device itself does not contain an algorithm for automatic cough identification or diagnosis.
7. Type of Ground Truth Used
- The 510(k) summary does not mention a specific type of ground truth used to evaluate the device's core function of recording. The "validity of the data obtained" (from the contact sensor) is stated to be ascertained by the air microphone channel, but this refers to technical signal validity rather than a clinical ground truth for cough events. For the analysis phase, where the user identifies coughs, the ground truth would implicitly be human expert identification, but this is a post-recording step leveraging the user, not an automated function of the device that requires an inherent ground truth during device operation.
8. Sample Size for the Training Set
- This information is not applicable and not provided. The device is a data recorder, not an AI-driven diagnostic or analytical tool that requires a training set (in the machine learning sense). Its functionality is based on hardware and firmware for signal acquisition and storage.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable and not provided. As mentioned above, the device does not use a training set in the machine learning context.
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).